The Philippine National Drug Policy & Rational Drug Use of Medicines

1. Briefly discuss the development of the PNDF, its goal and its five pillars.

2. Distinguish the term drug from the term medicines

3. Define rational medicine use. Cite examples of irrational medicine use.

4. Discuss the following program initiatives to promote rational medicine use:

RA 6675 (Generics Act of 1988) goal & key revisions, advantages of using INN/generic name Define Essential Medicine Concept, essential medicines list, access to essential medicines

Discuss the Quality Assurance Cycle for Rational Medicine Use activities standards, qualitative and quantitative assessment of performance, diagnosis of reasons for inadequate performance, target interventions.

It was during the time when democracy was brought back in the Philippines in 1986 when the Philippine National Drug Policy was established. It was through a series of multi-sectoral consultation and participation of the drug industry, academe, professional organizations, government agencies and consumers that it was formed in the hope of providing solutions to problems and the clamoring need to provide essential drugs to the people. Led by the Task Force on Pharmaceuticals, PNDP was created to attain the goal of promoting the rational use of essential drugs in the country

In 1987, Corazon C. Aquino declared publicly the Philippine National Drug Policy (PNDP) together with its four pillars, i.e., Quality Assurance, Rational Use of Drugs, Self-Reliance, and Tailored Procurement. Based on the issuance of E.O. Nos. 174 and 175 amendments to R.A. 5921 "The Pharmacy Law" and R.A. 3720 "Food, Drug, and Cosmetic Act" respectively.

At present, the PNDP has five pillar components which address the problem of inadequate provision of good quality essential drugs to the people. These pillars were created to bring about the availability and affordability of safe, effective, and good quality drugs for all sectors of the country especially the poor ones.

The five pillars of PNDP are (1) assurance of the safety, efficacy and usefulness of drug products through quality control (2) promotion of the rational use of drugs by health professionals and the general public (3) development of self reliance in local pharmaceutical industry (4) targeted procurement of drugs by government and (5) people empowerment.

QUALITY ASSURANCE

BUREAU OF FOOD AND DRUGS (BFAD)

VISION

The BFAD is a world-class regulatory agency and center of scientific excellence composed of professionally competent, legally qualified, efficient, and confident staff with unfettered enforcement capabilities

MISSION

To ensure the safety, efficacy, purity, and quality of processed foods, drugs, diagnostic reagents, medical devices, cosmetics and household hazardous substances through state-of-the art technology, as well as the scientific soundness and truthfulness of product information for the protection of public health.

The functions of BFAD are as follows:

Ensure the safety, purity and quality of food, drugs and cosmetics

Handles the policy formulation and sector monitoring arm of the minister on matters pertaining to food, drugs, traditional medicines, cosmetics and household products.

Prescribes general standards and guidelines with respect to the veracity of nutritional and medicinal claims in the advertisement of food, drugs and cosmetics in various media

Provide consultative, training and advisory services to all agencies and organizations involved in food and drug manufacturing and distribution with respect to assuring safety and efficacy of food and drugs Maintain a corps of specially trained food and rugs inspectors for assignment to the various field offices of the Ministry (of Health)

Conduct studies and research related to food and drug safetyRATIONAL DRUG USE

A component of the Philippine national Drug Policy that attempts to correct and limit inappropriate and wasteful utilization of pharmaceuticals in the community through thorough legislation and strategies (public education program) that tries to reach prescribers, dispensers and the consumers so they can use drugs properly, correctly and sanely. The goal of this pillar is fulfillment the SANE criteria in drug use: safety, affordability need and efficacy

