A publicidade testemunhal de medicamentos difundida por influenciadores digitais e seu enquadramento no direito luso-brasileiro / The testimonial advertising of medicines disseminated by digital influencers and its framework in Portuguese-Brazilian law

A indústria farmacêutica tem encontrado novas técnicas para promover os medicamentos isentos de prescrição médica junto do público geral. Neste contexto, a publicidade testemunhal permite incrementar a credibilidade da mensagem, ficando o seu enquadramento dependente da categoria do emissor nos ordenamentos jurídicos português e brasileiro. Adotando uma perspectiva de direito comparado, o presente trabalho visou analisar a publicidade testemunhal, com especial enfoque nos depoimentos veiculados por influenciadores digitais que recomendam o consumo de medicamentos. Trata-se de um estudo qualitativo, assente no levantamento bibliográfico e legislativo, bem como na análise detalhada de decisões dos organismos de autorregulação competentes, tanto em Portugal como no Brasil. Concluiu-se que alguns influenciadores digitais podem ser considerados pessoas famosas, e não meros consumidores, o que determina a ilicitude da publicidade difundida, atenta a necessidade de acautelar a objetividade e o uso racional dos medicamentos. No entanto, resultou das decisões analisadas uma abordagem tradicional destas novas técnicas de promoção de medicamentos, centrada ainda nas menções obrigatórias e nos princípios gerais vigentes em matéria de publicidade.

The pharmaceutical industry has found new techniques to promote over-the-counter drugs to the public. In this context, testimonial advertising makes it possible to increase the credibility of the message, its framework being dependent on the category of the sender, in the Portuguese and Brazilian legal systems. Adopting a comparative law perspective, the present work aimed at analysing testimonial advertising, with a special focus on testimonies given by digital influencers who recommend the consumption of drugs. It is a qualitative study, based on a bibliographic and legislative survey, as well as on a detailed analysis of decisions by competent self-regulatory bodies, both in Portugal and Brazil. It is concluded that some digital influencers can be considered famous people and not just consumers, which determines the unlawfulness of widespread advertising, considering the need to safeguard objectivity and the rational use of drugs. However, a traditional approach to these new techniques of drugs promotion, still focused on mandatory mentions and the general principles of advertising, resulted from the decisions analyzed.

Assessment of knowledge, attitude, and practice of self-medication among undergraduate medical students in a tertiary care teaching hospital

Background: Self-medication (SM) is defined as the use of medication by a patient on his own inventiveness or on the suggestion of a pharmacist or a untrained person instead of consulting a medical practitioner (WHO guidelines, 2000). Being future medical practitioners, SM has a special influence in medical students and they inevitably urge SM practice themselves and also for others as they are perusing professional course and will be learning different drugs and their proper use. Aim and Objectives: We had undertaken this study to estimate the prevalence of SM and also to find out the factors that influence SM practices in the second, third, and final year undergraduate medical students. Materials and Methods: The prospective and questionnaire-based study was undertaken among undergraduate medical students in a tertiary care hospital, after getting approval from the Institutional Ethics Committee to obtain information on SM practices. Descriptive statistics were used for analysis of data. Results: In our study, 58% were females and 42% were males. About 81.5% of the students were aware about Over the Counter drugs. About 97% of students had no knowledge on safety of SM, 69.5% did not prefer taking SM, and 92% do not want to prefer SM for non-medical persons. Medical stores were the major (81%) of SM and fever was the major symptoms for which students took SM. Commonly used drug for SM was Paracetamol. Conclusion: Conscientious SM can be promoted in both the medical students and the general public. From the present study, we conclude that SM is quite common in undergraduate medical students that may be because of easy accessibility of drugs and information from text books and classroom teaching.

