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Resumen Debido a las restricciones sanitarias secundarias a la pandemia de COVID-19, diversas interacciones entre la industria farmacéutica y los médicos cambiaron. Una de ellas ha sido el método promocional de medicamentos a través de reuniones académicas en torno a padecimientos de interés financiero. Una modalidad reciente ha sido la promoción unilateral de un fármaco determinado por parte de la industria farmacéutica por medio de eventos académicos con la invitación de aparentes "expertos". Estas reuniones frecuentemente están sesgadas no hacia la atención óptima de un padecimiento, sino a la promoción comercial de un medicamento específico que pudiera o no ser la mejor opción o sin la consideración de alternativas terapéuticas asociadas. El Comité de Ética y Transparencia en la Relación Médico-Industria, de la Academia Nacional de Medicina de México, analiza esta nueva circunstancia y propone algunas consideraciones a la comunidad médica.
Abstract Due to sanitary restrictions secondary to the COVID-19 pandemic, various interactions between the pharmaceutical industry and physicians have changed. One of them has been the method for promoting medicinal products through academic meetings around diseases of financial interest. A recent modality has been unilateral promotion by the pharmaceutical industry through academic events with the invitation of so-called "experts" for the promotion of a specific drug; these meetings are often biased not towards optimal care of a disease, but rather towards commercial promotion of a specific drug, which may or may not be the best option, without considering associated therapeutic alternatives. The Committee of Ethics and Transparency in the Physician-Industry Relationship, of the National Academy of Medicine, analyzes this new circumstance and proposes some considerations to the medical community.
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Background: Large numbers of new drugs are introduced into the market every day and pharmaceutical companies are in the business of development and selling of new drug. There are different modes of drug promotion which include visual aids, leave behind leaflets and audio visuals. Drug Promotional Literatures (DPL’s) claim to provide vital and accurate information regarding the drug. To ensure rational use of drugs a set of standards laid by the WHO for ethical drug promotion.Methods: A cross sectional observational study was performed in Department of Pharmacology at a tertiary care teaching hospital of Navi Mumbai. A total of 100 drug promotional literatures were randomly collected from different outpatient departments and were evaluated by using WHO guidelines.Results: None of drug promotional literature fulfilled all WHO criteria. Generic name, Brand name, active ingredients were mentioned in all. The problem causing ingredient was not mentioned in any of the cases. Safety information was not complete, adverse drug reactions were mentioned in only 45% of the cases, contraindications and drug interactions were mentioned in 39% of the cases. Manufacturer details including name and address of manufacturer was mentioned in 67% of the DPL’s. References were mentioned in 80% of the literature out of which 84% were from journal articles.Conclusions: None of the DPL’s satisfied all the WHO criteria. Incomplete information may lead to irrational prescription of drugs. Therefore, more strict regulations need to be implemented and physicians must critically evaluate DPL’s before considering the same for prescribing.
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Resumen Los médicos requieren flexibilidad para sus prescripciones. Sin embargo, algunos límites están marcados tanto por el conocimiento vigente como por las restricciones de acceso, normas y reglamentos. El Comité de Ética y Transparencia en la Relación Médico-Industria (CETREMI) propone varias sugerencias para ayudar a los pacientes, que incluyen la selección de las mejores alternativas para cada caso, la protocolización de variaciones a los estándares de prescripción (dosis, indicaciones, etcétera) por escrito en el expediente y eludir modas, novedades no probadas, argumentos simplemente publicitarios o promocionales y conflictos de interés.
Abstract Doctors require flexibility for prescription. However, some limits are laid down both by current knowledge and by restrictions imposed by access and rules and regulations. The Committee for Ethics and Transparency in the Physician-Industry Relationship (CETREMI) of the National Academy of Medicine proposes several suggestions to help patients, which include the selection of the best alternatives for each case, formalization of prescription standards variations (doses, drug indications, etc.) written down in the medical records, and avoidance of fashions, untested novelties, argumentations solely based on advertising or commercial promotion and conflicts of interest.
