world medicine statistics 2011

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THE WORLD MEDICINESSITUATION 2011

RATIONAL USE OF MEDICINES

Kathleen HollowayDepartment o Essential Medicines and Pharmaceutical Policies, WHO, Geneva

Liset van DijkUniversity o Utrecht, the Netherlands

GENEVA 2011

WHO/EMP/MIE/2011.2.2


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TheWorldMedicinesSituation2011

3rd Edition

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SUMMARY

n Irrational use o medicines is an extremely serious global problem that is wasteul

and harmul. In developing and transitional countries, in primary care less than 40%

o patients in the public sector and 30% o patients in the private sector are treated inaccordance with standard treatment guidelines.

n Antibiotics are misused and over-used in all regions. In Europe, some countries are

using three times the amount o antibiotics per head o population compared to other

countries with similar disease profles. In developing and transitional countries, while

only 70% o pneumonia cases receive an appropriate antibiotic, about hal o all acute

viral upper respiratory tract inection and viral diarrhoea cases receive antibiotics

inappropriately.

n Patient adherence to treatment regimes is about 50% worldwide and lower in

developing and transitional countries, where up to 50% o all dispensing events are

inadequate (in terms o instructing patients and /or labelling dispensed medicines).

n Harmul consequences o irrational use o medicines include unnecessary adversemedicines events, rapidly increasing antimicrobial resistance (due to over-use o

antibiotics) and the spread o blood-borne inections such as HIV and hepatitis B/C

(due to unsterile injections) all o which cause serious morbidity and mortality and

cost billions o dollars per year.

n Eective interventions to improve use o medicines are generally multi-aceted. They

include provider and consumer education with supervision, group process strategies

(such as peer review and sel-monitoring), community case management (where

community members are trained to treat childhood illness in their communities

and provided with medicines and supervision to do it) and essential medicines

programmes with an essential medicine supply element. Printed materials alone

have little eect and or guidelines to be eective they need to be accompanied by

reminders, educational outreach and eedback.

n Less than hal o all countr ies are implementing many o the basic policies needed

to ensure appropriate use o medicines, such as regular monitoring o use, regular

updating o clinical guidelines and having a medicine inormation centre or

prescribers or drug (medicine) and therapeutics committees in most o their hospitals

or regions.

n The second International Conerence on Improving Use o Medicines in 2004 and

World Health Assembly Resolution WHA60.16 in 2007 recognized the difculty o

promoting rational use o medicines in ragmented health systems. They recommend

a cross-cutting health system approach and the establishment o national programmes

to promote rational use o medicines, which would require much more investment

than governments and donors have so ar been willing to give.



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THE WORLD MEDICINES SITUATION 2011

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1.1 INTRODUCTION

What is rational use?

Medicine use is rational (appropriate, proper, correct) when patients receive the appropriate

medicines, in doses that meet their own individua l requirements, or an adequate period o

time, and at the lowest cost both to them and the community ( 1). Irrat ional (inappropriate,

improper, incorrect) use o medicines is when one or more o these conditions is not met.

Worldwide, it is estimated that over hal o all medicines are prescribed, dispensed or sold

inappropriately (2,3). Moreover, it has been estimated that hal o all patients ail to take

their medication as prescribed or dispensed (4). Irrational use may take many dierent

orms, or example, polypharmacy, over-use o antibiotics and injections, ailure to prescribe

in accordance with clinical guidelines and inappropriate sel-medication. However, despite

the global problem o inappropriate use, ew countries are monitoring medicines use or

taking sucient action to correct the situation (5).

Consequences o irrational useIrrational use is wasteu l and can be harmu l or both the individual and the population.

Adverse medicines events cause signicant morbidity and mortality and rank among the

top 10 causes o death in the United States o America (6,7). They have been estimated to

cost 466 million annually in the United Kingdom o Great Britain and Northern Ireland

and up to US$ 5.6 million per hospital per year in the USA ( 810). Antimicrobial resistance

is dra matically increasing worldwide in response to antibiotic use, much o it inappropri-

ate overuse (and is causing signicant morbidity and mortality (3). It has been estimated

that antimicrobial resistance costs annually US$ 40005000 million in the USA and9000

million in Europe (11,12). The use o unsterile injections is associated with the spread o

bloodborne inections, such as hepatitis B and C and HIV/AIDS (13). Although evidence-

based medicine has gained importance the use o both diag nostic and treatment guidelines issub-optimal and could be greatly improved.

Inappropriate antibiotic use

Overuse and misuse o antibiotics is a part icularly serious global problem. Established and

newly emerging inectious disea ses are increasingly threatening the health o populations.

I antibiotics become ineective, these diseases will lead to increased morbidity, health-care

use and eventually premature mortality (1416). Furt hermore, antibiotics are required or

other treatments (taken or granted in developed countries), such a s surgery and cancer

chemotherapy, which would become unavailable with the disappearance o eective anti-

biotics. Unortunately, while resistance to older antibiotics is increasing, the development

o new generations o antibiotic medicines is stalling (17). Thereore, ecient use o exist-

ing antibiotics is needed to ensure the availability in the long term o eective treatment

o bacterial inections. Ecient use includes both restr ictive and appropriate use. However

inappropriate and incorrect use o antibiotics occurs in both developing and developed

countries. Doctors prescribe antibiotics to patients who do not need them, while patients do

not adhere to their treatment causing the risk o antibiotic resistance (18). Two thirds o all

antibiotics are sold without prescription, through unregulated private sectors. Even in those

European countries where over-the-counter delivery o antibiotics is not allowed, patients

use antibiotics without prescription (19). Low adherence levels by patients are common,

many patients taking antibiotics in under-dose or or shortened duration 3 instead o

5 days (20,21).