Self-medication with antibiotics and analgesics among undergraduate medical students in a tertiary care teaching hospital

Background: Self-medication is to obtain and consume the drugs without the advice of a physician about the diagnosis and treatment. Medical students are different from the general population because of their exposure to numerous clinical cases and also the knowledge about diseases, diagnosis and drugs. Aim and Objectives: The objective of the study was to evaluate the self-medication practices among undergraduate medical students in a tertiary care teaching hospital. Materials and Methods: This study was conducted on 150 undergraduate medical students at Rajiv Gandhi Institute of Medical Sciences, Adilabad from September 2021 to November 2021 after obtaining approval from Institutional Ethics Committee. A structured and validated questionnaire was used to collect information regarding self-medication practices. The study was based on their knowledge and attitude about the practice of self-medication. Results: 150 students participated in the study. Out of 150 students, 136 practiced self-medication. Of them 86 were female and 50 were male. The most common reason which lead to the practice of self-medication was their convenience. Fever was the most common indication for self-medication. Paracetamol was the most common analgesic and Azithromycin was the most common antibiotic used for self-medication. Nausea was the most common among adverse drug reactions experienced by the students. Conclusion: This practice of self-medication masks the sign and symptoms of underlying pathology, and thus complicates and delays the diagnosis. It also creates drug resistance. The practice of self-medication assumes a special significance among the medical students as they will be the future medical practitioners and play a crucial role in counseling the patients about the practice and adverse effects associated with self-medication.

A cross-sectional study on knowledge and practice of over-the-counter drugs among 2nd year medical students in a tertiary care teaching hospital

Background: Over the counter drugs (OTC) are the drugs that can be sold by the pharmacist without the prescription of registered medical practitioner. There is an increase in the trend of usage of OTC drugs because of busy lifestyle which can result in adverse drug reactions, drug interaction, abuse, and misuse of drugs. Since medical students are future doctors and play an important role in educating the patients regarding benefits and risks of using OTC drugs, the present study is undertaken to assess the knowledge and practice of OTC drugs among MBBS students. Aim and Objectives: The main objectives of this study was to determine the commonly used OTC drugs and indications for the use of OTC drugs among MBBS students and to assess their knowledge on safety of use of OTC drugs. Materials and Methods: A cross-sectional, observational, and questionnaire-based study was conducted during December 2021 among 2nd year MBBS students, after getting approval from the Institutional Ethics Committee. Students were explained about the purpose of the study and questionnaire was administered to the students. The data collected were analyzed using descriptive statistics. Results: In our study, we observed that 75.3% of students practiced self-medication (SM) using OTC drugs for minor illnesses. The most common drugs used for SM were analgesics, antipyretics and antihistamines. The most common reason for using OTC drugs is due to influence from family and friends/seniors (30.2%). Conclusion: Use of OTC is widely practiced among health care professionals, since they are exposed to knowledge of drugs, from 2nd year MBBS itself. Since students are future doctors and play a very important role in communication of knowledge regarding medical therapy including use of OTC drugs to the patients, they should be educated in a larger way regarding pros and consequences of use of OTC drugs.

A study on use of over-the-counter drugs among 2nd year medical students – A cross-sectional study

Background: Over-the-counter (OTC) drug is a medicine that is available without a prescription, and hence also referred to as “nonprescription drug.” The sale of OTC medicines from pharmacies can help individual’s self-manage symptoms. However, some OTC medicines may be abused, with addiction and harms being increasingly recognized and found to be more common in undergraduate medical students. Aim and Objective: Objective of this study to analyze the use of OTC drugs among 2nd year medical students. Materials and Methods: A prospective, cross-sectional, and questionnaire based study was conducted among 2nd year medical students of Belagavi Institute of Medical Sciences Belagavi. Details and purpose of the study were explained to students and informed consent was taken. Questionnaires consist of 25 questions related to use of OTC drugs, their knowledge and attitude toward OTC drugs. Questionnaires are then collected back from students on the spot after 15 min. All the data pooled and results are analyzed in descriptive statistics. Results: A total of 88 respondents were analyzed, 87.5% participants knew the definition of OTC and 69.5% use medication without prescription. All the students practiced self-medication however only 37.5% students agree with practice. Fever, cold, and headache are the most common condition for using OTC drugs. Analgesic, antipyretics, and antihistamines are the highest among OTC stocked at home. About 61.3% students have knowledge of Adverse Drug Reactions associated with OTC drugs. Conclusion: Use of OTC drugs is common form of health care having potential benefits and health hazards. Awareness should be created among students to restrict the use of self-medication and pharmacists toward sale of drugs without prescription.