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Humans , Physicians/organization & administration , Practice Patterns, Physicians'/standards , Ethics, Medical , Physicians/ethics , Practice Patterns, Physicians'/ethics , Advisory Committees , MexicoABSTRACT
Background: Pharmaceutical companies used Drug Promotion Literatures (DPLs) as a major tool to advertise their new products. World Health Organization (WHO) has set some guidelines for promotion of drug literature. Thus, this study aimed to evaluate various DPLs for their accuracy and credibility as per WHO ethical criteria.Methods: This was an observational and cross-sectional study. Total 100 drugs advertisements published in various medical journals were collected from the library of the college. Advertisements were selected based on inclusion and exclusion criteria. The selected advertisements were evaluated based on the WHO ethical criteria for drug promotion.Results: From 100 advertisements, 73 were single drug whereas 27 were fixed drug combinations. Antimicrobials (16%) were the most promoted advertisements. Only 28% of the advertisements carried references to support their claim. Out of which majority (91.78%) were from journal articles. The generic name, brand name, names of active ingredients, manufacturer, distributor and dosage regimen were mentioned in majority of advertisements. Drug interactions (12%), contraindications (22%), precautions (24%) and side effects (22%) were least mentioned in the advertisements.Conclusions: It was observed that none of the advertisement followed all the guidelines laid down by WHO. Pharmaceutical companies should follow ethical regulatory measures to promote their product in various journals. The regulatory authority must ensure the pharmaceutical companies to follow ethical guidelines for publishing various drug promotional literatures.
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Background: Drug promotional literature (DPLs) is an integral approach of pharmaceutical marketing strategy, which can almost influence a physician to prescribe definite variety of medicine from a particular company. The objective was to evaluate the accuracy, consistency, and validity of the information in accordance with the World Health Organization (WHO) ethical criteria for medicinal drug promotion.Methods: This was an observational study, in which total 100 DPLs were sorted out to evaluate whether the information is consistent/relevant with that presented by the criteria laid down by the WHO guidelines; such as nature of claims, pictorial content presented, cited references, the indication and significance of various data such as figure, graphs, table and clinical data.Results: From all the 100 promotional literatures sorted out, all showed the INN name and brand name, amount of active ingredient, dosage form and name and address of manufacturers/distributers was shown in all; adjuvants known to cause problem were not shown. Moreover, approved therapeutic uses were clearly mentioned in 35, 48 were having pictures presented, scientific graphs and clinical data were shown in 19.Conclusions: The results reveal that, majority of DPLs satisfied only half of the WHO criteria for rational drug promotion and none of them fulfilled all the specified criteria. Incomplete or exaggerated information in DPLs may mislead and result in irrational prescription. Therefore, physicians should critically evaluate DPLs regarding updated scientific evidence required for quality patient care.
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Background: Pharmaceutical industries worldwide are heavily involved in aggressive drug promotions. WHO has framed guidelines for ethical drug promotion in 1988. The transparency of pharmaceutical advertisements is important because decision of the physician is likely to be influenced by the claims made by the pharmaceutical companies in the promotional drug brochures and pharmaceutical industries treat their marketing material as “educational material” for doctors. Authors did this study to analyze the information given on drug promotional brochures by the drug companies using ethical criteria of drug promotion by WHO 1988 and to verify the authenticity of the claims given by the pharmaceutical companies in drug promotional brochures.Methods: Cross sectional study extending from 1/8/2012 to 31/7/2013. 612 drug promotional brochures satisfied our inclusion criteria. Drug brochures were analyzed with WHO ethical criteria 1988 and further categorizing the data into type of claims, number and source of references. Validity of journal articles were checked by using a validity measure developed by Cardarelli.Results: Total 612 brochures satisfied inclusion criteria. INN was mentioned in 93.8% of collected brochures. Brand name was mentioned in 100% brochures. Content of active ingredients was mentioned in 92% of brochures. Name of the other ingredients known to cause problem 28.4% of brochures. Dosage form or regimen was mentioned in 23.2% of brochures. Approved therapeutic use mentioned in 65.7% brochures. Side effects and major adverse drug reactions were mentioned in 31.4% brochures. Precautions and contraindications and warnings were mentioned in 30.4% drug promotional brochures. Drug interactions were mentioned in 26.5% brochures. Name and address was mentioned by 69.1% brochures. There were 1144 claims and 739 references. Efficacy claims were 84.88% of the total claims. Main source of reference was from journal articles (74.1%) and among them 49.65% were randomized control trials. Only 47.94 % of the journal references were valid.Conclusions: Brochures were lacking in vital information which included contraindication, warning, precaution, name of the other ingredients known to cause problem hence companies were found violating WHO ethical criteria. Claims were not well supported with references. Less than half of the given journal references were only valid. This study highlights the need of healthcare professionals to remain cautious about promotional material presented by pharmaceutical representatives.