Irrational use ofmedicines is both

wasteful andharmful.


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This chapter covers irrational u se o medicines in both developing and developed countries,

with a ocus on developing and transitional countries. Since there is very little inormation

on medicines use or chronic diseases or on the use o over-the-counter (OTC) medicines in

developing countries, the chapter will ocus mainly on use o prescription-only medicines

in acute disea se, particularly antibiotics, although mention will be made o treatment ochronic diseases, especially in terms o ad herence to medication.

1.2 PRESENTSITUATIONANDTRENDS

Monitoring the use o medicines is essential to ensuring that they are properly used. This

section covers the assessment o medicines use, including the disparity in the amount o data

available in developed and developing countries, and methods which can help in assessments

o medicines use. Patterns and trends are a lso examined, with discussion o the ndings

rom WHOs database o studies on the use o medicines in primary c are in developing and

transitional countries. In add ition, antibiotic use and patients adherence to treatment are

covered. The section on targeted interventions to increase rational use concludes that multi-aceted interventions improving both education and managerial systems have tended to be

more eective than those that employ one strategy.

1.2.1 Assessing(measuring)medicinesuse

It is essential to have reliable data on how medicines are used in order to:

n assess the accessibility, quality and cost-eectiveness o care

n monitor trends in consumption

n provide a benchmark or comparison with similar countries, regions, acilities

n compare medicines use a gainst evidence-based guidelinesn increase awareness o stakeholders about medicine use

n identiy problematic areas to develop targeted intervention strategies.

In many developed countries, medicines use is routinely monitored, oten through insur-

ance data and electronic medical records. Data generated in this way have been eective in

improving use through eedback to prescribers and policy-makers. However, in developing

countries, electronic medical records and insurance data are oten absent and such monitor-

ing o use not undertaken, nor are interventions to improve use widely implemented.

There are several well- established, but quite dierent, methods which can be u sed to

assess medicines use. Aggregate methods, such as the Anatomical Therapeutic Classica-

tion (ATC)/Dened Daily Dose (DDD) methodology (developed by WHOs CollaboratingCentre or Drug Statistics in Oslo, Norway: http://www.whocc.no), can be used to compare

consumption among institutions, regions and countries. However, judgements about the

appropriateness o use can only be made indirectly, either by comparison with consumption

elsewhere, morbidity data and/or adherence to evidence-based guidelines.

Rapid appraisal o prescriptions, using standard methods and indicators, can useu lly

identiy general prescribing problems and quality o care. The WHO/INRUD (International

Network or the Rational Use o Drugs) indicators ca n be used to identiy general prescrib-

ing and quality o care problems at primary care acilities (22). The WHO/IMCI (Integrated

Management o Childhood Illness) indicators can be used to assess the quality o treatment

in children (23). Focused medicines use evaluation through examination o medical records

and prescriptions, and linking d iagnosis to treatment, can be used to identiy medicines

use problems in depth, especially in hospitals. The ATC/DDD methodology has been used


Standard methodsand indicators can

identify prescribingproblems and

quality of care.


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FIGURE 1.1Medicinesuseinprimarycareindevelopingandtransitionalcountriesovertime

% diarrhoea casestreated with ORS

% diarrhoea cases treatedwith antibiotics

% diarrhoea cases treatedwith antidiarrhoeals

% pneumonia cases treated withrecommended antibiotics

% upper respiratory tract infectionstreated with antibiotics

% ARI cases treated withcough syrups

1

1.5

2

2.5

3

0.5

0

100

80

60

40

20

0

19821991 19921994 19951997 19982000 20012003 20042006

Average number of medicines per patient

% medicines from Essential Medicines List

% patients treated according to clinical guidelines

% medicines prescribed by generic name

% patients with an antibiotic prescribed

% patients with an injection prescribed

Percentage

Number

WHO/INRUD medicines use indicators

Treatment of acute diarrhoea

Percentage

19821991 19921994 19951997 19982000 20012003 20042006

Treatment of acute respiratory infection

Percentage

100

80

60

40

20

0

100

80

60

40

20

0

19821991 19921994 19951997 19982000 20012003 20042006

Source: WHO/EMP database 2009.