Analysis of Decision-making Data for Payment of Adverse Drug Reaction Relief System to Over-the-counter Drugs to Promote Their Proper Use / 社会薬学

Adverse Drug Reaction Relief System is intended for people who suffer adverse health effects from drugs despite their proper use, including over-the-counter (OTC) drugs. The decision-making data for the payment of relief benefits associated with OTC drugs and the instructions-for-use provided by community pharmacists and registered retailers were investigated. The results showed that the relief benefit nonpayment rate for OTC drugs was 3.9% and the number of cases was 9, of which 5 were due to improper use. Among the OTC drugs covered by relief benefits, the most common were schedule II pharmaceuticals, which were sometimes used in combination with prescription drugs. These results suggest that pharmacists and registered retailers should check for the use of concomitant drugs (e.g., with drug notebooks) at the time of the OTC drug sale. Pharmacists and registered retailers should provide a detailed explanation of the drugs to consumers and confirm that the information is understood, especially when schedule II pharmaceuticals or psychotropic drugs are sold. Additionally, information on the initial symptoms of an adverse drug reaction and treatment should be provided to prevent serious reactions. Follow-up with consumers during OTC drug use may also reduce the risk of misuse.

Considerations on Relevant Technical Requirements for Listing Application of Over-the-counter Traditional Chinese Medicine / 中国实验方剂学杂志

In this paper， a comparative analysis is carried out on the policy of listed drugs in Australia， the policy of over-the-counter drugs in Japan， the policy related to the conversion of Chinese patent medicines to over-the-counter drugs， and the policy related to health food. The focus is on one of the possible situations for the registration of over-the-counter traditional Chinese medicines （TCMs）， namely new prescription-composed over-the-counter TCMs. This paper discussed separately from the three parts of the scope of Chinese medicinal materials in the prescription medicines， the scope of indications， and the technical requirements， in order to provide references for the technical requirements related to the registration of over-the-counter TCMs. Recommendations on the marketing and registration of new prescription-composed over-the-counter TCMs：①It is recommended to formulate a list of medicinal materials for the use of Chinese herbal medicines， and consider including raw materials of health food. On this basis， a batch of safe Chinese medicinal materials/decoction pieces was added. And consider dynamic supervision， such as allowing the addition or recall of Chinese medicinal materials/decoction pieces in the list of medicinal materials. ②The scope of indications is recommended to consider the scope of indications for the conversion of Chinese patent medicines to over-the-counter TCMs in China， and the selection of medium-risk indications can reflect the characteristics and advantages of TCM treatment. ③Efficacy evaluation needs to provide high-quality scientific evidence， including clinical research data， and consider relaxing the requirements for non-clinical pharmacodynamic trials.

Comorbid Zolpidem Dependence and Over-the-Counter Compound Analgesic Abuse

Zolpidem is a commonly prescribed hypnotic used to treat insomnia. However, its potential for abuse and dependence has recently become controversial. Although over-the-counter (OTC) medications are widely used, their abuse potential has not received much research attention. We report a case of comorbid zolpidem and OTC compound analgesic abuse. OTC analgesics may serve as gateway drugs, and physicians must be cautious about this issue, especially when prescribing hypnotics or benzodiazepines.

Determination of non-prescription generic reference preparations: the case analysis / 国际药学研究杂志

There are two ways for marketing Over The Counter(OTC)drugs in the US: the OTC monographs and new drug application/simple application(NDA/ANDA) review procedures. New products that meet the final monograph can be marketed without FDA approval, but the reference preparations and standard preparations are not searchable in the FDA database, so the reference preparation cannot be determined for such products generally. For the convenience of finding out and confirming the US non-prescription generic reference preparation, this paper introduces the US OTC drug review procedure and inquiry method, taking the US OTC product caffeine tablet as an example to show how to determine the US OTC generic drug reference preparations, so as to provide a reference for the selection of reference preparations in the consistency evaluation of generic drugs in China.

