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Rational use of drugs: an overview. Richard Laing with materials prepared by Kathleen Holloway Technical Briefing Seminar. Department of Medicines Policy and Standards. Objectives. Define rational use of medicines and identify the magnitude of the problem

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Rational use of drugs an overview

Rational use of drugs:an overview

Richard Laing

with materials prepared by

Kathleen Holloway

Technical Briefing Seminar

Department of Medicines Policy and Standards


Objectives
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 process 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.Source: 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.


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

Source: Quick et al, 1997, Managing Drug Supply

  • 15 billion injections per year globally

  • half are with unsterilized needle/syringe

  • 2.3-4.7 million infections of hepatitis B/C and up to 160,000 infections of HIV per year associated with injections

% of primary care patients receiving injections


Variation in outpatient antibiotic use in 26 european countries in 2002
Variation in outpatient antibiotic use in 26 European countries in 2002

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


Trends in the use of medicines 1990 2003
Trends in the use of medicines 1990-2003 countries in 2002

Source: WHO/PSM database 2004

n=average number of studies per year i.e. data point


Regional variation in prescribing 1990 2004
Regional variation in prescribing 1990-2004 countries in 2002

Source: WHO/PSM database August 2004

Baseline data covering all diseases and all ages


Treatment of ari cases
Treatment of ARI cases countries in 2002

Source: WHO/PSM database 2004.


Public private acute diarrhoea treatment
Public/private acute diarrhoea treatment countries in 2002

Source: WHO/PSM database, 2004.


Overuse and misuse of antimicrobials contributes to antimicrobial resistance
Overuse and misuse of antimicrobials contributes to antimicrobial resistance

Source: WHO country data 2000-3

  • 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


Adverse drug events
Adverse drug events antimicrobial resistance

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

  • 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


Changing a drug use problem an overview of the process

1. EXAMINE antimicrobial resistance

Measure Existing

Practices

(Descriptive

Quantitative Studies)

improve

diagnosis

4. FOLLOW UP

2. DIAGNOSE

Measure Changes

Identify Specific

in Outcomes

Problems and Causes

(Quantitative and Qualitative

(In-depth Quantitative

Evaluation)

and Qualitative Studies)

improve

3. TREAT

intervention

Design and Implement

Interventions

(Collect Data to

Measure Outcomes)

Changing a Drug Use Problem:An Overview of the Process


Many factors influence use of medicines

Intrinsic antimicrobial resistance

Prior Knowledge

Scientific Information

Habits

Information

Social &Cultural

Factors

Influenceof Drug

Industry

Treatment Choices

Societal

Economic &

Legal Factors

Workload & Staffing

Workplace

Infra-structure

Authority & Supervision

Relationships

With Peers

Workgroup

Many Factors Influence Use of Medicines


Strategies to improve use of drugs

Educational: antimicrobial resistance

  • Inform or persuade

    • Health providers

    • Consumers

Managerial:

  • Guide clinical practice

    • Information systems/STGs

    • Drug supply / lab capacity

Use of Medicines

Economic:

  • Offer incentives

    • Institutions

    • Providers and patients

Regulatory:

  • Restrict choices

    • Market or practice controls

    • Enforcement

Strategies to Improve Use of Drugs


Educational strategies goal to inform or persuade
Educational Strategies antimicrobial resistanceGoal: 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

Pre antimicrobial resistance

Post

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

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

% Prescribing Injections

80

60

40

20

0

Intervention

Control


Promotional materials are most used source of information antimicrobial resistanceIncreased adverts result in increased prescribing


Managerial and economic strategies goal to structure or guide decisions
Managerial and economic strategies antimicrobial resistanceGoal: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

  • Avoidance of perverse financial incentives

    • prescribers’ salaries from drug sales, flat prescription fees,

    • insurance policies that reimburse non-essential drugs or incorrect doses


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

Source: Kafuko et al, UNICEF, 1996.


