Drug Safety
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: Risks of abuse, misuse and diversion of opioids are of concern. Obtaining opioid prescriptions from multiple prescribers, known as opioid shopping, is a way in which opioids may be abused and diverted. Previous studies relied on counting the number of prescribers or number of pharmacies a subject goes to in a year to define shopping behaviour, but did not distinguish successive prescribers from concomitant prescribers. ⋯ : Overlapping of prescriptions is not unique to opioids and therefore a criterion that incorporates number of pharmacies is needed to define shopping behaviour. Having two or more overlapping prescriptions written by different prescribers and filled at three or more pharmacies differentiates opioids from diuretics and likely constitutes shopping behaviour.
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Preventable adverse drug events (ADEs) are common in both outpatient and inpatient settings. However, the proportion of preventable ADEs varies considerably in different studies, even when conducted in the same setting, and methods for assessing the preventability of ADEs are diverse. ⋯ Instruments for assessing the preventability of ADEs vary from implicit instruments to explicit algorithms. There is limited evidence for the validity of the identified instruments, and instrument reliability varied significantly. The process of assessing the preventability of ADEs is also commonly imprecisely described, which hinders the interpretation and comparison of studies. For measuring the preventability of ADEs more accurately and precisely in future, we believe that existing instruments should be further studied and developed, or that one or more new instruments should be developed, and the validity and reliability of the existing and new instruments be established.
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Unintended hepatic injury associated with the use of paracetamol (acetaminophen)-containing products has been growing. ⋯ Hepatic injury associated with paracetamol use is increasing significantly faster than population, paracetamol product sales and poison centre use. This suggests a growing portion of consumers is self-dosing paracetamol beyond the toxic threshold. This is true for paracetamol with and without opioids, but the increase in hepatic injury is greater when paracetamol is taken with an opioid. This disproportionate rise is greatest with misuse and abuse of paracetamol products in combination with opioids. Increasing self-dosage of the opioid combination products for the opioid effect is likely to result in more cases of toxic exposure to paracetamol. In contrast, cases of exposure to paracetamol-containing cough and cold products are underrepresented among those injured. In the absence of opioid-containing products, consumption of more than one paracetamol-containing product did not contribute to injury. Efforts to modulate unintentional paracetamol-related hepatic injury should consider these associations.
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There is little information on the status of the implementation of the isotretinoin Pregnancy Prevention Programme (PPP) in the EU, and on compliance with this programme by the regulatory agencies. ⋯ Despite implementation of the isotretinoin PPP in most member states, isotretinoin-exposed pregnancies were reported. This has led some member states to implement additional measures to the PPP, resulting in inconsistency with the approach agreed in 2003 following the European-wide review. It has been further suggested that common elements should be developed for PPPs for all medicines that are known to carry a high teratogenic risk.
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Adverse drug events (ADEs) are an increasingly relevant issue for healthcare systems as they are associated with poorer health outcomes and avoidable misuse of resources. The rates of ADEs are higher in the elderly population, as many older patients have comorbidities, multiple drug prescriptions and deteriorated physical and cognitive functioning. The occurrence of ADEs can lead to a perceived lack of therapy efficacy and further underuse or suboptimal adherence in elderly people, with detrimental clinical outcomes. ⋯ Although economic evidence in elderly patients is still limited, all studies seemed to confirm that the financial burden due to pharmacological treatment issues is relevant in elderly people. Including economic effects of adverse events in pharmacoeconomic analysis would be beneficial to improve the reliability of results. Preliminary evidence suggests that programmes aimed at comprehensively assessing geriatric conditions, detecting 'high-risk' prescriptions and training patients to comply with prescribed therapies could be costeffective measures to reduce the burden of ADEs.