a landscaping analysis of injectable antibiotics for ... · barriers to antibiotics for treatment...
TRANSCRIPT
i
FINAL REPORT
SAMASHA MEDICAL
FOUNDATION
MARCH, 2015
A Landscaping Analysis of Injectable Antibiotics for
Treatment of Neonatal Sepsis to Inform the MOH and
Partners how to Ensure the Availability and Appropriate
Use of Injectable Antibiotics to Treat Neonatal Sepsis in
Uganda:
ii
List of Acronyms
AFRINEST African Neonatal Sepsis Trial
CHAI Clinton Health Access Initiative
CHI Community Health Insurance
CSOs Civil Society Organizations
DHO District Health Officer
DHT District Health Teams
EC Every Woman Every Child
EMHS Essential Medicines and Health Supplies
FGD Focus Group Discussions
HBB Helping Babies Breathe
HC Health Centre
HCW Health care worker
IDI Infections Disease Institute
IMCI Integrated Management of Childhood Illnesses
MOH Ministry of Health
NDA National Drug Authority
NGOs Non-governmental Organizations
NMS National Medical Stores
PCHE Private Current Health Expenditure
PFP Private for Profit
PNFP Private Not for Profit
PSBI Possible Severe Bacterial Infection
QPPU Quantification and Procurement Planning Unit
iii
ReACT Action on Antibiotic Resistance
RMNCH Reproductive Maternal Newborn and Child Health
SATT Simplified Antibiotic Therapy Trial
SHU Save for Health Uganda
SNO Senior Nursing Officer
TCMP Traditional and Complementary Medicine Practitioners
UBOS Uganda Bureau of Statistics
UCG Uganda Clinical Guidelines
UHMG Uganda Health Marketing Group
UN United Nations
UNC Uganda Nurses Council
UNWU Uganda Nurses and Midwives Union
UPA Uganda Pediatric Association
VHT Village Health Team
iv
Table of Contents
List of Acronyms ................................................................................................................................ i
Acknowledgement ........................................................................................................................... vii
Executive Summary ......................................................................................................................... viii
CHAPTER 1: INTRODUCTION ...............................................................................................................1
1.0 Introduction ........................................................................................................................................ 1
1.1 Background ......................................................................................................................................... 1
1.2 Objectives, purpose and scope of Study ............................................................................................. 2
CHAPTER 2: METHODOLOGY AND APPROACH ....................................................................................3
2.0 Introduction ........................................................................................................................................ 3
2.1 Data Collection tools ........................................................................................................................... 3
2.2 Health facility selection ....................................................................................................................... 4
2.3 Health Facility Level ............................................................................................................................ 6
2.4 Data Analysis ....................................................................................................................................... 6
2.5 Data Management and Ethical Consideration .................................................................................... 7
2.6 Quality Control Measures ................................................................................................................... 7
CHAPTER 3: KEY FINDINGS..................................................................................................................8
3.1 Current Policy Environment ................................................................................................................ 8
3.2 The Public Sector Supply Chain System for Gentamicin and Dispersible Amoxicillin ......................... 9
3.3 Pricing Of Gentamicin and Dispersible Amoxicillin in the Private Sector ......................................... 12
3.4 Expenditure on Health in Uganda ..................................................................................................... 15
3.5 Cost Recovery Schemes that could be leveraged to increase access to Treatment of Neonatal
Sepsis ...................................................................................................................................................... 17
3.6 Availability of drugs, Use, and related barriers ................................................................................. 19
3.7 Diagnosis And Treatment Of Neonatal Sepsis .................................................................................. 27
3.8 Restrictive regulatory environment affecting ability to administer injectable antibiotics ............... 31
3.9 Accessible and acceptable presentation and delivery ...................................................................... 33
3.10 Challenges And Barriers To Treatment Of Neonatal Sepsis ............................................................ 34
3.11 Recommendations put forward to reduce neonatal sepsis deaths ................................................ 35
4: CONCLUSIONS AND KEY RECOMMENDATIONS .............................................................................. 38
4.1 Conclusions ....................................................................................................................................... 38
v
4.2 Recommendations ............................................................................................................................ 39
REFERENCES .................................................................................................................................... 41
LIst of Tables
Table 1: Key Stakeholder Organizations ....................................................................................................... 4
Table 2: Sampled Districts ............................................................................................................................. 5
Table 3: Summary of Pertinent Uganda Policies ........................................................................................... 8
Table 4: EMHS Kit by Type of Health facility ............................................................................................... 11
Table 5: Summary of Supply chain mark-ups .............................................................................................. 14
Table 6: Amoxicillin 250mg, generic and locally manufactured ................................................................. 14
Table 7: Amoxicillin 250 mg (100 capsules per pack) Generic, Imported ................................................... 15
Table 8: Private Current Health Expenditure by Schemes FY 2010/11 -FY 2011/12 .................................. 16
Table 9: Staff Availability by Type of Facility, n =64(%).............................................................................. 19
Table 10: Availability of selected medicines and supplies, All Facilities (n=64) .......................................... 21
Table 11: Availability of Drugs by Facility Type ........................................................................................... 22
Table 12: Availability of Injectable antibiotics in lower level health facilities (N=29) to manage neonatal
sepsis 23
Table 13: Average number of days stock-out at HC III ............................................................................... 26
Table 14: Number of staff available to treat with injectable antibiotics, Lower Level Health Facilities (HC
II &III) 27
Table 15: Staff availability staff at lower level health facilities that can treat neonatal sepsis using oral
antibiotics .................................................................................................................................................... 29
Table 16: Reported Commonly used Oral antibiotics ................................................................................. 30
Table 17: Implementing Partners active in Newborn Management .......................................................... 30
Table 18: Factors hindering Neonatal sepsis management and possible solution ..................................... 33
Table 19: Recommendations to help reduce neonatal mortality due to sepsis (n=61) ............................. 35
Table 20: Solutions made by lower Health facility to reduce neonatal sepsis deaths (n=28) .................... 36
List of Figures
Figure 1: Map of Uganda showing 10 demographic regions where data was collected .............................. 5
Figure 2: Number of Sampled Health Facilities by Type ............................................................................... 6
Figure 3: Availability of injectable antibiotics at HC II and HC III ................................................................ 23
vi
Figure 4: Adequate supplies of antibiotics at heath facility (N=61) ……………………………………………………..24
Figure 5: Quantities Procured by level of health facility (N=61) ................................................................. 24
Figure 6: Stock-out rates by level of Facility (n=64) .................................................................................... 25
Figure 7: Stock-out of selected Injectable antibiotics in HC IIIs .................................................................. 25
Figure 8: Health staff aware of interventions in case of stock-out over the last 3 months (n-59) ............. 26
Figure 9: Reported Health staff with skills to diagnose and treat Neonatal Sepsis (N=64) ........................ 27
Figure 10: Drugs commonly used to treat Neonatal Sepsis ........................................................................ 28
Figure 11: % of number of staff that can treat and manage using oral antibiotics ................................... 29
Figure 12: Awareness of any restrictive laws………………………………………………………………………………………..31
Figure 13: Restrictive Laws by type of facility ............................................................................................. 31
Figure 14: Willing to use a simplified regiment for treatment of neonatal sepsis ..................................... 32
List of Annexes
Annex 1: Landscape Analysis Structured Questionnaire ............................................................................ 42
Annex 2. Procurement, Wholesale, Warehousing And Distribution Agents Guide .................................... 47
Annex 3. District Level Structured Questionnaire ...................................................................................... 50
Annex 4. Health Facility Level Structured Questionnaire ........................................................................... 54
Annex 5. Focus Group Discussions Guide ................................................................................................... 59
vii
Acknowledgement
This is to acknowledge Save the Children for the financial support that enabled the landscaping
analysis to take place. The support of the Ministry of Health and particularly Prof. Anthony K
Mbonye, the Director Clinical and Community Health Services and chair of the RMNCH Country
Core team. The Assistant Commissioner Health Services, Child Health, Dr. Jesca Nsungwa were
very instrumental in the design of the data collection tools and providing a letter of
introduction for the study.
The Save the Children/Saving Newborn Lives team comprised of Hanifah Sengendo and Patrick
Aliganyira was very critical for the success of this activity.
Lastly many thanks for the Samasha team that organized and executed this activity. The
Samasha Team comprised of Dr. Moses Muwonge, Justine Kange, Cornelia Asiimwe, Denis Aliti
and Fiona Nalubega. The field teams comprised of Dr. Rebecca Kivumbi, Patrick Mubangizi, Dr.
Kasirye Phillip, Dr. Kazibwe Lawrence, Dr. Bagasha Peace, Dr. Atiku Isaac, Dr. Ajok Florence, Dr.
Kyokutamba Hellen, Dr. Mwanja Nicholas, Dr. Ssekikubo Jackson, Dr. Katumba Fredrick, and Dr.
Mutanda Julie.
viii
Executive Summary
The landscaping analysis was commissioned to assess policy and regulatory environment,
procurement and suppliers in Uganda, cost-recovery schemes, availability, use, and related
barriers to antibiotics for treatment of neonatal sepsis. The assessment aimed to understand
the feasibility and acceptability of the different packaging and delivery of antibiotics for
treatment of neonatal sepsis on an outpatient basis.
This was a nationwide assessment covering all the 10 regions as demarcated by the Uganda
Bureau of Statistics (UBOS). One health sub-district was randomly selected from each of the
regions. From each health sub-district, one Health Centre IV and two lower level health facilities
(HC III and HC II) were randomly selected. Wherever available, one private for-profit and one
private not-for-profit health facility were also selected, based on convenience of physical
access. In case the district had a district hospital, it was purposefully selected. The assessment
thus covered 40 public health facilities, 14 private for profit health facilities and 10 private not
for profit health facilities. Data was collected using a structured questionnaire and focus group
discussions were held with health providers at health facilities where the minimum number of
staff was at least five. National level key informant interviews were also conducted.
At national level, there are policy restrictions to prescription of injectable antibiotics to
neonates by nurses, but the policy allows nurses to administer injectable antibiotics once a
prescription has been made by a clinical officer or medical doctor. There is no specific
quantification for Gentamicin and dispersible Amoxicillin for treatment of neonatal sepsis at
NMS and MOH QPPU. The quantifications carried out for iCCM for treatment of Pneumonia
address children above 2 months. All the warehousing and distribution agencies surveyed had
adequate stock of Gentamicin and Amoxicillin; however, a limited number had dispersible
Amoxicillin.
At health facility level, there were stock outs which contributed to low use of Gentamicin and
Amoxicillin, with 42% of health workers reporting use of Gentamicin and 42% using dispersible
amoxicillin to treat neonatal sepsis. The majority of health workers (80%) expressed the need
for simplified regimens for treatment of neonatal sepsis. The major bottleneck to use of
injectable Gentamicin was the packaging. It was found that Gentamicin ampoule is very difficult
to open often leading to injuries to health workers and that there was a lot of wastage when
administering the injectable to neonates because neonates require small doses of the medicine
and the current available packaging is 40mg/ml.
ix
It is recommended that the policy on prescription and administration of injectable Gentamicin
be reviewed to allow task sharing by nurses and midwives to diagnose and treat neonatal sepsis
when adequately trained and facilitated and the current packaging for Gentamicin changed so
that the vials made easier to open. Health workers should be trained on how to differentiate
neonatal tetanus from neonatal sepsis. A national forecast and quantification for injectable
Gentamicin and dispersible Amoxicillin should be carried out to determine the quantities
required and budget implications for advocacy. We recommend that a study be commissioned
to determine the feasibility of outpatient neonatal sepsis management even at lower level
health facilities using simplified regimens. Smaller ampoules of Gentamicin should be produced
and made easier to break during administration of the medicine.
1
CHAPTER 1: INTRODUCTION
1.0 Introduction
This report has been produced under the auspices of Save the Children/ Saving Newborn Lives.
Its goal was to facilitate a landscaping analysis of antibiotics for treatment of possible severe
bacterial infection/neonatal sepsis with a focus on demand and supply-side bottlenecks which
would be an information input process for the upcoming study on the feasibility of out-patient
management of PSBI at lower level health facilities using simplified antibiotics regimens.