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FIGURE 1.2MedicinesuseinprimarycareindevelopingandtransitionalcountriesbyWorldBankregion


Sub-Saharan Afr ica Latin America & Caribbean Middle East & Central Asia

East A sia & Pacif ic South A sia

00

WHO/INRUD indicators


Percentage


Percentage

100

80

60

40

20

0

100

80

60

40

20

0

4

6

8

10

2

100

80

60

40

20

Percentage

Number

% prescribedmedicinesfrom EML

% medicinesprescribed bygeneric name

% patientsprescribedantibiotic

% patientsprescribedinjection

% patientstreated as

per guidelines

Averagenumber drugs

per patient

% diarrhoea casesprescribed antibiotics

% diarrhoea casesprescribed antidiarrhoeals

% diarrhoea casesprescribed ORS

% viral URTI casesprescribed antibiotics

% pneumonia casesprescribed antibiotics



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FIGURE 1.3Prescribinginprimarycarebydoctors,nursesandparamedicalstaffindevleopingandtransitionalcountriesinthepublicandprivatesectors

Public Private -for-prof it Private -not-for-prof it

Public Private-for-prof it

Public Private-for-prof it

00

WHO/INRUD indicators


Percentage


Percentage

100

80

60

40

20

0

100

80

60

40

20

0

4

6

8

10

2

100

80

60

40

20

Percentage

Number

% prescribedmedicinesfrom EML

% medicinesprescribed bygeneric name

% patientsprescribedantibiotic

% patientsprescribedinjection

% patientstreated as

per guidelines

Averagenumber drugs

per patient

% diarrhoea casesprescribed antibiotics

% diarrhoea casesprescribed antidiarrhoeals

% diarrhoea casesprescribed ORS

% viral URTI casesprescribed antibiotics

% pneumonia casesprescribed antibiotics



The medicine (drug) use indicators used in fgures 1.1, 1.2 and 1.3 include: % medicines prescribed thatbelong to the EML; % medicines prescribed by generic name; % patients prescribed one or more antibiotics;% patients prescribed one or more injections; % patients treated in accordance with clinical guidelines;average number o medicines prescribed per patient; % viral upper respiratory tr act inection cases treatedwith antibiotics; % pneumonia cases treated with appropriate antibiotics; % respiratory tr act inection casestreated with cough syrups, antitussives or expectorants; % acute diarrhoea cases treated with oral rehydrationsolution; % acute diarrhoea cases treated with antibiotics; % acute diarrhoea cases treated with antidiarrhoeals.


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varies widely among dierent European regions, with the highest rates in eastern and south-

ern countries, and the lowest in northern and western (25).

There is a clear correlation between outpatient antibiotic use and penicillin-resistant

pneumococci, emphasizing the importance o restrictive antibiotic prescribing policies (26).

Nevertheless, even in the Netherlands, a country with low antibiotic use, overprescribingexists as was shown in a national survey among general practitioners (GPs). Six diseases

or which national guidelines advised against prescribing o antibiotics were included. The

percentage o consultations in which GPs prescribed an antibiotic or these diseases ranged

rom 6% (asthma in children < 12 years) to 67.2% (sinusitis) (27). Figure 1.5 shows the

impact o antibiotic consumption on antimicrobial resistance with regard to Streptococcus

pneumoniae. It can be clearly seen that those countries with higher consumption also have

higher resistance.

FIGURE 1.4

Totaloutpatientantibioticusein25Europeancountriesin2003

Penicillins (J01C) Cephalosporins (J01D) Macrolides (J01F) Quinolones (J01M)

Tetracyclines (J01A) Sulphonamides (J01E) Others

0

DDD/1000 inhabitants/day

Greece

France

Luxembourg

Portugal

Slovakia

Italy

Belgium

Croatia

Poland

Spain

IrelandIceland

Israel

Finland

Slovenia

Hungary

Czech Republic

Norway

United Kingdom

Sweden

Germany

Denmark

Austria

Estonia

Netherlands

5 10 15 20 25 30

Source: Ferech, M. et al. J. Antimicrob. Chemother. 2006, 58:401407; doi:10.1093/jac /dkl188.


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Patient adherence to treatment: antibiotics and chronic medication

An important aspect o rat ional use is whether or not patients adhere to t heir treatment.

Many studies show that patients oten are not adherent. With regard to antibiotics, a patient

survey in 11 countries across the world showed that 22.3% o patients who received antibiotic

medication or acute community inections admitted not nishing the therapy. However,adherence rates varied widely across countries. The Asian countries, China and Japan, had

the highest admitted non-adherence rates and the two European countries, Italy and the

Netherlands, the lowest (18).

The problem o non-adherence is not only relevant or acute complaints, but even more so or

chronic diseases. Due to the increasing number o patients suering rom diseases such as

diabetes, cardiovascular disea se, mental health problems, epilepsy, and chronic obstructive

pulmonary disease (COPD) adherence to medication is becoming increasingly important.

Overviews that qua ntiy the extent o adherence abound, beginning in 1979 with the classic

work o Haynes et al., Compliance in Health Care, (28). DiMatteo compiled 50 years o adher-

ence research rom 1948 to 1998. She calculated adherence rates in a meta-analysis o 569

studies and ound an average non-adherence rate o 24.8% (29). She concluded that adherence

is highest in patients with HIV-disease, arthritis, gastrointestinal disorders and cancer, and

lowest in patients with pulmonary d isease, diabetes mellitus and sleep-disorders. Consis-

tent adherence among patients with chronic conditions is disappointingly low, dropping

most dramatically a ter the rst six months o therapy (30). For WHO, Sabat undertook an

overview o adherence or various medical conditions and concluded that it is a complicated

problem aected by actors at dierent levels: social and economic actors, therapy-related

actors, patient-related actors, condition-related actors and health system actors ( 4). Sabat

estimates that adherence to long-term therapies in the general population is around 50% ,

but lower in developing countries than in western society.


