Access to

Essential Medicines in Kenya

  

       

                

A Health  Facility  Survey  

Republic of Kenya

Ministry of Public Health and Sanitation

Ministry of Medical Services

Access to Essential Medicines in KenyaA Health Facility Survey

Published by the Ministry of Medical Services and Ministry of Public Health & Sanitationwww.health.go.ke

December 2009

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Users of this publication are encouraged to send any comments and queries to the followingaddress from which additional copies may be obtained:

The Chief PharmacistMinistry of Medical Services

Afya House, PO Box 30016 GPO, Nairobi 00100Email: chiefpharm@health.go.ke

This document was produced with the support of the World Health Organization (WHO) Kenya CountryOffice, and all reasonable precautions have been taken to verify the information contained herein.The published material does not imply the expression of any opinion whatsoever on the part of the

World Health Organization, and is being distributed without any warranty of any kind – eitherexpressed or implied. The responsibility for interpretation and use of the material lies with the reader.

In no event shall the World Health Organization be liable for damages arising from its use.

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Table of Contents

LIST OF TABLES............................................................................................................................ IIILIST OF FIGURES .......................................................................................................................... IIIABBREVIATIONS AND ACRONYMS...............................................................................................IVFOREWORD..................................................................................................................................VACKNOWLEDGEMENTS................................................................................................................VIEXECUTIVE SUMMARY ................................................................................................................. 11. INTRODUCTION ........................................................................................................................ 5

1.1 BACKGROUND ............................................................................................................................................. 51.2 IMPLEMENTATION OF THE SURVEY .................................................................................................................. 71.3 OBJECTIVES................................................................................................................................................. 7

2. COUNTRY BACKGROUND.......................................................................................................... 8

2.1 HEALTH SECTOR........................................................................................................................................... 9

2.1.1 Health status and indicators ...................................................................................................................................... 92.1.2 Health policy and strategic planning ....................................................................................................................... 102.1.3 Health system structure, status and challenges ...................................................................................................... 102.1.4 Health partnership and coordination ...................................................................................................................... 11

2.2 PHARMACEUTICAL SECTOR........................................................................................................................... 11

2.2.1 National Pharmaceutical Policy ............................................................................................................................... 122.2.2 Regulatory system ................................................................................................................................................... 122.2.3 Medicines supply system......................................................................................................................................... 132.2.4 Medicines financing................................................................................................................................................. 142.2.5 Rational use of medicines........................................................................................................................................ 15

3. STUDY DESIGN ANDMETHODS............................................................................................... 16

3.1 SAMPLING ................................................................................................................................................ 16

3.1.1 Sectors surveyed...................................................................................................................................................... 163.1.2 Sampling of regions (provinces)............................................................................................................................... 163.1.3 Sampling of districts ................................................................................................................................................ 163.1.4 Sampling of facilities ................................................................................................................................................ 173.1.4 Selection of patients ................................................................................................................................................ 173.1.5 Selection of prescriptions ........................................................................................................................................ 173.1.6 Selection of medicines to survey ............................................................................................................................. 17

3.2 DATA COLLECTION ..................................................................................................................................... 17

3.2.1 Organization of data collection................................................................................................................................ 173.2.2 Adaptation of tools .................................................................................................................................................. 183.2.3 Selection and training of data collectors ................................................................................................................. 183.2.4 Data Collection......................................................................................................................................................... 18

3.3 DATA ENTRY AND ANALYSIS.......................................................................................................................... 183.4MONITORINGOFMEDICINE PRICES AND AVAILABILITY (MMEPA)........................................................ 193.5 LIMITATIONS OF THE DATA........................................................................................................................... 19

4. RESULTS AND DISCUSSION ..................................................................................................... 20

4.1 DEFINITION OF TERMS AND CONCEPTS........................................................................................................... 20

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4.2 AVAILABILITY............................................................................................................................................. 214.3 PRICING AND AFFORDABILITY ....................................................................................................................... 264.4 GEOGRAPHICAL ACCESSIBILITY ...................................................................................................................... 324.5 MEDICINES QUALITY RELATED FACTORS ......................................................................................................... 334.6 RATIONAL USE OF MEDICINES....................................................................................................................... 354.7 HEALTH PROFESSIONALS PROFILES ....................................................................................................... 42

5. SUMMARY OF RESULTS .......................................................................................................... 466. DISCUSSION............................................................................................................................ 487. CONCLUSIONS ........................................................................................................................ 518. RECOMMENDATIONS ............................................................................................................. 52ANNEXES.................................................................................................................................... 54

ANNEX 1: SUMMARY LIST OF INDICATORS AND CORRESPONDING SURVEY FORMS USED FOR DATA COLLECTION .............. 56ANNEX 2: LEVEL II SURVEY FORMS ..................................................................................................................... 57ANNEX 3: CHARACTERISTICS OF OUTPATIENTS INTERVIEWED................................................................................... 72ANNEX 4: LIST OF DATA COLLECTORS .................................................................................................................. 73ANNEX 5: LIST OF SAMPLED HEALTH FACILITIES ................................................................................................... 74ANNEX 6: BASIC (CORE)MEDICINES LIST (COUNTRY LIST) .................................................................................... 77ANNEX 7: MMEPAMEDICINES LIST ............................................................................................................... 77

REFERENCES ............................................................................................................................... 78GLOSSARY .................................................................................................................................. 79

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LIST OF TABLES

Table 1: Kenya Economic & Health Indicators ..............................................................................9Table 2: Key Pharmaceutical Sub sector Indicators ................................................................... 11Table 3: List of Sampled Districts ............................................................................................... 16Table 4: Summary of Availability Indicators for 15 Basic Medicines ......................................... 21Table 5: Median availability of medicines (MMePA list)............................................................ 22Table 6: Percentage of prescribed medicines actually dispensed ............................................. 23Table 7: Medicines stock out duration in health facilities ......................................................... 24Table 8: Adequacy of Stock Records .......................................................................................... 25Table 9: Median Procurement Price Ratios (compared with IRPs) ............................................ 26Table 10: Free of charge medicines: public, FBHS and private facilities.................................... 27Table 11: Patient prices: ratio of median prices to IRP: public, FBHS & private sectors ........... 27Table 12: Median patient to procurement price ratios ............................................................. 28Table 13: Median MPRs for 14 medicines found in public, FBHS and private sectors .............. 28Table 14: Average Out Patient Medicines Costs........................................................................ 29Table 15: Affordability of selected standard treatments........................................................... 31Table 16: Geographical Access Transport Costs....................................................................... 32Table 17: Percent of Expired Medicines..................................................................................... 33Table 18: General Indicators for Rational Use of Medicines (by sector) ................................... 35Table 19: Adherence of prescribers to recommended treatment guidelines ........................... 39Table 20: Dispensing Indicators.................................................................................................. 40Table 21: Dispenser profile and compliance with the law......................................................... 43Table 22: Prescriber Profile ........................................................................................................ 44

LIST OF FIGURES

Figure 1: Core indicators used to monitor and assess ..................................................................6Figure 2: Map of Kenya..................................................................................................................8Figure 3: Health Sector Pyramid................................................................................................. 10Figure 4: Median Availability of Essential Medicines (country list) ........................................... 22Figure 5: Range of the % of prescribed medicines actually dispensed or administered ........... 23Figure 6: Average stock out duration of medicines in health facilities (range of days) ............ 25Figure 7: Affordability of adult and child pneumonia treatment (in days’ wages).................... 30Figure 8: Affordability of treatments: Adult diabetes, child asthma ......................................... 30Figure 9: Percentage of patients taking >1 hour to travel to a dispensing facility .................... 32Figure 10: Adequacy of medicines storage conditions .............................................................. 34Figure 11: Prescribing of antibiotics, injections, medicines on the EML and by INN................. 35Figure 12: Adequacy of labeling and patient knowledge........................................................... 40Figure 13: Percentage of prescription medicines bought without a prescription ..................... 42Figure 14: Dispenser Profile and Facilities Compliance with National Laws.............................. 44Figure 15: Prescriber Profile ....................................................................................................... 45

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ABBREVIATIONS AND ACRONYMS

AL Artemether/lumefantrineARI Acute Respiratory InfectionEML Essential Medicines ListDH District HospitalDisp DispensaryFBHS Faith Based Health ServicesFBO Faith Based OrganisationsGDP Gross Domestic ProductHAI Health Action InternationalHC Health CentreHDI Human Development IndexHFS Health Services SurveyHH HouseholdInd IndicatorInj InjectionIRP International Reference PriceKEPH Kenya Essential Package for HealthKES Kenya ShillingsKMPDB Kenya Medical Practitioners and Dentists BoardML WHOModel List of Essential MedicinesMMePA Monitoring of Medicine Prices and AvailabilityMOMS Ministry of Medical ServicesMSH Management Sciences for HealthNHIF National Health Insurance FundNMP National Medicines PolicyPGH Provincial General HospitalPSA Pharmaceutical Situation AssessmentRUM Rational Use of MedicinesSD Standard DeviationSDH Sub District HospitalSTG Standard Treatment GuidelinesUSD United States dollars (also $)WHO World Health Organization%ile Percentile

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FOREWORD

The stated goal of the revised Kenya National Pharmaceutical Policy (KNPP) is UniversalAccess to quality pharmaceutical services, Essential Medicines, essential health technologiesin Kenya. This national goal resonates with MDG8 Target E: in collaboration with thepharmaceutical industry, ensure access to affordable essential medicines in a sustainablemanner. The attainment of this MDG target would also contribute to the attainment of MDG4, 5 and 6, i.e. improving child health, maternal health, as well as control of HIV/AIDS, TB,Malaria and other diseases. Access encompasses the availability of Essential Medicines, theiraffordability, storage, record keeping, prescribing, dispensing and the personnel concerned –all with reference to national laws, established norms and standards.

Because the pharmaceutical sector is complex and multi faceted, several cross cutting factorsinfluence access to Essential Medicines. Therefore, regular monitoring and evaluation iscritical in determining the extent to which existing policies, strategies and interventions areimpacting on access. Pharmaceutical services in Kenya are provided in the context of theKNPP, the National Health Sector Strategic Plan (NHSSP II) and the strategic plans of theMinistries of Medical Services and Public Health and Sanitation. Pharmaceutical situationassessments are thus a core element of health sector M&E; and a key source of evidence forpolicy development and strategic planning.

This health facility survey is a timely addition to the body of evidence on the goal of NHSSP II:reversing the declining trends in key health sector indicators. The findings andrecommendations provide valuable insights into the status of access to Essential Medicines inKenya, and the factors positively or adversely influencing access. The information is expectedto facilitate evidence based planning, thus contributing to better integration ofpharmaceuticals within the health sector strategic and coordinating frameworks.Consequently, the evidence will be used as a platform for developing a PharmaceuticalStrategy to guide coordinated investment and resource allocation towards achievinguniversal access to Essential Medicines in Kenya.

This assessment was greatly facilitated by the existence of a comprehensive package of toolsdeveloped by WHO, which were subsequently adapted to the health sector in Kenya. It isexpected that standardized pharmaceutical situation assessments will be integrated into thehealth sector M&E framework, in order to inform evidence based investment (financial,infrastructure and human resources) that is aligned towards impacting outcomes across theentire spectrum of pharmaceutical services within the KEPH.

We strongly encourage all health stakeholders to make the best use of this report in theirhealth planning and monitoring activities. The information will be particularly useful toGovernment institutions and departments, health development and implementing partners,training and research institutions as well as other national and international stakeholders.We also welcome feedback and any suggestions towards improvement of future assessments.

Dr Francis M Kimani Dr S Sharif MBS, MBchB, MMed DLSHPM, MScDirector of Medical Services Director of Public Health & Sanitation

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ACKNOWLEDGEMENTS

The 2008 Pharmaceutical Situation Assessment was conducted by the Ministries of MedicalServices and Public Health and Sanitation, facilitated through the office of the ChiefPharmacist. This was the second such assessment after the baseline survey of 2003. Theexercise culminated in the production of two reports on Access to Essential Medicines inKenya – this health facility survey, and a separate household survey. The study would nothave been possible without the cooperation of the Provincial Medical Officers in all sixprovinces where the study was carried out. The Ministries also appreciate the support,cooperation and information provided by the public health facilities, the Faith Based HealthServices (FBHS) and the private pharmacies surveyed. Special thanks go to all thedepartments/sections of the Ministries, the health personnel and the patients who willinglyprovided the information analyzed in this report.

Special gratitude is extended to all those who participated in the data collection and dataentry (see Annex 4) and to the following members of the Advisory Group, for their invaluableinputs into the study design, sampling and analysis:

Fred Siyoi Deputy Chief Pharmacist/Deputy Registrar, MOMS

Ahmed Mohammed Deputy Registrar, Pharmacy and Poisons Board

Njeri Mucheru Deputy Chief Pharmacist, Division of Pharmaceutical Policy, MOMS

Christa Cepuch Programme Director, Health Action International (HAI Africa)

Joan Wakori Regional Liaison Officer, Kenya Medical Supplies Agency (KEMSA)

Jennifer Orwa Chairperson, INRUD/Kenya

Jane Masiga Head of Operations, Mission for Essential Drugs and Supplies (MEDS)

Regina Mbindyo National Medicines Adviser, World Health Organization Kenya

Martin Auton Consultant, HAI Africa

This facility survey was conducted with financial support through the World HealthOrganization (WHO) from the UK Department for International Development (DFID) projecton Access to Essential Medicines; and the European Commission’s EC/ACP/WHO Partnershipon Pharmaceutical Policies. The World Health Organization provided technical support for thesurvey in collaboration with HAI Africa, in the context of the DFID supported WHO/HAICollaboration project on Access to Essential Medicines. This assistance is gratefullyacknowledged.

Special gratitude is extended to Njeri Mucheru (MOMS), Joan Wakori (KEMSA), ChristaCepuch (HAI Africa) and Regina Mbindyo (WHO), for their tireless efforts in the data analysisand compilation of the report; and to Chris Forshaw who assisted with report editing andformatting.

DR KIPKERICH KOSKEIChief Pharmacist/Registrar, Ministry of Medical Services

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EXECUTIVE SUMMARY

BACKGROUNDThis survey on Access to Essential Medicines in Kenya was undertaken as part of the WHOLevel II Pharmaceutical Situation Assessment (PSA) for Kenya. This is a standardized surveythat aims to provide systematic data on access to essential medicines, from the perspectivesof the healthcare system (Health Facility Survey) and of households (Household Survey). Ahousehold survey was undertaken concurrently and is published as a separate report.Together, these reports comprise the second Pharmaceutical Situation Assessment in Kenya,providing updated data from an earlier baseline survey undertaken in 2003. This reportdocuments the Health Facility Survey undertaken in 2008, and compares the findings withthe 2003 baseline.

METHODSThe survey instruments are based on standardized methodologies for Level II PSA developedby the World Health Organization (WHO); and the standard methodologies for medicine pricemeasurement and monitoring, developed jointly by WHO and Health Action International(HAI). The survey was conducted in health facilities in six of the eight provinces: Nairobi, RiftValley, Western, Nyanza, Coast and North Eastern; and among the three healthcare providersectors (public, FBHS and private). In each region, six health facilities per sector weresurveyed, totaling 108 sites (i.e. 36 government health facilities, 36 private pharmacies and36 FBHS health facilities). Data was also collected from KEMSA and MEDS, the two centralwarehouses supplying the public and FBHS facilities respectively. Data was collected usingstandardized survey forms adapted to the country situation and additional data was obtainedfrom ongoing Monitoring of Medicine Prices and Availability (MMePA). This entails visits bydata collectors to total of 96 sites comprising public and FBHS facilities and privatepharmacies in four provinces (Coast, Eastern, Nairobi and Rift Valley) every three months, todocument prices and availability of 36 medicines using a standardized data collection form.Data was analyzed using Microsoft Excel®, and the WHO HAI workbook was used to analyzemedicine price and availability data.

KEY FINDINGSThe survey findings are reported as standard indicators, defined in detail in the WHO andWHO/HAI standard methodologies.

Availability of Essential Medicinesa) The majority of basic medicines to treat common conditions at primary care level were

available in all sectors during this survey period. However, a broader scope of essentialmedicines was less available in facilities across all sectors.

b) Public and FBHS facilities experience stock outs of basic essential medicines for about 46and 14 days per year respectively. The public sector supply chain is especially prone tosignificant interruptions and critical stock outs, extending beyond 30 or even 90consecutive days.

c) KEMSA and MEDS have high availability and virtually no stock outs of basic essentialmedicines and they maintain adequate medicine stock records.

d) The proportion of prescribed medicines that were actually dispensed to patients was 98%in FBHS facilities compared with 86% in public facilities. Therefore, patients were morelikely to obtain all prescribed medicines from the FBHS facilities.

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Medicine Prices and Affordabilitya) Procurement by KEMSA and MEDS is almost exclusively for generic products, and they

obtain price efficiency well below IRPs. With an MPR of 0.44, KEMSA obtainscomparatively lower procurement prices than MEDS with an MPR of 0.61.

b) Patients obtaining medicines from the public sector face comparatively lower or nofinancial barriers. Most (89%) surveyed medicines were issued for free in the publicsector, compared with 15% in FBHS facilities and none in the private pharmacies.

c) Patient prices (where charged) in the public sector were about 40% lower than those inthe FBHS facilities, and about 50% lower than those in the private sector.

d) Prices charged to patients for essential medicines in the public and FBHS facilities, are atleast four times higher than the respective procurement prices at the central level.

e) For the conditions studied, and with reference to the minimum wage, individualtreatments would be fairly affordable in all sectors and especially so in the public sector.

Qualitya) Incidence of expired medicines was only about 2% in all sectors; centrally and in facilities.b) Storage conditions in public facilities are critically inadequate, putting at risk the quality of

medicines distributed through this sector. Storage facilities were inadequate in 40% ofthese facilities, compared with 25% and 20% of FBHS and private pharmacies respectively.

c) The MEDS warehouse met all the criteria for medicines storage and conservation,compared to KEMSA which met only 50% of the criteria.

d) Storage conditions in public health facilities were found to have deteriorated or remainedinadequate both centrally and in health facilities compared to the baseline of 2003.

Rational Use of Medicinesa) The national STGs and EML key tools for promoting RUM were not available to most

health care workers in all sectors. STGs were available in 42% and 25% of public and FBHSfacilities respectively; and the EML in 39% and 47% of these facilities respectively.

b) Adherence of prescribers to standard treatment guidelines is mixed and inconsistent inboth sectors. Whereas there is some conformance to recommended first line treatments,prescribing of antibiotics was high, being 77% and 68% in the public and FBHS facilitiesrespectively, against a reference of 30%.

c) Prescribing by generic name was extremely low. Only 32% and 35% of medicines wereprescribed by generic name in the government and FBHS facilities respectively.

d) A median of 93.4% was found for medicines prescribed according to the national EML inthe public health facilities, indicating very good adherence of prescribers to this list.

e) Labelling of dispensed medicines was inadequate in all sectors and critically low in publicfacilities. Only 5% of medicines at public health facilities were adequately labelledcompared with 21% and 40% in FBHS facilities and private pharmacies respectively.

f) The majority of patients had fairly adequate knowledge of how to take the medicinesdispensed. Adequacy of this knowledge was lower (77%) for patients obtaining medicinesfrom public facilities, compared with 87% for FBHS facilities and 93% for privatepharmacies.

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Health Professionals Profilesa) Few public and FBHS facilities (38% & 31% respectively) complied with the law concerning

dispensing by qualified personnel, compared with 81% of llicensed private pharmacies.b) Untrained staff was the most frequent dispenser in public facilities (42%); nurses in FBHS

facilities (47%) and pharmaceutical technologists in private pharmacies (61%).c) A clinical officer was the most common prescriber, being in 53% of public and 61% of

FBHS facilities respectively; and the nurse was prescribing in 42% and 39% of thesefacilities respectively

d) Untrained staff were found prescribing in 14% of public facilities and 6% of FBHS facilities.

CONCLUSIONS1. The majority of basic essential medicines to treat common conditions at primary care

level are available and fairly affordable to Kenyans through the public, FBHS and privatesectors. But medicine stock outs are prevalent and sometimes critical and essentialmedicines for a broader scope of health needs are less available.

2. Centralized bulk procurement of essential medicines through KEMSA and MEDS is priceefficient and generally maintains adequate stocks of basic essential medicines.

3. The price barrier that people may face when accessing medicines is significantly less inthe public sector. Patients obtain the majority of basic essential medicines for free, or paythe lowest prices comparatively. However, frequent stock outs are a major barrier toaccess, especially for the poor.

4. The FBHS play a role in lowering the price barrier for medicines. Some medicines areissued for free and patient prices are generally lower than the private sector.

5. The price efficiency of centralized bulk procurement is not sustained in the pricing ofmedicines by the public and FBHS supply systems. Where medicines are not issued forfree, patients pay around four times the procurement prices in both sectors.

6. The storage infrastructure for medicines in the public sector is critically inadequatethroughout the supply chain, putting at risk the quality of medicines provided throughthis sector. Storage infrastructure in FBHS facilities is also inadequate.

7. There is mixed performance on RUM across all sectors, with some adherence to STGs buthigh prescribing of antibiotics and low prescribing by generic name. This may result froma lack of policy guidance or strategic approach to guide health sector investment inpromoting RUM.

8. The health sector faces a critical shortage of qualified pharmaceutical personnel tomanage medicines supply, dispensing and use. With about two thirds of public and FBHSfacilities lacking qualified personnel, pharmaceutical services are deficient: stock outs,inadequate records, inadequate dispensing practices and irrational use are consequencesof skewed priorities and uncoordinated investment in pharmaceutical services.

9. Regulations governing pharmaceutical services are not effectively enforced in the publicand FBHS sectors; and to a lesser extent the private sector. This is a serious threat both topublic safety and quality of pharmaceutical services delivery.

10. Licensed private pharmacies have a significant role in improving access to medicines.Basic essential medicines are available, fairly affordable and largely dispensed by qualifiedpersonnel; and the sector scores higher on most dispensing indicators.

Overall, findings of this survey indicate stagnating or deteriorating performance of thepublic sector since 2003. Whereas availability has not changed significantly, stock outs infacilities have increased; and stock records and labelling of medicines have deteriorated.

