Adu-Gyamfi Paa Kofi Tawiah, Mensah Kwesi Boadu, Ocansey Joseph, Moomin Aliu, Danso Bright Owusu, Agyapong Frank, Jnr Reginald Arthur-Mensah
Department of Nursing and Midwifery, Faculty of Health and Allied Sciences, Pentecost University Accra, Accra, Ghana.
Department of Pharmacology, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
BMC Nurs. 2022 Aug 30;21(1):242. doi: 10.1186/s12912-022-00965-4.
Pharmacovigilance may be defined as the continuous monitoring of the reaction between a drug agent or combination of drugs a patient took and steps taken to prevent any associated risk. Clinical trials conducted before drug approval cannot uncover every aspect of the health hazards of approved drugs. People with carefully selected characteristics are monitored for the safety and efficacy of the drug; hence, common adverse drug reactions (ADRs) following proper use of the medication can be detected. This calls for continuous monitoring of drugs to report any undocumented ADRs during the clinical trial. The study aimed to assess the knowledge, practice, and barriers to pharmacovigilance among nurses at a teaching hospital.
The study was a descriptive cross-sectional study, and a stratified sampling technique was used to select 125 nurses within the three units: medical, surgical, and pediatric wards. A structured questionnaire was developed and used for data collection based on the study's objectives and reviewed literature.
The majority (67.2%) of the respondents were females, and 32.8% were males. Most (71.2%) of the nurses had low knowledge of ADR reporting procedures. Also, 84.8% of the nurses knew the purpose of reporting ADRs. The purpose of ADR reporting, as perceived by respondents, was to identify safe drugs (80.8%) and calculate the incidence of ADR (75.2%). Additionally, among the nurses who reported having nursed a patient with ADRs, 52.54% stated they reported the case, while 47.46% did not report it. The most cited reason for not reporting ADRs was that nurses considered the reaction normal and commonly associated with that medicine (35.7%). In comparison, 28.5% of the nurses said they did not know they were supposed to report the adverse drug reaction. There was no statistically significant difference between ranks of nurses, ward, attending in-service training, and pharmacovigilance practice.
In conclusion, nurses in this study had inadequate knowledge of pharmacovigilance and its reporting procedure. The study found that most nurses fear that reporting ADRs may be wrong because most of the nurses in the study did not have any form of pharmacovigilance training.
药物警戒可定义为持续监测患者服用的药物制剂或药物组合之间的反应，以及为预防任何相关风险所采取的措施。药物批准前进行的临床试验无法揭示已批准药物健康危害的方方面面。针对具有精心挑选特征的人群监测药物的安全性和有效性；因此，正确使用药物后常见的药物不良反应（ADR）能够被检测到。这就需要持续监测药物，以报告临床试验期间任何未记录的ADR。本研究旨在评估一家教学医院护士对药物警戒的知识、实践及障碍。
本研究为描述性横断面研究，采用分层抽样技术从医疗、外科和儿科病房这三个科室中选取125名护士。根据研究目的和综述文献编制了一份结构化问卷，并用于数据收集。
大多数（67.2%）受访者为女性，32.8%为男性。大多数（71.2%）护士对ADR报告程序的了解较少。此外，84.8%的护士知道报告ADR的目的。受访者认为，ADR报告的目的是识别安全药物（80.8%）和计算ADR的发生率（75.2%）。此外，在报告曾护理过ADR患者的护士中，52.54%表示他们报告了该病例，而47.46%未报告。未报告ADR最常被提及的原因是护士认为该反应正常且通常与该药物相关（35.7%）。相比之下，28.5%的护士表示他们不知道应该报告药物不良反应。护士的职级、病房、参加在职培训情况与药物警戒实践之间无统计学显著差异。
总之，本研究中的护士对药物警戒及其报告程序的了解不足。研究发现，大多数护士担心报告ADR可能是错误的，因为本研究中的大多数护士没有接受过任何形式的药物警戒培训。
