Papers

What information is available on request from drug advertisers in India?

^a Departments of Pharmacology and Physiology, BJ Medical College, Ahmedabad 380 016, Gujarat, India

Correspondence to: Dr R K Dikshit.

Drug advertisements rarely give complete information on the product, but advertisers usually offer to give more information on request. We studied how often this request is met and the quality of the information given.

Methods

and results

We studied 87 advertisements in a recent issue of the Monthly Index of Medical Specialities (MIMS-India). Fifty five advertisements offered some more information; in 31 cases further information was offered, in 16 full prescribing information, in two complete prescribing information, in one detailed prescribing information, and in five further details. We posted a standard letter demanding the offered information to the given address of the 26 pharmaceutical companies that had placed the 55 advertisements for 58 products. Non-responders were reminded in a letter with a certificate of posting after six weeks. Information for 31 products was received after the first letter within three to 35 days (average 20). For a further 13 products a reply was obtained after the reminder letter within four to 89 days (average 21). Information was not made available for the remaining 14 products.

For 13 of the 44 products with further details, the information was in the form of promotional pamphlets with or without the prescribing details; for 11 it was the therapeutic index of the company (a list with some description of all products), for seven promotional booklets, for seven typed or printed text such as a statement of claims, for four package inserts, and for two a newsletter or trial report. We read and evaluated the information against standard, desirable headings (table 1).¹ None of the replies mentioned the legal category or the additives (sweeteners, flavourings, and colourings) used in the product. Pharmacological actions and details of overdosage and storage conditions were missing for 33 products. Side effects, precautions, contraindications, and drug interactions were not described in 12-20 products. Non-proprietary names, mechanism of action, indications, average dose, dosage form and its content quantity, or manufacturer's name were not given for nine products.

Table 1--Evaluation of information received for 44
pharmaceutical products
----------------------------------------------------------------
                                    No of products
                                    with information
Heading*                            made available
----------------------------------------------------------------
International non-proprietary name         42
Pharmacological data:
 Pharmacological effects                   10
 Mechanism of action                       35
Clinical information:
 Indications                               42
 Dosage regimen and relevant
 pharmacokinetic data+                    19-35
 Contraindications                         26
 Precautions and warning                   31
 Adverse effects                           32
 Drug interactions                         24
 Overdosage++                              11
Pharmaceutical information:
 How product can be given                  39
 Content quantity for each means of
  administration                           38
 Additives (sweeteners, flavourings,
  colourings)                               0
 Storage conditions and shelf life         11
 Pack sizes                                30
 Description of product and package        29
 Legal category                             0
 Name and address of manufacturer          40
----------------------------------------------------------------
*As suggested by World Health Organisation.1
+Includes average dose and range, dosing interval, duration of
treatment, and modifications as required.
++Symptoms, treatment, and antidote.

Comment

We found that a request for further information was usually answered, albeit slowly, although some requests were never answered. This may reflect the lack of appropriate legislation. Advertisers use different phrases to offer further information, which might just be a difference in semantics but could be of great importance legally. A uniformly worded offer would therefore be desirable.

Companies were also clearly unsure about the form of further information. In fact, the helplessness of the medical executive of a company was obvious when he wrote: "We are not clear about the type of information you need...." Generally, the information supplied was either too little (therapeutic index), too much (booklets up to 34 pages long), irrelevant (newsletter), purely promotional (pamphlets), or difficult to read (package inserts). Even when information seemed to be in order it was presented so mechanically that it would fail to impress busy practitioners who are not trained to understand clinical pharmacology.

The basic information given to prescribers is generally poorly presented and difficult to use.² Several formats of drug information have been suggested and are in use.³ In our study we used a format suggested by the World Health Organisation,¹ and we find it to be reasonable. The desired information can be given in this format in an easily read printed document of four to five pages long. However, information can lead to the optimum use of a drug only if it is comparative for every point. This is essential in developing countries with few sources of drug information and many commercial pressures. Our results are likely to be similar in most developing countries. We would, however, be interested to see how matters differ in developed countries.

1. WHO Expert Committee. The use of essential drugs. WHO Tech Rep Ser 1992 No 825:18-9.
2. Herxheimer A. Basic information that prescribers are not getting about drugs. Lancet 1987;i:31-3.
3. Brown EG. Product information. In: Mann RD, Rawlins MD, Auty RM, eds. A text book of pharmaceutical medicine: current practice. New York: Parthenon Publishing Group, 1993:295-308.

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