Antibiotics are one of the most effective agents in the management of neonatal sepsis globally
and the resistance of microbial agents to drugs has become a global point of concern. In
resource-limited settings, most young infants with signs of severe infection do not receive the
recommended inpatient treatment with intravenous broad spectrum antibiotics for 10 days or
more because such treatment is not accessible, acceptable or affordable to families4.
There is insufficient access and use of antibiotics and lack of appropriate products and
formulations for neonates at lower level health facility i.e HC II and HC III, where first contact of
a neonate with sepsis is most likely to occur. The MoH intends to conduct a pilot to determine
the feasibility and coverage of “adequate” treatment of newborn sepsis on outpatient
treatment using one or more of the simplified treatment regimens.
1.1 Background
The Uganda government developed the UN commission on Life Saving Commodities for
Women and Children implementation Plan 2013 known as the “catalytic work plan” that
augments or builds on existing programs and strategies. The catalytic plan is intended to ensure
a coordinated approach with UN Secretary General‘s Every Woman Every Child (EWEC)
initiatives and other related Reproductive Maternal Newborn Child Health (RMNCH) plans.
The Implementation plan prioritized commodities and recommendations based on country-
specific evidence, programs, and opportunities. These plans were costed, and in 2013, the UN
Commission on Lifesaving Commodities (UNCoLSC) provided one-year catalytic grant to
implement an initial year of activities. The Commodities Commission funds for the catalytic
Implementation plan are to be expended in a coordinated and complementary way with other
funding streams already present in the country, including those for EWEC-related initiatives.
The plan identifies insufficient access and use of injectable antibiotics and lack of appropriate
products and formulations for neonates at lower level health facilities where first contact of a
neonate with sepsis is most likely (HC II and HC III) to occur. Specific issues related to the 10
2
recommendations were identified especially in areas of evidence/ regulatory issues, provider
issues, formulation/ market shaping and awareness/ demand generation.
Based on the key issues identified, the implementation plan proposes a number of activities
including conducting operations research to demonstrate the opportunities for neonatal sepsis
management at lower level health facility through outpatient clinics using simplified treatment
regimens linked to existing community outreach structures.
1.2 Objectives, purpose and scope of Study
The goal of the landscaping analysis was to determine the feasibility and coverage of
“adequate” treatment of newborn sepsis from outpatient treatment using one or more of the
simplified treatment regimens. This is in line with the multi-country analysis regarding the
manufacturing capacity, availability, use of appropriate injectable antibiotics for newborn sepsis
by the global Injectable Antibiotics Technical Reference team which is part of the RMNCH Trust.
The purpose of this assignment was to conduct a landscaping analysis of antibiotics for
treatment of possible severe bacterial infection/neonatal sepsis with a focus on demand and
supply-side bottlenecks. This is an information input into processes for the upcoming study on
the feasibility of out-patient management of PSBI and at lower level health facilities using
simplified antibiotics regimens. This report will be critical in informing potential policy changes
that may be as a result of PSBI management algorithm changes. With regard to the scope and
specific tasks, this assessment involved a desk and field review that;
a) Assessed national policy and regulatory environment and financing strategies around the
procurement and use of antibiotics for the treatment of neonatal sepsis. Cost-recovery
schemes, national procurement budget allocations, and the impact of diverse financing
strategies were also studied more thoroughly.
b) Undertook a rapid situational assessment to gather country-specific data on the status,
availability, use, and related barriers to use of gentamicin and amoxicillin. Other antibiotics
for sepsis management including ampicillin, procaine benzyl penicillin, and ceftriaxone at
various levels of health care delivery were also reviewed but not in the same level of detail
as for Gentamicin and Amoxicillin.
c) Reviewed records and analyzed suppliers of available ampicillin, procaine benzyl penicillin,
gentamicin, and ceftriaxone products in Uganda.
d) Engaged with end-users and private/public sector providers to determine the most feasible
and acceptable presentation and delivery of gentamicin and amoxicillin for treatment of
newborn sepsis.
3
CHAPTER 2: METHODOLOGY AND APPROACH
2.0 Introduction
The study employed a descriptive design with both qualitative and quantitative methods.
2.1 Data Collection tools
Review of documents
The available MOH procurement policies, the National Drug Authority (NDA) regulatory
documents including the list of registered importers and registered injectable formulation for
neonates and the National Medical stores (NMS) and Joint Medical Stores (JMS) catalogues
were reviewed. In addition, relevant Ministry of Health policies and guidelines and strategies
were reviewed.
Questionnaires
Structured questionnaires (given in Annex 1) were developed to collect qualitative and
quantitative data from key informants at national, district, health sub district and health facility
level. Key informant interviews were carried out at national level to ascertain barriers and
potential /low hanging solutions to increasing access, availability and quality use of the
antibiotics.
The questionnaire addressed the following areas:
Policy and regulatory environment
Procurement and suppliers in Uganda
Cost-recovery schemes/financing for antibiotics (Gentamicin and Dispersible Amoxicillin)
Availability, use, and related barriers
Feasible and acceptable presentation and delivery
A semi structured questionnaire was developed to collect qualitative data from focus group
discussions with the health care providers. The focus group data was collected to understand
the provider perspective on barriers to use and preferred packaging and perception of quality
injectable Antibiotics.
Key Informant guides
Key Informant Guides were developed to collect qualitative data and get the opinions and
perceptions of the national-level stakeholders regarding management of neonatal sepsis.
National level key informant interviews were held with the following institutions shown in the
Table 1 below:
4
Table 1: Key Stakeholder Organizations
Category Key Informant
MOH Pharmacy division
Reproductive Health
Child Health
Planning division Warehousing organizations National Medical Stores (NMS)
Joint Medical Stores (JMS)
Uganda Health Marketing Group (UHMG)
Regulatory agencies The Nurses and Midwifery Council
National Drugs Authority (NDA)
Associations Uganda Nurses and Midwives Association
Uganda Private Midwives Association
Uganda Pediatrics Association
Uganda Nurses and Midwives Union Multilateral and Bilateral Organizations
WHO
Civil society Organizations Child fund
PATH
World Vision
Save The Children Others CHAI
Focus Group Discussion (FGDs)
Another data collection tool employed in this study was the Focus group discussion, a
qualitative tool that sought to get the opinions, perceptions of the health workers at health
facilities on antibiotics for treatment of possible severe bacterial infection / neonatal sepsis. A
total of 17 focus group discussions were held, with a minimum of one FGD per district.
2.2 Health facility selection
The country was divided into 10 regions based on the Uganda Bureau of Statistics (UBOS)
enumeration regions of Kampala, West Nile, Mid Northern, Central I, Central II, Mid-Western
and South Western, North East, East Central, Mid-Eastern as shown in Figure 1 below.
5
Figure 1: Map of Uganda showing 10 demographic regions where data was collected
One district was randomly selected from each region making it 10 districts (see Table 2).
Through random sampling, the following districts were selected for the field assessment.
Table 2: Sampled Districts
No Region District No Region District
1 Kampala Kawempe division 6 East Central Buyende
2 West Nile Arua 7 Central 1 Rakai
3 Mid Northern Pader 8 Central 11 Nakaseke
4 North East Abim 9 Mid Western Kibaale
5 Mid Eastern Parisa 10 South Western Kisoro
6
2.3 Health Facility Level
From the sampled districts above, Public health facilities (40), Private for profit health facilities
(10) and private not for profit health facilities (14) were sampled and a structured questionnaire
administered. At least one of each public health facilities (that is HC IV, HC III and HC II) were
purposefully selected in the health sub-district and one private for health facility and one
private-not-for-profit health facility). In instances where the district had a district hospital, it
was also purposefully selected.
During the field data collection, the facilities visited included the public health facilities, private-
not-for-profit and private-for-profit health facilities. A total of 64 health facilities were sampled
as shown in the Figure 2 below. It can be noted that public health facilities were the highly
sampled with n=40, while the PNFPs were 14 and Private-for-profit facilities (PFPs) 10.
Figure 1: Number of Sampled Health Facilities by Type
Source: Primary data
District level
The District Health Officers or designates of the 10 sampled districts were purposively selected
and interviewed. Data was collected using a structured questionnaire and focus group
discussions were held with health providers at health facilities where the minimum number of
staff was at least five.
2.4 Data Analysis
A data entry screen for quantitative data was developed by the statistician on this activity. The
data statistician developed appropriate data processing system using SPSS version 16 for data
7
entry and analysis. The data was then exported to Excel for further analysis. On the other hand,
the qualitative data was analyzed using conventional content analysis, coding categories were
derived directly from text and categorized into themes which are then related and linked into
meaningful clusters.
Training of data collectors
Prior to data collection, all survey personnel participated in a 2 day residential training to
familiarize with treatment of neonatal sepsis with antibiotics and the structured data collection
tool including the focus group discussion guide. Day one of the training covered introduction to
newborn sepsis including an overview of the RMNCH, the Uganda catalytic plan and objectives
of the assessment and the questionnaire. The second day involved piloting the questionnaire
with actual field data collection and feedback and final adaptation of the tool. Twelve (12) data
collectors were trained of which one data collector was each assigned one district, a Pharmacist
and Pediatrician conducted national level key informant interviews.
Field data collection
Data collection took a total of 7 days (5 days data collection and 2 travel days). This Landscaping
study was conducted over 5 days between 20st-26th January, 2015.
2.5 Data Management and Ethical Consideration
Both hard and soft data were managed centrally at Samasha Medical Foundation offices in
Najjera II, Kampala. Approval for the assessment was sought from Ministry of Health and
relevant authorities including district officials. Informed consent was sought from all
respondents of the survey. Names of all the respondents were kept confidential. Research team
was composed of duly trained professionals and there was no potential harm to the
respondents in participating in this assessment.
2.6 Quality Control Measures
Multiple quality assurance processes were used in the collection of data. The technical and
coordination team, in collaboration with the Save the Children/Saving Newborn Lives team
provided the overall quality assurance to review the assessment process, tools and reports. The
developed/adapted tools were pretested before survey and data collectors were trained and
pretested tools before data collection. Each district team on a daily basis cross checked all data
collected for completeness, legibility and consistency and communicated with the survey
manager. In order to check for validity, triangulation where multiple data sources were used to
produce deeper understanding and facility checks at some of the visited sites were carried out
by the overall data supervisor.
8
CHAPTER 3: KEY FINDINGS
National Level determinants of availability and use of injectable Gentamicin and Amoxicillin for
treatment of neonatal sepsis
3.1 Current Policy Environment
Gentamicin and Amoxicillin are classified as essential medicines that are vital for treatment of
infections. This is reflected in the National Drugs Policy act of 1993 which classifies Gentamicin
and Amoxicillin as class B under the second schedule. The Uganda clinical Guidelines (2012)
recommend use of Gentamicin for treatment of neonatal sepsis at the HC III and above by
clinicians and medical doctors. Nurses are not allowed to prescribe Injectable antibiotics
including Gentamicin to neonates. The Essential Medicines list (2012) classify Gentamicin as a
Vital antibiotic to be used at the HC III level and above while Amoxicillin is allowed for use at
the HC II level by nurses and community health workers. The UCG allows nurses to give pre-
referral antibiotics.
Below is the summary of the policies regarding use of antibiotics for treatment of neonatal
sepsis.
Table 1: Summary of Pertinent Uganda Policies
Policy Document Comments
National Drug Policy and Authority Act ,1993
Gentamicin and Amoxicillin are classified as Class B under second schedule of the act and may be supplied by retail only on the prescription of a duly qualified medical practitioner, dentist or veterinary surgeon, but only for medical, dental or animal treatment respectively. Nurses can only administer upon prescription by Medical doctor or
Summary of policy bottlenecks to use of antibiotics for treatment of Neonatal Sepsis
Nurses are not allowed to diagnose and prescribed antibiotics to neonates but
can administer upon prescription by clinical officer or doctor
Health Centre II facilities are not allowed to receive Injectable Gentamicin based
on the EMHSL
Advocacy priorities
Policy change to allow task sharing for nurses
Revise the EMHS List to allow HC II facilities to order for Gentamicin
Revise the UCG to allow treatment of neonatal sepsis at HC IIs
9
clinical officer
Uganda National Newborn Implementation framework 2010-2015
Creating an enabling environment includes newborn drugs and equipment included on the EMHS credit line
Uganda Clinical Guidelines, 2012 Allows treatment of neonatal sepsis from HC III (pre-referral) and above; The recommended treatment is: Ampicillin 500mg/kg every 8 hrs for 7 days plus Gentamicin 2.5mg/kg IV every 12 hrs or Benzylpenicilin 50,000 IU/kg every 8 hours and Gentamicin 2.5 mg/kg every 12 hrs for 3 weeks.
