Abstract

AUTHENTICATION OF PROMOTIONAL MATERIALS OF MEDICINAL DRUGS IN NEPAL: AN EVIDENCE BASED APPROACH

Rajan Manandhar*, Aashish Bhattarai, Sanukaji Shrestha, Bishnu Prasad Kandel, Jagadishwor Maharjan

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Abstract

In Nepal, the physician depends on the information provided by marketing representatives. The information containing in promotional material is not in accordance to the requirement of the National regulation authority. The information in the promotional materials is often misleading. The promotional materials are analyzed critically and audited with the help of currently available evidences in the medical literatures and the questionnaire was built to obtain the information about the marketing representatives. 1125 promotional materials were collected from the marketing office of the pharmaceutical companies, hospitals (Bir Hospital, Tribhuvan University Teaching Hospital, Nidan Hospital Pvt Ltd, Sumeru City Hospital) and marketing representatives in Kathmandu valley. The collected materials were analyzed for the misleading claims in those materials which are not substantiated by the scientific evidences. Out of total collected materials 780 were of Nepalese manufacturing company whole 345 where of multinational company. The collected promotional material have the active ingredients (99.37%), brand name (100%), source citation (12.98%), and the excipients and their role in 5 out of 1125 (0.44%) in the promotional material. Similarly only 4.44% of promotional material had information about date of production of information. Also, information about indication was present in 97.60%, side effect and major ADR’s in 42.67 % and precaution, contraindication and warnings in 37.33% of total collected promotional material. The misleading claims are overstated (71.36%), ambiguous (7.72%), false (4.56%) and debatable (16.36%) were identified by examining the promotional material critically. The information in promotional claims must be accurate, scientifically sound, truthful, objective and balanced and must reflect the correct state of knowledge. And the medical representatives should have appropriate scientific training and product knowledge.

Keywords: Promotional material. Misleading claims, Pharmaceutical marketing.