RANJIT ROY CHAUDHURY*

* For further information contact Professor Ranjit Roy Chaudhury, President of the Delhi Society for Promotion of Rational Use of Drugs, c/o National Institute for Immunology, Aruna Asif Ali Marg, New Delhi-1 10067, India.

Delhi can boast of being the only Indian state to have a comprehensive rational drug policy -a policy which is helping to provide the poor with the medicines they need. Thanks to the collective efforts of doctors, ministers and drug controllers, the policy has benefited a health system previously prone to problems in policy planning and implementation. Increasingly throughout Delhi the right drugs are being used in the right doses and for the right period of time. Measures including pooled procurement, the introduction of GMP inspection, training in rational prescribing and increased patient information have all played their part in reshaping the pharmaceutical sector. Widely seen as a major advance in attaining equity in health care, the rational drug policy is being emulated by other Indian state governments.

The Delhi Model

The State Government, working with WHO and the Delhi Society for Promotion of Rational Use of Drugs, an NGO, launched the Rational Use of Drugs Programme in 1994, when conditions in Delhi government hospitals were difficult. Dr Harsh Vardhan, Minister of Health and Family Welfare at that time, gave an insight into some of the problems. “At nearly every hospital I visited there were complaints that drugs were not available. Other complaints related to the quality of drugs, their procurement and distribution, and the information given to patients about the use of drugs. Each hospital had its own list of drugs, medicines came to hospitals in many different brand names, supply was erratic and the prescribing, very often, unrestrained.” All this naturally made hospital visits a frustrating experience for patients. Although 30-35% of the hospitals’ budget was spent on medicines, their shortage was chronic. However, within four years of the new drug policy being introduced through the Rational Use Programme, there has been a dramatic change. Ninety per cent of the drugs budget in hospitals is spent on essential drugs, the quality is generally assured and prescribing is more rational. Most importantly this means that safe, effective drugs are now available for patients.

TRANSFORMING POLICY

The scale of the task facing those implementing the Rational Use Programme was daunting. Delhi State covers 1,483 square kilometres with a population of 14 million. The State Government runs two teaching hospitals, 15 smaller hospitals and 150 health centres. There are 4,000 beds for in-patients and almost four million people visit out-patient departments annually. All medicines are free, irrespective of where the patient is from.

Essential Drugs List

One of the initial steps was for a high-level committee to draw up a common list of 250 essential drugs and another list specifically for smaller hospitals, containing 100 drugs. The first essential drugs list, in 1994, was based on WHO guidelines, and included 329 drugs in 28 different categories. Both lists were revised in 1996 and again in 1998, when 18 new drugs were added and 12 were deleted.

Queuing for drugs - but in Delhi State efforts are being made to reduce waiting times (Photo: Delhi Society for Promotion of Rational Use of Drugs)

Table 1: Comparative prices (in rupees) at which drugs were purchased in 1995

Strengthening prescribing

Guidelines for treatment at primary health centres were issued to help doctors working in this sector. The guidelines included treatment for conditions commonly encountered by physicians, covering 15 diseases affecting adults and five affecting children. An essential drugs list and important patient information were also provided.

Pooled procurement

A common pool for procuring drugs was introduced, supervised by a Special Purchase Committee. Soon all hospitals run by the Delhi Government began to use the same medicines.

Previously medicines were procured by indents raised by hospitals, and manufacturers supplied drugs to the Medical Stores Depot in Delhi. However this system had its drawbacks. Indentors did not know the prices of centrally procured drugs as bills were sent direct to pay and accounts offices. By the time drugs from the depots reached hospitals they were close to their expiry date. But only some drugs were procured centrally, and each hospital had to fend for itself to obtain the rest. Another problem was that 10 hospitals and the Directorate of Health Services for primary health centres were not covered by this scheme.

Now a much-improved “double envelope” system of obtaining a technical bid and a price bid in two separate envelopes ensures that only serious players, who fulfil all the necessary criteria, are considered. Only if all the details contained in the technical bid are approved will the price bid envelope be opened. Two or three suppliers are selected for each drug, all must have a minimum turnover of US$2.86 million, and hospitals can order their supplies direct. Major drug companies’ confidence in the system is evident by their participation in centralised bidding.

