Therapeutics Committee Manual

Summary of a Review of a DOH-Designed Therapeutics Committee Manual

United States Agency for International Development

Health Sector Reform Technical Assistance Project (HSRTAP)

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1

MANAGEMENT SCIENCES FOR HEALTH HEALTH SECTOR REFORM AGENDA TECHNICAL ASSISTANCE PROJECT

DRUG MANAGEMENT SYSTEMS

SUMMARY OF A REVIEW OF A DOH-DESIGNED THERAPEUTICS COMMITTEE MANUAL I Background and Rationale

The Policy, Planning, and Advocacy Division (PPAD) of the DOH has written a Therapeutics Committee (TC) Manual as a reference for functioning TCs in the Philippines. The reference is meant to guide the TCs in organizing themselves and in the performance of their functions. It discusses important tools that TCs can use to analyze and to improve drug selection and use. Finally, it discusses important issues that TCs are frequently faced with: drug donations, ethical drug promotions, etc. Before this manual can be distributed and used by the TCs, it is important to review and to test it, not only to identify the errors and to judge its usefulness, but also to rectify the errors and to increase its usefulness.

II Objective

To determine the usefulness of the TC Manual and to increase its utility. III Methodology

Originally, the TC Manual was to be tested by a TC as it was organizing itself after undergoing a TC Training. However, the TC Training was postponed because the participants were not available for the training. Thus, an alternative testing methodology was used. Comments on the manual were solicited from three types of sources: a group of local experts, 2 Chairpersons of hospital TCs, and a MSH consultant. A combination of structured and unstructured methods was utilized. The hospital TC chairpersons were asked to rate several parameters on a Likert scale: completeness of coverage of topics, relevance to function of TC, ease of understanding, format, and length. General comments were also solicited from them. On the other hand, local experts and the MSH consultant were asked to edit, comment, and recommend changes to the Manual.

IV Results

In general, the TC Chairpersons gave high scores to the Manual on all parameters.

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The comments and recommendations of the local experts and the MSH consultant resulted in the following changes to the Manual: 1) division of the Manual into two parts—The main body focuses on the functions,

composition, budget, and reporting system of the TCs. The annex contains the tools for analyzing drug expenditures and special topics for TCs: drug donations, good prescribing guidelines, pharmacovigilance, pharmacoeconomics, ethical promotions, and activities to promote rational drug use.

2) suggestions for additional topics, e.g., pharmacoeconomics 3) addition of report forms to the annex 4) addition of examples to demonstrate concepts 5) correction of conceptual, factual, and grammatical errors 6) formatting changes

V Conclusion

This review of the DOH TC Manual has resulted in improvements in its content and format, therefore, increasing its usefulness as a reference for TCs.

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Therapeutics Committee Manual 2

TABLE OF CONTENTS I. PREFACE ...........................................................................................................................................3 II. Introduction and Background........................................................................................................4 III. The Therapeutics Committee.........................................................................................................5

A. Significance of a Therapeutics Committee ...............................................................................5 B. Functions of the Therapeutics Committee ...............................................................................6

1. Organizational Structure within a Health Facility ...............................................................6 2. Organizational Structure Within a Health Agency...............................................................7 3. Model Terms of Reference for Therapeutics Committees....................................................8 4. Activities....................................................................................................................................9

C. Organization of the Therapeutics Committee........................................................................11 1. Membership............................................................................................................................11 2. Frequency of Meetings...........................................................................................................11 3. TC Functions ..........................................................................................................................12

a) Developing an Essential Drugs List.......................................................................................12 b) Adding and Deleting Drugs to the List ..................................................................................12 c) Conducting Drug Utilization Review (DUR) or Medication Utilization Evaluation (MUE) 13 d) Conducting Activities to Promote Rational Drug Use...........................................................14 e) Enforcing Generic Dispensing Policy....................................................................................15 f) Adverse Drug Reaction Monitoring ......................................................................................16 g) Reporting Medication Errors .................................................................................................18 h) Analyzing Drug Costs............................................................................................................19 i) Regulating Drug Representatives ..........................................................................................20

D. Budgeting for Therapeutics Committee Activities ................................................................20 E. Reporting for Therapeutics Committee Activities.................................................................21 F. Sources of Support for TCs .....................................................................................................21

IV. Special Topics ................................................................................................................................22 A. Standard Treatment Guidelines..............................................................................................22 B. Good Prescribing Practices .....................................................................................................23 C. Pharmacovigilance ...................................................................................................................27

1. Reporting Scheme ..................................................................................................................27 2. Definition of drug-reaction relationship codes ....................................................................28 3. Reporting Forms ....................................................................................................................30 4. Causality Assessment.............................................................................................................31

D. Pharmacoeconomics .................................................................................................................32 1. The Cost of a Drug .................................................................................................................32 2. Cost-Evaluation Methods ......................................................................................................33

a) Cost of Illness (COI)..............................................................................................................33 b) Cost Minimization (Cost-identification)................................................................................33 c) Cost-Effectiveness .................................................................................................................34

E. Tools for Analyzing Costs ........................................................................................................34 1. ABC Analysis..........................................................................................................................34 2. Therapeutic Category Analysis.............................................................................................36 3. VEL Analysis ..........................................................................................................................38

F. Ethical Promotions ...................................................................................................................39 G. Guidelines for Drug Donations................................................................................................40

1. WHO Guidelines ....................................................................................................................40 2. Drug Donations in the Philippine Setting ............................................................................42

H. Code of Ethics for a Therapeutics Committee Member........................................................44 V. LIST OF REFERENCES .............................................................................................................46


I. PREFACE

You are what I would consider a privileged reader of this document for this man-ual attempts to assist in the implementation of the Philippine National Drug Pol-icy. What are the problems with medicines that we face now? • Prices of medicines are high • They are inappropriately used and purchased • There is very little sound and scientific countervailing information to validate

or contest the aggressive industry promotions and marketing activities, some of which deviate from common-sense business ethics.

The Therapeutics Committee is a critical element in the smooth functioning of any hospital. You are the think-tank and advocator who rationalizes the procure-ment and use of drugs; you are the guardians of ethics in both business and clini-cal practice. We hope each member of the Therapeutics Committee considers the value of us-ing health economics in making these decisions. We are putting our confidence and trust in you, the implementers of a functional Hospital Therapeutics Commit-tee, and relying on you to help introduce creative and sound committee decisions based on scientific evidence and tempered with the art of clinical practice in the service of our people.

KENNETH Y. HARTIGAN-GO, MD, MD (UK), FPCP, FPSECP Deputy Director for Pharmaceuticals Bureau of Food and Drugs


II. Introduction and Background

In every hospital, medicines are critical to the delivery of service. However, the availability of medicines in the hospital depends not only on good supplies but also on efficient use through rational prescribing and dispensing practices. Several approaches have been tried to improve the management and use of drugs in vari-ous health settings. In a hospital setting, Therapeutics Committees (TCs) are thought to be effective in ensuring that medicines are used in a safe, appropriate, and cost-effective manner. When the Generics Act was passed in 1988, the establishment of therapeutics com-mittees in all field offices, hospitals, and medical centers nationwide was a strategy to implement the law and the national drug policy. These committees play a vital role in rational drug use, an important pillar of the national drug policy. Its main responsi-bility is to develop and maintain in their respective organizational set-up an essential drugs list, which serves as the basis for the procurement program.