The rational use of drugs means that patients receive medicines appropriate for their clinical needs, in doses that meet their individual requirements, for an adequate period of time, and at the lowest cost to them and their community. Irrational drug use by prescribers and consumers is a very complex problem, which calls for the implementation of many different interventions at the same time. Efforts to promote rational drug use should also cover the use of traditional and herbal medicines. Key policy issues are: development of evidence-based clinical, as the basis for training, prescribing, drug utilization review, drug supply and drug reimbursement;

establishment and support of drugs and therapeutics committees;

promotion of the concepts of essential drugs, rational drug use and generic prescribing in basic and in-service training of health professionals;

the need and potential for training informal drug sellers;

continuing education of health care providers and independent, unbiased drug information;

consumer education, and ways to deliver it;

financial incentives to promote rational drug use;

regulatory and managerial strategies to promote rational drug use

General Guidelines for proper drug use

The essential drugs concept is central to a national drug policy because it promotes equity and helps to set priorities for the health care system. The core of the concept is that use of a limited number of carefully selected drugs based on agreed clinical leads to a better supply of drugs, to more rational prescribing and to lower costs.

The reasons are clear. Essential drugs that is selected on the basis of safe and cost-effective clinical, give better quality of care and better value for money. The procurement of fewer items in larger quantities results in more price competition and economies of scale. Quality assurance, procurement, storage, distribution and dispensing are all easier with a reduced number of drugs. Training of health workers and drug information in general can be more focused, and prescribers gain more experience with fewer drugs and are more likely to recognize drug interactions and adverse reactions.

Promotion of Rational Drug use

REPUBLIC ACT NO. 6675 (Generic Act of 1988)The Generic Act of 1988 was passed by the Senate and the House Representatives on August 25, 1988 and August 31, 1988, respectively and was approved by President Corazon C. Aquino, September 13 of the same year. This Act consisting of 15 sections was created to uphold, necessitate and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines recognized by their generic names in the Philippines. As stated in Section 2. Statement of the Policy, the Act was specifically (1) to promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing drugs; (2) to ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients; (3) to encourage the extensive use of drugs with generic names through a rational system of procurement and distribution; (4) to emphasize the scientific basis for the use of drugs; in order that the health professionals may become more aware and cognizant of their therapeutic effectiveness; and (5) to promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions.The following terms which are essential to be understood in relation to the Act were defined:

Generic Name or Generic Terminology- is the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official generic name as determined by the Bureau of Food and Drugs of the Department of Health.

Active Ingredient- is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product.

Chemical Name- is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound.

Drug Product is the finished product form that contains the active ingredients generally but not necessarily in association with inactive ingredients.

Drug Establishment- is any organization or company involved in the manufacture, importation but not necessarily in association with inactive ingredients.

Drug Outlets- means drugstores, pharmacies, and any other business establishments which sell drugs or medicines.

Essential Drugs List or National Drug Formulary- is a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditionings obtaining in the Philippines as well as on internationally accepted criteria. It shall consist of a core list and a complimentary list.

Core List is a list of drugs that meets the health care needs of the majority of the population.

Complementary List- is a list of alternative drugs used when there is response to the core essential drug or when there is hypersensitivity reaction to the core essential drug or when, for one reason or another, the core essential drug cannot be given.

Brand Name is the propriety name given by the manufacturer to distinguish its product from those of competitors.

Generic Drugs- are drugs not covered by patent protection and which are labeled solely by their international non-proprietary or generic name.

PHILIPPINE NATIONAL DRUG FORMULARY

The Philippine National Drug Formulary is an integral component of the National Drug Policy (NDP). It is a major strategy in the promotion of rational drug use, by assuring the availability and accessibility of essential drugs of proven efficacy, safety and quality at affordable cost. It is formulated by the Department of Health through the National Formulary Committee (NFC), mandated by the R.A. 6675 also known as the Generics Act of 1988.

It was formulated utilizing submitted evidence tables, documentations and a series of deliberation meetings with a panel of experts and resource persons consisting of representatives from medical schools, Philippine Medical Association (PMA), academic, specialty and sub-specialty societies, drug industry, government and private hospitals, and other stakeholders.

In 1993, by virtue of Executive Order No. 49 s.1993 and the Philippine Health Insurance Act of 1995, the PNDF was officially adopted as the basis for procurement of drug products within the entire DOH.