Doctors are requested to prescribe only those drugs on the procurement list. However, hospitals are given some leeway, as they can prescribe non listed drugs up to the value of 10% of their budget.

Saving money

The new measures resulted in a sharp fall in the procurement prices of essential drugs (see Table 1), with bulk buying reducing costs.

Quality checks

The Programme acts to ensure the quality of drugs supplied to hospitals and health centres:

• The “double envelope” procurement system means that to a large extent firms with dubious products are excluded from consideration as suppliers.

• A panel of 12-15 experienced and highly qualified experts, working in teams of two, carry out good manufacturing practices inspection of companies wishing to supply drugs to Delhi State. Among the items checked are the facilities themselves, the equipment, hygiene standards, and staff knowledge and competence. The manufacturing standards followed are those recommended by WHO. Inspectors write a detailed report, ending with a clear recommendation as to whether medicines should be purchased from the factory. So far nine of the 27 factories inspected have been rejected and no medicines are purchased from these firms. In addition to inspection, random samples of drugs are sent for testing to recognised laboratories, not only in Delhi but all over India, to ensure substandard pharmaceuticals are not purchased.

• Doctors who feel that a medicine they are using is not working because its quality is substandard can send the sample to the hospital medical superintendent. Superintendents have the authority and the funds to have the drug tested at any recognised laboratory. Confidence in the Programme has increased because prescribers know that this can be done.

Looking ahead, the Government has approved the setting up of a State Drug Authority at Karkardoma, which will be responsible for drug procurement, storage and distribution. The premises are already under construction and will incorporate modem storage and inventory control techniques.

Training at home and abroad

Training in rational use is seen as essential to the Programme’s success and doctors are being trained in rational prescribing with the help of local and international partners. In December 1998 34 participants from 13 states attended a course in New Delhi, run by WHO/EDM, the International Network for the Rational Use of Drugs and the Delhi Society for Promotion of Rational Use of Drugs. Training focused on how to identify and solve problems related to the prescription, dispensing and consumption of drugs. More training sessions for doctors, pharmacists and nurses are being held in Delhi during 1999.

Several medical college teachers and specialists attended courses abroad to widen their perspective on rational drug policy. Countries visited, with WHO/EDM support, included the Netherlands, UK (England and Scotland), South Africa and Switzerland.

Publications such as the “Delhi State Essential Drugs Formulary” and “List of Essential Drugs for Delhi Hospitals” have helped by providing doctors with much-needed information, on drug categories, cautions, contraindications, side-effects and dosage, for example.

Positive media reaction

For any message to reach a wider audience the role of the media is crucial. And the Programme has reached out proactively to the media. As a result, television and press coverage in India has been good, leading to growing public awareness of the Programme’s benefits. An editorial in the Hindustan Times called the Delhi model for rational use of drugs a “healthy model”, whose “success has been commended by WHO as a positive initiative for delivering effective health care... the fact that drug prices have shot up several fold following introduction of the economic liberalisation in the past few years... further added to the importance of this initiative.” In its coverage The Indian Express called it “a common sense solution” to overcoming some of the problems in the health care delivery system. Such publicity has been instrumental in helping the Programme to spread to the States of Andrha Pradesh, Bihar, Chandigarh, Haryana, Himachal Pradesh, Karnataka, Madhya Pradesh, Maharashtra, Punjab, Rajasthan, Tamil Nadu and West Bengal.

MONITORING REINFORCES MESSAGE TO OTHERS

Prescribing practices have been monitored from time to time to ascertain progress. An independent team of clinical investigators drawn from various institutions around Delhi monitors:

• prices at which drugs are obtained through pooled procurement;

• the percentage of prescribed drugs the patients actually receive, (all drugs are provided free of charge);

• prescribing patterns and “drug” indicators;

• patient indicators, such as information provided to patients;

• system indicators, such as time spent on each prescription at the pharmacy, labelling etc.;

• quality of drugs being supplied.