FIGURE 1.5Correlationbetweenantibioticconsumptionandantimicrobialresistance

60

50

40

20

10

0

0

Penicillin-resistantS.pneumoniae

(%)

30

10 20 30 40

Total antibiotic use (DDD/1000 population/day)

Taiwan, China

Spain

France

USA

Portugal

Greece

Ireland

Canada

Luxembourg

IcelandAustria Belgium

ItalyUK

Australia

Finland

Germany

Norway

Sweden

Netherlands

Denmark

Source:Albrich, Monnet and Harbarth. Emerg. Infect. Dis, 2004, 10(3):5147.

Countries withhigher consumption

have higher rateof antimicrobial

resistance.

Patient adherence totreatment regimes is

about 50% worldwide.


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1.2.3 Targetedinterventionstoimproveuseofmedicines

Both in developing and developed countries numerous interventions studies have been

perormed to improve the rational use o medicines. The WHO Fact Book on Medicines Use in

Primary Care in Developing and Transitional Countries summarized such studies or developing

countries (3).

1.2.3.1 Targeted interventions in developing and transit ional countries

The WHO database o studies on the use o medicines in primary care in developing and

transitional countries a lso contains inormation on 386 interventions (rom 313 studies).

Only 121 interventions (rom 81 studies) were adequately evaluated (using random-

ized controlled trial, pre-post with control or time series study design) or their impact

on medicines use. Two methods were used to summarize the eects o dierent types o

intervention across studies which used various outcome measures, mostly INRUD and IMCI

indicators. Firstly, the largest reported improvement in a key medicines use outcome that

was targeted by the individual authors was compared across studies and the results are shown

in Figure 1.6. Secondly, a composite indicator o improvement or each study was estimated

by calculat ing the median eect across all outcomes measures reported in the main category

o outcomes targeted by the authors. A comparison across studies was then conducted using

this composite indicator and the results are shown in Figure 1.7. The second method provides

a much more conservative estimate o eect than the rst (3).

Most o the interventions were educational in nature. It was ound that the multi-aceted

interventions, involving both educational and managerial components, were more eec-

tive than those employing only one strategy. Interventions characterized by provider and

consumer education, enhanced health worker supervision and group process educational

strategies (such as sel monitoring and peer review) were particularly eective. The use o

printed materials and national medicine policies alone had limited impact.

FIGURE 1.6Largestreportedpercentagechangeinanystudyoutcome(medicinesuseindicators)forallinterventions,bytypeofintervention

Source: WHO/EMP/MAR/2009.3 (Reerence 3).

Highest change in individual study Median cross studies in group

-20 0 20 100

Greatest percentage change in outcome

Printed educational materials alone (n=5)

Provider education without consumereducation (n=25)

Provider plus consumer education (n=20)

Consumer education without providereducation (n=3)

Community case management (n=14)

Provider group educational process (n=8)

Enhanced supervision +/ audit (n=25)

Economic incentives to providers/patients(n=7)

EMP, NMP, other national policyor regulation (n=14)

40 60 80

25%

15%

22%

37%

28%

26%

20%

18%

107%

8%


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Further analysis (3) showed that the median largest eect size and t he median reported

percentage change across all study outcomes were respectively:

n 22% and 14% more where there was provider and consumer education with supervision

compared to provider and consumer education without supervision, and

n 12% and 10% more where there was an essential medicines programme (with amedicines supply component) compared to a national medicine policy.

Many o these intervention studies and other experiences rom developing countries

were presented at the rst and second international conerences or improving the use o

medicines held in Chiang Mai, Thailand, in 1997 and 2004 (ICIUM 1997 and 2004:

http://www.icium.org). The 2004 conerence ound that while many successul interven-

tions had been undertaken, global progress remains conned primarily to demonstration

projects and that ew large sca le national projects that could achieve public health impact had

been implemented. Three major recommendations were made:

n Countries should implement national medicines programmes to coordinate long-term

interventions on multiple levels o the health-care system to improve medicines use in

the public and private sectors.

n Successul multi-aceted interventions should be scaled up to national level in a sustain-

able way, with in-built monitoring systems using valid indicators to monitor the long-

term impacts.

n Interventions should address medicines use in the community, particularly ocus-

ing on education o children in schools, and provider education in pharmacies and

medicine shops in the inormal sector, regulation o medicine promotional activities,

and involvement o civil society, such as community representatives and proessional

bodies.


FIGURE 1.7Medianreportedpercentagechangeacrossallstudyoutcomes(medicinesuseindicators)forprescribingimprovementinterventions,bytypeofintervention

Source: WHO/EMP/MAR/2009.3 (Reerence 3).

Effective interventionsto improve use of

medicines are generallymulti-faceted. Printed

materials alone havelittle effect.

Median change in individual study Median cross studies in group

-20 0 20 100

Greatest percentage change in outcome

Printed educational materials alone (n=5)

Provider education without consumereducation (n=25)

Provider plus consumer education (n=20)

Consumer education without providereducation (n=3)

Community case management (n=14)

Provider group educational process (n=8)

Enhanced supervision +/ audit (n=25)

Economic incentives to providers/patients(n=7)

EMP, NMP, other national policyor regulation (n=14)

40 60 80

5%

6%

13%

13%

29%

2%

16%

7%5%


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1.2.3.2 Targeted interventions in developed countries

Many types o interventions to improve rational use o medicines have been undertaken in

developed countries. In this section we will ocus on three subjects: 1) the improvement o

guideline adherence by health care proessionals, 2) the improvement o patient adherence

to medication, and 3) public education.