General Guidelines for Establishing the Philippine National Drug Formulary

Drug selection for the Philippine National Drug Formulary must be based on the following:

1. Relevance to disease which is indicated in the treatment of prevalent diseases.

2. Efficacy and safety objectively obtained on pharmacologic studies, which includes at least expanded Phase II clinical trials and/or additional Phase III studies among Filipinos.

3. Quality control standards, including stability, and when necessary, bioavailability have to be met. The suppliers of pharmaceutical products must provide documentation of the products compliance with the requested specifications.

4. Cost of the treatment regimen.

5. Appropriateness to the capability of health workers at different level of health care must be considered.

6. Local health problems, the prevalent diseases or conditions on pharmacokinetic and pharmacodynamic parameters modifying therapeutic response have to be considered.

7. Most favorable benefit/risk ratio is selected when several drugs are available for the same therapeutic indication.

8. Preferential factors for evaluating therapeutically equivalent drugs:

a. Drug with best understood beneficial properties and limitations

b. Drug with clinical utility for treating more than one condition

c. Drug with most favorable pharmacokinetic properties

d. Drugs in a dosage form easily dispensed by health staff or safely administered to the patient

e. Drugs with greater acceptability

f. Drugs with favorable stability

g. Drugs for which local reliable manufacturing facilities exist for its production

9. Formulation as single compounds and fixed-ratio combinations are acceptable only when:

a. Use of more than one drug is clinically documented

b. Its therapeutic benefit is greater than the sum of each individual component

c. It is safer than the use of a single compound drug

d. It is cheaper or does not exceed the cost of the sum of individual products

e. Patient compliance is improved

f. Satisfaction of majority of the population is maintained

10. Period review of significant new therapeutic advances and information is necessary.

11. International Non-propriety Names for drugs should be used.

The PNDF is a component of the National Drug Policy which seeks to bring about the availability of safe, efficacious, and quality drugs at affordable cost. Through the Essential Drug Concept, it is a step to rationalize drug production, distribution, procurement and consumption.

Philippine National Drug Formulary (PNDF)

Is the Essential Drug List for the Philippines prepared by the National Drug Committee (NDC) with consultation to different experts in the field of pharmaceutics, which is updated every year, consisting of:

a. Core List drugs that are essential and are needed by the majority of the population and should be available at all times in appropriate dosage forms and in sufficient quantities.

b. Complimentary List drugs that are needed for treating rare disorders, drugs with special pharmaceutical properties and alternative drugs to be used when there is no response in medicating Core list drugs or when Core list drugs cannot be administered for a reason or situation.

SELF-RELIANCE

It is very important that the drug policy defines the future supply system. A well-coordinated supply system will ensure that public funds available for drug purchases are used effectively to maximize access, to obtain good value for money and to avoid waste. The most important objective should be to get quality essential drugs to the people who need them, at prices that the Filipinos can afford.

Production of drugs should be based on a careful situation analysis and on a realistic appraisal of the feasibility of domestic production. Pharmaceutical production can be classified into three levels:

Primary production - includes the manufacture of active pharmaceutical ingredients and intermediates;

Secondary production -includes the production of finished dosage forms from excipients and active substances;

Tertiary production- is limited to the packaging of finished products or repackaging of bulk finished products.

The government hopes to provide a regular supply of low-cost drugs to public health programmes aimed at disease control, through government-owned drug manufacture rather than through overseas procurement. In making the decision about being involved in pharmaceutical production of the government is based on a thorough situation analysis through determining its feasibility and the quality and prices with which the locally produced drugs will compete in the market.

The main goal of this pillar is to: manufacture pharmaceutical needs of most important drug locally and drug development from medicinal plants and other indigenous sources. Filipino Pharmaceutical Association promoted self reliance and encourages production especially of generic drugs. An achievement of being able to increase in the percent share of unbranded generics in the market was attained with 2% (1988) and 10% (1993).

