6.pndfs april 14 2010- Dr. Marife Yap

Dr Marife C YapAssociate Dean

Ateneo School of Medicine and Public Health

MECYap 14 April 2010Health Financing Summit

Brief Review: Historical Context Rationale PNDFS and its Mechanisms Pre-requisites and Implications: Implementing the

PNDFS


ASSESSMENT OF THE HEALTH TARGETS OF THE MEDIUM TERM PHILIPPINE DEVELOPMENT PLANRamon Pedro Paterno M.D. Paolo Victor N. Medina M.D.

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

Reduce the Cost of Medications by Half

Achievements Generics Act of 1988 Enactment into law of Republic Act 9502 –

“Universally Accessible Cheaper and Quality Medicines Act of 2008” Maximum Drug Retail Price Executive Order

22 Selected drugs reduced to half of their prices as mandated by law

Augment and Strengthen Generics Act, Pharmacy Act and Intellectual Property Act

Signing into law of Republic Act 9711 – “Food and Drug Administration Act” to ensure quality of drugs

Source: WHO, World Health Survey, 2002

Average 4-week Medicine Expenditures within Household Expenditure Quintiles

$0

$10

$20

$30

$40

Ghana Coted'Ivoire

Senegal Morocco

Tunisia India

Pakistan Philippines

Medic

ine E

xpendit

ure

s in

Last

4

Weeks

by

Quin

tile

s

Quintile 1 Quintile 2 Quintile 3 Quintile 4 Quintile 5

$88$153

Poor families cannot afford to pay for medicines

Recommendations

We have to go BEYOND: Cheaper and Quality Medicines Law Maximum Drug Retail Price EO Food and Drug Authority Law Generics Act of 1988

Expand coverage of MDRP to include ALL essential medications

Increase and sustain awareness and support of using generics not only among consumers, but among health professionals as well

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;

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


Bengzon et al, 2007

April 1987: Promulgation of the PNDP◦ Quality Assurance◦ Rational Drug Use◦ Self Reliance◦ Tailored Procurement

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


Bengzon et al, 2007

The Generics Act of 1988 is the legal instrument for the promotion of rational drug use (RA 6675, passed Sept 1988)

“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.”


Bengzon et al, 2007


“Government, because of the immense powers at its disposal, can readily institute measures to respondto 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. Suchquick fixes, at best, provide temporary relief from the

symptoms of the ills; in the worst case, long-termcomplications could arise. Without the benefit of

thorough diagnosis and management, a cure cannotbe effected.”

Bengzon et al, 2007

“The Philippine National Drug Policy provides a framework that weaves together the various elements necessary to effect successful reform in the area of pharmaceuticals.”

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”

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

22 January 2009Health Financing Summit

Bengzon et al, 2007

Impetus and Drivers of Change:◦ Globalization and its impact on the procurement and

utilization of drugs and medicines◦ Economic and Financial Challenges◦ Drivers of Technology and Information that allow greater

access of knowledge by people potentially moving towards greater empowerment and participation


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.

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.


Principles of a Drug Formulary System, October 2000

A.O. 2006-0018: Implementing Guidelines of the Philippine National Drug Formulary System

“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)

MECYap 14 April 2010 Health Financing Summit

To revise the inputs, processes, and outputs of the PNDF

The PNDF SYSTEM◦ Scope

Drug Procurement Guidelines for all government health facilities, units and offices

Guidelines on PhilHealth claims and reimbursements for the entire health sector (public and private)



USE

SELECTION

DISTRIBUTION

PROCUREMENT

DRUG MANAGEMENT CYCLE

Management Support•Human Resource

•Information Systems

Hartigan-Go et al, 2007

Formulary list◦ A drug selection tool

Formulary manual◦ A source of drug information

Formulary system◦ A drug management process◦ The whole system for developing, updating, and

promoting the formulary list or EDL




Physicians

FSGPNDFSTG/CPG

BACCOA

- A.O. No. 163 s. 2002

- E.O. 49 s. 1993



FORMULARY

LGU -COBAC

For Procurement

PRIVATE AND PUBLIC PHYSICIANS in prescribing

medicines

PHILHEALTH

3RD PARTY PAYORS

To determine reimbursements

BENEFICIARIES

To obtain information on

the drugs, including prices


A structure◦ The Formulary Study Group (FSG)

A process◦ The Formulary Selection Algorithm (FSA)

An output◦ The Formulary Manual (or the PNDF)


Components of the PNDF System (PNDFS)

The Formulary Executive Council (FEC) The Epidemiology Committees (EC)

◦ The Clinical Epidemiology Sub-committee (CES)◦ The Public Health Epidemiology Sub-committee (PHES)

The Pharmacology Committee (PC)

22 January 20092nd MeTA National Forum

Identify common health problems Select clinical practice guidelines (CPG) Assess cost-effectiveness of CPG drugs


Assess pharmacokinetic and –dynamic properties Approval or disapproval If disapproved, appeal to the USEC Health