Guideline adherence by providers

Clinical guidelines that give recommendations about appropriate health care a im to improve

the quality o care. A wide variety o guidelines has been developed in the last decades

or hospitals and physicians. For both acute and chronic diseases, the implementation o

guidelines is a complex process and the eects in terms o cost-eectiveness and long-term

outcomes in patients are not well-studied (3134). Research suggests that the implementation

o guidelines is enhanced by higher quality o evidence supporting the recommendations,

better compatibility o the recommendation with existing values; less complexity o the

decision-making needed; more concrete description o the desired perormance; and ewer

new skills and organizational changes needed to ollow the recommendations (33). Also, the

baseline level o adherence to recommended practice seems important: in a review on the

eect o audit and eedback in improving proessional practice, published in 2006, Jamtvedt

et al. conclude that eects o these interventions are likely to be greater when baseline adher-

ence is low (35).

In 2004, Grimshaw et al. conducted a review to evaluate several implementation strategies

(32). They conclude the ollowing:

n Reminders: the results o intervention studies suggest that reminders are potentially

eective and are likely to result in moderate improvements in process o care.

n Educational outreach is oten a component o a multiaceted intervention. Combina-tions o educational materials and educational outreach appeared to be relatively

ineective. As such, educational outreach may result in modest improvements in

process o care, which needs to be oset against the resources required to achieve this

change and practical considerations.

n Educational materials and audit and eedback showed modest eects. The addition o

educational materials to other interventions did not seem to increase the eectiveness

o those interventions.

n Multiaceted interventions do not appear to be more eective than single interventions

and the eects o multiaceted interventions do not appear to increase with the number

o interventions.

However, other review studies in developed countries state that a combination o strategies

to improve the implementation o guidelines is usually most eective (31,36). Dierences

in review ndings may relate to whether the review ocused on developed or developing

countries. In developed countries a single intervention may be as eective as multiple ones

due to e xisting health inrastructure. However, in developing countries, multiple interven-

tion packages oten include building inrast ructure, such as supervisory systems, which are

likely to increase impact.

Improving patient adherence: limited success

There have been many interventions to improve patient adherence to medication in devel-oped countries. These are diverse in approach and intensity. A number o systematic reviews

A combination ofstrategies to improve

implementation of

guidelines is usuallymost effective.


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have addressed their eectiveness (or example, Haynes et al. (2008), Bosch-Capblanch et

al.(2007), Vermeire et al. (2005), (3739). Van Dulmen et al. (2007) perormed a meta review,

including 38 review studies representing over 1300 original studies on interventions

targeted at improving adherence (40). They conclude that eective adherence interventions

include technical solutions such as simplications o dosage and packaging. However, gener-ally interventions on adherence have had varied and rather limited success. Eective inter-

ventions or long-term treatment are usually complex including combinations o solutions.

But even the most eective interventions do not induce large improvements in both adher-

ence and treatment outcomes (37). Haynes et al. state that important innovations are more

likely to occur i investigators join across clinical disciplines to tackle the problem, and take

into account the resistance that many patients have to tak ing medicines, perhaps includ-

ing patients in the development o new interventions (37). An international expert orum

on patient adherence conrmed that interdisciplinary solutions and patient involvement are

crucial or the development o interventions, as is the need or interventions that are simple

to implement in dai ly clinical practice (41).

Public education campaigns: an example

Many European countries have undertaken public education campaigns in recent years to

reduce inappropriate overuse o antibiotics. While some o these campaigns have had limited

success, others have been very eective (see Boxes 1.1 and 1.2) ( 42). Box 1.1 shows inorma-

tion on a French programme directed towards antibiotic use.

BOX 1.1PublicinformationcampaigninFrance

In 2002, the French National Health Insurance launched a long-term nationwide campaign

to decrease antibiotic use in the community by 25%. The campaign targets the use o

antibiotics in young children and is repeated every winter, because o the higher level o

prescribing during this season.

With the central theme Antibiotics are not automatic, the public education campaign is

directed at the parents o young children. It highlights issues such as higher consumption

rates are linked to higher resistance levels, that antibiotics do not cure viral respiratory

inections or even shorten duration o illness, and that it is important to ully respect the

treatment duration and dosage prescribed. Inormation appeared in national media outlets,

(prime-time television and radio and newspaper advertisements, and a web site, and in

physicians ofces, including putting booklets, handouts and posters in their waiting rooms).

The total number o antibiotic prescriptions per 100 inhabitants decreased by 26.5% over

fve years (compared to the two years beore the campaign was launched), with the greatest

decrease observed in children aged 615 years (35.8%). In this way the French national

campaign has succeeded in reducing unnecessary use o antibiotics.

Source: Sabuncu E et al. Signifcant reduction o antibiotic use in the community ater a nationwidecampaign in France. 20022007, PLoS Med, 2009; 6(6):e1000084.

1.2.4 Nationalpoliciestoimproverationaluseofmedicines

National policies, as well as interventions, can infuence the rational use o medicines.