Knowledge, attitude and practice of self medication among undergraduate medical students in a teaching institution

Background: Self medication is the usage of medicines without the advice of the physicians, without proper diagnosis of the illnesses and without any prescription. Medical students are more liable to self medicate themselves due to their partial knowledge and easy availability of drugs. This study was conducted to assess the pattern of self medication in undergraduate medical students. This study was conducted to assess the knowledge, attitude and practice of self medication among undergraduate medical students in Kanyakumari government medical college, a teaching institute in South Tamilnadu.Methods: A self-designed questionnaire was given to the undergraduate medical students who were willing to participate in the study. 264 students participated of which 111 were males and 153 were females in the age group of 17-24 yrs. Data were collected. Results were given as percentages and counts.Results: The prevalence of self medication was found to be 85.2% which is very high. Commonest reason was its usefulness in mild illnesses (89.3%). The commonly used group of drugs was antipyretics (98.6%), ointments (44.4%) and antibiotics (41.3%). The commonest source of information was old prescriptions (62.8%). The common ailments were fever (88%) and cough and cold (80.4%). Ironically 72.88% opined that self medication should not be practiced.Conclusions: Increased prevalence of self medication among medical students implies that they are highly exposed to the adverse effects of drugs. Steps should be taken to curtail self medication among medical students by educating and creating awareness among them.

Angioedema caused by over the counter use of dicyclomine hydrochloride and paracetamol fixed dose combination in a child: a case report

Authors describe a case of angioedema in a male child due to over-the-counter (OTC) use of fixed dose combination (FDC) of Tab. dicyclomine hydrochloride (20mg) and paracetamol (500mg) for abdominal pain. Use of OTC drugs in children without a doctor抯 suggestion can lead to unnecessary medication use and is not free of risks. Here, there is a probable causal relationship between the suspected drug and angioedema according to WHO-UMC criteria for Causality Assessment. This case was also reported to the Pharmacovigilance Programme of India (PvPI) through PvPI ADR android application.

A comparative study on self medication practices in ACSR Government medical college in Nellore, India

Background: Self medication is rampant in medical undergraduates. There is a need to evaluate the extent and factors that govern self medication. This study was conducted in 7th semester and 5th semester undergraduates to compare the knowledge, attitude and practice regarding self medication.Methods: It is a questionnaire based study in a total of 294 medical students comprising 147 students each belonging to 7th and 5th semesters to assess determinants and practice methods of self medication in the past one year.Results: 100% of 7th semester and 90% of 5th semester students self medicated. Majority followed modern medicine. Awareness of OTC drugs, essential drugs and generic drugs was not optimum. Students self medicated based on old prescriptions and text books for perceived mild illnesses like common cold, fever and headache. Non steroidal anti-inflammatory drugs and antihistamines were most commonly used. Not all students checked package insert prior to use.Conclusions: Self medication practice is more pronounced in 7th semester than in 5th semester students. 7th semester students used diverse drugs compared to 5th semester students who used limited groups of drugs.

Perceptions and practices of self-medication among undergraduate medical students at Gulbarga Institute of Medical Sciences, Kalaburagi, India

Background: Self-medication practice is widespread in many countries and the irrational use of drugs is a cause of concern. It assumes a special significance among medical students as they are exposed to knowledge about diseases and drugs. To assess practice and perception of self-medication among undergraduate medical students.Methods: It is a descriptive study in which study population was comprised of 2nd year undergraduate medical students of Gulbarga Institute of Medical Sciences, Kalaburagi, Karnataka, India. Total 134 students were included in the study. Written informed consent was obtained from each volunteer prior to the study. Students were given a questionnaire that included both open and close ended questions about self-medication practice. Data was analysed and presented as counts and percentages.Results: It was found that 72 (54%) students practiced self-medication. The principal morbidity for seeking self-medication was cold and cough as reported by 70 (53%) students. Antibiotics were most commonly self-medicated as reported by 55 (36%) students. Only 34 (25%) students opined that self-medication is part of self-care.Conclusions: Self-medication is widely practiced among under­ graduate medical students. In this situation, we should educate the students about advantages and disadvantages of self-medication.