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RECOMMENDATIONSArising from the findings and conclusions of the survey and within the context of the statedaims and objectives of the KNPP, the following are key recommendations addressed toGovernment, Development Partners, Civil Society, FBHS and the PPB:

To the Governmenta) Institutionalize and integrate monitoring and evaluation of pharmaceutical services within

the health sector coordination and M&E framework, to inform policies and strategies forimproving access to medicines.

b) Rationalize priorities and investments across the entire spectrum of pharmaceuticalservices within the KEPH, to target the diverse gaps in access to medicines. This wouldinclude personnel and storage infrastructure in line with defined norms and standards.

c) Develop policies to promote the use of quality assured generic products, as a means ofsustaining affordability of essential medicines.

d) Deploy qualified personnel to public and FBHS facilities in compliance with the law, tosafeguard patient safety and improve medicines management, prescribing and dispensing.

e) Prioritize the upgrading of medicines storage infrastructure in the health infrastructureimprovement plan, with particular focus on KEMSA, public and FBHS health facilities.

f) Develop and implement a coordinated strategy to promote RUM. This may include:g) Sustain and enhance the efficiencies of public and FBHS pharmaceutical procurement,

through collaborative mechanisms such as coordinated informed buying.h) In the elaboration of health financing policies, ensure that coverage for medicines is in

line with the Essential Medicines Concept; and that financial barriers are eliminated tothe greatest extent possible.

i) Enhance coordination of pharmaceutical issues within health sector coordinatingframework, to facilitate comprehensive strategies and investments that capture the fullscope of pharmaceuticals within overall health sector strategic framework.

To Development Partners in Health – Kenya (DPH K)a) Facilitate a coordinated and evidence based approach to pharmaceutical services support,

in the context of existing health sector coordinating and investment mechanisms.b) Support coordinated pharmaceutical sector M&E – including periodic comprehensive

pharmaceutical situation assessments and integrate into ongoing programmes.c) Enhance support to human resources for pharmaceutical services in the public and FBHS

sectors within the context of the Human Resource for Health Strategic Plan.

Faith Based Health Services (FBHS)a) In consultation with Government and Development Partners, institute mechanisms to

improve affordability of key medicines in FBHS facilities, in a manner that supports andmaintains high availability. This may involve expanded subsidization and rationalization ofcurrent health sector investments on pharmaceuticals.

Civil Societya) Advocate for and support evidence based programming and investment in

pharmaceutical services.b) Enhance consumer awareness on the core factors affecting access to Essential Medicines,

and their role in improving appropriate use of medicines.

Pharmacy & Poisons Boarda) Enforce full compliance with the law on the handling and dispensing of medicines. This

should apply equally to the public, FBHS and private sector health providers.b) Liaise with the KMPDB to ensure that medicines’ prescribing complies with the law.

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1. INTRODUCTION

1.1 BACKGROUNDAccess to medicines is part of the fundamental Right to Health, and its attainment is a prerequisite to achieve universal access to health services. Access to medicines implies access toEssential Medicines as defined by WHO:

The development, implementation and regular updating of a national pharmaceutical policyunderscore Government's commitment to ensure access to medicines for its population.Such a policy should address primary determinants in the development, production, selection,pricing and financing of essential medicines; the regulatory framework for assuring medicinesquality, safety and efficacy; an effective supply system that ensures availability and rationaluse; and overall governance of functional and administrative processes. Access to medicineswould therefore imply the availability, affordability, quality, and appropriate use (handling,prescribing and dispensing) of Essential Medicines.

Assessment, monitoring and evaluation underpin evidence based policy development andstrategic planning. The complexity of the pharmaceutical sector, with multiple and crosscutting factors that can influence access to and rational use1 of quality medicines, makes it isextremely important to have a standardized and systematic method for assessing thepharmaceutical situation at country, regional and global levels. Pharmaceutical sectorassessment, monitoring and evaluation aim to answer the following vital questions:

Do people have access to essential medicines?Are people obtaining medicines that are safe, effective and of good quality?Are these medicines being prescribed, dispensed and used properly?

As part of its mandate to provide technical support in the monitoring of health trends, WHOhas developed standardized methodologies for monitoring and assessing the nationalpharmaceutical situation, which require systematic surveys and data gathering at health carefacilities. In order to ensure their relevance and applicability to diverse country situations,these tools are periodically reviewed in consultation with global experts and using feedbackfrom countries that have undertaken such assessments, as well as trainers and experts whohave used the survey tools. The WHO tools are intended to be used as guides for countries to

1 Rational Use of Medicines: Patients receive medications appropriate to their clinical needs, in dosesthat meet their own individual requirements, for an adequate period of time, and at the lowest costto them and their community." (WHO, 1985). The term is used in this report synonymously withAppropriate Use of Medicines

Essential medicines are those that satisfy the priority health care needs of the population. They areselected with due regard to disease prevalence, evidence on efficacy and safety, and comparativecost effectiveness. Essential medicines are intended to be available within the context of functioninghealth systems at all times in adequate amounts, in the appropriate dosage forms, with assuredquality, and at a price the individual and the community can afford (WHO 2002).

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adapt to their specific situation. They enable the measurement of standardized indicatorswhich can be grouped into a multi level indicator pyramid as shown in Figure 1 below.

Figure 1: Core indicators used to monitor and assessthe national pharmaceutical situation

Monitoring of the pharmaceutical situation therefore aims to:i) assess country capacity (infrastructures and resources)ii) review implementation strategies so adjustments can be madeiii) measure outcomes of pharmaceutical objectives (access and rational use of quality

medicines)iv) evaluate progress towards identified objectives.

The various indicators provide policy makers and managers with a clear picture of nationaland institutional performance, capacities and gaps in ensuring access to essential medicines.Policy makers and managers can refer to study results when developing strategies tostrengthen the pharmaceutical sector. Results can also be used to synchronize policy actionsrelated to pharmaceuticals.

Level II indicators are measured in public health facilities, private drug outlets and inwarehouses supplying the public sector. Other sectors which provide a significant proportionof health services (e.g. the FBHS sector in Kenya) should also be included. They measure theexpected outcomes and impact of strategic pharmaceutical programmes in a country:improved access, quality and rational use.

The availability and affordability of essential medicines are assessed in all sectors, butespecially in the public sector where the majority of the poor access healthcare. Thepresence of expired medicines on pharmacy shelves as well as the adequacy of handling andconservation conditions are used as proxy indicators of the quality of medicines made

Level 1Core structure

& processindicators

Level 2Core outcome/ impact indicators

• Access to essential medicines• Rational Use of Medicines

Level 3In depth assessments of specific components of the

pharmaceutical sectorPricing Quality TRIPSHIV/ AIDS

Traditional Medicines

Key informant questionnairesent to countries

Systematic survey(health facilities andhouseholds)

Diversemethodologies

Level ICore structure

& processindicators

Level IICore outcome/ impact indicatorsAccess to essential medicinesRational Use of Medicines

Level IIIIn depth assessments of specific components of the

pharmaceutical sector

PricingHIV/AIDSDrug Supply

QualityMalaria

TRIPSTraditional MedicinesRegulatory Capacity

Key informant questionnairesent to countries

Systematic survey(health facilities andhouseholds)

DiversemethodologiesDiversemethodologies

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available to the population, since determination of the actual quality of medicine sampleswould be not be feasible under the survey conditions. Finally, rational use is measured byexamining the prescribing and dispensing habits of health providers and the implementationof key strategies such as the presence and use of standard treatment guidelines (STG) andessential medicines lists (EML).

This survey undertaken in 2008 using the standardized WHO methodologies is to date thesecond to be carried out, the first having been undertaken in 2003 which was able toestablish some key baseline figures against which subsequent progress could be measured. Itis recommended that such surveys should be repeated at least once every four years in orderto maintain an accurate profile of the pharmaceutical sector and thereby provide a vitalevidence base for use in formulating and developing pharmaceutical policy and relatedstrategic interventions.

1.2 IMPLEMENTATION OF THE SURVEYIn September 2008, a nationwide study of the pharmaceutical situation was undertaken ingovernment health facilities, FBHS health facilities, private pharmacies, and warehousessupplying the public and FBHS sectors in Kenya. The study was conducted using standardizedmethodology developed by the World Health Organization (WHO) to assess thepharmaceutical situation at health facility level (i.e. the WHO Level II Assessment). This is anindicator based survey that provides systematic data on access, rational use and quality ofmedicines through a facility based approach.

1.3 OBJECTIVESThe main objectives of the study were to obtain information on the status and outcomesrelated to the following key medicines policy questions with regard to Kenya:

Are medicines that are used to treat common conditions at primary care level, availableand affordable in government, FBHS and private dispensing facilities?Do people have adequate geographical access to government, FBHS and privatedispensing facilities?Are there expired medicines in government, FBHS and private dispensing facilities?Are medicines properly stored and handled in government health facilities, FBHS facilities,private pharmacies and central warehouses supplying the government and FBO sectors?Are medicines adequately prescribed, labelled and dispensed?Are patients adequately informed on how to use their dispensed medicines?Are medicines dispensed by qualified pharmaceutical personnel at health facilities andprivate pharmacies as required by law?Which personnel are prescribing medicines in health facilities?Do prescribers adhere to Standard Treatment Guidelines as part of good prescribingpractices?How is the public sector performing on access to medicines compared to 2003?

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2. COUNTRY BACKGROUND

Kenya lies along the Equator in Eastern Africa between Somalia and Uganda and bordersTanzania, Sudan, Ethiopia and the Indian Ocean. The total area is 582,650 sq km of which13,400 sq km is water. Administratively, the country is divided into 8 provinces and 712

districts, the district being the main administrative unit for health service delivery.

Figure 2: Map of Kenya

© United Nations Cartographic Section

The total population was estimated at 37.2 million in 2007, of which about 43% is below 15years3. Kenya is a low income country with a GDP of US $778 per capita (2007). The HumanDevelopment Index (HDI) is 0.532, ranking the country 144th out of 179 countries for whichdata are available; whereas the Human Poverty Index (HPI 1) of 31.4%, ranks the country 91st

among 135 developing countries for which the index has been calculated4. The country’semployment to population ratio (both sexes) was 73% in 20085. According to the KenyaDemographic and Health Survey of 2008, the mean size of a Kenyan household is 4.2 persons;the rate of under 5 mortality has declined from 92 per 1,000 live births in 2003 to 74 per1,000 live births; while maternal mortality remains high, having increased from 414 per

2 The survey was undertaken during an ongoing review of district boundaries at which time 71districts were recognized.3 Kenya Facts and Figures, Kenya National Bureau of Statistics, 20084 Human Development Report, UNDP 2008 Update5 Source: United Nations Statistics Division http://data.un.org

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100,000 live births in 2003 to a figure of 448 in 20086. The adult (15+) literacy rate was 61.5%in 2007 being higher for males (64%) than females (59%)7.

Table 1: Kenya Economic & Health Indicators

Indicator Value Year

Total population (millions) 37.2 2007

Gross Domestic Product (GDP) per capita (US$) 778.1 2007

Life expectancy at birth (M/F) (years) 54/59 2006

Healthy Life Expectancy at birth (M/F) years 44/45 2006

Under 5 mortality rate per 1,000 74 2008

Per capita total health expenditure (US$) 27 2006

Total health expenditure (THE) (as a % of nominal GDP) 4.8% 2006

Government health expenditure as a % of total government expenditure 6.4% 2007/08

Out of pocket health spending as a % of THE 29.1% 2006

Household health spending as a % of THE 35.9% 2006

% of out of pocket expenditure spent on medicines 69% 2003

% of MOH budget spent on medicines & medical supplies 11.3% 2006/07

Sources: Kenya National Health Accounts (2005/06)Kenya Household Health Expenditure and Utilization Survey (2009)

2.1 HEALTH SECTOR2.1.1 Health status and indicators

Key health impact indicators suggest stagnation or decline in the health status of Kenyans.This is attributable to the high disease burden due to existing, and new conditions, and aninadequate response to manage the disease burden. The health impact indicators alsosuggest wide disparities in health across the country, closely linked to underlying socioeconomic, gender and geographical disparities. Low immunization coverage and cross bordersocial disturbances in the recent past have also seen the recurrence of measles and polio,which had been brought under control. The main health challenges in the country includeHIV/AIDS, malaria, tuberculosis and non communicable diseases. Malaria prevalence is 14%8,and it is the leading cause of morbidity (30%), followed by respiratory diseases (24.5%)9.National HIV prevalence is 7.4% and an estimated 1.4 million adults are living with HIV. Only35% of those in need of ART are accessing treatment10. TB prevalence is 319 per 100,000against an MDG target of 63; 48% of TB cases are co infected with HIV and there is a growingthreat of MDR/XDR TB11.

General data are summarized in Table 1 above.

6 Kenya Demographic and Health Survey, 2008 097 Kenya National Bureau of Statistics Literacy Survey 20078 Kenya Malaria Indicator Survey 20079 Health Management Information System 200810 Kenya AIDS Indicator Survey 200711 WHO Global Tuberculosis Control Report 2009

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2.1.2 Health policy and strategic planning

The Kenya Health Policy Framework (KHPF 1994 2010) is the overarching health policy for thecountry. Its overall goal is to promote and improve the health status of all Kenyans throughthe deliberate restructuring of the health sector to make all health services more effective,accessible and affordable. The second National Health Sector Strategic Plan (NHSSP II 2005–2010), was developed with the aim of reversing the declining trends in key health sectorindicators, and it has five broad policy objectives: i) increase equitable access to healthservices, ii) improve the quality and responsiveness of services in the sector, iii) improve theefficiency and effectiveness of service delivery, iv) enhance the regulatory capacity of MOH,v) foster partnerships in improving health and delivering services and vi) improve thefinancing of the health sector.

Ministerial strategic plans for the Ministry of Public Health and Sanitation and Ministry ofMedical Services outline the investment decisions for the years 2008–2012 for strengtheningthe capacity of the two ministries to deliver public health, sanitation and medical services inline with Vision 2030. The plans outline strategic thrusts for each Ministry, which serve toguide investment and programming in the key priority areas towards the overall goals of theNHSSP II. Planning for health services and interventions is through Annual Operational Plans(AOP), capturing the short term actions and expected achievements for all health sectorplayers within the planning year. These also serve to align health planning with the nationalbudgeting process. Lessons learnt from previous AOP development and implementationstages usually inform the focus and process of planning for the successive year.

2.1.3 Health system structure, status and challenges

The health sector has defined the Kenya Essential Package for Health (KEPH) based on a lifecycle approach to delivery of a comprehensive healthcare package across 6 levels of care.

Figure 3: Health Sector Pyramid

Source: Norms and Standards for Health Service Delivery, MOH, 2006

The Government is the main provider of health services, accounting for about 52% of allhealth facilities. The private for profit and the private not for profit providers also serve asignificant proportion of the population, accounting for 34% and 14% of health facilities

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respectively12. To guide the implementation of KEPH, the health sector elaborated Norms &Standards13 for healthcare delivery, which defines the minimum and appropriate mix ofhuman resources and infrastructure required to ensure the efficient and effective delivery ofdefined health services at the different levels of the health system. Roll out of KEPH ishampered by inadequate quantities and qualities of resources (human, infrastructure,financial) and still evolving institutional capacity to manage the available resources.

2.1.4 Health partnership and coordination

According to the National Health Accounts14, 29.3% of health expenditure is public, with31.0% from donors and 35.9% from households. Coordination mechanisms are continuouslybeing strengthened between the various partners, with a Code of Conduct guiding partnerengagement in the sector. The major development partners15 came together under the JointSupport Programme to design areas of focus for their support. There is also activeengagement with the formal faith based16 and the non governmental service providers.Underlying socioeconomic factors and cross border issues require a broader basedpartnership platform, encompassing governance, political reform and regional collaborationto address underlying determinants of health and to tackle cross border health challenges.

2.2 PHARMACEUTICAL SECTORThe following are key facts and figures on the pharmaceutical sector in Kenya.

Table 2: Key Pharmaceutical Sector Indicators

Indicator Value Year

Date of National Drug Policy 1994* 2010*

Date of National Essential Medicines List 2002* 2010*

Date of Standard Treatment Guidelines 2002* 2009*

Public sector medicines expenditure (US$) 16 million 2002/3

Public sector medicines expenditure per capita (US$) 0.51 2002/3

% of MOH recurrent budget spent on medicines & medical supplies 11.3% 2006/7

Pharmaceutical sub sector value (US$) (PPB) 130 million 2004

Number of registered pharmaceutical manufacturers 45 2009

Number of registered retail pharmacies 1,279 2008

Number of registered pharmaceutical wholesalers 212 2008

Number of registered pharmaceutical products 12,008 2009

12 Facts and Figures on Health and Related Indicators, Ministry of Medical Services, 200913 Norms and Standards for Health Service Delivery, Ministry of Health, June 2006

14 Kenya National Health Accounts 2005/06,March 200915 Major Development Partners include DANIDA, DfID, GDC, Italian Cooperation, SIDA, UNICEF, USG, and theWorld Bank16 A Memorandum of Understanding (MoU) exists between the Government and the Faith Based HealthServices (FBHS), which recognizes their important contribution, prevailing status, challenges and potential tocontribute towards attainment of MDGs and other health goals. It elaborates various forms of collaborationincluding Government subsidies to FBHS, particularly for personnel, medicines and infrastructure maintenance.

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Indicator Value Year

Number of pharmaceutical inspectors 39 2009

Number of registered pharmacists 2,063 2009

Number of enrolled pharmaceutical technologists 2,323 2009

Pharmaceutical personnel population ratio 1:8710 2009

Number of pharmacists in basic training 280 2009

Number of pharmacists in public service 538 2009

Number of pharmaceutical technologists in basic training 2,655 2009

Number of pharmaceutical technologists in public service 226 2009

* Under revision at the time of the Survey. Date in Year column is the expected publication date of a new edition

2.2.1 National Pharmaceutical Policy

Kenya published the first National Drug Policy (KNDP) in 1994, addressing important issuesimpacting on pharmaceutical services. However, there was no clear and sustainable strategyfor its implementation, and monitoring and evaluation of its impact were minimal.

The revised Kenya National Pharmaceutical Policy (KNPP) of 201017 whose goal is UniversalAccess to quality pharmaceutical services, Essential Medicines and essential healthtechnologies in Kenya, outlines relevant policy direction and strategies for the pharmaceuticalsector, and the key institutional framework required to ensure access to, and rational use of,essential medicines by the population. A 5 year Pharmaceutical Strategic Plan for KNPPimplementation is under development; and implementation plans are developed annually,integrated within the health sector Annual Operational Plans (AOPs).

A baseline assessment of the pharmaceutical situation was undertaken in 200318 andrepeated in 2008 using WHO standard tools and methodology. The 2008 assessment coversthe overall pharmaceutical situation, with two separate reports covering the perspectives ofthe health system (this report) and of households. A comprehensive medicine price surveywas undertaken in 200419 and a medicine price component study in 200720. Quarterlymonitoring of medicine prices and availability is in place, coordinated by the Department ofPharmacy21.

2.2.2 Regulatory system

Kenya’s medicines regulatory authority is the Pharmacy and Poisons Board (PPB). It is fundedthrough the exchequer and through fees from regulatory services (e.g. registration ofmedicines, inspection and licensing) and for the issuing of professional and practice licenses.Regulatory personnel are subject to the civil service code of conduct, but no specific legalprovisions exist requiring transparency and accountability and promoting a code of conductin regulatory work. The medicines regulatory authority provides information on legislation,

17 Expected date of publication18 Assessment of the pharmaceutical situation in Kenya: a baseline survey, Ministry ofHealth/WHO/HAI, 200319 A Survey of Medicine Prices in Kenya, Ministry of Health, 200420 Price components and essential medicines in Nairobi, Kenya, WHO Kenya 2007 (unpublished draft)21 Monitoring Medicines Pricing & Availability (MMePA) in Kenya, undertaken quarterly since 2006

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regulatory procedures, prescribing information (such as indications, contra indications, sideeffects, etc.), authorized companies, and/or approved medicines.

Legal provisions exist for marketing authorization, and registration fees differ betweenimported and locally produced medicines. A cumulative total of 12,009 medicinal productshave been approved for marketing to date and a list of all registered products is publiclyaccessible on the PPB website 22 . Legal provisions are in place for the licensing ofmanufacturers, wholesalers, distributors, importers or exporters of medicines; and forregulation of medicines promotion and advertising. Regulatory procedures are in place toensure the quality of imported and locally manufactured medicines as part of the registrationprocess. A quality management system with an officially defined protocol for ensuring thequality of medicines is not in place in Kenya. Even so, medicines samples are routinely testedas part of the registration process and sometimes for post marketing surveillance. In a surveyof the quality of antimalarial medicines in the market in 2006, 43 batches were quality tested,with 16% failing to meet quality standards.

Legal provisions are in place for the licensing and practice of prescribers, pharmaceuticalpersonnel and pharmacies. No legal provisions exist requiring the prescribing of medicines bygeneric name or obligating the dispensing of generic medicines in any sector. Genericsubstitution is permitted in public, FBHS and private pharmacies and through the essentialmedicines concept, the public and FBHS sectors encourage the dispensing of genericmedicines.

2.2.3 Medicines supply system

Public and FBHS pharmaceutical procurement is pooled at the national level with separatecentralized procurement systems serving primarily the public and FBHS facilities respectively.The public supply chain has two systems in place – a kit based (push) system and aninventory based ordering (pull) system. The pull system which started in 2005 is under rollout, being fully operational in 3 Provinces. Procurement and distribution of EssentialMedicines and Medical Supplies for government is the responsibility of KEMSA, aprocurement agency under the Ministry of Medical Services. International competitivetender processes are used for public sector procurement with provisions for alternativemethods in specified circumstances. Public sector procurement is limited to medicines on theEssential Medicines List (EML) and any relevant and recently updated standard treatmentguidelines. To guide the procurement of medicines for the public sector, the publicprocurement agency develops and reviews an annual formulary list in consultation withstakeholders. This process aims to fine tune the specific products to be procured, derivedfrom the EML and/or other relevant treatment protocols. There are no regulations for localpreference in public sector procurement.