WHO recommends that countries implement the ollowing national policies to encourage or

ensure more appropriate use o all medicines (2):

n establishing a mandated multidisciplinary national body to coordinate policies on

medicines use and monitor their impact;



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n ormulating and using evidence-based clinical guidelines or standard treatment guide-

lines (STGs) or training, supervision and supporting cr itical decision-making about

medicines;

n selecting, on the basis o treatments o choice, lists o essential medicines (EMLs) that

are used in medicine procurement and insurance reimbursement;

n setting up drug (medicine) and therapeutics committees (DTCs) in distr icts and hospi-

tals to improve the use o medicines;

n promoting problem-based training in pharmacotherapy in undergraduate curricula;

n making continuing in-service medical education a requirement o licensure;

n promoting systems o supervision, audit and eedback in institutional settings;

n providing independent inormation (including comparative data) about medicines;

n promoting public education about medicines;

n eliminating perverse nancial incentives that lead to irrational prescribing;

n drawing up and enorcing appropriate regulation, including regulations to ensu re that

medicinal promotional activities are in keeping with the WHO Ethical Criteria or

Medicinal Drug Promotion adopted in resolution WHA41.17 (see chapter on medicines

promotion);

n reserving su cient governmental expenditure to ensu re equitable availability o

medicines and health personnel.

WHO has also created a database on pharmaceutical policy based on a questionnaire that

is sent to ministries o health once every our years. The last two such surveys were done in

2003 and 2007. Figures 1.8 and 1.9 show the results or 2003 and 2007 ( 5,43). Figure 1.8 showsthat less tha n hal o a ll countries are implementing many basic policies to encourage ratio-

nal use o medicines, even though the proportion o countries implementing many policies

has increased slightly rom 2003 to 2007. Thus, or example, less than hal o countries

regularly monitor the use o medicines, update their STGs every two years, have a medicine

inormation centre or prescribers, or have DTCs in the majority o their hospitals or regions.

Many countries allow OTC sales o antibiotics, some have run public education programmes

on antibiotics but ew have a national strategy to contain AMR, as is recommended by WHO

(44). Although there appears to have been a big increase in the number o countries limiting

public sector procurement exclusively to essential medicines still only a minority o countries

are using the EML in insu rance reimbursement. Figure 1.9 shows that the undergraduatetraining o doctors, nurses and paramedical sta has changed very little between 2003 and

2007. Only about 6070% o countries stated t hat they tra ined their medical students on

various aspects o prescribing and only about 50% required any orm o continuing medical

education. The basic training or nurses and paramedical sta , who oten do the majority

o prescribing, was even less, only about 40% o countries g iving them any basic training on

prescribing concepts, the EML, STGs or pharmacotherapy. The situation is probably even

worse than described here because many policies that ministries o health state are in place

are, in act, poorly implemented. Furthermore, in both 2003 and 2007, about 27% o minis-

tries o health mentioned that revenue rom the sale o medicines is used to pay or or supple-

ment health worker salaries and this is a serious incentive or over-prescribing. The existence

o most policies tended to be higher in high-income compared to low-income countries (5).


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FIGURE 1.8Nationalpoliciesinplaceaccordingtoministriesofhealthin2003and2007

2003

2007

0

% of countries implementing policies

Drug use in audit in last 2 years (n=100, 105)a

National strategy to contain AMR (n=116, 127)

Antibiotic OTC non-availabili ty (n=128, 136)

Public education on antibiotic use (n=121, 129)

DTCs in most regions/provinces (n=96, 113)

DTCs in most referral hospitals (n=99, 118)

Drug Info Centre for prescribers (n=131, 136)

STGs updated in last 2 years (n=121, 145)a

EML in private insurance reimbursement (n=93, 88)

EML in public insurace reimbursement (n=101, 104)

Public sector procurement limited to EML (n=93, 87)

EML updated in last 2 years (n=134, 151)a

20 40 60 80 100

a Over hal o countries responding to this question did not give a date and were assumed not to have donea drug use audit or updated the EML/STG in the last 2 years; n = the number o countries responding to thequestion, the frst number in 2003 and the second number in 2007.

Source: Level 1 pharmaceutical policy surveys 2003 and 2007.

FIGURE 1.9Basictrainingandobligatorycontinuingmedicaleducation(CME)available

a For prescribing concepts in undergraduate education, an average was estimated across nurses andparamedics.

Source: Level 1 pharmaceutical policy surveys 2003 and 2007.

2003 2007

Nurses and paramedics educationa

0 20 40 60 80 100

% of countries

Obligatory CME(n=114, 128)

Pharmacotherapy(n=82, 101)

Prescribing concepts(n=84, 108)

Clinical guidelines(n=86, 110)

Essential Medicines(n=94, 114)

Obligatory CME(n=108, 122)

Pharmacotherapy(n=76, 86)

Prescribing concepts(n=75, 94)

Clinical guidelines(n=80, 95)

Essential Medicines(n=85, 102)

0 20 40 60 80 100

% of countries

Doctors education


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Austvoll-Dahlgren et al. undertook a review that eva luated policies to improve drug use or

to save drug spending (or both) which were implemented by governments, non-government

agencies and health insura nce companies (45). They evaluated ve policies that made

patients nancially contribute or their medicines while lling their prescription in the

pharmacy. These ve included: 1) caps, which means that patients receive reimburse-ment or this medicine up to a maximum amount and have to pay the rest themselves; 2)

xed co-payments, where patients pay a xed amount per prescription or medicine; 3) tier

co-payments, where co-payment depends, or example, on whether the prescribed medicine

is a generic or not; 4) co-insurance, meaning that patients pay a proportion o the medicines

price and 5) ceilings, which means that patients pay a maximum amount (e.g. per year)

and do not pay once they have reached this maximum. The review showed that cap and

co-payment policies have the potential to decrease overall medicines use and the costs or

health insurers. These decreases were also ound or medicines that are important in treating

chronic conditions, which made the authors warn again st potential negative consequences.