Excerpts from the National Drug Policy The National Drug Policy is a policy and program of the national government to ensure that safe and ef-fective drugs are made available to all Filipinos at any time and place and at a reasonable and affordable cost. The DOH recognizes the fact that drugs and medicines are a vital component of health care. Given the low level of income of the vast majority of the Philippine population, the cost of pharmaceuticals is a major, if not dominant factor, in the overall cost of health care. Furthermore, the constitution recog-nizes the citizen’s right to health and mandates the government to address the issue of assuring the avail-ability of necessary drugs and medicines. The Therapeutics Committee (TC), is an advisory group that serves as an organizational line of commu-nication between the medical staff, the pharmacy staff, and other technical personnel. Therapeutics com-mittees shall be organized in all government health facilities as stipulated in AO 51 s 1988 (Implement-ing guidelines for DOH compliance to the Generics Act). The therapeutics committees shall perform advisory and educational functions and shall be composed of the heads of the major clinical departments, the chief pharmacist, the chief nurse, and the administrative officer.


III. The Therapeutics Committee

A. Significance of a Therapeutics Committee

Based on the World Health Organization (WHO) report, 90% of all ailments can be cured by about 250 essential drugs. In 1987, there were 12,000 different drug products, some of dubious quality, in the Philippine pharmaceutical market; in spite of this, the Philippines was still classified as a country where less than 30% of the population had regular access to essential drugs. Moreover, most Filipinos lack access to the medicines they need, while consuming unnecessary and ineffec-tive preparations. Faced with ever-increasing costs and a capped budget, hospitals must find ways to continue to offer effective but affordable care. These spiraling costs have been at-tributed to unregulated prices, unethical promotions, poor procurement proce-dures, and inefficient distribution mechanisms. Moreover, drugs are often pre-scribed, dispensed, and used inefficiently. When choosing between drugs, clini-cians often consider only efficacy and are not aware of the most cost-effective treatment regimen. On their part, dispensers often sell without the required pre-scription. All these contribute to irrational drug use. Apart from cost, the inefficient use of medicines also affects the safety and quality of therapeutic care. This is reflected in the WHO definition of the quality use of medicines:

When drug use is not in accordance with this definition, it is often associated with undesirable health and/or economic outcomes. An adverse drug reaction is one such undesirable and often preventable outcome. Inappropriate use of antibiotics also leads to the increased frequency and spread of resistant microorganisms. The inability to treat common infections with the antibiotic of choice can be costly or even disastrous. With scarce resources and an increasing demand for quality care, how can hospi-tals ensure that available resources are used efficiently for effective and afford-

When a drug is required, the appropriate drug must be chosen; it must be available at the right time at a price people can afford, it must be dispensed correctly, and it must be taken in the right dose at the right intervals and for the right length of time.


able treatments? The hospitals must develop and implement strategies for selec-tion and quality use of medicines. This cannot happen without doctors, pharma-cists, nurses, and financial managers coming into partnership to negotiate the best balance between cost and quality.

B. Functions of the Therapeutics Committee

The therapeutics committee should have its own terms of reference which spell out the committee’s place in the organizational structure of the agency, its goals, objectives, scope of authority, and responsibilities.

1. Organizational Structure within a Health Facility

CHAIRMAN Secretary

REGULAR

Dept. Heads/ Program

Coordinators Pharmacist

or Food and Drug

Regulation Officers

(FDROs) Surgery

Ob-Gyne

Medicine

Pediatrics

Pharmacologist

Administration (Administrative

Officer)

NDP Compliance

Officer

Chief Nurse or

Regional Nurse

PHIC

Consumer

EX-OFFICIO


2. Organizational Structure Within a Health Agency

REGIONAL DIRECTOR Or Chief of Hospital

Infection Control

Committee Medical Service/ Pro-curement, Bids and Awards Committee

(PBAC)

Pharmacy/FDROs

Therapeutics Committee

DUE Com-mittee

ADE/ADR Monitoring

Unit

CENTER FOR HEALTH DEVELOPMENT

Office of the Undersecretary/ Assistant Secretary


NDP Therapeutics Committee Chairman: Kenneth Hartigan-Go, MD Vice-Chairman: Cynthia C. Diza, MD Members: • Amor Cita Pallera,RPh - Secretary • Corazon Rivera, MD • Catalina Sanchez, RPh • Cleotilde How, MD

3. Model Terms of Reference for Therapeutics Committees

NAME: NDP Therapeutics Committee STATUS: Functional The TC is a standing committee responsible, through its chairman, to the agency executive.

• Chairman. The members of the

committee shall choose and elect a chairman who is respected by his peers and has wide experience in clinical pharmacology.

• Secretary. The committee secretary is usually the pharmacist. In hospitals without a pharmacist, the hospital executive can appoint any member of the committee to be the secretary.

• Members. The agency executive appoints the other committee members on a representational basis to take advantage of the available human resources in the agency.

GOALS: • Improved health and economic outcomes of

hospital care particularly those related to drug use.

• Rational and cost-effective drug use through collaborative drug management involving both health and non-health workers.

OBJECTIVES: The committee shall be responsible for defining its own specific objectives on an annual basis or as the need arises. Each committee can do this by reviewing the following objectives and choosing what they want to work on. It will be helpful for the committee to draw up an annual strategic plan of action. • To formulate and implement broad professional

policies regarding the selection, evaluation, procurement, distribution, safe practices, and other matters pertaining to drug use in the hos-pital.

• To develop and manage a hospital essential drugs list.

NDP Therapeutics Committee

• Vision: To ensure the

availability of safe, effec-tive, affordable, good quality drugs in the DOH.

• Mission: • Goal:

NDP Therapeutics Committee

Strategic Plan for the Year 2000

Activities:

1. RDU seminar 2. Etc.


• To develop and implement standard treatment guidelines. • To carry out drug usage review and evaluation in the hospital and to recom-

mend corrective measures, if necessary, to promote safe, effective, and appro-priate drug use.

• To provide prescribers with objective drug information. • To carry out educational and other activities aimed at improving prescribing

and dispensing practices in the hospital. • To establish programs and procedures that help ensure cost-effective drug-

therapy. • To monitor and to report adverse drug reactions. • To regulate operations of the medical product representatives in the hospital.

4. Activities To meet these objectives, the committee must plan and carry out certain activities that may include: • Drawing up and circulating criteria for selecting drugs for the hospital essen-

tial drugs list. Clinical efficacy and cost of therapy are two key criteria, but others may be considered.

• Appointing individual members within or outside the committee to develop standard treatment guidelines.

• Developing protocols and defining level of use for particular items such as blood, antibiotics, and high-cost drugs.

• Presenting drug consumption and cost information by ward or by consultant monthly or quarterly.

• Designing interventions (educational, managerial, or regulatory) to correct specific drug use problem.

• Evaluating the impact of interventions.


CYCLE IN DTC Activities and Functions

Standards

Criteria/guidelines for appropriate performance ! Standard treatment guidelines ! EDL ! Ethical criteria for pharmaceutical

promotion ! Policy recommendations on procurement

Assessment

Quantities assessment of performance ! Drug utilization studies of adherence to

STG ! Availability of essential drugs: %EDL use ! Indicators for monitoring RDU ! AMR surveillance ! ADR monitoring ! Pharmaceutical promotion monitoring ! Estimated drug requirements & consump-

tion ! Cost-benefit analysis

Diagnosis

Qualitative assessment ! Logistics and resources ! Patient/consumer factor ! Health providers ! Pharmaceutical industry influence ! Access of information

Intervention/Strategy

! Targeted intervention to improve practice

! Education of prescriber, dis-penser and other health workers

! Course and training ! Create drug information unit


C. Organization of the Therapeutics Committee

1. Membership Committee membership shall facilitate the building of partnership between all stakeholders including consumers. Typically, membership comprises administra-tors, doctors, pharmacists, nurses, and consumers. Studies have shown that the choice of a chairman is critical to the committee’s credibility and effectiveness. The chairman must be someone who is perceived as competent in therapeutics. The committee secretary ensures implementation, follow-up, and feedback on the committee’s decisions, preparation of meeting agenda and background materials for consideration by the committee. The secretary must be given sufficient time to do this work in-between meetings. The hospital (chief) pharmacist who is a regu-lar member is a natural choice for this position as he or she has great interest in and is appropriately skilled to deal with drug-related issues. Other committee members may include: • Representatives of each clinical division in the hospital • A clinical pharmacologist • An administrator • A microbiologist or laboratory technologist • A nurse • Medical records officer • A consumer (e.g., from the National Consumers’ Affair Council, NCAC). Consumer representation is a relatively recent development not yet widely prac-ticed. The consumer or consumer advocate is looked upon to bring a societal view to the committee.

