جستجوی مقالات مرتبط با کلیدواژه "pharmacovigilance" در نشریات گروه "پزشکی"

Underreporting of adverse drug reactions (ADRs) due to time constraints, limited awareness, reluctance, and legal fears demands integrating pharmacists with physicians and implementing an extensive continuing education module on pharmacovigilance for application-based learning. Our study aimed to integrate a pharmacist with a treating physician to enhance patient safety by facilitating ADR reporting, providing a continuing education module on pharmacovigilance to senior residents and interns, and providing an ADR alert card to patients. We carried out a cross-sectional study over ten months in the general medicine department of a tertiary care hospital. We integrated Doctor of Pharmacy intern students with treating physicians to facilitate easy identification of ADR and for issuing ADR alert cards. We provided a seven-day continuing education module on pharmacovigilance concepts for senior residents and final-year medical interns. We distributed an ADR alert card to 180 patients. The largest groups of patients affected by ADRs in our study were aged between 41-50 and 51-60 years, collectively accounting for nearly 50% of the affected population. Our study reported a slight female predominance (51.1%). The gastrointestinal system (31.1%), nervous system (20%), and skin and subcutaneous tissue (13.9%) were the most frequently affected organ systems, accounting for 65% of the ADRs. Most ADRs (92.2%) were not serious. Analgesics (aspirin), HMG-CoA inhibitors (atorvastatin), and antiepileptics (phenytoin) were the top three drug classes most associated with ADRs. Out of 23 participants, 21 (91.3%) correctly completed the reporting of ADR into the ADR form from anonymous case reports, identified predisposing factors, assessed causality correctly, and suggested prevention and management strategies according to the clinical scenario. Most participants (95.7%) indicated that the module significantly enhanced their awareness and comprehension of Pharmacovigilance concepts, with only a small percentage (4.3%) expressing neutral sentiment and none disagreeing. Integrating pharmacists, continuing pharmacovigilance education, and issuing ADR alert cards significantly enhanced ADR reporting, comprehension of pharmacovigilance concepts, and patient safety measures in the healthcare setting.

Pharmacovigilance is definedas “the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions or any other drug-related problems”.The framework of the national pharmacovigilance system illustrates the general pattern of howthe health system approaches the care of health products, defines the philosophy of supervision and policy orientation, and outlines the structure and development priorities of pharmacovigilance. The present study was conducted with the aim of presenting a framework of the national pharmacovigilance system framework for developing countries. The present study is of an applied study that was conducted descriptively in 2023. To present a framework of the national pharmacovigilance system framework, the main components of the national pharmacovigilance system framework were first identified and determined through a review of valid scientific sources and texts and national pharmacovigilance systems of the countries under study, considering the conditions and requirements of these countries. Then, the proposed model was put to the opinion of 65 experts for validation, and the Delphi method was implemented with a three-point scale in two rounds. Based on the results of the present study, the main components of thenational pharmacovigilance system framework include: functions, infrastructure, and network. Each component includes sub-components and related operations and was agreed upon by experts with an average agreement rate of 95%. The framework of the national pharmacovigilance system is essential as a guide for the implementation of the national pharmacovigilance system. This framework enables a comprehensive evaluation of the structures and national and regional institutions affecting pharmacovigilance and canlead to the optimal implementation of the national pharmacovigilance system in developing countries. The national pharmacovigilance system can reduce drug-related problems, and its ultimate result can be a reduction in mortality and morbidity rates.

Drug and Poison Information Centers (DPIC) play a pivotal role in pharmacovigilance, public education, and preventing adverse drug reactions, medication errors, and poisoning incidents.

This study presents an epidemiologic analysis of inquiries received by the DPIC at Hamadan University of Medical Sciences in Iran over four years (2019-2023). A descriptive cross-sectional analysis of recorded phone calls to the DPIC at Hamadan University of Medical Sciences from October 2019 to November 2023. The demographic distribution of inquirers, types of inquiries, and sources used to answer questions were considered in the analysis.

