Background Since incentives were introduced to promote orphan drugs in Europe, several dozens of drugs have been registered at the European level. However, patient access on a national level remains very heterogeneous across Europe. This can be explained by healthcare organization and drug reimbursement, which are within the purview of each Member State. We studied access to orphan drugs in France from the patients’ point of view, including marketing but also ease of supply from patients’ perspective, financial and time-based dimensions. Results We identified 91 registered orphan drugs in Europe, corresponding to 115 orphan drug–therapeutic indication pairs. In France, 78.3% (90/115) of these pairs were marketed: 100% were available to inpatients and 75.6% were available to outpatients. The median period between granting of the European marketing authorization and publication of the reimbursement decision was 360 days. The broadest availability—through community pharmacies—was guaranteed in only 31.1% of cases. Prescriptions were mainly restricted either to hospital-based doctors or to specialists. Inpatients were not financially responsible for these prescriptions and 72% of the orphan drug–therapeutic indication pairs available to outpatients were fully covered by national health insurance in France. Conclusions Patient access to orphan drugs is not universal in France. Access to reimbursement has a strong impact on patients’ effective access to orphan drugs, which may be restricted by difficulties with assessing the clinical value of these drugs and with pricing issues. Prescribing restrictions and drug delivery systems influence the ease of patients’ supply for reimbursed orphan drugs for patients. Patients do not seem to be limited by financial issues, but the growing budgetary impact of orphan drugs is worrisome from a societal point of view.
opened, to the hospital and patients' home conditions (light, temperature, humidity and microbiological). Purpose 1. To check the SODF-MUC requirement, after the container opening, in order to determine special conditions for its repackaging and storage. a. Dry place that does not exceed 40% average relative humidity at 20°C or the equivalent water vapour pressure at other temperatures. b. Room with temperature under 25°C. c. Refrigeration, (temperature between 2°to 8°C). d. Protected from the light. 2. To quantify the importance of the annual net price of hospital SODF-MUC.
BackgroundThe development of electronic prescriptions secures patient medication care in hospital. However, software can also lead to medication errors, for example when the drug data sheet is misconfigured.1 PurposeTo correct configuration errors related to prescription and distribution parameters in prescription software, in order to obtain a more accurate drug database, improve drug information and decrease the number of prescription errors.Material and methods3 pharmacists and 2 pharmacy residents developed a monthly checklist to consolidate the key data regarding drugs which were available in our hospital. Between June and October 2016, all of the data sheets corresponding to these drugs were extracted monthly and then analysed. Configuration errors were identified, quantified and corrected in prescription software (Orbisv8.4, AGFA).ResultsDuring the initial set up, 25 checkboxes and 15 path fields were available on 7 tabs. Using data mining, the main parameters of prescription (5 path fields) and distribution (5 path fields) were first studied. On average, 2073 data sheets per month were extracted. Regarding prescription parameters, 1641 of 2125 data sheets (77.2%) included at least 1 error in June. This rate decreased to 13.4% in October (270/2021). The rates of data sheets with at least 1 errors were, respectively, in June and October: 72.3% (1536/2125) and 9.6% (194/2021) for the pharmacotherapeutic groups, 8.4% (179/2125) and 3.4% (69/2021) for the pharmaceutical forms, 4.8% (102/2125) and 0.89% (18/2021) for administration routes, and 3.8% (80/2125) and 0.15% (3/2021) for prescription units. In June and October, 84.1% (1787/2125) and 2.28% (46/2021) of data sheets, respectively, included at least 1 error of distribution: respectively, 74.4% (1581/2125) and 0.30% (6/2021) for the minimum unit of distribution, 18.7% (397/2125) and 0.0% for the global order mode, 4.1% (87/2125) and 2.1% (42/2021) for the packaging, 3.8% (80/2125) and 0.15% (3/2021) for the distribution unit, and 2.4%(50/2125) and 0.0% for the restocking.ConclusionUpdating data have led to a more accurate drug database for prescription software. Enlargement of the method to other criteria (drug status, colour of the wording according to the class, etc) will improve drug information. This work should also decrease the number of medication errors in our hospital.References and/or acknowledgements1. Charpiat B, et al. Opportunities for medication errors and pharmacist’s interventions in the context of computerised prescription order entry. Ann Pharm Fr2012.No conflict of interest
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