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Background: The study was aimed to critically analyse Drug Promotional Literatures (DPLs) using WHO guidelines. This would help to create awareness about DPLs amongst healthcare providers thus encouraging the improvement of healthcare system.Methods: This cross sectional observational study was carried out at Department of Pharmacology, Medical College Baroda. DPLs were collected & critically analysed for consistency, accuracy, validity of the provided information as per WHO guidelines.Results: Out of total 616 DPLs collected, 371 satisfied the inclusion criteria. None of the DPL was fulfilling all criteria according to WHO guidelines. Most of DPLs were having information regarding; generic name / INN (98.39%), brand name (100%), amount of active ingredient per dosage (94.07%), approved therapeutic uses (84.91%), dosage form (91.37%) and name & address of manufacturers (91.91%). Of all the DPLs, information provided for safety parameters like; name of active ingredient known to cause problem (11.59%), dosage regimen (32.88%), side effects & drug reaction (14.56%), major drug interactions (14.02%) and precautions, contraindications and warning (14.29%) seemed to be grossly neglected. Total of 431 claims were evaluated, of which the most common type of claim was efficacy (55.45%). Relevant references to claims were present in (48.74%) DPLs. Total 203 references were evaluated from 371 DPLs, of which maximum reference were from journal article (74.38%).Conclusions: From this study, it was concluded that pharmaceutical companies didn’t follow the WHO guidelines for ethical drug promotion, thus failing to fulfil the rational promotion of drugs. Given the present findings physicians should be cautious about drawing conclusions regarding medicine based on DPLs provided by pharmaceutical companies.
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Introduction: Attention to undergraduate medical education on the relationship between physicians and the pharmaceutical industry has been increasing in North America and Europe. There are no reports, however, regarding this relationship in Japanese medical education.Methods: We conducted a cross-sectional survey using a self-administered questionnaire to investigate formal undergraduate curricula on the relationship between physicians and the pharmaceutical industry.Results: Forty-four of 80 medical schools approved participation in the study, with 16 (36.0%) reporting having a formal curriculum on drug promotion. Many of the themes included in the programs were related to research ethics or conflict of interest in research, with drug promotion covered in only a few programs.Discussion: More discussion and investigation into undergraduate education on the relationship between physicians and the pharmaceutical industry, especially on drug promotion, is warranted.
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Introduction: Attention to undergraduate medical education on the relationship between physicians and the pharmaceutical industry has been increasing in North America and Europe. There are no reports, however, regarding this relationship in Japanese medical education.Methods: We conducted a cross-sectional survey using a self-administered questionnaire to investigate formal undergraduate curricula on the relationship between physicians and the pharmaceutical industry.Results: Forty-four of 80 medical schools approved participation in the study, with 16 (36.0%) reporting having a formal curriculum on drug promotion. Many of the themes included in the programs were related to research ethics or conflict of interest in research, with drug promotion covered in only a few programs.Discussion: More discussion and investigation into undergraduate education on the relationship between physicians and the pharmaceutical industry, especially on drug promotion, is warranted.
