Swissmedic Vigilance News Edition 21 – November 2018

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frequently report ADR are patients who are, or were, themselves affected or professionals who use or dispense therapeutic products on a commercial basis. The latter are also obliged by the Swiss Federal Act on Medicinal Products and Medical Devices to report serious or previously unknown ADR. But numerous wide-ranging reasons are presented for nevertheless not reporting ADR. These include: erroneous assumptions that only safe medicines are on the market and that an ADR is therefore not possible. fear of becoming entangled in a legal dispute or of losing the patient's trust. subjective feelings of guilt that a medicine may have harmed more than helped. personal ambition to collect and publish case reports (publish or perish). unwillingness to report a drug-induced reaction solely on the basis of a suspicion without a definite connection, or simply the lack of time and interest: “The bureaucracy and completion of forms won’t help improve my patient’s situation.” Primary reporters are also not reimbursed for their time and intellectual input. Many of these possible reasons involve an active reluctance to report an ADR. However, an unintentional reticence should not be overlooked: the lack of knowledge concerning pharmacological principles, pathophysiological explanations of dose-dependent effects and side effects, the fundamental inclusion of an ADR in the differential diagnosis during the investigation of symptoms. In 2017 in Switzerland, 36,900 physicians (32,586 full-time equivalents) were employed in a wide variety of fields (SMF 2018; 99 (13-14): 408-413). 51% of these work in the outpatient environment and 47% in the inpatient sector. Many use medicines as treatments – but how many of them possess a sound knowledge of pharmacological principles that goes beyond the respective indication, dosage and certain warnings? So in 2016 all RPVC in Switzerland and Tox Info Suisse – the National Poisons Centre responsible for all questions and information related to overdoses – merged in a collaborative venture with the aim to focus people’s attention on drug safety (see SMF 2016;16(37):757–763). Together with the Swissmedic National Pharmacovigilance Centre, the decision was taken to provide regular educational articles consisting of clinically relevant pharmacovigilance cases with a subsequent pharmacological or toxicological explanation. The medium chosen for this purpose was the official training organ of the Swiss Medical Association (FMH), i.e. the most widely read medical education journal in Switzerland. The "Swiss Medical Forum” appears weekly in German and French, with a total circulation of 38,110 copies in Switzerland. This ensures that issues of relevance to drug safety are given the widest possible dissemination. The existing pharmacological and toxicological expertise is provided to refresh drug-related knowledge, place it in a clinical context and present it concisely and succinctly using casebased analyses. The higher-level aim is to improve drug safety in Switzerland, maintain standards of prescribing and, last but not least, increase national patient safety. Decant and carafe: Choosing the right vessel Every day physicians take countless histories. They ask questions about current symptoms, previous illnesses, familial predisposition, work, risk factors and many other matters. So physicians listen to countless histories from their patients. But they also like to read patient (hi)stories, since they are much more familiar with them from their daily clinical work than with statistics or methodological indicators. The RPVC collaboration therefore Swissmedic Vigilance News | Edition 21 – November 2018 16 | 39
agreed on the format of a brief case description of the ADR: How old? How serious? What medicine was used, why and at what dosage? What was the latency period prior to what symptoms? What was investigated in the differential diagnosis? What happened then? Were countermeasures initiated? Were there any predisposing factors, such as allergies, renal impairment or liver disease? Subsequent to the case report, a clinicallybased pharmacological or toxicological assessment of the case is provided, in which classical sources are presented as helpful guidance. The assessment is based on the Swiss product information of the drug which, in contrast with many other countries, is freely available on the Internet, at www.swissmedicinfo.ch. Depending on the clinical case and the ADR, drug-drug interactions, drug-herb interactions, drug-food interactions and drug-disease interactions are also discussed. A failure to recognise the ADR can result in prescribing cascades. Risk factors for the respective ADR – e.g. advanced age, poor compliance, substances with a narrow therapeutic range, multimorbidity, hepatic/renal impairment and polypharmacy – are included in the analysis. These factors may be associated with an increased risk of altered pharmacodynamics in terms of an increased response, pharmacokinetic and pharmacodynamic interactions or the patient’s limited compensation mechanisms. Other medical causes that may not yet have been excluded are also presented, together with case-related evidence and the pathophysiological plausibility for the respective reaction. The question as to whether the reaction could have been avoided is often posed. Were potential sources of error present, such as system-related risk factors with transcription errors, mix-ups, incorrect administration or multiple prescribing? Are there medical/pharmacological alternatives to the drug that may have caused the reaction? An example of such a case description with subsequent assessment is shown below. The clinical case: Acute hepatitis during the administration of amoxicillin/clavulanic acid The 58-year-old male patient presented at the hospital with severely itching jaundice and general malaise. Following a yellow fever vaccination (3 months previously), he had travelled to Tanzania, where he had developed swallowing difficulties two weeks ago. He also suffered from a blocked nose and earache. As treatment he took Triofan ® (carbocisteine, xylometazoline) nasal spray, Mebucaine ® f (tyrothricin, cetylpyridinium, oxybuprocaine), Voltaren ® Dolo liquid Caps 12.5mg (diclofenac) and two sachets of Neo- Citran ® (phenylephrine, pheniramine, ascorbic acid, paracetamol). Since the symptoms continued to deteriorate, he returned home prematurely after a few days and visited his physician, who diagnosed an upper respiratory tract infection and bilateral otitis media. The C-reactive protein level (CRP) was 48 mg/L (normal:
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Swissmedic Vigilance News Edition 21 – November 2018

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