Regulations


Clinical Practice Guidelines Public Health Practice Guidelines Essential Drug List Formulary Cross-reference Index


PNDF Manual to be published by DOH with assistance from PHIC

USEC for Health Regulations will supervise and guide the FSG

PHIC will provide administrative and secretariat functions for the EC and the PC


NDPP will provide administrative and secretariat functions for the FEC

BFAD will provide technical inputs and essential data requirements

PNDF will be basis of government procurement (EO 49)


Philhealth will only reimburse drugs in PNDF PNDF will be regularly updated (RA 6675)


DOH Secretary may authorize procurement of drugs not listed in the PNDF

All drug establishments must have a copy of the PNDF

BFAD-withdrawn drugs will be automatically delisted from the PNDF


Structure Process Outcome


The Formulary Study Group◦ The Formulary Executive Council (FEC)◦ The Epidemiology Committees (EC)

The Clinical Epidemiology Sub-committee (CES) The Public Health Epidemiology Sub-committee (PHES)

◦ The Pharmacology Committee (PC)


Identify common health problems Select clinical practice guidelines (CPG) Assess cost-effectiveness of CPG drugs


Frequency Severity


Burden of disease (BOD) ◦ A measurement of the gap between current health status

and an ideal situation where everyone lives into old age free of disease and disability


Sources of CPGs◦ DOH or PHIC◦ Professional medical societies in the Philippines◦ CPGs in Philippines-similar countries (ASEAN or

Latin American countries)◦ WHO◦ Cochrane Registry◦ CPGs from any country


Identify and enumerate drugs recommended in CPG for each of the priority diseases


Search databases◦ MEDLINE◦ EMBASE◦ SCISEARCH ◦ Google Scholar


Critical appraisal of CPG◦ Study validity◦ Incremental costs and outcomes◦ Generalizability

Hayward RSA et al. How to Use a Clinical Practice Guideline. JAMA (1995;274(7):570-4) and (1995;274(20):1630-2).


Conduct periodic drug utilization review of priority drugs

Rationale◦ Evaluates capability of the health workers to use the

drug◦ Basis for continued inclusion or deletion of drug from

PNDF


PHIC claims Special surveys of

◦ DOH and private hospitals◦ RHUs


Establish responsibility Develop scope of activities Establish criteria Perform DUR and collect data Analyze data Develop recommendations and plan of action Perform follow-up


Pharmacology Committee is part of the Formulary Study Group

The Committee will do drug evaluations (2 or 3 doctors with pharmacology background, 2 or 3 pharmacists)

Supported by a team of researchers within the secretariat (3 full time researchers with pharmacology or pharmaceutical science qualifications)

All willing to honestly declare conflict/vested interest and to sign confidentiality disclosure


Receives drug sets from Epidemiology Committee

Evaluates drugs on the basis of safety

Submits evaluation back to Epidemiology Committee for cost-effectiveness analysis

Have joint deliberations with Epidemiology Committee

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.


Support the Pharmacology Committee in matters of organizing literature research for evaluation

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

Following the joint deliberations of the Pharmacology & Epidemiology Committees, to prepare the write ups of the formulary using a standard framework.


The Epidemiology Committee – priority medical conditions and sets of drugs identified for further evaluation

Knowledge of unsafe drugs (for deletions)

Output: a list of less risky drugs.


Withdrawn from other countries Evidence of causing deaths or major organ

system damage (Signals) Estimates of risk: 1:10,000 vs 1:1000 If drug is deleted or removed, will it cause great

harm to sick population who needs this medicine?


The current anatomic organ-systems of medical conditions can be maintained

Redefine Core and Complementary listing in sync with WHO usage

Set of public health outpatient drug use (in primary care setting) and a set of hospital drugs. One or two prototype drugs per drug category

will be offered Clinical usage information for doctors and other

health professionals


To provide the framework on which the PNDFS is based;

To provide guideposts on the functions, roles and interactions of the key members and implementers of the PNDFS;

To define and articulate the relationships among the sub-committees and the secretariat for smooth functioning of the PNDFS;

To begin thinking through a transition plan for a seamless shift from the current system to the PNDFS.


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 SecretariatF

S

G

F

S

G


Accountability Alignment Transparency Strategic and critical alliances and partnership


Building on the gains from the past Parallel efforts

◦ Arrive at an alignment of where the PNDFS is to be brought (the envisioned state)

Information as tool◦ The very nature of the PNDFS as a SYSTEM requires

that all service users and stakeholders are informed and updated.

Staying the course


Implementation of the PNDFS should be in context with the components of HSRA and FOURmula ONE.

Implementation should be done in small, manageable and systematic phases.

PNDFS is just one of the tools to address drug access.

PNDFS provides more stakeholders an opportunity to improve on the gains, deal with issues in a more rigorous, multi-faceted approach.


6.pndfs april 14 2010- Dr. Marife Yap

Health & Medicine

Transcript of 6.pndfs april 14 2010- Dr. Marife Yap