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Background: Drug advertisements form one of the major sources for updating drug information by the medical professionals. It has been observed that Indian drug advertisements provide incomplete and poor quality of essential information. However, existing information on comparison of drug advertisements in Indian and foreign journals is limited. Hence, this study was planned to compare the drug advertisements published in Indian and foreign journals. Methods: A total of 200 drug advertisements, 100 each from Indian and foreign journals, were randomly selected excluding those of medical devices, surgical appliances, nutritional supplements and ayurvedic drugs. The drug advertisements from two sources were compared for drug groups, compliance to „Ethical criteria for medicinal drug promotion‟ of World Health Organization (WHO), retrievability of cited reference(s) and mention of any additional information. Results: Drug groups advertised frequently in the Indian journals were those used for chronic diseases whereas chemotherapeutic agents topped the list in foreign journals. Brand names were mentioned in 100% advertisements in both categories of journals whereas information on other ingredients known to cause problems was not mentioned in any of the studied advertisements. Overall, compliance to WHO guidelines by advertisements was 54.6% in Indian journals and 68.2% in foreign journals. The two categories of journals didn‟t differ significantly in retrievability of cited reference(s) and additional information except for information on drug storage which was significantly more mentioned in Indian journals. Conclusions: Drug advertisements in both Indian and foreign journals were incomplete for updating drug information by medical professionals
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Background: The research and marketing of a new drug requires a lot of money by the pharmaceutical companies. Promotion through advertising brochures and leafl ets is widely used to infl uence the physicians. Most of the times, this information is the only source of new drug information for the physicians. Hence, this study to analyze the appropriateness, accuracy, and validity of promotional drug literatures was undertaken. Methods: Promotional materials were collected from outpatient departments of C. U. Shah Medical College and Hospital, Surendranagr. They were evaluated according to the “WHO criteria, 1988,” and the references cited to support the claims were checked for their validity and authenticity. The images and the pictorial content were evaluated to fi nd out any biased nature of gender representation. Results: Evaluation of the total 486 brochures showed that none of them fulfi lled all the nine criteria. Of the 308 claims, only 208 (42.79%) gave references to support the claims. Only 27 (39.13%) of the research articles among the 125 journal article cited were of high methodological quality. Among the 218 human fi gures, 144 were patients, and 103 were doctors. Female patients (62.5%) were depicted more than male patients (37.5%). Conclusion: The present study showed that pharmaceutical companies do not strictly follow the WHO guidelines and majority of the research were sponsored by companies. Hence, more stringent regulations need to be implemented for the proper promotion and dissemination of information about the new drugs.
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El presente artículo es un resumen de un grupo de conferencias sobre la industria farmacéutica mundial ofrecidas entre 2010 y 2013 en diferentes foros nacionales e internacionales. El comportamiento de la producción y consumo de medicamentos en el mundo, teniendo en cuenta que se trata de un bien social que se utiliza para prevenir enfermedades y restablecer la salud del ser humano, ofrece un panorama extraño en relación con las reales necesidades de la población. Se analiza cuáles son los elementos implicados en ese comportamiento. Comienza con una caracterización de la industria farmacéutica mundial contemporánea y analiza tres aspectos que considera están relacionadas con estos resultados: la investigación médico-farmacéutica, la promoción e información médica y el funcionamiento de las agencias reguladoras nacionales de medicamentos. La industria farmacéutica mundial ha aportado enormes ventajas al tratamiento de las enfermedades. Es un hecho irrefutable, pero la Gran Pharma no es una industria cualquiera y requiere ser rentable. La globalización y el neoliberalismo han creado patrones de motivación y conducta basados fundamentalmente en los intereses del mercado. Debemos estar alertas en el futuro. Este nuevo siglo introduce nuevos retos a los pueblos, sus gobiernos y a la Gran Pharma en relación con la salud y la enfermedad y su enfrentamiento(AU)
This article summarized a group of lectures on the world drug industry delivered from 2010 to 2013 in a number of national and international fora. Taking into account that a pharmaceutical is a social asset used to prevent diseases and recover human health, the behavior of the drug production and consumption worldwide shows a awkward overview in terms of the real needs of the population. An analysis was made on the elements involved in such behavior, beginning with a characterization of the world current drug industry and analyzing three aspects related to the results: medical-drug research, medical promotion and information and operation of the national drug regulatory agencies. The world drug industry has provided huge benefits for the treatment of diseases and this is an undeniable fact; however, the Big Pharma needs to be profitable. Globalization and neoliberalism have created patterns of incentives and behaviors mainly based on the market interests. We should be aware of that in the future. This new century poses new challenges for the peoples, their governments and for the Big Pharma in terms of health, disease and how to face it(AU)
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Humans , Drug Industry/economics , Pharmaceutical Preparations/administration & dosage , Pharmaceutical Preparations/economicsABSTRACT
