Drug Information Sources Research Articles

Perceptions, experiences and expectations of physicians regarding the role of pharmacists in low-income and middle-income countries: the case of Tehran hospital settings

ObjectivePharmacists play a pivotal role in the health continuum, and the perceptions and expectations of physicians towards pharmacists have been reported as a key factor in the interprofessional relationship. This...

Status of package insert guidelines for drugs accessible as over the counter drugs

Background: As per Indian pharmacopoeia, package inserts are part of a label that provides information on the article. It may be the sole source of information for drugs, which are available in the pharmacies without the prescription and it may include both prescription and over the counter (OTC) drugs. So, to aid in safety and efficacy of these drugs, package inserts must follow the standard guidelines (The Drugs and Cosmetics rule, 1945). The objective of this study was to observe the status of the standard guidelines for package insert in drugs accessible as OTC drugs.Methods: Based on the inquiries made with pharmacies, list of drugs commonly bought without prescription was made. 256 drugs were evaluated. Their package inserts were observed for the extent to which the guidelines given by The Drugs and Cosmetics rule 1945, section 6.2 and 6.3 are being followed. Secondary objectives were made to assess if package inserts are physician friendly or patients friendly.Results: Package inserts were missing in 180 (70%) of the drugs. Therapeutic indications were present in 71% of the available package inserts (76). Pharmaceutical information was given in 57% of the package inserts. English was the preferred language and medicinal terms were used. Only one package insert was patient friendly.Conclusions: Package inserts should be made available in every drug. There should be a separate patient oriented package insert guideline, as per US food and drug administration (FDA), in India as well. This will aid in their safe and effective use.

An investigation on patient attitudes toward package inserts and their accessibility in Iran.

Background:Package inserts (PIs) can be a source of information for patients, especially when clinicians do not provide adequate consultations to the patients. Therefore, for the first time, we investigated the state of PIs in Iran and evaluated patients’ attitude toward PI.Materials and Methods:In this descriptive study, conducted in a major teaching pharmacy in Isfahan, Iran, in 2016, 100 patients who presented a prescription were interviewed randomly and all medications in their medication bags were examined. The main outcome measures were whether or not the dispensed medications were accompanied by a PI and the behavior of patients in reading these PIs.Results:From the 237 medication items investigated, 129 (54.4%) were dispensed with a PI. Eighty-four percent of patients read the PIs and only 19% stated reading a non-Farsi PI. The level of education was the only significant factor related to reading the PI (P = 0.02). Reading the side effects was the main reason for reading the PI (64%). PIs were considered useful by 83% while 25% kept PIs as a source of drug information. Experience of fear to take the medication after reading the PI was reported by 47%.Conclusion:About half of medications were dispensed along with the PI. Although the majority of patients report reading the PIs and consider them useful, confidence in using the medicine may be diminished after reading the PI. Patients with higher education read the PIs the most.

Pattern of Drug Information Queries in a South Indian Tertiary Care Teaching Hospital

Drug information centers have been established to provide unbiased information to healthcare workers and patients. The pattern of drug information queries received and answered by the drug information centre in a tertiary care teaching hospital in South India was assessed. Prospectively documented drug information queries, received and answered by the drug information centre over a 15-month period, were reviewed retrospectively for various parameters including status of the requestor, mode of receipt, mode of reply, type of query, purpose of query and references used. A total of 2010 queries were received and answered during the study period. Queries were received mainly from physicians (41 %), followed by nurses (n=595; 30 %) and pharmacists (n=462; 23 %). Dentists, students and healthcare professionals from outside the institution accounted for 139 (6 %) queries. Internet-based resource was the main reference source (n=952; 47 %) followed by textbooks, intranet resources and journals. Patient care-related queries were the most common. The information sought included product identification (22 %), drug dose or schedule (16 %), product availability (13 %), drug of choice/therapeutic alternatives/therapeutic use (10 %), product information (10 %), drug use in special populations and administration (6 % each), compatibility/stability/storage (5 %) and adverse reactions (4 %). The drug information center in a teaching hospital handles a wide range of queries from various healthcare workers, meets specific healthcare needs and serves as a valuable source of drug information. The impact of this service on improving patient care and minimizing errors warrants further study.