Also the use of traditional medicine was encourage in this pillar which implies that there should be continuous use of traditional or herbal medicine that must be widely practiced and its place in health care should be considered in the broader development of health policy. Traditional and herbal medicines are usually known by local names. It should be taken note that the use of the WHO guidelines for the assessment of herbal medicines is recommended.

TARGETED PROCUREMENTProcurement is an activity involving acquisition of goods, consulting services, contracting for infrastructure projects and lease of goods and real estate. In the procurement of drugs in the Philippines it is scientifically based on morbidity patterns, cost effectiveness considerations and the essential drugs concept.

It is mandatory in all government agencies under E.O. 49 s. 1993 to use the Philippine National Drug Formulary Vol.1 as sole basis for procurement of essential drugs. The former President Fidel V. Ramos ordered that the Therapeutics Committee/ Physician in charge of the clinic or infirmary/Procurement officer shall be responsible for determining which products and the corresponding quantity to be procured by the government, every requisition and issue voucher or any request to purchase drug shall be accompanied by a certification signed by the requisitioning officer that the drug products being requisitioned or procured fall within and conform with PNDF vol. 1, the commission on audit shall instruct all unit auditors/ heads of auditing unit to monitor compliance with this order and to disallow in audit claims/ disimbursment either from regular budget local and /or trust funds , for drugs not listed in PNDF a written request with corresponding justification addressed to the head of the national drug policy office who may approve or disapprove the request.

The goal of the department of health is to procure drugs satisfy the needs of the majority of the population and therefore should be available at all times, in adequate amounts in appropriate dosage forms and at a price the individual and the community can afford. It is should be scientifically based on morbidity patterns, cost effectiveness and the essential drug concept.

The Department of health has a Procurement and Logistic Service unit which have many functions. The role of this unit is to formulate plans, policies, standards and guidelines related to procurement and logistics management of the Department of Health; procures, maintains and manages supplies, materials and services to support the logistical requirements of the Department of Health; advises the Secretary of Health on matters pertaining to the procurement of goods and services and logistics management. The Procurement division specifically develops an annual procurement program for the Department of Health; provides assistance to field offices of the Department on matters pertaining to procurement of drugs, medicines, medical supplies, health equipment and other general supplies and materials; ensures that all offices/units adhere to procurement processes and procedures. The materials or management division specifically ensures proper handling and storage, adequate and timely distribution of drugs, medicines, medical supplies health equipment and other general office supplies and materials; maintains and updates inventory of goods, supplies and materials. The department allows yearly biding procedures in the procurement of drugs. They invite companies in the bidding procedure or companies will apply for it. Affordability is necessary or a prerequisite in the access of a drug. The department must find drugs which are affordable to the lower masses, but also they must put to mind that even if it is affordable it is still effective in the treatment of a disease.

PEOPLE EMPOWERMENT

Peoples participation is the core principle of Primary Health Care. As PHC agency of our country, Department of Health plays a catalyst role in sustaining and accelerating health care program implementation through active and collective participation of the community. This strategy is referred to as people empowerment.

People empowerment is the process of gaining mastery and power over ones community to produce change. Changing people's behavior or habits is not an easy task and generally requires a long term strategy based on the behavioral principles. A behavioral modification intervention has to be undertaken with knowledge of the social and cultural context in which it is based. Thus, empowerment is not merely an information campaign but a deliberate, planned strategy that uses various means and approaches to elicit needed action among those who can contribute to solving or reducing an identified problem in the community.

The main goal of people empowerment is to make people committed to health work since they take responsibility for their own health. In drug utilization, it helps consumers on their decision of purchase of an efficacious, affordable, safe and good quality drugs. It provides the consumer with a better understanding of the benefits and the potential dangers of drug use, and safe sources of drug information and supply. Achievement of this goal will produce informed and empowered consumers who are able to act in their own and in their community's best interests.