2. Frequency of Meetings The committee should meet regularly, at least monthly, with each meeting not ex-ceeding one hour and a half.

In Boston, USA, the timing (morning and lunchtime) and provision of food during meetings was found to be a strong incentive for regular attendance.


The secretary should ensure that: • Items of agenda, any background material, and minutes of the previous meet-

ing are circulated in sufficient time for members to prepare for the meeting. • All proceedings of the meeting are recorded accurately, showing the matters

discussed, the decisions taken, the persons responsible for acting on the deci-sions, and the time frame for implementing the decisions.

• Decisions of the committee are followed up in-between meetings.

3. TC Functions

Since it is neither possible nor desirable for the TC to do everything, it must pri-oritize the activities in which to invest time and human resources.

a) Developing an Essential Drugs List Selecting essential drugs for the hospital shall be the first major activity for the committee. This can be divided into two manageable parts such as in-patient and outpatient lists. The in-patient can be further divided into separate stocks for the surgical, medical, pediatric, emergency, and maternity wards.

b) Adding and Deleting Drugs to the List The committee shall develop guidelines for the management and periodic review of the list to ensure availability of a range of medicines sufficient to cover condi-tions treated at the hospital while at the same time avoiding duplication. These should include procedures for adding a new drug to the list or simply obtaining a non-listed drug either to initiate or continue therapy in the hospital. To add drugs to the list, all applications must be accomplished on the official application form and endorsed by the respective department head. It would be advisable for the committee to have two sets of criteria. One set of criteria would be for consideration of new treatments for conditions that are not amenable to existing drug therapy or treatments, representing major improve-ments in survival and quality of life and another set for treatments representing minor improvements in therapy compared to existing listed drugs. For new treat-ments or major improvements, the committee shall consider the following factors: • The efficacy and safety of the drug. Whether the hospital has the necessary

clinical expertise to use the drug and what role specialists should play to regulate therapy.

• An estimation of the cost (and potential savings) to the hospital should the drug be introduced. These should include costs of the drug itself, hospitaliza-tion, and investigation.

• The availability of the drug on the market.


As for drugs representing minor improvements in therapy, the committee shall consider at least the following: • Whether the drug is superior to existing ones in terms of efficacy, safety, or

convenience of dosing/administration. • How it will affect the budget compared to already listed drugs. Apart from additions to the list, the committee will also need to consider requests for non-listed drugs to cover special circumstances such as non-response or con-traindications to available drugs. Doctors may also request a non-listed drug to continue therapy for a patient who had been stabilized on a non-listed drug before admission to the hospital where changing to another drug is considered detrimen-tal. The pharmacy must keep a register of all non-listed drug requests for which the drug was requested. When compiled at the end of the year, this information helps the committee decide whether or not to add the drug onto the list.

c) Conducting Drug Utilization Review (DUR) or Medication Utilization Evaluation (MUE)

This is an important function of the TC to oversee. The purpose is to identify a problem that may be either a drug or a condition, set criteria (standards) for how the drug should be used, or the condi-tion should be treated. DUR or MUE is also a performance im-provement method that focuses on evaluating and improving medi-cation-use processes with the goal of optimal patient outcomes. This may be applied to a medication or therapeutic class, disease state or condition, a medication-use process (prescribing, prepar-ing, dispensing, administering, and monitoring), or specific out-comes. Further, it may be applied in and among the various prac-tices settings of organized health systems. Case notes are reviewed to see who are following the standards and results are fed back to the prescribers. In an organized health system, DUR/MUE must be conducted as an organization-ally authorized program or process that is proactive, criteria- based, designed and managed by an interdisciplinary team, and systematically carried out. It is con-ducted as a collaborative effort of prescribers, pharmacists, nurses, administrators, and other health care professionals on behalf of their patients. Certain events (indicators) serve as “flags” of potential opportunities to improve medication use. Some are: • Adverse medication events, including medication errors, preventable adverse

reactions, and toxicity. • Signs of treatment failures, such as unexpected re-admissions and bacterial re-

sistance to anti-infective therapy.


• Pharmacists’ interventions to improve medication therapy, categorized by medication and type of interventions.

• Non-formulary medications used or requests. • Patient dissatisfaction or deterioration in quality of life. Assessing drug utilization is an important function of the DTC and this system should be set up in the health facility. The following are the steps in instituting DUR/MUEs: • Step 1. Establish responsibility for the DUR/MUE process. This is usually the

therapeutics committee but may be allocated to a sub-committee. • Step 2. Establish the Scope for each Study. A DUR/MUE study may focus on

a drug or a condition. Selecting which condition or drug to study may be diffi-cult but making a matrix may be of help in making a choice.

• Step 3. Establish Criteria or Indicators for how the drugs should be used or how the condition should be treated. The criteria would usually define which patients should and should not receive the drug. Other criteria might depend on laboratory findings. Whatever the criteria selected, it must be easy to measure and it must be agreed upon.

• Step 4. Collect and organize data. Data collection forms can be developed which are simple tally sheets, observational checklist, or simple question-naires. Only a few items of data should be collected for each DUR/MUE study. Sources of data are mostly patient’s case notes but they may be obser-vational checklists, dispensing records, laboratory reports or dispensing regis-ters. Collect only data directly related to the problem being studied.

• Step 5. Analyze the data. • Step 6. Develop conclusions. • Step 7. Make recommendations. • Step 8. Take action. • Step 9. Follow up. DUR/MUEs should be an ongoing process where drug-related problems are ad-dressed on a regular basis. It is important to consider this a long-term program, one that is continuously updated and revised to reflect current situations and needs within the healthcare institution. A detailed description of DUR/MUE is included in Managing Drug Supply 2nd edition pp. 472-475.

d) Conducting Activities to Promote Rational Drug Use

An important function of therapeutics committee is to initiate and conduct train-ing programs for the medical and paramedical staff of the health facility. All healthcare professionals need constant updating of their skills and knowledge. It is impossible for the physicians or pharmacist to keep abreast with constant


changes in the pharmaceutical field without intensive efforts by the individual and the health facility to provide continuing education. The strategies to improve drug use fall into three main categories: • Educational • Managerial • Regulatory Each main category can be done in several ways. Among these are: • Educational: To inform or persuade

• Prescriber and dispenser training • Printed educational materials • Face–to-face education and persuasion • Media-oriented approaches

• Managerial: To structure or guide decisions

• Essential drug lists or formularies • Structured order forms • Standard treatment guidelines • Utilization audits plus ‘feedback’ to prescribers

• Regulatory: To restrict decisions

• Requirements for generic prescribing • Allowing generic substitution or dispensing of branded products • Limits on number or quantity of drugs per patient • Prescribing restrictions for specific drugs to higher levels of care

It is important that the committee should define clearly the target groups for these activities and what key messages should be transferred. Target groups would in-clude the prescribers, nurses, pharmacists, patients, opinion leaders, etc. It is equally necessary to evaluate the impact of these interventions regularly to be able to revise, improve or fill in gaps in its implementation.

e) Enforcing Generic Dispensing Policy

Generic Dispensing can be defined as dispensing the patient/buyer’s choice from among generic equivalents, i.e., finished pharmaceutical products having the same active ingredients(s), same dosage, and same strength as the prescribed drug. Considering the range of generic products available on the market and the signifi-cant difference in the price of brands compared to generics, generic substitution is clearly an efficient use of resources and can result in significant saving in the drug budget.