Preference for utilization of drug information sources among postgraduate medical residents

Background: Drug use information is vital for ensuring rationale and safe drug therapy. Physician across the globe use different sources of drug information during their routine practice. Postgraduate residents are in their interim-phase of education, research and clinical exposure. They are exposed to vast array of authentic and non-authentic drug information due to technology advancements and interaction with peers and medical representatives. There exists paucity in literature on their preference and drug information pattern. Therefore, this study was conducted to find out their preference for drug information sources.Methods: The present study was prospective, observational, questionnaire-based survey. The study was conducted between March 2017 and April 2017. The study included postgraduate medical residents pursing speciality courses at a tertiary care teaching hospital in Navi-Mumbai. Data was compiled and analysed in Microsoft excel.Results: Majority postgraduate residents preferred Non-electronics source for drug information. Text books (84%) were commonly preferred followed by medical journals in Non-electronic sources while internet-websites (76%) followed by e-journals and e-books were preferred in electronic sources. Majority preferred non-electronic sources for drug pharmacology and adverse reactions while electronic was preferred for indication, interaction, cost and therapy guidelines. For information on new drugs, majority preferred journals (71%) and websites (64%). Lack of time, source knowledge and high cost were perceived limiting factors for drug information.Conclusions: Postgraduate residents have varied preferences for drug information resources. Internet websites poses a challenge for authentic drug information. Interventions in the form of continuous medical education are required to improve their information-seeking behaviours.

Evaluation of indoor prescriptions of depression in psychiatry department of a tertiary care hospital in North India

Background: Depression is one of most common psychiatric illnesses affecting the human population and poses significant economic burden to society. Prescription for depression usually involves multiple medications sometime irrationally prescribed.Methods: Present study involved evaluation of 65 indoor prescriptions of patients diagnosed with depression from Psychiatry Department in a tertiary care hospital. The prescriptions were evaluated on basis of WHO Core Indicators for writing a good prescription. The demographic characteristics of the patient population were studied. Number of drugs prescribed per prescription and the average number per prescription were calculated to assess polypharmacy. The cost involved in treatment using latest market data from drug information source and the rationality of prescriptions were also evaluated.Results: 80% of the prescriptions were not in accordance with the WHO Core Indicators. An average of 2.415±1.102 medications were prescribed per prescription indicating polypharmacy. Insignificant difference was observed in cost per prescription per month of medicines when compared with lowest priced products available in market.Conclusions: Polypharmacy was found in most prescriptions and monotherapy was instituted in five prescriptions only, with clonazepam as the most prescribed antidepressant drug. Majority of prescriptions did not conform to WHO core indicators for prescription writing.

Development of a tool to assess the completeness of drug information sources for health care professionals: A Delphi study

The aim of this study was to create a standard set of essential drug information items as a tool to assess the completeness of any type of drug information source, regardless of its length, using a Delphi consensus panel of European health care professionals. A compilation of drug-related information items was performed by searching several resources for health care professionals and a final list of 162 items was obtained. Fifty-seven experts in drug information from 23 different European countries were invited to participate in a three-round Delphi technique to obtain consensus on items considered essential and non-essential content of information. Consensus for the first, second, and third rounds was defined as ≥90%, ≥80%, and ≥75% agreement, respectively. Of the 57 experts invited, 32 completed the first round, 27 the second, and 29 the third. Consensus was achieved for 28.3% of the items in the first round, 49.3% in the second, and 58.3% in the third. The final cumulative consensus was 67.7% (n = 126) for items considered essential and 16.1% (n = 30) for items considered non-essential. The final tool obtained to assess the completeness of drug information sources was composed by 126 essential items grouped into 11 sections. This tool allows for the comparison of different information sources for the same medicine and the information content for different medicines in the same source.

The clinical significance of QT prolongation associated with tamoxifen: A review of the literature.

