Pharmacovigilance Unit

New York City, United States

Pharmacovigilance Unit

New York City, United States

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Juhlin K.,Uppsala Monitoring Center | Karimi G.,Uppsala Monitoring Center | Ander M.,Uppsala Monitoring Center | Camilli S.,U.S. Food and Drug Administration | And 8 more authors.
Drug Safety | Year: 2015

Results: The assessment of a total of 147 clusters resulted in 8 confirmed, 12 potential and 51 unlikely substandard products, and a further 19 clusters were confirmed as not substandard. Reflecting the difficulty of evaluating suspected substandard products retrospectively when additional information from the primary reporter, as well as samples, are no longer available, 57 clusters were classified as indecisive.Conclusion: While application of the algorithm to VigiBase allowed identification of some substandard medicines, some key prerequisites have been identified that need to be fulfilled at the national level for the algorithm to be useful in practice. Such key factors are fast handling and transfer of incoming reports into VigiBase, detailed information on the product and its distribution channels, the possibility of contacting primary reporters for further information, availability of samples of suspected products and laboratory capacity to analyse suspected products.Background: Substandard medicines, whether the result of intentional manipulation or lack of compliance with good manufacturing practice (GMP) or good distribution practice (GDP), pose a significant potential threat to patient safety. Spontaneous adverse drug reaction reporting systems can contribute to identification of quality problems that cause unwanted and/or harmful effects, and to identification of clusters of lack of efficacy. In 2011, the Uppsala Monitoring Centre (UMC) constructed a novel algorithm to identify reporting patterns suggestive of substandard medicines in spontaneous reporting, and applied it to VigiBase®, the World Health Organization’s global individual case safety report database. The algorithm identified some historical clusters related to substandard products, which were later able to be confirmed in the literature or by contact with national centres (NCs). As relevant and detailed information is often lacking in the VigiBase reports but might be available at the reporting NC, further evaluation of the algorithm was undertaken with involvement from NCs.Objective: To evaluate the effectiveness of an algorithm that identifies clusters of potentially substandard medicines, when these are assessed directly at the NC concerned.Methods: The algorithm identifies countries and time periods with disproportionately high reporting of product inadequacy. NCs with at least 20 clusters were eligible to participate in the study, and six NCs—those in the Republic of Korea, Malaysia, Singapore, South Africa, the UK and the USA—were selected, taking into account the geographical spread and prevalence of recent clusters. The clusters were systematically assessed at the NCs, following a standardized protocol, and then compiled centrally at the UMC. The clusters were classified as ‘confirmed’, ‘potential’ or ‘unlikely’ substandard products; or as ‘confirmed not substandard’ when confirmed by an investigation; or as ‘indecisive’ when the information available did not allow a sound assessment even at the NC. © 2015, The Author(s).


Martins R.D.M.,Ministry of Health | Maia M.D.L.D.S.,Ministry of Health | Santos E.M.D.,Pharmacovigilance Unit | Cruz R.L.D.S.,Pharmacovigilance Unit | And 7 more authors.
Procedia in Vaccinology | Year: 2010

Viscerotropic disease (VD), a disease with high mortality, results from the dissemination of the yellow fever vaccine virus throughout the body. Twenty-six cases of VD following vaccination with the Bio-Manguinhos 17DD vaccine were reported, 21 from Brazil and 5 from other countries, of which 19 were confirmed, 4 probable and 3 suspect. These cases were not related to immunodeficiency diseases, but could be related to the existence of autoimmune diseases, such as systemic lupus erythematosus. Adverse neurological events following yellow fever vaccination are in general aseptic meningitis, with a good outcome, encephalitis, and autoimmune neurological events such as Guillain-Barré syndrome. In Rio Grande do Sul (2009) 2 cases of confirmed meningoencephalitis in newborns after yellow fever vaccination of a breastfeeding mother created a new and difficult problem to solve in a satisfactory manner. Bio-Manguinhos/Fiocruz is doing several studies to try to improve the yellow fever vaccine, such as a dose-response study, with the objective to know if the vaccine can be administered in a smaller dose than usual, which perhaps would be safer, Also, further purification of the current vaccine, and studies for the development of a non-live yellow fever vaccine are under way. © 2010.


