Critical evaluation of promotional drug literature based on the WHO criteria

Background: Pharmaceutical companies use drug promotional literature (DPL) as an important mode to promote their products and it also influences the prescribing behavior of prescribers. However, information provided in promotional literature may be inadequate or misleading which may lead to irrational prescribing. The WHO has provided ethical criteria for medicinal drug promotion. Aims and Objectives: This study was undertaken with the aim to analyze the promotional drug literature for their compliance to the WHO ethical criteria for medicinal drug promotion, 1988. Materials and Methods: A cross-sectional and observational study was carried out to evaluate the extent to which promotional literature collected from private physicians meet the WHO ethical criteria for medicinal drug promotion. A total of 100 promotional literature were evaluated for their fulfillment of the WHO criteria. Results: Information regarding brand name, generic name of drugs, dosage form, therapeutic uses, and active ingredient per dosage form was present in most of the promotional drug literature in the present study. However, the information such as safety profile of drugs, precautions, warnings, and drug interactions was not mentioned in most of the DPLs. Conclusion: The majority of DPLs evaluated in this study did not comply with the WHO guidelines for medical drug promotion. As prescribing behavior of physicians is influenced by promotional literatures, regular training of health professionals and medical students regarding critical analysis of DPLs can help in ethical and rational prescribing.

Perception of resident doctors regarding promotional drug literature

Background: Promotional drug literature (PDL) seems to be the source of information most commonly used by physicians to update their knowledge on existing and new drugs. Aim and Objectives: The objective of this study was to assess the knowledge and attitude of resident doctors about PDL. Materials and Methods: It was a prospective observational, questionnaire-based study. Approved by institutional Ethics committee. A pre-validated questionnaire (google form) was sent among the resident doctors. A total of 50 residents voluntarily participated in the study. The collected data were analyzed as frequencies and percentage. Results: About 88% of residents were aware about term PDL. Only 50% resident doctors felt that PDL provides adequate drug information. Around 78% participants were aware that both forms of nomenclature should be included in PDL. Almost 92% participants had knowledge regarding complete drug information in PDL. Regarding safety information, 70% resident doctors felt that contraindication should be included in PDL. About 48% participants agreed that PDL might influence prescribing practice. Around 78% participants agreed that doctors’ integrity could compromised by accepting gifts from pharmaceutical representative. Conclusion: However, participants had knowledge about PDL but there is a need to educate students at an early stage about ethical guidelines for assessing PDL.

Knowledge and attitudinal survey of drug promotional literature among second year undergraduate students: a questionnaire based study

Background: Promotion of drugs has been increased enormously with the advancement of technology and use of internet and media etc. Pharmaceutical manufacturers spend vast amount of money on promotion usually through medical representatives by providing printed advertisements. But, it has been seen that these printed advertisements are not up to the mark usually, they either overemphasize the efficacy or hide the safety profile for the sake of company抯 profit. All these promotional activities influence the prescribing pattern of doctors. So, the present study has been conducted to assess the knowledge and attitude of second year undergraduate students about promotional literature and to train them accordingly for improving the prescribing behaviour.Methods: A questionnaire based study containing 9 questions was conducted in 110 second year undergraduate students after taking informed consent. Statistical analysis was done by using descriptive statistics by graph pad prism version 6.01.Results: Among respondents 60 (61.2%) were males and rest 38 (38.8%) were females. 50 (51%) of the respondents have chosen Indian pharmacopoeia as a trusted source of information followed by others. Most common factor affecting the prescribing attitude was reported as updates from clinical trials 49 (50%) followed by prescriber抯 knowledge. Most important intervention taken to stop misleading drug promotional activities has been reported as formulation of strict regulation by the health care authorities against any misleading promotion.Conclusions: Promotional activities by manufacturers influence the attitude and prescribing pattern of doctors. So, it is important to teach the students about their rational use by critically analysing it.

Critical analysis of drug promotional literature available to the medical practitioners

