Bello Shaibu Oricha, Umar Muhammad Tukur
Department of Pharmacology, Usmanu Danfodiyo University, Sokoto, Nigeria.
Ann Afr Med. 2011 Jan-Mar;10(1):13-8. doi: 10.4103/1596-3519.76563.
BACKGROUND/OBJECTIVES: Adverse drug reactions (ADRs) are important causes of morbidities. Voluntary reporting of ADR is important in safety surveillance of medicines already in the market. This study was, therefore, conducted to appraise the current documentation of ADR in Sokoto, to analyze the extent to which clinicians appreciate factors that could affect reporting ADRs.
Four hospitals within Sokoto metropolis were selected by convenient sampling. Pre-validated questionnaires containing questions on demographic and professional characteristics, and questions that evaluate attitudes as listed in the so-called "deadly sins" of Inman were self-administered by physicians. Data from respondents were analyzed by logistic regression.
Of 61 physicians interviewed, 43 (70.5%) had encountered potential ADRs in the 12 months before the study but only 3 (7.0%) of these were reported. Fifty eight (95.1%) of the respondents were not aware that an ADR reporting system was available in Sokoto but all the 3 respondents who were aware of the existence of a reporting system had reported an ADR. Generally, there was no significant relationship between demographic and professional attributes and scores obtained on each of the Inman's attitude measured except that more experienced physicians tend to believe that ADRs are not impossible to identify and female physicians were more reluctant to engage representatives of pharmaceutical companies on ADRs related to their drugs. Additional attitudes that may influence ADRs reporting were identified.
Adverse drug reactions are under-reported in Sokoto. Lack of physicians' awareness of channels for reporting appears to be the major cause.
背景/目的:药物不良反应(ADR)是发病的重要原因。自愿报告ADR对已上市药品的安全性监测至关重要。因此,本研究旨在评估索科托目前ADR的记录情况,分析临床医生对可能影响ADR报告因素的认知程度。
采用方便抽样法从索科托市的四家医院选取研究对象。医生自行填写预先验证的问卷,问卷包含有关人口统计学和专业特征的问题,以及评估因曼所谓“致命缺陷”中列出的态度的问题。对受访者的数据进行逻辑回归分析。
在接受访谈的61名医生中,43名(70.5%)在研究前12个月内遇到过潜在的ADR,但其中只有3名(7.0%)进行了报告。58名(95.1%)受访者不知道索科托有ADR报告系统,但所有知道有报告系统的3名受访者都报告过ADR。一般来说,人口统计学和专业属性与因曼所测量的每种态度的得分之间没有显著关系,只是经验更丰富的医生倾向于认为ADR并非无法识别,而女医生更不愿意就与她们所开药物相关的ADR与制药公司代表接触。还确定了可能影响ADR报告的其他态度。
索科托的药物不良反应报告不足。医生对报告渠道缺乏认识似乎是主要原因。