OBJECTIVES: The study aimed to describe and assess the recommendations of published position statements regarding several aspects of biosimilars across specialties and determine whether these positions have changed with the emergence of new evidence.

METHODS: We systematically searched for published position statements of biosimilars in online databases and included statements written in English. The search was from the inception of the databases until May 2023. Two reviewers independently extracted the data. Only position statements that included recommendations to guide the use of biosimilars in clinical practice and were issued by health organisations and societies, including expert panels, were included. We synthesised recommendations on five aspects: prescribing practice, extrapolation of indication, interchangeability, treatment initiation with biosimilars in biologic-naïve patients, and pharmacovigilance.

RESULTS: The review included 25 papers involving eight specialties, 16 of which were from European countries, 1 from an international organisation representing 49 countries, and 6 from various countries. The papers were published between 2009 and 2020, with 19 published between 2015 and 2020. Of the five aspects of biosimilars assessed, nearly half (11 of 25) of the papers at the time they were published did not base their positions on a scientific or evidence-based approach. Only 4 of the 25 position papers were identified as revisions of their previous papers. With increasing experience in biosimilars and the emergence of new evidence, about 60% (16 of 25) of the papers contained outdated recommendations, particularly on two aspects. They were extrapolations of indications and interchangeability (including switching). The recommendations for most papers for three other aspects were still appropriate. These were prescribing biosimilars by their brand name and active ingredient, initiating treatment with biosimilars in biologic-naïve patients, and monitoring the long-term safety of biosimilars through pharmacovigilance. For four of the revised papers, their position evolved from opposing indication extrapolation for biosimilars to accepting it, while the position of two papers shifted from not recommending biosimilar switching to permitting the practice. Meanwhile, most papers were against automatic substitution by pharmacists because the evidence for this practice was still limited.

METHODS: A systematic and comprehensive articles search strategy was carried out in different seven electronic databases (PubMed, PubMed Central, Goggle Scholar, Ovid-SP, MEDLINE, Wiley Online Library, DergiPark) from 2010 to 2020. We searched to identify existing literature about cross-sectional observational studies investigating the KAP of HCPs regarding PV and ADRs reporting in different geographical regions of Turkey. Quality assessment and risk of bias were assessed among included studies.

RESULTS: Fifteen studies were chosen for full-text analysis. Finally, according to inclusion criteria, seven research articles were selected for systematic review. Overall, the KAP of HCPs varies across the studies. The lack of a standardized validated measuring tool to evaluate the KAP and differences in questionnaire items were the main limitations in included studies. Around, 69.1% (range: 54.6-100%) of HCPs were not aware of the national pharmacovigilance center in Turkey. About, 37.5% (range: 7.1-75.7%) of HCPs believed that reporting of ADRs is not important and 87.5% (range: 69.3-100%) stated that they never reported ADR previously during their practice. The most frequently highlighted barriers to PV were lack of time, uncertainty and did not know where to report.

METHODS: This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database.

RESULTS: Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015).

METHODS: A cross-sectional study was conducted using a validated self-administered questionnaire. A convenience sample of 147 community pharmacists working in community pharmacies in Riyadh, Saudi Arabia.

RESULTS: The questionnaire was distributed to 147 pharmacists, of whom 104 responded to the survey, a 70.7% response rate. The mean age of participants was 29 years. The majority (n = 101, 98.1%) had graduated with a bachelorette degree and worked in chain pharmacies (n = 68, 66.7%). Only 23 (22.1%) said they were familiar with the ADR reporting process, and only 21 (20.2%) knew that pharmacists can submit ADR reports online. The majority of the participants (n = 90, 86.5%) had never reported ADRs. Reasons for not reporting ADRs most importantly included lack of awareness about the method of reporting (n = 22, 45.9%), misconception that reporting ADRs is the duty of physician and hospital pharmacist (n = 8, 16.6%) and ADRs in community pharmacies are simple and should not be reported (n = 8, 16.6%). The most common approach perceived by community pharmacists for managing patients suffering from ADRs was to refer him/her to a physician (n = 80, 76.9%).

METHODS: Data on allopurinol ADR reports (2000-2018) were extracted from the Malaysian ADR database. We identified RMMs implemented between 2000 and 2018 from the minutes of relevant meetings and the national pharmacovigilance newsletter. We obtained allopurinol utilization data (2004-2018) from the Pharmaceutical Services Programme. To determine the impact of RMMs on ADR reporting, we considered ADR reports received within 1 year of RMM implementation. We used the Pearson χ2 test to examine the relation between the implementation of RMMs and allopurinol ADR reports.

RESULTS: The 16 RMMs for allopurinol-related SCARs implemented in Malaysia involved nine risk communications, four prescriber or patient educational material, and three health system innovations. Allopurinol utilization decreased by 21.5% from 2004 to 2018. ADR reporting rates for all drugs (n = 144 507) and allopurinol (n = 1747) increased. ADR reports involving off-label use decreased by 6% from 2011. SCARs cases remained between 20% and 50%. RMMs implemented showed statistically significant reduction in ADR reports involving off-label use for August 2014 [χ2(1, N = 258) = 5.32, P = .021] and October 2016 [χ2(1, N = 349) = 3.85, P = .0499].

