Research in the field of drug therapy safety management

Abstract

In August 2011, the Coordination Group for the implementation and continuation of the agenda for improving medication safety in Germany published a memorandum on the development of research in the field of drug therapy safety management (Memorandum on Drug Therapy Safety Management Research). The memorandum highlights the need for research into this field for the German health care system. It describes current research objectives, thematic priorities and the characteristics of the methodology of drug therapy safety management research. After presenting the current state of research into drug therapy safety management, suggestions are made regarding further necessary activities.

Relevance of drug therapy safety management

Medication errors lead to avoidable harm to patients in Europe. The incidence of medication errors in Europe lies at 7.5% of all prescriptions for outpatient treatment, and 0.3–9.1% for inpatient treatment [1].

The World Health Organization (WHO) estimates the incidence of patients who need to be hospitalized due to adverse drug events (ADEs) at up to 10% of all hospital admissions [2]. According to WHO experts, a large number of ADEs are avoidable. A significant proportion of ADEs in Germany also lead to preventable morbidity and mortality [3, 4]. This is confirmed by data from the network of regional pharmacovigilance centres in Germany, which shows that about 5% of recorded admissions to internal medicine departments are due to ADEs.

Germany's position in international research

The scientific literature demonstrates that similar problems in ensuring the management of drug therapy safety exist in all developed countries, and also that similar research efforts are being made in this area. Avoidable ADEs are the subject of numerous scientific studies [5]. These studies quantify avoidable ADEs and show that medication errors are the most common errors in medical treatment [6]. Furthermore, these studies demonstrate the effectiveness of risk minimizing interventions for drug therapy. The analysis ‘Summary of the Evidence on Patient Safety: Implications for Research’, by a group of experts from the World Alliance for Patient Safety of the WHO, for example, comes to the conclusion that electronic prescribing with decision support can significantly improve the safety of the prescription. Studies in this area show reductions in the frequency of prescribing errors of more than 80%, and a reduction in potentially serious prescribing errors of 55% [7].

It can generally be assumed that the results of international research also apply to Germany. However they cannot be applied uncritically to the German situation. It is therefore essential that research in this area is also conducted in Germany, especially due to the differences in the organization of the health care system in comparison with other countries. Special consideration must be given to the high level of fragmentation and differentiation within the health care system in Germany. The memorandum therefore focuses on describing the main research areas that are currently relevant to Germany. The task of the memorandum is to identify research requirements based on developments which will have implications for medicine and health care in Germany in the future (demographic change, personalized medicine).

Despite national differences, the authors consider it necessary to intensify international discussion on the development of drug therapy safety management research. The research focus of the memorandum in question therefore also includes comparative studies by drug safety organizations in developed industrial countries. This should help to facilitate international debate. Finally, this publication itself should also contribute towards this.

Economic importance of drug therapy safety management

There has been no direct research in Germany on the potential savings to be made from improving the safety of drug therapy. However, estimates from indirect research have shown that by averting 30% of preventable ADEs in internal medicine about 100 million euro could be saved annually [4]. Conservative estimates based on model calculations using the data available in Germany show potential savings from between 800 to 1300 million euro per year across the entire German health care system [4].

Data from teratology information services provide examples of specific and relevant cost factors, in addition to demonstrating the humanitarian implications of drug therapy safety management.

As a result of interventions by the teratology information service in Canada, which advises around 600 pregnant women per year, at least five major foetal malformations (saving 7.5 million USD) and 112 unnecessary terminations (saving 0.33 million USD) were avoided [8, 9]. Extrapolated for the Berlin Pharmacovigilance and Advice Center for Teratology Information, which advises around 6000 pregnant women per year, this would result in a saving of about 50 million euros.

Drug therapy safety management research as a public health focus

The development of strategies for the detection and prevention of medication errors is important, and strengthening research into drug therapy safety management is an essential condition for achieving wide-ranging improvements.

