Ecological studies: advantages and disadvantages

Background According to the good practice contract (CBUMPP), our University Hospital submits an annual self-evaluation to the Regional Health Authority (ARS) assessing the good practice of implantable medical devices (IMDs) prescriptions. Purpose To analyse the IMD indications according to CBUMPP requirements, namely to verify the conformity with national recommendations and justify off-label prescriptions. Materials and methods Each year in our hospital, an audit is performed to analyse all IMD prescriptions during a randomly selected week. Using various software, the hospital’s IT department establishes a database from patient and IMD records. This is matched against from the CBUMPP criteria. Pharmacists and surgeons consider the indications and look for evidence in the patient file if it does not conform. Results Over one week in 2013, the data collected from the entire hospital contained 746 lines containing IMDs. Our study focused on a sample of 485 IMD lines (65%) for 67 patients. The surgical branches represented were: Orthopaedics, Paediatrics (spine), Maxillofacial surgery (CMF), Otorhinolaryngology (ORL) and Ophthalmology. In many cases, multiple implants were often required for the same intervention (ranging from 1 to 32 implants in our study). 100% of the prescriptions complied with national recommendations. The main indications observed in Orthopaedics (41 patients) were prosthesis (141 IMDs), ligamentoplasty (27 IMDs), osteosynthesis (4 IMDs) and in Paediatrics (4 patients) were scoliosis (59 IMDs) and ligamentoplasty (2 IMDs). In CMF and ORL (22 patients), we analysed 252 IMDs. Conclusions In our sample, the good practice recommendations were followed. However, current national recommendations in these specialities are not very restrictive. Close collaboration between pharmacists and surgeons is essential to obtain complete data and evidence in order to evaluate the IMD conformity. No conflict of interest.