Essential Medicines and Health Supplies list , 2012
Allows Gentamicin injection 40mg/ml at HC 3 and Above and is classified as Vital medicines
Helping Babies Breathe Plus Guidelines, 2008
The Uganda Helping Babies Breathe Plus recommends management of neonatal sepsis using Gentamicin and Ampicillin Injections for a minimum of 7 days
Service standards for Newborn Health (MoH,2010)
The standards recommend availability of Gentamicin and Ampicillin Injection for sepsis management at health facilities (HC II and above) as a minimum
Integrated Management of Newborn and Childhood Illnesses Guidelines– (2014)
The 2014 updated IMNCI guide recommends that health workers trained in IMNCI give only 1st dose of intramuscular antibiotic (Gentamicin or/and Ampicillin) treatment and refer for higher level care in case of classification of very severe disease and give oral (Amoxicillin for 5 days) antibiotics in case of a local bacterial infection.
Integrated Management of Childhood Illnesses (ICCM), (2010)
This government program provides a platform for community newborn care which only includes trained Village Health Teams carrying out pregnancy surveillance, antenatal and postnatal home visits and assisting referral in case of danger signs in a newborn baby. This is a platform for - Demand generation and promotion of care seeking for
sick newborn babies - follow-up after initiation of treatment at the health
facility level to ensure compliance and community-based monitoring
3.2 The Public Sector Supply Chain System for Gentamicin and Dispersible
Amoxicillin
The NMS should increase the quantities of Gentamicin and Amoxicillin in the essential medicines Kit and also increase the budget for above for health centre IV and above.
NMS should procure the Gentamicin 10mg/Ml and 40 mg /ml ampoules to reduce on wastage and ease of use by Nurses
The Forecasting and quantification methodology used by the QPPU at the MOH Pharmacy Division should include quantities required for treatment of neonatal sepsis
The medicines for treatment of neonatal sepsis should be include on the RH
commodities budget line by NMS
10
Public sector Forecasting and supply planning
Ministry of Health established the Quantification and Procurement Planning Unit (QPPU) in
2012 at the Ministry of Health, Pharmacy division to provide leadership and coordination of
partners supporting procurement of pharmaceuticals for the public sector. In all the
quantifications done so far at the QPPU, in the methodology applied, there is no consideration
of Injectable Gentamicin and Dispersible Amoxicillin for treatment of neonatal sepsis.
The Quantification for iCCM commodities carried out by CHAI on behalf of the Ministry of
Health, considered Dispersible Amoxicillin for treatment of child pneumonia for a period 2014,
2015 and 2016. Children age group 2 months- 5 years was considered; there was no
consideration of children below 2 months in the quantification. It is critical that the MOH know
the current demand for antibiotics for treatment of neonatal sepsis in order for the government
to understand the financing gap and for CSOs to develop advocacy strategies for increased
funding and prioritization of antibiotics for treatment of neonatal sepsis.
The National Medical Stores with support from CHAI has developed an Essential Medicines
Platform that will enable NMS track annual procurement plans submitted by individual health
facilities. The Health facilities are responsible for determining the quantities of essential
medicines required for a year and developing annual procurement plans which are submitted
to NMS. NMS bases its procurement on the quantities submitted by Health facilities. None of
the health facilities visited had considered neonatal sepsis during the determination of the
health facility annuals EMHS requirements.
Public sector Financing and Procurement
All Essential Medicines and Health supplies (EMHS) for the public sector are procured, stored
and distributed to health facilities by NMS. This Financial Year 2014/15, NMS has been
allocated shs 219 billion for procurement of EMHS and of that amount, 12.56 billion has been
allocated to procure, store and distribute the EMHS basic kit to HC II and Shs 20.306 billion for
HC III. A special account for RH commodities was established at NMS in FY2004/05 and this FY
2014/15, Shs 8 billion has been allocated. The RH budget procures contraceptives and selected
maternal commodities including safe delivery kits and gloves. In all the above budgets, there is
no reference to a budget for treatment of neonatal sepsis.
The Ugandan kit system refers to a push system where the central level (MoH) determines the content and quantities of Essential Medicines and Health Supplies, which are sent (pushed) out
to the health facilities with a standard set of medicines and supplies.
11
The EMHS kit contains antibiotics, painkillers, non-ACT antimalarials, IV fluids & cannulas,
gauze, wool, plasters, gloves, iodine. The antibiotics in the EMHS Kit for both the HC II and HC
IIIs are illustrated in the Table 4 below.
Table 4: EMHS Kit by Type of Health facility
HC IIs HC IIIs
- Amoxicillin dispersible tablets
125mg
- Amoxicillin Capsule 250mg for
adults
- Benzylpenicilin 1MU/600mg
injection (PFR)
- IM Auto disable syringe and
Needle (2ml)
- Amoxicillin dispersible tablets
125mg
- Amoxicillin Capsule 250mg for
adults
- Benzylpenicilin 1MU/600mg
injection (PFR)
- IM Auto disable syringe and
Needle (2ml)
- Ampicillin 500mg powder
- Gentamicin 80mg/2ml
Injection IV/M Vials
- Cannulas 18G and 20G
The health centre IIs and IIIs are allocated Shs 1.3 million (approx $500) and Shs 3.8 million
(approx $1,500) respectively to procure the EMHS kits for 2394 health facilities out of 2622
public health facilities.1 Based on the meager budget allocated, health facilities are expected to
prioritize the medicines that are deemed vital for the health facility2. Within the EMHS kit for
HC III, Gentamicin and dispersible Amoxicillin are deemed expensive and would increase the
budget and reduce the overall quantities of the various medicines required by Health facility.
Local market shaping efforts to reduce on the cost of dispersible amoxicillin and other
Injectable Gentamicin would increase access and availability of these commodities. A strategy is
needed to ensure that neonatal sepsis treatment is prioritized within the EMHS kits and unit
prices of Gentamicin and Dispersible Amoxicillin reduced.
Public sector Distribution system
The National Medical stores is a government parastatal mandated to procure, warehouse and
distribute all pharmaceutical commodities and supplies to the public health facilities. There are
2622 public health facilities that are served by the National Medical Stores. NMS procures and
distributes essential medicines based on the Essential medicines list and clinical guidelines.
1 UHSSIP 2011-2015
2 NMS essential Medicines Kit 2014/15
12
NMS will not distribute essential medicines at the health facility level not permitted by the
essential medicines list and clinical guidelines.
NMS operates a pull system for health centre IV and above and a PUSH system for lower level
health facilities (HC II and HC III) on a Bi- Monthly basis (every two months). Health facilities are
required to submit the annual procurement plans which are used by NMS to make national
procurement plans. NMS uses its fleet of vehicles to transport commodities to the district and
contracts a transport company to distribute to the health facilities.
3.3 Pricing Of Gentamicin and Dispersible Amoxicillin in the Private Sector
In the private for profit sector (PFP) health sector, supply and distribution chain,
wholesalers/importers which are agents of manufacturers from different countries sell
medicines to wholesalers, retailers and hospitals at lower levels in different parts of the
country. Imports contribute to 90% of the medicines on the market.3 Procurement in the
Private for profit (PFP) sector is determined by the demand market, general antibiotic
suspensions are still widely available however powder suspension of amoxicillin is not widely
available. In the human medicines register by the NDA, there are more than 15 registered
suppliers of the Inj. penicillin’s and Inj. Gentamicin while ceftriaxone has fewer suppliers
probably due to cost and turnover of the products on the shelves4. In the PFP sector, pediatric
needles 23 gauge and pediatric syringes 2ml were available and sold as separate products in a
few wholesale and retail pharmacies. They were available at JMS and NMS at the time of the
survey.
The retails price of medicines in Uganda is dependent on the various cost drivers as identified
by the recent study by SAMASHA and HEPS Uganda. There are no import tariffs on medicines.
Imported medicines incur banking fees (letters of credit), Insurance and Freight costs. Imported
3 MOH (2008) Pharmaceutical baseline assessment 4 NDA Human drugs register 2014
The Price of a dose of Gentamicin and Dispersible Amoxicillin on the Uganda
pharmaceutical market is still very high, less affordable and hence limiting access. In order
to ensure increased affordability in the private sector, there is need to address the price
mark Ups that range between 60% to 600%
There is need to increase the number of registered suppliers of Gentamicin and
Dispersible Amoxicillin
Build local capacity for production of Gentamicin
13
products pay an insurance and freight average of 8% by sea and 20% by air. Clearing charges
are between 2% and 5%. At the National Drug Authority, the importer pays a verification fee
which constitutes 2% of the Free on Board (FoB) price.
In the listed medicines for treatment of neonatal sepsis, all the injectable antibiotics are
imported including Gentamicin; this could have long term implications about availability in case
of disruptions of the supply chain. In Uganda, Abacus Parenteral is the only pharmaceutical
plant that engages in large manufacturer of injectable but does not produce Injectable
Gentamicin.
Importers/Local Technical Representative (LTR)
These are representatives of manufacturers and are responsible for quality issues of the
products on market. They have special arrangements with manufacturers and get better prices
compared to other importers of the same products in Uganda. They also access credit facilities
in form of advance stock to be paid after sale, promotion stock and capital to support
marketing of products. They are responsible for follow up and registration of new products by
the NDA. They imposed a mark-up of 10% - 20% on imported products. In order to make the
price of Gentamicin affordable, there is need to increase the number of Gentamicin brands
registered in the country to increase competition and to negotiate with the agents to reduce
the mark ups
Wholesale Stage 1
This constitutes mainly importers who purchase medicines from the LTR and sometimes import
for themselves. They impose a mark-up of 20% - 40% on different products depending on
specific product characteristics such as turnover rate, registered similar products on market,
purchasing power of customers and the packages of the product.
Whole sale stage 2
This constitutes wholesalers based at the districts and regional headquarters. They purchase
medicines from the capital city and sell to retailers, clinics and hospitals at the district and rural
levels. For locally manufactured products, it constitutes agents that are mostly representatives
of manufacturers. This was the most highly competitive stage of the medicines supply chain and
the mark ups have been declining over the past 10 years. They currently add a mark-up of 5-
10% on products sold to their customers.
Retailers
These include community pharmacies, hospitals, drug shops and facilities that sell medicines to
the final client, the families. Compared to wholesalers and importers, these facilities, excluding
hospitals, have less working capital and have overheads which have to be covered by the mark
ups. Administrative overheads constitute the highest expenditure for such health facilities and
14
many struggle to break even. For the pharmacies and drug shops, the working capital is tied up
in medicine stocks. Retailers prioritize medicines to be purchased and sold mainly based on
turnover and ability to generate returns quickly to purchase new products. They impose a
mark-up of 50% - 600% depending on the products and their package sizes, see Table 5 below.
Table 5: Summary of Supply chain mark-ups
Stage in supply chain Add-on Imported Product Local Manufactured
Stage I: Manufacturer Insurance and freight 7-15% N/A
Stage II:
Importation
NDA Verification fees
Clearing and Forwarding
Importers mark up
2%
2-5%
7-20%
N/A
Stage III:
Wholesale
Wholesale mark up
(Kampala)
Wholesaler mark up
(Upcountry)
6-25%
25%
15-25%
25%
Stage IV: Retail Retailer’s mark-up 50-600% 50-600%
Looking at an example of Amoxicillin 250mg generic and locally manufactured (Table 6) vis-à-vis
that locally imported (see Table 7) purchased by the private sector using (an Exchange rate: US
$ 1 = Ugx 2500), it can be observed that the retailers are able to have high turnovers and
generate quick returns evidenced by the high markups imposed.
