6.pndfs april 14 2010- Dr. Marife Yap

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Dr. Maria Eufemia C. Yap, M.D., M.Sc.
Serving as Associate Dean
Dr. Yap finished with a Bachelor of Science degree in Biology from the Ateneo in 1983. She pursued her medical studies at the Far Eastern University - Nicanor Reyes Medical Foundation in 1987.
She attended the University of Heidelberg, where she graduated Master of Science in Community Health and Health Management in 1997.
She has held positions in the Ateneo’s health-related projects such the Center for Community Services (CCS) and Health Alternatives for Total Human Development Institute (HEALTHDEV), before she joined the AGSB as a faculty member and then as Associate Director and Assistant to the Vice President for the Professional Schools. Since 2003, she has been Director of the AGSB's Health Unit.[1]

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6.pndfs april 14 2010- Dr. Marife Yap

  1. 1. Dr Marife C Yap Associate Dean Ateneo School of Medicine and Public Health MECYap 14 April 2010 Health Financing Summit
  2. 2. <ul><li>Brief Review: Historical Context </li></ul><ul><li>Rationale </li></ul><ul><li>PNDFS and its Mechanisms </li></ul><ul><li>Pre-requisites and Implications: Implementing the PNDFS </li></ul>MECYap 14 April 2010 Health Financing Summit
  3. 3. ASSESSMENT OF THE HEALTH TARGETS OF THE MEDIUM TERM PHILIPPINE DEVELOPMENT PLAN Ramon Pedro Paterno M.D. Paolo Victor N. Medina M.D.
  4. 4. <ul><li>Reduce the cost of medicines commonly bought by the poor to half of their 2004 prices and make these available nationwide through a distribution network as determined by DOH, in coordination with the PITC </li></ul>Reduce the Cost of Medications by Half
  5. 5. Achievements <ul><li>Generics Act of 1988 </li></ul><ul><li>Enactment into law of Republic Act 9502 – “Universally Accessible Cheaper and Quality Medicines Act of 2008” </li></ul><ul><ul><li>Maximum Drug Retail Price Executive Order </li></ul></ul><ul><ul><ul><li>22 Selected drugs reduced to half of their prices as mandated by law </li></ul></ul></ul><ul><ul><li>Augment and Strengthen Generics Act, Pharmacy Act and Intellectual Property Act </li></ul></ul><ul><li>Signing into law of Republic Act 9711 – “Food and Drug Administration Act” to ensure quality of drugs </li></ul>
  6. 6. Average 4-week Medicine Expenditures within Household Expenditure Quintiles Source: WHO, World Health Survey, 2002 $88 $153 Poor families cannot afford to pay for medicines
  7. 7. Recommendations <ul><li>We have to go BEYOND : </li></ul><ul><ul><li>Cheaper and Quality Medicines Law </li></ul></ul><ul><ul><li>Maximum Drug Retail Price EO </li></ul></ul><ul><ul><li>Food and Drug Authority Law </li></ul></ul><ul><ul><li>Generics Act of 1988 </li></ul></ul><ul><li>Expand coverage of MDRP to include ALL essential medications </li></ul><ul><li>Increase and sustain awareness and support of using generics not only among consumers, but among health professionals as well </li></ul>
  8. 8. <ul><li>To many Filipinos, good health has always been associated with the availability of medicines and the capacity to purchase these medicines and complete the prescribed dosage; </li></ul><ul><li>It is not any wonder therefore that many lay persons (non-health professionals) premise their clamor for cheaper quality medicines on the assumption and definition that </li></ul>MECYap 14 April 2010 Health Financing Summit Bengzon et al, 2007
  9. 9. <ul><li>April 1987: Promulgation of the PNDP </li></ul><ul><ul><li>Q uality Assurance </li></ul></ul><ul><ul><li>R ational Drug Use </li></ul></ul><ul><ul><li>S elf Reliance </li></ul></ul><ul><ul><li>T ailored Procurement </li></ul></ul><ul><li>The Philippine National Drug Formulary (PNDF) or the EDL which was based on the WHO World Drug Situation Report and the UNIDO-sponsored Pharmaceutical Industry Development Study was the MAIN INSTRUMENT for promoting access to essential drugs </li></ul>MECYap 14 April 2010 Health Financing Summit Bengzon et al, 2007