Factors Associated with the Use of Over-the-Counter Medications in the Elderly Living Alone / 정신신체의학

OBJECTIVES: This study aimed to describe the use of over-the-counter (OTC) drugs and to identify predictors for their use in the elderly living alone. METHODS: This is a cross-sectional study that enrolled 1,099 subjects. Data regarding socio-demographic status, medical condition, cognition, mood disorder and use of OTC drugs were collected using self-administered questionnaire and from a specific semi-structured interview by a trained nurse. Data regarding use of OTC drugs were analyzed using descriptive statistics. Logistic regression analysis was applied to examine factors associated with the use of OTC drugs. RESULTS: The use of OTC drugs were reported by 35.4% of the subjects. Analgesics (13.6%) was the most frequent drugs. Depression (OR=1.10, 95% CI=1.10–1.87) and comorbidities measured by cumulative illness rating scale (CIRS) (OR=1.08, 95% CI=1.03–1.12) were significantly associated with the use of OTC drugs in the elderly living alone. CONCLUSIONS: Depression and severity of underlying medical conditions could be a predictor of the use of OTC drugs in the elderly living alone. The clinicians should be vigilant regarding the potential use of nonprescription medications in the elderly.

The Narrative Structure and Message Disseminated by Television Commercials about Over-The-Counter Oral Drugs─A Qualitative Analysis / 社会薬学

This study aimed to identify the messages disseminated by television commercials about over-the-counter (OTC) oral drugs for analyzing the narrative structure of contents at a view of community pharmacists. We analyzed 92 television commercials about OTC oral drugs aired by 5 key commercial broadcasting stations from April 2013 to March 2014. We did the content analysis of the transcripts of television commercials ; 20 labels and 8 categories were found. The categories were “interesting the story,” “inspired desire for symptom improvement,” “emphasized attraction of the products,” “standing as a specific cure,” “products created a state of happiness,” “information about effect-efficacy and dosage,” “showing something other than drug-induced symptomatic improvement,” and “encouraging consumers to purchase the product.” The most common used categories to start TV-CM stories were “interesting the story” or “inspired desire for symptom improvement” and to end it was “encouraging consumers to purchase the product.” The message disseminated by television commercials about OTC oral drugs might misinform consumers regarding OTC drugs and self-care. Pharmacists should communicate with consumers to clear these misunderstandings instead of simply providing information about the effect-efficacy and dosage of OTC drugs.

Genre-based comparison of package inserts of Chinese materia medica and medicine produced in US / 中草药

The package insert is an important source of drug information which plays a critical role in guiding patients taking the medicine. Package inserts of 60 over-the-counter (OTC) oral drugs produced in the US and OTC oral traditional Chinese medicine (TCM) were collected respectively in order to compare their macrostructure and contents. The results show that there are more moves in package inserts of TCM while the contents of those US drugs are more detailed and complete. The results further deepen the understanding of package inserts as a genre and contribute to the improvement of package inserts of TCM.

Effective Use of Over-The-Counter (OTC) Drugs during a Disaster: / 医薬品情報学

<b>Objective: </b>For effective use of over-the-counter (OTC) drugs that are provided as relief supplies during a disaster, we aimed to develop a list of OTC drugs that can be used during a disaster.<br><b>Methods: </b>We obtained information about OTC drugs useful during a disaster by examining results of previous studies and lists of drugs used during a disaster.  We analyzed this information with the expert pharmacist of disaster support and established a rationale for our list and developed “the List of Useful OTC Drugs During a Disaster” and “the Information Card on Useful OTC Drugs During a Disaster.”<br><b>Results: </b>We developed our list of OTC drugs based on the following parameters: (1) while people with severe disorders (e.g. renal failure) are treated by medical teams, those with minor physical conditions are treated using OTC drugs and (2) those OTC drugs that can be used as substitutes for prescription drugs were preferably selected.  The List of Useful OTC Drugs ()—During a Disaster (containing 56 items) was developed for use mainly by medical professionals.  Further, pharmacists from disaster-relief medical teams may not always be available in disaster-stricken areas; therefore, the Information Card on Useful OTC Drugs During a Disaster was developed to enable disaster victims to independently make a certain level of decision.  The information card contained pictograms to call the attention of the disaster victims.<br><b>Conclusion: </b>Our results can provide a common tool for drug suppliers, medical professionals engaging in relief works in disaster-stricken areas, and disaster victims.