Martins R.D.M.,National Interinstitutional Committee for Pharmacovigilance in Vaccines | Pavao A.L.B.,Fiocruz and Institute of Scientific and Technological Communication and Information in Health | de Oliveira P.M.N.,Pharmacovigilance Unit | dos Santos P.R.G.,Pharmacovigilance Unit | And 9 more authors.
Vaccine | Year: 2014

Neurological adverse events following administration of the 17DD substrain of yellow fever vaccine (YEL-AND) in the Brazilian population are described and analyzed. Based on information obtained from the National Immunization Program through passive surveillance or intensified passive surveillance, from 2007 to 2012, descriptive analysis, national and regional rates of YFV associated neurotropic, neurological autoimmune disease, and reporting rate ratios with their respective 95% confidence intervals were calculated for first time vaccinees stratified on age and year. Sixty-seven neurological cases were found, with the highest rate of neurological adverse events in the age group from 5 to 9 years (2.66 per 100,000 vaccine doses in Rio Grande do Sul state, and 0.83 per 100,000 doses in national analysis). Two cases had a combination of neurotropic and autoimmune features. This is the largest sample of YEL-AND already analyzed. Rates are similar to other recent studies, but on this study the age group from 5 to 9 years of age had the highest risk. As neurological adverse events have in general a good prognosis, they should not contraindicate the use of yellow fever vaccine in face of risk of infection by yellow fever virus. © 2014 Elsevier Ltd.


PubMed | Pharmacovigilance Unit, Sanofi S.A., Institute Pierre Richet Ipr Institute National Of Sante Publique Insp, Bouake University Hospital and 3 more.
Type: Journal Article | Journal: Malaria journal | Year: 2017

In many malaria-endemic, sub-Saharan African countries, existing pharmacovigilance systems are not sufficiently operational to document reliably the safety profile of anti-malarial drugs. This study describes the implantation of a community-based pharmacovigilance system in Cte dIvoire and its use to document the safety of ASAQ WinthropThis prospective, longitudinal, descriptive, non-comparative, non-interventional study on the use of artesunate-amodiaquine in real-life conditions of use was conducted in seven Community Health Centres of the Agboville district in Cte dIvoire. Twenty trained Health Centre employees and 70 trained community health workers were involved in data collection in the field. All patients with suspected uncomplicated falciparum malaria, seeking treatment at one of the participating Health Centres, and treated with artesunate-amodiaquine could be enrolled. Two visits were planned, one for inclusion at the Health Centre and a second at home, performed by a community health worker 3-10days after the inclusion visit. Administration of artesunate-amodiaquine was unsupervised. Adverse events (AEs) were documented at the home visit or during any unexpected visit to the Health Centre or to the hospital and coded and adjudicated by a local pharmacovigilance committee. Symptoms suggestive of hepatic failure, severe neutropaenia, extrapyramidal disorders and retinopathy were considered a priori as AEs of special interest.Some 15,228 malaria episodes in 12,198 patients were evaluated; 2545 AEs were documented during 1978 malaria episodes (13.0%). The most frequently observed events were asthenia (682 cases), vomiting (482 cases) and somnolence (174 cases). Most reported AEs were of mild or moderate intensity and resolved without corrective treatment. One-hundred and five (105) AEs reported during 100 episodes (0.7%) were considered as serious. Three serious cases of transient extrapyramidal disorders, identified as AEs of special interest were reported in three patients.The fixed dose artesunate-amodiaquine combination ASAQ Winthrop


Hunt J.R.,University of Bristol | Dean R.S.,University of Nottingham | Davis G.N.D.,Pharmacovigilance Unit | Murrell J.C.,University of Bristol
Veterinary Journal | Year: 2015