  10. 10. <ul><li>The Generics Act of 1988 is the legal instrument for the promotion of rational drug use (RA 6675, passed Sept 1988) </li></ul><ul><li>“ While the PNDP and the Generics Act were conceived independently, they evolved into synergistic efforts because of a congruency of objectives with respect to rational drug use.” </li></ul>MECYap 14 April 2010 Health Financing Summit Bengzon et al, 2007
  11. 11. MECYap 14 April 2010 Health Financing Summit “ Government, because of the immense powers at its disposal, can readily institute measures to respond to the problems raised to its attention. In doing so, however, approaches may be over simplistic, indicating a failure to appreciate the immensity and complexity of the proposed area of reform. Such quick fixes, at best, provide temporary relief from the symptoms of the ills; in the worst case, long-term complications could arise. Without the benefit of thorough diagnosis and management, a cure cannot be effected.” Bengzon et al, 2007
  12. 12. <ul><li>“ The Philippine National Drug Policy provides a framework that weaves together the various elements necessary to effect successful reform in the area of pharmaceuticals.” </li></ul><ul><li>E.O. 49, Jan 21, 1993: “Directing the Mandatory Use of the Phil National Formulary Vol 1 as the Basis for Procurement of Drug Products by the Government” </li></ul><ul><li>A.O. 163 s. 2002: “Implementing Guidelines and Procedures in the Procurement and Requisition of Drugs and Medicines by the DOH pursuant to E.O. 49” – procedural bases </li></ul>22 January 2009 Health Financing Summit Bengzon et al, 2007
  13. 13. <ul><li>Impetus and Drivers of Change: </li></ul><ul><ul><li>Globalization and its impact on the procurement and utilization of drugs and medicines </li></ul></ul><ul><ul><li>Economic and Financial Challenges </li></ul></ul><ul><ul><li>Drivers of Technology and Information that allow greater access of knowledge by people potentially moving towards greater empowerment and participation </li></ul></ul>MECYap 14 April 2010 Health Financing Summit
  14. 14. <ul><li>Drug Formulary - a continually updated list of medications and related information, representing the clinical judgement of physicians, pharmacists and other experts in the diagnosis and/or treatment of disease and promotion of health. </li></ul><ul><li>Drug Formulary System - an ongoing process whereby a health care organization, through its physicians, pharmacists, and other health care professionals, establishes policies on the use of drug products and therapies, and identifies drug products and therapies that are the most medically appropriate and cost-effective to best serve the health interests of a given patient population. </li></ul>MECYap 14 April 2010 Health Financing Summit Principles of a Drug Formulary System, October 2000
  15. 15. <ul><li>A.O. 2006-0018: Implementing Guidelines of the Philippine National Drug Formulary System </li></ul><ul><li>“ After reviewing the implementing policies and procedures that ensure the use of the PNDF and the instruments used for the drug inclusion in and deletion from the formulary, the DOH finds it necessary to revise the inputs, processes, and outputs of the PNDF, collectively referred to, thereafter as the Philippine National Drug Formulary System (PNDFS) </li></ul>MECYap 14 April 2010 Health Financing Summit
  16. 16. <ul><li>To revise the inputs, processes, and outputs of the PNDF </li></ul><ul><li>The PNDF SYSTEM </li></ul><ul><ul><li>Scope </li></ul></ul><ul><ul><ul><li>Drug Procurement Guidelines for all government health facilities, units and offices </li></ul></ul></ul><ul><ul><ul><li>Guidelines on PhilHealth claims and reimbursements for the entire health sector (public and private) </li></ul></ul></ul>MECYap 14 April 2010 Health Financing Summit
