Malikova Marina A
Department of Surgery, Boston University, Boston Medical Center, 72 East Newton Street, Collamore building, Boston, MA 02118, USA.
Ther Adv Drug Saf. 2020 Apr 15;11:2042098620909614. doi: 10.1177/2042098620909614. eCollection 2020.
Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports. The cumulative information, obtained from these reports, can be used to assist pharmacovigilance professionals in the detection of potential safety signals by monitoring evolving trends. If there is a message identifying concern as potential safety signal, the transmission of individual case reports, as well as cumulative and aggregate reports will occur from pharmaceutical industry to the regulators; and based on their assessments of causality in relationship to the drug, the regulatory decisions will be made. Once regulators confirming a signal as a possible safety alert have made the decision, the decisions and the reasons must be communicated to health professionals, the pharmaceutical industry, and other parties involved (e.g. clinical trials participants, investigators, consumers and medical professionals at post-marketing stage, etc.).
药物警戒是一个沟通至关重要的领域，信息交流应及时进行。来自个别病例报告的信息从制药行业和卫生专业人员传递给监管机构。通过分析个别病例和汇总报告来确立药物的安全性概况。从这些报告中获得的累积信息可用于协助药物警戒专业人员通过监测不断变化的趋势来检测潜在的安全信号。如果有信息将某种担忧识别为潜在安全信号，个别病例报告以及累积报告和汇总报告将从制药行业传递给监管机构；监管机构将根据其对与药物相关因果关系的评估做出监管决策。一旦监管机构确认某信号为可能的安全警报并做出决策，就必须将决策及其理由传达给卫生专业人员、制药行业以及其他相关方（例如临床试验参与者、研究者、上市后阶段的消费者和医学专业人员等）。
