The MEREAFAPS project (Epidemiological Monitoring of Adverse Drug Reactions and Events in Emergency Room) was launched in Lombardy in 2006. The rationale is simple: the vast majority of adverse drug reactions that occur at home take the patient to the emergency room, where doctors and nurses, overburdened by work, do not have time to fill in the reporting forms; some of these reactions are somewhat avoidable, and the MEREAFAPS project, since its inception, intended to focus attention on this aspect to identify the causes and consequently the activities of improvement in drug management. The project started in Lombardy in 8 hospitals (a total of 15 Emergency Rooms), with this organization: a monitor, which could have been a non-employee doctor, or a pharmacist or a nurse, would have helped the staff of the Emergency Room to fill in the reporting forms. The system by which emergency doctors informed the monitor was various, from direct information to a flag placed on the cards.
Results over time
The results of the first year of the project were very interesting: in the 8 hospitals in Lombardy, 1,448 reports of adverse reactions were collected, corresponding to about 50% of the national reports of the previous year. Not only that, but the report from the Emergency Room had definitively changed the quality and type of reports; the cards were richer in information, clinical and laboratory tests, the reactions were more serious, and involved drugs, such as anticoagulants, which until then were not the most reported.Confirmed by the good results of the first year, the project leaders of MEREAFAPS have expanded the number of hospitals involved. First the number of hospitals in Lombardy increased to 16 with 33 Emergency Hospitals, then Lombardy was joined by Piedmont, Campania, Emilia-Romagna and Tuscany. MEREAFAPS reports, which were 5,500 until 2009, rose to 13,000 in 2011.With the important contribution of the MEREAFAPS project (and also of the other pharmacovigilance projects that have been launched), Italian reports have increased from 6,000 to 54,000 in less than ten years, with a significant percentage increase in serious reactions, reaching a reporting rate close to that of New Zealand and the Scandinavian countries, the highest in the world. To date, more than 80,000 reports originating from the MeREAFAPS project are present in the national pharmacovigilance network.A work by the WHO Uppsala Monitoring Centre has stated that reports from Italy are among the best quality.1 The high number of reports is not just a quantity record: it stabilises the characteristics of the reports, which cannot be easily influenced by clusters of reports from individual locations or hospitals. Moreover, not to be underestimated, the MEREAFAPS project has led, directly or indirectly, hundreds of emergency doctors and several hundred young doctors and pharmacists to confront the practice of pharmacovigilance, creating a widespread culture of drug safety so far unknown in Italy.So, are you all right? Are there no problems? In the real world there are always problems. One of these is a secondary effect due to the progressive computerization of hospitals, including first aid records and medical records. The availability of data, even without direct interaction with the staff of the Emergency Room, risks to exclude again from the pharmacovigilance the staff, with a return to the past. The need to report the information and conclusions of studies to the data generators is a necessity for pharmacovigilance.
The MEREAFAPS project, in addition to collecting a great deal of data and spreading the culture of pharmacovigilance, has also allowed the realization of various scientific works, in different fields. Recently, the ASST Vimercate has conducted an analysis on the preventability of adverse reactions from oral anticoagulants in patients admitted to the Hospital's Medical Divisions during the period of one year. The data are very significant: out of 102 cases of ADRs from oral anticoagulants, the percentage of preventable reactions exceeded 70%. For vitamin K inhibitors (acenocoumarol and warfarin), prevention was given by INR levels above 5, which showed inaccurate control, and by the value of HAS-Bled, which in 65 cases out of 68 was compatible with a high risk of bleeding. For direct coagulation inhibitors the inappropriateness was related to the presence of major interactions (with antiaggregants, or other drugs) and low values of glomerular filtration rate, which contraindicated the use of these drugs. Many of the patients were hospitalized with signs of heart failure induced by unidentified bleeding or undiagnosed chronic anemia.For all oral anticoagulants the risk of bleeding was increased by advanced age (in the study the media age was 81 years with a range from 60 to 95), polypharmacy (more than 80% in therapy with more than 5 drugs and 31% with more than 10) and poor patient information (especially those in therapy with direct coagulation inhibitors, which do not require periodic laboratory checks). These data confirm what is already present in the literature, which highlights the increased risk of direct oral anitcoagulants in patients with interactions, with low glomerular filtration rate and with insufficient information.Randomized clinical trials have shown the effectiveness of oral anticoagulant therapy in preventing thromboembolic events in patients at risk (for example in non-valvular atrial fibrillation); however, to obtain the same results, patients, especially the elderly, must be followed with the same attention as patients in clinical trials. The therapeutic plan of direct anticoagulants provides for an annual renewal: but in elderly patients it is necessary to periodically check renal function, emochrome and circulation.Avoiding the burden of pain, suffering and even costs, caused by preventable adverse reactions and the inappropriateness of the use of anticoagulants, is an important objective for both clinicians and the health service; an important information campaign for doctors, health professionals and patients is necessary to minimize these serious adverse events.
MEREAFAPS Project Coordinator
U.O. General Medicine
- Drug Saf 2014;37:65-77. CDI