Table 6: Amoxicillin 250mg, generic and locally manufactured
Stage Component Charge
basis
Charge
value
Total
(UGX)
Percent
cumulative
mark up
1 Manufacturer Selling
Price (MSP)
2255
2 Local transport 2.0% 45 2300 2%
Wholesale procure price 2300
3 Wholesale mark-up 8.7% 200 2500 11%
4 Retail mark-up 300% 7500 10000 313%
Final cumulative % Mark up and
Price
10000 313%
15
Table 7: Amoxicillin 250 mg (100 capsules per pack) Generic, Imported
Stage Component Charge
basis
Charge
value
Total
(UGX)
Percent
cumulative
mark up
1 FOB 1090
2 Local tech rep/ importer 10% 109 1199 10%
Pre-shipment inspection (SGS) 2% 24 1223 12%
Letter of Credit (LoC) 2% 24 1247 14%
Insurance 2% 25 1272 16%
Sea freight 8% 102 1374 26%
Clearing 2.5% 34 1409 29%
Local transport 2.5% 35 1444 32%
NDA 2.0% 12 1455 34%
3 Wholesale level 1/importer
mark up
10% 145 1600 47%
4 Wholesale level 2 mark up 212.5% 3400 5000 359%
5 Retail mark up 100% 5000 10,000 459%
Final % Mark up and Price 10,000 459%
Note: The wholesale stage may have more than one level. The importer may wholesale but most times
sells to other wholesalers.
The above mark ups negatively impact on the availability, affordability of Gentamicin and
Amoxicillin for treatment of neonatal sepsis. In addition, it leads to reduced quantities of
Gentamicin procured in the public sector.
3.4 Expenditure on Health in Uganda
The National Health Accounts (NHA) FY2011/12 indicates that allocation of funds between
public, private and Development partners was 15.3%, 38.4% and 46.5% respectively. The per
capita health expenditure was $50, below the WHO recommended per capita expenditure of
$60 for low income countries. Of the private sector expenditure on health, 90% comes from
The National Health Accounts need to include expenditure on treatment of neonates as
a sign of commitment to reduce infant mortality rates.
There is need to address pricing of Gentamicin in the private sector in order to reduce
the burden of treatment of neonates at private clinics/hospitals
16
the households. The household Out Of pocket (OOP) expenditure as percentage of the Current
health expenditure (CHE) increased from 33% in 2010/11 to 37% in 2011/12 (MoH, 2014). The
lack of adequate public sector financing for health manifests into lack of access to services and
medicines for neonates in Uganda.
Households are the dominant payers in the private sector which accounts for 33.4 % of CHE in
2010/11 and 37.4% of CHE in 2011/12. The OOP reflected in Table 8 is presumed to be
predominantly cash. Other private funds are mainly through private insurance firms (1%),
private firms (10%), Government-based voluntary (0.0%) of CHE in 2011/12.
Table 2: Private Current Health Expenditure by Schemes FY 2010/11 -FY 2011/12
FY2010/2011 FY2011/2012
Amount
(UGX
Millions)
Share (%) Amount
(UGX
Millions)
Share (%)
Compulsory private insurance
schemes
100 0.01% 104 0.01%
Employer-based insurance (other
than enterprises schemes)
131,046 7.8% 48,041 2.6%
Other voluntary health insurance
schemes (n.e.c.)
66 0.004% 38 0.002%
Enterprises (except health care
providers) financing schemes
9,193 0.5% 550 0.03%
Revenues from households 1,533,500 91.61% 1,775,600 97.33%
TOTAL 1,673,905 100.0% 1,824,333 100.0%
Table 8 above shows the PCHE by schemes. Schemes relates to financing arrangements through
which people pay for their health service. In Uganda the two most common options are
voluntary insurance, or pay at the point of service from their primary income/savings (.i.e. out
of pocket). Voluntary health insurance schemes include employer based insurance, employee
based voluntary insurance and other insurance coverage such as those from group or
community based schemes. Expenditures in these schemes have decreased in UGX value expect
out of pocket expenditure on health which has increased by 242 billion from 2010/11 to
2011/12.
Cost recovery schemes are mechanisms through which initial resource expenditures are
recouped either on an asset or service provided. Stemming from the high costs of healthcare
provision, cost recovery schemes have evolved in Uganda such as the use of user chargers/fee
charging, voucher systems and community insurance schemes some of which apply to newborn
healthcare.
17
The cost recovery schemes aim at use of scarce financial resources amicably and increase
revenue for the provision of quality healthcare services. These cost interventions aim to reduce
health costs of affordability, accessibility and utilization of health facilities and quality services
by mothers and newborns.
Health cost recovery schemes have interplay of benefit among the healthcare providers and
consumers. Most of the schemes in Uganda benefit the later more than former due to the
combined interest of all the providers to improve the quality of healthcare thereby reducing
maternal and infant mortality rates.
The key players on the health cost recovery schemes are the Government, Households,
Philanthropists/Donors and NGOs/CBOs mainly guided by existing Government policies on
Health.
3.5 Cost Recovery Schemes that could be leveraged to increase access to
Treatment of Neonatal Sepsis
Types of cost recovery schemes
Community Insurance schemes
Community Health Insurance (CHI) are voluntary Health insurance schemes organized at
community level. They have continued to exist in partnership with Public-not-for-profit (PNFP)
health facilities to ensure affordable quality health care and manageable out-of-pocket health
expenditure. In Uganda most CHI schemes are hospital-based with exception of “save for health
Uganda (SHU) scheme”. The current Community Health insurance schemes to-date include:
Save for Health Uganda (SHU) scheme has implemented a number of the community health
insurance schemes aimed at addressing maternal and newborn challenges, through improving
the MNCH services utilization since 2009. One of the schemes has been a 3-year pilot project in
Bushenyi in 2012 titled “Reducing delays to maternal and infant health care in Bushenyi.” This
project focused on Safe motherhood and newborn survival, and helped at pooling resources at
community level by all resident families and subsidizing the premiums to allow for the
automatic enrolment of women aged 18 – 49 years into the community health insurance
schemes (CHIS).
The current health schemes could be leveraged to prioritize treatment of neonatal
sepsis and increase access in the private sector.
Build capacity for the implementers to manage neonatal sepsis through outpatient basis
18
Despite SHU registering one of its successes as community participation in financing healthcare,
the CHI schemes still continue to face challenges of poor community understanding on the
systems of operation of insurance schemes and this calls for more sensitization and
Government to fast track the implementation of the National Health Insurance Scheme that
was slated to start in 2014.
Despite the numerous health community schemes, very few of these actually have packages
specific for maternal and neonatal health. An example of this is the eQuality scheme of Bwindi
Community Hospital.
Voucher system
A voucher is a card that entitles a poor, pregnant woman to subsidized maternity care. In
Uganda, we have different vouchers for instance the Safe Motherhood vouchers which provide
poor pregnant women subsidized access to maternal health services including antenatal visits,
assisted baby delivery including any complications, and a postnatal visit. Currently, voucher
system for maternal and child health are being implemented under the auspices of Marie
Stopes Uganda and Uganda Health Marketing Group (UHMG).
Okwero, P et al (2012) stated that the voucher program has been implemented in Masaka &
Mbarara Districts respectively in Uganda by the Reproductive Healthcare Vouchers Program
(RHVP). These subsidized vouchers to reduce cost of health care to women for packages of
birthing services in clinics by qualified health practitioners. The voucher scheme offered two
different products. The first was a Safe Delivery (SD) Voucher (sold under the Healthy Baby
brand name) that provided: Four visits with a skilled medical practitioner before a baby’s birth
(antenatal visits); normal deliveries with a medical professional in attendance, as well as any
emergency treatment/transportation required; The second was monitoring by medical staff
after the birth for up to three days; and one postnatal visit including family planning counseling.
The above cost recovery schemes moderate Household out of pocket expenditure on
healthcare on newborns.
User Charges
These are payments made by patients for the services they receive directly from a physician.
User chargers are the mechanisms of cost recovery in Private Not for Profit (PNFP) Facilities.
Government scheme of user fee as a cost recovery mechanism was eliminated in March 2001.
However it missed the point to remove catastrophic expenditures on Healthcare costs due to
the continued demand for health services in the private sector amidst the ill equipped
government health facilities.
19
3.6 Availability of drugs, Use, and related barriers
Availability of Human Resource at Health Facilities
The majority of the health workers (21%) were enrolled midwives, followed by enrolled
comprehensive nurses at 16% and 8% Medical Clinical Officers. It can be observed from Table 9
below that HC IIs are primarily run by Nursing Assistants at 35%. Nursing assistants have no
formal qualifications but support nurses. They are not supposed to diagnose or treat any
patients.
Table 9: Staff Availability by Type of Facility, n =64(%)
Qualification HC II
N =14
HC III
N=15
HCIV
N=4
Hospital
N=7
PNFP
N=10
PNP
N=14
Clinical Officer 7% 6% 12% 25% 13% 25%
Enrolled Midwife 18% 29% 24% 18% 17% 40%
Enrolled Comprehensive Nurse 11% 21% 6% 15%
Registered Comprehensive Nurse 3% 4% 4%
Senior Clinical Officer 12% 6% 11%
Enrolled Nurse 18% 9% 4% 11% 5%
Medical Clinical Officer 3% 6% 32% 9% 5%
Registered Midwife 9% 6% 4% 7% 10%
Assistant Nursing Officer 3%
Nursing Assistant 36% 3% 6% 4% 17% 10%
Nursing Officer 11% 3% 35% 7%
The main Human resource challenges reported in the sampled districts was that nurses and
midwives are not allowed to allow diagnosing and managing neonatal sepsis. This was
supported by one respondent, who cited,
“Nurses and midwives are the ones available and approachable both in hospital and
lower level facilities” (KI, Pallisa) while another respondent said. “…as long as they are
trained they can handle neonatal sepsis” (KI, Arua).
The nursing assistants are the majority at lower level health facilities and will be critical in
ensuring neonates get treatment
Gentamicin should be included on the tracer medicines list in order to ensure no stockout
Gentamicin and Dispersible amoxicillin should be included on the emergency re-order list as it is
done for ARV’s and Ant-TB drugs
20
Availability of medicines for treatment of neonatal sepsis
The National Medical Stores (NMS) has employed a mixture of pull/push system in the
distribution of essential medicines to health facilities at different levels of care. At district level,
respondents said that they have drugs all the time while at health Centre level, the respondents
said they were experiencing drug stock out which interrupted treatment of neonatal sepsis.
Lower level Health facilities (HC IIs) refer patients to higher level health facilities. The patients
more often that no does not want to go for referral for different reasons like cultural beliefs,
ignorance of neonatal sepsis. This brings about delay in initiating treatment and loss to follow
up. One respondent recommended that;
“..we advise mothers to buy drugs that are out of stock..” (FGD Participant, Buyende)
One of the respondents stated that “dispersible amoxicillin is not readily available and so there
is need to advocate for it’ while another respondent from PATH and Uganda Pediatric
Association (UPA) expressed great concern that amoxicillin has been widely used hence the
possibility of resistance. It would therefore do good to carry-out ‘sensitivity studies’ before the
policy is passed.
There is also need for increased supervision of the health facilities by district officials so that
they get to know the status of health facilities in relation to availability of antibiotics for
treatment of neonatal sepsis as some of the districts visited were not aware of stock outs in the
health facilities.
The methodology used for calculation of quantities for treatment of neonatal sepsis need to be
streamlined to ensure that in the epidemiological considerations, neonatal sepsis is covered in
addition to other conditions such as pneumonia that use the same antibiotics.
At the time of the study, NMS and JMS had all the five medicines in their inventory. JMS in
particular has amoxicillin suspension in stock as the sector transitions away from suspensions to
dispersible tablets. Though these medicines are available at the central level (at NMS),
availability in the facilities is not frequently monitored.
MoH only monitors the consistence in availability and stock-out of 5 key tracer medicines5
within the public sector supply chain. The percentage availability of the key tracer medicines at
the time of study was still below 50%. Over a 3 month period the availability of these
5 Tracer medicines are Cotrimoxazole 480mg tablets, Depo-Provera injection, Sulfadoxine/ pyrimethamine tabs,
Oral rehydration salts, and Artemether/Lumefantrine tablets 120/20mg (6 pack)
21
medicines at NMS was 54%6. Considering the above findings, the stock status for the medicines
used in neonatal sepsis is not monitored.
All districts surveyed reported availability of antibiotics i.e. Gentamicin, benzyl penicillin with
67% and 73% respectively. However ceftriaxone is only available at HCIV and hospitals.