Methods: A systematic search was conducted in PubMed, Web of Science, Google Scholar, Scopus and Nepal Journal Online (NepJOL) databases. 'Adverse Drug Reactions' or 'ADRs' or 'ADR' or 'Adverse drug reaction' or 'AE' or 'Adverse Event' or 'Drug-Induced Reaction' or 'Pharmacovigilance' or 'PV' and 'Nepal'. The search covered 15 years (January 2004 to December 2018) of study on ADRs and PV in Nepal. Only articles retrieved from databases were included, whereas published/unpublished drug bulletins, pharmacy newsletters and thesis were excluded. The articles thus retrieved were recorded, and thereafter analyzed. Word count code was used for the analysis of keywords used in the retrieved articles.

Results: A total of 124 articles were retrieved, with the highest rate of publications in 2006 and 2007, with 16 papers each. Among the articles, 10 (8.1%) were published in Kathmandu University Medical Journal (KUMJ). Single papers were published in 38 different journals. Brief reports (1.6%), case reports (31.2%), case series (0.8%), education forums (0.8%), letters to the editor (5.6%), original research articles (41.9%), review articles (9.7%), short communications and short reports (8.1%) on ADRs and PV were recorded. Out of 124 papers, 52 (41.9%) were original research publications. The majority (74.1%) of research was done in the category of ADR incidence, types, prevention, and management, followed by policy and suggestions for strengthening national and regional pharmacovigilance centers of Nepal (14.5%).

Methods: A qualitative approach was used to conduct this study. A semi-structured interview guide was developed, 10 hospital pharmacists were recruited and interviewed through convenience sampling technique. All interviews were audio-taped, transcribed verbatim, and were then analyzed for thematic contents analysis.

Results: Thematic content analysis of the interviews resulted in 6 major themes, including (1) Familiarity with medication safety & adverse drug reaction concept (2) Current system of practice and reporting of adverse drug reaction in hospital setting, (3) Willingness to accept the practice change (4) Barriers to adverse drug reaction reporting, (5) Policy change needs and (6) The recognition of the role. Majority of the hospital pharmacists were familiar with the concept of medication safety and ADR reactions reporting however they were unaware of the existence of national ADR reporting system in Pakistan. Several barriers hindering ADR reporting were identified including lack of awareness and training, communication gap between the hospitals and regulatory authorities.

METHODS: We conducted a two-round modified Delphi survey among local and international communication experts, and also recipients of medicines risk communication in Malaysia. We developed a list of 37 strategies based on the findings of our previous studies. In Round 1, participants were asked to rate the priority for each strategy using a 5-point Likert scale and suggest additional strategies via free-text comments. Strategies scoring a mean of ≥ 3.75 were included in Round 2. We defined consensus for the final list of strategies a priori as > 75% agreement. Data were analysed using descriptive statistics and thematic analysis.

RESULTS: Our final Delphi panel (n = 39, 93% response rate) comprised medicines communication experts from nine countries and Malaysian healthcare professionals. Following Round 1, we dropped 14 strategies and added 11 strategies proposed by panellists. In the second round, 21 strategies achieved consensus. The priority areas identified were to improve the format and content of risk communication, increase the use of technology, and increase collaboration with various stakeholders. Priority ratings for the strategy "to offer incentives to pharmaceutical companies which maintain effective communication systems" were significantly higher among recipients compared to communicators [χ2(1, N = 39) = 10.1; p = 0.039] and among local versus international panellists [χ2(1, N = 39) = 14.3; p = 0.007].

RESEARCH DESIGN AND METHODS: All suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients' demographic and clinical variables, and severity of involvement of organ system.

RESULTS: A total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18-64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. 'Injury, Poisoning, and Procedural Complications' remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas.

METHODS: A modified questionnaire was sent to the PV team heads of 21 PV agencies based in the APEC countries, between June 28 and September 12, 2017, to gather information on the structure, process, and outcome of PV status in these countries.

RESULTS: Of the 21 APEC countries, 15 responded. We found harmonized laws and regulations for general PV and risk management systems. However, variations were found in PV structure: for example, 11 out of 15 countries had national regulatory representatives responsible for PV in pharmaceutical companies, while four did not. For PV process, discrepancies were also found in the source type of adverse drug reaction (ADR) reports and reporting of medication errors and therapeutic ineffectiveness in cumulative ADR reports. With respect to PV outcomes, among countries that performed active surveillance, the United States of America was more active, with hundreds of projects including additional pharmacoepidemiological studies etc. Among the nine countries that responded, Japan had the greatest number of product label changes followed by Taiwan, Malaysia, and Korea.