The study reports a total of 3904 recorded calls over the four-year period, with an average of 78.08 calls per month. The majority of callers were female (61%). The top three questions focused on coronavirus, side effects, and drug-drug reactions. Psychiatric agents, gastrointestinal agents, and antibiotics were the top three drug families inquired about. The data were collected from various references, with UptoDate® being the most frequently used (43.3%).

This study provides a comprehensive epidemiologic analysis of inquiries received by the DPIC at Hamadan University of Medical Sciences. The findings underscore the importance of DPICs in providing evidence-based information, contributing to pharmacovigilance, and enhancing patient safety.

Adverse Drug Reactions (ADRs) present significant challenges in healthcare, necessitating vigilant monitoring and analysis to enhance medication safety protocols. This retrospective study aimed to analyse ADRs reported at an Adverse Drug Reactions Monitoring Centre (AMC) to understand prevalence, patterns, and characteristics of ADRs.

Retrospective data from January to December 2023 were collected from the AMC at Vaishampayan Memorial Medical College, Solapur. A total of 282 ADR reports were analysed for frequency, severity, implicated medications, patient demographics, and associated clinical factors. Causality assessment was performed using the WHO-UMC scale.

The majority of ADRs were associated with the oral route of drug administration (79.43%), and most were categorized as minor severity (68.44%) and probable causality (91.84%). Common ADR symptoms included vomiting (9.55%) and rash (9.22%). Antimicrobial agents were the most suspected drugs causing ADRs (17.38%). The study revealed discrepancies in ADR reporting patterns and highlighted the importance of pharmacovigilance in capturing and addressing ADR occurrences. Strategies to improve ADR reporting and enhance medication safety protocols are warranted to optimize patient care.

Our study provides valuable insights into the prevalence, patterns, and characteristics of ADRs, emphasizing the need for continued surveillance and reporting to promote patient safety and improve healthcare outcomes.

Medication errors (MEs) are common among nursing staff due to the fear or lack of knowledge and time in reporting MEs.

This study aims to identify the barriers and facilitators of voluntary ME reporting according to the nursing staff in India.

This cross-sectional study was conducted on 398 nurses of a hospital in India, working in three different shifts with various specialties, who were selected by a convenience sampling method. A validated questionnaire was used to collect data which was prepared in Google Forms. The chi-square test was used to determine whether there was any statistical difference among the responses.

Results showed that 87% of nurses were female and 13% were male. The majority were at an age range of 31–40 years (44.9%) and had good knowledge of MEs and the reporting system in the hospital (96.2%). Regarding the barriers, 29.9% (P<0.001) were a beginner in using the reporting system, while 70% had prior experience with the system; 85.4% (P=0.024) reported the lack of a relaxing working environment, 54.7% (P=0.031) reported burnout, 27.6% (P=0.0001) reported personnel problems, 21.6% (P<0.001) reported peer pressure and so on. Receiving support and encouragement from the multi-disciplinary team (91.7%), receiving feedback for the reported MEs that focuses on the system and not on the individuals (90.7%), professional encouragement for the reported MEs (90.4%), and developing a “no-blame” culture (86.9%) were the facilitators of the voluntary ME reporting by the nursing staffs (none of them were statistically significant). 

Although it is impractical to eliminate all MEs, the engagement of nursing staff is essential in ME reduction and prevention.

Epilepsy is the second most common neurological disorder that affects 1 percent of globalpopulation. Since antiepileptics have narrow therapeutic index having multiple adverse drug reactions (ADRs)thus have significant safety concerns. The aim of this study was to observe adverse drug reactions due toantiepileptics in neurology department M.Y.H. Indore, India.

An observational prospective study was done from November 2021 to January 2022. Patients havinghistory of seizures attending neurology outpatient department at MYH Hospital, who were on antiepilepticdrugs were recruited. Suspected adverse drug reaction forms were recorded and their causality assessment wasdone by Naranjo’s scale.