Dispersible amoxicillin was also available at only 25% of the sampled districts, with some health
workers stating having never heard of the term “dispersible Amoxicillin”
“I have not seen this formulation yet” (KI, Kibaale)
Table 10 below indicates the overall availability of selected medicines and supplies for
treatment of neonatal sepsis in the districts sampled. Injectable Gentamicin was available in
67% of health facilities while dispersible amoxicillin was available in 25% of the health facilities.
On the day of the visit, 19% of the health facilities were stocked put of Gentamicin and 15%
stock-out of Dispersible Amoxicillin.
Table 10: Availability of selected medicines and supplies, All Facilities (n=64)
Strength Availability Average
stock at
hand
Average
Number
of weeks
out of
stock
(last 3
months)
Number
of
facilities
with stock
outs on
the day of
the visit
% of
facilities
with
stockou
t on the
day of
the visit
Freq. % Freq %
Inj Gentamicin 80ml 43 67% 416 vials 3 11 19%
Dispersible
Amoxicilin
125mg 16 25% 42 packs
of 100
4 7 15%
Inj Ampicilin 500mg 40 63% 94 vials 4 11 23%
Inj Procaine 1g 47 73% 123 vials 3 5 10%
Inj Ceftriaxone 1g 36 56% 64 vials 3 5 10%
Gloves (disposable) 50 78% 165 pairs 4 1 2%
Auto-disable syringes
(2ml)
2ml 52 81% 148
pieces
2 3 6%
Disinfectant 4% 49 77% 4 litres 2 4%
Cotton 500g 52 81% 17 rolls 2 4 8%
Weighing scale 48 75% 1 piece
Sharps container 52 81% 16 piece
TOTAL N=64 (N=64) (N=48)* 100% * Where n is the number of Health facilities that reported having stockouts
6 Uganda SURE (2014): Securing Ugandans’ Right to Essential Medicines Program: Final Report (2009-2014)
22
A detailed description of the available drugs by facility type is shown in Table 11 below. The
majority of selected medicines and supplies were readily available at health facilities.
Dispersible Amoxicillin tablets were stocked in less than 21% of public HC II’s, 20% of PFP and
none PNFPs. The majority of public HC IV’s (75%) was well stocked yet based on the current
policy Dispersible amoxicillin should be 100% available at HC II & III’s.
The essential medicines kit for HC II does not include Ampicillin and that explains the non
availability at any of the HC II’s. Gentamicin is not included on the Essential medicines kit for HC
II however, due to demand, some health facilities received quantities from the HC III’s and
above during the re-distribution at district level. The system for redistribution has been
introduced and implemented at district level since 2013.
Table 11: Availability of Drugs by Facility Type
HC II HC III HC IV Hospital PNFP PFP
Inj. Gentamicin 21% 80% 100% 57% 86% 80% Dispersible Amoxicillin
21% 40% 75% 29% 0% 20%
Inj Ampicillin 60% 100% 71% 57% 90% Inj. Procaine Benzyl Penicillin
21% 87% 100% 71% % 80%
Inj. Ceftiaxone 14% 20%
100% 71% 86% 90%
Auto-disable Syringes (2ml)
57% 73% 50% 71% 86% 80%
Disposable gloves
71% 53% 100% 71% 93% 80%
Disinfectant 57% 73% 100% 57% 57% 70% Cotton 79% 73% 100% 57 93% 90% Weighing scale 71% 60% 100% 71% 100% 90% Sharps container
79% 53% 100% 71% 100% 90%
23
Figure 3: Availability of injectable antibiotics at HC II and HC III
Table 12: Availability of Injectable antibiotics in lower level health facilities (N=29) to
manage neonatal sepsis.
HC II HC III
Freq % Freq. %
Ampicillin 3 21% 7 47%
Ceftriaxone 1 7% 1 7%
Gentamicin 7 50% 5 33%
Procaine Benzyl
Penicillin 3 21% 2 13%
14 100% 15 100%
The above situation indicates limited availability of injectable antibiotics at level health facilities
and this is reflected in the findings of the focus group discussions held at health facilities. One
of the respondents at Limoto HC II in Pallisa further stated that’
‘HC IIs do not receive any injectable antibiotics with the Push system. They simply prescribe and
the caretaker buys, then do we administer.’
Adequacy of Amount procured/supplied
It was noted that 49% of all the health facilities had adequate supplies while 51% did not as
shown Figure 4 below. Figure 5 shows a breakdown by level of health facility. At lower level
health facilities, 18% of HC IIs and 27% of HC IIIs had sufficient stock.
24
Figure 4: Adequate supplies of antibiotics at heath facility (N=61) Figure 5: Quantities
Procured by level of health facility (N=61)
Stock-outs
Despite the health facilities stating that they receive sufficient supplies, 68% of the sampled
health facilities reported ever getting stock-outs in the last 3 months while the remaining 32%
reported rarely getting these stock outs of antibiotics. Numeric stock-outs were used for
analysis, that is, the measurement of absence of certain commodities, regardless of their
volume. The stock-outs can be explained by the seasonal discrepancies in demand and supply.
It can be observed from the Figure 6 below that health Centre IIs and IIIs ranked highly in
experiencing stock outs of antibiotics at 85% and 93% respectively compared to higher level
facilities. It can also be seen that the Private for profit facilities do not have stock-outs because
they readily replenish supplies based on demand. Health facilities (78%) reported monitoring
stock-outs through use of stock cards and physical counts.
25
Figure 6: Stock-out rates by level of Facility (n=64)
Further analysis at the lower health facilities, in particular HC IIIs, stock outs of the selected
injectable antibiotics were noted with Gentamicin as high as 40%, as shown in Figure 7 below.
Figure 7: Stock-out of selected Injectable antibiotics in HC IIIs
It was imperative for the study team to identify the duration of these stock-outs of the selected
antibiotics over the last 3 months. It was noted that the stock-outs on average went as long as
30 days in some cases. This is illustrated in the Table 13 below. However, this number varied
across the different health facilities.
26
Table 13: Average number of days stock-out at HC III
Injectable Antibiotics
Average Number of stock-out
days
Inj. Gentamicin 37
Dispersible Amoxicillin 26
Inj. Ampicillin 18
Inj. Procaine Benzyl Penicillin 11
Inj Ceftriaxone 9
District level/NMS Interventions in cases of emergency stock-outs
From Figure 8 below, only 44% of all the health facilities sampled were aware of District level or
national interventions dealing with cases of emergency stock-outs.
Figure 8: Health staff aware of interventions in case of stock-out over the last 3 months (n-
59)
The health facilities that experienced intervention to avert stockout were 44% and some of the
interventions highlighted included purchase from the local / open market like Joint Medical
Stores (JMS) for private health facilities, borrowing from other health facilities in case of public
health facilities and provision of alternative treatment. It was also noted that this does not
apply to the Push system from NMS, especially for these selected drugs (Gentamicin and
Dispersible Amoxicillin).
27
When asked about whether they are aware of emergency orders for injectable antibiotics from
NMS, the majority said they are aware of it however it works for ARVs and anti -TBs medicines
only and always borrow from the nearest stocked health facility as stated by one of the
respondents below;
“Emergency orders are usually brought in the next cycle” ( KI, Kampala).
3.7 Ddiagnosis And Treatment Of Neonatal Sepsis This study used benchmarks where at least two diagnostic criteria had to be present simultaneously in a
neonate to be treated for sepsis. Some of the symptoms reported by health workers included high fever,
breast sucking reduced or stopped and umbilical infection. Figure 9 below shows that almost all the
sampled health facility levels have potential to diagnose and treat neonatal sepsis. However
21% of the public HC II’s and 30% of PFP’s did not have the trained staff with skills to diagnose
and treat neonatal sepsis. Table 14 shows 64% of HC IIs not having staff skilled to treat and
manage Neonatal Sepsis.
Figure 9: Reported Health staff with skills to diagnose and treat Neonatal Sepsis (N=64)
Table 14: Number of staff available to treat with injectable antibiotics, Lower Level Health
Facilities (HC II &III)
HC II (N=14) HC III (N=15)
Staff Number Freq % Freq %
None 9 64% 3 20%
Less than 5 4 29% 8 53%
6 to 10 1 7% 3 20%
10+ 0 0% 1 7%
14 100% 15 100%
28
Treatment of Neonatal sepsis using Injectable Antibiotics
The majority of the health care workers sampled treat neonatal sepsis with Gentamicin (41%)
while 37% treated Ampicillin. A smaller number of staff 7% mentioned Ceftriaxone and 11%
used Procaine Benzyl Penicillin as shown in Figure 10 below. Most of the health workers
reported that the majority of children who report early for treatment improve while those who
report late most times die. There was no knowledge of the outcome of children who do not
report at the health facilities.
Figure 10: Drugs commonly used to treat Neonatal Sepsis
Treatment of Neonatal sepsis using Oral antibiotics
Figure 11 below shows the number of staff at the visited health facilities who can treat and
manage neonatal sepsis using oral antibiotics with 53% of the facilities having less than 5 staff
able to treat neonatal sepsis or possible severe bacterial infection. Table 15 also illustrates this
fact at the HC IIs and IIIs.
29
Figure 11: % of number of staff that can treat and manage using oral antibiotics
Table 15: Staff availability staff at lower level health facilities that can treat neonatal sepsis
using oral antibiotics
Currently pharmacists train health care workers on management of injectable
antibiotics/medicines, according to Uganda Nurses and Midwives Union (UNWU). In 2011, MoH
trained community health workers on HBB (helping babies breathe). Other trainings that target
neonatal sepsis include emergency obstetric care and Uganda clinical guidelines.
The research team also sought to identify the different oral antibiotics used in the management
of neonatal sepsis. Amoxicillin ranked highly at 42%, followed by Cotrimoxazole at 15%;
Ampicillin/Cloxacilin and Erythromycin both at 12%. In regard to the health centre IIs and IIIs,
Amoxicillin was the commonly used antibiotic at 32% and 36% respectively. This is shown in
table 16 below.
HC II (N=14) HC III (N=15)
Freq % Freq %
None 2 14% 2 13%
Less than 5 11 79% 6 40%
6 to 10 1 7% 5 33%
10+ 0 0% 2 13%
14 100% 15 100%
30
Table 16: Reported Commonly used Oral antibiotics
HC II
HC III
Freq. % Freq %
Amoxicillin 6 32% 9 36%
Ampicillin 0 0% 1 4%
Ampiclox 4 21% 2 8%
Cotrimoxazole 5 26% 6 24%
Metronidazole 1 5% 2 8%
Amoxyl 2 11% 3 12%
Erythromycin 1 5% 2 8%
(N=12) 100% (N=15) 100%
Reasons for non-treatment of Neonatal sepsis with both Oral and injectable antibiotics included
having no knowledge in the management of the neonatal sepsis, respondents from HC II stated
lack of equipped, lack of knowledge managing newborn babies, lack of knowledge of the
medicines for initial treatment before referral to higher level health facilities. Poor staffing at
HC III while other health facilities like Nakaseke Wakyato HC III, St. Jude Health Clinic in Arua
stated that they rarely receive such cases. In addition, a respondent from Pajule HC IV in Pader
reported misdiagnosis of neonatal sepsis.
Implementing partners active in newborn sepsis management
It was observed that there are Implementing partners doing work on Saving Newborn Lives that
include Infectious Disease Institute (IDI) in Kibaale, NUHITES in the northern Uganda, STAR-EC in
Pallisa and Save the Children at national and sub national level. It was noted that only 4 districts
out of 10 sampled districts had focal persons for newborn care.
Only 24% of the sampled health facilities were aware of any implementing partners active in
newborn sepsis management. The implementing partners identified are given in the Table 17
below.
Table 17: Implementing Partners active in Newborn Management
District Implementing Partner
Nakaseke Save the Children
Abim Cuamm
Pallisa/ Buyende MUSPH Manifest Project
Kibaale Infectious Disease Institute
31
3.8 Restrictive regulatory environment affecting ability to administer
injectable antibiotics
Only 23% of all the health facilities stated awareness of any restrictive regulations affecting the
ability to administer injectable antibiotics (see Figure 12). The restrictive regulations included
Nursing Assistants not allowed to administer injectable antibiotics unless under supervision
while the other health facility Cadres can only administer but not prescribe. A health worker
from Pajule HC IV in Pader stated thus,
‘We are only allowed to administer Ampicillin and Gentamicin in emergencies. In other cases,
we refer to the clinicians.’