Encouraging results

Hospitals used to tender themselves, with very limited quality assurance procedures. Pooled procurement is now in place for all state run hospitals and 150 primary health care centres. This has led to reducing duplication of work, better prices (about 30-40% cheaper), better quality assurance and GMP inspections (see also below).

Monitoring of prescribing at the San-jay Gandhi Memorial Hospital, Mangolpuri, showed that 87.3% of prescriptions are of essential drugs and that 59.7% are actually available to patients. And at Aruna Asaf Ali Hospital 98.3% of essential drugs are prescribed and 97.3% are available to patients.

In comparison, data from three major hospitals in Delhi where the Programme has not been instituted show very different results. The percentage of prescribed drugs actually made available to patients was 5% at one, 22% at the outpatient department of another and 10% at the third hospital.

In addition to this independent monitoring, in-house investigations are sometimes carried out to determine progress. At the Lok Nayak Teaching Hospital monitoring showed that the percentage of those receiving adequate information had increased from 39% to 77.4%. The percentage of adequately labelled drugs had increased from 76% to 95.5%, which was probably a factor in the increased number of patients with adequate information on drugs.

In its enthusiasm to tackle urgent problems the Programme focused on immediate action, adopting and adapting proven essential drugs strategies. However, this desire to act and to act quickly in a situation where so much needed to be done to improve drug access and use, led to pre-intervention data not being scientifically collected. The Programme staff now regret this lack. Other states now undertaking drug policy and system development are being strongly urged to integrate scientific evaluation systematically into their work from the outset.

Despite the lack of systematic pre-post intervention data, it is apparent to all stakeholders that the hospitals participating in the Programme have improved patient access to essential drugs of assured quality. Data also indicate that drugs are being prescribed and dispensed more rationally. The monitoring system now in place is starting to provide the hard evidence needed to convince others that these strategies work and to wholeheartedly promote the Programme throughout India.

PROMOTING CHANGE AND OVERCOMING DIFFICULTIES

Dispelling initial scepticism

When the Programme was announced there was widespread scepticism over whether it would work, and resentment from doctors that their freedom to prescribe any drug they wished was being curtailed. With this attitude the Programme was bound to fail. Dialogue and yet more dialogue with the doctors at every hospital - large or small, teaching or non teaching - gradually changed cynicism and resentment to qualified approval for the Programme. A minimum of two hospital visits was made by the author, (then Adviser to Delhi’s Minister of Health), and his team, with the Minister himself present twice. The new system’s possible benefits were explained, focusing on the following points:

• previously doctors could prescribe any medicines, but within three or four months these had run out. In the new system medicines, albeit a limited list, would always be available;

• previously doctors often received drugs they did not need or herbal medicines they did not use. In the new system this could not happen;

• previously there were no built-in quality assurance measures, whereas in the new system the Programme took responsibility for the quality of drugs supplied.

Gradually doctors began supporting the Programme. In some cases those who had been most critical of change became the most vociferous advocates for change.

Promoting ownership of the Essential Drugs List

In the early days doctors, including specialists, felt that they must “get in” their drugs and so used to propose long lists. Problems were overcome by adopting strict and transparent guidelines for selection, with the decision on including a new drug made on transparent criteria:

• is the drug more effective than existing drugs on the list?
• does the drug induce lesser side-effects than drugs on the list?
• does the drug have a wider mechanism of action than the existing drug?
• is it cheaper than the existing drugs on the list?

Decisions were made only on objective evidence and not on subjective findings. Criteria such as availability of research trials data were seriously considered. Every meeting of the Committee for Selection of Drugs was attended by a group of 5-6 clinical pharmacologists and pharmacists armed with all available reference books on drugs and prices. For teaching hospitals we increased the number of drugs which could be purchased from outside the list, from 10% to 20% of their drug budget, so that specialists could have particular drugs they needed. Doctors are now convinced that the list is their own and that they are able to change it. The Delhi Essential Drugs List has been changed twice since 1994.