Data of total 70 patients were recorded. Males reporting ADRs due to antiepileptics were67.1% and females 32.8%. Using Naranjo’s scale, we noted 93.3% ADRs as “probable” and 6.7% as“possible”. Common causes of prescribing antiepileptic drugs were known case of epilepsy (78.5%),oldcase of neurocysticercosis (11.4%),post traumatic(4.3%),gliosis (2.8%) and tuberculoma (2.8%). MostADRs were dermatological 76% (rashes),central nervous system (16%) (nocturnal enuresis, poor schoolperformance, dizziness, headache, sleep disturbances, personality changes) ,Gastrointestinal (8%) (gastricirritation, nausea, vomiting and hepatotoxicity) .Most common drug for causing ADRs were sodiumvalproate(58.5%),carbamazepine(17.14%),phenytoin(14.2%),leviteracetam(7.1%),and lamotrigine(2.8%).

Our study aimed us to know the incidence and patterns of adverse drug reactions due toantiepileptics in a tertiary care institute of central India. Despite of recent advances and novel therapies usedfor the treatment of epilepsy, conventional drugs like sodium valproate, phenytoin and carbamazepine still arethe first choice for the management and treatment of seizures and their ADRs are very common.

The global consumption of herbal medicines continues to increase steadily. Indeed, many people use herbal medicines for health promotion and therapeutic purposes in developing and industrialized countries. However, reports of adverse events in mass media are usually sentimental and generally render a negative feeling about the usage of herbal medicines instead of identifying the reasons for such incidences, which can be associated with a number of issues. Both national health specialists and the common people are concerned about the safety of herbal medicines. The World Health Organization (WHO) has recommended the inclusion of herbal medicines in the current national pharmacovigilance systems to fortify national capability in keeping the safety of herbal medicines under surveillance and investigating the reasons for adverse events, and to share related data at different levels in the world. Iranian pharmacovigilance system fulfills most of the WHO pharmacovigilance criteria. However, the underreporting of adverse drug reactions (ADRs), particularly medicine-related hospital admissions and deaths is a major weakness of this system. In addition to paying more attention to ADRs reporting, the Iranian pharmacovigilance program requires to include herbal medicines that constitute a high proportion of medicinal products in Iran. Due to the absence of reporting mechanisms (for herbal medicines), there have so far been few reports on herbal medicine-induced adverse events. However, an extremely small number of reports do not guarantee the complete safety of herbal products. Therefore, herbal pharmacovigilance is required to ensure safety of herbal medicines in Iran.

Evaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement.

This study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran.

Iran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed.

A robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators’ status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.

Vaccine safety surveillance is important to identify and manage adverse events following immunisation (AEFI) and avoid vaccine hesitancy. Currently, COVID-19 vaccines are administered to large numbers of people to try and curb the pandemic. In this paper, quantitative methods for causality assessment of AEFI are described. Qualitative methods for causality assessment involve an expert panel reviewing each AEFI report to determine whether the AEFI can be attributed to the vaccine. Each AEFI is determined to be classified as consistent, inconsistent, indeterminate or unclassifiable in terms of causality. Quantitative approaches can strengthen causality assessment outcomes. However, the potential for bias and errors should be considered for each safety signal identified. Vaccine and population specific factors may affect AEFI incidence, with a need to obtain background rates to frame safety signals identified into the local context. Several case scenarios from the vaccine safety surveillance in Brunei are used to illustrate the practical application of quantitative approaches for AEFI causality assessment (including comparison of AESI incidence to background rates and disproportionality analysis), which complement the traditional qualitative methods.

