The CMR system (in phase II) consists of a website (http://www.medicatieveiligheid.info
), a database, a web-based reporting form, an application to import reports generated in other reporting systems (including a real-time interface), an application to generate an overview of reported medication incidents (including trend analyses), and a national warning system for healthcare providers (alerts and newsletters by email, which are also made available through the website).
Web-based reporting form
Users can access the reporting form on a secure part of the CMR website. The reporting form consists of four sections: administrative information; patient data; information about the medication incident; and questions concerning the need to issue an alert.
In the administrative information section the user needs to fill in the reporting date, the date of the medication incident and the identification number of the healthcare organization. Personal patient data are limited to gender and year of birth of the patient (when applicable). Based on the experience of the US Institute for Safe Medication Practices (ISMP) the description of the medication incident starts with an open question to describe the medication incident. The remaining questions are multiple-choice questions with predefined answers in drop-down menus. The three most important questions are: What type of medication incident is it? What were the underlying cause(s)? What has been the harm to the patient? The fourth and final section of the reporting form consists of questions about the risk of recurrence, the educational potential for other healthcare providers and the perceived need for an alert (see supplementary appendix I, available online only).
Classifications in reporting form
The CMR reporting form has three important classifications: a medication error classification; a classification of causes; and a classification of harm to the patient. For the CMR in phase II we adapted the initial classification system of medication errors (based on work by Van den Bemt and Egberts).10
For this revision we also used the WHO international classification for patient safety, earlier experiences of hospitals, and suggestions from a panel of eight community pharmacists.11
The revised classification distinguishes eight steps in the medication distribution process and each step contains several subcategories (see supplementary appendix II, available online only).
The classification of causes was based on the Eindhoven classification method, which was originally developed for the chemical industry.12
The Eindhoven classification method is also useful to identify failure factors of medication incidents.13
This classification discriminates between technical, organizational, human, communication, and patient-related failure factors.
The CMR uses the Dutch coding system for patient safety, The Netherlands technical agreement 8009, to classify harm. The Netherlands technical agreement divides the harm into five classes: none, minimal/mild harm, serious temporary harm, serious permanent harm, and death.14
In the case of a near miss the healthcare provider can estimate the potential harm (what if the patient would have been exposed to the error) on a five-point scale.
One of the routes for reporting a medication incident is the web-based reporting form. Most Dutch hospitals have their own internal system to register all kinds of reported events including medication incidents. If the hospital does not use the web-based reporting form then the hospital can use one of the two computerized ways to send these reports to the CMR database. The first way is to extract these reports manually from the internal reporting system and the hospital manually uploads these reports to the CMR database through the CMR website. Since 2007, hospitals can also use a direct real-time interface between their internal reporting systems and the CMR database for submitting their internal reports about medication incidents directly. Some community pharmacy chains are now also using internal reporting systems with a direct interface to the CMR. Both the manual upload function and the real-time interface prevent double reporting activity for the healthcare provider (reporting to two separate internal and multicenter reporting systems). For both functions the obligatory questions of the CMR have to be built into the internal reporting system. In the literature we have found that a state-wide reporting system in the USA (the Pennsylvania patient safety reporting system) is helping facilities to construct such an interface between existing reporting systems in hospitals and the Pennsylvania patient safety reporting system because of complaints that reporting to two separate systems (the internal and multicenter system) required extra work.3
Besides these formal ways healthcare providers may also contact the CMR team (currently consisting of a clinical pharmacologist, two pharmacists, one nurse, and two pharmacy technicians) informally by telephone or email.
Analysis and feedback
The CMR team screens the submitted reports every week by hand to sort out which medication incidents are potentially interesting. This is primarily done on the basis of three predefined general criteria: (1) risk of recurrence; (2) educational potential for other healthcare providers; and (3) actual or potential risk of serious harm to the patient. Reports may also be selected for further scrutiny when they concern a predefined topic of special interest (such as an accidental interchange of patients or of sound-alike and look-alike medicines). The CMR team decides which reports potentially qualify for an alert or as an item for the CMR newsletter, and which ones should be marked for further analysis of a special interest topic. The CMR team can also perform additional analyses of the entire database to track and define similar earlier cases.
Users can analyze their own reports and compare these with all the reported medication incidents within a sector (hospitals, community pharmacies, mental care institutions).
National warning system
Alerts consist of reported medication incidents with a high risk of recurrence, high educational potential for other healthcare providers, and/or actual or potential risk of serious harm to the patient. The healthcare providers can notify on the report form whether the medication incident meets the requirements of an alert, but the CMR organization forms its own opinion during the screening process. The CMR organization is submitting the selected reports for further evaluation to a multidisciplinary expert panel (consisting of an experienced general practitioner, internal medicine physician, psychiatrist, hospital pharmacist, clinical pharmacologist, pharmacist in mental care, community pharmacist, nursing home physician, nurse and patient representative). If the panel decides that an alert is warranted, a CMR alert is prepared in accordance with a prespecified format (a brief summary of the medication incident, general background information and comments, and specific recommendations to reduce the risk of recurrence). The CMR organization sends the alerts out to healthcare professionals by email and they are also made available through the public part of the CMR website.
Less urgent but relevant matters are communicated through a periodical electronic newsletter on the website and incidental publications in the Dutch Pharmaceutical Journal. The newsletter is sent out every 3 months by email and may be consulted through the public part of the CMR website.
All practising pharmacists in The Netherlands receive (for free) the alerts and newsletters. To receive the alerts and newsletters it is not necessary for the pharmacists to participate or to report actively to the CMR. Other healthcare providers only receive the newsletters when they have actively subscribed to them (also for free). If the alert is relevant for specific groups of other healthcare providers, the CMR organization informs their scientific and professional associations. The CMR has chosen distribution by email because of the quick delivery and because all pharmacists can be readily reached by email.
Security and confidentiality
The hosting and IT security comply with the latest Dutch ICT standard (NEN 7510), which is based on the international standard ISO/IEC 17799.15
Healthcare providers always submit their report over a secure Internet connection.
Each member of the CMR team has signed a contract of confidentiality. The CMR cannot publish any report without formal approval of the healthcare provider, even when the publication does not contain retraceable information. The database only records the ID number of the reporting healthcare practice. The analyst does not have information that is directly retraceable to the healthcare organization or person who reported the medication incident or was involved in it.
According to Dutch law, the CMR team is not obliged to hand over the content of the CMR database to public bodies like the Healthcare Inspectorate, Ministry of Health, etc. The healthcare provider always remains the legal owner of the submitted reports.
The CMR database is a relational database that is maintained in a Microsoft SQL server. The applications use ColdFusion for data driving and the operating system is a Microsoft Windows server. The applications and data storage communicate use XML. The CMR database and the applications have been developed and are maintained by a software development firm (Ritense BV, Amsterdam—http://www.ritense.com