In the formulation of any policy, it is advisable to seek the active involvement of all those to be affected by the policy. Some of the criticism against generic pre-scribing and substitution arises from doubts about the bioequivalence of generics. It is important to acknowledge clinically important bioavailability problems with generic products where these exist.

f) Adverse Drug Reaction Monitoring

One important criterion in the selection of drugs for the formulary is that of safety. This requires close attention to established information on the drug as well as current post-marketing surveillance of the drug’s safety record. Drugs are known to be two-edged swords. They can either heal (therapeutic effects) or harm (side effects) the patient. Therapeutics committee has to set-up a monitoring system of adverse drug reac-tion (ADR) unit within the health facility. The monitoring of these unwanted side effects fall under Pharmacovigilance. Adverse drug reaction monitoring and re-porting should be encouraged in the health facility. This would ensure the achievement of the following objectives: • The rational and safe use of drugs. • Education and information of patients and health staff. • Reduction in the potential cost of treating drug reactions that can be very high,

both in monetary terms and in lowered patient quality of care. Adverse drug reaction has been defined as “any response to a drug which is nox-ious and unintended and which occurs at doses used in man for prophylaxis, diag-nosis or therapy. These may result from effects of the drugs, of the illness, or their interactions with each other. Causality between the clinical event and the drug may not always be present, although with a reaction (ADR), causality is more definite.

For example, the committee may stipulate that the pharmacy may supply the generic equivalent of any drug ordered, unless the pre-scriber has specifically endorsed on the prescription that there shall be no substitution for the specified brand product because the drug has bioequivalence problems. When a generic equivalent is dis-pensed, the patient must be informed.


An adverse drug event/experience, on the other hand, is a reaction that occurs in a patient receiving a drug, or within a certain period of time after stopping the use of the drug, whether it is an actual adverse reaction or not. Adverse drug reactions fall into six (6) classifications: • Type A or Augmented. Type A reactions are the results of an exaggerated, but

otherwise normal, pharmacological action of a drug given in the usual thera-peutic doses. These are generally dose-dependent. Examples: atropine—dry mouth, nitroglycerin—headache

• Type B or Bizarre. Usually unrelated to the known therapeutic properties of a drug. They are neither dose-dependent nor predictable. Even very small doses of the drug may elicit the reaction once allergy or idiosyncrasy is established. Allergy, idiosyncrasy and drug dependence would fall under this classifica-tion. Examples: phenacetin—methemoglobinemia, sulfonamides—hemolytic anemia

• Type C or Continuous. Long-term effects are usually related to the dose and duration of treatment. Example: ethambutol—optic neuropathy

• Type D or Delayed. Examples of this type would be Carcinogenesis (hormo-nal, gene toxicity, suppression of immune response) and Adverse effects asso-ciated with reproduction (teratogens).

• Type E or Ending of Use (Withdrawal syndromes). Examples: barbiturates—restlessness and mental confusion, opioids—narcotic withdrawal

• Type F or Failure of Efficacy. Attributed to a lack of efficacy of drug prod-ucts. Examples: failure to control infection, apparent anti-microbial resistance, uncontrolled hypertension

Counterfeit medicines are also responsible for some ADRs and can thus com-promise a patient’s welfare. In addition to failure of efficacy, counterfeit medi-cines can be associated with all the above-mentioned types of ADR (A, B, C, D, E) due to the presence of (or adulteration with) various active or toxic ingredients. Setting up an ADR unit in the health facility can be initiated by the Therapeutic Committee. A program coordinator is chosen who is willing to provide training for the health staff and to communicate regularly with the ADRMP (based in BFAD) by sending in completed ADR forms for collation and analysis. What to report: • Death • Danger to life • Admission to hospital • Prolongation of hospitalization • Absence from productive activity • Increased investigational or treatment costs • Birth Defects


Who makes the report: The Therapeutics Committee should encourage all health workers to bring to its attention any cases of suspected therapeutic failure, any adverse effect of chang-ing between brand and generic products, adverse effects of herbal and traditional medicines and adverse reactions to vaccines. Suspicion is enough to report ad-verse effect of reaction. Basic Information Needed: • Patient Details • Age • Sex • Weight • Ethnic Group • Pertinent medical history Reaction Details: • What happened? • When? • What was done? • What was the outcome? Drug Details: • Suspected agent (brand names) • What other drugs are involved • Batch and Lot number of the medication Reporter: • Who? The monitoring and reporting of adverse drug reactions (ADRs) is important. This is because “reporting of a seemingly insignificant or common adverse reaction or side effect may help pinpoint a more widespread prescribing problem”. Apart from being a health hazard, ADR may contribute to increased health care costs if serious enough to require treatment. It is important to encourage ADR monitoring and reporting especially of new medicines whose safety has only been evaluated in pre-marketing clinical trials. ADR monitoring and reporting is an important as-pect of post-marketing surveillance which contributes to better understanding of the drug’s safety and effectiveness in the real world of practice as opposed to pre-market clinical trials which are conducted in a highly-selected small population.

g) Reporting Medication Errors

Medication errors are defined as “failure in the treatment process that leads to, or has the potential to lead to, harm to the patients.” It can also mean a “dose administered to the patient that deviates from the


physician’s orders, such as an omission, wrong dosage, or unauthorized drug.” Errors can occur in the prescribing, dispensing, and administration of medi-cines to patient. One of the committee’s functions is to monitor and report on the occurrence of medication errors in order to avoid possible adverse consequences or their recurrence. The following is a list of some of the possible errors that should be monitored in the hospital. • Drug given to the wrong patient: • Wrong drug or IV fluid administered • Wrong dose or strength given • Wrong route of administration • Wrong rate of administration • Wrong time or frequency of administration • Potentially interacting drugs prescribed or administered Having a pharmacist or nurse or another doctor review the prescription before the drugs are administered can prevent some of these errors. If an error occurs in the administration or application of medication, the proper official should be in-formed immediately. Medication errors should not be discussed with the patient. A detailed account of the error, whether of omission or commission should be prepared with a duplicate copy and forwarded to the proper official. All errors should be compiled and a report presented to the full TC monthly. It is important to do this in a non-confrontational manner without mentioning names of the doctor, nurse, or pharmacist responsible for the errors.

h) Analyzing Drug Costs

There are several analytical tools which can be utilized to quantify costs and to identify areas where costs can be reduced; the information garnered can be used to design and monitor interventions to control costs. These tools include: • VEN analysis • ABC analysis • Therapeutic category analysis • Price comparison analysis • Total variable cost analysis • Lead-time and payment-time analysis • Expiry date analysis • Hidden cost analysis For this manual, the tools discussed are limited only to the first three. The tools are discussed in more detail on “Managing Drug Supply” (MDS) 2nd Edition, Chapter 41, pages 633-642.


i) Regulating Drug Representatives Drug representatives interested in promoting a drug sold by the company frequently bring information into hospi-tals. The committee may choose from different options to regulate access of medical product representatives (med-reps) in the hospital. They may choose to ban them entirely, which can be counter-productive, as the reps then approach doctors outside the hospital. One option used in other countries is that of equal time presentation. In this approach, reps are required to submit their materials in advance. The pharmacist or clinical pharmacologist reviews the materials. A meeting is arranged in which the medical representative presents his information. By debating the merits of a new drug it is possible to gain a balanced perspective of the drug. Drug representatives shall not be given access to service areas. The area in the hospital where they can give samples to physicians shall be identified. Drug sampling shall be restricted, if possible, only to innovative products . “In order to avoid any bias in the selection of drugs and supplies, TC members are not allowed to hold any business relations with any pharmaceutical com-pany (manufacturer or distributor).”

