Rational Use of Drugs in the Public and Private Sectors · PPT file · Web viewRational use of...

Rational use of drugs:an overview

Kathleen HollowayTechnical Briefing Seminar

November 2009

Department of Essential Medicines and Pharmaceutical Policy TBS 2009

Department of Essential Medicines and Pharmaceutical PolicyTBS 2009

Objectives

• Define rational use of medicines and identify the magnitude of the problem

• Understand the reasons underlying irrational use

• Discuss strategies and interventions to promote rational use of medicines

• Discuss the role of government, NGOs, donors and WHO in solving drug use problems


The rational use of drugs requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, and at the lowest cost to them and their community.

WHO conference of experts Nairobi 1985

• correct drug

• appropriate indication

• appropriate drug considering efficacy, safety, suitability for the patient, and cost

• appropriate dosage, administration, duration

• no contraindications

• correct dispensing, including appropriate information for patients

• patient adherence to treatment


Adequacy of diagnostic processSource: Thaver et al SSM 1998, Guyon et al WHO Bull 1994, Krause et al TMIH 1998, Bitran HPP 1995, Bjork et al HPP 1992, Kanji et al HPP 1995.

0 10 20 30 40 50 60

Tanzania

Angola

Senegal

Burkino Faso

Bangladesh

Pakistan

% observed consultations where the diagnostic process was adequate


5-55% of PHC patients receive injections - 90% may be medically unnecessary

0% 10% 20% 30% 40% 50% 60%

Eastern Caribean

J amaica

El Salvador

Guatemala

Ecuador

L.AMER. & CAR.

Nepal

Indonesia

Yemen

ASIA

Zimbabwe

Tanzania

Sudan

Nigeria

Cameroon

Ghana

AFRICA

% of primary care patients receiving injections

Source: Quick et al, 1997, Managing Drug Supply

15 billion injections per year globally half are with unsterilized needle/syringe2.3-4.7 million infections of hepatitis B/C

and up to 160,000 infections of HIV per year associated with injections


0

5

10

15

20

25

30

35

FR GR LU PT IT BE SK HR PL IS IE ES FI BG CZ SI SE HU NO UK DK DE LV AT EE NL

DD

D p

er 1

000

inh.

per

day

Variation in outpatient antibiotic use in 26 European countries in 2002

Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.


Database on medicines use

• Database of all medicines use surveys using standard indicators in primary care in developing and transitional countries

• Studies identified from INRUD biliog, PUBMED, WHO archives

• Data on study setting, interventions, methods and drug use extracted & entered

• All data extraction and entry checked by 2 persons

• Now > 900 studies entered• Systematic quantitative review• Evidence from analysis used for

WHA60.16 in 2007


% compliance with guidelines by WB region

0102030405060

1982-1994 1995-2000 2001-2006

Sub-Saharan Africa (n=29-48) Lat. America & Carrib (n=5-13)Middle East & C. Asia (n=4-8) East Asia & Pacific (n=7-11)South Asia (n=6-12)


Public / private treatment of acute diarrhoea by doctors, nurses, paramedical staff

0

10

20

30

40

50

60

70

80

% diarrhoea casesprescribed antibiotic

% diarrhoea casesprescribed anti-diarrhoeals

% diarrhoea casesprescribed ORS

Public (n=54-90) Private-for-profit (n=5-10)


Treatment of ARI by prescriber type

0

10

20

30

40

50

60

70

80

% viral URTI casesprescribed antibiotic

% pneumonia casesprescribed antibiotic

% ARI cases treated withcough syrup

Doctor (n=26-62) Nurse/paramedic (n=12-86) Pharmacy staff (n=9-17)


Overuse and misuse of antimicrobials contributes to antimicrobial resistance• Malaria

– choroquine resistance in 81/92 countries• Tuberculosis

– 0-17 % primary multi-drug resistance• HIV/AIDS

– 0-25 % primary resistance to at least one anti-retroviral• Gonorrhoea

– 5-98 % penicillin resistance in N. gonorrhoeae• Pneumonia and bacterial meningitis

– 0-70 % penicillin resistance in S. pneumoniae• Diarrhoea: shigellosis

– 10-90% ampicillin resistance, 5-95% cotrimoxazole resistance• Hospital infections

– 0-70% S. Aureus resistance to all penicillins & cephalosporins

Source: WHO country data 2000-3


Community surveillance of AMR and use (1)• Developing & piloting method for

integrated surveillance of AMR & AB use & collection of baseline data in 2 resource-constrained settings