A session at one of the training courses on rational use of drugs, held in New Delhi (Photo: Delhi Society for Promotion of Rational Use of Drugs)

Some doctors at Delhi State hospitals continued to prescribe outside the list and patients purchased drugs on the open market. But this was a problem for only a few months. The State Minister of Health issued a circular clearly stating that doctors in government hospitals were required to prescribe drugs only from the essential drugs list. Anyone prescribing a drug outside the list would need to explain why. This reminder was effective. The success of the procurement system in actually making drugs available to them also won over doctors. They could see that the system worked, was providing drugs and that the inspection teams were ensuring quality.

Increasing confidence in the procurement system

Since the Programme began five years ago the Committee established for purchasing drugs has really established its credibility. At a time when allegations of corruption are not uncommon, this is a particularly important asset for the Programme. The stature of the Committee’s membership was largely responsible for this, with a former Secretary of Health of India heading it. Others included the former Deputy Auditor General of India, the author, Adviser to the Minister of Health, the Secretary of Health, the Director of Health Services, the Director of a national medical institute and the Drugs Controller. The Deputy Director responsible for Procurement was the Committee’s Secretary. The presence of Finance and Legal Department representatives was extremely important in enabling the Committee to take important and sometimes unconventional decisions.

Because meetings were so regular, sometimes between four and six a month, members were able to keep up to date and procure drugs 30-35% cheaper than other government agencies obtained the same drugs, even from the same manufacturer.

Another factor that certainly helped was the system’s total transparency, in which suppliers were informed why technical bids had been rejected. Tender bids were opened in the presence of members of the tendering unit and representatives of other pharmaceutical companies.

In the beginning a pharmaceutical company had to have a turnover of Rupees 50 million before it could be considered and have its “price envelope” tender opened. This qualifying limit was then raised to Rupees 120 million (US$2.86 million), on the basis that these companies would have the infrastructure to supply drugs on time. The change led to protests by smaller firms, some of which were losing large orders. One company went to the High Court and brought a case against the Delhi Government and the Procurement Committee. The Court dismissed the case. What the Programme can do for smaller pharmaceutical companies is to help them reach the necessary good manufacturing practice standards. Through the inspection system such firms can receive technical guidance on what needs improvement, but they have to pay for any improvements themselves. Once they have reached the standards the qualifying criteria can be reduced but not before.

Some companies initially refused to accept the inspection teams, even at the last minute when they were waiting at the door. They were informed by telephone that unless the team was allowed to carry out its inspection, their quotations would not be considered. Also every other state government would be notified that they had refused a factory inspection. This solved the problem.

Some 40-50 drugs are not quoted for by any firm, because, although they are essential drugs, their use is limited and the amount purchased small. We have to buy these on the open market at much higher prices. This is currently an unresolved problem, but only a temporary irritant. Next year when the Procurement, Storage and Distribution Centre in Karkardoma is ready the Procurement Committee will buy these drugs in bulk from the manufacturer and store them.

Certain drugs on the Essential Drugs List are marked with an asterisk. This means that the hospitals should ensure that they are used with particular care. These are very expensive drugs, or ones for use only in special circumstances or only by specialists in a particular discipline. Although some hospitals have set up a mechanism to try to ensure this, the system is probably not working as well as it should.

Optimising training

Although courses in rational prescribing have been organized successfully, it is sometimes difficult for the doctors who would benefit from them to be available, as they are so busy. This is a continuing problem. Courses can be restricted to doctors at one institution, so no travel is needed and logistics are easier, but in this case fewer doctors attend, as coverage needs to be maintained. Alternatively if a few doctors come from several hospitals, it is easier for people to be spared but logistics are more problematic. Of course there should always be a large faculty membership from the host institution.

Working together

Collaboration at all levels has been the key to the Programme’s success. Throughout it has received both technical and financial support from WHO’s Department of Essential Drugs and Medicines Policy, and in 1997 became part of the joint India-WHO Programme on Essential Drugs. At state level Delhi’s Rational Use of Drugs Programme has only been possible because of the close working and personal relationship between the Minister and his staff (political support), the bureaucracy and the technical and professional experts numbering over 25 - all pulling together for this common endeavour. This feeling of working towards a common goal has now filtered through to all levels of the health sector. In a nutshell this is the fundamental reason for the Programme’s success, how it has been able to resolve problems, and has become a model which other Indian states are emulating. It has given hope to the poorest in one of the world’s most populous nations, and can serve as an example for others striving for equity and efficiency in health care.