Objective To review the literature discussing QT prolongation associated with the use of tamoxifen in order to evaluate the clinical significance. Data sources A search of PubMed (1946 to 2017), MEDLINE (1946 to 2017) and EMBASE (1947 to 2017) was performed using a combination of the following search terms: tamoxifen, estrogen antagonist, selective estrogen receptor modulator, QT prolongation, QT interval, long QT syndrome and torsades de pointes. All searches were limited to human subjects. Reference lists of the literature found were also reviewed but did not reveal any further articles. Study selection Articles reviewed were relating to humans only and included clinical trials and case reports that mentioned QT prolongation in association with the use of tamoxifen. Data synthesis It can be common for patients on tamoxifen to also be on a number of different medications being used to treat comorbid medical conditions. Such combinations of medications increase the potential risk for drug interactions, such as drug-induced QT prolongation. Tamoxifen is often flagged by tertiary drug information sources as a drug with indeterminate effects on the QT interval. However, the risk may be elevated when combined with other QT-prolonging agents. A total of five publications were identified, including two phase I clinical trials and three case reports, which discussed the association between tamoxifen and QT prolongation. Conclusions Tertiary drug information sources identify tamoxifen as an agent that may cause QT prolongation when used in combination with other QT-prolonging agents. However, based on the limited number of published reports found, it would suggest that the use of tamoxifen concurrently with other agents known to prolong the QT interval is likely to be of low risk for causing a clinically significant QT-prolonging event, especially at a dose of 20 mg daily.

Information about medications in the district of Bamako, Mali.

The aim of our study was to investigate the quality of information about pharmaceutical products in Mali. The study surveyed 98 prescribers, 60 pharmacists, and the package inserts of a basket of 30 generic medicines, compared to those of the corresponding proprietary versions. We made a rational choice of 98 doctors from various specialties and levels of the health system and randomly selected 60 of the 215 pharmacies in the district of Bamako (Mali). A rational sampling of generic medicines provided us with a basket of 30 drug notices for the antimalarial, antibiotic, antalgic, antipyretic, and anti-inflammatory agents used most in the Republic of Mali. This study showed that the pharmaceutical industry, through its sales representatives, are the main sources of drug information and that this information is not always adequate. The study also found that the content provided with generic medicines is sometimes different from the information for the proprietary brand-name drugs.

Drug schedules: knowledge among undergraduate medical students in a government medical college in Eastern India

Background: In India many of the prescription only drugs (Schedule H) are available without prescription, leading to injudicious use, incidences of dangerous drug interactions, and unnecessary economic burden. Thus awareness among healthcare professionals and among common public are equally important. Objective was to assess the knowledge among undergraduate medical students in a government medical college in Eastern India regarding drug schedules in India.Methods: Willing 3rd semester and 5th semester students participated in the study. We used a pre-tested validated two-part questionnaire to assess the knowledge of undergraduate medical students regarding different drug schedules.Results: 5th semester students gave significantly higher correct answers (P<0.0001) regarding awareness about Drugs and Cosmetics Act 1940, different drug schedules in India, expiry period, guidelines for maintaining the details of standards for patent and proprietary medicines, guidelines regarding import and manufacture of new drugs, guidelines regarding import and manufacture of new drugs, any special license is required for the manufacture and sale of psychotropic drugs, drugs marketed only under “generic name”, guideline regarding pack size of drugs, and guidelines regarding good manufacturing practice (GMP)?. Analysis of second set of questionnaires revealed that the 5th semester students identified the different drug categories more correctly compared to the 3rd semester students.Conclusions: Doctors are one of the principle and reliable sources of drug information for the general population. Thus, it becomes relevant that the undergraduate medical students should regularly brush up their knowledge regarding drug regulations even after passing Pharmacology examination in the later years of training.

A critical evaluation of information in drug promotional brochures for validity as per WHO criteria

Background: Promotion of drugs through publication of promotional literature is a standard practice of pharmaceutical companies. This study is aimed at critically analyzing the drug promotional brochures.Methods: Observational study was conducted in Department of Pharmacology, Government Medical College Amritsar according to WHO guidelines. 100 brochures of different pharmaceutical companies were collected at random from various OPDs of a tertiary care hospital.Results: Only 14 % of total brochures demonstrated overall adherence to WHO guidelines. Safety information was lacking in 88%. Irrelevant pictures were found in 66% brochures while relevant illustrated information was included in only 23 % of brochures. Out of total illustrations found relevant (n=44), 45.5% did not quote any reference, and results didn’t match with original study in 11.4%.Conclusions: Our study points towards big lacuna in drug promotional brochures, an important source of drug information. Low percentage of adherence to the guidelines in the study reflects commercial interest of pharmaceutical companies and lack of will to correctly disseminate the drug related information.