The FBHS procurement agency (MEDS) undertakes procurement and supply of essentialdrugs and medical supplies, to FBHS facilities, some public facilities and other health not forprofit healthcare providers. MEDS’ stock list is reviewed periodically by a formularycommittee comprising experts in the various health disciplines and clinicians from healthfacilities, hence the public and FBHS supply lists may be similar, but are not identical. Inaddition to medicines supply, the FBHS services also involve training of health workers on

22 See www.pharmacyboardkenya.org

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various aspects of healthcare, and other capacity enhancement services as part ofstrengthening healthcare provision. The FBHS are a significant and complementary service tothat of Government with facilities that comprise a significant proportion of all health facilitiesin Kenya, most of which are located in remote, rural and marginalized areas.

2.2.4 Medicines financing

Public financing of the health sector through the exchequer is US$ 10.9 per capita23, whichfalls below the WHO recommended level of US$ 34 per capita (of which a minimum of $2.50should be on essential medicines). This is far short of the Government’s commitment tospend 15% of the national budget on health, as agreed in the Abuja Declarations of 2001 and2006. Such under funding has reduced the sector’s ability to ensure an adequate level ofservice provision to the population, and has led to significant levels of out of pocketexpenditure. For example, households accounted for 36% of the total health expenditure(THE) in 2005/06 and of this, 29% was out of pocket. Cost sharing accounted for 7.4% of theMinistry’s recurrent expenditures in 2005/200624, and this contributes to inequity in accessto healthcare for the poor and disadvantaged groups.

There is a national policy (the ‘10/20 policy’) that requires public primary care facilities(Levels 2&3) to provide health care (including medicines) free of charge, with patients onlypaying minimal registration fees25. Children under 5 years are entitled to free health care(including medicines) in public and FBHS facilities and a waiver system is in place for patientswho cannot afford treatment. Publicly procured medicines for priority health programmes,such as contraceptives and medicines for malaria, HIV/AIDS and TB, are also provided for freethrough public and FBHS facilities. Cost sharing applies for treatment of other conditions inadults and children over 5 years, at levels 4 6 in the public facilities. Revenues from patients’fees or medicines sales are never used to pay the salaries or supplement the income of publichealth personnel in the same facility. FBHS facilities charge for the cost of treatment for mostconditions, but some provisions exist for subsidies and waivers. The private sector provideshealth services including medicines on a full cost recovery basis. Prescribers in the publicand private sectors sometimes dispense medicines.

In Kenya, only about 10% of the population has some form of health insurance. Amongst theinsured, the National Health Insurance Fund (NHIF) has the widest coverage of about 84%overall, and it covers all or part of in patient treatment, but does not cover out patientmedicines. About 8% and 12% of the population has private or employer based healthinsurance respectively, which covers some or all medicines costs26. There is no policy to guidethe pricing of medicines in any sector, but publicly procured medicines are highly subsidized.There is no import tax on pharmaceutical raw materials or finished products; however, theGovernment levies a 2.75% fee on all imported medicines for processing of importdocumentation, i.e. the Import Declaration Form (IDF) fee.

23 Facts and Figures on Health and Related Indicators, Ministry of Medical Services, 200924 Adapted from the Health Sector Report 200725 Registration fee at Level 2 (Dispensary) and Level 3 (Health Centre) is KES 10 (equivalent to USD0.14) and KES 20 (USD 0.28) respectively.26 Kenya Household Health Expenditure and Utilization Survey, Ministry of Health, 2007

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The national EML does not play a direct role in the setting of medicine prices in the privatesector, and price setting is not part of marketing authorization. Kenya has a national medicineprice monitoring system for retail/patient prices. There are no regulations mandatingretail/patient medicine price information to be made publicly accessible. There are officialwritten guidelines on medicine donations that provide rules and regulations for donors andprovide guidance to the public, private and/or NGO sectors on accepting and handlingdonated medicines27.

2.2.5 Rational use of medicines

The national Essential Medicines List (EML) is the basis for public sector procurement. TheEML was last updated in 2002, and it was under revision at the time of the survey, withreference to the most current WHO Model List. The National Medicines and TherapeuticsCommittee (NMTC) is responsible for spearheading the selection of products on the nationalEML, although it was not functional at the time of the survey. The health ministry producesnational Standard Treatment Guidelines (STG) for major conditions. These were last updatedin 2002, and were also under revision. However, some disease specific guidelines for priorityhealth programmes have been updated more recently. Antibiotics are frequently sold overthe counter without a prescription, and even injections are occasionally also sold in this way.

27 Kenya National Guidelines on Donations of Drugs and Medical Supplies, Ministry of Health, March 2001

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3. STUDY DESIGN ANDMETHODS

This study was conducted using the standardized WHO Level II Assessment methodology forhealth facilities. This is an indicator based survey that applies standardized data collectionforms, which enable calculation of the indicators. A survey advisory group adapted thestandardized forms to the country situation, and provided technical oversight throughout thesurvey design, fieldwork, data interpretation and report writing. The survey methodology hasa component on patient prices of essential medicines, but, as part of ongoing monitoring ofpharmaceutical services, a Monitoring of Medicines Prices and Availability (MMePa) wasalready in place, undertaken quarterly by the Ministry, using a methodology jointlydeveloped by WHO and HAI. To avoid unnecessary data duplication, the advisory groupdeemed it necessary and preferable to integrate the monitoring into the survey process,hence data collection for the coinciding quarter of MMePA was synchronized with the survey.

3.1 SAMPLING3.1.1 Sectors surveyed

The survey covered the three main health service providers in Kenya, i.e. the government,faith based and private sectors, as defined in the health sector coordination framework.

3.1.2 Sampling of regions (provinces)

Six provinces and three locations within each province, were selected as "survey areas" fordata collection. The major urban centre and capital city (Nairobi) was purposively selected asone survey area while North Eastern was selected as representative of a low income area.Other provinces selected were Coast, Rift Valley, Nyanza andWestern. Central province wasexcluded from the sample due to its similarity to Nairobi province whilst parts of Easternprovince were considered to be represented by Nairobi, Coast and North Eastern provinces.

3.1.3 Sampling of districts

To sample the districts, a stratified sampling technique was adopted where three districtswere chosen from each province, one being the location of the largest hospital and twoothers selected randomly using the random number function inMicrosoft Excel®.

Table 3: List of Sampled Districts

Province Largest Hospital DistrictTwo other Districtsselected randomly

Nairobi Kenyatta National Hospital Nairobi Nairobi

Rift Valley Nakuru PGH Nakuru Narok, Baringo

Nyanza Nyanza PGH Kisumu Bondo, Rachuonyo

Western Kakamega PGH Kakamega Busia, Bungoma

Coast Coast PGH Mombasa Kilifi, Tana River

North Eastern Garissa PGH Garissa Mandera, Wajir

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3.1.4 Sampling of facilities

The sample of six government facilities per province was identified as follows: the largestpublic hospital, then from the two other selected districts, all government hospitals werelisted and one primary hospital selected randomly. Similarly, one health centre was selectedfrom the third district from which no hospital had been selected. To complete the list, all thepublic dispensaries from the three districts were listed, and three government dispensarieswere selected at random from the list whilst ensuring that not more than two facilities (ofany type) were selected per district. A similar process was used for FBHS facilities, i.e. thelargest FBHS hospital in the province, a second hospital (or large Health Center) from adifferent district, a dispensary sampled randomly from the same district as the largesthospital and another from same district as the 2nd hospital, and two facilities sampledrandomly from the third district. This process yielded the complete list of government andFBHS facilities to be surveyed (see Annex 5, p74).

Sampling of private pharmacies entailed selecting the private licensed pharmacy nearest toeach selected government facility. Licensing status was established by referring to thecurrent list of registered facilities obtained from the Pharmacy & Poisons Board (PPB).Additionally the two central warehouses that supply the public and FBHS sector respectivelywere selected, resulting in a total sample of 36 government health facilities, 36 FBHS healthfacilities, 36 private pharmacies and 2 central warehouses.

3.1.4 Selection of patientsProspective sampling was used to collect patient care data. For each facility surveyed, thirtypatients were identified for interviewing (after obtaining verbal consent) as they were leavingthe dispensing area/pharmacy or leaving the facility after they had been treated and receivedmedicines. This was done without disrupting the normal activities of the facility.

3.1.5 Selection of prescriptionsRetrospective sampling of prescriptions was used to collect data on prescribing indicators.Thirty patient encounters were sampled by random selection of out patient records from theprevious 12 month period.

3.1.6 Selection of medicines to survey

Verification of medicines availability, stock out and expiry was based on a core list of basicmedicines, selected according to the first line therapeutic choice to treat the most commonand important health conditions at the primary health care level. Availability was alsomeasured using medicines on the MMePA list to enable comparison of medicine prices inKenya with those in other countries. In measuring the affordability of treatments, theadvisory group opted to include human insulin and beclomethasone inhaler (for managementof insulin dependent diabetes and asthma in children respectively), on the premise thatthese medicines were unaffordable, although they would only be supplied through hospitals.

3.2 DATA COLLECTION3.2.1 Organization of data collection

The Ministry of Medical Services and the Ministry of Public Health and Sanitation, bothorganized and gave approval for the survey. To obtain specific approval and cooperation for

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data collection, formal communication was sent to the Provincial Medical Officers and headsof the sampled facilities. The survey teams carried copies of this communication.

3.2.2 Adaptation of tools

The survey forms were adapted by considering the national structures and processes in placein the health sector, in order to ensure that data and findings can be adequately interpreted.For each category of facility surveyed data was collected using a set of Survey Forms (Annex 2,p57). Annex 1, p56 summarizes the Level II indicators and lists the corresponding surveyforms where information on data collection and calculation can be found.

3.2.3 Selection and training of data collectors

Pharmaceutical staff comprising pharmacists, pharmaceutical technologists and pharmacistinterns were chosen as data collectors (see Annex 4). The supervisors were pharmacists withknowledge of the Kenya pharmaceutical sub sector in general and knowledge of healthfacility management including pharmaceutical procurement and supply systems. Theyprovided logistical support to, and technical oversight of, the data collection process.

The field team comprised 26 data collectors and 2 supervisors. Data collectors were selectedand assigned to the survey provinces taking into account abilities to communicate in the locallanguages. The selection also aimed to achieve a combination of local data collectors fromthe various provinces so as to resolve concerns the data collectors may have had abouttraveling to unfamiliar areas and national data collectors to minimize bias (real or perceived).The field team were trained together with data entry clerks, during a 5 day training held inNairobi from 8 12 September 2008. The training covered survey methodology and tools, andallowed data collectors to participate in final adaptation and field testing of the tools, as wellas briefing them on their specific roles and survey logistics.

3.2.4 Data Collection

Data was collected over a period of three weeks from 22 September to 10 October 2008. Datacollectors were divided into seven teams, six of which covered a province each, and a team oftwo covered the central warehouses. The teams that went out to the provinces had fourmembers each including the team coordinator who was liaising with the supervisors. Thecentral warehouses team collected data over a one week period. Data collection entailedobservations guided by check lists, review of clinical and pharmacy records and interviews ofhealth workers and patients after obtaining their verbal consent.

Some facilities sampled were not surveyed during the actual field work. Some were found tobe non operational or inaccessible for security reasons while others had an inadequatenumbers of interviewees. The team leaders and survey supervisors would the consult toidentify alternate facilities, taking into account their similarity with the facilities initiallysampled, and their accessibility by the data collectors. This problem was mainly found inNorth Eastern province and especially for FBHS facilities. Most interview data was collectedfrom adult patients, comprising a higher proportion of females (54%). Annex 3 shows thecharacteristics of out patients interviewed.

3.3 DATA ENTRY AND ANALYSISOn each survey form, the relevant indicator measures were calculated manually andrecorded on the form. After review of completed Survey Forms by the two designated survey

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supervisors, the data summaries were entered into the standard Workbook, both in MSExcel® and in freeware provided as part of the WHO survey package, which enabled indicatorcalculation. For data on drug prices and affordability the WHO HAI work book was used28.

3.4 MONITORING OF MEDICINE PRICES AND AVAILABILITY (MMEPA)This is an ongoing quarterly exercise, undertaken by the Department of Pharmacy in theMinistry of Medical Services in collaboration with WHO and HAI Africa since 2006. Themethodology used was jointly developed by WHO and HAI; and adapted to the countrysituation by a national advisory team. Data is collected quarterly in four provinces, from 32health facilities comprising public, FBHS and private pharmacies. Data collectors arepharmaceutical personnel based within the survey regions. They visit each facility every 3months, and they collect the data using manual standardized forms, which are sent analysisusing a standardized Excel Workbook.

3.5 LIMITATIONS OF THE DATAThe WHO Level II core outcome indicator survey has been designed to provide a picture ofthe national pharmaceutical situation, using relevant information from an as simple aspossible data collection process and small sample size. The regions and facilities selectedcumulatively represent the national situation. The study is not intended to give a detailedanalysis of the pharmaceutical sector but rather to provide an overview of the nationalsituation in the country, to help in policy analysis and design of appropriate interventions forimproving access to medicines. Whereas larger sample studies would give more preciseresults, they would be costly, time consuming and require more complex logistics. Samplesize is therefore a balance between what is desirable and what is feasible. The best samplesize is the smallest one providing data with the desired degree of precision. More details onsample bias and error can be found in the Annex 2b of the Manual29.

The sample sizes used are not large enough to enable inter facility comparisons. For example,for patient care indicators, such comparisons would require a minimum sample size of 100.This survey uses a sample size of only 72. However, providing that majority of the data iscollected and the results are statistically different, comparisons between geographicalregions (provinces) can be made. These may be of interest where a group of relatedindicators shows wide variation or contrast. Regional comparisons should be done cautiouslyas not all provinces are represented. Over emphasis on the six provinces included in thestudy may detract focus from the study’s significance as a national survey.

Medicine prices are mostly presented as medians instead of means (with standarddeviations). Medians and percentiles are less sensitive to extreme values than means(averages) and are thus the best summaries of skewed indicator data. The methodology formeasuring availability only enables measurement at a specific point in time (cross sectional),and refers to the situation on the day of the survey. Availability should be interpreted inrelation to concurrent data on stock out days, which encompasses data spanning 12 months.

28Measuring medicine prices, availability, affordability and price components,WHO & HAI, WHO,Geneva, Switzerland, 200829 WHO Operational package for assessing, monitoring and evaluating country pharmaceuticalsituations: Guide for coordinators and data collectors, WHO December 2007

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4. RESULTS AND DISCUSSION

4.1 DEFINITION OF TERMS AND CONCEPTS

Median Price Ratio (MPR)Results on medicine prices gathered by the WHO/HAI survey are usually expressed as“median price ratios” or MPRs. The MPR is a ratio of the local price divided by aninternational reference price (converted into the same currency). For example: an MPR of 2means the price in Kenya is twice the international reference price and an MPR of 0.5 meansthe price in Kenya is half the international reference price.

The reference price serves as an external standard for evaluating local prices, and allows forcomparison of prices between countries and regions. The MPR results in this survey arebased on reference prices taken from the 2008 Management Sciences for Health (MSH)International Drug Price Indicator Guide30. The MSH Guide pools together information fromrecent price lists of large, non profit generic medicine suppliers. These suppliers typically donot sell to individual private pharmacies. Rather, they sell in bulk to governments and NGOs,and accordingly, prices in the MSH Guide tend to be low. However, they offer a very usefulstandard against which locally available products can be compared in any country.

Minimum Data Points for AnalysisFour data points for patient prices and one data point for procurement prices are theminimum number of data points that are necessary for the full analysis to be performed bythe workbook. If there are fewer data points than this, then no calculation of MPR isperformed. Availability is however calculated for all medicines irrespective of the number ofoutlets stocking each medicine.

Use of Medians and AveragesAs averages can be skewed by outlying values, median values are generally used (unlessotherwise stated) throughout the presentation of results and discussion as a betterrepresentation of the midpoint value.

Reporting of Quartiles/PercentilesA quartile is a percentile rank that divides distribution into 4 equal parts. The range of valuescontaining the central half of the observations, that is, the range between the 25th and 75thpercentiles (the range including values up to 25% below or above the median) is called theinter quartile range. In this section on findings, where medians and inter quartile ranges arenot presented in tables, the following format will be used to report the number ofoccurrences and the inter quartile range: n = 29; 25th and 75th percentiles = 0.60, 0.83.

AvailabilityThis refers to the physical availability of a defined basket of medicines on the day of datacollection. Availability denotes the proportion of surveyed health facilities in which themedicine was found. The indicator is computed as a median of the availabilities of individualmedicines in the basket.

30 See http://erc.msh.org/

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AffordabilityAffordability refers to the cost of treatment in relation to peoples’ income. The WHO/HAImethodology measures affordability as the number of days’ wages for the Lowest PaidUnskilled Government worker required to purchase a course of treatment for an acutedisease or a month’s treatment for a chronic disease. In this survey, the daily wage of thelowest paid unskilled Kenya Government worker (Job Group A) was KES shillings 166.167(USD 2.045)31 at the time of the survey. However, according to the World DevelopmentIndicators (2006), 46.6% of the Kenyan population lives below the poverty line32; hence, evenwhen treatments may appear affordable to the lowest paid government worker, these wouldbe less affordable to the majority of the population.

4.2 AVAILABILITYAvailability on the day of the survey was measured on two levels: i) for a list of 15 basic (core)medicines for treatment of common conditions at primary health care level, selectedspecifically with reference to Kenya (the country list Annex 6, p77); and ii) for the MMePAlist of 36 medicines which allows inter country comparisons (Annex 7, p77). A medicine wasrecorded as available if found on the shelves on the day of data collection.

4.2.1 Availability of basic medicines in government and FBHS health facilities,warehouses, and private pharmacies

The study measured the availability of 15 basic medicines to treat common health problemsin public health facility dispensaries, private drug outlets and warehouses. Table 4 and Figure4 below illustrate the percentage availability of medicines on the country list.

Table 4: Summary of Availability Indicators for 15 Basic Medicines

Availability ofBasic Medicines

nNationalMedian(%)

25th

%ile75th

%ileMin Max

NationalMean

SD

Government health facilities 36 87.0 73.3 93.8 40 100 82.6 15.8

FBHS health facilities 36 93.0 86.7 93.3 53.3 100 89.1 10.1

Private pharmacies 36 93.3 86.7 100 53.3 100 90.7 11.6

Government warehouse 1 100.0

FBHS warehouse 1 86.7

SD = standard deviation

31 At the time of the study, the Kenya shilling (KES) exchange rate was 81.2722 to the US Dollar (USD).

32 See http://data.worldbank.org/country/kenya

22

Figure 4: Median Availability of Essential Medicines (country list)

Median availability of key essential medicines

87.0

100.093.0

86.793.3

0

10

20

30

40

50

60

70

80

90

100

1Health Facility Type

% availability

Government health facilities

KEMSA

Mission health facilities

MEDS

Private Medicine Outlets

The median availability of the 15 basic medicines was 87%, 93% and 93% at public healthfacilities, FBHS facilities and private pharmacies respectively.Of the public health facilities surveyed, availability within the 25th percentile was 73% ofthe medicines; compared to 94% availability in the 75th percentile. In comparison, FBHSfacilities within the 25th percentile had up to 87% of the medicines available; and those inthe 75th percentile had 93% availability.All (100%) of the surveyed medicines were found at the government warehousecompared with 87% at the FBHS warehouse (MEDS).

Essential medicines to treat common diseases should be available in all health facilities,especially in public sector facilities providing health services for the poor. These findingsindicate an acceptable level of availability for basic medicines in all sectors with slightly loweravailability in government facilities. This points to a need to improve medicines distributionand replenishment, since the medicines were 100% available in KEMSA.

4.2.2 Availability of medicines on the MMePA list

Table 5 below shows the median availability of the 32 medicines on the global list in public,FBHS and private facilities.

Table 5: Median availability of medicines (MMePA list)

Median Availability by Sector

Government(n = 36)

FBHS(n = 36)

Private(n = 36)

67% 66% 81%

The median availability was similar for public and FBHS facilities (67% and 66%respectively) and lower than the private sector (81%)In all the sectors, the median availability of the medicines on the MMePA list was lowerthan for medicines on the basic list.

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The MMePA list contains essential medicines for a broader range of health conditions.Therefore, lower availability of medicines on this more extensive list infers that, for the fullrange of medicines on the national EML, availability would be lower in all sectors.

4.2.3 Percentage of prescribed medicines actually dispensed or administered topatients

To measure the degree to which facilities are able to provide prescribed medicines, theproportion of prescribed medicines actually dispensed or administered was calculated. Thedata is based on exit interviews conducted on a prospective sample of 30 outpatientencounters at each of the surveyed facilities. Patients sampled were those leaving thedispensing area or leaving the facility after they had been treated and received medicines.For each patient, the number of chemical entities prescribed and dispensed was recorded,and the median proportion was computed for each sector. The distribution of theproportions among the surveyed facilities was further analyzed. Table 6 and Figure 5 showthe findings for the government and FBHS facilities.

Table 6: Percentage of prescribed medicines actually dispensedor administered to patients

% of prescribed medicinesdispensed/administered

NationalMedian

Value

Min Max

Government health facilities 86 41 100

FBHS health facilities 98 80 100

In the public facilities surveyed, 86% of the prescribed medicines were actually dispensedor administered to patients, and hence 14% of prescribed medicines were not provided.In the FBHS facilities surveyed, 98% of prescribed medicines were actually dispensed oradministered to patients.

This finding indicates that patients seeking treatment in FBHS facilities were more likely toreceive all medicines prescribed, compared to those treated in public facilities.

Figure 5: Range of the % of prescribed medicines actually dispensed or administered

% of prescribed medicines actually dispensed or administered

0.0% 3.3%

30.0%

66.7%

0.0% 0.0% 0.0%

100.0%

0%

20%

40%

60%

80%

100%

< 25% 25 50% 50 75% > 75%% range of prescribed medicines dispensed or administered

%of

Facilities

24

Of the patients interviewed in public health facilities, 3.3% received less than half of theprescribed medicines; while 66.7% received more than 75% of the medicines.Patients interviewed in the FBHS facilities received at least 75% of the prescribedmedicines.