However, another respondent from Buyende HC II stated that all qualified staff nurses and
midwives and clinicians can give injectable antibiotics. A respondent from Bondo HC III stated
that the Nursing council does not authorize them to administer drugs without prescription but
this is not always followed because of the lack of staff.
It can also be noted from Figure 13 below that only 57% of the Hospital staff are aware of
restrictive regulations affecting use of injectable antibiotics and 13% for HC III staff.
Figure 12: Awareness of any restrictive laws Figure 13: Restrictive Laws by type of facility
Mother Health seeking Behavior
It was noted that 50% of the mothers seeking care for newborn babies report to traditional
attendants, 30% report to the health facilities and 20% report the nearest drug shop. The
reasons as stated by the health workers for this choice of health seeking behavior was lack of
knowledge regarding neonatal sepsis, cultural beliefs like fever in neonates is caused by
32
‘tonsillitis’ and mothers who deliver from Traditional Birth Attendants being stigmatized from
reporting to the health facility.
On the other hand, it was reported by the mothers in Buyende and Kisoro districts that they
prefer to report to the nearest drug shops because of lack of drugs at health facilities, easy
access and proximity to and from their homes. This is further supported by one of the
respondents who stated that;
“…sometimes we lack transport especially at night when the newborn gets ill so we end up
going to nearest clinic.” (FGD participant, Buyende).
Treatment of Neonatal sepsis using a new simplified regimen
As seen from Figure 14, 80% of all the health facilities showed willingness to treat neonatal
sepsis using simplified regiment of 2 days of Gentamicin injection + Dispersible amoxicillin and a
continuous dose of amoxicillin for 5 days on an out-patient basis. That is achievable with the
right training of health workers and community sensitization of the importance of adherence.
The remaining 20% were not willing to adopt to the new treatment regimen because it they
believed it would be hard to manage and the unwillingness of mothers to comply to the new
regimen.
Figure 24: Willing to use a simplified regiment for treatment of neonatal sepsis
The District Health Teams (DHTs) believe that the mothers would be to bring their babies to the
health facilities for treatment by nurses since they have always been treated and managed
them and whenever services are available. According to Respondent in Nakaseke “communities
feel injections work well’. The DHTs believe that mothers will accept coming for injections
because it’s better than being admitted for 7 days and this will be effective if they are well
sensitize.
It is worth noting that the Ministry of Health has not yet stated training any health workers in
use of the simplified treatment guidelines for neonatal sepsis.
33
Factors making it difficult to manage neonatal sepsis and solutions to address them
A number of factors were put forward by the respondents from the health facilities that hinder
treatment of neonatal sepsis as illustrated in the Table 18 below.
Table 18: Factors hindering Neonatal sepsis management and possible solution
FACTOR HINDERING NEONATAL
SEPSIS MANAGEMENT
SOLUTION TO ADDRESS PROBLEM
1. Lack of the drugs and supplies Provide adequate drugs and supplies used in
management of Neonatal sepsis
2. Delay in seeking behavior Community sensitization about the importance of
early seeking behavior
3. Ignorance of community about
sepsis
Encourage home visits and follow-ups to educate and
sensitize communities about condition
4. Poor infrastructure like roads,
facilities specific to neonate
health, lighting
Improve the infrastructure for instance provide solar
lighting equipment
5. Misconceptions and misbeliefs
about neonatal sepsis
Community mobilization and sensitization
6. Poor knowledge or skills of health
workers
7. Lack of qualification to prescribe
or administer
- Facilitate trainings to improve on the skills of
health workers to be able to handle and manage
newborn health
- Hold CMEs at the different health units
- Update the current policies to allow for provision
of nurses to manage condition
3.9 Accessible and acceptable presentation and delivery
Affordability
Universal access to health care includes physical accessibility, affordability and acceptability
(WHO). The physical access to neonatal sepsis treatment has been addressed under Financing,
procurement and availability. This section of the report analyses the issues of affordability and
acceptability of antibiotics for treatment of neonatal sepsis.
The health services in Uganda are free of charge at all public health facilities. There are 4394
health facilities in Uganda out of which 2,622 are public sector health facilities, Private Not for
Profit (PNFP) making 774 and private for profit (PFP) owning 998 health facilities. This in effect
34
implies that 40% of all health facilities in Uganda charge a fee for health care services.
Approximately 72% of the population lives within 5 KM of the Public or PNFP health facility.
The private health care delivery system comprising of PNFPs, PFPs and Traditional,
Complementary Medicine Practitioners (TCMP) contribute 50% of reported health outputs.7
The Faith Based PNFPs alone contribute 41% of the hospitals and 22% of the Lower level health
facilities. All the Private and PNFP health facilities charge a fee for services and this has led to
the Out Of Pocket expenditure (OOP) on health increasing from 33% in 2010/11 to 37% in
2011/12. In a study conducted in 2008 on public health facility user’s satisfaction indicated wide
range of issues such as long waiting times and unofficial fees being levied (HSSIP 2010/11-
2015/16).
A medicines price Monitor (HEPS, 2013) shows that there is no difference in pricing between
the Private for profit health facilities and Private not for private health facilities for Gentamicin
and Amoxicillin. Availability of Gentamicin in public sector was low at 45% compared to the
PNFP at 63 and PFP at 80%. There was a big disparity in availability of Amoxicillin suspension
250 mg/5ml with the PNFP and PFP having more than 70% availability while Public sector
having 11%. This scenario re-enforces the fact that the private sector takes time to adopt the
government policies. In Uganda, the syrups have been discouraged for use and that explains the
low availability in the public sector.
3.10 Challenges And Barriers To Treatment Of Neonatal Sepsis
The challenges faced by Health Care Workers when diagnosing neonatal sepsis in the districts of
Arua, Pallisa, Buyende and Kisoro districts included lack of skills in diagnosing neonatal sepsis,
inadequate supply of drugs i.e. Gentamicin and oral amoxicillin, lack of laboratory services and
lack of budget to buy medicines when they were out of stock at the public health facility.
It was noted that some of the health workers could not differentiate between neonatal sepsis
and tetanus. For instance, during a focus discussion, one participant stated that;
“the cases of neonatal tetanus are many and sometimes differentiating them from
convulsions with sepsis is difficult”(FGD participant, Kisoro)
The participants also noted that they had a challenge of late reporting of the sick neonates to
the health facility. This results in children coming in when they are very sick and on top of that
7 HSSIP 2010/11-2015/16
35
the facilities lack ambulance services for quick referral of children they can’t handle. For
instance, it was noted that;
“some significant numbers of babies are first treated with traditional herbs at the
community level before coming to the health facility. They believe in their herbs more than the
drugs at the health facility”,
Further still “…the ceftriaxone supplied at the facility is sometimes not enough for the number
of patients that come. We need more of it”(FGD Participant, Kisoro)
Health care workers expressed need to undergo training through CMEs, mentoring and
supervision. It was noted that nurses most times consult senior colleagues at the health facility
if available. The nurses believed that challenges of neonatal sepsis can be overcome by
referring complicated cases to the higher level health facilities.
Further health facilities reported not having job aids/guidelines and find it difficult to determine
the dosage of the antibiotics especially Gentamicin. The health care workers have not received
any additional training and are using knowledge acquired during pre-service training. There is
therefore need to train health care workers in managing neonatal sepsis and this will improve
their quality of work.
There is a lot of wastage especially for Gentamicin as the available ampoule (80mg/2ml)
supplied by NMS is for adults and one has to remove a very small dose for the baby. The
remaining quantity is likely to be wasted as storage is difficult. HCW suggested that if possible
let them be provided with pediatric vials which are easier to measure and there is less wastage.
Breaking the bottle neck for Gentamicin was found to be difficult, HCW have sustained injuries
during the process of breaking the ampoule.
3.11 Recommendations put forward to reduce neonatal sepsis deaths
The following were suggested by the health facilities as quick wins in improving newborn sepsis
management. Increasing the supplies in the health facilities was at 39%, sensitization and
community education in bid to encourage deliveries at the health facilities and timely care
seeking was 23%. These recommendations are summarized in the Table 19 below.
Table 19: Recommendations to help reduce neonatal mortality due to sepsis (n=61)
Freq %
a) Increase supplies 24 39%
b) Encourage Deliveries at health
facilities
14 23%
c) Health education 12 20%
36
It was noted that 46%
of Health Centre IIs recommended health education of the community while 40% of Health
Centre IIIs advocated for deliveries in health facilities. This is shown in the table 20 below.
Table 20: Solutions made by lower Health facility to reduce neonatal sepsis deaths (n=28)
HC II HC III
Freq. % Freq. %
Early diagnosis 1 8% 1 7%
Health Facility deliveries 2 15% 6 40%
Health Education 6 46% 4 27%
Increase supplies 1 8% 2 13%
Train Health Workers 2 15% 2 13%
Strengthen referral system 1 8% 0 0%
13 100% 15 100%
Major risk factors for outpatient treatment of neonatal sepsis at HCII and III include cultural
issues e.g.
“…mothers are not supposed to move with newborn babies” (KI, Child Fund)
World Vision and child fund were concerned about monitoring new born, for instance a
respondent stated
“Mothers may not detect danger signs according” (KI, Child Fund) in addition, HC IIs are
also managed by nursing assistants who are not considered skilled.
Mothers are encouraged to attend antenatal care and this is where they receive health
education. VHTs have the role of sensitizing the community on neonatal sepsis and also
discourage the bad cultural practices.
d) Early diagnosis 4 7%
e) Strengthen referral system 4 7%
f) Train health workers 2 3%
g) Follow up with mothers 1 2%
61 100%
37
FGD indicated that provision of ambulance services to health facilities will improve on the
referral of the very sick newborns. In Kisoro, health workers stated that;
“there is no proper working ambulance yet people are poor and can’t afford own
transport and so mothers decline referral and prefer to stay insisting that HCW should do their
level best”.
Health care workers expressed need for additional training which should be done every year for
better service delivery.
Nine out of ten districts reported that most neonatal deaths occur in the community due to
poor hygiene during delivery and poor infection control measures and this was being brought
about by the poor cultural practices that they exhibit. According to the Acting DHO, Buyende
District,
“…most deaths occur at community level but are not reported and cannot be quantified”
It was noted in some districts that some death occur in the district referral hospitals because of
late referral to hospital. One of the Key informants reported that most deaths occur in district
referral hospitals,
“because there is knowledge gap among nurses and also not giving special attention to
neonatal sepsis as any other condition” (KI, Buyende)
In addition the babies who die at lower level facilities die because of misdiagnosis and lack of
appropriate antibiotics for treating sepsis.
It was also noted that newborns that die of neonatal sepsis die because health care workers
treat for a few days and don’t complete the treatment. Treatment is better at higher facilities
i.e. HCIV and Hospitals.
In Kibaale district, IDI has a project working on saving newborn. According to the DHO, Kibaale
district “since the coming of saving mothers with IDI project to the district, all cases of neonatal
sepsis are being appropriately diagnosed and treated”.
In the same district, most of the health care workers have received training on management of
newborn sepsis. All the other 9 districts sampled in this study have not received this training
since there are no implementing partners.
38
4: CONCLUSIONS AND KEY RECOMMENDATIONS
4.1 Conclusions
A policy on use of injectable antibiotics by nurses for treatment of neonatal sepsis is not yet
available. However health care workers use Uganda Clinical guidelines (2012) for
management of neonatal sepsis.
Nurses need to be protected by law to use antibiotics by putting in place a policy that allow
them to use injectable antibiotics in management of neonatal sepsis.
There is need to take services of managing neonatal sepsis up to the level of HCII by availing
commodities and policy to HCIIs.
The essential medicines list need to be improved on to cater for management of neonatal
sepsis at the lower most level health facility since the same antibiotics are also used for
other conditions such as pneumonias.
Amoxicillin has been used widely and so issues of resistance should be looked into before a
policy is put in place.
Gentamicin packaging needs to be improved as the bottles have injured health care workers
during breaking the bottle neck and also there is a lot of wastage as they need only a few
mls from the 2ml bottle
Referral services need to be improved and also streamlined so that neonates who cannot be
managed at a certain level can be referred efficiently to the next level
A lot of capacity building is recommended i.e. training, supportive supervision and
mentorship country wide for effective management of neonatal sepsis and neonatal deaths.