Thus there is a potential imbalance between quality and costs, which should be taken into

account. In 2000, Australia tried to nd such balance by ormally adopting the NationalMedicines Policy with as its overall policy goal to meet medication and related service

needs, so that both optimal health outcomes and economic objectives are achieved (46). For

that purpose the National Prescribing Service was established (see Box 1.2).

Only a ew studies have evaluated the impact o national policies on medicines use. One

such study was done in the Republic o Korea, where a national policy, introduced in 2000,

prohibiting dispensing by GPs, was associated with a reduction in antibiotic use rom 80.3%

to 72.8% o viral illness episodes and rom 91.6% to 89.7% or bacterial illness episodes ( 47).

Another study was done in Chile, where a new regulation in 2000 prohibiting the dispensing

o antibiotics without prescription by private retail outlets was associated with a reduction

in overall sales o antibiotics in the private sector rom 0.34 DDD/1000 inhabitant-days(US$37,603,688) in 1996 to 0.25 DDD/1000 inhabitant-days (US$32,141,856) in 2000 (48).

1.3 FUTURECHALLENGESANDPRIORITIES

Irrational use o medicines is a global public health crisis a nd the lack o investment to

improve the situation is a major challenge or the uture. In order to advocate or more

investment, more research must to be done and inormational needs addressed.

1.3.1 Unaddressedglobalpublichealthcrisisofirrationaluseofmedicines

There is now substantial global evidence or continuing irrational use o medicines. Less

than 40% o patients in the public sector and less than 30% in the private sector are treated in

accordance with existing guidelines, and the situation is not improving in either developing

or transitional countries. Likewise, in developed countries there is much evidence o irratio-

nal use o medicines. While much intervention research has been undertaken and eective

interventions identied or improving the use o medicines, ew o these interventions have

been scaled up to national level. Furthermore, about hal o all countries are not implement-

ing many basic policies recommended by WHO to promote rational use o medicines. Many

health system actors and stakeholders infuence the use o medicines and due to these complex

underlying actors, it has been recommended that countries develop a coordinated national

approach to promoting rational use o medicines and containing antimicrobial resistance(ICIUM 2004, WHO 2001). Furthermore, WHO Member States endorsed such a coordinated

approach in adopting Resolutions WHA 58.27 in 2005 and WHA60.16 in 2007 ( 49,50).

Countries shoulddevelop a coordinatednational approach to

promoting rationaluse of medicinesand containing

antimicrobial

resistance.


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A major reason or this ailure to adopt a coordinated approach is that promoting rational use

o medicines has not been institutionalized within health systems in many countries and

so there is no structure to undertake the necessary monitoring and coordination o policy.

While many rich nations have adapted their health systems to address this issue by setting up

national systems or medicines selection, prescription monitoring and obligatory continuing

medical education, ew low- and middle-income countries have done this. Although such

eorts in rich countries may seem to be piecemeal and not within a national programme,

they are eective because they are implemented within an existing coordinated underlying

national inrastructure, including strong health insurance systems. Such an inrastructure

oten non-existent in low- and middle-income countries where there may be a need or a

dierent national model which is cost-eective (due to the inevitable resource limitations). Amajor challenge will be to adapt health systems to institutionalize promotion o the rational

use o medicines and incorporate the necessary structures within their health systems.

BOX 1.2AntibioticprogrammesoftheNationalPrescribingServiceinAustralia

Australia has an extensive National Medicines Policy (see also chapter on medicine policy).

One o its main objectives is Quality Use o Medicines (QUM). In 1998, the National

Prescribing Service (NPS) was established to undertake work in QUM. Its purpose is tosupport the best use o medicines to improve health and well-being. The NPS provides

health proessionals and consumers access to inormation and other supports or good

prescribing and medicines use decisions. For health proessionals this includes proessional

education activities (e.g. peer group meetings and meetings with QUM acilitators [academic

detailing], case studies, clinical audit s and pharmacy practice reviews) and access to a

range o inormation resources (e.g. new medicines inormation [NPS Radar], therapeutic

topic reviews [NPS News], a journal on drug and therapeutic issues [Australian Prescriber])

via a variety o channels (e.g. print, web, prescribing sotware). In addition, medical and

pharmacy students use the National Prescribing Curriculum, a set o online learning

modules modelled on the WHO manual, Guide to Good Prescribing. Consumers have

access to a range o inormation resources (e.g. new medicines inormation [Medicines

Update], actsheets on medicines [Consumer Medicines Inormation] and about managing

your medicines [Medicines Talk], and on topics such as help with managing common colds.

Mass media campaigns are run rom time to time and work is undertaken with specifc

groups in the community (e.g. seniors).

