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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.
RATIONAL USE OF MEDICINES
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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
RATIONAL USE OF MEDICINES
Standard methodsand indicators can
identify prescribingproblems and
quality of care.
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RATIONAL USE OF MEDICINES
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
Source: WHO/EMP database 2009.
Sub-Saharan Afr ica Latin America & Caribbean Middle East & Central Asia
East A sia & Pacif ic South A sia
00
WHO/INRUD indicators
Treatment of acute diarrhoea
Percentage
Treatment of acute respiratory infection
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
% ARI cases treated withcough syrups
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RATIONAL USE OF MEDICINES
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
Treatment of acute diarrhoea
Percentage
Treatment of acute respiratory infection
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
% ARI cases treated withcough syrups
Source: WHO/EMP database 2009.
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.
RATIONAL USE OF MEDICINES
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.
RATIONAL USE OF MEDICINES
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