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   2020| October-December  | Volume 11 | Issue 4  
    Online since October 28, 2020

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Comparison of the extent and prevalence of prescription of potentially inappropriate medications prescribed to geriatric age group residing in old-age homes versus those receiving care from tertiary care hospital using Beers criteria
Aakash Rajendra Sheth, Ruchir B Dave, Devang Rana, Diti Sheth
October-December 2020, 11(4):144-149
Context: Certain medications have higher chances of causing adverse effects in geriatric age group. Evidence is against prescribing these medications to the elderly. A list of such medications is called Beers criteria, which was revised by the American Geriatrics Society in 2015. Aims: Using the Beer's list as reference, the researchers intend to find the extent and prevalence of potentially inappropriate medication (PIM) in geriatric population residing in different settings. Settings and Design: The researchers analyzed prescription pattern of 200 individuals with age ≥65 years, 100 individuals from old-age homes (OAHs) and 100 individuals from a tertiary care hospital. After collecting data, the researchers tallied each prescription with list of drugs in Beers criteria to find all the possible PIMs in both the groups. Results: It was found that the average age of residents of OAHs was significantly higher (P < 0.002) than the corresponding group from a tertiary care hospital. The residents of OAHs were also a receiving significantly higher (P < 0.0001) number of PIM than their counterparts from the tertiary care hospital. The average number of PIMs prescribed to females in OAHs was also significantly higher than those in the other group. About 55% of residents of OAHs received at least one PIM, compared to just 26% in the other group. At least 27% of individuals of OAHs received two or more PIMs, compared to just 2% in a tertiary care hospital. Lorazepam was the most commonly prescribed PIM in OAHs, whereas ranitidine was the most common PIM in a tertiary care hospital. Ibuprofen was the second most common PIM, with 15% of OAHs residents receiving this drug, while none of the patients from a tertiary care hospital received ibuprofen. Conclusion: All the results point toward a poor prescription pattern in the residents of OAHs compared to those receiving care from a tertiary care hospital.
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Real-world perspective on career of pharmaceutical physicians in India: A working report (2018)
Sandeep Lahiry, Sreekanth Gattu
October-December 2020, 11(4):150-157
Background: Pharmaceutical physicians support drug development in various capacities and contribute tremendously to the healthcare system. However, there is lack of substantial information on career progression of pharmaceutical physicians in India. Materials and Methods: This cross-sectional survey involved distribution of a questionnaire via internet, to be self-administered and returned electronically from March 1, 2018, to May 31, 2018 (3 months). Respondents were pharmaceutical physicians from India. Results: Of the 410 surveyed across 32 specialties, 197 completed responses (48%) were analyzed. Top physician specialty noted was Pharmacology. Medical Advisors constituted bulk responders. Oncology and Medical Affairs were the preferred therapeutic segment and portfolio, respectively. Medical affairs also recorded the highest physician recruitment and retention figures. Majority cited a need for Pharmaceutical Medicine as a specialty curriculum in India. ‘MBA’ was perceived to be nonenabling for entry-level hires; sensitization through ‘industry apprenticeship’ was highly recommended in this regard. Better work–life balance and aversion to clinical work were top reasons for physician influx in the industry. Important challenges at workplace included diversified work and difficult colleagues. Work-related issues were a common basis for most job attritions. Annual compensation figures ranged from INR 10–20 Lakhs (at entry-level) to INR 30–40 Lakhs (at senior-manager level); however, salary dissatisfaction was prevalent (58%). Lack of information and aversion to corporate work culture were top reasons for physician hesitancy when considering career options in the pharmaceutical industry. Conclusion: A career in pharmaceutical medicine has tremendous scope for young medical graduates. One should thoroughly explore such career option and inculcate a learner-centric approach.
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Clinical trial master file migration: A preordained step for a centralized electronic trial master file
Zainab Mehboob Rupani
October-December 2020, 11(4):139-143
The need to speed up clinical trial processes in a cost-effective manner, increased importance of data integrity, and ensuring timely compliance to regulatory requirement updates regarding the Trial Master File (TMF), has made the pharmaceutical industry delineate the requirement to maintain a centralized TMF with quality control. With the exponential increase in the number of sponsors using centralized electronic TMF (eTMF), the shift of trend positively impacts the need for data migration requirements in the TMF space. With an objective to serve the readers handling migration projects, this review article discusses the data migration requirements in clinical operations and eTMF in clinical trials, possible techniques to consider avoiding anticipated roadblocks, and a few other key points. The article also focuses on steps to be taken post migration to ensure meeting the quality of the migrated data in terms of regulatory compliance.
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Disclosure of conflict of interest in scientific publications
Suhasini Sharma
October-December 2020, 11(4):137-138
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Drug labeling: The study of compliance of regulatory requirements for prescription drugs in India
Suchi Shah, Anil Singh
October-December 2020, 11(4):164-167
Objectives: The objective was to check the compliance of regulatory requirements of drug labeling in India according to guidelines given under the Drug and Cosmetic Rules (D & CRs) 1945, Section 96, 97; drug samples were collected from government drug supply and private practitioners (PPs). Materials and Methods: A total of 100 drugs were selected randomly from schedule H. They were divided into two groups, each containing 50 drugs: (1) drug samples from drug store of a government hospital, manufactured for Gujarat government and (2) drug samples from PPs which are given to them by pharmaceutical companies. Each drug label was checked according to the criteria given under the D & CRs 1945, Section 96, 97. Data entry was done in Microsoft Excel 2013 and analysis was done. Results: Major deficiencies were seen in criteria of pharmacopeia (absent in 8% samples from government supply [GS] and 64% in samples from PPs), schedule (absent in 18% GS samples and 32% in PP samples), warning of schedule (absent in 6% GS samples and 4% in PP samples), Rx (absent in 22% GS samples and 28% in PP samples), red line (absent in 14% GS samples), and drug warning (absent in 84% GS samples and 72% in PP samples). Conclusion: As the study results show lacunae in the contents of the labeling of prescribed drugs in samples from both the groups, there should be strict enforcement of D & CR 1945 and monitoring of drug labels for better and safer use of medicines.
