Discrepancies in the physician-acquired medication history at admission do not always correlate with discrepancies during hospitalization because of clinical pharmacists' interventions; however, discrepancies at admission may be associated with at least half of the discrepancies at discharge. Clinical pharmacist-conducted medication reconciliation can reduce these discrepancies, provided the erroneous information in the physician-acquired medication history is corrected and each intentional change in the medication plan is well documented during hospitalization and at discharge.
Pharmacist-acquired medication histories enhance the medication reconciliation process, both in patients residing at home and in a nursing home prior to hospitalization. A focus should be placed on seamless care procedures that facilitate the transfer of medication histories between primary and secondary care in both of these populations.
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The clinical evidence level of orphan medicines in European market authorization submissions is low: few randomized controlled trials, short treatment follow‐up, rarely hard clinical endpoints. • The success rate at centralized market authorization is lower for orphan drugs (62.9%) than for non‐orphan medicines (70.7%). • The burden of disease of rare diseases is high, affecting the lives of at least 30 million patients in the European Union (EU). WHAT THIS STUDY ADDS • As opposed to market authorization, orphan drugs gain reimbursement more easily than non‐orphan innovative drugs. • Lower quality of evidence of clinical efficacy and safety, more uncertainty on cost‐effectiveness and higher product prices are accepted for orphan drugs. • There is a need for collaboration between the European Commission, competent for market authorization, and the EU member states, competent for reimbursement, in assessing the therapeutic risks and benefits of orphan drugs, to reduce the evidence gap post marketing. AIM We analysed the Belgian reimbursement decisions of orphan drugs as compared with those of innovative drugs for more common but equally severe diseases, with special emphasis on the quality of clinical evidence. METHODS Using the National Health Insurance Agency administrative database, we evaluated all submitted orphan drug files between 2002 and 2007. A quality analysis of the clinical evidence in the orphan reimbursement files was performed. The evaluation reports of the French ‘Haute Autorité de Santé’, including the five‐point scale parameter ‘Service Médical Rendu (SMR), were examined to compare disease severity. Chi‐squared tests (at P < 0.05 significance level) were used to compare the outcome of the reimbursement decisions between orphan and non‐orphan innovative medicines. RESULTS Twenty‐five files of orphan drugs and 117 files of non‐orphan drugs were evaluated. Twenty‐two of 25 (88%) submissions of orphan drugs were granted reimbursement as opposed to 74 of the 117 (63%) non‐orphan innovative medicines (P= 0.02). Only 52% of the 25 orphan drug files included a randomized controlled trial as opposed to 84% in a random control sample of 25 non‐orphan innovative submissions (P < 0.01). The duration of drug exposure was in most cases far too short in relation to the natural history of the disease. CONCLUSIONS Orphan drug designation predicts reimbursement despite poor quality of clinical evidence. The evidence gap at market authorization should be reduced by post‐marketing programmes, in which the centralized regulatory and the local reimbursement authorities collaborate in an efficient way across the European Union member states.
Management of spruce budworm, Choristoneura fumiferana (Clem.), outbreak spread requires understanding the demographic processes occurring in low, but rising populations. For the first time, detailed observations were made in the early stages of outbreak development. We sampled populations over a three-year period in both treated and untreated populations in the Lower St-Lawrence region of Quebec, Canada, and measured the density-dependence of survival and population growth rates, and the impact of natural enemies and insecticides. Insecticides tested were Bacillus thuringiensis (Berliner 1915) and tebufenozide. We recorded strong density-dependence of survival between early larval stages and adult emergence, explained largely by the variation of natural enemy impacts and overcrowding. We also observed inverse density-dependence of apparent fecundity: net immigration into lower-density populations and net emigration from the higher, linked to a threshold of~25% defoliation. Because of high migration rates, none of the 2013 treatments reduced egg populations at the end of summer. However lower migration activity in 2014 allowed population growth to be reduced in treated plots. This evidence lends support to the conclusion that, for a budworm population to increase to outbreak density, it must be elevated via external perturbations, such as immigration, above a threshold density of~4 larvae per branch tip (L 4 ). Once a population has increased beyond this threshold, it can continue growing and itself become a source of further spread by moth migration. These findings imply that populations can be brought down by insecticide applications to a density where mortality from natural enemies can keep the reduced population in check, barring subsequent immigration. While we recognize that other factors may occasionally cause a population to exceed the Allee threshold and reach outbreak level, the preponderance of immigration implies that if all potential sources of significant numbers of moths are reduced on a regional scale by insecticide applications, a widespread outbreak can be prevented, stopped or slowed down by reducing the supply of migrating moths.
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