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

Source: Holloway, Gautam & Reeves, HPP, 2001


Phc prescribing with and without bamako initiative in nigeria
PHC prescribing with and without Bamako initiative in Nigeria

Source: Scuzochukwu et al, HPP, 2002


Regulatory strategies goal to restrict or limit decisions
Regulatory strategies NigeriaGoal: 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


DDD/1000 inhabitant-days Nigeria

This is where a large graphic or chart can go.

Source: Bavestrello & Cabello, ICIUM 2004


Impact of multiple interventions on injection use in indonesia

Seminar (both groups) Nigeria

District-wide monitoring

(both groups)

Interactive group discussion (IGC group only)

Impact of multiple interventions on injection use in Indonesia

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


Review of 30 studies in developing countries Nigeria

size of drug use improvements with various interventions

Minor

Moderate

Large

Large group training

Small group training

Diarr. community case mgt

ARI community case mgt

Info/guidelines

Group process

Supervision/audit

EDP/Drug supply

Economic strategies

10

20

30

40

50

60

0

Improvement in outcome measure (%)

Source: Ross-Degnan et al, Plenary presentation, ICIUM 1997, Chiang Mai, Thailand.


Interventions 844 in 204 study sites 18 evaluated with adequate study design
Interventions: 844 in 204 study sites Nigeria18% evaluated with adequate study design

Source: WHO/PSM database, ICIUM 2004


10 national strategies to promote rum needs sufficient govt investment for medicines staff
10 national strategies to promote RUM Nigerianeeds sufficient govt. investment for medicines & staff !

Source: WHO Policy Perspectives no.5

1. Evidence-based standard treatment guidelines

2. Essential Drug Lists based on treatments of choice

3. Drug & Therapeutic Committees in hospitals

4. Problem-based training in pharmacotherapy in UG training

5. Continuing medical education as a licensure requirement

6. Independent drug information e.g bulletins, formularies

7. Supervision, audit and feedback

8. Public education about drugs

9. Avoidance of perverse financial incentives

10. Appropriate and enforced drug regulation


What are countries doing to promote rational use of medicines
What are countries doing to promote rational use of medicines ?

Source: TCM pharmaceutical database 2003

% countries implementing policies to promote rational use


Why does irrational use continue
Why does irrational use continue? medicines ?

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?


Who priorities
WHO priorities medicines ?

  • Developing a model formulary process, the WHO Essential Drugs Library

  • Training programmes

  • Promoting drug & therapeutic committees

  • Pilot projects to contain antimicrobial resistance

  • Intervention research to promote RUM

    • cost-effectiveness of interventions, policies

  • Advocacy for the rational use of medicines (RUM)

    • Essential Drug Monitor, effective drug information

    • WHO Resolution


Who sponsored training programmes
WHO-sponsored training programmes medicines ?

  • 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


Dtc training course results 2000 3
DTC training course results medicines ?2000-3

  • 361 people trained from 56 countries

  • 87 (24%) responded to follow-up e-mail request

  • 57 (16%) participants had undertaken 152 DTC related activities

  • 24 (7%) participants from 10 countries attended the follow-up workshop for active participants

    Requires more support from donors


% Px with medicines ?

Av.no.drugs / Px

Abs/Inj.

100%

5

80%

4

No.drugs

60%

3

Antibiotics

40%

2

Injections

20%

1

0%

0

1

2

3

4

5

6

7

8

Months

Promoting DTCs: monitoring, training & planning through hospital DTCs in Laos

Source: Sisounthone, WPRO-EDM, 1(1), March 2002


Local pilot projects to contain amr
Local pilot projects to contain AMR medicines ?

  • Objectives

    • develop, implement & evaluate interventions to contain AMR using surveillance data in local sites

    • to develop a new method for the integrated surveillance, at community level, of antimicrobial use and resistance that can be used in many different countries

    • to build local capacity in developing a multi-disciplinary approach to the containment of AMR

  • 3 phases

    • (1) set up surveillance,

    • (2) develop, implement & evaluate interventions

    • (3) expand to other sites


Looking at trends in cotrimoxazole resistance and use in mumbai india 2002
Looking at trends in cotrimoxazole resistance and use in Mumbai, India, 2002

Source: Thatte et al, ICIUM 2004


25% Mumbai, India, 2002

100%

20%

80%

15%

60%

sputum

treated

isolates

10%

40%

% patients

% resistant

with cotri

5%

20%

0%

0%

10

11

12

1

2

3

4

5

6

7

PHC clinics

Pharmacies

Private Practitioners

H.influenzae resist.