• 3 sites in India & 2 in S. Africa• AMR & AB use data collected

monthly for 1-2 years from same communities

• 4 sites measured AMR in E.Coli & 1 in S.pneum & H.influenzae

• AB use by private GPs, retailers, public & priv hospitals & PHCs by exiting patient interview or prescribing & dispensing records

• Qualitative study (FGDs) into provider & consumer behaviour


Community surveillance of AMR and use (2):results

• Antimicrobial resistance– pathogenic E.Coli in pregnant women's urine in India

• Cotrim 46-65%; Ampi 52-85%; Cipro 32-59%; Cefalex 16-50%– S.Pneumoniae & H.influenzae in sputa in S. Africa

• Cotrim > 50% (both organisms); Ampi >70% (H.influenzae)• Antibiotic use

– About ½ patients in India & ¼ or less of patients in S.Africa get ABs – Much inappropriate AB use especially in India e.g. use of fluoroquinolones

for coughs and colds in private sector• Motivation of providers & consumers

– Patient demand – looking for quick cure – Lack of CME & unwillingness to attend for fear of losing custom– Uncontrolled pharmaceutical promotion, involving financial gain


Adverse drug events

• 4-6th leading cause of death in the USA

• estimated costs from drug-related morbidity & mortality 30 million-130 billion US$ in the USA

• 4-6% of hospitalisations in the USA & Australia

• commonest, costliest events include bleeding, cardiac arrhythmia, confusion, diarrhoea, fever, hypotension, itching, vomiting, rash, renal failure

Source: Review by White et al, Pharmacoeconomics, 1999, 15(5):445-458


Changing a Drug Use Problem:An Overview of the Process

1. EXAMINEMeasure Existing

Practices(Descriptive

Quantitative Studies)

2. DIAGNOSEIdentify Specific

Problems and Causes(In-depth Quantitative and Qualitative Studies)

3. TREATDesign and Implement

Interventions (Collect Data to

Measure Outcomes)

4. FOLLOW UPMeasure Changes

in Outcomes (Quantitative and Qualitative

Evaluation)

improveintervention

improvediagnosis


Treatment Choices

Prior Knowledge

HabitsScientific Information

RelationshipsWith Peers

Influenceof DrugIndustry

Workload & Staffing

Infra-structure

Authority & Supervision

Societal

Information

Intrinsic

Workplace

Workgroup

Social &CulturalFactors

Economic &Legal Factors

Many Factors Influence Use of Medicines


Strategies to Improve Use of Drugs

Economic: Offer incentives

– Institutions– Providers and patients

Managerial: Guide clinical practice

– Information systems/STGs– Drug supply / lab capacity

Regulatory: Restrict choices

– Market or practice controls– Enforcement

Educational: Inform or persuade

– Health providers– Consumers

Use of Medicines


Educational StrategiesGoal: to inform or persuade

• Training for Providers– Undergraduate education– Continuing in-service medical education (seminars, workshops)– Face-to-face persuasive outreach e.g. academic detailing– Clinical supervision or consultation

• Printed Materials– Clinical literature and newsletters– Formularies or therapeutics manuals– Persuasive print materials

• Media-Based Approaches– Posters– Audio tapes, plays– Radio, television


Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC Facilities

Intervention Control0

20

40

60

80

% Prescribing Injections

PrePrePostPost

Source: Hadiyono et al, SSM, 1996, 42:1185


Training for prescribersThe Guide to Good Prescribing

• WHO has produced a Guide for Good Prescribing - a problem-based method

• Developed by Groningen University in collaboration with 15 WHO offices and professionals from 30 countries

• Field tested in 7 sites

• Suitable for medical students, post grads, and nurses

• widely translated and available on the WHO medicines website


Managerial strategies Goal: to structure or guide decisions

• Changes in selection, procurement, distribution to ensure availability of essential drugs– Essential Drug Lists, morbidity-based quantification, kit systems

• Strategies aimed at prescribers– targeted face-to-face supervision with audit, peer group

monitoring, structured order forms, evidence-based standard treatment guidelines

• Dispensing strategies – course of treatment packaging, labelling, generic substitution


RCT in Uganda of the effects of STGs, training and supervision on % of Px conforming to guidelines

Randomisedgroup

No. healthfacilities

Pre-intervention

Post-intervention

Change

Control group 42 24.8% 29.9% +5.1%

Dissemination ofguidelines

42 24.8% 32.3% +7.5%

Guidelines + on-site training

29 24.0% 52.0% +28.0%

Guidelines + on-site training + 4supervisory visits

14 21.4% 55.2% +33.8%

Source: Kafuko et al, UNICEF, 1996.