These findings show that patients seeking treatment in government facilities may fail toobtain a significant proportion of prescribed medicines. The potential reasons for patientsfailing to obtain all medicines prescribed include:

non availability or un affordability of the prescribed medicinelack of treatment guidelines and/or formulary in the facility to guide prescribinglack of adherence to existing guidelines/formulary in the procurement, prescribing anddispensing of medicines

4.2.4 Medicines Stock out Duration

Frequent or prolonged stock outs affect the ability of patients to obtain medicines as andwhen required. Therefore, retrospectively measuring the duration of stock outs is anotherapproach to assessing availability. This entailed examining stock records for the previous 12months for each of 15 key medicines. Table 7 illustrates the findings on stock out duration inthe public and FBHS facilities and central warehouses.

Table 7: Medicines stock out duration in health facilitiesand central warehouses

Average stock out duration(days) over past year

NationalMedian

Percentile Value NationalAverage

StandardDeviation25th 75th Min Max

Government health facilities 46.0 32.3 65.8 4.8 169 55.8 35.4

FBHS health facilities 13.5 0.0 36.4 0 72 19.7 22.3

Government warehouse 0.0

FBHS warehouse 0.3

The median stock out duration of the basket of medicines in government health facilitieswas 46 days compared with 14 days in FBHS facilitiesThe central warehouses had virtually no stock outs of these medicines

These findings indicate that there are interruptions in the public sector supply chain andcomparatively less in the FBHS supply chain. In light of the finding of that central warehouseshad virtually no stock outs, stock outs in health facilities point to weaknesses in thedistribution systems. Median stock out duration for government facilities, has increased fromthe 25 days baseline figure in 2003 to 46 days.

4.2.5 Severity of Medicines Stock out Duration

Data on stock outs of the 15 basic medicines was further analyzed with respect to theseverity of their duration in government and FBHS health facilities. Findings are shown inFigure 6 below.

25

Figure 6: Average stock out duration of medicines in health facilities (range of days)

Stock of Duration- Distribution of Health facilities

19.4%

38.9%

13.9% 13.9%

72.2%

25.0%

2.8%0.0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

<30days 30-60days 60-90days >90days No. of stock out days - Range

% o

f Fac

ilitie

s

Access in GoK facilities

Access in Mission facilities

Of the public health facilities that had experienced stock outs of the surveyed medicines,19.4% of had a stock out duration of less than 30 days. The majority (66.7%) had stockouts of more than 30 days and of these, 14% were more than 90 daysOf the FBHS facilities that experienced stock outs of the surveyed medicines, these hadlasted less than 30 days for most (72%) facilities and none had lasted more than 90 days.

An effective medicines management system should ensure that essential medicines are instock at all times. These findings indicate that medicine stock outs of in public facilities aresometimes critical, extending beyond 30 or even 90 days. Comparatively, stock outs in FBHSfacilities are less severe, and this correlates with the lower stock out duration in this sector.

4.2.6 Adequacy of stock records in public health facilities and regional warehouses

Stock records are critical for an effective medicine supply system. Comprehensive, accurateand up to date records contribute to proper management, estimation of needs andmedicines re ordering. To determine the adequacy of stock records, stock cards for the 15target basic medicines were examined to ascertain those for which there were transactionentries33 covering the latest continuous period of at least 6 consecutive months in theprevious 12 months. This indicator only assesses the existence of the records, withoutverification of whether the records are accurate. Adequacy of stock records was calculatedas the proportion of the surveyed medicines with complete records.

Table 8: Adequacy of Stock RecordsAdequacy of records National Median

Government health facilities 76.7

FBHS health facilities 83.3

Government warehouse (KEMSA) 100

FBHS warehouse (MEDS) 100

33 Key entries considered were: quantities received, quantities issued and stock on hand

26

The median proportion of adequate stock records was 77% in government healthfacilities, compared with 83% in FBHS health facilities.Both KEMSA and MEDS had adequate stock records for all medicines surveyedAdequacy of stock records had declined in government health facilities compared to the2003 baseline survey when it was 93%.

Findings indicate that FBHS health facilities had more adequate stock records than publichealth facilities. Further, there has been a decline in the adequacy of stock records in publichealth facilities since the 2003 baseline.

4.3 PRICING AND AFFORDABILITYThrough the provisions of the KNDP 1994 and the KNPP, the government is committed tomake Essential Medicines available and affordable to the population. Whereas progress isbeing made towards this goal, there are circumstances where patients may often have to payfor the medicines that they need. Consequently, where medicine prices are high, people(especially the poor) may have to forego treatment or incur debts in order to afford the outof pocket expenses for the life saving medicines they need. Although the purchasing ofmedicines represents only part of the costs associated with the management of an illness, itis clear that the high cost of medicines can have catastrophic effects on poor people.

4.3.1 Ratio of median unit procurement price to MSH international reference price

The price paid for Essential Medicines by central procurement agencies, is a majordeterminant of the prices charged to patients for the medicines. Price efficiency inprocurement can therefore contribute to enhanced access. To assess this, the medianprocurement prices of the government and FBHS central warehouses were computed, as aratio of the MSH international reference prices for the corresponding medicines. Table 9shows the MPRs for the 36 MMePA list medicines surveyed.

Table 9: Median Procurement Price Ratios (compared with IRPs)for public & FBHS sectors

SectorOriginator brand MedianMPR (n=1 for each sector)

Lowest price generics

MPR Min Max

Government (n=21) 3.39 0.44 0.13 0.84

FBHS (n=32) 2.48 0.61 0.19 1.33

Of the 36 medicines included in the survey, only one originator brand and 21 genericswere found in KEMSA whilst one originator and 32 generics were found in MEDS.Based on the median MPRs, KEMSA is procuring generics at 0.44 times their internationalreference prices (IRP) whilst MEDS is procuring at 0.61 times their IRP.The one originator brand found in the government warehouse was procured at 3.4 timesits IRP, whereas that found in the FBHS warehouse was procured at 2.5 times the IRP

The findings indicate that the government and FBHS procurement agencies are almostexclusively procuring generic products and are obtaining price efficiency in medicinesprocurement, with the government sector obtaining comparatively lower prices.

27

4.3.2 Medicines provided free of charge: public, FBHS and private facilities

In Kenya, various public health and disease control initiatives34 have enabled the provision ofessential medicines ‘free of charge’35 in government facilities, and in other sectors for specificprogrammes. The survey sought to determine the extent to which this policy was beingimplemented in the 3 sectors (i.e. medicines being issued for free). Data for the 36 MMePAlist medicines (Annex 7) and 96 health facilities (32 facilities per sector) was computed forcases where a medicine was available in the facility and issued for free to patients.

Table 10: Free of charge medicines: public, FBHS and private facilities

SectorOverall

AvailabilityMedian prevalence of

Issued for free Priced

Public 67.2% 89.4% 10.6%FBHS 65.6% 15.5% 84.5%Private 81.3% 0% 100%

In public health facilities, a substantial proportion of available medicines (89.4%) wereprovided free of charge to patients, compared with 15.5% in FBHS facilities and none inprivate pharmacies.

These findings indicate that the price barrier that people may face when accessing medicinesis significantly lower in the public sector and that Government policies on issuance ofmedicines for free are largely being implemented. However, given the relatively low (67%)availability of the surveyed medicines in government health facilities, the full potential of thissector to impact access cannot be realized. The findings also indicate that the FBHS sector isalso playing a role, albeit limited, in lowering the price barrier for essential medicines.

4.3.3 Ratio of median patient prices to MSH international reference price (IRP)

The survey documented prices charged to patients for those 36 medicines on the MMePA listthat were available in each survey site. For each medicine, the median patient price36 wascomputed separately for the public, FBHS and private facilities. To obtain the Median PriceRatio (MPR), these median patient prices were then compared to the corresponding medianprice for the medicine, quoted in the MSH Drug Price Indicator Guide 2008, and a medianMPR computed. Table 11 presents the median MPR for the public, FBHS and private facilities.

Table 11: Patient prices: ratio of median prices to IRP: public, FBHS & private sectorsSector Median Ratios No. of MedicinesPublic 1.66 14

FBHS 2.6 32

Private 3.29 32

34 Such initiatives include the reduction of user fees in July 2004. A standard fee of KES 10 or KES 20 fordispensaries & health centers respectively, replaced the cost sharing fees previously charged for medicines.Disease control initiatives include the provision of free medicines for conditions of public health priority, e.g.malaria, TB, HIV/AIDS through Government financing and financial support from health development partners.35 Although there is no charge levied for a medicine supplied, a standard fee is charged per patient (see above)for registration which covers any medicines provided.36 For details on the calculation of the MPR, see Definition of Terms and Concepts, p17

28

In the public sector, the prices that patients pay for medicines when charged are 1.66times the international reference price (IRP). This ratio was 2.6 in the FBHS facilities and3.29 in private sector facilities.

The public sector MPR was only computed for the 14 medicines for which a median price wasavailable in this sector. The other 22 medicines were either not available in the facilities onthe day of the survey or were issued to patients for free. For the 14 medicines, the findingsindicate that patient prices in the public sector are fairly affordable. However, since themethodology only computes price medians where 3 or more price data points are availableand does not include a zero price (free medicines) the ratio of 1.66 is distorted, and in realityis much lower. Furthermore, patient prices in the public sector are about 40% lower thanthose in the FBHS facilities, and about 50% lower than those in the private sector.

4.3.4 Ratio of median patient prices to median procurement prices

To compare procurement prices with the final patient prices, ratios were computed for thosemedicines where medians for both of these prices were available. Table 12 illustrates MPRsfor the public and FBHS sectors.

Table 12: Median patient to procurement price ratiosfor public and FBHS sectors

Sector Median MPR No. of medicines

Public 4.51 10

FBHS 4.42 30

In the public sector, the prices patients pay for medicines are 4.5 times the medianprocurement price. This ratio was similar in the FBHS facilities (4.42).

These price differences represent various add on costs along the medicines supply chain.Since the public and FBHS central procurement agencies are obtaining efficient procurementprices well below IRPs, the four fold increase in the final prices to patients represents adisconnect between the pricing structures at the procurement level and those in healthfacilities. This reflects a lack of policy guidance in the medicines supply chain, where priceefficiency upstream is not sustained for the public benefit.

4.3.5 Comparison of patient prices in the public and private sectors

To determine the significance of patient prices on access in the three sectors, ratios werecomputed for those medicines where medians for all sectors were available. Of the list of 36medicines surveyed, all sector medians were available for only 14 medicines. The medianratios between sectors are illustrated in Table 12 below.

Table 13: Median MPRs for 14 medicines found in public, FBHS and private sectors

Comparison Median MPR

Private/Public 2.22

FBHS/Public 2.29

Price variance between the public and the other two sectors were comparable, being2.22 and 2.29 for the private and FBHS facilities respectively.

29

These findings further highlight that patients pay lower prices for medicines in the publicsector. Although the FBHS/public ratio is slightly higher than the private/FBHS ratio, this maynot reflect overall higher prices in the FBHS sector as compared to the private sector, butrather, the situation for only the 14 medicines.

4.3.6 Out patient medicines costs

On the day of the survey, the amount that each patient paid out of pocket for all medicinesreceived was recorded. The average medicines cost was calculated as the mean of the totalamount recorded for all respondents in each sector. Table 14 summarises findings for thegovernment, FBHS and private health facilities surveyed.

Table 14: Average Out Patient Medicines Costs

Average medicines cost(KES)

NationalMedian

Min MaxNationalAverage

Government facilities 0 0 460 33

FBHS facilities 153 0 851 206

Private pharmacies 182 36 1363 233

KES = Kenya Shillings 1US$ = KES 81.27

Patients interviewed in public health facilities had incurred virtually no out of pocketexpenditure on medicines.The median average cost for medicines per visit to an FBHS health facility and privatepharmacy was found to be KES 153 and KES 182 respectivelyThe lowest amount spent on medicines by any of the respondents was nil in both publicand FBHS facilities; compared to KES 36 in private facilities.The highest amount spent on medicines by any of the respondents was KES 460, KES 851and KES 1,363 in government, FBHS and private facilities respectively.

Out of pocket medicines expenditure is a barrier to access, especially for the poor. Thefindings show that patients obtaining medicines from the public sector generally face loweror no financial barriers compared with other sectors.

4.3.7 Affordability of standard treatment regimens

The affordability of treatment for certain common conditions at government, FBHS andprivate health facilities was estimated as the number of days wages37 of the lowest paidunskilled government worker needed to purchase a prescribed standard course of treatment.For acute conditions, treatment duration was defined as a full course of therapy, while forchronic diseases, the affordability of a 30 days supply of medicines was determined. The dailywage of the lowest paid unskilled government worker used in the analysis was KES 249(approx US$ 3).

37 See Glossary, p89

30

Affordability of treatment of adult and child pneumonia

Figure 7: Affordability of adult and child pneumonia treatment (in days’ wages)

Affordability of pneumonia treatment for adults & children(in minimum wage work days)

0.0 0.0

0.50

0.20

0.48

0.20

0.0

0.2

0.4

Affordability of pneumoniatreatment for adults

Affordability of pneumoniatreatment for children

NationalM

edian

Public Health Pharmacy

Private Pharmacy

Mission Facilities

The median affordability of the standard treatment for moderate pneumonia in adultsand children was nil days wages in public facilities (i.e. medicines were provided freewhen they were available)The affordability of pneumonia treatment in adults in private medicine outlets was verysimilar to that in the FBHS sector at 0.5 and 0.48 days wages respectively.The affordability of pneumonia treatment in children was found to be equivalent to 0.2days wages in both the FBHS health facilities and private pharmacies.

In all sectors, the amount paid for pneumonia treatment was relatively affordable, being lessthan one day’s wage.

Affordability of treatment of diabetes in adults and asthma in children

Figure 8: Affordability of treatments: Adult diabetes, child asthma

Affordability of diabetes treatment for adults and asthma in children(in minimumwage work days)

2.4

4.0

1.2

0.0

5.4

1.4

0

2

4

6

Diabetes in adults Asthma in children

NationalM

edian

Public Health Pharmacy

Private Pharmacy

Mission Facilities

31

The median affordability of insulin treatment for adult diabetes in government and FBHShealth facilities and private pharmacy outlets was 1.2, 4.0 and 5.4 days wages respectivelyThe median affordability of asthma treatment for a child (with beclomethasone inhaler)in government health facilities was nil days wages (medicines provided free whenavailable) whereas the same treatment in FBHS facilities and private pharmacy outlets 1.4and 2.4 days wages respectively

These findings indicate that standard treatments for adult diabetes and asthma in childrenwere most affordable in public health facilities and were more affordable in FBHS healthfacilities than private pharmacies. The lowest paid government worker would spendconsiderably more than 1 days wage to purchase any of these standard treatments in any ofthe sectors, except for treatment of asthma in children which was free at public healthfacilities. This represents a large investment for just one medicine/treatment for one person.

4.3.8 Affordability of selected standard treatments: public, FBHS and private sectors

To measure affordability, the treatments of choice (based on current STGs) were identified,and the number of units needed to complete the treatment computed. The unit pricecharged to patients was obtained, plus any applicable charges (dispensing fees, syringes, etc).If a flat fee was charged for a medicine, this was recorded as the treatment price. For eachtreatment, affordability (in day’s wages) was subsequently computed. Table 15 illustrates themedian affordability of the standard treatments in the public, private and FBHS facilities.

Table 15: Affordability of selected standard treatmentsin public, FBHS and private sectors

Disease condition and ‘standard’ treatmentMedian affordability oftreatment by sector(in days wages )

ConditionDrug name, strength,

dosage formTreatmentschedule

Public Private FBHS

AsthmaBeclomethasone

50 mcg/dose inhaler1 inhaler of 200 doses 0.80 3.01 1.81

Diabetes Glibenclamide 5mg tab 1 tab twice daily for 30 days = 60 0.23 1.02 0.60

Depression Amitriptyline 25mg tab 1 tab thrice daily for 30 days = 90 0.30 0.36 0.36

Adult ARI

Ciprofloxacin 500mg tab 1 tab twice daily for 7 days = 14 0.28 0.62 0.39

Amoxicillin 500mg cap 1 cap thrice daily for 7 days = 21 0.34 0.51 0.51

Ceftriaxone injection1g/vial

1 vial 1.45 1.93 3.61

Child ARICotrimoxazole240mg/5ml susp

5ml twice daily for 7 days = 70 ml 0.14 0.17 0.13

Arthritis Diclofenac 50mg tab 1 tab twice daily for 30 days = 60 0.34 0.73 0.48

ARI = acute respiratory infection

Standard treatments for most conditions would cost one days wage or less in all sectors.The exceptions were beclomethasone inhaler, ceftriaxone injection and glibenclamidetablets.Only ceftriaxone injection would cost more than a day’s wage in all sectors, being 1.45,3.61 and 1.93 days in the public, FBHS and private sector respectively.

32

These findings indicate that individual treatments for most conditions are relativelyaffordable in all the sectors, but most affordable in the public sector.

4.4 GEOGRAPHICAL ACCESSIBILITYThe time taken by patients to reach a health facility is a significant determinant of access tomedicines. The cost of travelling to the facility (including costs for accompanying personswhere the patient cannot travel alone) is an additional component of this determinant.Through exit interviews of a sample of 90 patients who had obtained treatment in the public,FBHS or private facilities (30 patients per sector), the survey measured the time taken andtransport costs incurred by patients to reach that health facility. Figure 9 below illustrates theproportion of patients who took more than one hour to reach the health facility; and Table16 below shows the median travel costs for patients to that facility.

Figure 9: Percentage of patients taking >1 hour to travel to a dispensing facility

Access: Geographical Accessibility

19.1%

6.7%

10.0%

0%

10%

20%

% patients taking more than one hour to travelto the facility

NationalM

edian

Public Health PharmacyPrivate PharmacyMission Facilities

The median % of patients taking over an hour to travel to a dispensing facility was 19%,10% and 6.7% for the public, FBHS and private facilities respectively.

Table 16: Geographical Access Transport Costs

Facility typeAverage transportation cost to health facility

(National median)

KES Days wages

Public 9.7 0.04FBHS 26.0 0.10Private 33.9 0.13

The average travel cost to FBHS health facilities and private pharmacies was about 0.1days wage which was about 3 times that to public health facilities.

These findings show that most patients accessing treatment in all sectors take under an hourto reach the health facility. However, a larger proportion of those accessing treatment in thepublic sector take over an hour, compared with other sectors. Since patients may travel tohealth facilities on foot or by vehicle, the time taken is not necessarily a reflection of the

33

distance to the facility from the patients’ homes. Therefore, the cost of travelling to thefacility gives further insight into geographical accessibility.

The findings indicate that patients accessing treatment in public facilities spend less on travel.The average travel cost to all facilities was about 0.1 days wages, which may be unaffordableto the poor in Kenya. When examined against the relatively higher proportion of patientswho take over an hour to reach these facilities and the relatively higher transport costsincurred to FBHS and private facilities, it may be inferred that more patients travel to publicfacilities on foot (hence taking longer and spending less) compared with FBHS or privatefacilities (where patients take a shorter time, but spend more). Therefore, poverty is animportant factor affecting geographical access and may explain these findings.

4.5 MEDICINES QUALITY RELATED FACTORSThe survey examined two factors that critically affect the quality of medicines, i.e. medicinesexpiry and conditions for conservation and handling at health facilities and warehouses.

4.5.1 Presence of expired medicines

The existence of expired medicines on dispensing shelves, indicates the possibility of patientsreceiving them. To determine if such medicines were being distributed or sold, the expirydates of the available stock (generic and branded forms) of the 15 basic target medicines waschecked by direct examination and any pack of expired medicine noted.

If expired medicines were listed and kept in a designated location in the store to bedestroyed, this was not considered as an expiry. Table 17 highlights the findings in thegovernment, FBHS and private facilities; and the central warehouses.

Table 17: Percent of Expired Medicines

Average % expired medicines (by item)

Government health facilities 2.3

FBHS health facilities 2.1

Private medicines outlets 1.9

Government warehouse 0.0

FBHS warehouse (MEDS) 0.0

Incidences of expired medicines on dispensing shelves were noted for 2.3% of themedicines surveyed in government health facilities, compared with 2.1% in FBHS facilitiesand 1.9% in private retail outletsNo expired medicines were found on the shelves in KEMSA and MEDS warehouses

The low incidence of expired medicines in public and FBHS facilities, private pharmacies andcentral warehouses indicates that adequate measures are in place in all sectors to guardagainst expiry of medicines.

34

4.5.2 Adequacy of storage conditions in health facilities and the central warehouses

To determine the status of conservation and handling of medicines, a check list of theminimum criteria for adequacy of medicines handling and conservation conditions wasdeveloped prior to the survey, and is attached as Survey Form 5 (see Appendix 3). Theproportion of criteria met was noted separately for the medicines storeroom and dispensingarea of each facility surveyed, and an average was calculated for all facilities in each sector.Figure 10 illustrates the average proportion of adequate conservation and handlingconditions for medicines in the government, FBHS and private facilities.

Figure 10: Adequacy of medicines storage conditions

Adequacy of storage conditions (%)

60.0 61.8

75.0 72.7

80.077.3

50.0

100.0

0

20

40

60

80

100

Storeroom Dispensing area

GoK Facilities

Mission Facilities

Private medicine outlets

KEMSA

MEDS

The median adequacy of conservation and handling conditions for medicines was only60% in the storerooms and 62% in the dispensing areas of government health facilities;compared to 75% and 73% respectively in the FBHS health facilities.The central warehouse for the government sector (i.e. KEMSA) met only 50% of theminimum criteria for adequacy of medicines handling and conservation conditions,compared with the central FBHS warehouse (MEDS) which met all the criteria.Except for the central FBHS warehouse (MEDS) which met all the criteria, the adequacy ofmedicines handling and conservation conditions ranged from 50% in the governmentwarehouse to 80% in private medicine outlets.There were no significant variations in the storage conditions of medicine storeroomscompared to those of dispensing areas in all the sectors.

These findings indicate that storage conditions in public health facilities are criticallyinadequate, putting at risk the quality of medicines distributed through this sector. Comparedwith 2003, storage facilities for medicines have deteriorated or remained inadequate bothcentrally and in health facilities in the public sector. It is noteworthy that the central FBHSwarehouse met all the criteria, suggesting that systems are in place and resources deployedto better ensure proper conservation and handling of medicines in this warehouse.

