At a media aperitif in Zurich, the topic was drug safety worldwide and in Switzerland. Pharmacovigilance is a strategy to constantly evaluate the benefits and risks of a drug and prevent any adverse effects. How can all instances of the health care system work together here for the benefit of the patient and which fields of action are particularly relevant (such as drug interactions)?
(ag) Dr. med. Lutz Petersdorf, Berlin, spoke about the so-called “pharmacovigilance”. This is a continuous monitoring process of the safety profile of drugs, which is included in the research costs and requires cooperation between drug manufacturers, authorities, physicians and patients. The process is based on four pillars: recognize, evaluate, understand, avoid.
On the one hand, signals should be detected, i.e. a worldwide pharmacovigilance system and a structured “search” for possible safety signals are necessary. For this purpose, individual case reports, study results, literature/publications, authority inquiries, and press reports are used (i.e., one surveys the complete evidence situation). Furthermore, it is a matter of regular evaluation of this evidence, including identification of knowledge gaps. This results in safety reports (understanding) for national and international regulatory authorities as well as benefit-risk analyses with the aim of either increasing the benefit or minimizing the possible risk (i.e. a prudent avoidance strategy). Routine minimization measures include changes in professional information and modified packaging; in addition, educational materials, patient cards, so-called “Dear HealthCare Professional Communication” and controlled dispensing can contribute to minimized risk. Conversely, such risk assessments also in turn drive research (post-approval safety/efficiency studies) where knowledge deficits have been identified in an area. “Product-specific risk management plans clearly describe all known risks of a drug, explain avoidance and minimization measures, and are coordinated with or approved by regulatory authorities,” he said. Pharmacovigilance is therefore an important area of action for both the authorities and the manufacturers and can only function in an exchange between the two entities. The assessment of the risk-benefit ratio should consider the totality of all patients, but also the individual case, as both levels are relevant and may condition different risk-minimization measures.
Drug safety in Switzerland
Marco Egbring, MD, Clinical Pharmacology, University Hospital Zurich, discussed the financial consequences of adverse drug reactions. A study by Bates et al. showed as early as 1997 [1] that approximately one-third of all error-related adverse events are preventable and two-thirds can at least be alleviated. Side effects significantly prolong hospitalization (by 2.2 days) and also lead to high follow-up costs: According to the study, the prevention of avoidable side effects alone could have saved 4685 dollars per case (according to the authors, these figures are even rather low). Efforts to reduce additional costs by developing preventive strategies are therefore more than justified. Screening for specific genetic traits that confer risk for toxic drug side effects provides one option [2]. “Polypharmacy is also a relevant issue in this regard: as many as 16.7% of the total population take five or more medications at the same time, and this figure is already 41.2% among those over 65 years of age. Drug interactions must therefore be prevented in any case if they are classified as dangerous,” explained Dr. Egbring. For example, by means of electronic instruments, clinically relevant interactions can be detected and, above all, visualized (the speaker referred to the EPha.ch service). Of course, tools such as the interaction check do not replace the informed decision of the physician, but merely promote his or her decision-making ability. In a matrix, well-founded therapy alternatives are presented graphically in a comprehensible way. The physician is supported in his competence to select a reasonable therapy alternative.
Source: “Drug Safety”, Media-Apéro, 21. October 2014, Zurich
Literature:
- Bates DW, et al: The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA 1997; 277(4): 307-311.
- Wusk B, et al: Thiopurine S-methyltransferase polymorphisms: efficient screening method for patients considering taking thiopurine drugs. Eur J Clin Pharmacol 2004 Mar; 60(1): 5-10.
HAUSARZT PRAXIS 2015; 10(1): 2
