Barbara Mintzes | 1998 | Download PDF
Citation: Mintzes, B. 1998, Blurring the boundaries: new trends in drug promotion, Health Action International, Amsterdam
The salaries of sales representatives remain the largest single marketing expenditure of pharmaceutical companies. A June 1997 article in Scrip Magazine states that, “sales and marketing expenditure for a typical brand-based company represents an estimated 35% of sales, roughly 20% in salesforce and 15% in advertising, promotion and other marketing expenses.”(131)
What sort of information do sales representatives supply to doctors? In 1997 Joel Lexchin reviewed English language studies carried out between 1966 and 1996.(132) A computerized literature search and bibliographic review revealed only three studies, from Finland, the US, and an unpublished M.Sc. thesis from Australia. Additionally, a French drug bulletin, La revue Prescrire, has monitored sales representatives’ presentations from 1991 to 1998 via an anonymous doctors network.(133)
The results were consistent over time and in all four countries: sales representatives almost always stated the indications and the drug’s brand and generic name, but usually failed to include safety information such as side effects and contraindications and many statements contained inaccuracies. In other words, there was a lack of balance in the information provided, with a greater emphasis on the drugs’ benefits and inadequate information on risks. These studies are limited, but are supported by research from Belgium, the UK, and the US which has shown a consistent association between doctors’ reliance on the information provided by detailers and inappropriate prescribing.(134)
In Australia, Libby Roughead recorded 16 sales representative presentations to GPs, involving 64 drugs in total, after obtaining consent from both the representative and the doctor. Adverse reactions were mentioned for just over a quarter of the drugs, contraindications were never mentioned, and use in pregnancy was only mentioned on one occasion. Risk information tended to be associated with claims that risks were minimal. There were factual inaccuracies in 13 of the 64 presentations, including in some cases recommendations for unapproved indications. If anything, this study would be expected to underestimate the degree of bias in information provision as the representatives knew they were being recorded.(135)
Prescrire’s survey involves a rotating anonymous network of French general practitioners (GPs) who fill out questionnaires on each visit by a sales representative and compare the information provided to that available in the French prescribing guide, the Vidal. Over the first six years of this ongoing survey (1991 to 1996 inclusive), they found that sales representatives consistently failed to mention side effects, contraindications and interactions in about three-quarters of visits and the drug’s indications were extended or changed about one-quarter of the time.(136) This survey is ongoing and results are regularly updated and published in the drug bulletin La revue Prescrire.
| La revue Prescrire’s Survey of Sales Representatives* Do the indications match those on the data sheet? yes no Does the dose regimen match that on the data sheet? yes no Did the representative spontaneously mention side effects? yes no Did the representative spontaneously mention contraindications? yes no Did the representative spontaneously mention drug interactions yes no Given the type of drug, do you think the representative should have mentioned information on side effects, contraindications and interactions? yes no Was the representative willing to answer your questions? yes no Did you find the representative convincing? yes no Were there strong inducements to prescribe the drug(s)? yes no Source: Adapted from: Bardelay D, Boucle B. Visits from medical representatives: fine principles, poor practice. Prescrire International 1995 Aug; 4(18)120-122. |
A 1995 survey of doctors in three Eastern European countries showed a high degree of reliance on information supplied by sales representatives. Doctors were asked their preferred sources of information on medicines and how frequently they used each information source. In Hungary 91% of GPs surveyed said they used sales representatives as an information source often or very often.(137) Internists and cardiologists, who were also surveyed, also relied heavily on sales representatives, although not as heavily as GPs. The number of sales representative visits was also for GPs: an average of 15.7 per month during the 1995 survey as opposed to 7.6 for cardiologists and 8.04 for internists. A similar survey in Poland showed a high degree of reliance on sales representatives among gynaecologists and psychiatrists. In the Czech Republic, doctors identified the medical press as their most frequent source of product information.