35

4.6 RATIONAL USE OF MEDICINES

Rational medicines use is essential if waste and hazard to patients is to be minimised and thepotential for desired therapeutic outcomes maximised. Appropriate medicines prescribingand dispensing following well established good practices for each activity contribute toensuring that patients receive the correct medicines in the correct dose regimens togetherwith all necessary relevant and practical information on correct use and storage of eachmedicine. Prescribing and dispensing indicators can gauge health professionals’ practices androle in promoting appropriate medicines use.

4.6.1 Prescribing Indicators

Data on prescribing was collected through a retrospective review of outpatient treatmentrecords in each health facility. All available treatment records for the previous 12 monthswere obtained before beginning the sampling and a sample of 30 prescriptions selected ineach facility. This sample was used to determine the five prescribing indicators as describedin section 4.6.1. Table 18 and Fig 11 illustrate the findings on prescribing of medicines in thepublic and FBHS facilities and each indicator is discussed separately in the following sections.

Table 18: General Indicators for Rational Use of Medicines (by sector)

IndicatorReferencevalues

National Median

Public FBHS

Average no. medicines per prescription* <2 3.0 3.0

% patients prescribed an antibiotic <30 76.7 68.4

% patients prescribed an injection <20 13.3 26.8

% prescribed medicines on the EML 100 93.4 79.2

% medicines prescribed by generic name (INN) 100 31.8 34.7

% availability of standard treatment guidelines 100 41.7 25.0

% availability of essential medicines list 100 38.9 47.2

* This indicator was measured through patient exit interviews and facility sampled prescriptions,and the findings were the same

Figure 11: Prescribing of antibiotics, injections, medicines on the EML and by INN

Rational Medicines Use: Prescribing Practices

76.7

13.3

93.4

31.8

68.4

26.8

79.2

34.7

0

20

40

60

80

100

% patientsprescribedantibiotics

% patientsprescribedinjections

% prescribedmedicines on theessential medicines

list

% medicinesprescribed by

generic name (INN)

National%

GoK Facility Mission Facility

36

a) Average number of medicines per prescription

Polypharmacy the unnecessary prescribing of a large number of medicines for any singlecondition can be used as a proxy measure for irrational use of medicines. The number ofmedicines prescribed was established from the sample of 30 retrospective outpatient recordsin each facility, as described in (see section 3.1.5, p17).

The median number of medicines prescribed was found to be 2.8 and 2.9 for the FBHSand government facilities respectively meaning that the average patient exiting thefacilities had received 2 to 3 medicines.Outpatient records showed that in the past year, patients had received a median of 3medicines in both the FBHS and government health sectors.

The finding show similarities in prescribing practice between public and FBHS facilities; andpoly pharmacy is not a major problem in these facilities.

b) Percentage of patients prescribed an antibiotic

Over prescribing of antibiotics is a common type of inappropriate medicine use. The level ofantibiotic prescribing was determined through a sample of 30 retrospective outpatientencounters in the 36 health facilities in each sector (see section 3.1.4, p17). The proportion ofencounters where at least one antibiotic38 had been prescribed was determined.

The median % of patients prescribed one or more antibiotics in government healthfacilities was found to be 76.7% compared with 68.4% of patients in the FBHS sector.In 84.2% of government health facilities and in 83% of FBHS facilities, over 75% ofpatients were prescribed one or more antibiotics.

This finding suggests that antibiotic prescribing is high in both government and FBHS healthfacilities, being higher in the former. Over prescribing of antibiotics has many negative effectsincluding most importantly encouraging the development of antimicrobial resistance.

c) Percentage of patients prescribed an injection

Over prescribing of injections for out patients is a common type of inappropriate medicineuse. Injectable formulations are relatively expensive and require additional expenses such asneedles, syringes and other associated medicine administration costs. In additions, injectionscontribute to increased risks of infection transmission (e.g. Hepatitis B and HIV) throughcontaminated needles, injection abscesses and nerve damage. The prevalence of outpatientinjection use was determined through the same sample of 30 retrospective outpatientencounters in each health facility (see section 3.1.4, p17). The encounters where an injectionhas been prescribed were determined39.

The median % of patients prescribed one or more injections in government healthfacilities was found to be 13% compared with 27% in the FBHS sector.

38 Since antimicrobial agents are not always classified in the same way, definition of the medicinesconsidered to be antibiotics was agreed upon by the Survey Advisory Group and the data collectorsduring planning for the survey.39 For the purposes of this indicator, immunizations and injectable contraceptives were not counted.

37

This finding indicates a high prevalence of injection use in government and FBHS facilities,with the prevalence in FBHS facilities being twice as high as that in government facilities.

d) Percentage of prescribed medicines on the national EML

The Essential Medicines Concept is a core principle of the national pharmaceutical policy, andserves to guide health investments towards those medicines of priority importance for publichealth, thus promoting medicines access. In order for this goal to be attained, the nationalEssential Medicines List (EML) should be the basis for all public medicines procurement andprescribing. To measure the degree to which prescribing practice conforms to the nationalEML, the same sample of 30 retrospective outpatient encounters in each health facility (seesection 3.1.4, p17) was used, and the proportion of prescribed medicines that were listed inthe current EML was determined40.

The median % of medicines prescribed that were on the public sector supply list wasfound to be 93% and 79% in the government and FBHS health facilities respectively.

The finding indicates a high degree of conformance with the public sector supply list ingovernment health facilities, but less so in FBHS facilities. Given that an updated nationalEML was not published at the time, the lower level of conformance in the FBHS facilities isnot surprising, since the FBHS supply system would not necessarily be restricted to the publicsector supply list. Furthermore, this finding underscores the importance of having an updatednational EML to serve as a reference document for all sectors, and to facilitate objectivemonitoring of medicines use.

e) Percentage of medicines prescribed by generic name (INN)

Prescribing by its International Non proprietary Name (INN) enables the patient to obtain themost cost effective medicine available, without reference to its brand name or specificmanufacturer. The degree to which prescribing practice conforms to the principles of genericprescribing was measured through the same sample of 30 retrospective outpatientencounters in each health facility (see section 3.1.4, p17). Of the total medicines prescribed,the proportion prescribed by their generic (INN) name was determined.

The median number of medicines prescribed by generic name was 31.8% in governmenthealth facilities and 34.7% in FBHS facilities.

These findings indicate that prescribing by generic name is extremely low in public and FBHSfacilities. If medicines are prescribed by trade name and not subsequently substituted bygeneric equivalents at the time of dispensing, patients may pay unnecessarily more, andaffordability (and consequently accessibility) will be adversely affected. Prescribing by tradename can also mean that prescribers do not become adequately familiar with, and thereforedo not relate well to official medicines and therapeutics documents such as the EML and SCG,in which medicines are always stated by generic name.

40 For the purposes of this indicator, the public sector formulary list was used as proxy for thisindicator, because the national EML was under revision at the time of the survey.

38

f) Percentage availability of STG and EML

A national Essential Medicines List (EML) and Standard Treatment Guidelines (STG) orclinical guidelines are key documents for ensuring that medicines are procured, prescribedand dispensed rationally and in line with public health priorities. Decentralized health units,e.g. district level health services or individual health facilities may develop further morespecific formulary lists and manuals, based on the EML. These serve to guide medicines usewithin the context of the community where the health services are provided.

The survey sought to establish the availability of these documents in the public and FBHSfacilities.

The national EML, facility specific formulary and /or model WHO ML were found in 41.7%of the government health facilities.Standard Treatment Guidelines were found in 38.9% of the government health facilitiesThe national EML, facility specific formulary and/or model WHO EML were found in 25%of FBHS health facilities whilst STGs were found in 47.2% of these facilities.

These results indicate that these key documents for promoting RUM are not available tomost health care professionals.

g) Percent of tracer cases treated with the medicines recommended in national STGs

The national guidelines for management of diarrhoea in children below 5 years recommendoral rehydration salts (ORS). Antibiotics and/or antiprotozoals should only be prescribed fordysentery, and suspected cholera or amoebiasis. In the treatment of mild/moderatepneumonia in children under 5 years, the recommended first line antibiotic is cotrimoxazoleor amoxicillin (for patients previously treated with cotrimoxazole). The use of more than oneantibiotic is only recommended in cases of severe pneumonia, where two injectableantibiotics may be administered. The recommended treatment for URTI is symptomatictreatment of cough with simple linctus or a home remedy, adequate fluid intake +/ anantipyretic if fever is present but NO antibiotic. Artemether lumefanthrine is the medicineof choice in the management of uncomplicated malaria, and quinine tablets are therecommended second line treatment.

Treatment of diarrhoea in children under 5 yearsA major assumption was made that any diagnosis indicated as diarrhoea was equivalent tonon bacterial diarrhoea. This is because the tendency is to diagnose bacterial diarrhoea asthe causative agent, e.g. typhoid, amoebiasis, cholera, etc.

The median % use of ORS was 80% in public facilities and lower (60%) in FBHS facilities.The median % use of one or more antibiotics was high, at 70% and 50% in public andFBHS facilities respectively.The median % use of an anti diarrhoeal and/or antispasmodic agent in children under 5with diarrhea was 0% in the public facilities and 5% in FBHS facilities.

39

Table 19: Adherence of prescribers to recommended treatment guidelines

Condition Indicator Public FBHS

Median Ave Median Ave

Non bacterial diarrhoeain children <5 years

Total # of cases 10.0 9.4 10.0 8.9

% ORS 80.0 71.5 60.0 52.5

% Antibiotics 70.0 61.9 50.0 44.7

% Antidiarrhoealand/or Antispasmodic

0.0 13.9 5.0 16.4

Mild/mod. pneumonia inchildren <5 years

Total # of cases 10.0 9.6 10.0 9.2

% receiving any single 1st

line antibiotic95.0 80.3 61.3 63.7

% receiving >1 antibiotic 20.0 30.3 33.8 37.3

Non pneumonia ARI inpatients of all ages (URTI)

Total # of cases 10.0 9.7 10.0 9.2

% Antibiotics 100.0 87.9 90.0 90.0

Treatment of mild/moderate pneumonia (outpatient) in children under 5 yearsThe median % of patients receiving any single 1st line antibiotic was found to be 95% and61% in the government and FBHS facilities respectivelyThe median % receiving more than one antibiotic was found to be 20% and 34% in thegovernment and FBHS facilities respectively. This is clearly excessive.

Treatment of non pneumonic acute (upper) respiratory tract infection:

The median % use of antibiotics was found to be 100% and 90% in government and FBHSfacilities respectively

The findings on adherence to STGs for selected conditions are mixed. Whereas there is someconformance to recommended first line treatments, e.g. ORS for non bacterial diarrhea and afirst line antibiotic for mild moderate pneumonia, there was overall high prescribing ofantibiotics where they are not indicated.

4.6.2 Dispensing Indicators

Adequate labeling of medicines contributes to their appropriate use. If medicines are to beused properly, they should be labeled appropriately by the person dispensing them. Aneffective dispensing encounter should result in a patient having adequate knowledge thatwould enable them take the dispensed medicines correctly. The adequacy of medicineslabeling and patients’ knowledge of how to take their medicines, were used as proxies toassess quality of dispensing practice. Data on the % of prescription only medicines suppliedwithout a prescription was only obtained from private pharmacies.

Data was obtained from 30 prospective outpatient encounters at each health facilitysurveyed (see sec 3.1.5, p13). The interviewees were sampled from patients leaving thedispensing area or facility after they had been treated and received medicines. Table 20 andFigure 12 illustrate the findings on adequacy of labeling and patients’ knowledge ondispensed medicines.

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Table 20: Dispensing Indicators

IndicatorNational Median (by sector)

Public FBHS Private

%Medicines adequately labeled 5 21 40

% Patients who know how to take their medicines 77 87 93.3

% prescription medicines bought without a prescription 60.8

Figure 12: Adequacy of labeling and patient knowledge

Rational Medicines Use:Labelling & Patient Knowledge

5.34

76.64

20.69

86.87

40.00

93.33

0

20

40

60

80

100

% medicines adequately labelled % patients that Know how to takemedicines

GoK Facility Mission Facility Private Pharmacy

a) Percentage of medicines adequately labelled

An adequate label should include the patient’s name, the medicine name and strength andwritten instructions on how much is to be taken and the frequency of administration. Foreach medicine dispensed to the patient, the label was examined to check if it conforms to allrequirements for adequate labeling. A label was considered as adequate only if allrequirements were met.

The median % medicines adequately labeled in government facilities was found to be5.3%, i.e. only about 1 in every 20 labels were found to be adequateThe median % medicines adequately labeled in private pharmacies and FBHS facilities was21% and 40% respectively.

These findings indicate that labeling of medicines was grossly inadequate in all sectors andcritically low in government health facilities.

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b) Percentage of patients who know how to take dispensed medicines

Adequate knowledge includes knowing the complete and correct dose regime for eachmedicine, ie. appropriate dosage (how much) the frequency (how often) and the duration(how long).

The same patients sampled for adequacy of medicines labeling were also interviewed toassess this knowledge. At the exit interview, each patient was asked to explain briefly howthe medicine dispensed to them should be taken. A patient was considered as havingadequate knowledge only if, for each dispensed medicine, the patient recalled the completeand correct dose regime. The median percentage of those with adequate knowledge wascalculated separately for patients interviewed in government and FBHS facilities, and privatepharmacies.

For patients who obtained their medicines in government health facilities, 77% hadadequate knowledge of how to take of the medicines dispensed; compared to 87% and93% of those obtaining medicines from FBHS facilities and private pharmaciesrespectively.

Interestingly, despite the inadequacy of medicines labeling in all sectors, the majority ofpatients had adequate knowledge of how to take all the medicines dispensed. This couldindicate simply that patients had received adequate counseling from the prescriber and/ordispenser on how to take their medicines and were able to easily recall this recently receivedinformation. In comparing the adequacy of labeling and patients’ knowledge on dispensedmedicines across sectors, it is noteworthy that private pharmacies had the highest scores andgovernment facilities had the lowest scores. This would imply that the level of professionalpractice at least as it applies to labeling of dispensed medicines and counseling of patientsis higher in the private sector than the other (and in particular government) sectors.

c) Percentage of prescription only medicines bought without a prescription in theprivate sector

The existence of a prescription (and therefore a medical encounter) as the source of(prescription ) medicine seeking behavior should be the basis for all such medicine dispensingas a way to promote rational use of these medicines. Data was therefore collected fromprivate pharmacies to determine if consumers are purchasing and dispensers are sellingprescription medicines without prescription.

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Figure 13: Percentage of prescription medicines bought without a prescription

Rational Use of Medicines: % prescription medicines bought withoutprescription distribution of pharmacies

23.3%20.0% 20.0%

36.7%

0%

10%

20%

30%

40%

< 25% 25 50% 50 75% > 75%% range of prescription medicines bought without prescription

%of

Facilities

The above figure shows the proportion of private pharmacies which supplied prescriptiononly medicines without a prescription in four ranges for the proportion of these medicinessupplied in this way.

The median % of prescription medicines bought without a prescription was 61%Over 75% of prescription medicines were bought without a prescription in 37% of theprivate pharmacies

These findings indicate that in the private sector there is widespread dispensing ofprescription only medicines without a prescription. This suggests a lack of enforcement oflegal requirements for prescribing and dispensing of medicines.

4.7 HEALTH PROFESSIONALS PROFILESAppropriately trained health personnel contribute to rational use of medicines, throughcorrect diagnosis, prescribing and dispensing in accordance with established treatmentguidelines. The survey assessed the profiles of the personnel dispensing and prescribingmedicines in the health facilities, and the findings were assessed against the correspondinglegal requirements41.

4.7.1 Dispenser profile

The law in Kenya (the Pharmacy and Poisons Act Chapter 244, including subsequentamendments) recognizes the registered pharmacist and the enrolled pharmaceuticaltechnologist as the only two cadres of health personnel qualified to dispense medicines, andvests the authority to enforce these requirements with the Pharmacy and Poisons Board(PPB). The survey sought to establish the extent to which these authorized personnel were in

41 The Kenya Pharmacy and Poisons Act (Cap 44) section 29 allows sale of prescription only medicinesby pharmacists against prescriptions from duly qualified medical, dental and veterinary prescriptions

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fact dispensing medicines to out patients on the day of the visit to each facility, and whetherother health facility personnel were involved in the dispensing of medicines.

Table 21: Dispenser profile and compliance with the law

Professionals dispensing at time of visit% of Facilities per Sector

Public FBHS Private

Pharmacist 19.4 5.6 33.3

Pharmaceutical Technologist 27.8 27.8 61.1

Nurse 27.8 47.2 11.1

Pharmacy aide/Health assistant 11.1 30.6 44.4

Pharmacist intern 25.0 2.8 0.0

Untrained staff 41.7 25.0 13.9

Facilities complying with the law (i.e. presence ofa Pharmacist or Pharmaceutical Technologist)42

38.2 30.6 80.6

A pharmacist was found in only 19.4% and 5.6% of public and FBHS health facilitiesrespectively, and a pharmaceutical technologist in 27.8% of both public and FBHS facilities.Pharmacy interns were almost exclusively found in the public sector, in 25% of thesefacilities.Of the private pharmacies, 33.3% and 61.1% had pharmacists and pharmaceuticaltechnologists respectively. Overall 80.6% of the private dispensing outlets complied withthe law on dispensing by legally qualified personnel, a factor that may be attributed tothe fact that only registered drug outlets were included in the sample.Pharmacy aides/Health assistants were found more frequently in the FBHS facilities (31%)and private pharmacies (44%), and less so in the public sector (11%).Untrained staff were most frequent dispenser found in the public facilities (42%).

The findings suggest that few public and FBHS facilities adhere to the law concerningdispensing by qualified personnel. This is an indication of less stringent regulatoryenforcement in these sectors compared with the private sector. Furthermore, dispensing ofmedicines has largely been left to facility staff that are not recognized within existing legaland policy frameworks. This underscores the critical lack of trained pharmaceutical personnelin public and FBHS facilities, which inevitably has a serious negative impact on patients’safety and the quality of pharmaceutical services across the board. The minimumrequirements for pharmaceutical personnel are defined in the health sector norms andstandards43. These should be applied and appropriately reviewed to address this shortcoming.

42 Totals do not add up to 100 because in some facilities more than one staff member was founddispensing medicines43 Norms and Standards for Health Service Delivery, Ministry of Health, Kenya, June 2006

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Figure 14: Dispenser Profile and Facilities Compliance with National Laws

Dispenser Profile and Compliance with the Law

27.8%25.0%

41.7%

80.6%

33.3%

11.1%

61.1%

44.4%47.2%

25.0%

38.2%

19.4%

27.8%

11.1%

0.0%

13.9%

30.6%

2.8%

27.8%30.6%

2.8%

0%

20%

40%

60%

80%

100%

Facilities thatcomply withthe law

Pharmacistdispensing

Nursedispensing

PharmaceuticalTechnologistdispensing

Pharmacyassistant

Pharmacistintern

dispensing

Untrained staffdispensing

%of

Facilities

GoK Health Facility Private Pharmacy Mission Health Facilities

4.7.2 Prescriber profile

Depending on the norms and standards applicable to each level of health service delivery andthe availability of the required qualified personnel, different health cadres may be foundprescribing medicines in health facilities. The survey sought to determine the profiles ofpersonnel prescribing medicines to out patients. These prescriber profiles are summarised inTable 22 below.

Table 22: Prescriber Profile

PrescriberPrescribing at Most senior present

GOK FBHS GOK FBHS

Doctor 16.7% 27.8% 27.8% 30.6%Nurse 41.7% 38.9% 38.9% 30.6%Clinical Officer 52.8% 61.1% 30.6% 38.9%Other health worker 2.8% 0.0% 2.8% 0.0%Untrained staff 13.9% 5.6% n/a n/a

TOTAL 100% 100%Note: Figures rounded to nearest decimal place

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Figure 15: Prescriber Profile

Prescriber Profile: GoK and Mission facilities

41.7%

2.8%

13.9%

27.8%

0.0%

61.1%

52.8%

16.7%

5.6%

38.9%

0%

10%

20%

30%

40%

50%

60%

70%

Doctor Nurse Trained Health worker Clinical Officer Untrained Healthworker

Prescriber type

National % GoK Facilities Mission Facilities

The most frequent prescriber was a clinical officer found in 52.8 % of the governmentfacilities and 61% of FBHS facilities respectivelyNext was a nurse found in 41.7% of the government facilities and 38.9% of FBHSfacilities respectivelyThe most senior prescriber was found to be a medical doctor present in 28% ofgovernment health facilities though found actually prescribing in only 17% of the samplefacilities. Of these senior prescribers, 69% had participated in rational use of medicinestraining in the previous yearIn FBHS facilities the most senior prescriber was found to be a medical doctor present in31% of facilities surveyed and found prescribing in 28% of these. Of these seniorprescribers, 75% had participated in RUM training in the previous yearUntrained staffs were found prescribing in 13.9% of public facilities, and 5.6% of FBHSfacilities

The most frequent prescriber was the clinical officer, followed by the nurse. The medicaldoctor was present in less than one third of government and FBHS facilities, and was actuallyfound dispensing in even fewer of these facilities. Untrained personnel were sometimesfound dispensing in government and FBHS facilities, and more frequently in governmentfacilities. This finding underscores the shortage of properly trained and duly qualifiedprescribers and frequently particularly at lower level facilities prescribing is left in thehands of under qualified, or even in some cases unqualified staff. This inevitably has a seriousdetrimental effect on the quality of diagnostic and prescribing practices with potentialserious consequences for patient safety and therapeutic outcomes.

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5. SUMMARY OF RESULTS

Availability of Essential Medicinesa) The majority of basic medicines to treat common conditions at primary care level were

available in all sectors during this survey period. However, a broader scope of essentialmedicines was less available in facilities across all sectors.

o Of the basic 15 medicines, 87% were available in government facilities, 93% in FBHSfacilities, 100% in KEMSA, 87% in MEDS and 93% in private pharmacies.

o For a broader list of 36 essential medicines, 67% were available in governmentfacilities, 66% in FBHS facilities and 81% in private pharmacies.

b) Public and FBHS facilities experience stock outs of basic essential medicines for about 46and 14 days per year respectively. The public sector supply chain is especially prone tosignificant interruptions and critical stock outs, extending beyond 30 or even 90consecutive days.

c) KEMSA and MEDS have high availability and virtually no stock outs of basic essentialmedicines and they maintain adequate medicine stock records.

d) The proportion of prescribed medicines that were actually dispensed to patients was 98%in FBHS facilities compared with 86% in public facilities. Therefore, patients were morelikely to obtain all prescribed medicines from the FBHS facilities.