D. Budgeting for Therapeutics Committee Activities

The activities of the Therapeutics Committee must be supported by a budget drawn up against a plan of action at the beginning of the year. Costs to be consid-ered are: staff time costs, meeting costs (food, secretarial and duplication), DUR/MUEs data collection costs, intervention costs, and reporting costs. • Staff time costs are to cover a small sitting allowance for members who are

not employed by the agency such as private practitioners and consumer repre-sentatives.

• Meeting costs must cover food served during meetings, secretarial services,

duplication of minutes and any other background reading materials. • Data collection for DUR/MUE is often very involving and may have to be

done by staff outside the normal working hours. It is best to fix a payment rate per record collected or reviewed rather than time taken.

If intervention is planned, a budget should be allocated for it to cover all activities having to do with the implementation and evaluation of the intervention. These may include fees for an outside speaker, production of printed materials, and data collection for evaluation.


Reporting costs should cover production and dissemination of all reports by the TC quarterly and annually.

E. Reporting for Therapeutics Committee Activities

The TC should report on its activities to the Agency executive, the district and provincial health executives, the Policy, Planning and Advocacy Division (PPAD) of BFAD every 20th day of January and December (AO No. 107 s 2000). To ac-complish this task, it may be better to submit quarterly reports and then compile these to make semi-annual reports. Publications of reports make information dis-semination to other TCs useful.

F. Sources of Support for TCs

The National Drug Policy Program of the Department of Health has overall responsibility in the implementation and evaluation of the Generics Act and the national drug policy. As such, the department together with the other government facilities shall assist other health facilities to organize therapeutic committees in their units. Support is available in the form of technical assistance, reference materials, and others.


IV. Special Topics

A. Standard Treatment Guidelines

Local manuals are needed in every health system because of differing decisions about drug choices and the patterns of illness within a country. Disease oriented manuals are called standard treatment guidelines (STGs), treatment protocols, or prescribing policies. The selection of drugs to be included on the essential drug list is based on preva-lent pattern of illness and the standard treatments decided upon to treat these con-ditions. Training, drug supply, assessment, and quality evaluation are based on these standard treatments. Standard treatments list the preferred drug and non-drug treatments for common health problems experienced by people in a specific health system. Information would include the name, dosage form, strength, average dose (pediatric and adult), number of doses per day, and duration of treatment. Advantages that can be achieved through the use of standard treatments include: • Describe appropriate care based on the best available scientific evidence and

broad consensus. • Reduce inappropriate variation on practice. • Provide a more rational basis for referral. • Provide a focus for continuing medical education. • Promote the efficient use of health care resources. • Act as a focus of quality control, including audit. • Highlight the shortcomings of existing literature and suggest appropriate fu-

ture research. The use of standard treatment guidelines is a strategy to promote rational drug use and is now a basis for the reimbursement of drugs with the Philippine Health Care Insurance (PHIC Memo Cir. No. 09-1999).


Figure 1. Standard Treatments in the Therapeutic Process

Rx = Focus of standard treatments (Taken from RDU module)

B. Good Prescribing Practices

At the start of clinical training, most medical students find that they do not have a very clear idea of how to prescribe a drug for their patients or what information they need to provide. This is because their earlier pharmacology training has con-centrated more on theory than on practice. In many medical schools, methods of teaching pharmacology and therapeutics have not changed, despite great progress in pharmacotherapeutic approaches to disease. Teaching often remains character-ized by transferring knowledge about drugs, rather than training students to treat patients in a rational way. Clinical training for undergraduate students often fo-cuses on diagnostic rather than therapeutic skills. Sometimes students are only expected to copy the prescribing behavior of their clinical teachers, or existing standard treatment guidelines, without explanations as to why certain treatments are chosen. Some students may think that they will improve their prescribing

Signs & Symptoms

Diagnosis (Health Problems)

Treatment

Adherence (Compliance)

Clinical Outcome

Rx

Drug Supply

Rx

Rx

Rx


skills after finishing medical school, but research shows that despite gains in gen-eral experience, prescribing skills do not improve much after graduation. Bad prescribing habits lead to ineffective and unsafe treatment, exacerbation or prolongation of illness, distress or harm to the patient, and higher costs. They also make the prescriber vulnerable to influences that can cause irrational prescribing, such as patient pressure, bad example of colleagues, and high-powered salesman-ship. Later on, new graduates will copy them, completing the circle. Changing ex-isting prescribing habits is very difficult. The Generics Acts of 1988 (RA 6675) orders that all prescriptions be written in generics and that drugs prescribed are those listed in the Philippine National Drug Formulary (PNDF). It is imperative therefore, that Filipino medical practitioners have a good grasp and understanding of RA 6675 and the implementing rules and guidelines issued by the Department of Health. These guidelines introduce the concept of a personal formulary (P-drugs) of es-sential drugs, based on rational selection criteria of efficacy, safety, convenience, and cost. P-drugs refer to those drugs that a prescriber has chosen to use regularly, with which he has become familiar, and are the prescriber’s priority choice for given indications.


What is the advantage of having one’s own P-drugs? • Through developing your P-drugs, you will learn how to handle pharmacol-

ogical concepts and data. It enables you to determine its pharmacological value and to evaluate conflicting information from various sources.

• Learn alternatives when your P-drug is not available or has adverse reactions or contraindications.

• The latest or the most expensive drug is not necessarily the best, the safest, or the most cost-effective.

The steps in choosing your P-drugs are: • Define the diagnosis. When selecting a p-drug, it is important to remember

that you are choosing a drug of first choice for a common condition. You are not choosing a drug for an individual patient.

• Specify the therapeutic objective. Know the pathophysiology of the disease to define what you want to achieve with a drug.

• Make an inventory of the effective groups of drugs for a specific disease. Look at groups of drugs that can be linked with the therapeutic objective. The important criterion for selection is efficacy. There are two ways to make iden-tification of drugs easier. One is to look at formularies (PNDF) or guidelines (treatment guidelines) in the health facility. Another would be to consult a good pharmacology reference book.

• Choose an effective group according to criteria. In selecting a drug, one would find it helpful to follow the SANE criteria (safety, affordability, need, and efficacy). This would be practicing (promoting) rational drug use.

• Choose a P-drug. • Choose an active substance and a dosage form. Reminder: Drugs sold un-

der generic name are usually cheaper than branded ones. • Choose a standard dosage schedule. Copy the different dosage schedules

found in desk references or pharmacology books into your own formulary. • Choose a standard duration of treatment. The total amount of a drug to be

prescribed depends on the dosage schedule and the duration of treatment. If the duration of treatment is not known, the monitoring interval becomes important. Three months should be about the maximum monitoring inter-val for drug treatment of a chronic disease.

Guidelines adapted from WHO Guidelines on Good Prescribing.


?

Generic

Branded

Rational Drug

? ? ?

? ?

Every doctor is now being asked to conduct a self-audit of prescribing habits.


C. Pharmacovigilance

1. Reporting Scheme

Reports of suspected adverse drug reactions are best made by using the prescribed reporting form and sent to the Adverse Drug Reaction Monitoring Unit in BFAD, Alabang, Muntinlupa, Telephone No. 807-8517.


ADR MONITORING PROGRAM

Dear Doctor, Thank you for your support!

KEEP YOUR REPORTS COMING!!

