Prescrire international
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Vaccines against human papillomavirus (HPV) types 6/11/16/18 (Gardasil) and 16/18 (Cervarix) are non-viable vaccines composed of recombinant HPV proteins. As a precaution, they should not be given during pregnancy. However, some women are vaccinated shortly before conceiving or early during an undiagnosed pregnancy. ⋯ There are more, relatively reassuring, data on the HPV 6/11/16/18 vaccine. Women who are vaccinated just before conceiving or early in pregnancy should receive appropriate information. Active pharmacovigilance must continue.
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In marketing, "key opinion leaders" are used to influence purchasing behaviour through their perceived position of authority. In drug marketing, key opinion leaders are renowned physicians and other healthcare professionals on whom the medical profession rely when forming an opinion on a drug or practice. Pharmaceutical companies use key opinion leaders as marketing tools to promote their drugs or influence the decisions of regulatory agencies and other institutions. Opinion leaders are carefully handled and their management is often outsourced to specialised marketing agencies.
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In Europe, in mid-2011, about 30 cases of dependence, abuse or withdrawal symptoms attributed to pregabalin had been reported to Swedish and French pharmacovigilance centres and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). About 20 cases of gabapentin addiction were published in detail. The most frequently reported disorders were withdrawal symptoms. ⋯ In practice, it is better to avoid exposing patients to these risks when the expected benefits are not properly documented. Healthcare professionals should take care to prevent and detect addiction to pregabalin or gabapentin. When necessary, assistance with tapering off the medication should be offered.
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Prescrire international · May 2012
Review2011 drug packaging review: too many dangers and too many patients overlooked.
Every year, Prescrire's analysis of drug packaging confirms the importance of taking packaging into account in assessing a drug's harm-benefit balance. Safe, tried and true options are available, yet the quality of most of the drug packaging Prescrire examined in 2011 left much to be desired. Few of the packaging items examined help prevent medication errors and many actually increase the risks: misleading and confusing labelling, dosing devices that create a risk of overdose, bottles without a child-proof cap, and inadequate or dangerous patient information leaflets. ⋯ Some patients are at greater risk: the patient leaflets for NSAIDs endanger pregnant women and their unborn babies; children are insufficiently protected by paediatric packaging and are at risk due to the lack of child-proof caps on too many bottles. The raft of regulatory measures taken by the French drug regulatory agency (Afssaps) in the aftermath of the Mediator disaster overlooked the importance of packaging. Until drug regulatory agencies tackle the vast issue of drug packaging, it is up to healthcare professionals to protect patients from harm.