Developing lifetime pharmacology skills in India

B. GITANJALI

Students engrossed in a session preparing an essential drugs list of analgesics for primary health care. Other students comment after they have checked morbidity data and cost (Photo: Jipmer)

There has been much concern over the lack of information and training on essential drugs and rational drug use given to medical graduates in India. The main criticism of pharmacology curricula in India is their lack of relevance and failure to teach the long lasting skills needed for medical practice. For example, medical students, five years from now, will be using many drugs not taught to them in medical school.

Do pharmacologists equip their students to evaluate drug trials? Internet is still out of reach of many doctors in India. Do pharmacologists teach students where to seek unbiased drug information? Most information on new drugs comes from drug advertisements and drug representatives. Yet, how many students are taught to critically analyse drug advertisements and to cope with unethical marketing strategies? Dosage forms such as inhalers and transdermal drug delivery systems have to be used properly for optimal therapeutic effect. Do doctors know how to instruct patients on their correct usage? The consultation is the most important part of the therapeutic exercise, but very few doctors know how to effectively communicate with their patients about the drugs they are prescribing to them.

More meaningful approach

All these aspects can be very effectively taught by a clinical pharmacologist, using the time that was previously spent on outdated dispensing experiments. By focusing on skills which will last a life-time, the faculty at the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, India, have combined clinical pharmacology with problem-based medical education techniques to make learning more meaningful and enjoyable. The new approach has been documented in a recently issued manual to facilitate other teachers who would like to opt for this approach.

The manual covers 30 exercises in practical pharmacology for training undergraduate medical students on various aspects of drug use. It includes exercises on communication skills, adverse drug reaction monitoring, critical appraisal of drug advertisements, informed consent and essential drugs lists. As part of the practical exercises on essential drugs, students are provided with morbidity data, population size and a demographic profile and asked to make essential drugs lists for a particular group of drugs. Exercises such as these create wide scope for discussion because students get a taste of what it is to actually develop a list and comprehend its underlying rationale.

Checklists for conducting practical examinations are also given and useful exercises, such as preparation of a solution for a test dose of penicillin; calculation of drip rate for dopamine; management of snake-bite, scorpion sting etc., are all included in the manual.

Positive response

Students have already shown their enthusiasm for the curriculum changes. “An eye-opener” was how one student described the class in which a faculty member shared past experiences with drug companies. Another, commenting on the session on medical ethics, said that it had come at a good point in the course, when demands on students were fewer and they had more time to develop their opinions on ethical issues.

Evaluation planned

The first students to use the manual will take their pharmacology examinations in December 1999. A formal evaluation is planned in 18-months time when they become interns and begin to prescribe drugs independently. Their prescribing patterns will be compared with those of a group of interns who finished their pharmacy course before the manual’s introduction. Only then can staff discover whether their initial goals were fulfilled and to what extent.

For further information on The Manual of Practical Exercises in Pharmacology contact: Dr B. Gitanjali, Associate Professor, Department of Pharmacology, JIPMER, Pondicherry 605 006, India. E-mail: batmanabane@vsnl.com

(For more about the global changes in pharmacotherapy teaching, see the article, Problem-based pharmacotherapy in practice, on this page and also Letters to the Editor).

Problem-based pharmacotherapy in practice

The photograph below is a very symbolic illustration of the global change in pharmacology teaching. In the Medical School of the University of La Plata, Argentina, students participate in small group teaching in pharmacotherapy.

Teaching is problem-based, using patient cases for which students have to define the best (drug) treatment, collecting the necessary information and discussing treatment alternatives. These small group learning sessions have replaced the traditional laboratory practicals in basic pharmacology. The student laboratory facilities are now only used for such working groups, and the four laboratory benches can accommodate four student groups at the same time.

Photo: P Buschiazzo