Medicine Prices and Affordabilitya) Procurement by KEMSA and MEDS is almost exclusively for generic products, and they

obtain price efficiency well below IRPs. With an MPR of 0.44, KEMSA obtainscomparatively lower procurement prices than MEDS with an MPR of 0.61.

b) Patients obtaining medicines from the public sector face comparatively lower or nofinancial barriers. Most (89%) surveyed medicines were issued for free in the publicsector, compared with 15% in FBHS facilities and none in the private pharmacies.

c) Patient prices (where charged) in the public sector were about 40% lower than those inthe FBHS facilities, and about 50% lower than those in the private sector.

d) Prices charged to patients for essential medicines in the public and FBHS facilities, are atleast four times higher than the respective procurement prices at the central level.

e) For the conditions studied, and with reference to the minimum wage, individualtreatments would be fairly affordable in all sectors and especially so in the public sector.

Qualitya) Incidence of expired medicines was only about 2% in all sectors; centrally and in facilities.

b) Storage conditions in public facilities are critically inadequate, putting at risk the quality ofmedicines in this supply system. Of those surveyed, 40% had inadequate storage facilities,compared with 25% and 20% of FBHS and private pharmacies respectively.

c) The MEDS warehouse met all the criteria for medicines storage and conservation,compared to KEMSA which met only 50% of the criteria.

d) Storage conditions in public health facilities were found to have deteriorated or remainedinadequate both centrally and in health facilities compared to the baseline of 2003.

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Rational Use of Medicinesa) The national STGs and EML key tools for promoting RUM were not available to most

health care workers in all sectors. National STGs were available in 42% and 25% of publicand FBHS facilities respectively whereas the EML was available in 39% and 47% of thesefacilities respectively.

b) In public and FBHS sectors, outpatient prescribing of injections in public and FBHSfacilities was 13% and 27% respectively, against a reference (target) value of 20%.

c) However, prescribing of antibiotics was high, being more than twice the reference valueand highest in public facilities. The proportion of patients prescribed an antibiotic in thepublic and FBHS facilities was 77% and 68% respectively, against a reference of 30%.

d) Prescribing by generic name was extremely low. Only 32% and 35% of medicines wereprescribed by generic name in the government and FBHS facilities respectively.

e) A median of 93.4% was found for medicines prescribed according to the national EML inthe public health facilities, indicating very good adherence of prescribers to this list.

f) Adherence of prescribers to standard treatment guidelines is mixed and inconsistent inboth sectors. Whereas there is some conformance to recommended first line treatments,there was overall high prescribing of antibiotics where not indicated.

g) Labeling of medicines was inadequate in all sectors and critically low in public facilities.Only 5% of medicines at public health facilities were adequately labeled compared with21% and 40% in FBHS facilities and private pharmacies respectively.

h) The majority of patients had fairly adequate knowledge of how to take the medicinesdispensed. Adequacy of this knowledge was lower (77%) for patients obtaining medicinesfrom public facilities, compared with 87% for FBHS facilities and 93% for privatepharmacies.

Health Professionals Profilesa) In the public and FBHS sectors, few facilities (38% and 31% respectively) complied with

the law concerning medicines dispensing by qualified pharmaceutical personnel.

o Pharmacists were found dispensing in only 19% and 6% of public and FBHS facilitiesrespectively; pharmaceutical technologists in 28% of both public and FBHS facilities.

o Dispensing was largely done by unqualified personnel. In particular, unqualifiedpersonnel were found dispensing in 41% of public facilities, compared to 25% of FBHSfacilities.

b) Licensed private pharmacies largely comply with the law on dispensing by qualifiedpersonnel: overall 33% and 61% had a pharmacist and a pharmaceutical technologistrespectively, and 81% complied with the law.

c) Untrained staff was themost frequent dispenser in public facilities (42%); nurses in FBHSfacilities (47%) and pharmaceutical technologists in private pharmacies (61%).

d) Pharmacy interns were almost exclusively found in the public sector (25% of facilities).

e) The clinical officer, followed by the nurse, was the most frequent prescriber. A clinicalofficer was prescribing in 53% of public and 61% of FBHS facilities respectively; and anurse was prescribing in 42% and 39% of these facilities respectively.

f) The medical doctor was present in less than one third of government and FBHS facilities,and was actually found prescribing in 17% and 28% of these respectively.

g) Untrained staff was found prescribing in 14% of public facilities and 6% of FBHS facilities.

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6. DISCUSSION

Essential Medicines to treat common diseases should be available in all health facilities,especially those where the poor access health services. Measures of availability refer to theactual situation on the day of the survey. They are dependent on the number of medicinesstudied and their scope with respect to the health priorities that have evolved with prevailingpolicies and practices of the health system. This survey reports an inverse variation inavailability of three expanded lists with respect to number and scope of medicines. Forexample, availability of the 15 basic medicines (Annex 6) was 85% and above in all sectors. Incomparison, for the broader global and the MMePA lists (32 and 36 medicines respectively),availability was much lower in all sectors. Most notably, the public and FBHS facilities hadonly about 66% of these medicines available. These findings infer that, for the full list ofmedicines on the EML, availability would be low.

Medicine stock outs in health facilities point to weaknesses in the distribution system, andlow overall performance of the supply chain. Any stock out of key medicines is a seriousoccurrence, since patients would fail to obtain the medicine when needed. KEMSA and MEDShad virtually no stock outs of basic medicines and maintained complete records for allmedicines, reflecting adequate stock management at these central warehouses. Against thisfinding, the more severe stock outs in public health facilities represent inadequacies in thecurrent system for medicines distribution and replenishment. Stock outs extending beyond30 days are serious, and those beyond 90 days critically jeopardize health service delivery.

The low performance of health facilities compared with the central warehouses may reflect alack of systematic investment in pharmaceutical services across all levels of the healthcaresystem. This is further supported by the finding of incomplete stock records for 23% of themedicines surveyed in public facilities. Adequate and complete stock records are a prerequisite for proper quantification and stock management, which ensure high availability andminimize stock outs. Whereas the FBHS facilities showed better performance compared withpublic facilities, the findings highlight gaps in this sector, especially in terms of stock outs andinadequate stock records.

The low proportion of public facilities with qualified pharmaceutical personnel is furtherevidence of skewed investment in pharmaceutical services, and a major hindrance toeffective health care delivery. This correlates with the low performance of health facilities,reflected in inadequate records and grossly inadequate labeling of medicines. More critically,the safety of patients is jeopardized when unqualified personnel assume responsibility forhandling and dispensing medicines, including the provision of drug information and patientadvice. Compared with private facilities, the lower compliance of public and FBHS facilitiesrepresents the current lack of enforcement of regulatory requirements for these providers.This is attributable to the lack of separation of roles (regulatory and service provision) in theMinistry of Medical Services. The dispensing of medicines by unqualified personnel in publicfacilities is particularly unacceptable.

A very positive finding is that KEMSA and MEDS are almost exclusively procuring genericproducts and are obtaining price efficiency in procurement well below IRPs. Furthermore,when public sector facilities provide the majority (89%) of these medicines for free, then theprice barrier that people may face when accessing medicines is significantly lowered.However, given the relatively low (67%) availability and frequent stock outs of the surveyed

49

medicines, the full potential of this sector to positively impact access cannot be realized.Furthermore, patient prices do not reflect the benefits of efficient centralized procurement.For some medicines, there is a four fold increase in the final prices to patients, representingdis connect between pricing structures at the procurement level and those in health facilities.Since KEMSA issues medicines to health facilities at procurement cost, charging patients fourtimes the KEMSA price may indicate lack of policy guidance on pricing of publicly procuredmedicines, through which patients would obtain the full price benefits of bulk procurement.

The survey demonstrates that the public, FBHS and private sectors approach the pricing ofmedicines differently, and patients obtaining medicines from the public sector generally facelower or no financial barriers. Whereas the private sector charged patients for all medicines,the public sector issued 89% of the medicines for free, compared with about 15% in FBHSfacilities. This infers good compliance of the public sector with Government policies onissuance of medicines for free. Furthermore, of the medicines that were charged for, patientprices in the public sector were about 40% lower than those in the FBHS facilities, and about50% lower than those in the private sector. Out of pocket medicines expenditure is a welldocumented barrier to access to medicines and appropriate treatment, especially for thepoor. The provision of free medicines for outpatients in public sector health facilities helps toimprove access to essential medicines, especially for those who could not afford to obtainmedicines from alternative sources.

The assessment of affordability was done with reference to the minimum government wage,and the selected individual treatments would be fairly affordable in all the sectors andespecially in the public sector. However, it should be noted that this affordability only refersto medicine prices, and not other treatment costs such as consultation or diagnostic tests. Inreality, many people in Kenya are unemployed, or in informal employment where they earnless than the minimum wage. As such, even treatments that would appear affordable may betoo costly for the poorest in the population. Furthermore, whereas individual treatmentsmay appear affordable, the treatment of co morbidities or chronic conditions often requiresa combination of medicines, and hence the cost of treating and managing a chronic conditionsuch as asthma, diabetes, and cardiovascular disease is likely to be more unaffordable than isreported in this study. The burden of treatment costs may be further compounded whenmore than one family member requires treatment, and some of the medicines areunavailable in public facilities.

The low incidence of expired medicines in government, FBHS and private facilities andcentral warehouses, indicates that effective measures are in place in all sectors to guardagainst expiry of medicines. This infers a minimal likelihood that expired medicines could bedispensed to patients. In contrast, storage conditions in public health facilities are criticallyinadequate, putting at risk the quality of medicines distributed through this sector. Comparedto 2003, storage facilities for medicines have deteriorated or remained inadequate bothcentrally and in health facilities in the public sector. In particular, the KEMSA warehouse metonly 50% of the minimum criteria for storage conditions, and public facilities about 60%.Because KEMSA supplies the majority of the health facilities in the country including someFBHS and private facilities the quality of publicly procured medicines is at risk throughinappropriate storage conditions. It is noteworthy that the central FBHS warehouse met allthe criteria, suggesting that systems are in place and resources deployed to better ensureproper conservation and handling of medicines in MEDS.

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Key tools for promoting RUM were not available in most health facilities, and this is reflectedin the mixed findings on prescribing and dispensing practices. Prescribers in public facilitieswere largely prescribing those medicines provided through the public supply system44,suggesting a high degree of ownership of this restricted list, which may be attributable to theconsultative process applied in annual reviews of the list. The FBHS has a similar reviewprocess which largely involves MEDS and prescribers in FBHS facilities. In the absence of anupdated national EML (as was the case during the survey) the supply lists for KEMSA andMEDS may be similar but not identical, and not surprisingly, prescribing in the FBHS facilitiesconformed less to the KEMSA List. Further, while poly pharmacy was not a major problem inboth the public and FBHS sectors and outpatient prescribing of injections was within thereference levels, antibiotic prescribing was high in both sectors and highest in the publicfacilities; and prescribing by generic name was extremely low. Prescribing by brand name,especially where the medicine is out of stock in the facility, may lead to the patients payingunnecessarily high prices for expensive branded products in the private sector.

The findings on adherence to STGs for tracer conditions are mixed. Whereas there is someconformance with recommended first line treatments, e.g. ORS for non bacterial diarrheaand a first line antibiotic for mild moderate pneumonia, not all children were prescribed ORS(median of 80% for public and 60% for FBHS facilities) and many patients received antibioticsthat were not indicated.

In the public and FBHS sectors, few facilities adhere to the law concerning dispensing byqualified pharmaceutical personnel and dispensing of medicines was largely done byunqualified personnel. It is especially noteworthy that untrained staff was the most frequentdispenser found in the public sector, suggesting that dispensing of medicines by unqualifiedpersonnel was widespread in public facilities. It is therefore not surprising that labelling ofmedicines was critically inadequate in these facilities, and patient knowledge on how to takedispensed medicines was low compared with other sectors. It can be inferred that patientsafety is seriously compromised by the widespread dispensing by unqualified personnel. Thisfinding points to the need for effective regulatory oversight of public and FBHS facilities, toensure conformance with the law. It is notable that some aspects of pharmaceutical serviceswere more adequate in FBHS facilities, compared with public facilities; this may beattributable to the systematic skills upgrading provided by the FBHS services.

Medicines’ prescribing is mostly done by clinical officers and nurses in public and FBHSfacilities, and they constitute critical cadres for promoting RUM. This importance isunderscored by the finding that medical doctors were present in less than one third of publicand FBHS facilities, and were actually found prescribing in fewer of these. However,untrained personnel were sometimes found prescribing in public and FBHS facilities, morefrequently in public facilities. This situation seriously compromises patient safety, as well asthe quality and credibility of health services. Although norms and standards have beendefined for ensuring effective delivery of the KEPH, current staffing levels for clinical andpharmaceutical personnel are well below these norms.

44 The public sector formulary list (i.e. KEMSA list) was used as the reference EML for this study,because the national EML was being revised at the time of the survey.

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7. CONCLUSIONS

This survey aimed to provide up to date information on access to essential medicines, withrespect to the performance of the health system, and the achievement of expectedoutcomes. Where feasible, progress is identified through comparison with 2003 baselineassessment. From the findings of this survey, it can be concluded that:

The majority of basic essential medicines to treat common conditions at primary carelevel are available and fairly affordable to Kenyans through the public, FBHS and privatesectors. But medicine stock outs are prevalent and sometimes critical and essentialmedicines for a broader scope of health needs are less available.

Centralized bulk procurement of essential medicines through KEMSA and MEDS is priceefficient and generally maintains adequate stocks of basic essential medicines.

The price barrier that people may face when accessing medicines is significantly less inthe public sector. Patients obtain the majority of basic essential medicines for free, or paythe lowest prices comparatively. However, frequent stock outs are a major barrier toaccess, especially for the poor.

The FBHS play a role in lowering the price barrier for medicines. Some medicines areissued for free and patient prices are generally lower than the private sector.

The price efficiency of centralized bulk procurement is not sustained in the pricing ofmedicines by the public and FBHS supply systems. Where medicines are not issued forfree, patients pay around four times the procurement prices in both sectors.

The storage infrastructure for medicines in the public sector is critically inadequatethroughout the supply chain, putting at risk the quality of medicines provided throughthis sector. Storage infrastructure in FBHS facilities is also inadequate.

There is mixed performance on RUM across all sectors, with some adherence to STGs buthigh prescribing of antibiotics and low prescribing by generic name. This may result froma lack of policy guidance or strategic approach to guide health sector investment inpromoting RUM.

The health sector faces a critical shortage of qualified pharmaceutical personnel tomanage medicines supply, dispensing and use. With about two thirds of public and FBHSfacilities lacking qualified personnel, pharmaceutical services are deficient: stock outs,inadequate records, inadequate dispensing practices and irrational use are consequencesof skewed priorities and uncoordinated investment in pharmaceutical services.

Regulations governing pharmaceutical services are not effectively enforced in the publicand FBHS sectors; and to a lesser extent the private sector. This is a serious threat both topublic safety and quality pharmaceutical services delivery.

Licensed private pharmacies have a significant role in improving access to medicines.Basic essential medicines are available, fairly affordable and largely dispensed by qualifiedpersonnel in compliance with the law; and the sector scores higher on most dispensingindicators.

Overall, findings of this survey indicate stagnating or deteriorating performance of the publicsector since 2003. Whereas availability has not changed significantly, stock outs in facilitieshave increased; and stock records and labelling of medicines have deteriorated.

52

8. RECOMMENDATIONS

The findings of this pharmaceutical situation assessment point to a mix of policies andstrategies that need to be implemented to improve access to Essential Medicines and theirappropriate use. The following are key recommendations addressed to Government,Development Partners, Civil Society, FBHS and the PPB:

To the Governmenta) Institutionalize and integrate monitoring and evaluation of pharmaceutical services within

the health sector coordination and M&E framework, to inform policies and strategies forimproving access to medicines.

b) Rationalize priorities and investments across the entire package of pharmaceuticalservices within the KEPH, to target the diverse gaps in access to essential medicines. Thiswould include appropriate personnel and storage infrastructure in line with publishednorms and standards.

c) Develop policies to promote the use of quality assured generic products, as a means ofsustaining affordability of essential medicines.

d) Deploy qualified personnel to public and FBHS health facilities in compliance with the law,in order to safeguard patient safety and improve medicines management, prescribing anddispensing.

e) Prioritize the upgrading of medicines storage infrastructure within the healthinfrastructure improvement plan, with particular focus on KEMSA, public health facilitiesand FBHS facilities.

f) Develop and implement a coordinated strategy to promote RUM. This may include:Institutionalized review, updating, dissemination and regular monitoring of therevised Standard Treatment Guidelines and Essential Medicines ListCoordinated and targeted training of health workers on Good Prescribing Practices,Good Dispensing Practices and injection safety practices.Monitoring the supply, pricing and utilization of specific medicines, e.g. injections andantibiotics.

g) Sustain and enhance the efficiencies of public and FBHS pharmaceutical procurement,through collaborative mechanisms such as coordinated informed buying.

h) In the elaboration of health financing policies, ensure that coverage for medicines is inline with the Essential Medicines Concept; and that financial barriers are eliminated tothe greatest extent possible.

i) Enhance coordination of pharmaceutical issues within health sector coordinatingframework, to facilitate comprehensive strategies and investments that capture the fullscope of pharmaceuticals within overall health sector strategic framework.

To Development Partners in Health – Kenya (DPH K)a) Facilitate a coordinated and evidence based approach to pharmaceutical services support,

in the context of existing health sector coordinating and investment mechanisms.b) Support coordinated pharmaceutical sector M&E – including periodic comprehensive

pharmaceutical situation assessments and integrate into ongoing programmes.c) Enhance support to human resources for pharmaceutical services in the public and FBHS

sectors within the context of the Human Resource for Health Strategic Plan.

53

Faith Based Health Services (FBHS)a) In consultation with Government and Development Partners, institute mechanisms to

improve affordability of key medicines in FBHS facilities, in a manner that supports andmaintains high availability. This may involve expanded subsidization and rationalization ofcurrent health sector investments on pharmaceuticals.

Civil Societya) Advocate for and support evidence based programming and investment in

pharmaceutical services.b) Enhance consumer awareness on the core factors affecting access to Essential Medicines,

and their role in improving appropriate use of medicines.

Pharmacy & Poisons Boarda) Enforce full compliance with the law on the handling and dispensing of medicines. This

should apply equally to the public, FBHS and private sector health providers.b) Liaise with the KMPDB to ensure that prescribing of medicines is done in conformance

with the law.

54

ANNEXES

55

56

ANNEX 1: SUMMARY LIST OF INDICATORS AND CORRESPONDINGSURVEY FORMS USED FOR DATA COLLECTION

Indicator Survey Form

Availability and Affordability1 a) Availability of key medicines in government & FBHS health facilities, private drug

outlets and central warehouses supplying government and FBHS health facilitiesb) Mean availability of originator brand and generic medicines in the government andprivate sectors

1, 10, 15,18

MMePA

2 % of prescribed medicines dispensed or administered to patients at government andFBHS health facility dispensaries

6,22

3 Average stock out duration in government & FBHS health facilities, and centralwarehouses supplying these

4, 16, 20

4 Adequate record keeping in government & FBHS health facilities, and centralwarehouses supplying these

4, 16, 20

5 Geographical accessibility of government & FBHS health facilities, and private drugoutlets

6, 14, 22

6 Indicators related to affordability and prices of medicines:a) Patient prices for generic and innovator drug in the government and private sectorsb) Prices of generic and innovator drug in government and private sector compared

with international price indexc) Affordability: ratio of cost to treat common conditions using standard regimen, to

the lowest daily government worker wage for moderate pneumonia, diabetes andasthma (in children) (no. of days wages to purchase lowest priced generic medicinesfrom government and private sectors)

MMePA

3,19

Quality1 % medicines expired in government & FBHS health facility dispensaries, private drug

outlets, and central warehouses supplying the government & FBHS facilities1, 10, 15, 18

2 Adequacy of storage conditions and of handling of medicines in government healthfacilities, warehouses supplying the government sector, and FBHS health facilities

5, 13, 17, 21

Rational Use of Medicines1 % medicines adequately labelled at government & FBHS health facility dispensaries, and

private drug outlets6, 14, 22

2 % patients knowledge of how to take medicines at government & FBHS health facilities,and private drug outlets

6, 14, 22

3 Average no. medicines per prescription at government and FBHS health facilities 6, 7, 22, 234 % patients prescribed antibiotics in government and FBHS health facilities 7, 235 % patients prescribed injections in government and FBHS health facilities 7, 236 % prescribed medicines on the EML at government and FBHS health facilities 7, 237 % medicines prescribed by generic name (INN) at government and FBHS health facilities 7, 238 Availability of standard treatment guidelines at government and FBHS health facilities 8, 249 Availability of essential medicines list at government and FBHS health facilities 8, 2410 % tracer cases treated according to recommended treatment protocol/guide at

government and FBHS health facilities9, 25

11 % prescription medicines bought without a prescription 14Health Professionals Profiles1 % facilities complying with the law (presence of a pharmacist) Section A, C, E2 % facilities with pharmacist, nurse, pharmacy aide/assistant or untrained staff

dispensingSection A, C, E

3 % facilities with doctor, nurse, trained health worker/health aide prescribing Section B, F4 % facilities with prescriber trained in RDU Section B, F

57

ANNEX 2: LEVEL II SURVEY FORMS45

Section A: Survey Forms 1 6

Survey Forms

Government Health Facility Pharmacies / Dispensaries

SF 1% key medicines available

% medicines expired

SF 3Affordability of treatment for adults and children under 5 years(pneumonia with no hospitalization)

SF 4 Average stock out duration

Adequate record keeping

SF 5 Adequate storage conditions and handling of medicines in storeroom & dispensing area

SF 6

Average number of medicines per prescription

% medicines dispensed or administered

% medicines adequately labelled

% patients knowing how to take medicines

Average cost of medicines

Geographical accessibility of dispensing facilities

General information: Government health facility pharmacy

Facility Date

Region Investigator 1

Investigator 2

Does the law require a pharmacist / pharmaceutical technologist to be present during hours ofoperation of government / government / FBHS pharmacies / medicines outlets?

