Evaluation of rationality of promotional drug literature using World Health Organization guidelines

Abstract

Objectives:The study was aimed to evaluate collected drug promotional brochures for accuracy, consistency, and validity of the information presented in it, using World Health Organization (WHO) criteria for ethical medicinal drug promotion. Drug promotional brochures were evaluated for the type of claims and pictorial content presented in it and for references cited in support of these claims.Material and Methods:This observational, cross-sectional study was conducted in the outpatient department of Government Medical College and Hospital, Nagpur, India. In addition to the fulfillment of “WHO criteria, 1988,” we examined 513 promotional brochures for the type of claims and pictorial content presented in it and references quoted in support of claims to check their retrievability, type, and authenticity.Results:None of the promotional literature fulfilled all WHO criteria. Majority (92%) brochures claimed about the efficacy of product, and a few about safety (37.8%). Out of 1003 references given in support of various claims, 84.4% were from journals and only 28.5% were validly presented researches. Brochures presenting irrelevant pictures were 41.3%, whereas brief prescription information (BPI) of the promoted drug was given only by 8.8% brochures.Conclusion:Pharmaceutical industries did not follow the WHO guidelines while promoting their products, thus aiming to satisfying their commercial motive rather than fulfill the educational aspect of promotion.

Critical appraisal of drug promotional literature using World Health Organisation guidelines

“…Similar line of findings was reported from various other studies. [10][11][12][13][14] The pharmaceutical industries rather accomplish their own commercial motive and neglected the ethical educational aspect. This carries a marked impact on the overall health delivery system.…”

Comparison of drug advertisements published in Indian and foreign journals

“…Avoidance of information on safety parameters like side effects, major adverse drug reactions, precautions, warnings, major interactions in Indian journals more than in foreign journals might be not to discourage the prescribers from prescribing that product. Mali et al (2010) have also observed mention of safety parameters only in 8.8% of Indian advertisements. 6 Lack of references in Indian journals" advertisements more than foreign journals increases the risk of claims being false.…”

“…Mali et al (2010) have also observed mention of safety parameters only in 8.8% of Indian advertisements. 6 Lack of references in Indian journals" advertisements more than foreign journals increases the risk of claims being false. However, compared to another similar study by Lal A et al (1997), the compliance of Indian advertisements to WHO criteria, in this study, has been found to be higher in most of parameters including safety parameters.…”

“…4 Since the pharmaceutical companies have commercial interest in promoting their products, these sources usually highlight the information which encourages the medical professionals to prescribe these products rather educating them 5 and have potential for inducing inappropriate prescribing practices and increasing health care costs 6 as these newer drugs are usually relatively costly.…”

“…A number of studies have shown that the drug promotional literature in India often provides incomplete and poor quality of essential information. 6,9,10 However, existing information on comparison of drug advertisements in Indian and foreign journals (i.e. journals published from countries other than India) is limited.…”