Implementing partners/ funders need to focus on neonatal sepsis as it contributes
significantly to neonatal mortality.
Community based organizations and health care workers need to sensitize their
communities on dangers and management of neonatal sepsis and they also need to
discourage bad cultural practices that contribute to neonatal sepsis.
Improving obstetric care cord hygiene, clean deliveries, health education, community
involvement are still the main preventive measures in reducing neonatal sepsis and
therefore neonatal deaths.
39
4.2 Recommendations
Recommendation Responsible Institution
Policy and regulation
1 A Task sharing policy for nurses to treat diagnosis and treat neonatal
sepsis should be developed
Child Health division , MOH
2 The Essential Medicines and health supplies list 2012 should be revised
to include use of Gentamicin at HC II
Pharmacy Division, MOH
3 The Uganda clinical Guidelines 2012 should be revised to include
diagnosis and treatment of neonatal sepsis at HC II by Nurses
Planning division of MOH
Public sector supply chain
1 Forecasting and quantification of medicines and supplies for treatment
of neonatal sepsis at all levels in public sector and determination of the
financing required to ensure availability of medicines d
MOH pharmacy division QPPU
2 The essential medicines kit for HC II should include Gentamicin for
treatment of neonatal sepsis
NMS
3 Gentamicin and amoxicillin should be included on the medicines that
can be ordered on emergency basis once stocked like it is done for
ARV and TB system
NMS
4 Small vials of 10 mg/ml should be procured for treatment of neonatal
sepsis to avoid wastage
NMS
5 Specific budget for procuring medicines for treatment of neonatal
sepsis should be established and this could be integrated into the RH
commodities budget line at NMS
NMS, MOH child health
division, Planning division and
Pharmacy division
6 Include Gentamicin as the 7th tracer drug to be tracked through HMIS
to ensure 100% availability.
HMIS/Resource centre, MOH
Private sector supply chain
1 Engage private sector to reduce on the mark ups on Gentamicin PPP desk at MOH
2 Increase the number of suppliers of Gentamicin on the Uganda Market PPP desk
40
Diagnosis and treatment of neonatal sepsis
1 Capacity building for health workers on treatment of neonatal sepsis
using the new regimen
MOH and partners
2 Distribution of UCG, EMHSL and other relevant policy documents to all
health facilities and if possible to each health worker
MOH/ local
government/Partners
3 Community sensitization on early signs of neonatal sepsis MOH/Local
government/Partners
4 Strengthening of the referral system MOH/Partners
5 Pilot the new treatment regimen in Uganda MOH/Partners
Health systems strengthening
1 A feasibility study to understand the different system inputs for
effective management of newborn sepsis even at lower level health
facilities and on an outpatient basis should be conducted to inform
potential policy changes
MOH/partners
41
REFERENCES 1. Ministry of Health. Situation analysis of newborn health in Uganda: current status and
opportunities to improve care and survival. Kampala: Government of Uganda. Save the
Children, UNICEF, WHO; 2008.
2. www.path.org/publications/files/APP_un_comm_com6.pd Safe guard women and
children with essential commodities, technical reference team, commodity; injectable
antibiotics.
3. www.reactgroup.org/news/313/18.html May 16, 2013 - The report looks at the critical
first day of life when mothers and their newborn babies face the greatest threats to
survival but which also.
4. Simplified Regimens for Management of Neonates and Young Infants With Severe
Infection When Hospital Admission Is Not Possible: Study Protocol for a Randomized,
Open-label Equivalence Trial. AFRINEST (african neonatal Sepsis Trial) GrouP
5. Simplified Antibiotic Therapy Trial (SATT) results revealed
www.newshour.com.bd/.../simplified-antibiotic-therapy-trial-results-reve
6. Ensuring quality in AFRINEST and SATT: clinical ... - logo
www.pubfacts.com/.../Ensuring-quality-in-AFRINEST-and-SATT
7. Ministry of Health (2011) Health Sector Strategic and Investment Plan (HSSIP) 2010/11-
2015/16
8. Hall, S.N Et al (2013). Ensuring Quality in AFRITEST and SATT Pediatr Infect Dis J. 2013
Sep; 32(Suppl 1 Innovative Treatment Regimens for Severe Infections in Young Infants):
S39–S45.
9. Okwero, P., Villegas, L., Nonay, C., and Johannes, L., 2012. Providing Safe Delivery
Services with Vouchers: The Reproductive Healthcare Voucher Project (RHVP) in
Western and Southern Uganda. Smart Lessons, International Finance Corporation
42
Annex 1: Landscape Analysis Structured Questionnaire
1. NATIONAL LEVEL QUESTIONNAIRE: PURPOSEFULLY SELECTED ORGANIZATIONS AT
NATIONAL LEVEL
Name of Interviewer
Name of Organization
Name of Interviewee
Position
Contact email
Contact phone Number
Location of the organization
Date
Time
INTRODUCTION: Good morning. My name is ……………………………………………………………………………..
I am a researcher conducting a survey on behalf of the Ministry of Health, SAVE THE CHILDREN
and Samasha Medical Foundation (SMF)
The purpose of this assignment is to conduct a landscaping analysis of antibiotics for treatment
of possible severe bacterial infection/neonatal sepsis with a focus on demand and supply-side
bottlenecks. The information collected will input into the process for the upcoming study on
the feasibility of out-patient management of PSBI and at lower level health facilities using
simplified antibiotics regimens. The report out of this assessment will also be critical in
informing potential policy changes that may be as a result of PSBI management algorithm shift.
I would like to ask you some questions about antibiotics for treatment of possible severe
bacterial infection/neonatal sepsis and your opinion on the current situation and this will take
about 30 minutes. We are doing this assessment at national level, district level and health
facility level incorporating government, civil society and private sector and your organization
has been at purposefully selected. All your responses will be treated confidentially. For
purposes of keeping up with the all records, I will be using the recordings of our conversation.
May I proceed with the interview? Thank you and I want to remind you that you are free to
change your mind and end the interview at any time. Also, if you have any further questions
you may contact Dr. Jesca Nsungwa, Assistant Commissioner Health Services, Child Health at
MOH (0772509063) or Patrick Aliganyira, Program Officer, Save the Children (0772767158).
(CONSENT SIGNATURE)
______________________________________________________________
OFFICE: Back checked by Supervisor: Date: _______ Time: ___________
Comments: ____________________________________________
43
Questions
1.0 National Policy and Regulatory environment for Antibiotics for Newborn Sepsis
Management
1.1 Does Uganda have a policy on use of injectable antibiotics by
nurses
Yes No Not
aware
If yes, what does the policy say? And ask for a copy of the policy document if available
1.2 Does Uganda have a policy on use of Dispersible amoxicillin for
treatment of neonatal sepsis?
Yes No Not
aware
If No, why?
1.3 Does Uganda have a policy on what level of health care is
permitted to provide injectable antibiotics to neonates?
Yes No Not
aware
If yes, what level of health care is permitted to administer antibiotics to neonates? And ask
for a copy of the policy document if available
1.4 Does Uganda have a policy on use of antibiotics for neonatal
sepsis management in the private sector
Yes No Not
aware
If yes, what does the policy say? And ask for a copy of the policy document if available
If no, why?
1.5 Do the Uganda clinical guidelines allow nurses to use
antibiotics for management of newborn sepsis (Injectable
Gentamicin and Dispersible Amoxicillin)?
Yes No Not
ware
If no, what could be the reason?
44
1.6 What is the referral policy from community to the highest level? (probe for more
details)
1.7 What other policy interventions do you think should be introduced at the national
level to reduce neonatal mortality due sepsis?
1.8 What are the training packages for health facility staff (in-service training) that
include use of antibiotics for newborn sepsis management?
1.9 What is the annual training schedule for health facility staff (in-service training) that
includes management of a sick newborn using antibiotics?
1.10 Who are the main partners in Uganda investing and committed to reducing
neonatal sepsis/improving newborn health?
1.11 Have product quality issues been observed or suspected in association with
antibiotics for managing sepsis in newborn babies (Gentamicin and Dispersible
Amoxicillin)?
1.12 Are there procurement plans for antibiotics for managing newborn sepsis at the
National level?
1.13 Are the antibiotics newborn sepsis management included in the Essential Medicines
List and HC II and HC III essential medicines Kit?
45
1.14 What do you see are the major risks to making outpatient treatment for newborn
sepsis available at;
HCII:
HCIII:
1.15 Is there adequate follow up in place to monitor outpatient sepsis cases following
treatment at the facility?
1.16 Would your organization be willing to bridge the funding gap in-case the MOH
indicated a need? If no why
Has your organization experienced this situation before? If yes please explain
Barriers to Use
1.17 What do you think are the main barriers to reducing sepsis deaths among
neonates?
1.18
In your own view and experience, what could be the possible barriers to use of
Injectable Gentamicin for treatment of neonatal sepsis?
1.19 In your own view and experience, what could be the possible barriers to use of
Dispersible Amoxicillin for treatment of neonatal sepsis?
1.20 What do you think are the main barriers to reducing sepsis deaths among
neonates?
46
1.21 Is there a task sharing policy for nurses to use Antibiotics for
newborn sepsis management?
Yes No Not
aware
1.22 What might be an effective strategy to introduce task sharing for antibiotics for
treatment of neonatal sepsis?
1.23 Do you carry out regular support supervision for rational use of antibiotics for
treatment of neonatal sepsis? Probe more how this is done
Thanks very much for your time
47
Annex 2. Procurement, Wholesale, Warehousing And Distribution Agents Guide
Name of Interviewer
Name of Organization
Name of Interviewee
Position
Contact email
Contact phone Number
Location of the organization
Date
Time
INTRODUCTION: Good morning. My name is …………………………………………………………………………….. I am a
researcher conducting a survey on behalf of the Ministry of Health, Save the Children and SAMASHA
Medical Foundation (SMF)
The purpose of this assignment is to conduct a landscaping analysis of antibiotics for treatment of
possible severe bacterial infection/neonatal sepsis with a focus on demand and supply-side bottlenecks.
The information collected will input into the process for the upcoming study on the feasibility of out-
patient management of PSBI and at lower level health facilities using simplified antibiotics regimens. The
report out of this assessment will also be critical in informing potential policy changes that may be as a
result of PSBI management algorithm shift.
I would like to ask you some questions about antibiotics for treatment of possible severe bacterial
infection/neonatal sepsis and your opinion on the current situation and this will take about 30 minutes.
We are doing this assessment at national level, district level and health facility level incorporating
government, civil society and private sector and your organization has been at purposefully selected. All
your responses will be treated confidentially. For purposes of keeping up with the all records, I will be
using the recordings of our conversation. May I proceed with the interview? Thank you and I want to
remind you that you are free to change your mind and end the interview at any time. Also, if you have
any further questions you may contact Dr. Jesca Nsungwa-Sabiiti, Assistant Commissioner Health
Services, Child Health at MOH (0772509063) or Patrick Aliganyira, Program Officer, Save the Children
(0772767158).
(CONSENT SIGNATURE)
______________________________________________________________
OFFICE: Back checked by Supervisor: Date: _______ Time: ___________
Comments: ____________________________________________
48
2. 0 Forecasting and procurement
2.1 Does your organization carryout forecasting and quantification for any the following
commodities
2.1a Inj Gentamicin Yes No Not aware
2.1b Dispersible amoxicillin Yes No Not aware
2.1c Inj Ampicillin Yes No Not aware
2.1d Inj Procaine Benzyl penicillin Yes No Not aware
2.1e Inj ceftriaxone Yes No Not aware
2.2 In your forecasting methodology, did you consider the above commodities specifically
for treatment of neonatal sepsis? If no, kindly give the reasons
2.3 In the process of forecasting, do you consider additional supplies for administration of
injectable antibiotics for neonates mentioned below
2.3a Pediatric needles (23 gauge) Yes No Not aware
2.3b Pediatric syringes (2 ml) Yes No Not aware
2.3c Combined pediatric needle and syringe Yes No Not aware
2.4 Do you have a procurement plan and budget for the above
supplies?
