Dataset Information

Neurologists' Knowledge, Practice, and Attitudes towards Pharmacovigilance and Adverse Drug Reactions Reporting Process in Epileptic Patients-Comparative Analysis from Poland and Egypt.

ABSTRACT:

Objectives

To compare neurologists' knowledge, practice, and barriers of pharmacovigilance (PV) process among patients with epilepsy in Poland and Egypt.

Methods

It was an international study that used an online questionnaire e-mailed to neurologists registered to practice in Poland and Egypt.

Results

Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs), but relatively few neurologists knew where to report ADRs, especially the Egyptian neurologists. Only 31.11% of the neurologists from Egypt and 39.90% neurologists from Poland declared that they had reported ADRs at least once during their professional practice, and few of them declared the regular reporting of such incidents. The main reason for the neurologists not reporting ADRs was the lack of time and a conviction that reporting ADRs would be an additional burden that would generate extra work.

Conclusion

The standards of pharmacovigilance process, safety control, and quality are not the same throughout the world. System-regulated PV stabilization in a country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the academic curricula of physician courses.

SUBMITTER: Kopciuch D

PROVIDER: S-EPMC8998900 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Neurologists' Knowledge, Practice, and Attitudes towards Pharmacovigilance and Adverse Drug Reactions Reporting Process in Epileptic Patients-Comparative Analysis from Poland and Egypt.

Kopciuch Dorota D Kamal Nashwa Nabil NN Kamal Nashaat Nabil NN Hamdy Nermin Aly NA Paczkowska Anna A Zaprutko Tomasz T Ratajczak Piotr P Fliciński Jędrzej J Kus Krzysztof K Nowakowska Elżbieta E

International journal of environmental research and public health 20220331 7

<h4>Objectives</h4>To compare neurologists' knowledge, practice, and barriers of pharmacovigilance (PV) process among patients with epilepsy in Poland and Egypt.<h4>Methods</h4>It was an international study that used an online questionnaire e-mailed to neurologists registered to practice in Poland and Egypt.<h4>Results</h4>Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs), but relatively few neurologists knew where to report ADRs, especially the E ...[more]

PMID: 35409851

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Project description:BackgroundThe emergence of cyclin-dependent kinases 4/6 inhibitors (CDK4/6i) represented a major breakthrough in the treatment of breast cancer over the past decade. In both clinical trials and real-world settings, it was observed that patients using CDK4/6i might experience psychiatric adverse events (PAEs). Herein, we conducted a pharmacovigilance study to comprehensively assess the correlation between CDK4/6i and PAEs.MethodWe obtained individual case safety reports submitted to the FDA Adverse Events Reporting System (FAERS) during the period from January 2015 to December 2023. In disproportionality analysis, the reporting odds ratio (ROR) and information component (IC) values were calculated for each adverse event-drug combination. Univariate logistic regression analysis was utilized to explore factors associated with PAEs following CDK4/6i treatment.ResultsA total of 95,591 reports related to CDK4/6i were identified, with 6.72% reporting PAEs, and this proportion exhibited an annual upward trend. Based on the ROR and IC values, 17 categories of PAEs were defined as CDK4/6i-related PAEs. Among these PAEs, insomnia, stress, eating disorder, depressed mood, and sleep disorder were very common, each accounting for over 10% of CDK4/6i reports. Ribociclib showed the highest risk signal of CDK4/6i-related PAEs (ROR = 1.89[1.75-2.04], IC025 = 0.79), followed by palbociclib (ROR = 1.47[1.41-1.53], IC025 = 0.49), while abemaciclib did not exhibit a significant signal (ROR = 0.52[0.44-0.62], IC025 = -1.13). Female sex, younger age and weight exceeding 80 kg were significant risk factors for the incidence of CDK4/6i-related PAEs.ConclusionsUsing data from a real-world, large-scale spontaneous reporting system for adverse drug reactions, our study delineated the spectrum of PAEs to CDK4/6i. This potentially offered valuable insights for healthcare professionals to manage the risk of PAEs in patients receiving CDK4/6i treatment, particularly those with psychiatric disorders.

