Collaboration between patient and pharmacovigilance organizations to gain insight into adults' experiences with drug use and ADRs for the treatment of ADHD.

BACKGROUND: Patient organizations have good access to patients, which can be of interest in gaining knowledge about patients' experiences with drugs. The aim of this study is to investigate if a collaboration between a pharmacovigilance center and an ADHD patient organization can give more insight in patients' experiences with drug use and ADRs for the treatment of AD(H)D. METHODS: Pharmacovigilance Centre Lareb and ADHD patient organization Impuls & Woortblind created a web-based questionnaire asking about patients' experiences with drug use and ADRs. Patients were approached to participate by e-mail and an open web-link. They were also asked to report ADRs through the official reporting form of Lareb. RESULTS: A total of 1160 patients completed the questionnaire, of which 75.2% of the respondents experienced ADRs and 60.7% discontinued treatment because of an ADR. More than 70% experienced positive effects of their drugs. Additionally, 5.0% of the respondents reported their ADRs to Lareb. CONCLUSIONS: Collaboration with patient organizations provide useful insight into patients' experiences with drug use and ADRs taking into account establishing clear 'rules of engagement'. An active approach to collaborate with patient organizations is a way forward to gain more information about drug use and ADRs in a selective cohort.

A global view of undergraduate education in pharmacovigilance.

PURPOSE: The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum. METHOD: A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants. RESULTS: The questionnaire was filled out by 307 respondents from 88 different countries with a response rate of 29.3% for the email invitation and an unknown rate for the web link. Respondents were mainly pharmacists and physicians. Currently, lectures are the largest proportion of educational activities and all healthcare profession curricula have a mode of 2 h as number of contact hours per course. Respondents rated clinical aspects as the most important subdomain to be included in the core curriculum with prevention of adverse drug reactions as the most important subtopic. This was followed by communication aspects between parties, with communication between regulatory authorities and healthcare professionals, methodological aspects with causality assessment, and regulatory aspects with benefit-risk assessment. This is similar to subjects addressed in current educational activities with little difference between medical and pharmacy curricula. CONCLUSION: This study gave a good general impression in current educational activities and the respondents' needs and wishes for future activities worldwide, which both will be used for the development of the undergraduate pharmacovigilance core curriculum.

Drug-induced Fanconi syndrome associated with fumaric acid esters treatment for psoriasis: a case series.

BACKGROUND: Fumaric acid esters (FAEs), an oral immunomodulating treatment for psoriasis and multiple sclerosis, have been anecdotally associated with proximal renal tubular dysfunction due to a drug-induced Fanconi syndrome. Few data are available on clinical outcomes of FAE-induced Fanconi syndrome. METHODS: Descriptive case series with two cases of Fanconi syndrome associated with FAE treatment diagnosed at two Dutch university nephrology departments, three cases reported at the Dutch and German national pharmacovigilance databases and six previously reported cases. RESULTS: All 11 cases involved female patients with psoriasis. The median age at the time of onset was 38 years [interquartile range (IQR) 37-46]. Patients received long-term FAEs treatment with a median treatment duration of 60 months (IQR 28-111). Laboratory tests were typically significant for low serum levels of phosphate and uric acid, while urinalysis showed glycosuria and proteinuria. Eight (73%) patients had developed a hypophosphataemic osteomalacia and three (27%) had pathological bone fractures. All patients discontinued FAEs, while four (36%) patients were treated with supplementation of phosphate and/or vitamin D. Five (45%) patients had persisting symptoms despite FAEs discontinuation. CONCLUSIONS: FAEs treatment can cause drug-induced Fanconi syndrome, but the association has been reported infrequently. Female patients with psoriasis treated long term with FAEs seem to be particularly at risk. Physicians treating patients with FAEs should be vigilant and monitor for the potential occurrence of Fanconi syndrome. Measurement of the urinary albumin:total protein ratio is a suggested screening tool for tubular proteinuria in Fanconi syndrome.