Economic strategies:Goal: to offer incentives to providers an consumers

• Avoid perverse financial incentives – prescribers’ salaries from drug sales– insurance policies that reimburse non-essential

drugs or incorrect doses – flat prescription fees that encourage polypharmacy

by charging the same amount irrespective of number of drug items or quantity of each item


Pre-post with control study of an economic intervention (user fees) on prescribing quality in Nepal

Fees (completedrug courses)

control fee / Pxn=12

1-band item feen=10

2-band item feen=11

Av. no. itemsper prescription

2.9 2.9(+/- 0)

2.9 2.0(-0.9)

2.8 2.2(-0.6)

% prescriptionsconforming toSTGs

23.5 26.3(+2.7%)

31.5 45.0(+13.5%)

31.2 47.7(+16.5%)

Av.cost (NRs)per prescription

24.3 33.0(+8.7)

27.7 28.0(+0.3)

25.6 24.0(-1.6)

Source: Holloway, Gautam & Reeves, HPP, 2001


PHC prescribing with and without Bamako initiative in Nigeria

5.3

72.8

64.7

93

35.4

2.1

38

25.6

21

15.3

0 20 40 60 80 100

no.drug items/Px

% Px with injections

% Px with antibiotics

% pres EDL drugs

no.EDL drugs avail

21 Bamako PHCs 12 non-Bamako PHCs

Source: Scuzochukwu et al, HPP, 2002


Regulatory strategiesGoal: to restrict or limit decisions

• Drug registration• Banning unsafe drugs - but beware unexpected results

– substitution of a second inappropriate drug after banning a first inappropriate or unsafe drug

• Regulating the use of different drugs to different levels of the health sector e.g.– licensing prescribers and drug outlets– scheduling drugs into prescription-only & over-the-counter

• Regulating pharmaceutical promotional activities

Only work if the regulations are enforced


Intervention impact: largest % change in any medicines use outcome measured in each study

Intervention type No. studies Median impact 25,75th centiles

Printed materials 5 8% 7%, 18%

National policy 6 15% 14%, 24%

Economic strategies 7 15% 14%, 31%

Provider education 25 18% 11%, 24%

Consumer education 3 26% 13%, 27%

Provider+consumer education 12 18% 8%, 21%

Provider supervision 25 22% 16%, 40%

Provider group process 8 37% 21%, 59%

Essential drug program 5 28% 26%, 50%

Community case mgt 5 28% 28%, 37%

Providr+consumr ed & supervis 7 40% 18%, 54%

source: database on medicines use 2009


Impact of multiple interventions on injection use in Indonesia

Source: Long-term impact of small group interventions, Santoso et al., 1996

0%

20%

40%

60%

80%

100%

1 3 5 7 9 11 13 15 17 19 21 23 25

Months

Prop

ortio

n of

vis

its w

ith in

ject

ion

Comparison group Interactive group discussion

Interactive group discussion (IGC group only)Seminar (both groups)

District-wide monitoring(both groups)


What national policies do countries have to promote rational use?

Source: MOH Pharmaceutical policy surveys 2003 and 2007

0 20 40 60 80 100

EML updated in last 2 years

STGs updated in last 2 years

UG doctors trained on EML/STGs

Obligatory CME for doctors

Drug Info Centre for prescribers

DTCs in >half general hospitals

Public education on antibiotic use

Antibiotic OTC non-availability

National strategy to contain AMR

Drug use audit in last 2 years

% countries implementing policies2007 (n>85) 2003 (n>90)


Percent change in antibiotic consumption,out-patient care in 25 European countries 1997-2003

Data from ESAC

-20

-15

-10

-5

0

5

10

15

20

25

Perc

ent c

hang

e

For Iceland, total data (including hospitals) are used

Increase

Decrease

Slide courtesy of Otto Cars, STRAMA, Sweden


Percent change in antibiotic consumption,out-patient care in 25 European countries 1997-2003

Data from ESAC

-20

-15

-10

-5

0

5

10

15

20

25

Perc

ent c

hang

e

For Iceland, total data (including hospitals) are used

Co-ordination programs and national campaigns

Slide courtesy of Otto Cars, STRAMA, Sweden


Why does irrational use continue?

Very few countries regularly monitor drug use and implement effective nation-wide interventions - because…

• they have insufficient funds or personnel?• they lack of awareness about the funds wasted

through irrational use?• there is insufficient knowledge of concerning the cost-

effectiveness of interventions?


What are we spending to promote rational use of medicines ?