Yes NoIs a pharmacist / Pharm Tech present at the time of the visit? Yes NoAssessment

1 complies with the law (items 1 and 2 are both Yes)2 does not comply with the law (item 1 Yes and item 2 No)

Who is dispensing during the time of visit? (check all that apply)Pharmacist (1=Yes; 0=No) Pharmacy assistant (certificate) (1=Yes; 0=No)Nurse (1=Yes; 0=No) Pharmacy Intern / Student (1=Yes; 0=No)Pharm Tech (1=Yes; 0=No) Untrained staff (1=Yes; 0=No)

45 Note: certain survey forms applicable to the FBHS or private sectors have not been included In theAnnexes as they are identical to included forms used in government facilities

58

Survey Form 1: Government Health Facility Pharmacy

Indicators: % key medicines available % medicines expired

Facility Date

Province Investigator 1

District Investigator 2

Key Medicines for Common ConditionsIn stockYes=1,No=0

Expired medicineson shelvesYes=1, No=0

[A] [B] [C]1 ORS (WHO recommended formula) (note if old formula)

2 Zinc sulfate tablets 20mg

3 Amoxicillin capsules 250mg or 500mg

4 Amoxicillin suspension 125mg/5mL

5 Artemether/Lumefantrine) tablets 20/120mg (any pack size)

6Ferrous salt tablets (any salt, either alone or in combinationwith folic acid)

7 Albendazole tablets 400mg

8 Tetracycline eye ointment

9 Adrenalin injection 1mg/mL

10 Clotrimazole cream 1%

11 Paracetamol tablets 500mg

12 Paracetamol syrup / suspension 120mg/5mL

13 Metronidazole tablets 200mg

14 Ciprofloxacin tablets 250mg (or Norfloxacin tablets 400mg)

15 Chlorpheniramine syrup 2mg/5mL

[B1] = Sumof B =

[C1] = Sum of C =

[B2] = % instock = B1 ÷15 x 100 =

[C2] = % expired =C1 ÷ B1 x 100 =

Notes:

[A] The list of 15 key medicines has been identified at national level and is preprinted on the survey forms.

[B]Mark “1” if any quantity of any dosage form of the medicines is in stock in the facility on the day of the visit.

Mark “0” if the medicine is not available in stock. Add the total at the bottom [B1]. Calculate the percentage in stock [B2]by dividing the total in stock [B1] by 15 and multiplying by 100.

[C] For all medicines in stock, check if any of the stock is expired. If any amount of a medicine has expired mark “1” foryes. Do not count expired medicines stored in a separate area for destruction. Add the total at the bottom [C1]. Calculatethe percentage expired [C2] by dividing the total expired [C1] by the total number of medicines in stock [B1] andmultiplying by 100.

Facility # _____(1 – 36)

59

Survey Form 3: Government Health Facility Pharmacy

Indicators: Affordability of treatment moderate pneumonia for adults &children under 5 years of age (equivalent no. of days’ wages)

Facility Date

Province Investigator 1

District Investigator 2

Medicine /INN and Preparation

No. of unitsneeded tocompletetreatment

Unit price(one vial,tab or cap)

(KES)

Total cost oftreatment[D] = B x C

(KES)

Equivalentno. dayswages

[F] = D ÷ E

[A] [B] [C] [D] [F]

Moderate pneumonia (without hospitalization): Treatment of Choice:

Adult: Amoxicillin 250mg capsules 42 caps [F¹] =

Child <5: Amoxicillin 125mg/5mL susp 100mL 1 bottle [F²] =

Other adult condition: Diabetes Insulin dependent (without hospitalization)

Human Insulin 30/70 10mL vial [F³] =

Other paediatric condition: Asthma (without hospitalization) Child <5 treatment of choice:

Beclomethasone inhaler 50mcg/dose 1 inhaler [F4] =

[E] = Lowest daily government salary = KES 249Notes:

[A] Using standard treatment guidelines, the treatment of choice and the recommended preparation (dosage strength & form)were identified and pre printed for moderate pneumonia (no hospitalisation). Do not include medicines used only for relief ofmild symptoms, e.g. paracetamol or cough syrup.

[B] The number of units of each medicine needed for the duration of treatment (based on STG) should be identified at thenational level and preprinted on the survey forms.If the other condition is a chronic illness, include the number of units in a month’s supply.

[C] Indicate in local currency the unit price or the price the facility charges patients for each medicine. The lowest pricedbranded or generic equivalent medicine should be used. If there are flat charges paid for each medicine given to patients, thisamount should be recorded as the price of the medicine. Indicate “0” if medicines are given free. Add cost of syringes to theunit price, if applicable.

[D] Calculate total cost of treatment [D] by multiplying the number of units needed [B] by unit price [C]. If patients are chargeda flat fee for treatment course, record this as total cost of treatment.

[E] Identify at the national level and preprint on the form the lowest daily government salary. If the weekly salary is known,divide this by 7 to obtain the daily salary. If the monthly salary is known, divide this by 30 to obtain the daily salary.

[F] Calculate the number of days wages needed to pay for treatment by dividing the cost of treatment [D] by the lowest dailygovernment salary [E].

Example:

Medicine /INN and Preparation

No. of unitsneeded tocompletetreatment

Unit price(one vial/ tab/cap)

(KES)

Total cost oftreatment[D] = B x C

(KES)

Equivalent no.days wages[F] = D ÷ E

[A] [B] [C] [D] [F]Moderate pneumonia (without hospitalization)Procaine penicillin: 1g (1 MU) 3 injections 280 (inj + syringe) 840 11.2Amoxicillin: 125mg/ml susp. 100ml 1 bottle 220 220 2.93[E] = Lowest daily government salary = KES 249

Facility # _____(1 – 36)

60

Survey Form 4: Government Health Facility Pharmacy

Indicators: Average stock out duration Adequate record keeping

Facility Date

Province Investigator 1

District Investigator 2Only collect data for medicines with records covering at least 6 months within the past 12 months

Key medicines forcommon conditions

Records coverat least 6 mthswithin past 12mths Yes=1,

No=0

No.ofdaysout ofstock

No. of dayscovered byreview (at

least 6 mths)

Equivalent no.of stock outdays /year

[E] = C x 365 ÷ D

# [A] [B] [C] [D] [E]

1ORS (WHO recommended formula)(note if old formula)

2 Zinc sulfate tablets 20mg3 Amoxicillin capsules 250mg or 500mg4 Amoxicillin susp. 125mg/5mL5 AL tablets 20/120mg (any pack size)

6Ferrous tablets (any salt, either aloneor in combination with folic acid)

7 Albendazole tablets 400mg8 Tetracycline eye ointment9 Adrenalin injection 1mg/mL10 Clotrimazole cream 1%11 Paracetamol tablets 500mg12 Paracetamol syrup/susp 120mg/5mL13 Metronidazole tablets 200mg

14Ciprofloxacin tablets 250mg orNorfloxacin tablets 400mg

15 Chlorpheniramine syrup 2mg/5mL[B1] = Sum of B = [E1] = Sum of E =

[B2] = % adeq.records = B1 ÷ 15x 100 =

[F] = Average number of stock out days = E1 ÷ B1 =

Notes:

[A] The list of 15 key medicines identified for Survey Form 1 is preprinted on this form.

[B] Go through the stock cards and indicate which medicines have records covering at least 6 months within the previous12 months. Add the total at the bottom [B1]. Calculate the % of medicines with adequate records [B2] by dividing thenumber of medicines with records covering at least 6 months [B1] by 15 and multiplying by 100.

[C] The review should cover 6 12 months. Go through the stock cards covering the review period. Indicate the number ofdays each medicine was not available or marked “0” on the card. A medicine is considered in stock if any quantity of it isavailable in generic or brand.

[D] Indicate the number of days actually reviewed for each medicine.

[E] Compute the equivalent number of stock out days/year for each medicine by multiplying the number of days out ofstock [C] by 365 and dividing by the number of days covered by the review [D]. Add the total number of stock out days [E1].

[F] Calculate the average number of stock out days by dividing the total number of stock out days [E1] by the total numberof medicines reviewed [B1].

Facility # _____(1 – 36)

61

Survey Form 5: Government Health Facility Pharmacy / Dispensary

Indicator: Adequate storage conditions and handling of medicines instoreroom and dispensing area

Facility Date

Province Investigator 1

District Investigator 2

Checklist

StoreroomTrue=1,False=0

DispensingArea/Room

True=1, False=0[A] [B]

1. There is a method in place to control temperature (e.g. roof &ceiling with space between them in hot climates, airconditioners, fans, etc)

2. There are windows that can be opened orthere are air vents

3. Direct sunlight cannot enter the area (e.g. window panes arepainted or there are curtains/blinds to protect against the sun)

4. Area is free from moisture(e.g. leaking ceiling, roof, drains, taps, etc.)

5. There is a cold storage in the facility (fridge/cold room)

6. There is a regularly filled cold storage temperature chart

7. Medicines are not stored directly on the floor

8. Medicines are stored in a systematic way (e.g. alphabetical,pharmacological)

9. Medicines are stored first expiry first out (FEFO)

10. There is no evidence of pests in the area

11. Tablets/capsules are not manipulated by naked hand

[A1] = Sum ofA =

[B1] = Sum of B =

[A2] = Score =A1 ÷ 10 x 100 =

[B2] = Score = B1 ÷11 x 100 =

Notes:

[A] Indicate “1” if all parts of the statement are true for the storeroom and “0” if any part is false. Sum the totalnumber of true statements in [A1]. Calculate the score for the storeroom [A2] by dividing the sum of truestatements [A1] by 10 and multiplying by 100.

[B] Indicate “1” if all parts of the statement are true for the dispensing room and “0” if any part is false. Sum thetotal number of true statements in [B1]. Calculate the score for the dispensing room [B2] by dividing the sum of truestatements [B1] by 10 and multiplying by 100.

* It may be necessary to look elsewhere in the facility for some of the criteria (e.g. refrigerator)

Facility # _____(1 – 36)

62

Survey

Form

6:Gov

ernm

entHealthFacilityPh

armacy/Dispe

nsaryPa

tien

tCa

reExitInterview

Indicators:

Average

numbe

rof

med

icines

perprescription

%pa

tien

tskn

owho

wto

take

med

icines

%med

icines

dispen

sedor

administered

Average

costof

med

icines

%med

icines

adeq

uatelylabe

lled

Geo

grap

hicalaccessibilityof

facilities

Facility

Date

Region

Investigator

1

District

Investigator

2

Patien

tsex

M/F

Age

(yrs)

1)<5

2)5–15

3)16

–60

4)>60

No.

ofmed

icines

prescribed

No.

ofmed

icines

dispen

sedor

administered

No.

ofmed

icines

adeq

uately

labe

lled

Patien

tkn

owsho

wto

take

med

icines?

Yes=1,

No=

0

Amou

ntpa

tien

tpa

idfor

purcha

sed

med

icines

(KES)

How

long

didittake

for

thepa

tien

tto

getto

the

health

facilitytoda

y?1)

<30

mins

2)31

60mins

3)>60

mins

How

muchdiditcost

tocomehe

re?

(KES)

[A]

[B]

[C]

[D]

[E]

[F]

[G]

[H]

[I]

1 2 up to 30

[A1 ]=

Sum

cases=

[B1 ]=Sum

of1=

[B2 ]=Sum

of2=

[B3 ]=Sum

of3=

[B4 ]=Sum

of4=

[C1 ]=Sum

ofC=

[D1 ]=Sum

ofD

=

[E1 ]=Sum

ofE=

[F1 ]=Sum

ofF=

[G1 ]=Sum

ofG=

[H1 ]=Sum

of1=

[H2 ]=Sum

of2=

[H3 ]=Sum

of3=

[I1 ]=Sum

ofI=

[I2 ]=Average

tran

sportcost=

I1÷totalrespo

nses

=[A

2 ]=

Sum

females=

[C2 ]=

Average

no.o

f

[D2 ]=%

dispen

sed=D1

÷C1

x10

0=

[E2 ]=%

adeq

uately

labe

led=E1

[F2 ]=%

know

how

totake

[G2 ]=

Average

cost=G1÷

[I3 ]=Average

Facility#_____

(1–36

)

63

Patien

tsex

M/F

Age

(yrs)

1)<5

2)5–15

3)16

–60

4)>60

No.

ofmed

icines

prescribed

No.

ofmed

icines

dispen

sedor

administered

No.

ofmed

icines

adeq

uately

labe

lled

Patien

tkn

owsho

wto

take

med

icines?

Yes=1,

No=

0

Amou

ntpa

tien

tpa

idfor

purcha

sed

med

icines

(KES)

How

long

didittake

for

thepa

tien

tto

getto

the

health

facilitytoda

y?1)

<30

mins

2)31

60mins

3)>60

mins

How

muchdiditcost

tocomehe

re?

(KES)

[A]

[B]

[C]

[D]

[E]

[F]

[G]

[H]

[I]

[A3 ]=%

females

=A2÷A1

x10

0=

med

icines

=C1

÷A1=

÷D1x10

0=med

icines

=F1÷A1x

100=

total

patien

ts=

tran

sportcostto

minim

umda

ilysalary

=[I2 ]÷[J]=

[J]=

Lowestda

ilygo

vernmen

tsalary

=24

9KS

hNotes:

[A&B]

Interview30

patie

ntsleavingthedispen

sing

area

/ph

armacy.Obtainthesexandageof

thepatie

nt,not

thoseof

thepe

rson

obtainingthemed

icine.Use

thenu

mbe

rof

patie

nts/casesableto

respon

dto

correspo

ndingqu

estio

nsas

deno

minatorsfor(G,H

,I,J,K)

[A]R

ecordthenu

mbe

rof

cases[A

1 ]andthenu

mbe

rof

females

[A2].C

alculate

the%of

females

bydividing

thetotalnum

berof

females

[A2]

bythetotalnum

berof

cases[A1]

and

multip

lyingby

100.

[C]R

ecordthenu

mbe

rof

med

icines

prescribed

foreach

patie

nt.C

ombinatio

nmed

icines

inon

edo

sage

form

coun

tason

emed

icine.Sum

thenu

mbe

rof

med

icines

prescribed

forall

patie

nts[C1].Ca

lculateaveragenu

mbe

rof

med

icines

prescribed

[C2]

bydividing

numbe

rof

med

icines

prescribed

[C1]

bynu

mbe

rof

cases[A1].

[D]R

ecordthenu

mbe

rof

med

icines

dispen

sedor

administeredto

each

patie

nt.Sum

thetotalnum

ber[D1].Calculate

the%of

med

icines

dispen

sed[D2]

bydividing

thenu

mbe

rof

med

icines

givento

allpatients[D1]

bythetotalnum

berof

med

icines

prescribed

[C1]

andmultip

lyingby

100.

[E]R

ecordthenu

mbe

rof

med

icines

labe

lledwith

atleastthe

name&strength

ofthemed

icineandho

wto

take

it(dose&freq

uency–inwords)*.C

ount

onlymed

icines

meetin

gbo

thcrite

ria.Sum

thetotal[E1].Calculatethe%of

med

icines

adeq

uatelylabe

lled[E2]

bydividing

thetotalnum

berof

adeq

uatelylabe

lledmed

icines

[E1]

bythetotalnum

berof

med

icines

dispen

sed[D1]

andmultip

lyingby

100.

[F]D

etermineifpatie

nt(oran

adulta

ccom

panyingapaed

iatricpatie

nt)kno

wsho

wto

take

allm

edicines

dispen

sed(patient

know

sdo

sage

anddu

ratio

nof

alldispe

nsed

med

icines*).M

ark

“1”on

lyifpatie

ntcancorrectly

stateho

wALL

med

icines

shou

ldbe

takenand“0”othe

rwise.

Sum

thetotal[F1].Calculatethe%of

patie

ntswho

know

howto

take

allm

edicines

[F2]

bydividing

thetotalnum

berwho

know

howto

take

allm

edicines

[F1]

bythetotalnum

berinterviewed

[A1]

andmultip

lyingby

100.

[G]R

ecordtheam

ount

each

patie

ntpaidou

tof

pocket

forallm

edicines

received

atthefacility.Ch

eckwith

areceiptifp

ossible.Sum

thetotalamou

nt[G1].Calculate

theaverage

med

icines

costby

dividing

theam

ountspaidformed

icines

[G1]

bythetotalnum

berinterviewed

ableto

respon

d.

[H]R

ecordthetim

eittook

thepatie

ntto

gettothefacility.Indicate

thecode

s13.Sum

thetotalofp

atientsineach

category

[13].

[I]N

otetravelcostinlocalcurrency(in

clud

ingcostsforaccompanyingpe

rson

whe

repatie

ntcouldno

ttravelalone

).Sum

thetotalamou

nt[I1

].Calculatetheaveragetransportcost[I2

]by

dividing

theam

ountspaidfortransport[J1]

bythetotalnum

berinterviewed

person

sableto

respon

d.To

calculatethe=Average

transportcostto

minim

umdaily

salary

[I3],divide

the

averagetransportcostb

ytheminim

umdaily

salary

[J]

64

Section B: Survey Forms 7–9

Survey FormsGovernment Health Facilities

SF 7* Average number of medicines per prescription% patients prescribed antibiotics% patients prescribed injections% prescribed medicines on Essential Medicines List (EML)% medicines prescribed by generic name (INN)

SF 8 Availability of Standard Treatment Guidelines (STG)Availability of Essential Medicines List (EML)

SF 9 % tracer cases treated according to recommended treatment protocol / guide

*For SF 7: Use only general outpatient records. Do not select patients from well child visits, preand post natal visits, specialist consultations, or even separate clinics for adults and paediatriccases because treatment practices are different.

General information: Government health facility

Facility Date

Region Investigator 1

District Investigator 2

1.Who is prescribing during the time of visit? (check all that apply)*

doctor (1=Yes; 0=No) nurse (1=Yes; 0=No)

trained health worker / health aide (1=Yes; 0=No)

clinical officer (1=Yes; 0=No) untrained health worker (1=Yes; 0=No)

1.1Who is the most senior prescriber?

doctor (1=Yes; 0=No) nurse (1=Yes; 0=No)

trained health worker/health aide (1=Yes; 0=No)

clinical officer (1=Yes; 0=No)

2. Has the most senior prescriber named in 1.1 attended rational use of medicines (RUM)related training within the last year? (Note: RUM curriculum can include any of the following:rational prescribing, essential medicine concept, use of IMCI or other clinical guidelines)

Yes (=1) No (=0)

* If there are several prescribers, interview the most senior prescriber only.

65

Survey Form 7: Government Health Facility: Prescribing Indicator Form

Indicators: Average number of medicines per prescription; % prescribed medicines onEML; % patients prescribed antibiotics/injections; % medicines prescribed bygeneric name

Facility Date

Region Investigator 1

District Investigator 2

TypeR/P

Age (yrs)1) <52) 6 153) 16 604) > 60

SexM/F

No. ofmedicines Rxd

AntibioticRxdYes=1No=0

InjectionRxd

Yes=1,No=0

No. of Rxdmedicineson EML

No. ofmedicines Rxdby genericname INN)

[A] [B] [C] [D] [E] [F] [G]

1

2

Upto

30

[A] = Sum of cases=

[B1] = Sumof females=

[C1] =Sum of C =

[D1] =Sum of D=

[E1] =Sum of E =

[F1] =Sum of F =

[G1] =Sum of G =

[A1+2] = Sum of paed.cases = (1) + (2) =

[B2] = %females =B1 ÷ A1 x100 =

[C2] = Ave.no. ofmedicines= C1 ÷ A1 =

[D2] = %receivinga/biotics =D1 ÷ A1 x100 =

[E2] = %receivinginjections= E1 ÷ A1 x100 =

[F2] = %EML = F1 ÷C1x 100 =

[G2] = % INN =G1 ÷ C1 x 100 =

[AP] = % paediatriccases = A1+2 ÷ A x 100 =

Rxd = Prescribed;Notes

[A] From outpatient treatment records, select 30 patients seen within the last 12 months(R = retrospective sampling). If records are not available, select 30 patients currently being treated (P = prospective sampling).Sample can combine R & P. Mark “R” if patient was selected retrospectively; “P” if patient was selected prospectively. Record thenumber of cases [A] and the number of paediatric cases [A1+2]. Calculate the percentage of paediatric cases by dividing the totalnumber of paediatric cases [A1+2] by the total number of cases [A] & multiplying by 100.

[B] Record the number of females [B1]. Calculate the percentage of females by dividing the total number of females [B1] by thetotal number of cases [A1] and multiplying by 100.

[C] Record number of medicines (chemical entity, INN, generic) prescribed. Combination medicines in one dosage form count asone medicine. Total the number of medicines prescribed [C1]. Calculate average number of medicines prescribed [C2] by dividingnumber of medicines prescribed [C1] by number of cases [A1].

[D] Record “1” if patient was prescribed any antibiotics and “0” otherwise. Total the cases receiving antibiotics [D1]. Calculatepercentage of cases with antibiotics [D2] by dividing number of cases with antibiotics [D1] by number of cases [A1] andmultiplying by 100. (For Kenya Consider only oral/injectable anti bacterial agents)

[E] Record “1” if patient was prescribed any injections and “0” otherwise. Total the cases receiving injections [E1]. Calculatepercentage of cases receiving injections [E2] by dividing number of cases with injections [E1] by total number of cases [A1] andmultiplying by 100.

[F] Record number of prescribed medicines on the national Essential Medicines List (EML). Total the number of prescribedmedicines on the EML [F1]. Calculate the percentage of prescribed medicines on the EML [F2] by dividing the number of medicineson the EML [F1] by the number of medicines prescribed [C1] and multiplying by 100.

[G] Record number of medicines prescribed by INN. Total the number of medicines prescribed by INN [G1]. Calculate percentageof medicines prescribed by INN [G2] by dividing number of medicines prescribed by INN [G1] by number of medicines prescribed[C1] and multiplying by 100.