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Study of adverse drug reactions to antiretroviral therapy in a tertiary care hospital, Tirupati
Rajalakshmi Rukmangathen, Vasundara Devi Brahmanapalli, Durga Prasad Thammisetty, Deepishka Pemmasani, Sai Deepak Gali, Ramesh Babu Atmakuru
October-December 2020, 11(4):158-163
Purpose: Human immunodeficiency virus-infected patients do not adhere to their antiretroviral therapy (ART) due to adverse effects of drugs. The continuous monitoring of adverse drug reactions (ADRs) may ensure the safe use of drugs in patients. Hence, a retrospective analysis was carried out to assess the ADRs pattern, causality, and severity associated with various antiretroviral drug regimens in patients receiving ART. Materials and Methods: A retrospective, analytical study was carried out at ART nodal center in Sri Venkateswara Ramnarain Ruia Government General Hospital, Tirupati. Data were collected by spontaneous reporting of health-care professionals from ART centers using Suspected ADR Reporting Forms of Indian Pharmacopoeia Commission to record the ADRs occurred in the patients who underwent treatment from December 2015 to November 2016. A total of 299 ADR reports were collected during the study period. The causality and severity of the reported ADRs were assessed using suitable scales. Results: From a total of 299 ADR reports, females (63.81%) experienced higher ADRs than males (36.12%). The highest number of ADRs was reported to zidovudine/lamivudine/nevirapine (ZLN) regimen (76.92%) than tenofovir/lamivudine/efavirenz (TLE) regimen (23.07%). Cutaneous reactions were higher (34.34%) among patients receiving ZLN therapy, and drowsiness (53.62%) was the most common ADR in patients receiving TLE regimen. According to the World Health Organization causality assessment scale, most of the ADRs were possible (75.92%). On the assessment of Modified Hartwig and Siegel Severity Scale, 55.09% of ADRs were moderate. Conclusion: The study showed an increased incidence of ADRs to ART which calls for efficient pharmacovigilance systems to improve patient care and drug safety.
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An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals
Debdipta Bose, Shagun Nasta, Renju Ravi, Urmila M Thatte, Nithya J Gogtay
October-December 2020, 11(4):168-173
Background: A conflict of interest (COI) in publication exists when the primary interest of publication is influenced by a secondary interest (financial or non-financial). International guidelines are available that can be used by journal editors to formulate their own COI policies. The present study was carried out with the objective of evaluating COI policies existing among Indian biomedical journals. Materials and Methods: MEDLINE/PubMed and MedIND/IndMed databases were searched. Inclusions were journals that were active and indexed. Outcome measures were proportion of journals: (a) mentioning COI disclosure statement for authors, reviewers, and editors, (b) adequately explaining COI, (c) referring to three international guidelines, and (d) the proportion of PubMed/other than PubMed indexed journals mentioning COI policy for authors, reviewers, and editors and providing an adequate explanation for COI. Apart from descriptive statistics, associations between indexing and COI Policy for all three stakeholders were evaluated. Results: A total of n = 106 journals formed the final sample. Among them, 82 (77%) were PubMed and 24 (23%) were MedIND/IndMed indexed. COI disclosure statement was mentioned in 93 (87.7%) journals for authors, 10 (9.4%) for reviewers, and 06 (5.6%) for editors. Only 35 (33%) journals adequately explained COI. A total of 61 (57.5%) journals endorsed all the three international guidelines. PubMed indexing was found to be associated with approximately 19 times the odds of COI policies being present on the journal's home page relative to the journals indexed with other indexing agencies (crude odds ratio - 18.8, 95% confidence interval [4.6, 77],P < 0.0001). Conclusion: Very few Indian biomedical journals have COI policies for reviewers and editors and most did not explain it adequately. Nearly, a fifth of the journals we evaluated did not follow any guideline for disclosing COI.
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Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
Arun Bhatt
October-December 2020, 11(4):174-177
Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations – voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investigator, and the ethics committee – are discussed briefly.
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Study designs: Part 8 - Meta-analysis (I)
Priya Ranganathan, Rakesh Aggarwal
October-December 2020, 11(4):178-181
A systematic review is a form of secondary research that answers a clearly formulated research question using systematic and defined methods to identify, collect, appraise, and summarize all the primary research evidence on that topic. In this article, we look at meta-analysis – the statistical technique of combining the results of studies included in a systematic review.
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Indian Regulatory Update-2 during the COVID-19 pandemic
Amita Bhave
October-December 2020, 11(4):182-184
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Are the VAERS-included reactions following the human papillomavirus immunization correlated to the number of vaccine doses?
Dimitri Poddighe
October-December 2020, 11(4):185-186
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