There is limited mechanism to monitor the drug promotional campaign by pharmaceutical industries despite the fact that there is enough evidence of irrational pharmacotherapy increasingly encountered even in the developed countries. Unethical pharmaceutical promotional practice is a common cause of irrational pharmacotherapy which is a most common problem worldwide. Main objective of this study was to evaluate the medicinal promotional literatures provided by the pharmaceutical companies for accuracy, consistency and validity of the information presented in it, using World Health Organization (WHO) criteria for ethical medicinal drug promotion. Two hundred & fifty (n=250) literatures were collected randomly from selected doctors chambers in Barisal, Bangladesh. One hundred & thirty (130) of those literatures were excluded for being either duplicates, reminder literatures, promoting medical devices or cosmetics. The remaining (120) literatures were then screened to match their macro-informational contents against same advised in world health organization ethical criteria for medicinal drug promotion. The name of active constituent(s), content of active ingredient(s) per dosage form & brand name, were mentioned in 100% (n = 120) of promotional literatures, whereas dosage form were mentioned in 91.66% (n = 110), therapeutic indications were mentioned in 99.1% (n = 119) of literatures but informations on side effects mentioned in only 55.33% (n = 70), contraindications in 63.33 % (n = 76), precautions in 51.67% (n = 62) & references in 70 % (n = 84) of drug promotional literatures (DPLs). None of them mention anything about adjuvant. None of the promotional literatures fulfilled all the WHO criteria. Screened literatures were found to display poorly reliable and unbalanced medication information. Healthcare providers shall, accordingly, seek independent medicinal information sources, and not solely depend on commercial sources of medicinal information. Official regulators shall strictly define and mandate medication information contents in printed pharmaceutical promotional materials. Healthcare providers should, also, master the skills of appraising such promotional printed materials if rational medication use is to be achieved. Pharmaceutical industries did not follow the WHO guidelines while promoting their products, thus aiming to satisfying their commercial motive rather than fulfilling the educational aspect of promotion.
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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.
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Background: Though drug promotion regulations exist worldwide, low quality of journal drug advertising is a global issue. Medical journals are regarded as a leading source of information for new drugs. They may also modulate prescribing behavior of physicians without their knowledge. A comparative analysis of advertisements from different countries may provide insights regarding strengths and weaknesses of different regulating systems. Aims: Prescription drug advertisements from the Indian Journal of Dermatology, Venereology, and Leprology (IJDVL) and Journal of American Academy of Dermatology (JAAD) were compared to check their compliance with criteria of World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Methods: All the prescription drug advertisements of at least one page length appearing in all the issues of IJDVL and JAAD from January 2012 till December 2012 were included in this study. The contents of both advertisements were compared for compliance regarding different criteria of ethical codes for drug advertising of WHO and IFPMA. Statistical analysis was done using Fisher’s exact test. Results: Compared to IJDVL, more advertisements in JAAD complied with WHO and IFPMA codes. On the whole, advertisements in IJDVL had signifi cantly less information regarding the approved usage, dosage, abbreviated prescribing information (API), summary of scientifi c information, safety information regarding the drug, and references to the scientifi c literature to support various claims. However, JAAD had more advertisements with multiple claims than IJDVL, and many advertisements interspersed between scientifi c articles while IJDVL had none. Conclusion: The complex issue of ethical drug advertising in dermatology journals requires constant review and discussion. Dermatologists should be cautious in assessing any advertisement or claim even if it seems evidence-based. The results from our study highlight the need for a global, proactive and effective regulatory system to ensure ethical medicinal drug advertising in medical journals.
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Dermatology , Humans , India , Prescription Drugs , United StatesABSTRACT
Comenzando con un análisis crítico del rol de los medicamentos en la práctica de profesionales de salud y consumidores, el texto intenta recalcar la influencia ejercida por las estrategias promocionales, tanto las mas antiguas como las mas recientes, por iniciativa de los productores, con el fin de reforzar valores y creencias que sobrepasan lo que se puede obtener con la utilización de un fármaco. Son seleccionados algunos ejemplos para ilustrar el problema de la intensificación del proceso de medicalización, particularmente a partir de los equívocos advenidos del uso irracional de anfetaminas volcadas hacia el control del apetito, o hacia los niños clasificados como hiper-activos y con deficit de atención, además de los fármacos para andropausia o depresión.
Beginning with a critical analysis of the role drugs play in the behavior of consumers and health professionals, this text aims at evaluating the influence of both traditional and new promotional strategies of the pharmaceutical industry designed to create values and believes that exceed what in fact can be expected from drug consumption. Some examples were chosen to illustrate the intensification of the medicalization process. Special emphasis was given to the irrational use of amphetamines to diminish the appetite and to control weight or to treat children supposedly suffering from Attention-Deficit Hyperactivity Disorder (ADHD) as well as to drugs used in cases of depression and supposed andropause.