• Global sales of medicines 2002-3 (IMS): US$ 867 billion

• Drug promotion costs in USA 2002-3: US$ >30 billion

• Global WHO expenditure in 2002-3: US$ 2.3 billion

– Essential Medicines expenditure 2% (of 2.3 billion)

– Essential Medicines expenditure on promoting rational use of medicines 10% (of 2%)

– WHO expenditure on promoting rational use of medicines 0.2% (of 2.3 billion)


2nd International Conference for Improving Use of Medicines, Chiang Mai, Thailand, 2004472 participants from 70 countries

Recommendations for countries to:• Implement national medicines programmes to

improve medicines use• Scale up successful interventions • Implement interventions to address community

medicines use

http://www.icium.org


WHO priorities

• Resolution WHA60.16– Urges Member States " to consider establishing and/or

strengthening…a full national programme and/or multidisciplinary national body, involving civil society and professional bodies, to monitor and promote the rational use of medicines "

– WHO to support countries to implement resolution

• Continue to give technical advice to countries– Model EML and formulary– Training on promoting RUM in community, PHC, hospitals– Research to identify cost-effective interventions– Advocacy


Health systems with no national programs:•No coordinated action•No monitoring of use of medicines

Health systems with national programs:•Coordinated action•Regular monitoring of use of medicine

Develop national plans of action

Situational analysis

Modify action plans

Implement & evaluate national action plans using govt & local donor funds

WHO facilitating multi-stakeholder action in countries


Health system rapid appraisal tool (1): structurefor national stakeholders to rapidly appraise their own health systems in order to develop evidence-based national plans of action

• Introduction– How to use the tool (in workbook format) and carry out the assessment

(preparation, data collection, analysis)– Systematic data collection using document review, key informant

interviews and observation with triangulation of results• Key respondent questionnaires

– MOH senior dept managers (incl. dept pharmacy, DRA), – national drug supply organisation, insurance organisation(s), – health training institutions, health professional organisations, – health facility staff and health facility survey

• Data collation and analysis by component– Identify recommendations for each component

• Cross-cutting analysis & presentation to govt & donors– Analysis across components, prioritisation and formulation of national

recommendations (to be completed)


Health system rapid appraisal tool (2): components

• Components– Medicines use surveys and activities– Medicines policy framework– Health system factors

• Service delivery & human resources, insurance, drug supply, regulation, financial (dis)incentives

– Specific technical areas for RUM• National program coordination, MTCs, EMLs, STGs, monitoring,

provider & consumer education, independent medicines info, AMR• Data for each component

– Taken from key informant questionnaires & health facility survey, identifying relevant data from coding system of questions

• Analysis for each component – Compares actual practice against best practice, choosing solutions from

a menu of interventions


Creating the WHO Essential Drugs Libraryto facilitate the work of national committees

WHOModel List

Summary of clinical guideline

Reasons for inclusionSystematic reviewsKey references

WHO Model Formulary

Cost:- per unit- per treatment- per month- per case prevented

Quality information:- Basic quality tests- Internat. Pharmacopoea- Reference standards

Evidence-based clinical

guideline


WHO-sponsored training programmes

• INRUD/MSH/WHO: Promoting the rational use of drugs

• MSH/WHO: Drug and therapeutic committees

• Groningen University, The Netherlands / WHO: Problem-based pharmacotherapy

• Amsterdam University, The Netherlands / WHO: Promoting rational use of drugs in the community

• Newcastle, Australia / WHO: Pharmaco-economics

• Boston University, USA / WHO: Drug Policy Issues


Global monitoring and identifying effective strategies to promote rational use of medicines

• WHO/EMP databases on drug use and policy– quantitative data on medicines use and interventions to

improve medicines use from 1990 to present day– data from MOHs on pharmaceutical policies every 4 years –

1999, 2003, 2007

• ICIUM3 in 2011– 3rd international conference on improving the use of

medicines (ICIUM3)

• Surveillance of antimicrobial use & resistance– method for community-based surveillance in poor settings– interventional approach for improving use in private sector


Conclusions

• Irrational use of medicines is a very serious global public health problem.

• Much is known about how to improve rational use of medicines but much more needs to be done– policy implementation at the national level– implementation and evaluation of more interventions,

particularly managerial, economic and regulatory interventions

• Rational use of medicines could be greatly improved if a fraction of the resources spent on medicines were spent on improving use.


ActivityDiscuss in groups the following questions

• What should be the roles of:• government, • NGOs and donors, • WHO,

in promoting the rational use of medicines?

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