Drug Use and Sources of Drug Information Among Secondary School Students in Imo State, Nigeria

This study was an investigation into drug use and sources of drug information among secondary school students in Imo State, Nigeria. A sample of 1400 students, aged 16-17 years was studied. Percentages were used to describe the students’ drug use and sources of drug information. Chi-square was used to verify the four hypotheses postulated for the study. Results showed that the main drugs the students who took part in the study used included analgesics, stimulants, anti-malaria, alcohol, worm expellants, nasal decongestants, sleeping pills, laxatives, and anti-biotics and their main sources of drug information included print media, television, radio, and friends and peers. Chi-square tests indicated that the differences in the use of drugs between boys and girls were significant in most cases. It is recommended that drug education be made an integral part of secondary school curriculum.

An audit of drug package insert: a survey based study in India

Background: The primary source of drug information is a Package Insert. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label or prescribing information. Regulatory requirements for drug package inserts or leaflets vary across nations. United States-Food and Drug Administration (US-FDA) and European Medicines Agency (EMA) amend their regulations governing the content and format of labelling for drug products from time to time. US-FDA has published a revised guideline in the Federal Register of January 2006, which is being followed by pharmaceutical industry of the country.Methods: Around 192 package inserts were collected from pharmacies located at different areas. They were analyzed according to Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945.Results: Out of 192 package inserts, most available information in therapeutic indications is Posology and method of administration (97.3%) followed by Contra-indications(93.2%) in pharmaceutical information, it is Special precautions for storage (77%) followed by Shelf life in the medical product as packaged for sale (33.8%).Conclusions: Contents of the package inserts should be complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society. Therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.

Analysis of completeness of drug package inserts available in India

Background: Information about the drug used can be obtained from various sources of drug information. One of the easily available sources of drug information is package insert (PI). The PI is the primary source of drug information. The PI or leaflet is the leaflet containing information about the medicinal product which accompanies the medicinal product. A good PI contains the approved, essential, and accurate information and it contains information in a language that is not promotional, false, or misleading. It is evidence based and periodically updated. However, not all PIs conform to all the above standards. Hence, the present study was undertaken to evaluate the appropriateness of presently available drug PIs. Aims and Objectives: The aim of this study is to evaluate the completeness of the presently available PIs and grade them. Materials and Methods: The present study was cross-sectional, observational, prospective study. 55 PIs were collected from various pharmacies in request. Out of them, 5 were found to be duplicated and were rejected. Remaining 50 PIs were analyzed based on criteria laid under the Drugs and Cosmetics Rules 1945 under section 6.2 and 6.3 of schedule D. Results: Among the 50 PIs, 35 (70%) were of Indian companies and 15 (30%) were of multinational companies. Furthermore, 31 (62%) were parenteral preparations, 15 (30%) were oral formulations, and 04 (8%) were topical preparations. PIs were inadequate as to retail price of drug (0%), references (14%), effect on ability to drive machines(26%), updated information, and provision of full information on request (38%). 52% of PIs were A category, 48% of PIs were B category, and none of PIs were C category. Conclusions: The present study shows that there is still paucity of information and requirement of standardization of the presently available PIs, especially with regard to the size and shape of PIs, font size, references, effect on ability to drive machines, updated information, and provision of full information on request. Furthermore, PIs should be made mandatory with all medications.