2. Definition of drug-reaction relationship codes

• Certain: a clinical event, including laboratory test abnormality, occurring in a plausible time relationship to drug administration, and which cannot be ex-plained be concurrent disease or other drugs or chemicals. The response to withdrawal of the drug (de-challenge) should be clinically plausible. The event must be definitive pharmacologically or phenomenologically, using a satisfactory re-challenge procedure if necessary.

• Probable/Likely: a clinical event, including laboratory test abnormality, with a

reasonable time sequence in administration of the drug, unlikely to be attrib-uted to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal (de-challenge). Re-challenge in-formation is not required to fulfill this definition.

• Possible: a clinical event, including laboratory test abnormality, with a rea-

sonable time sequence to administration of the drug, but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.

• Unlikely: a clinical event, including laboratory test abnormality, with a tempo-

ral relationship to drug administration which makes a causal relationship im-probable, and in which other drugs, chemicals, or underlying disease provide plausible explanations.


• Conditional/Unclassified: a clinical event, including laboratory test abnormal-

ity, reported as an adverse reaction, about which more data is essential for a proper assessment or the additional data are under examination.

• Unassessible/Unclassifiable: a report suggesting an adverse reaction which

cannot be judged because information is insufficient or contradictory, and which cannot be supplemented or verified.


3. Reporting Forms

Confidential Report on Adverse Drug Experience

Note: submission of this report does not constitute an admission that the drug caused the adverse reaction. Identities of the reporter, institution and patient will remain confidential. Please mark all appropriate items.

Patient’s initial

Age Sex Male Female

Wt. (Kg) Ethnic group Filipino

Chinese

Describe the reaction/s: Onset of reaction:

Time a.m. . p.m. .

Mo Day Year

Drugs used prior to ADE (brand names) Pls. check the suspect drug/s Pls. indicate manuf. If generic names are used. Pls. indicate batch and lot. number if applicable

Route Dose Dosing time

Date/time started Date/time stopped Indication/s

ti m d y ti m d y Treatment of reaction/s: Outcome Recovered Not yet recovered Unknown Died

Date: _____/______/ 200___ Date: _____/______/ 200___

Resulted in prolonged hospitalization? No Yes Sequelae? No Yes Please describe: Comments: Allergies Previous exposure/reaction to suspect drugs Pregnancy with LMP Relevant history Others Name of reporter

Signature Date reported: _____/______/ 200___

Address of reporter

Tel. No.

MD Nurse Pharmacist Patient Others


4. Causality Assessment

CONDITIONAL POSSIBLE

Report of an ADE

Is there a definitive clinical event/laboratory abnormality?

Is it plausible relationship?

Is it reasonable rela-tionship?

Yes No/Not sure

UNASSESSABLE

Is there a time relationship with drug administration?

Yes No

UNASSESSABLE

Not sure

UNLIKELY

Can the event be explained by concurrent dis-ease/chemicals/other drugs?

Yes No Not sure

Was there a challenge?

Yes No

CONDITIONAL

Yes No

POSSIBLE Plausible Response Reasonable Response

Was a re-challenge done?

Yes

CERTAIN

No

PROBABLY/LIKELY


D. Pharmacoeconomics

The careful evaluation of new drugs before inclusion in the formulary must in-volve efficacy, safety, quality, and cost. Cost is an important consideration in the evaluation of new drugs. The therapeutics committee must know how evaluate the cost of a drug; this includes not only its procurement cost, but also the cost impact on the entire healthcare system, especially on the patient. Pharmacoeconomics refer to the description and analysis of the costs of drug therapy to healthcare sys-tems and society. Pharmaceutical companies sponsor many pharmacoeconomic studies to prove the economic superiority of their drug over a competitor drug. This is especially true when comparing drugs of similar efficacy and safety. However, the quality of these studies is frequently poor and consequently it becomes imperative that the reader of any study takes this into consideration. Pharmacoeconomic data and evaluations can be obtained in three different ways: • Evaluate the published literature in conjunction with procurement cost to

make cost comparisons. • Use established pharmacoeconomic-modelling techniques on published data

and local data to apply to real life situations. • Perform a formal pharmacoeconomic evaluation at a hospital or clinic.

1. The Cost of a Drug Cost is defined as the total resources consumed in producing a good or service. The most basic cost of a pharmaceutical is reflected in the acquisition price from a supplier. However, it is also important to look beyond the acquisition cost of a drug and obtain all cost associated with using the drug. There are three types of cost associated with drug in a health facility: direct, indi-rect and intangible. These three cost when taken collectively will give the most comprehensive assessment of actual drug cost. • Direct Costs

• Acquisition cost of the drug or drug price • Supply management costs • Supply personnel salary • Storage facilities, including warehouse, freezer, refrigerator

• Professional Services Costs • Pharmacist salary- manage, prepare, dispense, etc. • Nursing salary - to administer • Physician- to manage and prescribe

• Supplies to administer drug • Equipment for administration - syringes, gauze, IV sets


• Other direct cost

• Treating adverse drug reactions • Inpatient & outpatient treatment of poor response to drug therapy • Emergency room use • Hospital costs • Laboratory services

• Indirect Cost

• Cost of illness to the patient • Lost time from work

• Intangible Cost

• Quality of life

2. Cost-Evaluation Methods

a) Cost of Illness (COI) This is defined as the cost involved in treating a particular disease without provid-ing a particular relationship to any type of medical therapy or drug treatment. This is descriptive analysis and does not provide information as to the appropriateness of therapy. This type of analysis will answer the following questions:

• What is the current cost of treating a particular disease? • What is the distribution of the department budget for the various services

that are provided? • What is the cost impact of a particular disease on any given department,

i.e., diabetes or acute respiratory diseases on the pharmacy department? This kind of information will be helpful for the TC in providing recommendations to add drugs to the formulary and for hospital administration to allocate resources to the appropriate departments.

b) Cost Minimization (Cost-identification) Cost minimization analysis is a method of calculating drug costs to project the least costly drug of therapeutic modality. This is most often used by pharmacy departments in evaluating the cost of a certain drug. This can only be used to compare two products that have been shown to be equivalent in dose and thera-peutic effect. Therefore, this method is most useful for comparing generic and therapeutic equivalents or "me too" drugs. If therapeutic equivalence cannot be demonstrated, then this type of cost comparison should not be used. The cost of preparation and administration is also reflected in this analysis.


c) Cost-Effectiveness This analysis is utilized when it is necessary to measure both costs and benefits of the drugs as measured in health care improvements and outcomes from the use of the drug. The effectiveness component of this evaluation is determined by one measurable outcome. Some examples of measurable outcomes or health care im-provements for specific conditions are as follows: • Hypertension - blood pressure measurement • Diabetes - Glycosylated hemoglobin, blood glucose units • Coronary Heart Disease - angina attacks • UTI- incidence of infections • Obesity - weight measurements • Seizure disorders - seizures • AIDS - CD4 counts • Heart Failure (and any other disease) - Years of life saved or quality-adjusted

life years (QALY) and Disability-adjusted life year (DALY) A cost-effective ratio is calculated based on the cost of the drug and the targeted medical endpoint. The numerator will be the cost in monetary units and the de-nominator will be the effectiveness expressed in the measurement of reportable units.

E. Tools for Analyzing Costs

1. ABC Analysis

An ABC analysis examines the annual consumption of drugs and expenditures for procurement. It can: • Reveal high usage items for which there are lower-cost alternatives on the list

or available on the market. • Identify purchases for items not on the hospital essential drugs list. In summary, the steps in performing an ABC analysis are: • List items consumed or purchased and enter the unit cost of each item. To ac-

count for changes in price over time, calculate the average unit cost. • Enter the number of units purchased or consumed. • Calculate the value of consumption by multiplying the unit cost by the number

of units consumed for each item. The total value of consumption is the sum of item values.