Actitudes del consumidor después de elegir un producto equivocado / Consumer Attitudes After Choosing a Wrong Product

Al suponer que ha existido confusión con la elección de un medicamento de venta libre, este estudio analiza de qué manera la emoción de frustración que expresa un consumidor da lugar a intenciones conductuales particulares. La actitud de un consumidor ante la confusión es la dinámica entre sus emociones y las conductas que este anticipa (i.e., cambio del producto, búsqueda de información e intención de consumo). Esta dinámica es analizada en una situación experimental simulando una decisión errónea. Los resultados demuestran que a) la emoción ante la confusión explica la intención de cambio y que b) la intención de cambio a su vez está asociada con un menor interés en consumir un producto equivocado y con una mayor intención de obtener información.

Because of consumers' confusion with an over the counter drug, feelings of frustration lead an individual to particular behavioral intentions. Consumers' attitude towards confusion is the relationship between their emotions and behavioral intentions (i.e., changing the product, intention to seek for information, and intention to consume). This relationship is analyzed in an experimental setting simulating a wrong decision. Results demonstrate that a) emotions due to confusion explain higher intentions to exchange a product and that b) this is then associated with lower intentions of taking a medicine and higher intentions of gathering information.

Survey of Education about Over-the-counter Drugs in Pharmaceutical Universities / 医薬品情報学

<b>Objective: </b>Over-the-counter (OTC) drugs play an important role in medical treatment.  Triage and counseling by pharmacists are important to ensure that self-medication with OTC drugs is effective.<br><b>Methods: </b>We conducted a questionnaire survey to evaluate the education about OTC drugs offered by 79 Japanese pharmaceutical universities, from August to September 2009.  The questionnaire asked whether or not lectures and practical training concerning OTC drugs are given to students, and if so, the number of hours and the school year in which they are given.  Questions about future plans were also included.<br><b>Results: </b>The response rate was 70 %.  Eighty percent of respondent universities gave lectures on OTC drugs, and 98 % expected to do so in the future.  Lectures on OTC drugs were most commonly given in the fourth year.  Fifty percent of universities offered practical training about OTC drugs, and 75 % expected to do so in the future.<br><b>Conclusion: </b>Compared with our 2005 survey, the number of universities offering lectures had increased more than twofold.  Although education about OTC drugs in pharmaceutical universities has improved, it remains insufficient.

Over-the-counter whitening agents: a concise review

Tooth discoloration is commonly found in the dental clinic and tooth bleaching has been considered the preferred esthetic alternative, being more conservative, safe and with predictable results. Supervised home-use of 10 percent Carbamide Peroxide (CP) bleaching with custom-trays is the most common bleaching procedure dispensed by dentists to their patients. The good results obtained with this technique stimulated the flourishing of new products and techniques. Over-the-counter (OTC) bleaching products appeared as a low-cost alternative to bleach discolored teeth without dentist supervision. Different OTC products are available in supermarkets, drug stores or on the Internet, including rinses, paint-on brushes, toothpastes, chewing guns, dental floss, and whitening strips. There is lack of clinical evidence regarding the safety and effectiveness of these products, being most of the studies supported by the manufacturers'. Basically, toothpastes, chewing gums, and dental floss are removal agents of superficial stains. Rinses and paint-on brushes with low levels of hydrogen peroxide have some whitening effect, but without clinical relevance. Strips present similar esthetic results and side-effects, compared to bleaching with 10 percent CP using trays; however, the studies have financial support from the manufacturers and were based on short term evaluations. Legislation varies widely in different countries regarding OTC dental bleaching. Concerns have appeared due to the potential abusive use of these self-medication agents, especially in young patients, with potential harmful results. Dentists should be acquainted with this kind of products to be able to inform their patients. In conclusion, there is a need for independent clinical trials to provide sufficient evidence regarding the use of OTC bleaching products.