Legislation and regulation for best practices in pharmacy ra psn

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  • 1. Legislation andRegulation for BestPractices in Pharmacy
  • 2. Issues to consider Pharmacy  Legislation  Then  Regulation  Now  Guidelines  Future  Ethics Best Practices  Norms  People  Places  Processes  Products Remi ADESEUN
  • 3. PharmacyThen... Now...  Combined Honours  Pharmaceutical Care  Apothecaries  Restoring the original practised pharmacy & role of looking after medicine the patient in addition simultaneously as far to providing the back as 2000 B.C. medicine  Separate Profession  Broad Spectrum  From the 13th  Ensuring optimum drug Century onwards with therapy through compounding & production, supply & control of medicines as dispensing as main well as provision of functions info/advice to patients &  “Lick, Stick & Pour”! prescribers Remi ADESEUN
  • 4. Values & Value across theValue-Chain The Future of Pharmacy  Depends to a great extent on:  the Pharmacists ability to INNOVATE  ETHICS, INTEGRITY & PROFESSIONALISM  Pharmacy’s ability to demonstrate its RELEVANCE by creating VALUE for Patients/Consumers/Customers/Chain members  ALERTNESS, COHESION, ARTICULATION, & POLITICAL SAVVY to pre-empt and counteract unfriendly laws Remi ADESEUN
  • 5. Who determines best practices? Policy Makers Regulators Professionals Academics Global Standards Peer Review Other Team Members Public
  • 6. Who determines best practices? Policy Makers/Enforcers MOH  Federal  State Legislature  Exclusive List  Concurrent Judiciary Customs/Police
  • 7. Who determines best practices? Regulators  PCN  NAFDAC  SON  FEPA  EML Committee  NDLEA Opportunity for a “Nigeria Inter-Bank Settlement System” Model
  • 8. Who determines best practices? Professionals  PSN  National  State  Technical Arms  ACPN  NAIP
  • 9. Who determines best practices? Academics  Research  Training Global Standards  WHO  FIP
  • 10. Who determines best practices? Peer Review/Benchmarking  ECOWAS  AU  COMMONWEALTH  BRICS  NEXT 11+1 Bangladesh, Egypt, Indonesia, Iran, Mexico , (Malaysia) Nigeria, Pakistan, Philippines, Turkey, South Korea, and Vietnam
  • 11. Who determines best practices? Other Team Members  Doctors  Nurses  Others Public  Consumers  Observers  Global Citizens
  • 12. Best Practices People  Processes  “Quantity”  Research &  “Quality” Development  Spread/Distribution  Manufacturing  Distribution Places  Manufacturer/Importer  Products  Wholesaler  Registration  Safety & Efficacy  Retailer  Formulary  Hospital  Marketing & Sales Remi ADESEUN  Surveillance/Recall
  • 13. Best Practices....People“Quantity”Benchmarks Nigeria “Quantity” per 100,000  Nigeria Total: 5  Lower Income  Lagos State:25 Countries: 2-45  Lower Middle Income  FCT:59 Countries: 7-50  Oyo State:6  Upper Middle Income  Enugu State:9 Countries: 32-77  High Income  Anambra State:6 Countries: 29-206  Zamfara State:0.4  Yobe State: 0.6  Ghana: 10 Remi ADESEUN
  • 14. Best Practices....People“Quality” Fitness to Practise  Pharmacy professionals are considered “fit to practise” when they can demonstrate the skills, knowledge, character and health required to do their job safely and effectively. A pharmacy professionals fitness to practise can be impaired for a number of reasons including misconduct, lack of competence, ill-health and through having been convicted of a criminal offence. Remi ADESEUN
  • 15. Pharmacy Best Practices...HerePharmacists Council NAFDAC People  Process Places  Product Remi ADESEUN
  • 16. Pharmacy Best Practices...ThereRegulator=Pharma Society Independent Regulator Ireland  UK (GPhC Since Northern Ireland 2010)  USA  South Africa  Australia  Canada Remi ADESEUN
  • 17. Pharmacy Legislation &Regulation.....Purpose  To Protect Public Health  Governments need to approve comprehensive laws and regulations and to establish effective national regulatory authorities to ensure that the manufacture, trade and use of medicines are requlated appropriately and that the public has access to accurate information on medicines.  Should not be simply punitive  Creating a positive situation tends to be more effectiveRemi ADESEUN
  • 18. Pharmacy Legislation &Regulation.....Why?Actions/Omissions leading to Harmful consequence Use of medicines  Can lead to: which are:  Therapeutic Failure  Ineffective  Exacerbation of Disease  Resistance to medicines  Poor Quality  DEATH!  Harmful  Also, undermines confidence in:  Health systems, Health professionals, manufacturers/importers, retailers, Govt Remi ADESEUN
  • 19. Pharmacy Legislation &RegulationLegislation Regulation Laws are acts passed by a  Regulations are rules legislative body promulgated by a part of the Laws are (should be) usually executive branch of govt, written in fairly general usually based on a law giving terms to meet present and the agency statutory possibly future needs authority for the regulation Laws usually have language  After approval, a regulation that enables the Govt to has the same power as the issue regulations based on law itself. the law.  Can be passed more rapidly Usually a lengthy process and simply than laws. with the legislative branch  Can also be altered more giving final approval. easily. Remi ADESEUN
