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Drug Management Cycle: SelectionEssential DrugsTreatment GuidelinesFormularies

Class Period #4, 7 February 2007Prof. Hazel H. Seaba

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Drug and health commoditymanagement cycle

Selection

Procurement

Distribution

Use

Policy and Legal Framework

Management

Support

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Objectives

• Define an essential medicine, essential medicines lists (EMLs), formularies and standard treatment guidelines (STGs)

• Apply evidence-based criteria to medication selection

• Explain the benefits of STGs and essential medicines formularies (EMF)

• Describe the importance of proper development and active implementation of EMF and STG

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Equitable access to essential medicines: a framework for collective action. WHO Perspectives on Medicines, March 2004.

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List of common diseases and complaints

Training andsupervision

Financing and supply of drugs

Standard treatment guidelines

Treatment choice

Preventionand care

Essential medicines formulary

Essential medicineslist

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Essential Medicines Definition

• Essential medicines are

– those that satisfy the priority health care needs of the population

– selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness

– intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information and at a cost that individuals and the community can afford

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WHO Model List of Essential Medicines

• 1977: First model list published with about 200 active substances

• List is revised every 2 years by WHO Expert Committee on the Selection and Use of Essential Medicines based on submissions

• Last revision (March 2005) contains 312 active substances

• Composed of a core list and a complementary list• http://www.who.int/medicines/publications/

essentialmedicines/en/index.html

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DispensaryS S

All medicinesworldwide

Registered medicines

National list ofessential medicines

Levels of use

Supplementaryspecialistmedicines

CHW

Health center

Hospital

Referral hospital

Private sector

The Essential Medicines Target

CHW: community health worker with an essential drugs list of 12-18 items

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156 Countries with Essential Medicines Lists

There are 156 countries with an official selective list for training, supply, reimbursement, or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists.

National Essential Medicines List

< 5 years (127)

> 5 years (29)

No EML (19)

Unknown (16)

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Table 1: Selected country progress indicators 1999–2003 1999 2003 Target for 2007 1999 2003

Target for

2007

Countries with an official national medicines policy implementation plan— new or updated within the last 5 years

41/106*

39%

49/103

48%

61%

Countries with a national list of essential medicines – updated within the last five years

129/175

74%

82/114

72%

75%

Countries implementing basic medicines regulatory functions

70/138

51%

90/130

69%

74%

Source: WHO Medicines Strategy :Countries at the Core, 2004–2007.

Essential Medicines Lists

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Number of Medicines on National Essential Medicines Lists

0

200

400

600

800

1000

1200

Nicaragua (1

994)

Nepal (1993)

Tajikistan (1

998)

El Salva

dor (1993)

Mozambique (1993)

OECS (1993)

Guatemala (1992)

Kazakhstan (1998)

Ecuador (1993)

Pakistan (1

994)

Jamaica (1992)

Source: Selected MSH studies

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Availability of Essential Medicines Lists in Health Facilities

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Source: Selected MSH studies, 1993–2001.

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Medicines Formulary Definition

• A continually revised compilation of pharmaceuticals (plus important ancillary information) that reflects the current clinical judgment of the medical staff. [American Society of Hospital Pharmacists]

• A restricted list of medicines from which appropriate therapy can be selected.

• Drug-oriented

• The WHO Model Formulary http://mednet3.who.int/EMLib/

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Formulary Management Principles

• Select drugs on the basis of need (diseases and conditions that have been identified locally)

• Select drugs that can be used by personnel available• Consider cost (total cost of treatment) and financial

resources• Select “drugs of choice,” safety and efficacy

demonstrated• Product: assured quality, bioavailability, and stability• Maintain a limited number of drugs (avoid duplications)• Use INN (generic) names (versus trade names)• Use combination products (fixed dose) only in specific

proven conditions e.g. TB

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Definition: Standard Treatment Guideline (STG)

• A systematically developed statement designed to assist practitioners and patients in making decisions about appropriate treatment for specific clinical circumstances

• Treatment-orientedSource: Managing Drug

Supply

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Examples of Standard Treatment Guidelines

United States: National Guideline Clearinghouse http://www.guideline.gov/

WHO: Health Topics, http://www.who.int/topics/en/

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The International Pharmacopoeia, Volume 5, 3rd Edition

• Part I. guidance on the correct performance and application of certain general tests and other methods (recommended quality specifications and methods of analysis for selected pharmaceutical products, excipients, and dosage forms) used in quality control, followed by general requirements pertaining to the testing of different dosage forms.