  17. 17. MECYap 14 April 2010 Health Financing Summit Hartigan-Go et al, 2007 USE SELECTION DISTRIBUTION PROCUREMENT DRUG MANAGEMENT CYCLE <ul><li>Management Support </li></ul><ul><li>Human Resource </li></ul><ul><li>Information Systems </li></ul>
  18. 18. <ul><li>Formulary list </li></ul><ul><ul><li>A drug selection tool </li></ul></ul><ul><li>Formulary manual </li></ul><ul><ul><li>A source of drug information </li></ul></ul><ul><li>Formulary system </li></ul><ul><ul><li>A drug management process </li></ul></ul><ul><ul><li>The whole system for developing, updating, and promoting the formulary list or EDL </li></ul></ul>MECYap 14 April 2010 Health Financing Summit Hartigan-Go et al, 2007
  19. 19. MECYap 14 April 2010 Health Financing Summit Physicians FSG PNDF STG/ CPG BAC COA - A.O. No. 163 s. 2002 - E.O. 49 s. 1993 Hartigan-Go et al, 2007
  20. 20. MECYap 14 April 2010 Health Financing Summit FORMULARY LGU -COBAC For Procurement PRIVATE AND PUBLIC PHYSICIANS in prescribing medicines PHILHEALTH 3 RD PARTY PAYORS To determine reimbursements BENEFICIARIES To obtain information on the drugs, including prices Hartigan-Go et al, 2007
  21. 21. <ul><li>A structure </li></ul><ul><ul><li>The Formulary Study Group (FSG) </li></ul></ul><ul><li>A process </li></ul><ul><ul><li>The Formulary Selection Algorithm (FSA) </li></ul></ul><ul><li>An output </li></ul><ul><ul><li>The Formulary Manual (or the PNDF) </li></ul></ul>MECYap 14 April 2010 Health Financing Summit Components of the PNDF System (PNDFS)
  22. 22. <ul><li>The Formulary Executive Council (FEC) </li></ul><ul><li>The Epidemiology Committees (EC) </li></ul><ul><ul><li>The Clinical Epidemiology Sub-committee (CES) </li></ul></ul><ul><ul><li>The Public Health Epidemiology Sub-committee (PHES) </li></ul></ul><ul><li>The Pharmacology Committee (PC) </li></ul>22 January 2009 2 nd MeTA National Forum
  23. 23. <ul><li>Identify common health problems </li></ul><ul><li>Select clinical practice guidelines (CPG) </li></ul><ul><li>Assess cost-effectiveness of CPG drugs </li></ul>MECYap 14 April 2010 Health Financing Summit
  24. 24. <ul><li>Assess pharmacokinetic and –dynamic properties </li></ul><ul><li>Approval or disapproval </li></ul><ul><li>If disapproved, appeal to the USEC Health Regulations </li></ul>MECYap 14 April 2010 Health Financing Summit
  25. 25. <ul><li>Clinical Practice Guidelines </li></ul><ul><li>Public Health Practice Guidelines </li></ul><ul><li>Essential Drug List </li></ul><ul><li>Formulary </li></ul><ul><li>Cross-reference Index </li></ul>MECYap 14 April 2010 Health Financing Summit
  26. 26. <ul><li>PNDF Manual to be published by DOH with assistance from PHIC </li></ul><ul><li>USEC for Health Regulations will supervise and guide the FSG </li></ul><ul><li>PHIC will provide administrative and secretariat functions for the EC and the PC </li></ul>MECYap 14 April 2010 Health Financing Summit
  27. 27. <ul><li>NDPP will provide administrative and secretariat functions for the FEC </li></ul><ul><li>BFAD will provide technical inputs and essential data requirements </li></ul><ul><li>PNDF will be basis of government procurement (EO 49) </li></ul>MECYap 14 April 2010 Health Financing Summit
  28. 28. <ul><li>Philhealth will only reimburse drugs in PNDF </li></ul><ul><li>PNDF will be regularly updated (RA 6675) </li></ul>MECYap 14 April 2010 Health Financing Summit
  29. 29. <ul><li>DOH Secretary may authorize procurement of drugs not listed in the PNDF </li></ul><ul><li>All drug establishments must have a copy of the PNDF </li></ul><ul><li>BFAD-withdrawn drugs will be automatically delisted from the PNDF </li></ul>MECYap 14 April 2010 Health Financing Summit
  30. 30. MECYap 14 April 2010 Health Financing Summit
  31. 31. <ul><li>Structure </li></ul><ul><li>Process </li></ul><ul><li>Outcome </li></ul>MECYap 14 April 2010 Health Financing Summit