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Project description:BackgroundHealthcare professionals' involvement and reporting of adverse drug reactions are essential for the success of a pharmacovigilance program. The aim of this study was to assess healthcare professionals (medical doctors, pharmacists, nurses, dentists, midwives, and paramedics) current knowledge, attitude, practices, and barriers regarding pharmacovigilance and adverse drug reactions reporting in multicentral healthcare settings.MethodsA cross-sectional face-to-face survey was conducted among currently working healthcare professionals in various hospitals in ten districts of Adana province, Türkiye from March to October 2022. A self-administered, pretested questionnaire (Cronbach's alpha = 0.894 for knowledge, attitudes and practices variables) was used for data collection. The questionnaire's final draft included five sections (sociodemographic/general information, knowledge, attitude, practices, and barriers) with 58 questions. The collected data was analyzed in SPSS (version 25) using descriptive statistics, the chi-square test, and logistic regression.ResultsOf the total 435 distributed questionnaires, 412 completed the entire questionnaire, yielding a 94% response rate. The majority of healthcare professionals (60.4%; n = 249) had never received pharmacovigilance training. Among healthcare professionals 51.9% (n = 214), 71.1% (n = 293) and 92.5% (n = 381) had poor knowledge, positive attitudes and poor practices, respectively. Only 32.5% of healthcare professionals kept the record of an adverse drug reaction and only 13.1% reported adverse drug reactions. The profession (medical doctors, pharmacists, nurses, dentists, midwives, and paramedics) of healthcare professionals and a lack of training were predictors of poor adverse drug reaction reporting (p < 0.05). A statistically significant difference in healthcare professionals and knowledge, attitude and practices scores was also observed (p < 0.05). The main barriers which were supposed to discourage adverse drug reactions reporting by the healthcare professionals were higher workload (63.8%) followed by thinking that a single adverse drug reaction report makes no impact (63.6%) and lack of a professional atmosphere (51.9%).ConclusionIn the current study, most healthcare professionals had poor knowledge and practice, but they had a positive attitude toward pharmacovigilance and adverse drug reactions reporting. Barriers to under-reporting of adverse drug reactions were also highlighted. Periodic training programs, educational interventions, systematic follow-up of healthcare professionals by local healthcare authorities, interprofessional links between all healthcare professionals, and the implementation of mandatory reporting policies are critical for improving healthcare professionals knowledge, practices, patient safety and pharmacovigilance activities.

Project description:In the past twenty years, the consumption of opioid medications has reached significant proportions, leading to a rise in drug misuse and abuse and increased opioid dependence and related fatalities. Thus, the purpose of this study was to determine whether there are pharmacovigilance signals of abuse, misuse, and dependence and their nature for the following prescription opioids: codeine, dihydrocodeine, fentanyl, oxycodone, pentazocine, and tramadol. Both the pharmacovigilance datasets EudraVigilance (EV) and the FDA Adverse Events Reporting System (FAERS) were analyzed to identify and describe possible misuse-/abuse-/dependence-related issues. A descriptive analysis of the selected Adverse Drug Reactions (ADRs) was performed, and pharmacovigilance signal measures (i.e., reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean) were computed for preferred terms (PTs) of abuse, misuse, dependence, and withdrawal, as well as PTs eventually related to them (e.g., aggression). From 2003 to 2018, there was an increase in ADR reports for the selected opioids in both datasets. Overall, 16,506 and 130,293 individual ADRs for the selected opioids were submitted to EV and FAERS, respectively. Compared with other opioids, abuse concerns were mostly recorded in relation to fentanyl and oxycodone, while tramadol and oxycodone were more strongly associated with drug dependence and withdrawal. Benzodiazepines, antidepressants, other opioids, antihistamines, recreational drugs (e.g., cocaine and alcohol), and several new psychoactive substances, including mitragynine and cathinones, were the most commonly reported concomitant drugs. ADRs reports in pharmacovigilance databases confirmed the availability of data on the abuse and dependence of prescription opioids and should be considered a resource for monitoring and preventing such issues. Psychiatrists and clinicians prescribing opioids should be aware of their misuse and dependence liability and effects that may accompany their use, especially together with concomitant drugs.

Dataset Information

Neurologists' Knowledge, Practice, and Attitudes towards Pharmacovigilance and Adverse Drug Reactions Reporting Process in Epileptic Patients-Comparative Analysis from Poland and Egypt.

Objectives

Methods

Results

Conclusion

Publications

Neurologists' Knowledge, Practice, and Attitudes towards Pharmacovigilance and Adverse Drug Reactions Reporting Process in Epileptic Patients-Comparative Analysis from Poland and Egypt.

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