Yes No Not aware
2.5 Is the budget allocated for procurement adequate Yes No Not aware
2.6 If the answer is no, what is the funding gap?
2.7 Is there adequate number of suppliers of the above
commodities?
Please mention them
Yes No Not aware
2.8 If no, what do you think is the cause of this state of affairs?
What could be done to improve the situation?
Yes No Not aware
Warehousing and distribution
2.9 Is there adequate warehousing space for these commodities Yes No Not aware
2.10 How do you distribute the supplies
49
2.11 Any challenges with distribution?
Availability of Antibiotics for Management of Newborn Sepsis (coming 3 months)
No Name Strength Pack Unit Stock on
Hand
On Order
1 Inj Gentamicin
2 Dipsersibe Amoxicilin
3 Inj Ampicillin
4 Inj Procaine Benzyl penicillin
5 Inj ceftriaxone
Use of Antibiotics for Management of Newborn Sepsis (previous 3 months)
No Name Strength Pack Unit Quantity
Ordered
Quantity
Issued
1 Inj Gentamicin
2 Dispersible Amoxicilin
3 Inj Ampicillin
4 Inj Procaine Benzyl penicillin
5 Inj ceftriaxone
50
Annex 3. District Level Structured Questionnaire
Particulars
Name of Interviewer
Name of District
Name of Interviewee
Position
Contact email
Contact phone Number
Location of the District
Date
Time
INTRODUCTION:
Good morning. My name is …………………………………………………………………………….. I am a
researcher conducting a survey on behalf of the Ministry of Health, Save the Children and
SAMASHA Medical Foundation (SMF)
The purpose of this assignment is to conduct a landscaping analysis of antibiotics for treatment
of possible severe bacterial infection/neonatal sepsis with a focus on demand and supply-side
bottlenecks. The information collected will input into the process for the upcoming study on
the feasibility of out-patient management of PSBI and at lower level health facilities using
simplified antibiotics regimens. The report out of this assessment will also be critical in
informing potential policy changes that may be as a result of PSBI management algorithm shift.
I would like to ask you some questions about antibiotics for treatment of possible severe
bacterial infection/neonatal sepsis and your opinion on the current situation and this will take
about 30 minutes. We are doing this assessment at national level, district level and health
facility level incorporating government, civil society and private sector and your organization
has been at purposefully selected. All your responses will be treated confidentially. For
purposes of keeping up with the all records, I will be using the recordings of our conversation.
May I proceed with the interview? Thank you and I want to remind you that you are free to
change your mind and end the interview at any time. Also, if you have any further questions
you may contact Dr. Jesca Nsungwa-Sabiiti, Assistant Commissioner Health Services, Child
Health at MOH (0772509063) or Patrick Aliganyira, Program Officer, Save the Children
(0772767158).
(CONSENT SIGNATURE)
______________________________________________________________
OFFICE: Back checked by Supervisor: Date: _______ Time: ___________
Comments: ____________________________________________
51
Questions
3.0 Neonatal sepsis treatment at district level
3.1 Is there any policy on use of antibiotics for neonatal sepsis management that
you know of?
3.2 As a district health management team, do you receive from the MOH any
guidance on treatment of neonatal sepsis? (Probe more for the current guidance)
3.3 Are there any restrictions that you are aware of in use of antibiotics for
treatment of newborn sepsis?
3.4 Based on your experience, where are most neonatal sepsis deaths occurring and
why?
3.5 From your experience, do you think health workers are effectively managing
cases of newborn sepsis in health facilities in this district?
3.6 Is there adequate follow up in place to monitor outpatient newborn sepsis
cases following treatment at the health facility?
3.7 How available is Gentamicin at all levels? Probe for more details
3.8 How available is Benzyl Penicillin at all levels? Probe for more details
52
3.9 How available is ceftriaxone at all levels?
3.10 How available is dispersible amoxicillin at all levels?
3.11 Have your health workers received adequate training in management of
newborn sepsis in the last 6 months?
3.12 Currently the policy does not explicitly allow nurses and midwives to manage
sick newborn babies (diagnose and prescribe) using antibiotics. Would you be
comfortable to have nurses diagnose and treat neonatal sepsis?
If yes, why?
If no, Why?
3.13 Do you think the community would be willing to seek care from lower health
facility managed by a nurse/midwife for treatment of newborns? Expound
3.14 Do you think that a mother coming for injections for 2 days at outpatient will
be adhered to in case of a policy change for newborn sepsis management at lower
level health facilities? Explain
53
Availability of injectable antibiotics and dispersible amoxicillin at district level for
treatment of neonatal sepsis
3.15 Is the amount procured/supplied of Injectable antibiotics and Dispersible
Amoxicillin sufficient?
3.16 Do you ever experience stock out of Injectable antibiotics and Dispersible
amoxicillin?
Are stock-outs monitored?
3.17 Are you aware of district level/NMS interventions in cases of emergency
stock-outs?
3.18 Are you aware of other partners active in sepsis management/improving
newborn health at district or national level?
3.19 What do you think should be done to reduce neonatal sepsis deaths?
3.20 Does the district have a focal person for “Newborn Health?
54
Annex 4. Health Facility Level Structured Questionnaire
Name of Interviewer
Name of Health facility
Name of Interviewee
Position
Contact email
Contact phone Number
Location of the Health facility
Date
Time
INTRODUCTION:
Good morning. My name is …………………………………………………………………………….. I am a researcher
conducting a survey on behalf of the Ministry of Health, Save the Children and SAMASHA Medical
Foundation (SMF)
The purpose of this assignment is to conduct a landscaping analysis of antibiotics for treatment of
possible severe bacterial infection/neonatal sepsis with a focus on demand and supply-side bottlenecks.
The information collected will input into the process for the upcoming study on the feasibility of out-
patient management of PSBI and at lower level health facilities using simplified antibiotics regimens. The
report out of this assessment will also be critical in informing potential policy changes that may be as a
result of PSBI management algorithm shift.
I would like to ask you some questions about antibiotics for treatment of possible severe bacterial
infection/neonatal sepsis and your opinion on the current situation and this will take about 30 minutes.
We are doing this assessment at national level, district level and health facility level incorporating
government, civil society and private sector and your organization has been at purposefully selected. All
your responses will be treated confidentially. For purposes of keeping up with the all records, I will be
using the recordings of our conversation. May I proceed with the interview? Thank you and I want to
remind you that you are free to change your mind and end the interview at any time. Also, if you have
any further questions you may contact Dr. Jesca Nsungwa-Sabiiti, Assistant Commissioner Health
Services, Child Health at MOH (0772509063) or Patrick Aliganyira, Program Officer, Save the Children
(0772767158).
(CONSENT SIGNATURE)
______________________________________________________________
OFFICE: Back checked by Supervisor: Date: _______ Time: ___________
Comments: ____________________________________________
Questions
55
4.1 Services and staffing provided
Staffing
Name Qualification Can Manage (Diagnose and treat) neonatal sepsis
4.2 Does your facility diagnose and treat neonatal sepsis? Yes No Not aware
If yes, how do you diagnose neonatal sepsis? (signs and symptoms of a sick newborn)
How do you treat neonatal sepsis?
What are your comments on determination of dosage to give to the neonate?
What do you use as the right dosage for newborns sepsis management?
4.3 Last Training on diagnosis and treatment of neonatal sepsis (last 6 months)
Name Trained (Y
or N)
By whom?
(agency/Partner)
56
4.4 How many staff are treating neonatal sepsis with injectable antibiotics?
Can you mention the injectable antibiotics you are using to treat?
4.5 How many staff are treating with oral antibiotics
Can you mention the oral antibiotics your are using to treat?
4.6 For the nurses that are not treating neonatal sepsis with antibiotics (both oral and injectable), what
could be the reasons
4.7 Availability of antibiotics for treatment of neonatal sepsis (last 3 months)
Dispensary
No Name Strength Pack
Unit
Stock on
Hand
On Order Days out
of stock
1 Inj Gentamicin
2 Dispersible Amoxicillin
3 Inj Ampicillin
4 Inj Procaine Benzyl
penicillin
5 Inj ceftriaxone
6 Syringes (2ml)
7 Gloves (Disposable)
8 Needles (23 G)
9 Auto-disable syringes
(2ml)
10 Disinfectant
11 Cotton
12 Weighing scale
13 Sharps Container
57
4.8 Store
No Name Strength Pack
Unit
Stock on
Hand
On Order Days out
of stock
1 Inj Gentamicin
2 Dispersible Amoxicillin
3 Inj Ampicillin
4 Inj Procaine Benzyl
penicillin
5 Inj ceftriaxone
6 Syringes
7 Gloves
8 needles
9 Auto-disable syringes (2ml)
10 disinfectant
11 Cotton
12 Weighing scale
13 Sharps Container
4.9 Is the amount procured/supplied sufficient?
Do you ever get stockouts?
4.10 Are stock-outs monitored?
4.11 Are you aware of district level/NMS interventions in cases of emergency stock-outs?
4.12 Are you aware of other implementing partners active in newborn sepsis
management/improvement of newborn health in your area?
4.13 What do you think should be done to reduce neonatal sepsis deaths?
4.14 Are aware of any restrictive laws and regulations that affect your ability to administer
injectable antibiotics?
58
4.15 In your view, where do you think mothers go when their newborn babies get sick to seek care?
Why?
4.16 In your view, would you be comfortable to manage (diagnose and treat) neonatal sepsis using
simplified regimens of 2 days of Gentamicin injection + Dispersible amoxicillin and 5 days of
amoxicillin after on an out-patient basis?
4.17 Can you mention any factors that make it difficult to manage a baby with sepsis in your
catchment area?
4.18 What suggestion do you have to improve in the treatment of neonatal sepsis?
4.19 What are your comments on the packaging of Gentamicin for neonatal sepsis management?
59
Annex 5. Focus Group Discussions Guide
INTRODUCTION:
Good morning. My name is …………………………………………………………………………….. I am a researcher
conducting a survey on behalf of the Ministry of Health, Save the Children and SAMASHA Medical
Foundation (SMF)
The purpose of this assignment is to conduct a landscaping analysis of antibiotics for treatment of
possible severe bacterial infection/neonatal sepsis with a focus on demand and supply-side bottlenecks.
The information collected will input into the process for the upcoming study on the feasibility of out-
patient management of PSBI and at lower level health facilities using simplified antibiotics regimens. The
report out of this assessment will also be critical in informing potential policy changes that may be as a
result of PSBI management algorithm shift.
I would like to ask you some questions about antibiotics for treatment of possible severe bacterial
infection/neonatal sepsis and your opinion on the current situation and this will take about 30 minutes.
We are doing this assessment at national level, district level and health facility level incorporating
government, civil society and private sector and your organization has been at purposefully selected. All
your responses will be treated confidentially. For purposes of keeping up with the all records, I will be
using the recordings of our conversation. May I proceed with the interview? Thank you and I want to
remind you that you are free to change your mind and end the interview at any time. Also, if you have
any further questions you may contact Dr. Jesca Nsungwa-Sabiiti, Assistant Commissioner Health
Services, Child Health at MOH (0772509063) or Patrick Aliganyira, Program Officer, Save the Children
(0772767158).
Group Consent
1.
2.
3.
4.
5.
6.
60
Guiding questions
The focus group discussions will have a minimum of five persons including the community
health workers, health facility workers, if available. The questions below provide a rough guide
but the interviewer should play the role of probing and digging out more detailed information.
Sample questions
5.1 What challenges do you face while diagnosing and treating neonatal sepsis at this health
facility?
5.2 How do you overcome those challenges?
5.3 What is your preferred treatment regiment for treating neonatal sepsis?
5.4 What has been the most common outcome of treatment of neonates who present with
sepsis
5.5 Are there challenges with other supplies like syringes, canulas, weighing scale, cotton
swabs and gloves
5.6 Are there challenges with the packaging of Gentamicin?
5.7 Are there challenges with measuring the dose?
5.8 What could be done that would make treatment of neonatal sepsis simpler?
5.9 Do you have enough support in case of complications or referral?
5.10 Do you feel confident to administer injectable antibiotics to neonates
5.11 Is the training sufficient to carry out the work of neonatal sepsis management?
5.12 Is there sufficient support supervision related to improving sepsis management?
5.13 As a mother, would you be comfortable to bring your newborn to this health facility
and what can be done to gain your confidence?