  32. 32. <ul><li>The Formulary Study Group </li></ul><ul><ul><li>The Formulary Executive Council (FEC) </li></ul></ul><ul><ul><li>The Epidemiology Committees (EC) </li></ul></ul><ul><ul><ul><li>The Clinical Epidemiology Sub-committee (CES) </li></ul></ul></ul><ul><ul><ul><li>The Public Health Epidemiology Sub-committee (PHES) </li></ul></ul></ul><ul><ul><li>The Pharmacology Committee (PC) </li></ul></ul>MECYap 14 April 2010 Health Financing Summit
  33. 33. <ul><li>Identify common health problems </li></ul><ul><li>Select clinical practice guidelines (CPG) </li></ul><ul><li>Assess cost-effectiveness of CPG drugs </li></ul>MECYap 14 April 2010 Health Financing Summit
  34. 34. <ul><li>Frequency </li></ul><ul><li>Severity </li></ul>MECYap 14 April 2010 Health Financing Summit
  35. 35. <ul><li>Burden of disease (BOD) </li></ul><ul><ul><li>A measurement of the gap between current health status and an ideal situation where everyone lives into old age free of disease and disability </li></ul></ul>MECYap 14 April 2010 Health Financing Summit
  36. 36. <ul><li>Sources of CPGs </li></ul><ul><ul><li>DOH or PHIC </li></ul></ul><ul><ul><li>Professional medical societies in the Philippines </li></ul></ul><ul><ul><li>CPGs in Philippines-similar countries (ASEAN or Latin American countries) </li></ul></ul><ul><ul><li>WHO </li></ul></ul><ul><ul><li>Cochrane Registry </li></ul></ul><ul><ul><li>CPGs from any country </li></ul></ul>MECYap 14 April 2010 Health Financing Summit
  37. 37. <ul><li>Identify and enumerate drugs recommended in CPG for each of the priority diseases </li></ul>MECYap 14 April 2010 Health Financing Summit
  38. 38. <ul><li>Search databases </li></ul><ul><ul><li>MEDLINE </li></ul></ul><ul><ul><li>EMBASE </li></ul></ul><ul><ul><li>SCISEARCH </li></ul></ul><ul><ul><li>Google Scholar </li></ul></ul>MECYap 14 April 2010 Health Financing Summit
  39. 39. <ul><li>Critical appraisal of CPG </li></ul><ul><ul><li>Study validity </li></ul></ul><ul><ul><li>Incremental costs and outcomes </li></ul></ul><ul><ul><li>Generalizability </li></ul></ul><ul><li>Hayward RSA et al. How to Use a Clinical Practice Guideline. J AMA (1995;274(7):570-4) and (1995;274(20):1630-2). </li></ul>MECYap 14 April 2010 Health Financing Summit
  40. 40. <ul><li>Conduct periodic drug utilization review of priority drugs </li></ul><ul><li>Rationale </li></ul><ul><ul><li>Evaluates capability of the health workers to use the drug </li></ul></ul><ul><ul><li>Basis for continued inclusion or deletion of drug from PNDF </li></ul></ul>MECYap 14 April 2010 Health Financing Summit
  41. 41. <ul><li>PHIC claims </li></ul><ul><li>Special surveys of </li></ul><ul><ul><li>DOH and private hospitals </li></ul></ul><ul><ul><li>RHUs </li></ul></ul>MECYap 14 April 2010 Health Financing Summit
  42. 42. <ul><li>Establish responsibility </li></ul><ul><li>Develop scope of activities </li></ul><ul><li>Establish criteria </li></ul><ul><li>Perform DUR and collect data </li></ul><ul><li>Analyze data </li></ul><ul><li>Develop recommendations and plan of action </li></ul><ul><li>Perform follow-up </li></ul>MECYap 14 April 2010 Health Financing Summit
  43. 43. MECYap 14 April 2010 Health Financing Summit
  44. 44. <ul><li>Pharmacology Committee is part of the Formulary Study Group </li></ul><ul><li>The Committee will do drug evaluations (2 or 3 doctors with pharmacology background, 2 or 3 pharmacists) </li></ul><ul><li>Supported by a team of researchers within the secretariat (3 full time researchers with pharmacology or pharmaceutical science qualifications) </li></ul><ul><li>All willing to honestly declare conflict/vested interest and to sign confidentiality disclosure </li></ul>MECYap 14 April 2010 Health Financing Summit
  45. 45. <ul><li>Receives drug sets from Epidemiology Committee </li></ul><ul><li>Evaluates drugs on the basis of safety </li></ul><ul><li>Submits evaluation back to Epidemiology Committee for cost-effectiveness analysis </li></ul><ul><li>Have joint deliberations with Epidemiology Committee </li></ul><ul><li>Have specific EDL medicines listed in the PNDF only if there is evidence that the generic drug has bio-availability or bio-equivalence data, when required and comes from a drug industry with certified full compliance to cGMP. </li></ul>MECYap 14 April 2010 Health Financing Summit