Background: To ascertain whether the pharmaceutical companies are following the WHO criteria for “Ethical medicinal drug promotion 1988” and “OPPI Code of pharmaceutical marketing practices, 2012” and to what extent. Also, to evaluate the therapeutic claims made by them in their drug promotional literature and other aspects.Methods: Drug Promotional Literature (DPL) from different pharmaceutical companies was collected from various Medical practitioners and analysed to see if they achieved objectives. Therapeutic claims made by them were classified as authentic, exaggerated, controversial, false, and misinterpreted.Results: Total 250 DPLs were collected and critically analysed for information content. Out of the 11 WHO criteria for ethical medicinal drug promotion (1988), Majority (30%) followed only 54.54% of the criteria while only 4% followed 100% of the criteria. The total number of claims in the 250 DPL were 354 of which 52.8% were authentic and 47.2% were misleading. From the misleading claims: 28.7% were exaggerated, 34.7% were controversial, 22.8% were false, 23% were ambiguous.Conclusions: This study enabled us to find out to what extent the pharmaceutical industries follow the standard criteria for DPL and evaluate the claims made by them. DPL is one of the important sources of drug information. Some of the pharmaceutical companies failed to follow the WHO criteria while advertising their products in order to make them look more lucrative having an underlying commercial motive. As they influence prescribing patterns of the clinicians, misleading promotional literature would result in irrational prescribing of drugs. To avoid this, DPL has to be critically evaluated.

Critical Review of Drug Promotional Literature Using the WHO Guidelines: An Observational Study

Background: Drug promotion refers to all the informational and persuasive activities of the pharmaceuticals, which include theactivities of medical representatives, drug package insert, provision of gift and samples, conducting or organize seminar, etc.However, promotion of drug by ethical way is important because it may influence the irrational drug prescriptions.Objective: The objective of this study was to evaluate and analyze the drug promotional literature distributed by pharmaceuticalcompanies to physicians using the World Health Organization (WHO) criteria for ethical medicinal drug promotion.Materials and Methods: A total of 100 drug promotion literatures were evaluated collected from the various outpatientdepartments and evaluated according to the WHO criteria for drug promotion.Results: Among 100 drug promotional literatures (DPLs), a total of 109 drugs were promoted. However, only 33% of DPLsgives side effect, precaution, contraindication, and warning and only 10% of DPLs gives drug interaction information. None ofthe DPLs fulfills all criteria of who drug promotion.Conclusion: Information on the DPLs given only focus on the positive aspect of the drugs and not fulfill all the WHO criteriaof drug promotion

Drug promotional literatures (DPLs) evaluation as per World Health Organization (WHO) criteria.

This study was aimed to evaluate the drug promotional literatures (DPLs) as per World Health Organization (WHO) criteria and also to evaluate claims, references and pictures presented in DPLs. It was an observational, cross-sectional study conducted at the outpatient department of Civil Hospital, Ahmedabad, a tertiary care teaching hospital for period of 2 months. Printed drug promotional literatures for modern drugs were collected as per selection criteria and analyzed. WHO guidelines were not fulfilled in any of the 200 DPLs. Out of 299 claims, most commonly presented claim in 192 DPLs was efficacy (45.15%) followed by pharmaceutical properties (26.75%). 130 (65%) DPLs did not provide any references to support claims while only 70 (35%) DPLs provided references. Most commonly used reference was journal articles 66 (88%) followed by websites 5 (6.66%). Most common source of journal article reference was research article 53 (85.48%) followed by review article 7 (11.29%). 125 (78.61%) DPLs presented with irrelevant pictures while only 25 (15.72%) DPLs presented appropriate pictures. Information on adverse drug reactions, contraindications and drug interactions was missing in most of DPLs. None of the promotional literatures contained all of the information as per WHO guidelines for medicinal drug promotion. They were lacking with scientific and critical information.

Pharmaceutical promotional literature: opinions of physicians in a tertiary care hospital in Mumbai.

Backgrounds: The aim of this study was to assess physician’s opinion regarding pharmaceutical promotional material and make an objective assessment about their opinion on current drug promotional methods. Methods: 250 questionnaires were sent to physicians. Questionnaires was based on question assessing physicians opinion about 1) Influence of information provided on their prescription writing pattern. 2) Most common information which they seek for and find missing, was assessed on a Likert scale of 1 to 5 for each type of information 3) Type of promotional material preferred for drug information. 4) Significance of the various types of references cited which was assessed on likert scale of 1 to 5. Results: 207 questionnaires were returned. 59.5 % of the physicians were of the opinion that the information provide in promotional literature mostly influences their prescription. Physicians feel that there is minimal information on adverse drug reaction, comparison with other drugs, price, drug interactions and clinical trial results and contraindications. Likert score of 4.8, 4.7, 4.6, 4.6, 4.5 and 3.9 respectively. 41.07% physicians prefer pamphlets, and leave behind leaflet. Whereas they consider randomized controlled trials, meta-analysis and case controlled or cohort studies as significant references, with likert score 4.9, 4.7, and 4.6 respectively. Conclusion: There is need for strong regulatory infrastructure and monitoring of the content of pharmaceutical promotional activities. Therefore, in the absence of effective regulations and standards physicians should be aware of the risks of using non independent information sources.