Self-medication practices among 2nd year medical students in a rural medical college of Telangana state

Background: Self-medication is a part of self-care, hence responsible use of drugs by physician is vital to prevent their acute and chronic adverse effects. People take medicines with their previous experiences and old prescriptions. People also take drugs on suggestion of pharmacist, friends and relatives during mild illness and emergencies. Aim and Objectives: To study the prevalence, knowledge, perception, and reasons in practice of self-medication among undergraduate medical students in rural medical college of Telangana state. Materials and Methods: Study was conducted among 2nd year medical students of Kamineni Institute of Medical Sciences, Narketpally, Nalgonda, Telangana by using questionnaire. Results: 129 students participated in study of which 96% of medical students use drugs for self-medications. Allopathic drugs (86%) are commonly using drugs. Students use drugs for fever (74%), cold and cough (68%), headache (50%), and pain (41%). Frequently using drugs are antipyretics (62%), and non-steroidal anti-inflammatory drugs (NSAIDs) (48%), cough suppressants (43%) and antibiotics (34%). The sources of drug information are old-prescription (53%) and pharmacists (30.6%). Reasons for self-medication are mild nature of illness (79%) and urgency. Conclusions: Self-medication is common practice in medical male and female students. They commonly use allopathic medicines like paracetamol and other NSAIDs for fever and sore throat. They use self-medication during mild diseases and also urgency. Frequently use old prescription and pharmacist’s assistance as sources of drug information.

Drug promotion in a resource-constrained Nigerian environment: A cross-sectional study of the influence of pharmaceutical sales representatives on the prescribing behaviors of medical practitioners in Abia State

Background: Pharmaceutical drug promotion is an important component of pharmaceutical care and is one of the factors that may lead to unethical drug prescriptions. As the impetus for rational drug use grows, emphasis should also be focused on prescribing behaviors of physicians, particularly in resource-poor settings. Aim: The study was aimed at describing the influence of drug promotion by pharmaceutical sales representatives (PSRs) on the prescribing behaviors of medical practitioners in Abia State, Nigeria. Materials and Methods: A descriptive study was carried out on a cross-section of 185 medical practitioners in Abia State, Nigeria. Data collection was done using a pretested, self-administered questionnaire that elicits information on practice and attitude to drug promotion, types of incentives, frequency of visits, drug promotion methods and information, sources of drug information, and awareness of code of regulation on drug promotion. Results: The age of the participants ranged from 28 to 71 years. There were 166 males and 19 females. The prescribing practices of 47.6% of the medical practitioners were influenced by drug promotion and 66.5% of them had positive attitude to drug promotion. One hundred and sixty-four (88.6%) were visited >12 times in the previous year. The most common incentive received was branded stationeries (100.0%); predominant drug promotional method and information were in-person clinic encounter (100.0%) and brand names of the drugs (100.0%), respectively. The most common source of drug information was calling a colleague/pharmacist (93.5%) while 84.9% of the respondents were aware of code of regulation on drug promotion. The prescribing practice (P = 0.041) and attitude (P = 0.032) to drug promotion were significantly associated with working in public hospitals. Conclusion: Drug promotion by PSRs influenced prescribing practices of medical practitioners with 66.5% of them having positive attitude to drug promotion. The most common incentive, drug promotion method, and information were branded stationeries, in-person clinic encounter, and brand names of products/drug indications, respectively. The most common source of drug information was calling a colleague/pharmacist, and awareness of code of regulation of drug promotion was inadequate.

A Qualitative and Quantitative Comparison of Adverse Drug Reaction Data in Different Drug Information Sources.

Background:For safe use of medicines, awareness regarding the existing knowledge of adverse drug reactions (ADRs) is essential to prevent, identify, and manage them.Aim:The present study is planned to assess variation in documented ADRs of antihypertensive drugs in various sources of drug information.Material and Methods:A cross-sectional, observational study was undertaken to analyze the different sources of ADRs-related information. Textbooks, National Formulary India (NFI), Drug Today (DT), and Current Index of Medical Specialties (CIMS) were analyzed for ADRs pertaining to nine antihypertensive groups comprising a total of 44 drugs. ADRs were categorized according to body systems, tabulated, and compared. Quantitative and qualitative analyses of ADRs and serious ADRs were done.Results and Discussion:Textbooks mostly provided ADRs of drug groups as a whole and not of individual drugs. None of the analyzed sources mentioned all antihypertensive drugs. DT contained information for the maximum number of drugs studied (81.8%) and NFI gave information for 29.7% drugs only. There was a wide variability among various resources while listing ADRs. NFI listed the maximum number of total ADRs, and least ADR information was provided by DT. NFI mentioned the maximum number of serious ADRs (47) for prototype drugs followed by CIMS (36) and DT (8). The quality of data was better in NFI, but none of the resources studied were found to be complete.Conclusion:No source of information was complete in providing wholesome information of ADRs studied, and there was a wide variability in describing them.