  46. 46. <ul><li>Support the Pharmacology Committee in matters of organizing literature research for evaluation </li></ul><ul><li>Scan the horizon for unsafe drugs that are in the formulary or proposed to be entered into the formulary and send Flags to the sub-committee </li></ul><ul><li>Following the joint deliberations of the Pharmacology & Epidemiology Committees, to prepare the write ups of the formulary using a standard framework. </li></ul>MECYap 14 April 2010 Health Financing Summit
  47. 47. <ul><li>The Epidemiology Committee – priority medical conditions and sets of drugs identified for further evaluation </li></ul><ul><li>Knowledge of unsafe drugs (for deletions) </li></ul><ul><li>Output: a list of less risky drugs. </li></ul>MECYap 14 April 2010 Health Financing Summit
  48. 48. <ul><li>Withdrawn from other countries </li></ul><ul><li>Evidence of causing deaths or major organ system damage (Signals) </li></ul><ul><li>Estimates of risk: 1:10,000 vs 1:1000 </li></ul><ul><li>If drug is deleted or removed, will it cause great harm to sick population who needs this medicine? </li></ul>MECYap 14 April 2010 Health Financing Summit
  49. 49. <ul><li>The current anatomic organ-systems of medical conditions can be maintained </li></ul><ul><li>Redefine Core and Complementary listing in sync with WHO usage </li></ul><ul><li>Set of public health outpatient drug use (in primary care setting) and a set of hospital drugs. </li></ul><ul><li>One or two prototype drugs per drug category will be offered </li></ul><ul><li>Clinical usage information for doctors and other health professionals </li></ul>MECYap 14 April 2010 Health Financing Summit
  50. 50. MECYap 14 April 2010 Health Financing Summit
  51. 51. <ul><li>To provide the framework on which the PNDFS is based; </li></ul><ul><li>To provide guideposts on the functions, roles and interactions of the key members and implementers of the PNDFS; </li></ul><ul><li>To define and articulate the relationships among the sub-committees and the secretariat for smooth functioning of the PNDFS; </li></ul><ul><li>To begin thinking through a transition plan for a seamless shift from the current system to the PNDFS. </li></ul>MECYap 14 April 2010 Health Financing Summit
  52. 52. MECYap 14 April 2010 Health Financing Summit Secretary of Health Undersecretary of Health for Regulations Formulary Executive Council (FEC) Epidemiology Committees Clinical Epi Subcomm Public Health Epi Subcomm Pharmacology Committee FSG / NFC Secretariat F S G F S G
  53. 53. <ul><li>Accountability </li></ul><ul><li>Alignment </li></ul><ul><li>Transparency </li></ul><ul><li>Strategic and critical alliances and partnership </li></ul>MECYap 14 April 2010 Health Financing Summit
  54. 54. MECYap 14 April 2010 Health Financing Summit
  55. 55. <ul><li>Building on the gains from the past </li></ul><ul><li>Parallel efforts </li></ul><ul><ul><li>Arrive at an alignment of where the PNDFS is to be brought (the envisioned state) </li></ul></ul><ul><li>Information as tool </li></ul><ul><ul><li>The very nature of the PNDFS as a SYSTEM requires that all service users and stakeholders are informed and updated. </li></ul></ul><ul><li>Staying the course </li></ul>MECYap 14 April 2010 Health Financing Summit
  56. 56. <ul><li>Implementation of the PNDFS should be in context with the components of HSRA and FOUR mula ONE . </li></ul><ul><li>Implementation should be done in small, manageable and systematic phases. </li></ul><ul><li>PNDFS is just one of the tools to address drug access. </li></ul><ul><li>PNDFS provides more stakeholders an opportunity to improve on the gains, deal with issues in a more rigorous, multi-faceted approach. </li></ul>MECYap 14 April 2010 Health Financing Summit

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