M. CHERAGHALI, F. SOLAYMANI, G. SHALVIRI

THE Islamic Republic of Iran's Ministry of Health has a mission to provide access to sufficient quantities of safe, effective and high quality medicines that are affordable for the entire population of 65 million. Since the 1979 revolution, Iran has adopted a full generic-based National Drug Policy (NDP), with local production of essential drugs and vaccines as one of the main goals. Currently 55 pharmaceutical companies produce more than 96% (quantitatively) of medicines on the market. Although over 85% of the population use an insurance system to reimburse their drug expenses, the government subsidises pharmaceutical production in order to increase affordability of medicines. Today, essential medicines are available and affordable for more than 85% of the population.¹

Iran has adopted a national drugs list, compiled by the Iran Drug Selection Committee, comprising medical specialists, pharmacists, pharmacologists, and drug regulatory and national control authority members. The committee meets regularly and evaluates medicines, based on their efficacy, safety and cost-effectiveness. Iran's drug list includes more than 1500 drugs, listed by generic name, and including different dosage forms. In order to improve affordability, drug procurement is centralized to one State-owned company that is responsible for procuring most of the imported drugs, and two semi-private companies. Iran has a highly regulated pharmaceutical market and all medicines including biologicals require registration before granting marketing authorisation. Both the national regulatory authority and national control laboratories in the Ministry of Health are well developed.

However, there are convincing data which show that excessive prescribing occurs. Evidence of irrational use of drugs, including a high number of drugs per prescription, and a high level of use of injectable drugs and antibiotics, convinced the Ministry of Health to set up a Centre for Promoting Rational Use of Drugs (RUD) and coordinating all related activities. Founded in 1995, the Centre has three main functions, collecting data through a unique prescribing auditing system, disseminating drug and poison information, and coordinating the country's Adverse Drug Reaction Centres. The RUD Centre now has branches in all the major provinces, and has trained many health professionals. It publishes regular updates of the Iran Drug List and distributes it among health professionals, especially doctors. The first and second editions of the National Formulary of Iran (NFI) were published in 1998 and 2000 respectively, and the third edition will be published in late 2003.

As one of the active centres of Iran's RUD network, The Tehran Medical Science University hosted the first international training course on RUD to take place in WHO's Eastern Mediterranean Region (EMRO), in May 2001. Held jointly with WHO/EMRO the course attracted 29 participants from 12 countries, both within EMRO and in other regions. "Tehran proved to be an excellent venue for this type of training activity, with motivated staff and several examples of successful local rational drug use interventions that have already taken place (including a prescription database system for medical auditing)."² Building on this success, the University hosted the second international course in June 2002, attended by 31 participants from 13 countries.

Drug and Poison Information Centres

The impact of drug use on the health of a population not only depends on availability, affordability or accessibility, but more importantly on the rational use of drugs at clinic level. Drug and Poison Information Centres have a significant role in educating medical groups and the public. The main objective of Iran's Centres is answering patient-oriented questions from medical professionals (passive dissemination) and also updating medical staff about drugs (active dissemination). The Centres promote and educate on rational use of medicines to prevent unwanted/toxic effects. As more Centres are opened around the country, their beneficial effects will increase.³ For further information on Drug and Poison Information Centres in Iran see Monitor No.28/29.⁴

National Prescribing Auditing Committee

Prompted by the high number of drugs per prescription, unjustified use of parenteral drugs, antibiotics and Clinical Nurse Specialist (CNS) medications, the National Committee of Prescriptions Auditing was created in 1996 and later developed its national network, with 40 sub-committees cross the country. The Committee collects prescription data from different provinces and analyses them, based on the drugs prescribed, the most used drugs/dosage forms, the most prescribed drug categories, etc. using Rx Analyst software. Data analysis provides information on:

• a physician's prescribing pattern in comparison to that of other physicians in the same area or in the country;

• prescribing patterns of a group of physicians or a medical specialty in comparison to other physicians or medical specialties in the same area or the country;

• frequency of prescribing a certain drug; a certain class of drug; and a certain drug dosage form in a specific place, part of a city, a whole city, province, and finally in the country as a whole;

• average number of items per prescription;

• potential drug interactions in three categories: severe, moderate and mild.

