Medicines Information and the Regulation of the Promotion of Pharmaceuticals

Alves, Teresa Leonardo; Lexchin, Joel; Mintzes, Barbara

doi:10.1007/s11948-018-0041-5

Cited by 41 publications

(38 citation statements)

References 76 publications

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“…Some physicians may have been influenced by opioid‐related industry payments 67 . Most were likely misled by views of upstream organizations and industry's marketing (category I‐III organizations) promoting CR oxycodone's long‐term effectiveness and safety even when given in high doses (discussed earlier) 53,60,65,97,127‐129 . Lack of access to non‐opioid treatments for pain was a barrier for health care professionals 123,130 …”

Section: Category IV Organizations: Strongly Influenced By Category I‐iii Organizationsmentioning

confidence: 99%

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

Makhinson

Seshia

Young

et al. 2021

Evaluation Clinical Practice

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Rationale Prescribed opioids are major contributors to the international public health opioid crisis. Such widespread iatrogenic harms usually result from collective decision failures of healthcare organizations rather than solely of individual organizations or professionals. Findings from a system‐wide safety analysis of the iatrogenic opioid crisis that includes roles of pertinent healthcare organizations may help avoid or mitigate similar future iatrogenic consequences. In this retrospective exploratory study, we report such an analysis. Methods The study population encompassed the entire age spectrum and included those in whom opioids prescribed for chronic pain (unrelated to malignancy) were associated with death or morbidity. Root cause analysis, incorporating recent suggestions for improvement, was used to identify possible contributory factors from the literature. Based on their mandated roles and potential influences to prevent or mitigate the iatrogenic crisis, relevant organizations were grouped and stratified from most to least influential. Results The analysis identified a chain of multiple interrelated causal factors within and between organizations. The most influential organizations were pharmaceutical, political, and drug regulatory; next: experts and their related societies, and publications. Less influential: accreditation, professional licensing and regulatory, academic and healthcare funding bodies. Collectively, their views and decisions influenced prescribing practices of frontline healthcare professionals and advocacy groups. Financial associations between pharmaceutical and most other organizations/groups were common. Ultimately, patients were adversely affected. There was a complex association with psychosocial variables. Limitations The analysis suggests associations not causality. Conclusion The iatrogenic crisis has multiple intricately linked roots. The major catalyst: pervasive pharma‐linked financial conflicts of interest (CoIs) involving most other healthcare organizations. These extensive financial CoIs were likely triggers for a cascade of erroneous decisions and actions that adversely affected patients. The actions and decisions of pharma ranged from unethical to illegal. The iatrogenic opioid crisis may exemplify ‘institutional corruption of pharmaceuticals’.

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Section: Category IV Organizations: Strongly Influenced By Category I‐iii Organizationsmentioning

confidence: 99%

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

Makhinson

Seshia

Young

et al. 2021

Evaluation Clinical Practice

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“…Widespread advertising of the many new antibacterial medicines that became available during the period we studied may have, at least in part, driven the overuse of those drugs and hence the emergence of resistant organisms. This speculation is supported by the following evidence: promotion influences prescribing and the appropriate use of medicines; increased promotion leads to an inappropriate increase in prescribing rates, and less appropriate prescribing and/or increased prescribing costs; antimicrobial drugs were the most commonly advertised products during the study period and would therefore have been widely prescribed (Table ); the numbers of adverts appearing reflected the number of available products (Figure ); bacterial resistance is partly driven by overprescribing …”

Section: Discussionmentioning

confidence: 96%

“…• increased promotion leads to an inappropriate increase in prescribing rates, and less appropriate prescribing and/or increased prescribing costs; 10,11 • antimicrobial drugs were the most commonly advertised products during the study period and would therefore have been widely prescribed (Table 1);…”

Section: Discussionmentioning

confidence: 99%

The British Pharmacological Society's WDM Paton Memorial Lecture 2019: How doctors were informed about pharmaceutical products through advertising in the British Medical Journal from 1955/6 to 1985/6

Aronson

Green

2019

Brit J Clinical Pharma

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We have reviewed pharmaceutical advertisements in every available issue of the British Medical Journal (BMJ) in 12‐month periods during 1955/6, 1965/6, 1975/6, and 1985/6. We have determined the amount of advertising, the therapeutic areas covered, and whether adverts reflected the large number of New Chemical Entities (NCEs) launched during that time. For each product we recorded the therapeutic indications, the marketing company, and the number of adverts appearing. The total number of products advertised fell from 340 in 1955/6 to 260 in 1965/6, 70 in 1975/6, and 16 in 1985/6. Advertisement numbers and companies advertising also fell. Antimicrobial drugs and cardiovascular drugs were the top products advertised over the 30 years, with respiratory, analgesic, and gastrointestinal drugs also in the top five. The number of different drugs advertised by individual companies fell from around eight per company in 1955/6 to one or two in 1985/6. There was good concordance between the most advertised therapeutic areas and NCEs entering the market. From the 1950s to the 1980s prescribers were extensively informed about pharmacological advances in therapeutics through BMJ advertisements. Many novel drugs that were advertised proved to be of lasting value. The Medicines Act 1968 introduced product licensing, regulations requiring demonstration of quality, efficacy, and safety, and restrictions on advertising. Subsequently many companies reduced their advertising or stopped altogether. Since advertising influences prescribing, and since antimicrobial drugs were the most commonly advertised products during 1955–86, we speculate that advertising, resulting in excess use, may have, at least partly, driven bacterial drug resistance.

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“…Importantly, Pakistan should adopt standard codes of ethics on pharmaceutical marketing, such as WHO or IFPMA with inhouse modifications in line with the needs of local health care and pharmaceutical market. However, critics of the way that pharmaceutical promotion is regulated believe that the WHO code is significantly stronger than the IFPMA one [ 31 , 32 ]. Besides, professional bodies and councils should audit the conduct of their members and must have system of periodic assessment of drug related knowledge of practicing MDs.…”

Section: Discussionmentioning

confidence: 99%

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

Gul¹,

Saeed²,

Saleem

et al. 2021

BMC Med Ethics

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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.

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Medicines Information and the Regulation of the Promotion of Pharmaceuticals

Cited by 41 publications

References 76 publications

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

The British Pharmacological Society's WDM Paton Memorial Lecture 2019: How doctors were informed about pharmaceutical products through advertising in the British Medical Journal from 1955/6 to 1985/6

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

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