Adherence of Drug Promotional Literatures Distributed by Pharmaceutical Companies to World Health Organization Ethical Criteria for Medicinal Drug Promotion

Abstract

Background: Drug Promotional Literatures are usually relied upon for drug promotion, however studies have shown them to contain several pitfalls. World Health Organization has time and often revised the guideline to address the issue and World Health Organization Ethical Criteria for Medicinal Drug Promotion was established. Based on this guideline, several regional as well as national guidelines have been formulated. Though laws to regulate drug promotion is existent, studies have shown problems with drug promotional literatures in Nepal also. This study was carried out to analyse the drug promotional literatures distributed by pharmaceutical companies in Nepal as per World Health Organization Ethical Criteria for Medicinal Drug Promotion.Methods: A cross-sectional study over a period of one year was conducted at our department. Pharmaceutical companies registered in Department of Drug Administration, Kathmandu and consenting for the study were requested to provide ten unique drug promotional literatures of their products. Collected drug promotional literatures were analysed for inclusion of essential information as per World Health Organization Ethical Criteria for Medicinal Drug Promotion, level of biasness. Different drug promotional literatures were also classified and compared for these aspects. Results: A total of 48 pharmaceutical companies were included in the study. Drug promotional literatures (n = 372) were analysed during the study. Adherence to criteria concerned with positive attributes of the promoted medicine was found to be higher, most of the drug promotional literatures adhered to 5-8 criteria of World Health Organization Ethical Criteria for Medicinal Drug Promotion and were categorised into grade B. Difference in adherence as well as number of biased drug promotional literatures was also seen when drug promotional literatures were compared on different basis. Conclusions: Adherence to World Health Organization Ethical Criteria for Medicinal Drug Promotion was found to vary when drug promotional literatures were classified as per pharmaceutical company, type of formulation being promoted, type of drug promotional literatures.Keywords: Drug act Nepal 1978; drug promotional literatures; WHO-ethical drug criteria for medicinal drug promotion.

<p>Critical Evaluation of Drug Advertisements in a Medical College in Lalitpur, Nepal</p>

“…This is not good as DAs should have authentic references which can help doctors verify the authenticity of the claims made, if they so desire. Fortythree percent of DAs were not supported by appropriate references in a study from Nepal, 12 whereas 50% of the claims made in DAs were not supported in a study done in Bangladesh. 28 DAs citing references of non-placebo controlled randomized control trials were maximum (n=6) followed by review articles (n=3).…”

“…This is similar to other studies done elsewhere. 12,18 Though these are prescription-only drugs, their irrational use is commonly seen around the globe. [18][19][20][21][22][23] Thirty-nine DAs were having pictorial presentations of body organs followed by 18 DAs with pictures of women and 17 DAs with pictures of healthy people.…”

“…This finding was consistent with the findings from previous studies done in Nepal and Brazil. 11,12,30 Another study also highlighted the fact that the information for adverse reactions and warnings about drug interactions were missing in all the drug advertisements analyzed. 11 Regarding the references, other studies have also found that only 60% of the DAs had citable/retrievable references.…”

“…9 The DAs may not contain information about the adverse effects drug interactions and contraindications caused while using the medicine. [10][11][12] Ethical drug promotion and authenticity of the DAs are important to promote the rational use of medicines. It has been found that the information provided in the DAs may not follow the code of ethics and can promote irrational prescribing behaviors.…”

“…These studies used WHO criteria for assessing the DAs. 4,11,12 WHO has developed eleven different criteria which a drug advertisement should contain and these are shown in Table 1. Some of the Health Action International (HAI) criteria were also used to analyze the DAs.…”