The central challenge is to ensure effective, risk-minimizing strategies for improving drug therapy safety management. The aim of drug therapy safety management research is to develop interventions and to prove their effectiveness and practicality in the real world. This must be done through high quality studies in order to create the conditions and the legitimacy for their widespread use.

Drug therapy safety management is understood as a set of measures to ensure the correct use of a drug. The aim is to achieve optimal organization of the medication process by avoiding ADEs, especially as a result of medication errors, and thus to minimize the risk to the patient during drug therapy [10].

Drug therapy safety management research is concerned with the analysis, optimization and evaluation of the medication process, whilst aiming to improve the conditions for the proper use of drugs.

The improvement of drug therapy safety management was highlighted as a research priority in Section 4 of the Federal Government's Health Research Framework Programme of December 2010, which was drawn up by the Federal Ministry of Health (BMG) and the Federal Ministry of Education and Research (BMBF) [11].

The Memorandum on Drug Therapy Safety Management Research [12] was developed by a group of experts in cooperation with the Road Map for Safety in Drug Therapy 13 in order to emphasize the necessity of drug therapy safety management research, and to describe the methods, goals and conditions of implementation. This group of German experts consisted of representatives of all local government sectors in the fields of health care, health services research, pharmacoepidemiology and social pharmacy. The Memorandum was developed during a number of workshops.

The Memorandum includes the following key points:

1. Aims of research into drug therapy safety management

In Germany, research into the safety management of drug therapy is still in the initial stages of development. This must be taken into account in the aims of the research. At the moment it is particularly important to improve the basis for systematic research in this field. In order to achieve this, the following short and medium term aims have been identified:

• Development of methodological standards for drug therapy safety management research

• Analysis of the development of the safety of drug therapy management in Germany

• Development of interventions that minimize risks

• Implementation of effective interventions in routine processes

• 2 Special features of drug therapy safety management research

Drug therapy safety management research is characterized by the fact that it aims to analyze and optimize the process of medication under routine conditions. In contrast to other research fields such as clinical trials, drug therapy safety management research does not take place under controlled conditions, but has to consider variations and changing parameters in routine care, as well as other influencing factors. The memorandum highlights a number of specific features of this field of research:

• complex cause and effect relationships

• the large number of entities that are involved

• wide range of methods

• complexity of possible interventions

• need for gradual development of interventions

• strong influence of implementation results and framework conditions on outcome

• developments in medicine can change outcome results

The multisectoral issues of drug therapy safety management research are usually processed in a multidisciplinary manner so that methodology consists of different research strategies, which are also used in other fields of research. Research tools mainly come from health services research, especially pharmacoepidemiology and social pharmacy. The instruments of drug therapy safety management research (e.g. patient safety indicators, questionnaires, rating scales, registers) have to be determined according to the particular research target. Due to the complexity of the medication process in drug therapy safety management research, complex interventions (i.e. simultaneous interventions at different points of the medication process) are particularly significant. In light of the problems of drug therapy safety management, they are generally indispensable and require appropriate study design.

• 3 Focus of research in Germany

According to the current status of drug therapy safety management research, the following topics are particularly important:

• Cooperation of the parties involved in the drug therapy

• Using information technology to improve drug therapy safety management

• Use of systematically collected data to improve drug therapy safety management

• Drug therapy safety management for selected high risk drugs

• Drug therapy safety management for particular patient groups.

Since drug therapy safety management research is not yet established in Germany, the aim of the memorandum is to develop this field of research in Germany by discussing the research topics and the specific needs and methods of this research field. The complete Memorandum on Drug Therapy Safety Management Research is available on the Internet [12].

Impact of the memorandum

The memorandum was submitted to the Federal Minister of Health by the Federal Minister of Education and Research. This prompted a particular focus upon drug therapy safety management research in the Guidelines on the Promotion of Studies in Health Services Research, which came into force on 15 August 2012 [12]. As a consequence, a variety of research proposals have been made and a decision will be reached on their funding in the near future.

Competing Interests

Both authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf and declare no support from any organization for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work.