• Calculate the percentage of total value for each item by dividing the value of each item by the total value. Express the percentage to two decimal places.


• Rearrange the list by ranking the items by value of consumption or percentage value of consumption (either gives the same result) in descending order.

• Classify the items into ‘A’, those few items accounting for 75-80% of total value, ‘B’, those items which take up the next 15-20% and ‘C’, the bulk of items which only account for the remaining 5-10% of value. Usually, class A items constitute 10-20% of all items, with class B items constituting another 10-20% and the remaining 60-80% being category C. See illustration.


2. Therapeutic Category Analysis This method makes a review of the volume of use and the value of various thera-peutic categories and subcategories of drugs. Building on the ABC analysis, it sorts out the therapeutic categories (based on cumulative volume and value of the individual drugs in those categories) this technique can: • Help the committee choose the most cost-effective drugs within a therapeutic

class and to choose alternatives for therapeutic substitution. • Indicate potential appropriate use if used together with information on the

morbidity pattern. • Identify drugs that are overused or whose consumption is unaccounted for by

the number of cases of a particular disease for example, rifampicin and tuber-culosis.

The procedure is similar to ABC analysis: • Do the first three steps of ABC analysis to produce a list of all items by vol-

ume and value of consumption. • Assign a therapeutic category to each drug using the WHO Model List of Es-

sential Drugs. • Rearrange the list into therapeutic categories and sum the percentage value of

items in each category. Like in ABC analysis, a small number of high-cost therapeutic categories account for most of the expenditure.


Table 1. Example of Therapeutic Category Analysis (Source: MDS)

Formulary Category No. of Products

Category Total Cost (Php)

% Total Cost

Cumulative Percentage

1 Antibacterial/antifungal agents, systemic

30 46,053 19.17 19.17

2 Antidiabetic agents 5 36,175 15.06 34.23 3 Hypotensive agents 8 31,006 12.91 47.13 4 Replacement solution/agents 10 14,834 6.17 53.31 5 Topical anti-infectives 4 14,302 5.95 50.26 6 Caloric agents (dextrose solutions) 6 12,480 5.19 64.46 7 Analgesics/antipyretics 10 11,835 4.93 69.38 8 Diagnostic strips 1 6,496 2.70 72.09 9 Antiasthmatic drugs 8 6,195 2.58 74.66 10 Antihistamines 5 4,892 2.04 76.70 11 Disinfectants 3 4,846 2.02 78.72 12 Psychotherapeutic agents 14 4,574 1.90 80.62 13 Multiple vitamins 3 4,318 1.80 82.42 14 Iron Preparations 3 3,207 1.33 83.75 15 Miscellaneous gastrointestinal

drugs 4 3,039 1.26 85.02

16 Anthelmintics 2 2,663 1.11 86.13 17 Dispensing envelopes 1 2,643 1.10 87.23 18 Adrenal hormones 4 2,246 0.93 88.16 19 Antitussive/antiexpectorant 2 2,240 0.93 89.09 20 Antacids 2 1,781 0.74 89.84 21 General Anesthetics 3 1,693 0.70 90.54 22 Topical antifungals 4 1,633 0.68 91.22 23 Vitamin B preparations 5 1,547 0.64 91.86 24 Anticonvulsant agents 5 1,465 0.61 92.47 25 IV administration sets 1 1,300 0.54 93.02 26 Skeletal muscle relaxants 3 1,283 0.53 93.55 27 EENT anti-infectives 4 1,283 0.53 94.08 28 Diuretics 5 1,248 0.52 94.60 29 Antitubercular agents 5 1,212 0.50 95.11


3. VEL Analysis This method is ideal in setting priorities for selection, procurement, and use based on the potential health impact of each drug. Assign each drug in the formulary to one of the following categories: • V: vital drugs are potentially lifesaving, have significant withdrawal side ef-

fects (making regular supply mandatory), or are crucial to providing basic health services,

• E: essential drugs are effective against less severe but nevertheless significant

forms of illness but are not absolutely vital to providing basic health care, • L: less-essential drugs are used for minor or self-limited illnesses, are of ques-

tionable efficacy, or have a comparatively high cost for a marginal therapeutic advantage. Drugs identified to be non-essential shall be deleted from the for-mulary.

The classification of drugs should not be a one-time exercise. As the formulary or essential drugs list is updated, and as public health priorities change, the VEL or VEN categories should be reviewed and updated. Any new drugs added to the list should be categorized appropriately; and category assignments for older drugs should be reviewed and changed if needed.

Table 2. Guidelines for Drug Classification

Characteristics of Individual Drugs Vital Essential Less Essential (non-essential)

Occurrence of Target Conditions

-Persons affected (% of population) -Persons diagnosed (cases/100,000

population/year) -Persons treated (frequency of target

Condition seen by health worker)

>5%

200

Moderate

1-5%

50-100

Low

<1%

<50

Very Low Severity of Target Conditions

-Life threatening (likely to cause death

if untreated) -Chronic (likely to cause recurrence,

relapse, continued disease if untreated) -Disabling (likely to cause permanent

disability if untreated) -Restricting (likely to cause loss of working and housekeeping time)

Possibly

Possibly

Possibly

Frequently

Infrequently

Infrequently

Infrequently

Occasionally

Rarely

Rarely

Rarely

Rarely


Characteristics of Individual Drugs Vital Essential Less Essential (non-essential)

Therapeutic Effects

Drug Action

Prevention of disease; cure of disease; pre-vention of complica-

tion

Cure of disease; pre-vention or treatment

of complication

Relief and/or mitiga-tion of self limited disease; palliative

treatment of minor symptoms/

Complications Cost

- Average cost of single course of therapy (acute therapy)

-Average yearly cost of therapy (chronic therapy)

Low

Low

Moderate

Moderate

High

High

Source: Primary Medical Care Drugs Handbook (PNDP1997) F. Ethical Promotions It is an undeniable fact that both doctors and the pharmaceutical industry have a common goal in the treatment of disease. Medical representatives will always be a source of information with regards to the latest development in the field of phar-maceuticals. Doctors, on the other hand, must see to it that the information given is based on scientific evidence to ensure product safety and efficacy. Therapeutics committee members must operate in a manner that insures transparency and avoids conflicts of interest with drug manufacturers and distributors. A strict eth-ics policy must be provided and rigorously enforced to maintain objectivity and credibility. The doctor-industry relationship must be kept on a strictly profes-sional level to encourage the flow of unbiased information about the drug prod-ucts being promoted. Some doctors assume that they are immune from skilled advertising techniques. While physicians are trained to make rational decisions, they may be no more re-sistant than other community members to expertly designed promotions, which are created to appeal to emotions and to tap into personal values and biases. As much as possible promotional activities must be done to groups of doctors and not individually and any assistance in the form of donations (books, reference ma-terials, etc.) must be given to the clinical department concerned. The giving of samples should be limited to new drugs (innovative products) only. The pharmaceutical industry provides sponsorship both for organizing meetings and to physicians for attending them. While this sponsorship is provided with the expressed aim of contributing to continuing education, the manner in which it is provided may leave the reasons for its provision open to the perception that the physician is being unduly influenced by the industry. The ideal manner for the pharmaceutical industry to provide sponsorship is through an independently or-ganized scientific meeting for which the costs of bringing in invited speakers are


defrayed by the funds provided by industry; the cost of travel and attending such a meeting is met by physicians because of its value to their continuing education. Sponsorship may be offered to an individual who is already involved as a speaker or chairman independently of the organizing committee of the meeting. This is less appropriate and the sponsor should be encouraged to make the support avail-able through the organizing committee of the meeting. A policy must be set that will regulate the interaction between hospital staff and the industry. The Therapeutics Committee should promote the guiding principles that “All promotion-making claims concerning medicinal drugs should be reli-able, accurate, truthful, informative, balanced, up-to-date, capable of substantia-tion, and in good taste.”