The NPS ran seven antibiotic programmes or general practitioners (GPs) and pharmacists

between 1999 and 2009. Key messages o these programmes were: antibiotics are not

indicated or most upper respiratory tract inections and when indicated amoxicillin is

generally frst l ine, and they have been consistent with national clinical practice guidelines

(Therapeutic Guidelines). At frst GP participation was low but in 2005, 5000 GPs took

part in the programme through academic detailing or clinical audits. All campaigns

included prescribing eedback and newsletters. In addition, consumer campaigns have

been run regularly since 2000 to make the public aware that antibiotics are not eective

or coughs and colds. The campaigns involved promotion o key messages through local

newsletters, radio, TV, storybooks and distribution o resources to all GPs and community

pharmacies. The campaigns cost Aus$1 million in 2007 and Aus$500,000 in 2008. During

this past decade o provider and consumer education campaigns, it was ound that the

number o prescriptions or those antibiotics commonly used or upper respiratory tract

inections declined rom 80 per 1000 consultations in 1996 to 50 per 1000 consultations

in 2007. Furthermore, the number o prescriptions or all antibiotics ell rom 15.5 per 100

encounters in 1999 to 13.25 per 100 encounters in 2007.

Source: National Prescribing Service, Australia: http://www.nps.org.au and personal communication romLynn Weekes and Jonathan Dartnell o NPS.



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1.3.2 Lackofinvestmentinpromotingrationaluseofmedicines

At present there appears to be relatively little investment in promoting rational use o

medicines. Restructuring health systems on the lines mentioned above and undertaking

the necessary monitoring and implementation o interventions and policy will require

signicant extra investment. It could be argued that such investment would be paid backmany times over by the savings rom better use o medicines, particularly reduced misuse

(46). However, these savings would take some time to achieve and thus might not be elt by

the investing government, particularly in health systems where there is a very large private

sector and most medicines are paid or out-o-pocket by patients and not by government.

In developed and some transitional countries, where a large proportion o the population

is covered by health insurance, the health insurance agency may play a signicant role in

promoting rational use o medicines by only reimbursing prescriptions that comply with

guidelines or that contain essential medicines. In some high- and middle-income countries

insurance agencies are reimbursing medicines according to whether they are essential

medicines, generic medicines or approved or a certain use. However, in many low-incomecountries, insurance coverage is low and there is insucient inrastr ucture to establish

health insurance in the short term. A major uture challenge will be to persuade govern-

ments, donors, and the international community to invest suciently in promoting rational

use o medicines.

An added challenge is that while governments are not investing in promoting more prudent

use o medicines, the pharmaceutical industry is promoting increased use o its products.

Globally, most prescribers receive most o their prescribing inormation rom the pharma-

ceutical industry and in many countries this is the only inormation they receive. Unortu-

nately, inormation rom the industry may be biased, and the huge imbalance in expenditure

between industry and government with regard to providing prescribers with adequateinormation needs to be addressed urgently (see the chapter on medicine promotion).

1.3.3 Researchandinformationalneeds

Much is now known about medicines use in primary care and how to improve it (even i ew

governments have adopted proven interventions on a national scale). However, relatively

little is known globally about medicines use outside o primary care acilities and how

to promote rational use o medicines in these settings. Particular areas that need urther

research include:

n community use o medicines, including inormal medicine sellers in the private sector;

n prescribing and dispensing in the private sector where nancial incentives encourage

over use o medicines and the use o more expensive medicines;

n hospital use, particularly with regard to antibiotic use in developing countries;

n establishing quality assu rance mechanisms on prescribing, including monitoring

systems, supervisory systems and DTCs;

n national policy implementation and monitoring;

n improving adherence in patients with chronic diseases, part icularly since there will

be a global increase in the number o patients who need chronic medication (see

chapter 2).


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Unlike the situation or medicines use in primary ca re, or which robust standardized

indicators to assess u se have been developed and utilized, equivalent indicators have yet to

be developed or those areas requiring urther research listed above (i.e. indicators to assess

medicines use in hospitals, communities and the inormal sector, indicators to assess patient

adherence and indicators on the unctionality o DTCs, and the degree o implementation onational policies). This makes monitoring progress dicu lt, i not impossible. Future areas

o research should include the development o standardized indicators in each o the above

areas. While the urgent need or indicator development may seem more obvious in some

areas, such as hospital or community use or adherence to treatment, it equally applies to the

areas o policy implementation, and unctional supervisory systems and DTCs. Without the

latter, progress in improving the rational use o medicines will remain e xtremely limited.

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ABBREVIATIONS

AMR Antimicrobial Resistance

ATC Anatomical Therapeutic Classication

ARI Acute Respiratory Tract Inection

CME Continuing Medical Education

COPD Chronic obstructive pulmonary diseaseDDD Dened Daily Dose

DTC Drug (medicine) and Therapeutics Committee

EML Essential Medicines List

ESAC European Surveillance o Antibiotic Consumption

GPs General Practitioners

HIV/AIDS Human Immunodeciency Virus/Acquired Immunodeciency Syndrome

ICIUM International Conerence or Improving the Use o Medicines

INRUD International Network or Rational Use o Medicines

IMCI Integrated Management o Childhood IllnessNPS National Prescribing Service

ORS Oral Rehydration Solution

OTC over-the-counter

QUM Quality Use o Medicines

STG Standard Treatment Guidelines

WHA World Health Assembly

WHO World Health Organization

URTI Upper Respiratory Tract Inection

USA United States o America

world medicine statistics 2011

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