The Unethical Practices of the Pharmaceutical Industries in Bangladesh in their Drug Promotion and its Impacts

This article highlights the unethical practices of pharmaceutical industries in Bangladesh in their drug promotion and its impacts. It is evident that pharmaceutical industry is one of the promising sectors in the industrial field of Bangladesh. Now, the pharmaceutical industries of Bangladesh are exporting their products to more than 100 countries in the world after meeting the local demand. This study also represents the growth and market share of pharmaceutical industries, total exports of last five years, unethical practices in promotion of pharmaceutical industries and impacts of unethical practices. To conduct the study both secondary and primary data have been used. The target population of this study was medical professional men including physicians of Phultala Thana in Khulna District. Finally the study provides some recommendations to overcome the situation. There are a lot of rooms for Bangladesh to develop in this sector. In this study, the unethical practices in promotion of pharmaceutical industries that can make obstacle in the sustainable growth of pharmaceutical business in Bangladesh are discussed meticulously.

LEGAL AND ETHICAL ASPECTS OF PROMOTION OF DRUGS IN SPECIALIZED PRINTED MEDIA

The article presents the results of assessing the quality of information used in the promotion of drugs in specialized pharmaceutical print media (PM). The research was carried out on 224 unique promotional modules about medicinal products, placed in specialized PMs. The content of the modules was assessed for compliance with the requirements of federal laws "On Circulation of Medicines", "On Advertising" and the criteria of the Code of Good Practice of the Association of International Pharmaceutical Manufacturers (AIMP). The analysis of the mechanisms of legislative support for the promotion of drugs in specialized PMs showed that the existing requirements are fragmented and vague in terms of content, which can lead to a violation of the principle of balancing information about drugs when making a professional decision on their appointment or recommendation. Existing regulatory requirements do not provide professional information needs of specialists, since they do not meet the criteria for completeness and reliability of information presentation, which creates the problem of specialists seeking additional professional information to ensure the rational use of medicinal products. The obtained results of the study indicate the discrepancy of the entire studied set of promotional modules about drugs in specialized PMs with the ethical criteria for promoting drugs. In modern conditions, due to insufficient legislative regulation of the content component of drug promotion among healthcare professionals and the fragmentary observance of ethical standards for drug promotion in specialized PMs, the role and relevance of specialized PMs as a source of professional information about drugs for pharmaceutical workers is lost.

Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases

Context: Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing. However, in 2012, a federal circuit court ruled in United States v. Caronia that truthful off-label promotion was protected under the First Amendment, threatening government enforcement in this area. Methods: The authors extracted cases from the WestLawNext database that mentioned Caronia from 2012 to 2019. They collected information about plaintiff, procedural history, product and manufacturer involved, and case outcome. Cases were categorized as either “follows,” “does not follow,” or “distinguishes” from Caronia. The authors qualitatively reviewed the full text of each case to verify whether Caronia was given substantive discussion for perceptions of off-label promotion, application of commercial speech rights, and how courts interpreted Caronia. Findings: Among 42 cases in the study cohort, 22 (52%) followed Caronia's core holding that truthful, non-misleading off-label promotion was not actionable under FDA rules. By contrast, 20 cases (48%) treated Caronia negatively, either declining to follow (9 cases) or distinguishing it (11 cases). Conclusions: Enforcement on off-label marketing became more challenging after Caronia. This gives manufacturers greater flexibility to promote drugs for unapproved uses despite the substantial public health risks.

Perceptions of and barriers to ethical promotion of pharmaceuticals in Pakistan: perspectives of medical representatives and doctors

Background In Pakistan, drug promotion practices, ethical or unethical, have rarely been in the spotlight. We aimed to assess the perception and barriers of medical representatives (MRs) and doctors (MDs) regarding ethical promotion of pharmaceuticals in Pakistan. Methods A cross sectional survey was conducted in seven major cities of Pakistan for 6-months period. Self-administered questionnaire was used for data collection. Logistic regression and five-point Likert scale scoring was used to estimate the perceptions and barriers. Results Compared to national companies (NCs), the medical representatives (MRs) of multinational companies (MNCs) strongly believed that their companies follow World Health Organization (WHO) (OR; 5.31, p = 0.0005), International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (OR; 6.45, p = 0.0005) and national codes of ethics (OR; 5.84, p = 0.0005). MNCs trained their MRs (OR; 6.68, p = 0.0005), provide accurate and valid scientific data (OR; 4.01, p = 0.007) with adequate system of accountability and controls on product samples (OR; 1.96, p = 0.047), while, NCs sponsor social or entertainment activities, seminars and conferences, and all sort of facilitation in form of gifts of their choice and clinic renovation for medical doctors (MDs). MDs perceptions were similar to MRs mentioned above, yet strongly agreed that companies offer cash payments or equivalents to MDs. The MRs of NCs/MNCs and MDs agreed/strongly agreed that no external accountability, profiteering, pressure on sale targets, job insecurity, condoning unethical promotion by high-ups’ and business promotion by junior MDs were the predominant barriers. Conclusion In conclusion, MRs of MNCs and MDs believed that MNCs follow certain codes of ethics in the promotion of pharmaceuticals, while NCs tend to be more profit oriented and even condone unethical promotion. All stakeholders, MRs, MDs and companies, might pose certain barriers, intentionally or unintentionally, in ethical promotion.

Drug Promotion and Self-Medication Practices in Lagos, Nigeria

The study examines the effects of drug promotional practices and self-medication behaviour on public health in Lagos. It used a multistage sampling method to select 315 respondents. The researcher selected 12 in-depth interviewees and six focus group discussants to provide qualitative data based on his knowledge of their relevance. The data were analyzed. The logistic regression analysis indicated that drug promotions were less than once more likely to trigger self-medication behaviour among residents relative to being a rule-breaking activity. The study concludes that self-medication endangers public health in Lagos. It suggests the partnership of the stakeholders to promote public drug education, provide free healthcare for all, and criminalize unethical drug promotion practices in Lagos.