G. Guidelines for Drug Donations

1. WHO Guidelines

In 1996, the World Health Organization (WHO) developed a set of guidelines re-garding Drug Donations that reflect a consensus between the major international agencies active in humanitarian relief. They are not an international regulation, but are intended to serve as a basis for national or institutional guidelines, to be reviewed, adapted and implemented by governments and organizations dealing with drug donations. There are several benefits that can be derived from the Guidelines and are as fol-lows: • Provides a framework for improved drug donation practices and procedures. • Serves as a support to a country’s national drug policy • Requests for donations are more carefully solicited and formulated in keeping

with the Guidelines. • Helps to ensure the quality of donations. Medicines will always be an essential element in alleviating suffering and interna-tional humanitarian efforts can greatly benefit from donations of appropriate drugs. However, certain problems that can arise from drug donation are: • Irrelevance to the existing emergency situation. • Not appropriate for the prevailing disease pattern and level of care that is

available in the community • The quality of the drug may not always comply with standards in the donor

country.


• The drugs may have a high-declared value. Import taxes and overheads for storage and distribution may be unnecessarily high and the inflated value of the donation may be deducted from the government drug budget.

• Drugs may be donated in wrong quantities, and some stock may have to be destroyed.

• Stockpiling of unused drugs can encourage pilfering and black market sales. Probably, the most important underlying factor for these problems is the common but mistaken belief that in an acute emergency any type of drug is better than none at all. Moreover, there is usually a general lack of communication between donor and the recipient. In summary, guidelines are needed because: • Possible inconveniences and unwanted consequences may arise at the receiv-

ing end. • Communication barriers may interfere with how recipients can specify how

they want to be helped. • Donated drugs must be selected and distributed based on the existing policies

and administrative systems in the recipient country. • Quality requirements of drugs are different from other donated items. In essence, drug donations must follow four (4) core principles: • Maximum benefit to the recipient based on an expressed need. • Respect for the wishes and authority of the recipient. • No double standards on quality. • Effective communication between donor and recipient. The following articles (a-l) of the Guidelines rests on the four core principles (A-D) stated above and are distributed into four (4) main categories: • Selection of Drugs • Quality and assurance • Presentation, packaging and labeling • Information and management Selection of Drugs • Must be based on an expressed need and is relevant to the disease pattern in

the recipient country. • Donated drug or their generic equivalence should be approved for use in the

recipient country. • The presentation, strength and formulation of donated drugs should, as much

as possible, be similar to those commonly used in the recipient country. Quality Assurance and Shelf Life


• All donated drugs; should be obtained from a reliable source and must comply with quality standards in both donor and recipient country.

• Drugs given to health professionals as free samples or issued to patients should never be included in the donation.

• Drugs should have a remaining shelf life of at least one (1) year. Presentation, packaging and labeling • All drugs must be labeled with their international non-proprietary names

(INN) or generic names. • They should be presented in large quantity packs, which are cheaper and less

bulky to transport. • Donations should be packed in conformity with international shipping regula-

tions and must be accompanied by a detailed packing list specifying the con-tents of each carton by INN, dosage form, quantity, batch no., expiry date, volume, weight (should not exceed 50 kg) ; and any special storage condi-tions.

Information and Management • Recipients should be informed of all drug donations that are being considered,

prepared or actually underway. Information must include among others, type and quantity of donated drugs, expected date of arrival, port of entry, and the identity and contact address of the donor.

• Declared value of the donated drugs should be based upon the wholesale price of its generic equivalent in the recipient country or on the wholesale world-market prices of its generic equivalent.

• Costs of shipping, warehousing, post clearance and storage and handling should be paid in advance by the donor agency, unless specifically agreed upon otherwise.

2. Drug Donations in the Philippine Setting

In the Philippines, these guidelines shall be observed with amended principles in compliance with Philippine laws and policies. The Bureau of Food and Drugs (BFAD) issued Memorandum Circular No. 004-88, which stipulated the proce-dures to be followed regarding donations of pharmaceutical products in the coun-try. Donated drugs are classified under accelerated registration wherein, only a test of the potency range of the active ingredients (as per label claim) is being conducted by the BFAD laboratory section. The following government and private institutions are recognized to deal with drug donations and are required to secure accreditation from the Department of Social Welfare and Development (DSWD).


• Foundations • Medical Missions • Religious Missions • Professional Groups • Non-Governmental Organizations (NGOs) • Political-based Organizations Documentary Requirements: • Accreditation letter from DSWD • Letter or Pledge of donation from group (s) • Letter of Acceptance from Recipient • SEC Papers (Optional) • Letter of Exemption from the Department of Finance • Letter from the Department of Health (DOH) Foreign Assistance & Coordina-

tion Services (FACS) for endorsement to BFAD. • List of Drug donations and quantity indicating on the label the following in-

formation printed on the label and shall be in English or with English transla-tion.

• Formulation • Generic Name/brand name, if any • Dosage forms/strength • Batch & lot number • Expiry date. Drugs should have a shelf-life of at least six (6) months after the

estimated arrival in the country of destination. • Storage condition. • Name and address of the manufacturer/distributor • Bill of Lading/ Airway bill • Plan of Action indicating where donated drugs are intended. ONLY DRUGS HAVING SIMILAR PREPARATIONS REGISTERED WITH BFAD SHALL BE ACCEPTED AS DONATIONS. THE FOLLOWING DRUGS ARE NOT ACCEPTABLE FOR DONATIONS: × Dangerous Drugs × Exempt-Preparation Drugs × Drugs under the Monitored-Release Registration (New drugs)


H. Code of Ethics for a Therapeutics Committee Member The principles of professional conduct for Therapeutics Committee mem-bers are established as guide in the discharge of their duties and functions and in their relationship with other members of the Committee, fellow practitioners, pharmacists, other health practitioners and the public.

Section 1

Members of the Therapeutics Committee shall perform their functions diligently and with integrity.

Section 2

Members of the Therapeutics Committee shall abstain from seeking any form of personal sponsorship or receive any compensation, whether in cash or in kind, from any drug company.

Section 3

Members of the Therapeutics Committee shall refrain from endorsing or promot-ing any pharmaceutical product that is not listed in the Philippine National Drug Formulary.

Section 4

Members of the Therapeutics Committee shall conduct himself in a manner that insures transparency and shall maintain a strictly professional relationship with the drug industry.

Section 5

Members shall sign a “Declaration of Interest” that will bind them to the working principles and ethics of this committee.


FLOWCHART:


V. LIST OF REFERENCES

1. Hospital Pharmacy Management Manual, 2nd ed. DOH. 2. Administrative Order No. 51, s. 1988. DOH 3. Establishing Therapeutics Committee, A Practical Manual in Zimbabwe. 4. Guidelines for Drug Donations. Revised 1999 (WHO) 5. Adverse Drug Reactions. A Guide to Participating Hospitals. May 1999. DOH 6. Guidelines for Hospital Drug and Therapeutic Committee. WHO Draft. 7. BFAD Circular 004-88. General Guidelines on Donation of Pharmaceutical 8. Managing Drug Supply. Second Edition. Management Sciences for Health. 9. A.O. 107 s. 2000. Amendment to A.O. 51 sec. 9.1, 9.3, 9.4, and 10.2 s. 1988. Re-

constitution and Strengthening of the Membership of the Therapeutics Committee at the Centers for Health Development, Special Hospitals, National Medical Cen-ters, Regional Medical Centers, Regional Hospitals and Sanitaria.

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Therapeutics Committee Manual

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