Macedonia National Drug Policy 2000 2001

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MacedoniaNational Drug Policy2000 - 2001

• IH 820
• Spring 2001

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Macedonia Background

• 1994 Census
• Population 2 million
• 66.5 Macedonians
• 22.9 Albanians
• 4.0 Turks, 2.3 Gypsies, 2 Serbs, 0.4 Vlachs
• Official Language Macedonian
• 9/8/91 Independence via referendum
• 11/17/91 Adopted new Constitution
• April 1993 member of UN, IMF, WHO

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Health Indicators

• Birth rate 15.8/1000
• Mortality rate 8.1/1000
• Mortality rate per 100,000 from
• circulatory diseases 445.6
• malignant neoplasm 133.5
• respiratory diseases 39.0
• injuries and poisonings 31.0

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Health Indicators

• Number of inhabitants per 1
• physician 410
• dentist 1,398
• pharmacist 3,023
• 5.2 beds/1,000 population
• Average length of stay 15.1 days
• 77.1 rate of hospital utilization

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Health Care System

• 90 population health care w/in 30 minutes travel
• Primary health care at municipal level
• health stations, centres, medical centres
• Secondary health care on referral
• Tertiary health care in Skopje

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Organizational Structure of Health System

• Flow chart from case study

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Situation Analysis Conducted by WHO Consultant

• Provided framework to NDP
• Findings
• May 1998 New Drug Law Enacted
• goal harmonize w/EU standards regulations
• establishes Drug Agency/Bureau yet to be
  formed-(activities currently done by MOH)

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Situation Analysis (2)

• No differential fees for drug registration
• US 650 to Treasury, 14,000 denars to MOH
• Generic substitution by pharmacists ILLEGAL
• health professionals only use trade names
• No control over promotion
• Lack of capacity to enforce regulations
• 3 inspectors at MOH
• No price controls

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Situation Analysis (3)

• No OFFICIAL national EDL (draft exists)
• National registration list NOT available to
  health professionals
• Positive list created by HIF for primary care
• reimbursement list (partial or full)
• similar list being created for hospitals
• difficult without PTCs

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Situation Analysis (4)

• High unemployment
• HIF in serious debt to suppliers
• cannot supply drugs to public sector
• cannot get credit
• result SHORTAGES!

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Private Pharmacy in Prilep, Macedonia
October 2000
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Private Pharmacy in Prilep, Macedonia
October 2000
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Inside Private Pharmacy Prilep
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Public Pharmacy in Prilep, Macedonia October
2000
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Public Pharmacy in Prilep, Macedonia
October 2000
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Situation Analysis (5)

• 1999 Most reimbursement towards injectables
• overuse of injectables
• Public sector needs estimated 40million (20
  per capita) based on experience rather than sound
  methodology (WHO 10-50 per capita)

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Situation Analysis (6)

• FYR Macedonia prices 370-398 HIGHER than
  international price
• Reasons
• Insufficient suppliers w/registered products
• Sources are local/regional
• No real competition
• Purchased in expensive packaging
• Purchase in small quantities

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Situation Analysis (7)

• Drug Law only drugs registered in FYR Macedonia
  may be imported supplied
• packaging must be in Mac. Language and approved
  by authorities
• drug must be sold through manufacturers agent in
  FYR Macedonia
• Implications
• Cannot buy from India
• Cannot parallel import

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Other Issues

• Irrational prescribing
• lack of funds, equipment, working conditions
• inappropriate distribution of network of
  pharmacies
• few clinical guidelines (not evidence-based)
• RDU not part of curriculum
• Curriculum outdated and theoretical
• Pharmacy harmonized with EU
• MedicineNO!

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Clinic in Prilep, Macedonia October 2000
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Other Issues (2)

• GPP and GCP absent from both curricula
• CME project financed by World Bank towards PHC

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NDP Development Process

• February 3, 2000 Launch Meeting
• Organized by MOH
• Technical assistance WHO (RL)
• Morning presentations
• Afternoon workshops
• Conclusion recommendations for further work

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March 2000 MOH Appoints 14 Working Group Members

• Outstanding members in pharm. field
• Educated about NDP including country samples
• 5 subgroups created
• Legislative and Regulatory
• Selection
• Rational Use and DI
• Supply and Economic Strategies
• Human Resources, Devt., Monitoring, Evaluation
• Time Frame 3-6 months

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Process

• Working groups overseen by WHOs Humanitarian
  Office in Skopje and RL
• May 2000 RL visits and meets with working groups
• Asked to present analysis of strengths and
  priority problems
• priority objectives, strategies, and indictors
  for monitoring implementation

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Process (2)

• October 2000 RL visits again
• Working groups combine drafts into harmonized
  document
• Field Visits to Prilep

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The capital is not the country! RL

• Discrepancy between assumption reality
• Computer system to track inventory, but only HIF
  personnel can access
• No control over budget
• If drug OOS in public, can purchase in private
  submit for remibursement..NO!
• Prices in private CHEAPER than public
• No knowledge of national DIC or newsletter

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Process (3)

• Circulation of draft (1 month)
• Revision (2-4 weeks)
• Adoption workshop
• Final document

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Strengths

• Full support from MOH
• Opinion leaders from pharm. Sector are involved
• NDP product was created by the user
• Working groups have good analysis strategic
  abilities

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Weaknesses

• Insufficient involvement of people in the field
  and of correlated sectors
• Difficulty defining priority problems
• Possible pressure from political and economic
  actors
• Working group members have regular workload

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Where Does it Stand Now?

• Adopted by Parliament
• Yet to be Implemented?

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Valley containing village and lead factory in
Macedonia October 2000
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Public Pharmacy in Prilep, Macedonia October
2000
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Public Pharmacy in Prilep, Macedonia
October 2000