Information in Package Inserts: A study in Eastern India

Introduction: Package insert (PI) is the printed leaflet available with the medicines containing information about the drug based on regulatory guidelines for its safe and effective use. Information in a PI is incorporated since the developmental phase of a pharmaceutical product with careful scrutiny of available information. PI contains evidenced based information about a drug, updated from time to time as soon as relevant preclinical and clinical data were obtained. Various studies had shown poor compliance 50-60% to the medicine prescribed for the treatment of chronic conditions like hypertension, diabetes and dyslipidemia. These diseases proved to be major cause of mortality and morbidity related to cardiovascular diseases in India. The information of the PI has an important impact on patients compliance and hence effectiveness of the drug used and for health professionals they can serve as reliable and accurate sources of drug information. Material & Methods: Present study was observational and Prospective with study duration of 1 month. 93 package inserts were collected from different pharmacies of the Patna on request. Analysis of content of Package Insert was based on criteria laid down by Indian Drug and Cosmetic Rules, 1945 under section 6.2 of schedule D. Result: A total number of 106 PI were received, among which 93 PIs were analysed for the result remaining 13 PIs were discarded due to duplicity and unauthenticity. Out of them, 87 were from Indian pharmaceutical companies and 6 from multinational companies [Graph-2]. All PIs of antihypertensives and hypolipedemic were of oral preparations. Out of 93 PIs 37 were antihypertensives, 34 were antidiabetics and 22 hypolipidemics. Out of 34 anti-diabetic PIs, 22 (59.6%) were oral and 12 (40.4%) were injectable preparations. Out of 93 PIs, 40 (43%) belonged to Grade A (including all injectable preparations) and remaining 53 (57%) to Grade B. No PIs belongs to Grade C.87 PIs were from Indian companies and 6 PIs were from multinational companies. It was observed that more PIs from Indian companies belonged to Grade A. Conclusion : we are facing the pandemic of diseases like hypertension, diabetes mellitus and other diseases. In such situation PI can play a vital role in improving the patient compliance and thereby the prognosis of disease. Hence a smart PI which is complete, reliable and up-to-date is the need of the hour.

Drug information by public health and regulatory institutions: Results of an 8-country survey in Europe

PurposeTo evaluate the framework of drug information produced by public health and regulatory institutions in Europe. Materials and methodsWe carried out a short survey asking editors of ISDB bulletins of the European region to indicate the main sources of drug information provided by public health and regulatory authorities in their countries, the specific kind of information produced and their opinions about strengths and weaknesses of such information. The availability of evaluations about the added therapeutic value of drugs and of tools facilitating the implementation of such information were particularly addressed and checked on the websites of those institutions. ResultsAnswers pertaining to eight countries were available. Regulatory information and safety alerts are generally available, but just UK and Germany stand out by showing quite an advanced framework of evidence-based, comparative drug information for health professionals, decision-makers and for the general public. National plans to implement evidence-based drug information seem lacking. ConclusionMore efforts are warranted to develop sharp formats to make evidence-based drug information easier to access, understand and put in context, showing the place in therapy of medicines and their added therapeutic value. Harmonization of different sources, also at European level, would be important to favor their access and limit dispersion. Appropriate tools and specific plans are then necessary to favor implementation of information materials.

Risk perception regarding drug use in pregnancy

Pregnant women, but also physicians, have unrealistically high perceptions of teratogenic drug effects. This may result in suboptimal treatment of disease and even influence decisions of whether to continue pregnancy. To attain more realistic teratogenic risk perceptions, several factors that influence this issue should be considered, and these are further discussed in this Clinical Opinion. Importantly, drug use may have several benefits, both for the pregnant woman's health and to avoid negative fetal effects of untreated maternal disease. A greater focus on this aspect may act to balance risk perceptions. Furthermore, both pregnant women and physicians need access to drug information sources that provide realistic risk estimates to increase confidence in appropriate drug use and prescribing. We suggest that access to decision support and individually tailored information provided by drug information centers may contribute to this goal.