A group photo at the second Iranian course on Promoting Rational Drug Use

Photo:Health of Ministry

The Committee analyses the prescription pattern of every general practitioner at least once a year and not only informs doctors about their patterns of prescribing, including their weakness and strengths, but provides training seminars and workshops on RDU for medical doctors and pharmacists. So far the Committee has trained more than 5000 medical professionals in three-day RDU workshops. The National Committee is served by three sub-committees: policy and legislation, computer and data analysis, and medical science advisory. Depending on their focus the sub-committees consist of officials and experts from the Ministry of Health, the Iranian Medical Council, universities and health insurance providers.

The National Committee's responsibilities towards local committees include policy-making, standard-setting for qualitative analysis of RUD in doctors' daily practice; providing software, hardware and technical support for local data collection and analysis; annual budgeting; and cooperation in organizing seminars, workshops, and continuing education courses on RUD. Local committees consist of an advisory subcommittee of medical experts and an executive sub-committee for prescription data collection, analysis and other local activities.

Box 1

Box 2

Local committees send a copy of computerised data to the National Committee for national analysis, plus a seasonal report of all of their activities for review and feedback.

Figures 1 and 2 show that all of these efforts are having an effect, but more needs to be done. Although the average number of drugs per prescription and use of injectables have declined they are still very high, and the percentage of patients receiving antibiotics continues to rise. More work and new interventions must be considered. However, the availability of such information will be helpful to several sections of the MOH and other government and private organizations, in the following ways:

• predicting and ensuring correct programming for the annual importation, production and distribution of pharmaceuticals in different parts of the country, according to their real needs;

• estimating the annual budget for the pharmaceutical needs of the Iranian population by the Ministry of Health and health insurance providers;

• changing medical schools' curricula to ensure students are properly educated to practice RUD, with emphasis on the frequent problems caused by irrational therapy;

• discovering local or endemic diseases in certain parts of the country and taking all the necessary steps to find and possibly eradicate the reasons for them, treat the patients correctly and prevent the expansion of communicable diseases. Seminars, workshops, and continuing education courses on RUD programmed according to the problems and needs of each region.

Figure 1. Average number of medicines per prescription

Figure 2. Percentage of patients receiving injectable drugs or antibiotics

Figure 3. Number of adverse drug reaction reports sent to the National Centre 1998 - 2002

Adverse Drug Reaction Monitoring Centre

The Adverse Drug Reaction Monitoring Centre is another essential element in Iran's multi-faceted approach to promoting rational use of medicines. A member of the WHO International Drug Monitoring Programme since 1998, the Centre collects Adverse Drug Reactions (ADR) reports from all over Iran and analyses the data received. The Centre's main objective is to evaluate drug safety by detecting and assessing ADRs reported to it. It aims to cover all aspects of pharmacovigilance, including detecting new and unknown ADRs; detecting sudden increases in the frequency of known ADRs; preventing recognised preventable ADRs; and promoting rational and safe use of drugs. The Centre depends on voluntary reporting by health professionals, and sends the cards designed for ADR reporting to all health professionals. All reports are followed up, missing data searched and feedback sent to the originators.

Coming up…

There are plans to publish a national ADR bulletin, to have on-line reporting of ADRs and to provide an ADR database. It is also intended to do intensive hospital monitoring of ADRs by training staff in university teaching hospitals, and to monitor adverse events induced by vaccines and herbal medicines.

For further information contact: Ministry of Health, Food and Drug Department, Promoting Rational Use of Drugs Centre, 2nd Fl., Fakhr-e-Razi St., Enghelab Avenue, Tehran - I.R. Iran. Tel: (+9821) 6404223/6405569; Fax: (+9821) 6417252.

References

1. R. Dinarvand. Iran: an evolving national drug policy. Essential Drugs Monitor, No.22. Geneva: World Health Organization; 1998.

2. Essential Drugs in Brief, No.5. Geneva: World Health Organization; 2001.

3. M. Abdollahi, S. Nikfar. Three year report on Tehran Drug and Poison Information Centre. Proceedings of the VII World Conference on Clinical Pharmacology and Therapeutics, Division of Clinical Pharmacology, and 4th Congress of the European Association for Clinical Pharmacology and Therapeutics. Florence, Italy, 15 - 20 July 2000, p. 114.

4. S. Nikfar, M. Abdollahi, A. Cheraghali. Going from strength to strength - Iran's drug and poison information service. Essential Drug Monitor, No.28/29. Geneva: World Health Organization; 2000.

Box 3