TERRY GREEN, ALIX BEITH,
JOHN CHALKER*

During the past half century there have been great advances in the treatment of many medical conditions, especially infectious diseases. Unfortunately, the use of inappropriate drugs to treat these has led to serious health care problems, resulting in increased morbidity, mortality, costs and, more recently, emerging antimicrobial resistance (AMR).

Irrational use of drugs in hospitals in developing countries is a major problem and little has been published on how to improve it. A suggested starting point is to develop hospital Drug and Therapeutics Committees (DTCs) to act as agents of change. This was one of the recommendations from the first International Conference on Improving Use of Medicines (ICIUM), held in Thailand in 1997 (see box p. 11 for details of ICIUM 2004). The recommendation was based on lessons from developed countries, where more has been published about the effectiveness of such Committees.

In many hospitals the selection process for antimicrobials does not follow an evidence-based methodology and antimicrobials are overused, producing an environment conducive to the development and spread of AMR. The WHO Global Strategy for Containment of Antimicrobial Resistance,¹published in September 2001, recommends setting up DTCs, as one way of helping in the efforts to contain the increase in AMR.

Among other problems that occur with inappropriate use of drugs is an increase in adverse drug reactions (ADRs), medication errors and the use of relatively unsafe drugs. It has been estimated that in the USA 10.8% of hospital inpatients suffer from an ADR, at an annual cost of between US$1.4 billion and US$4 billion, and ADRs are between the 4^th and 6^th most common cause of death.² A DTC can establish mechanisms that have the potential to reduce ADRs.

Many countries already have DTCs to deal with the problems of drug selection, procurement, distribution and use, and to address the continuing and emerging problems of AMR. The majority of DTCs are in developed countries, including Australia, the USA and European countries. In Australia, 92%³ and in the UK (in 1990), 86% of hospitals had developed some type of hospital therapeutic committee. In the USA, DTCs or similar committees are required in order to receive accreditation. In different settings they may also be known as a Pharmacy and Therapeutics Committee, a Pharmacotherapy Committee, a Formulary Committee or a Rational Drug Use Committee.

What do DTCs do?

DTCs are organizations within a hospital or primary care clinic that are responsible for evaluating the clinical use of drugs, developing policies for managing drug use and administration, and managing the formulary system. A forum to evaluate and discuss all aspects of drug therapy, they advise the medical, nursing, administrative and pharmacy departments on drug-related issues.

Who should be on a Committee?

A successful Committee needs to have the appropriate leadership and members, and to meet regularly. It must be dynamic, resourceful and use all members skills. It is crucial that all key stakeholders in the hospital are on the Committee, and that hospital managers give members the necessary time to contribute in a sustainable and effective way. Membership structure varies in different countries. Ideally a Committee has a strong chairperson, who is an opinion leader and who commands the respect of hospital and health leaders. Members often include: specialists from medicine, surgery, obstetrics and gynaecology, psychiatry and infectious diseases, pharmacists, a clinical pharmacologist, a drug information specialist, and nurses (either clinical or administrative nurse representatives), an infection control nurse, and the administrative officer or other high level hospital administration official.

For a Committee to be effective there must be a structured drug selection system that is explicit in its methodology, and that is transparent and evidence-based. The Committee must have the ability to design and implement interventions to improve the use of drugs. The hospital administration must give the Committee authorisation and support to carry out its functions, and have made explicit a clear line of authority to top administration officials. There is a need for regular meetings with published minutes and close follow up on all activities. When a functioning Committee has these key features, it can be expected that it will be effective and that the result will be improved patient outcomes.

A combination of interventions, instituted by the DTC, will have the most significant effect on drug use and AMR.⁴ These include the appropriate selection of formulary drugs, the development of formulary-based guidelines, monitoring and evaluating drug use, surveillance, detection and appropriate care of patients with resistant organisms, and promotion and monitoring of basic infection control practices.¹

Are DTCs effective?

In developed countries, studies have shown that DTCs can have a significant impact in promoting rational drug use, monitoring drug use and controlling drug costs.^3,5 In developing countries the evidence is less compelling, but there is sufficient evidence to show that the individual functions of a DTC provide effective interventions to improve drug use and control costs. Proven successful interventions include: establishing and implementing a formulary list or an essential medicines list⁶ and standard treatment guidelines;⁴ and using educational techniques, especially interactive problem-oriented methods in face-to-face settings, and repeat sessions with different prescribers.^4,7 Success has also been achieved through establishing and implementing audit and feedback (including drug use evaluation) of provider prescribing;⁸ and supervising and monitoring prescribing habits using indicators or simple protocols.⁴ A well-organized DTC will provide the structure to facilitate management of all of these well proven activities, and so it is reasonable to assume that it can be effective.

Promoting DTCs in developing countries

WHO/EDM in cooperation with Management Sciences for Health (MSH) is developing a manual on how to establish and maintain a DTC at hospital level, to help developing countries instigate basic DTC activities and so improve drug management in hospitals. The manual will be published in 2003.

At the same time MSH’s Rational Pharmaceutical Management Plus (RPM Plus) programme in cooperation with WHO, has developed an 8-10 day DTC training course. The course promotes the creation of DTCs, trains potential and actual Committee members and promotes the effective functioning of DTCs on formulary management and drug use. It is designed for physicians and pharmacists who are interested in improving the rational use of drugs through DTCs, or who will be able to provide training and technical assistance to other DTCs.