S.pneumoniae resist.

Monitoring community cotrimoxazole resistance and use in Durban, S.Africa, 2002-3

Source: Gray and Essack et al, ICIUM 2004


Identifying effective strategies to promote more rational use of drugs
Identifying effective strategies to promote more rational use of drugs

  • Joint research initiative between WHO/PSM, MSH, Harvard and Boston Universities, and ARCH

    • over 20 intervention research projects in developing countries

  • WHO/PSM database on drug use

    • quantitative data on drug use and interventions to improve drug use over the last decade


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

http://www.icium.org

Recommendations for countries to:

  • Implement national medicines programmes to improve medicines use

  • Scale up successful interventions

  • Implement interventions to address community medicines use


What are we spending to promote rational use of medicines
What are we spending to promote rational use of medicines ? use of drugs

  • Global sales of Px medicines in 2000: US$ 282.5 billion

  • Drug promotion costs in USA in 2000: US$ 15.7 billion

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

    • Essential Medicines expenditure 2%

    • Essential Medicines expenditure on promoting rational use of medicines 10%

    • WHO expenditure on promoting rational use of medicines 0.2%


2007 rud resolution wha60 16
2007 RUD Resolution use of drugs WHA60.16

1. URGES Member States:

(1) to invest sufficiently in human resources and provide adequate financing in order to strengthen institutional capacity in order to ensure more appropriate use of medicines in both the public and private sectors;

(2) to consider establishing and/or strengthening, as appropriate, a national drug regulatory authority and a full national programme and/or multidisciplinary body, involving civil society and professional bodies, to monitor and promote the rational use of medicine;

(3) to consider developing, strengthening and implementing, where appropriate, the

application of an essential medicines list into the benefit package of the existing or new insurance funds;

(4) to develop and strengthen existing training programmes on rational use of medicines and ensure that they are taken into account in the curricula for all health professionals and medical students, including their continuing education, where appropriate, and to promote programmes of public education in rational use of medicines;


2007 rud resolution wha60 161
2007 RUD Resolution use of drugs WHA60.16

(5) to enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor promotion of medicines, and to develop and implement programmes that will provide independent, nonpromotional information about medicines;

(6) to develop and implement national policies and programmes for improving medicine use, including clinical guidelines and essential medicines lists, as appropriate, with an emphasis on multifaceted interventions targeting both the public and private health sectors, and involving providers and consumers;

(7) to consider developing, and strengthening where appropriate, the capacity of hospital drug and therapeutic committees to promote the rational use of medicines;

(8) to expand to national level sustainable interventions successfully implemented at local level;


2007 rud resolution wha60 162
2007 RUD Resolution use of drugs WHA60.16

2. REQUESTS the Director-General:

(1) to strengthen the leadership and evidence-based advocacy role of WHO in promoting rational use of medicines;

(2) in collaboration with governments and civil society, to strengthen WHO’s technical support to Member States in their efforts to establish or strengthen, where appropriate, multidisciplinary national bodies for monitoring medicine use, and implementing national programmes for the rational use of medicines;

(3) to strengthen the coordination of international financial and technical support for rational use of medicines;


2007 rud resolution wha60 163
2007 RUD Resolution use of drugs WHA60.16

(4) to promote research, particularly on development of sustainable interventions for rational medicine use at all levels of the health sector, both public and private;

(5) to promote discussion among health authorities, professionals and patients on the rational use of medicines;

(6) to report to the Sixty-second World Health Assembly, and subsequently biennially, on progress achieved, problems encountered and further actions proposed in the implementation of WHO’s programmes to promote rational use of medicines.


Conclusions
Conclusions use of drugs

  • 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.


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