The results of a questionnaire survey sent out by the Nordic Council on Medicines to a sample of doctors and pharmacists in Estonia, Latvia and Lithuania in late 1996 also indicated heavy reliance on commercial information sources. Ninety-five percent of the doctors and 96% of the pharmacists said they received information on new drugs from drug companies, as compared to only 68% of doctors who reported reading about new drugs in medical journals or hearing about them from colleagues; and 42% who stated that they received information on new drugs from the regulatory authorities. About three-quarters of the doctors and pharmacists also listed drug companies as their most important source of drug information.(138)
| Two hospital initiatives to curb the influence of sales representatives At a teaching hospital in Beirut, drug representatives are not allowed to visit doctors in their clinics. A table has been set aside away from the clinics where reps can meet doctors during their free time. A poster at the clinics’ entrance prominently displays the rules governing interactions between reps and doctors.(139) In The Netherlands, a community-based hospital decided to ban all visits by sales reps. Instead, they invite sales reps to present new drugs and the results of trials at once monthly meetings of the entire staff. Often a company’s medical advisor, rather than a rep, will make the presentation and the quality of the information provided has greatly improved.(140) |
Setting the agenda: A Guide Doctors can Provide to Sales Representatives
Please be prepared to discuss your product using the following guidelines:
Product name:
Generic name:
Indications for use:
Efficacy:
Provide critical evidence that the product works for the above indication.
Comparative randomized clinical trials are most useful.
Safety:
Side effects:
What are the common side effects that my patients need to know about?
What are the rare but serious side effects?
Drug interactions:
Contraindications:
Warnings:
Cost:
What is the cost per unit?
Per course of therapy?
Compliance:
What about this product will increase or decrease compliance?
Availability:
Formulary:
Is this covered by provincial, insurance or hospital formularies?
Formulation:
Is the product available in a variety of formulations?
When should each be used?
Is there a pediatric formulation?
Information Sources Checked:
(Checklist of national prescribing references and therapeutic guidelines provided)
Clinical pharmacology
Prescribing information
Therapeutic guidelines
Published peer-reviewed reviews
Source: Adapted from: Shear NH, Black F, Lexchin J. Examining the physician-detailer interaction. Can J Clin Pharmacol 1996;3(4):177; Figure 1.Clinical pharmacology
Although companies are still investing more heavily in sales representatives than any other promotional activity, sales representatives remain largely unmonitored and unregulated, with few if any sanctions for inaccurate information provision, even when these inaccuracies may endanger health.
Recommendations – sales representatives
1. National legislation controlling drug promotion should include explicit provisions for the type and balance of information which sales representatives provide to doctors during each visit. This should be based on the official data sheet and should include a balanced presentation of potential benefits and risks, including the generic name, indications, dosage and administration, side effects, contraindications and warnings.
2. Ongoing monitoring of sales representatives’ visits is needed, with effective sanctions for inaccuracies and omissions. This could be based on randomized sampling of visits funded through a fee levied on companies and based on the size of their sales forces. Monitoring the quality of information provided by sales representatives should be a responsibility both of agencies regulating drug promotion and of professional medical and pharmaceutical associations.
3. Curricula for medical education should include sessions on how to judge the content and accuracy of information provided by medical representatives.
4. Individual doctors and health services may wish to consider choosing not to see sales representatives, and to devote the time saved to consulting independent information sources assessing new and existing therapies. This can be part of an initiative for a “promotion-free zone.”
5. Hospitals, clinics and other health facilities can also introduce guidelines to regulate the activities of sales representatives within their premises. Initiatives which have proved useful include: pre-approval of sales rep visits to a health facility; not allowing reps into patient care areas; permitting only group presentations and not allowing sales reps to speak at educational events.