For effective formulary management, DTC members need to make their decisions on inclusions or exclusions using evidence-based drug management principles. Participants need information on the principles, concepts, approaches and tools of clinical pharmacology (drug efficacy), pharmacoepidemiology (drug safety), pharmacoeconomics (drug costs) and pharmaceutics (drug product quality). The course also covers effective methods of improving drug use, aggregate and indicator methods for assessing drug use, and successful methods of implementing and monitoring change. The exchange of experiences and ideas among participants adds depth to the learning process in this highly participatory course. The methodology is based on brief interactive presentations, with group and plenary discussions followed by exercises and field visits.

As far as possible sessions are integrated, so, for example, during the STG exercise participants are given all the data to develop evidence-based STGs for pneumonia and surgical prophylaxis for Caesarean section. Then these STGs are used when making drug utilization review (DUR) criteria. On the field visits to local hospitals the STG/DUR protocols are used to look at practice and costs. These practical exercises during field trips can have important results. For example, when looking at drugs and doses in surgical prophylaxis for Caesarean section at one hospital, it was found that by not following the STG and using unnecessary antimicrobials, the cost paid per patient was US$6.47-13.6 times more than necessary.

Follow-up

Training courses on their own rarely result in sustainable behaviour change, so participants are asked to develop a one-year work plan for their institution, which is followed up to assess progress and give advice when needed. Follow-up is done in different ways. For local courses someone visits or telephones the participants, but the challenge is greater with international courses, and e-mail and a course web site are used. The site stimulates interactive learning for those who have been on a course. Each team’s work plan and updates on its progress are posted, along with personal profiles and photos of participants. Successes and failures are shared through a discussion board, so that people learn from each other. The site also provides links to important DTC resources. In addition, the RPM Plus web site (www.msh.org/projects/rpmplus) has valuable information on DTCs, including a fact sheet, links to training course sessions, and DTC course announcements.

Enjoying the sunshine in Mumbai, India - participants at the highly acclaimed international training course on Drug and Therapeutics Committees, held in 2002

Photo: MSH

Progress

To date, the training course has been presented in 10 countries to 295 participants from 42 different countries. Locations have included: International courses in Indonesia (June 2001), Kenya (October 2001) and India (September 2002): Regional courses in Bolivia (December 2001), Guatemala (February 2002), Moldova (June 2002) and Jordan in December 2002: and National courses in the Philippines (February 2001), Turkey (July 2001), Nepal (December 2001) and South Africa (March 2002).

While a significant number of participants have been lost to follow-up, we know that many others are involved in post-course DTC activities, including:

• Further courses - so far there have been 14 courses and nine more are planned in eight countries.

• DTCs are being created or restructured in 11 countries.

• Three countries have introduced new processes for drug selection, improving formulary management.

• STGs have been developed in at least three countries.

• DURs have been conducted in four countries. ABC and VEN analysis of pharmaceutical purchases completed in two countries and ADR and medication error reporting programmes are underway in two countries.

All of these activities facilitate identification of potential problems. Given that most of the courses took place very recently it is expected that many more participants will provide us with information about achievements in their DTC-related work activities in the future.

Great potential

In hospitals in developing and developed countries a DTC can be a key instrument in improving drug selection and drug use. Yet in many cases DTCs are not functioning optimally. This is often because the chairperson is not committed, the membership is not representative of all stakeholders, or lacks adequate training, or the administration is not supportive in terms of recognition and remuneration for the time needed for Committee work.

The DTC training course is proving a major step towards promoting effective DTCs internationally, and we now need to develop a longer-term, sustainable, framework for presenting and following up this course. Our focus will be on determining the main factors that make DTCs as effective as possible in developing country settings.

DTCs offer the opportunity and environment to improve drug management within hospitals and primary care settings. Overall these important Committees can provide the link to control and manage drug use, improve patient outcomes, and contain AMR.

* Terry Green, Alix Beith and John Chalker work for the Rational Pharmaceutical Management Plus Program, Center for Pharmaceutical Management, Management Sciences for Health, 301 North Fairfax Drive, Suite 400, Arlington, VA 22203, USA. Tel: + 1 703 524-6575, fax: + 1 703 524-7898, e-mail: rpmplus@msh.org
References

1. WHO global strategy for containment of antimicrobial resistance. Geneva: World Health Organization; 2001. pp 34-35.

2. Lazarou J, Pomeranz, Corey P. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 1998 Apr 15;279(15):1200-1205.

3. Weekes LM, Brooks C. Drugs and therapeutics committees in Australia: expected and actual performance. Br. J Clin Pharmacol, 1996, 42:551-557.

4. Interventions and strategies to improve the use of anti-microbials in developing countries, a review. Drug management program. Geneva: World Health Organization; 2001. WHO/CSR/DRS/2001.9.

5. Soumerai SB, Avorn J. Efficacy and cost-containment in hospital pharmacotherapy: state of the art and future directions. Milbank Memorial Fund Quarterly Health and Society, 1984, 62:447-474.

6. Laing RO, Hogerzeil HV, Ross-Degnan. Ten recommendations to improve use of medicinces in developing countries. Health Policy and Planning 2001; 16(1): 13-20.

7. Wade W, Spruill WJ, Taylor AT, Longe L, Hawkins DW. The expanding role of pharmacy and therapeutics committees: the 1990s and beyond. Pharmacoeconomics 1996 Aug;10(2):123-128.

8. Thompson O Brien MA, Oxmas AD, Davis AD, Haynes RB, Freemantle N, Harvey EL. Audit and feedback: effects on professional practice and health care outcomes. Cochrane Collaboration Abstract. November 1997.