Drug package inserts are officially approved documents provided along with the drugs by the drug marketing company. They act as an important source of information about the drug for both patients and physicians, which helps in proper administration and improving the safe use of medications. The pharmacological and clinical information presented in them for its consistency and completeness were analyzed in this study. The drug package inserts were collected and analyzed for the pharmacological and clinical information, based on the headings under Section 6.2 & Section 6.3 mentioned in Schedule D of Drugs and Cosmetics Act and Rules, 1945. The drug package inserts that were analyzed in this study included different drug formulations and drugs belonging to different systems. This study shows that the generic name, the brand name of the drug, its active ingredient, therapeutic uses, dosage form, and manufacturer details are present in all the package inserts (100%). But details about safety and precautions are given only in about 90%. Information about pharmacokinetics, pharmacodynamics, pharmaceutical particulars, and the antidote for drug overdose are missing in many package inserts.From our study, we conclude that a majority of the package inserts provide adequate details regarding key information. However, we recommend mentioning the approximate cost of the drug, references for the information provided in it, along with the Toll-free number of the Pharmacovigilance Programme of India (PVPI) for reporting adverse drug effects.

 Epilepsy is a disorder that affects 1% of the global population. It is the second most common serious neurologic disorder after stroke, affecting humans. Since antiepileptic drugs have a narrow therapeutic index and their adverse effects can affect any organ, their widespread use has significant safety implications.

 The study assessed adverse drug reactions (ADRs) using antiepileptic drugs in the Department of Neurology at a Tertiary Care Hospital, Srinagar, Jammu & Kashmir, India.

 This prospective observational study was conducted in the Department of Neurology of a Tertiary Care Hospital, Srinagar, Jammu & Kashmir, India, for eight months. It was a spontaneous reporting of ADRs by practicing physicians in the outpatient and inpatient settings that were included in the study.

 Of the 3,300 patients who were on the anti-epileptic drug (AED), 92 (3.07%) had AED-related ADRs. A total of 18 cases were reported in the inpatient department and 74 cases in the outpatient setting. The most common ADRs were loss of appetite (34.78%), skin rashes (17.39%), and gum hypertrophy (9.78%). Of 80 ADRs, 42.5% were related to valproate, followed by phenytoin, carbamazepine, and levetiracetam. The suspected drug was changed in 22 patients with ADRs.

 For the early diagnosis and avoidance of ADRs, the frequent follow-up of patients on AEDs is needed to improve patient compliance with drug therapy and provide better drug therapy for avoiding associated morbidity and mortality.
 

Drug therapeutic failures (TFs) are included in pharmacovigilance reporting, as some authors consider them a type of adverse drug reaction. Given their high frequency in Colombia, we studied their importance as a cause of admission to an intensive care unit (ICU).

This was a cross‑sectional observational study. Clinical records of patients who arrived at the emergency service of a third‑care level university hospital were reviewed. Information was collected by a resident in clinical toxicology, and each case was validated and analyzed by a research team using the algorithm proposed by Vaca González and Schumock and Thornton criteria for preventability to evaluate the existence of possible medication errors.

In total, 697 clinical records were evaluated and 18 patients presented TFs (2.6%, 95% confidence interval 1.5%–4.1%) as the cause of admission to the ICU. The most frequent TFs were seizures (56%) and hypertension (28%). The most commonly associated medications were valproic acid (28%) and losartan (28%). Ten cases (56%) were associated with drug misuse and the same number of cases was preventable, according to Schumock and Thornton criteria.

This is the first study assessing TFs as a cause of admission to the ICU in the Colombian population. The frequency of TFs in our study was similar to that described in the literature; being the most common cause the inappropriate drug use, particularly for drugs with complex kinetics, such as antiepileptic drugs.

To assess the knowledge, attitude, practices (KAP), and barriers regarding pharmacovigilance and adverse drug reaction (ADR) reporting among medical and dental faculties of the teaching hospitals.

This study was conducted for a period of 3 months among medical and dental faculties. A self-structured, 42-item closed-ended questionnaire based on pharmacovigilance and ADR reporting was used in this study. Data were analyzed using Statistical Package for the Social Sciences Version 21. All the items of the domains along with demographic variables were summarized as absolute and relative frequencies. Intergroup comparison was done using Kruskal–Wallis test and Mann–Whitney U-test. The correlation between the domains was assessed by Spearman correlation coefficient.