IRRATIONAL MEDICINE USE

PROBLEMS RELATED TO DRUG USE IN THE PHILIPPINES

The factors that influence drug use are many and interrelated. Changing complex practices that are embedded in cultural and social beliefs and shaped by knowledge, attitudes, infrastructure and economic interests is very difficult. No single approach is likely to work, and some interventions may produce unintended effects. A combination of strategies tailored to the needs of the different groups and different environments is needed.Taking drug is a component of health seeking behavior in all communities. Currently, the local market is swamped with thousands of pharmaceutical preparation. Majority of Filipinos are not able to afford essential drugs. Limited resources put aside for medicine are being utilized to purchase irrational products as influenced by political, cultural, and economic factors revolving around the lives of many Filipinos. In many parts of the country, objective information on drugs is scarce. Health workers receive limited basic training or continuing education on drugs. Knowledge, on the other hand, is only a component of the crisis.

Moreover, problems of access to quality drugs and rational use persist. Although few hard data are available, it is likely that in the rural parts of the Philippines where more than half the population still lacks access to essential drugs. And there are new challenges that may have an impact on access, such as the expansion of the private sectors role in pharmaceuticals, health sector reforms and the effects of globalization. The changing pattern of diseases, antimicrobial resistance and emerging new diseases are other factors. Particularly important is the current trend of governments to reduce health care spending because of inadequate resources, despite increasing health needs.

Overuse and misuse of drugs occurs as a consequence of prescribing more than enough medicine needed and consumption of medicine which is more than the amount required. Drugs are being used even when not indicated; some are prescribed inappropriately for non-specific and self limiting illness. Incorrect drug use occurs in the sense of incorrect prescribing as well as inappropriate use of consumers. Thus, duplication in medications and consumption of drugs with potentially adverse drug reactions are unavoidable.

Drugs are insufficiently prescribed and taken. Due to poverty and more important necessities in life, patients have a propensity to just buy multivitamins, cough and cold preparations to relieve the existing illness they are experiencing. Also, other patients do not complete their antimicrobial treatment leading to much cases of drug resistance. Drugs like antibiotics, anti-diarrheas, and painkillers exceed the incidence of the disease they are supposed to treat. Prescribing and dispensing patterns are influenced by socio-cultural factors such as patients demand, the attitude of the prescribers, and previous prescribing experiences and drug promotions.

Extravagant use of drug products. Physicians have the tendency to prescribe expensive drug products and treatments of choice for common illness are not usually prescribed. This may be influenced by the extensive marketing done on the part of the pharmaceutical companies wherein physicians as well as the Filipino people are blinded by the colorful advertisements and famous celebrities as endorsers of the drugs.

Inappropriate promotion of medicinal drugs remains a problem in our country. Problems relate to scientific accuracy and balance of information, improper inducements to prescribers or dispensers, lack of full product information, misleading presentations by medical representatives, and promotional activities disguised as educational or scientific exercises.Non-compliance of the patients also affix to the issues related to drug use. Correct prescribing does not guarantee that drugs are used properly. Non adherence to doctors prescription is very common. Inadequate drug information, insufficient labeling, lack of money, and cultural perception on drugs are just some of the many reasons of patients who do not conform to what their physicians advise them.

Self medication is very rampant in the Philippine setting and this is compounded with the inclination of dispensing drugs over the counter. Other health professionals may recommend drug even if they are not authorized to do so. Suggestions of friends and relatives also contribute notably to self medication. This can lead to inappropriate use and to delays in the correct diagnosis and treatment. Unrestricted availability can also contribute to the emergence of drug resistance, drug interactions and adverse effects, and inefficient use of scarce household resources.ADVANTAGES OF USING INN/GENERIC NAME

1. Rationalizes drug use

Avoids drug duplication thereby preventing over dosage or toxicity

Minimizes drug-drug interaction

Minimizes medical error

2. Internationally understood and accepted ensures continued administration of drugs in long term therapy

3. Valuable teaching tool for doctors, dentists, vets, pharmacists and nurses at various stages of training and practice

4. Reduces the total cost of drug treatment