ISQUA16-2356A NATIONAL SCHEME TO ENSURE MEDICATION SAFETY: THE NATIONAL CERTIFICATION SYSTEM FOR COMPUTERIZED PHYSICIAN ORDER ENTRY (CPOE) IN FRANCE

Abstract

Objectives: The French National Authority for Health (HAS), an independent public scientific authority, is required to define a national mandatory certification system for CPOE. Certification requirements focus on health specifications with potential impacts on patient safety, quality of care and efficiency, drug prescription safety, drug cost, and simplifying users' work. Methods: Two certification schemes were defined by the HAS in 2008 and 2012 by consensus among user representatives, public stakeholders and representatives of software companies: - one for hospital CPOE systems based on hospital drug formulary (« Hospital CPOE » published in 2012) - one for CPOE systems used in ambulatory care settings where medication orders are not restricted by a drug formulary (« Ambulatory CPOE » published in 2008) These certification processes must be conducted by an accredited certification body under ISO/CEI 17065 norm. These certification schemes were paired with an approval process for Pharmaceutical Data Bases (PDB) also defined at national level by the HAS: only CPOE incorporating approved PDB are allowed to apply for certification. This prerequisite aims at ensuring the ability of CPOE systems to provide comprehensive, referenced, neutral, updated and complete drug information. Results: In France, five PDB are now approved by the HAS. In February 2016, 60 softwares representing 75% of CPOE used in primary care are certified « Ambulatory CPOE » under the scheme published in 2008. The most frequently used hospital CPOE in France are certified « Hospital CPOE » under the scheme published in 2012. The extent of implementation of certification of hospital CPOE has not been assessed as of this date. Dissemination is expected to reach a similar level as in primary care. Certified CPOE: - are not allowed to show advertisement; - provide security checks for drug use with medical record data including maximum dosage, drug interactions, pregnancy, lactation, medical history and allergy; - allow users to prescribe using International Nonproprietary Names without the pharmaceutical brand name for a wide range of drugs with the same security checks; - provide price of drug, reimbursement rates by the national health insurance, and costing of drug prescriptions; - provide updated, neutral and comprehensive drug information including information from the Health Technology Assessment process. Conclusion: The HAS is stepping up on these actions. In December 2015 HAS published a mandatory certification scheme for community pharmacy-dispensing software. HAS has also recently been required to define a mandatory certification scheme for hospital pharmacy-dispensing software. Further versions of all these schemes of certification will extend their functional scope to therapeutic choices and interoperability.