Among the study subjects, 272 (60.4%) were females and 178 (39.6%) were males. The number of medical and dental faculties was 360 (80%) and 90 (20%), respectively. The mean KAP scores for medical and dental faculties were 7.58 and 5.37, 8.78 and 6.01, and 6.91 and 6.32, respectively. The Spearman correlation coefficient (ρ) was found to be significant for knowledge–attitude and knowledge–practice domains. The values obtained between attitude with practice and barrier also were significantly correlated.

Our study findings advocate that although medical faculties have better knowledge about pharmacovigilance and ADR reporting, dentists have a positive attitude, thereby suggesting a huge scope of progress if more emphasis is given on the need for continuous educational initiatives and including the topic in their academic curriculum.

Adverse drug reactions (ADRs) are one of the leading causes of mortality and morbidity. Avoiding adverse reactions requires comprehensive knowledge about how they can be monitored, controlled, and reported.

The current study aimed to evaluate the knowledge, attitude, practices, and perceptions of the health care professionals concerning the adverse drug reactions monitoring and reporting in Lahore, Pakistan.

A prospective cross-sectional study was conducted in Lahore, Pakistan, from October 2018 to December 2018. Descriptive statistics were obtained and the Pearson chi-square test was used to analyze the association between categorical variables.

In total, 150 pharmacists, physicians, and nurses were approached, that 40, 39, and 46 of them responded, respectively. Almost 95% pharmacists, 17.3% of nurses, and 58.9% of physicians correctly defined the “pharmacovigilance”, while 70, 10, and 30.5%, respectively, defined ADRs correctly. The current study revealed that 87% of pharmacists, 82.5% of physicians, and 82.6% of nurses had a history of identifying ADR in patients. Out of which only 52, 41, and 19% of pharmacists, physicians, and nurses had a history of reporting adverse drug reactions, respectively.

This study revealed inadequate knowledge of health care professionals. Most healthcare professionals were motivated to report identified ADRs. However, the responsibility lies with the governing authorities to provide them with a suitably efficient platform to practice proper ADR reporting and monitoring. Educational campaigns and training, financial incentives, and simplification of the reporting process might change the levels of knowledge and attitude.

Glutamine has been considered as a dietary supplement with a non-essential amino acid structure. Some studies found that liver failure may be associated with a high plasma glutamine level. Consumption of this product may be associated with potential adverse effect. This report describe the first case of glutamine induced hepatotoxicity. A 35-year-old female athlete with severe abdominal pain and scleral icterus was referred to the hospital. She has been taking glutamine powder for the past three weeks ago. Impaired liver function test and imaging evaluation suggested hepatotoxicity. Glutamine consumption was discontinued and the patient was closely monitored. Finally, after two weeks, the patient recovered successfully. This novel case was the first report regarding glutamine induced hepatotoxicity. Health care providers must know that consumption of dietary supplement such as glutamine may be associated with serious side effects. Liver damage is a possible side effect of glutamine. Hence it is necessary to consider hepatotoxicity as an adverse reaction in case of glutamine supplement consumption.

To characterise consumer adverse drug reaction (ADR) reports for phosphodiesterase type 5 (PDE5) inhibitors.

We included ADR reports submitted by adults to the European ADR database (EudraVigialnce) from 2007 to 2011. ADRs were classified according to type, seriousness and age and sex of consumers. The unit of analysis was one ADR.

Totally,328ADRs were reported for sildenafil and vardenafil,and only 5% of these were serious.The largest number of reported ADRs was found for sildenafil, i.e., “lack of efficacy” and/or “drug efficacy decreased” (n = 134) and “headache” (n = 21).

ADRs reported by consumers for PDE5 inhibitors were relatively low, and only few ADRs were serious.