• Part II. (more extensive) presents monographs for 24 substances included in the WHO Model List of Essential Drugs. Each monograph provides exact instructions concerning which tests are required and which method should be used.

• http://www.who.int/medicines/publications/pharmacopoeia/en/

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Benefits of Standard Treatment Guidelines (and Essential Medicines Formularies)

• Providers– Provides expert consensus– Provider can concentrate on diagnosis– Especially helpful where expertise limited (e.g. newly

qualified doctors)– Simple basis for monitoring

• Patients– Consistency amongst prescribers – Most effective treatments– Improved drug supply– Lower cost

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• Supply Managers– Procurement, quality control, storage, &

distribution easier and more efficient– Pre-packs of common items– Drug demand more predictable

• Health Policy Makers– Funds used more efficiently– Assess quality of care– Therapeutic integration of special programs– Information & training easier & more focused

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Key Steps in developing STGs and Essential Medicines Formularies (EMF)

• Determine the target user groups

• Identify all the relevant stakeholders

• Set up a STG or EMF Committee

• Establish roles/responsibilities of committee members

• Agree on the scope and content of the STG or EMF

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• Establish methods of medicines and treatment selection process

– Use of unbiased information – Evidence-based selection– Major criteria: efficacy, safety, cost, convenience– Method of establishing consensus where level of

evidence appears inadequate

• Revise the draft based on wide consultation with external reviewers

• Field test the document before formal launch

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Role of Drug and Therapeutics Committees

• Develop or adapt STGs/EMF

• Assess adherence to STGs/EMF

• Develop and implement appropriate strategies to ensure adherence

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Some Indicators Relating to Guidelines and Formularies

• Is there a national STG with standardized treatments?

• Is there a national EMF manual with basic information?

• Are STG and EMF consistent with the national list of essential drugs?

• Is there a National Drug Policy statement to encourage use of STG/EMF?

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• Are STG and EMF used for basic and in-service training of health personnel?

• What % of public-sector health facilities has a copy of STG and/or EMF?

• What % of prescriptions in public-sector health facilities complies with the STG?

Source: Managing Drug Supply

Percentage of Medicines Prescribed from Essential Medicines List, by Sector

97%

70%

93%

65%

82%

66%72%

62%58%

63%

70%

49%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Cambodia India (R) El Salvador Brazil (MG)

Public

NGO/Mission

Private

Source: MSH SEAM studies, 2001

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Malaria Medicines

• Antimalarial medications for prophylaxis and treatment

•chloroquine, sulfadoxine-pyrimethamine (SP), artemether-lumefantrine (Coartem), quinine, mefloquine, atovaquone-proguanil (Malarone), tetracycline (doxycycline), primaquine

• Intravenous glucose and other fluids • Medication for treatment of anemia

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Complexities in establishing and implementing STGs for HIV/AIDS, TB, and Malaria

• Multiple single agents and fixed-dose combinations

• Multiple regimens approved (for HIV/AIDS)

• Differing laboratory monitoring facilities

• Differing and often weak pharmaceutical management capacities

• Different recommendations for special groups, e.g., pregnant women, children

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Complexities in establishing and implementing STGs for HIV/AIDS, TB, and Malaria (2)

• Newer facts and recommendations becoming available fast, e.g, in HIV/AIDS treatment

• Treatment failure/drug resistance patterns

• Cost and logistics in changing from one regimen to another

• Need to mobilize both public and private sectors

• Non-pharmaceutical management and counseling issues

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Exercise

Part 1 – 20 minutes:

• Read the case study in your handout

• Prepare a list of responses

Part 2 – 10 minutes

• Whole group discussion of responses