  • 20. Pharmacy Legislation &Regulation Guidelines  Do not carry the force of law, and can be more easily modified and updated  Offers information on what the Govt’s thinking is concerning the best way to implement regulations  Following guidelines helps avoid misinterpretation of and facilitate compliance with laws and regulationsRemi ADESEUN
  • 21. Pharmacy & Drug Laws Poisons and Pharmacy Act (PPA) Cap 535 LFN 1990 PCN CAP P17 LFN 2004 PCN Disciplinary Tribunal Rules 2000(Official GazzetteNo 70 Vol 87 NAFDAC CAP N1 LFN 2004 Food and Drugs Act Cap S32 2004 LFN Food and Drugs Registration etc CAP S33 2004 LFN Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Cap C34 LFN 2004 NDLEA Act of 1989 Dangerous Drugs Act (DDA) Cap 91 LFN 1990 National Drug Formulary and Essential Drugs List Act Cap 252 LFN 1990/Essential Drugs ProgrammeRemi ADESEUN
  • 22. Other Laws affecting Pharmacy NHIS Act PROCUREMENT ACT 2007 FEPA Act 1988 SON Act 1990 NATIONAL DRUG FORMULARY AND ESSENTIAL DRUGS ACT Consumer Protection Council (CPC) Trade Malpractices Decree 1992 National Health Bill PROPOSED NATIONAL TRADITIONAL MEDICINE BILL PROPOSED NATIONAL PHARMACOVIGILANCE BILL HEALTH COMMODITIES AND MEDICINES SUPPLY MANAGEMENT PROPOSED TERTIARY HOSPITALS BILL (FMCs) Remi ADESEUN
  • 23. Evolution of Policy & Law Long Process  Key Success  Informal Factors Agreement  Clear definition of  Govt Guidelines what all parties-  Law manufacturers, National Health Policy pharmacists, doctors are National Drug Policy required to do Single National Drug  Clarity and Law? harmony in the Federal vs State? roles of regulatory agencies Remi ADESEUN
  • 24. Key Questions to ask whenrevising/initiating Laws What are the most important goals to achieve in the short, medium & long term? What means are available to achieve them? In which sequence can they best be tackled? What help is available?
  • 25. Considerations in evaluatingthe current Pharmacy Laws Is incremental change to existing Pharmacy Laws enough? Is a modern, accountable and efficient system of regulation required? fitness to practise provisions for people and places the public interest comes first to protect, maintain and promote the health and safety of the public. the issue of conflicts of interest between those who prescribe and those who dispense drugs
  • 26. Drafting and revising PharmaceuticalLegislation and Regulations Inventory the laws and regulations already in force Legal Drafters and Pharma/Health Experts meet to decide what legislative instrument is requiredAssistance available from ICDRA & WHO(http://apps.who.int.medicinedocs/en/cl/CL1.1.1.1.2/clmd,50.html#hlCL1_1_1_1_2). Discuss early drafts of the law with all interested parties: Health professions, trade/industry groups, concerned govt depts, consumer groups When the law is approved, regulations are developed to guide the implementation of the law. When a regulation is revised, research and take into account which other laws will be affected by the revision
  • 27. Elements of a ComprehensiveDrug Law General Provisions  Powers of Control of Enforcement Availability and  Powers to make Marketing rules and regulations Control of Supply  Repeals and Mechanisms transitional Drug Control provisions Administration  Exemptions from provisions of the law Remi ADESEUN
  • 28. Change Management for NewLaws/Regulations/Guidelines Neccesity Vision Sysytems Success Capabilities Structures
  • 29. New Drug Distribution Guidelines Introduced in March 2011 Sanctions for Non-Compliance expected to commence with effect from 12th July 2012 Does it pass the test?  Necessity & Vision? Probably Yes.  Are the necessary Structures, Capabilities & Systems in place to ensure Success? A big NO!  What should be the right spirit? Create Awareness, Interest and Participation of major stakeholders. Pilot Scheme.
  • 30. Summary Realistic and effective laws and regulations are needed for the pharma sector because:  Pharmaceuticals concern the whole population  Many parties are involved: patients, health providers, manufacturers, etc.  Serious consequences, including injury and death, can result from the lack or misuse of medicines  The consumer has no way to determine product quality  Informal controls are insufficient In drafting or revising legislation, it is important to:  Inventory the laws and regulations already in force  Determine what type of legislative is required  Involve both legal and health experts  Keep all stakeholders informed
  • 31. Thank You!Contact Information:Remi ADESEUNChairmanRodot Group.Healthcare.Architecture.Consulting08057713769/07065156473r.adeseun@rodot.orgkojere@yahoo.com