| Incentives to prescribe In a new twist on incentives to prescribe, in 1996 Searle told doctors in Canada that they would be contributing to a charitable campaign to help battered women if they prescribed its oral contraceptives, Demulen (ethynodiol diactate and ethinyl estradiol) and Synphasic (norethindrone and ethinyl estradiol). The company is free to support charitable social campaigns. Advertising to doctors that it will contribute more if they prescribe a specific prescription drug, however, is another story. Where do health concerns and patient choice come in? |
PERSONALIZED PRESCRIBING DATA
In April 1996 the provincial Health Minister in British Columbia, Canada, took the unusual step of amending the bylaws of the College of Pharmacists. The reason? Three hundred provincial pharmacies had been regularly selling prescription information to IMS, an international company specializing in marketing information, which then sold the data to multinational drug companies. Prescriptions included doctors’ names and this allowed the companies to individually target their promotional efforts. “I believe that drug companies should not be allowed to buy information on doctors’ prescribing habits,” said Health Minister MacPhail. “And I believe the public expects the government to take the action needed to ensure that the sale of this information is not permitted.”(141)
Only one other Canadian province, Quebec, has similarly banned sale of prescribing data(142) although the Canadian Medical Association has expressed opposition to the sale and use of individual prescribing data without prior consent. Anthony Boone, director of corporate communications at IMS in Canada, said in June 1996 that the company collected information on individual prescribers from about 3,000 pharmacies nationally.(143) Judy Erola, president of PMAC, the Canadian association of multinational brand name companies, supported her members’ right to buy individualized prescribing information, saying that current market research techniques, “are so sophisticated that everybody is watching out for your behaviour, and I guess doctors aren’t really any different in this case.”(144)
What about other regions and countries? IMS is active internationally and many pharmacies now maintain computerized prescribing databases. These “have made it possible to capture high quality information on prescriptions presented and dispensed from retail pharmacies”, writes Tory Tanaka, an IMS Marketing manager.(145)
In the eastern US, a similar tactic is being used to personally target consumers.(146) A large chain running supermarket drugstores, CVS Corp., uses a computerized database marketing company, Elensys, to manage its prescription databases. Elensys arranges for drug companies to pay pharmacies for the right to send “educational material” to individual consumers. These personalized letters, signed by “your CVS pharmacist” either remind consumers to refill a prescription for one of the company’s products or promote a new drug, targeting consumers who have used products for the same condition in the past. The supporting company is only mentioned in fine print at the bottom of the letter. “It’s a gross invasion”, says Dr George Lundberg, editor of JAMA, “…Do you want…the great computer in the sky to have a computer list of every drug you take, from which can be deduced your likely diseases–and all without your permission?” State authorities in nearby Maryland and Virginia have expressed concerns that these activities breach confidentiality and are discussing taking legislative or regulatory action.
RECOMMENDATIONS: Sales and provision of prescribing data
1. Pharmacists should not be allowed to sell personal prescribing information; this information reflects a confidential interaction between doctor and patient and should not be sold to a third party without the expressed written consent of both doctor and patient, whether the doctor’s name, the patient’s name or both are included.
2. National and regional information on drug utilization and sales, based on anonymized data, should be publicly available to interested consumers and health professionals as it can be used to develop and analyze the impact of health policies.
Chapter References
(131) Devlin J, Helmsley P. 1997 op cit.
(132) Lexchin J. What information do physicians receive from pharmaceutical representatives? Can Fam Phys 1997;43:941-945.
(133) Becel B, Bardelay D, ‘t Hoen E. A french physician’s network monitoring medical representatives. La revue Prescrire, 1997; Bardelay D, Bécel D, Visits from medical representatives: fine principles, poor practice. Prescrire International 1995; 4(18):120-122.
(134) Lexchin J. 1997 op cit.
(135) Roughead L. The pharmaceutical representative and medical practitioner encounter: Implications for quality use of medicines. [M.Sc. thesis] School of Pharmacy, University of South Australia, 1996.
(136) Becel B, Bardelay D, ‘t Hoen E. 1997 op cit.
(137) Talbot-Montgomery. Evaluating marketing measures in Eastern Europe. Scrip Magazine. 1997 Feb:31-32.
(138) Nordic Council on Medicines. NLN Baltic Conference [meeting report];44, Riga, 1997.
(139) Saab B. Personal communication, 1997 Sept; Beirut.
(140) Offerhaus L. Personal communication, 1997 Sept; Amsterdam.
(141) British Columbia Ministry of Health. Government acts to prohibit sale of prescription information.[News release] 1996 April 11; posted on: http://www.hlth.gov.bc.ca/cpa/newsrel/1997/087.html.
(142) Wysong P. Drug companies getting hands on physicians’ prescribing habits. The Medical Post. 1996 April 9.
(143) Robb N. Sale of prescribing data by pharmacists causes growing concern among physicians. Can Med Assoc J 1996;154(1):1747-49.
(144) Ibid.
(145) Tanaka T. 1997 op cit.
(146) O’Harrow R. Prescription sales, privacy fears; CVS, Giant share customer records with drug marketing firm. The Washington Post, 1998 Feb 15;SectA:1.