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Declaration of Alma-Ata (1978). Health is a fundamental human right
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1. Primary Health Care (3) Health facilities, essential drugs and laboratories
GH 511/Epi 531
Fall 2008
Steve Gloyd
2. Declaration of Alma-Ata (1978) Health is a fundamental human right & requires inter-sectoral action
Existing gross health inequality unacceptable
Improved health and peace require economic and social development based on a new international economic order (NIEO)
Governments have responsibility to provide adequate health and social measures for health
Primary health care is appropriate, accessible, acceptable, affordable and requires community participation (Specifies components of PHC)
Governments need the will to formulate and implement PHC policies
International cooperation is necessary
HFA 2000 requires redirecting resources from military to social expenditures (including health)
3. “Essential components” of Primary Health Care Health education
Environmental sanitation, especially food and water
The employment of community or village health workers
Maternal and child health programs, including immunization and family planning
Prevention of local endemic diseases
Appropriate treatment of common diseases and injuries
Provision of essential drugs
Promotion of nutrition
5. Condition of health facilities Worse and better than we think (but dynamic and changing)
Maintenance is key
7. Philippines clinic franchises
8. Drugs & Primary Health Care 1978 Alma-Ata PHC conference sponsored by WHO/UNICEF
essential drugs concept adopted as a component of primary health care
WHO prepared its first EDL, 224 drugs and vaccines
9. Why drugs are important Drugs save lives and improve health
Drugs promote trust and participation in health services
Drugs are costly
Drugs are different from other consumer products
Substantive improvements are possible
10. Historical perspective 1897 aspirin
1941 penicillin
1943 chloroquine (malaria)
1944 streptomycin (tuberculosis)
1950s oral contraceptives, anti-diabetics, drugs for mental illness, vaccines
11. Access to drugs 30-35% lack access worldwide
in poor Africa and Asia, 50% lack access
More accessibility in cities
Shortages in the supply of the right drugs
50-90% drugs in poor countries are paid for out of pocket
burden falls heavily on poor
12. Individual private spending on drugs (as a % of total drug spending)
13. Cost to Governments 25-50% of national health budgets for drugs
many ineffective and expensive drugs in use
expensive drugs used
14. Pharmaceutical spending as % of total health spending is greatest in developing countries
18. Inappropriate utilization of drugs in poor countries 75% of antibiotics prescribed inappropriately
50% of patients worldwide take medications incorrectly
90% of consumers can only buy 3 days supply or less for antibiotics Modified package inserts and recommendations
Drugs with serious side effects (Clioquinol, chloramphenicol)
Polypharmacy: toxicity & antimicrobial resistance
19. Poor quality of drugs
Unregulated manufacturers (Italy, local)
10-20% of sampled drugs fail quality control
Poor storage (light, cold chain)
Expired drugs
Street manufacture
Counterfeit drugs
$75B by 2010
20. Street sales – ‘cures STI’
21. Proliferation of brands – little regulation
22. Aggressive marketing of drugs
23. Drug Promotion Inadequate education to providers, public
Misleading and dubious claims (Squibb-UK cough tonic promoted as a brain tonic in India)
Conflicting drug indications (Antihistamine cyproheptadine sold as an appetite suppressant in India and Pakistan)
Advertising practices (package inserts)
Free drug samples (get providers & patients hooked)
Gifts (pens, books, conferences)
DTCA (direct to consumer advertising) – legal in USA, NewZealand
24. Pharmaceutical Representatives 1 drug rep per 6 MDs in USA (~100,000 reps in 2006)
1 per 10 MDs 1n 1995 (38,000 reps), 1/15-20 in 1985
Avg income $81,000; $15,000 per doctor spent
In 1990
1/8 Ecuador
1/5 Colombia
1/4 Tanzania
1/3 Guatemala, Mexico, Brazil
1/2.5 Indonesia, Philippines
25. Third World “Donations” (Dumping) of Pharmaceuticals Dubious “gifts”
Genuine gifts
clear out stocks of nearly-expired drugs/poor sellers
tax write-offs (up to 2x production costs)
26. Third World “Donations” (Dumping) of Pharmaceuticals Egregious Examples:-Expired Ceclor to Central Africa-Garlic pills and TUMS to Rwanda
-50% of donations to Bosnia expired or medically worthless
Donation recommendations from WHO:-WHO list of essential drugs-Expiration date at least 1 year away
27. The rise of the Essential drugs concept “Why not concentrate first on a basic list of reliable drugs to meet the most vital needs’’
Norway - before WWII
Papua New Guinea - in 1950’s
Sri Lanka - in 1959
Cuba - in 1963
WHO by 1970s
28. WHO essential drug program
1970-75 Concerns voiced by NGOs, Churches, WHO
Halfdan Mahler (1975) “those drugs considered to be of utmost importance and hence basic, indispensable, and necessary for the health needs of the population… should be available at all times, in the proper dosage forms to all segments of society”
1975 WHO Expert advisory committee
1977 First Model Essential Drug List (EDL)
– 208 drugs
1997– 306 drugs (166 new, 68 deleted)
2007 – 340 drugs
136/192 countries have adopted EDLs
29. Additional action Program on Essential Drugs (1977)
National drug policies
Health economics and drug financing
Drug management and supply strategies
Rational use of drugs
Regulation and quality assurance capacity
30. National Drug Policy Policy and Legal framework (NDP, Legislation, Production policy, Regulation)
Drug management Strategy (selection, procurement, distribution, Rational use)
Support systems (organization &management, financing & sustainability, Information resources, human resources)
31. Rural Hospital in MozambiquePhysician in Pharmacy
32. Rural Hospital Pharmacy - Mozambique
33. Rural Health Center - Mozambique
34. Rural health post with one nurse
35. Botswana Health Center pharmacy
36. Health post pharmacy in Sudan
37. Pakistan – Essential drugs for ER
38. Pakistan public hospital
39. Bamako Initiative: "Women and Childrens's health through funding and management of esssential Drugs at the community level Mandate: drug charges to recover expenditures
180m for 1989-91
start-up costs for basic equip
short term provision of basic drugs
support costs (supervision, training, social mobilization)
first years proceeds as seed capital
second and successive years as replenishment
Community health committees planned for 75% of pop
40. WTO and multilateral trade agreements (mandatory compliance) Trade Related Intellectual Property (TRIPs)
Patent protection “harmonized” to 20 yrs
Alternatives
Compulsory licensing
a government can license a manufacturer to produce a patented product without the agreement of the patent holder - as long as the patent holder receives substantial compensation
Parallel importing
A government can purchase brand name drugs from a third party in another country, rather than from the manufacturer (prices vary in different countries)
41. Drug regulation status in selected countries
42. Differences in Amoxil®, by country
47. Laboratory Capacity Quality varies tremendously at all levels
Maintenance
Reagent stockouts
Qualified Personnel
Quality control systems
48. Varied conditions
49. Quality control is possible - Mozambique
50. Donations everywhere
51. Chem 20
52. Medical equipment in Rawalpindi, Pakistan