Facility # _____(1 – 36)

66

Survey Form 8: Government Health Facility: Essential Medicine Information

Indicators: Availability of Standard Treatment Guidelines (STG)Availability of Essential Medicines List (EML)

Facility Date

Region Investigator 1

District Investigator 2

Standard Treatment Guidelines (STG) availableYes=1, No=0

[A]

STG for pneumonia (as part of combined or disease specific STG)

STG for malaria (as part of combined or disease specific STG)

[A1] = Both STGs are present =

Essential Medicines List (EML) updated within last 5 years availableYes=1, No=0

[B]

National EML 0

Provincial / District EML (Not applicable to Kenya)

Facility specific EML

Other EML (describe):

[B1] = At least one current EML is present =

Notes:

[A] Identify the second required STG at the national level and preprint on the form. Thisshould be for an important disease in the region, e.g. malaria in endemic areas orhypertension. Check to see if there is a copy of each of the STGs either as part of a combinedSTG or a disease specific STG. Record “1” if the facility is able to present a copy of thedocument and “0” if the facility is unable to present the document. If both STGs are presentrecord “1” in [A1] otherwise record “0”.

[B] Record “1” next to each type of EML updated within the last 5 years that is physicallypresent in the facility. If the facility is unable to present the document or if the EMLpresented has not been updated in the last 5 years, record “0”. If any current EML isavailable, mark “1”in [B1], otherwise record “0”.

Facility # _____(1 – 36)

67

Survey Form 9: Government Health Facility

Indicator: % of tracer cases treated according torecommended treatment protocol / guide

Facility Date

Region Investigator 1

District Investigator 2

Tracerconditions &medicinesprescribed

[A]

Use of medicines by caseYes=1, No=0 [B] Total

no. ofcases[C]

No. ofcases Rxdmedicine

[D]

% ofcases Rxdmedicine[E] =D ÷ C x100[E]

1 2 3 4 5 6 7 8 9 10

Non bacterial diarrhoea in children under 5 years

Antidiarrhoealand/orantispasmodic

Mild/moderate (outpatient) pneumonia in children under 5 years

[A1] First line antibiotic(s) in national STG: amoxicillin suspension 125 mg/5mL or cotrimoxazolesuspensionPrescribed >1antibiotic

Non pneumonia acute respiratory tract infection (ARI) in patients of any age

Any antibiotic

[A2] Optional tracer condition 1: Malaria

Quinine tablets

Notes:[A] At the national level, identify and preprint on the form the first line antibiotic(s) mentioned in thenational STG for pneumonia [A1]. If data on treatment of other important local conditions is desired,preprint on the form the optional tracer conditions [A2] and the medicines that will be used tomeasure recommended or non recommended practices.[B] From general adult or paediatric outpatient records, select 10 patient encounters with each targetcondition. If possible, choose only single diagnosis encounters. Write “1” or “0” for each case selectedto indicate whether or not each target medicine was prescribed.[C] Total the number of cases in each row.[D] Total the number of cases in each row that were prescribed the target medicine.[E] For each row, calculate the percentage of patients receiving each medicine [E] by dividing the totalnumber of cases that were prescribed each medicine [D] by the total number of cases [C] andmultiplying by 100.

Facility # _____(1 – 36)

68

Survey form 15: Central/regional/district warehouse supplying the public sector

Indicator: % key medicines available % medicines expired

Facility Date

Region Investigator

Key medicines to treat common conditionsIn stock

Yes=1, No=0

Expiredmedicines on

shelvesYes=1, No=0

[A] [B] [C]

1. ORS (new formula)

2. Amoxicillin capsules 250mg/500mg

3. Amoxicillin suspension 125 mg/5ml

4. Artemether/lumefantrine (20/120 mg) tablets (any pack)

5. Ferrous salt tablets (alone or in combination with folic acid)

6. Albendazole 400mg tablets

7. Tetracycline eye ointment 1%

8. Povidone iodine 10% solution

9. Clotrimazole cream 1%

10. Paracetamol tablets 500mg

11. Paracetamol/syrup suspension 120mg/5ml

12. Metronidazole tablets 200mg

13. Ciprofloxacin tabs 250mg/norfloxacin tabs 400mg

14. Glibenclamide tablets 5mg

15. Nifedipine retard tablets 20mg

[B1] = Sum of B=

[C1] = Sum of C =

[B2] = % in stock= B1 ÷ 15 x 100 =

[C2] = % expired= C1 ÷ B1 x 100 =

Notes

[A] The same lists of 15 key medicines used for Survey Form 1 preprinted on the survey forms.

[B] Mark “1” if any quantity of any dosage form of the medicine is in stock in the facility on the day of thevisit. Mark “0” if the medicine is not available in stock. Add the total at the bottom [B1]. Calculate thepercentage in stock [B2] by dividing the total in stock [B1] by 15 and multiplying both by 100.

[C] For all medicines in stock, check if any of the stock is expired. If any amount of a medicine has an expiryproblem, mark “1” for yes. Do not count expired medicines stored in a separate area for destruction. Addthe total at the bottom [C1]. Calculate the percentage expired [C2] by dividing the total expired [C1] by thetotal number of medicines in stock [B1] and multiplying by 100.

Central/district warehouseFacility #____ (1 5)

69

Survey Form 16: Central/regional/district warehouse supplying the public sector

Indicators: Average stock out duration Adequacy of record keeping

Facility Date

Region Investigator

Only collect data for medicines with records covering at least 6 months within the past 12 months

Key medicinesto treat common conditions

Records coverat least 6 mthswithin the past12 monthsYes=1, No=0

No ofdaysout ofstock

No of dayscovered bythe review(at least 6months)

EquivalentNo of daysper year

[E] = C x 365 ÷D

[A] [B] [C] [D] [E]

1. ORS (new formula)

2. Amoxicillin caps 250mg/500mg

3. Amoxicillin susp 125 mg/5ml

4. Artemether/lumefantrine(20/120 mg) tablets (any pack)

5. Ferrous salt tablets (alone or incombination with folic acid)

6. Albendazole 400mg tablets

7. Tetracycline eye ointment 1%

8. Povidone iodine 10% solution

9. Clotrimazole cream 1%

10. Paracetamol tablets 500mg

11. Paracetamol/syrup suspension120mg/5ml

12. Metronidazole tablets 200mg

13. Ciprofloxacin tabs250mg/norfloxacin tabs 400mg

14. Glibenclamide tablets 5mg

15. Nifedipine retard tablets 20mg

[B1] = Sum of B=

[E1] = Sum ofE =

[B2]=%adequaterecords =B1÷ 15x 100 =

[F] = Average number of stockout days = E1 ÷ B1 =

Central/district warehouseFacility #____ (1 5)

70

Notes

[A] The list of 15 key medicines and optional additional medicines identified for Survey Form1 should also be preprinted on this form.

[B] Go through the stock cards and indicate which medicines have records covering at least 6months within the previous 12 months. Add the total at the bottom [B1]. Calculate thepercentage of medicines with adequate records [B2] by dividing the number of medicineswith records covering at least 6 months [B1] by 15 and multiplying by 100.

[C] The review should cover 6 12 months. Go through the stock cards covering the reviewperiod. Indicate the number of days each medicine was not available or marked “0” onthe card. A medicine is considered in stock if it is available in generic or branded form.

[D] Indicate the number of days actually reviewed for each medicine.

[E] Compute the equivalent number of stockout days per year for each medicine bymultiplying the number of days out of stock [C] by 365 and dividing by the number of dayscovered by the review [D]. Add the total number of stockout days [E1].

[F] Calculate the average number of stockout days by dividing the total number of stockout days[E1] by the total number of key medicines reviewed [B1].

Example:

Key medicinesto treat common conditions

Records coverat least 6 mthswithin the past12 monthsYes=1, No=0

No ofdaysout ofstock

No of dayscovered bythe review(at least 6months)

EquivalentNo of daysper year

[E] = C x 365 ÷D

[A] [B] [C] [D] [E]

Cotrimoxazole 1 90 180 182.5

Paracetamol 1 30 365 30

Amoxicillin 0

[B1] = Sum of B= 2

[E1] = Sumof E = 212.5

[B2] =%adequaterecords = B1÷15 x 100 = 66.7

[F] = Average number of stockout days = E1 ÷ B1 = 106.25

71

Survey Form 17: Central/regional/district warehouse supplying the public sectorIndicator: Adequacy of conservation conditions and

handling of medicines

Facility Date

Region Investigator

ChecklistStoreroom

True=1, False=0

[A]

1. There is a method in place to control temperature (e.g. roofand ceiling with space between them in hot climates, airconditioners, fans, etc)

2. There are windows that can be opened or there are air vents.

3. Direct sunlight cannot enter the area (e.g. window panes arepainted or there are curtains/blinds to protect against the sun)

4. Area is free from moisture (e.g. leaking ceiling, roof, drains,taps, etc.).

5. There is a cold storage in the facility

6. There is a regularly filled temperature chart for the cold storage

7. Medicines are not stored directly on the floor

8. Medicines are stored in a systematic way (e.g. alphabetical,pharmacological)

9. Medicines are stored first expiry first out (FEFO)

10. There is no evidence of pests in the area

[A1] = Sum of A =

[A2] = Score

= A1 ÷ 10 x 100 =

Notes:

[A] Indicate “1” if all parts of the statement are true for the storeroom and “0” if any part ofit is false.Sum the total number of true statements [A1].Calculate the score for the storeroom [A2] by dividing the sum of true statements [A1] by10 and multiplying by 100.

* It may be necessary to look elsewhere in the facility for some of the criteria (e.g.refrigerator)

Central/district warehouseFacility #____ (1 5)

72

ANNEX 3: CHARACTERISTICS OF OUTPATIENTS INTERVIEWED

Category of healthfacility

No. ofoutpatientsinterviewed

No.Female

%Female

Age No. %

Public Hospital 355 213 60.00

1) under 5 yrs. 112 31.55

2) older children 40 11.27

3) adults 188 52.96

4) over 60 yrs 15 4.23

Public Health Center 232 140 60.34

1) under 5 yrs. 69 29.74

2) older children 44 18.97

3) adults 112 48.28

4) over 60 yrs 10 4.31

Public Dispensary 430 216 50.23

1) under 5 yrs. 174 40.66

2) older children 79 18.37

3) adults 154 35.81

4) over 60 yrs 23 5.34

FBHS Hospital 386 220 56.99

1) under 5 yrs. 85 22.02

2) older children 72 18.65

3) adults 227 58.81

4) over 60 yrs 32 8.29

FBHS Health Centre 104 62 59.61

1) under 5 yrs. 32 30.77

2) older children 17 16.35

3) adults 44 42.31

4) over 60 yrs 11 10.58

FBHS Dispensary 411 230 55.96

1) under 5 yrs. 109 26.52

2) older children 71 17.27

3) adults 207 50.36

4) over 60 yrs 24 5.84

Private Pharmacy 920 450 48.91

1) under 5 yrs. 154 16.74

2) older children 109 11.85

3) adults 574 62.39

4) over 60 yrs 70 7.61

Totals 2838 1531 53.95

1) under 5 yrs. 735 25.59

2) older children 432 15.12

3) adults 1506 53.06

4) over 60 yrs 185 6.21

73

ANNEX 4: LIST OF DATA COLLECTORS

Name Designation

1 Dr. Caroline Olwande Pharmacist

2 Dr. Oduor Onyango Pharmacist

3 Dr. Hadley Sultani Pharmacist

4 Dr. Stanley Ndwiga Pharmacist

5 Dr. Marsellah Ogendo Pharmacist

6 Dr. Tracy Njonjo Pharmacist

7 Dr. Newton Angawa Pharmacist

8 Omar Farah Ibrahim Pharm Tech

9 Ali S. Kidzuga Pharm Tech

10 Rose Makena Kiunga Pharm Tech

11 Abdullahi Abdikadir Pharm Tech

12 Dr. Julia Kimondo W Pharmacist intern

13 Dr. Alex Muchugia Pharmacist intern

14 Dr. Mark Makomere Nduku Pharmacist intern

15 Dr. Faith Riziki Mjambili Pharmacist intern

16 Dr. Nancy W. Njuguna Pharmacist intern

17 Dr. Winnie Nganga Pharmacist intern

18 Grace M. Komen Pharm Tech

19 Maina P. Njuguna Pharm Tech

20 Ibrahim O. Mokaya Pharm Tech

21 James Kariuki Thuo Pharm Tech

22 Andrew M. Kairu Pharm Tech

23 Solomon K. Koech Pharm Tech

24 K. Yussuf Hassan Pharm Tech

25 Joseph M. Mutungi Pharm Tech

26 Gideon K. Too Pharm Tech

74

ANNEX 5: LIST OF SAMPLED HEALTH FACILITIES

Table 1: List of Government Facilities

Province Largest Hospital Other HospitalHealthCentre

Other dispensingoutlets

NairobiKenyatta NationalHospital

Mbagathi DH Ruai HC

Eastleigh HC

Huruma Lions Disp

Lower Kabete Disp

Rift Valley Nakuru PGH Chemolingot SDH Nairage HC

Tinet Disp

Ngambo Disp

Naibor Ajikjik Disp

Nyanza Nyanza PGH Bondo DH Kabondo HC

Anyuongi Disp

Nduru Kadero Disp

Kokwanyo Disp

Western Kakamega PGH Sirisia SDH Sio Port HC

Buduta Disp

Eshikuyu Disp

Mihuu Disp

Coast Coast PGH Kilifi DH Garsen HC

Railways Disp

Mbalambala Disp

Mirihini Disp

North Eastern Garissa PGH Wajir DH Hulugho HC

Khalalio Disp

Tarbaj Disp

Saka Disp

75

Table 2: List of FBHS Facilities

Province Facility Name District

NORTHEASTERN

Kag Sombo Dispensary Garissa

Khadija Mosque Dispensary Mandera

Elwak MHC Clinic Mandera

Wajir AIC Dispensary Wajir

Wajir Catholic Dispensary Wajir

NYANZA

Kendu Hospital Rachuonyo

Matata Nursing Home Rachuonyo

Lwak St.Elizabeth Hospital Bondo

Nyamonye Catholic Dispensary Bondo

Bolo St. Clare Dispensary Kisumu

St.Monicah' Hospital Kisumu

COAST

Chonyi St.Theresa Dispensary Kilifi

Wema Dispensary Tana

Emmaus Dispensary Tana River

Zion Community Dispensary Mombasa

Mary Immaculate Cottage Hosp Mombasa

Mewa Medical Centre Mombasa

WESTERN

Namboboto Mission Disp ACK Busia

Nangina Holy Family Hospital Busia

Kalacha AIC Dispensary Kakamega

Musoli St Pius Dispensary Kakamega

Friends Lugulu Mission Hosp. Bungoma

St Damiano Medical Centre Bungoma

RIFT VALLEY

St. Mary's Catholic Hospital Nakuru

Njoro Pcea Health Centre Nakuru

Kapeddo Mission Hospital Baringo

Marigat Catholic Mission Clinic Baringo

Siyiapei Aic Dispensary Narok

Naikarra Health Centre AGC Narok

NAIROBI

St Mary's Mission Hospital NRB Nairobi

Good People World Family Clinic Nairobi

St.Angela Dispensary Nairobi

Mukuru Mary Immaculate Clinic Nairobi

Korogocho Health Centre RGC Nairobi

Buruburu Friends Church Clinic Nairobi

76

Table 3: Facilities sampled but not surveyed during field work

Province Facility Name DistrictReasons forsubstituting

Alternative facility

NORTHEASTERN

AshabitoDispensary

Mandera Area insecure Khalalio Dispensary

KAG Sombo Disp. Garissa Could not be traced Al Farouk dispensary

Towba MedicalCare Garissa

Could not be traced AIC Dispensary Garissa

Khadija Mosquedispensary Mandera

Institutional facility in agirl’s school.

Simahu Mission Hospital

Elwak MHC Clinic Mandera Could not be tracedYoung MuslimDispensary

Wajir CatholicDispensary

WajirInadequate no. ofinterviewees

SDA Mission Hospital

NYANZA

Matata NursingHome

RachuonyoFound to be a privatefacility

St.Joseph NyabondoMission (KisumuDistrict) sampled sinceno other facilities inRachuonyo

Bolo St. ClareDispensary

KisumuInadequate no. ofinterviewees

Awasi Catholic Mission

COAST

EmmausDispensary

Tana RiverDistrict HealthManagement Teamunaware of its existence.

St. Raphael Dispensary

MbalambalaDispensary

Tana RiverFacility inaccessible dueto security reasons.

Pumwani Dispensary

RIFT VALLEY Tinet Dispensary NakuruClosed following postelection violence

Njoro Health Centre

NAIROBIGood People WorldFamily Clinic

Nairobi Could not be traced.Coptic Hospital NgongRoad

WESTERN

NambobotoMission Disp Ack

BusiaInadequate no. ofinterviewees

Butula Mission HealthCenter

Kalacha AicDispensary

KakamegaInadequate no. ofinterviewees

St. Elizabeth Mukumu

Musoli St PiusDispensary

Kakamega

Unable to locate it andDistrict HealthManagement Teamunaware of its existence.

St.Mary's Mumias

77

ANNEX 6: BASIC (CORE) MEDICINES LIST (COUNTRY LIST)1. ORS (new formula)2. Amoxicillin capsules 250mg/500mg3. Amoxicillin suspension 125 mg/5ml4. Artemether/lumefantrine (20/120 mg) tablets (any pack)5. Ferrous salt tablets (alone or in combination with folic acid)6. Albendazole 400mg tablets7. Tetracycline eye ointment 1%8. Povidone iodine 10% solution9. Clotrimazole cream 1%10. Paracetamol tablets 500mg11. Paracetamol/syrup suspension 120mg/5ml12. Metronidazole tablets 200mg13. Ciprofloxacin tabs 250mg/norfloxacin tabs 400mg14. Glibenclamide tablets 5mg15. Nifedipine retard tablets 20mg

ANNEX 7: MMEPA MEDICINES LISTThis list was used to gather medicines data for determination of availability and affordability indicators:

1. Aciclovir tab 200 mg2. Amitriptyline tab 25 mg3. Amodiaquine tab 200mg4. Amoxicillin susp 125 mg / 5 mL5. Amoxicillin cap / tab 250 mg6. Amoxicillin / clavulanic susp 125 / 31 mg / mL7. Amoxicillin / clavulanic tab 500 / 125mg8. Artemether / lumefantrine tab 20 / 120mg9. Atenolol tab 50mg10. Beclomethasone inhaler 50 mcg / dose11. Carbamazepine tab 200 mg12. Ceftriaxone inj 250 g powder13. Ciprofloxacin tab 250 mg14. Clotrimazole cream / oint 15% w/v15. Co trimoxazole paed susp 8 / 40 mg / mL16. Co trimoxazole tab 80 / 400mg17. Diclofenac tab 25mg18. Ferrous Sulfate / Folic Acid combination tab 200mg/400mcg19. Fluconazole cap / tab 200 mg20. Fluphenazine inj 25 mg / ml21. Furosemide tab 40 mg22. Glibenclamide tab 5 mg23. Ibuprofen tab 200 mg24. Insulin human 30 / 70 injection25. Lamividine / stavudine / nevirapine tab 3TC/d4T/NVP 150 / 40 / 200 mg26. Metformin tab 500 mg27. Nifedipine retard 20 mg28. Omeprazole cap 20 mg29. ORS (new WHO formula) sachet for 500 mL30. Oxytocin inj 5 IU / mL31. Phenytoin cap 100 mg32. Pyrimethamine / sulfadoxine 25 / 500 mg33. Quinine dihydrochloride inj 300 mg / mL34. Ranitidine tab 150 mg35. Salbutamol inhaler 0.1 mg / dose36. Zidovudine (AZT)/ lamivudine (3TC) tab 300 / 150 mg

78

REFERENCES

1. Norms and Standards for Health Service Delivery, Ministry of Health, Kenya, June 2006

2. Assessment of the pharmaceutical situation in Kenya: a baseline survey, Ministry ofHealth/WHO/HAI, 2003

3. Kenya National Pharmaceutical Policy (KNPP), Ministry of Medical Services/Ministry ofPublic Health, 201046

4. Price components and essential medicines in Nairobi, Kenya, Ministry of Health, WHO andHealth Action International Africa; 2007 (unpublished draft)

5. WHO Operational Package for Assessing, Monitoring and Evaluating CountryPharmaceutical Situations: Guide for Coordinators and Data Collectors. WHO/TCM/2007.2(includes Level 1 Assessment Questionnaire)

6. Using indicators to measure country pharmaceutical situations: Fact Book on WHO Level Iand Level II monitoring indicators.WHO/TCM/2006.2

7. Results from other countries can be found in the above document, in WHO country specificreports, and periodically in journals, such as the Bulletin of the World Health Organization.

46 Expected date of publication

79

GLOSSARY

Healthy Life Expectancy at Birth (HALE): aka Disability Adjusted Life Expectancy is a WHOsummary measure of the level of health that captures the full health experience of thepopulation, and not just mortality. It is a measure of life expectancy adjusted for non fataloutcomes, and is used to assess health systems performance. It is most easily understood asthe lifespan in full health, i.e. without disability.(see http://www.euro.who.int/document/ehr/e76907d.pdf orhttp://www.who.int/healthinfo/statistics/indhale/en/ for more details)

Median: In a series of numbers, the median is the value in the middle of the distribution. Half ofthe responding facilities would have reported values below the median, and half a value abovethe median. Similarly, the 25th and 75th percentiles are the values reported by 25 and 75 percent of the facilities, respectively

Medicines: this term has generally superseded the term ‘drugs’ in current health andparticularly pharmaceutical documents. In this report the term is generally used in a broadersense to include other health consumable items (i.e. than just pharmaceuticals), also known asmedical supplies or health supplies, which may be required for provision of health services, e.g.dressings, syringes, needles, diagnostic consumables, etc.

Pharmaceuticals: these are the specifically drug related items used in provision of healthservices which are presented and administered in various dose forms, e.g. tablets, capsules,injections, creams, etc. The term is often used synonymously with the term medicines in manyhealth related documents.

Public (health) sector: The Government Sector which is managed primarily and jointly by theMinistry of Public Health and the Ministry of Medical Services. This sector also includes anumber of health facilities under the authority/responsibility of the Ministry of LocalGovernment and other public sector bodies such as the Army, Police, Prisons and nationalparastatals.

Ministry of MedicalServices

ofand

Ministry  Public HealthSanitation