Elsevier

Health Policy

Volume 119, Issue 8, August 2015, Pages 1046-1054
Health Policy

How to make medication error reporting systems work – Factors associated with their successful development and implementation

https://doi.org/10.1016/j.healthpol.2015.03.002Get rights and content

Highlights

  • Several factors at national and local levels impact functionality of MER systems.

  • These factors should be considered when developing and implementing MER systems.

  • National recognition of deficiencies in medication safety needs to precede actions.

  • Political will and adequate resources are crucial when introducing MER systems.

  • National coordination and leadership must be organised for functional MER systems.

Abstract

This study explored factors associated with successful development and implementation of medication error reporting (MER) systems in different healthcare contexts. A descriptive online questionnaire comprising of structured and open-ended questions was responded to by 16 medication safety experts in 16 countries. The present paper describes the rich and multidimensional qualitative data from the experts’ narratives from open-ended questions. Several factors related to the national context of MER systems, i.e., the operational environment, were identified to impact successful development and implementation of these systems. The factors were: awareness of deficiencies in medication safety at local and national levels to justify the need for MER systems; gaining political will for the development and implementation actions together with international and governmental support; creating or reforming legislation and national regulations, guidelines and strategies to support MER; allocation of adequate human and financial resources; establishment of an organisation or centre to coordinate and lead MER; and extending systems approach and safety culture to all parts of the operational environment to facilitate openness on and learning from medication errors. In conclusion, operational environments of MER systems must be constructed to support functionality of these systems, and need to be improved in many countries.

Introduction

Medication errors constitute a serious threat for healthcare safety internationally [1]. They are defined as any preventable events that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer [2]. Medication errors can occur during various stages of the medication use process, e.g. while prescribing, dispensing or administering a medicine [3]. It has been estimated that medication errors cause the death of 7000 patients annually in the United States alone [4]. Studies on medication errors have shown them common and costly; medication errors and other adverse drug events cost tens of billions of dollars for healthcare systems around the world each year [3].

The current understanding about learning from medication errors is based on the systems approach stating that errors are mainly consequences of systematic factors and organisational weaknesses [5]. To detect and learn from medication errors, medication error reporting (MER) systems have been recommended as tools to manage safety risks in medication use [6], [7]. The primary goal of MER is to ensure long-term quality improvements in healthcare by understanding the systems factors contributing to medication errors, not plain counting of errors [7]. Thus, MER systems should support achievement of this goal.

Some countries have implemented local and/or national MER systems into their healthcare systems [8]. While MER practices may have varied between healthcare settings and countries, they have encountered similar difficulties, for example with healthcare professionals’ lack of willingness to report errors [9], [10]. Other central barriers to reporting have found to be healthcare professionals’ lack of time for and training in reporting, and the lack of organisational leadership and support for reporting and learning from errors [8]. Therefore, the information and lessons learnt from countries with a current system are essential in maintaining existing systems, and in the development and implementation of new systems. While many MER systems are under development [11], this information is needed. As little previous research has been conducted on the development and implementation of MER systems in healthcare, our aim was to explore what makes a MER system work and what are the factors associated with the successful development and implementation of national and local MER systems in different healthcare contexts.

Section snippets

Study design

The data was collected by consulting medication safety experts knowledgeable about MER systems in their own countries. The study produced both qualitative and quantitative data. In the present paper we concentrate on the rich and multidimensional qualitative data; the quantitative findings have been reported elsewhere [8]. However, some of the quantitative data was used to support the interpretation of the qualitative data. This information comprised of the existence of a MER system in an

Results

Overall, 16 experts (5 females, 10 males and 1 gender unknown) responded from a heterogeneous group of 16 countries in Africa (Ghana, Rwanda and Zambia), Australasia (Australia, Japan and India), Europe (Austria, Czech Republic, Finland, Hungary, Kosovo, Latvia, Norway, Serbia and Sweden) and North-America (Canada) [8]. Fig. 1, Fig. 2 describe the factors necessary for the development and implementation of a successful MER system. These factors were suggested by the experts and were identified

Discussion

Altogether 16 national medication safety experts described the operational environments of MER systems in their countries and the factors associated with the successful development and implementation of these systems. Our findings give ample information on how the operational environment should support MER systems. To our knowledge, no previous research has explored these factors in such extent. Indeed, the lack of focus in operational environments may explain why many current MER systems are

Conclusions

Operational environments of MER systems must support functionality of these systems and need to be improved in many countries. Several factors at the national and local levels impact on the functionality of MER systems and should be considered in relation to their development and implementation. A lack of resources may inhibit establishing MER systems in some countries, representing a target for international collaboration. The safety culture should be extended to all parts of the operational

Conflict of interest statement

The authors declare that they have no conflicts of interest.

Acknowledgements

We wish to thank: Prof. Marjorie Weiss, University of Bath, UK, Dr. Tana Wuliji, University Research Co., LLC – Center for Human Services, US, Xuan Hao Chan, International Pharmaceutical Federation and the International Pharmaceutical Federation (FIP) for participating in the entire study process; Dr. Jane Sutton, University of Bath, United Kingdom, for reviewing the study proposal; the FIP Patient Safety Working Group and the World Health Organization World Alliance for Patient Safety for

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