This study aimed to analyse UK pharmacovigilance data to quantify adverse events (AEs) associated with the non-steroidal anti-inflammatory drug (NSAID) molecules found in veterinary medicines authorised for use in dogs and cats. It was hypothesised that the frequency of AEs would be lower when associated with cyclo-oxygenase-2 selective (coxib), compared to non-selective (non-coxib) NSAIDs. The UK Veterinary Medicines Directorate (VMD) supplied frequencies of AEs derived from Periodic Safety Update Reports subdivided by formulation and species for each NSAID molecule.Frequencies of AEs were similar between species. The five most reported AEs were emesis, death, anorexia, lethargy, and diarrhoea. Reported frequency of emesis, renal insufficiency and death was higher with injectable compared to oral NSAIDs (. P = 0.043). Reported frequency of emesis, lethargy and death was higher with coxib, compared to non-coxib NSAIDs (. P = 0.029). Median (range) interval since authorisation was shorter for coxibs at 5 (2.5-9) years compared to non-coxibs at 15 (12-25) years. A negative correlation between time elapsed since authorisation and the frequency of AEs was identified (. rs = -0.11 to -0.94). Higher frequency of reported AEs with injectable NSAIDs may be related to perioperative administration. The AE frequency associated with coxib and non-coxib NSAIDs may be confounded by changes in reporting habits over time.This study highlights the value of interrogating passive surveillance data to identify low frequency AEs and the need to facilitate improvement in recording and collecting AEs in small animal practice. © 2015 Elsevier Ltd.


Davis G.,Pharmacovigilance Unit | Cooles S.,Pharmacovigilance Unit | Diesel G.,Pharmacovigilance Unit | Blenkinsop J.,Pharmacovigilance Unit
Veterinary Record | Year: 2016

The following article has been produced by the pharmacovigilance unit at the Veterinary Medicines Directorate (VMD) to provide a summary of some of the results from its surveillance work carried out in 2014. © 2016, British Veterinary Association. All rights reserved.


Mehta U.,University of Cape Town | Dheda M.,Pharmacovigilance Unit | Steel G.,NDoH | Blockman M.,University of Cape Town | And 4 more authors.
South African Medical Journal | Year: 2014

This report outlines findings and recommendations of a national pharmacovigilance workshop held in August 2012 in South Africa (SA). A survey of current pharmacovigilance activities, conducted in preparation for the meeting, identified multiple programmes collecting drug safety data in SA, with limited co-ordination at national level. The meeting resolved that existing pharmacovigilance programmes need to be strengthened and consolidated to ensure that important local safety issues are addressed, data can be pooled and compared and outputs shared more widely. Pharmacovigilance activities should inform treatment guidelines with the goal of improving patient care. A variety of pharmaco-epidemiological approaches should be employed, including nesting drug safety studies within existing sentinel cohorts and the creation of a pregnancy exposure registry. The attendees agreed on key principles that will inform a national pharmacovigilance plan and compiled a list of priority pharmacovigilance issues facing public health programmes in SA.


Olszanecka-Glinianowicz M.,Medical University of Silesia, Katowice | Smertka M.,Medical University of Silesia, Katowice | Almgren-Rachtan A.,Pharmacovigilance Unit | Chudek J.,Medical University of Silesia, Katowice
Pharmacological Reports | Year: 2014

Background Overweight and obesity decrease the effectiveness of antihypertensive therapy despite the more frequent use of polytherapy. One method for improving therapy effectiveness is by decreasing non-compliance with the use of fixed-dose combinations (FDC). The aim of this study was to assess the effectiveness, tolerance, and satisfaction with ramipril/amlodipine FDC antihypertensive therapy in relation to nutritional status. Methods The survey enrolled 24,240 hypertensive patients recently switched to ramipril/amlodipine FDC (EGIRAMLON) at the same doses as previously prescribed separate pills. Results The effectiveness of antihypertensive therapy increased during follow-up from 32.9% to 76.5%. Overweight and obesity were associated with the increased risk of not attaining the recommended BP values [adjusted for age OR = 0.74 (95% CI 0.67-0.83) and 0.70 (0.61-0.81) for overweight; 0.54 (0.47-0.60) and 0.49 (0.42-0.57) for obese, at the first and the second examination, respectively]. "Very good" or "good" the FDP tolerance was reported by 98.8%, 97.6% and 96.4%, respectively. Adverse events (AE) were reported in 0.35% of patients regardless of nutritional status. High levels of satisfaction with the FDC were reported by 57.0% of patients with normal weight, 54.5% of overweight, and 50.6% with obesity. Effectiveness and convenience were the most important for patients. Conclusions The effectiveness of therapy with ramipril/amlodipine FDC in the study population was high, but slightly lower in overweigh and obese. This FDC was well tolerated and a significant number of patients satisfied with the therapy regardless of nutritional status. Although the perceived tolerance and satisfaction with treatment were lower in obese and overweight than in normal weight patients; the incidence of AE and perceived benefit from the use of a single-pill, compared to multiple tablets, were comparable irrespective of nutritional status. © 2014 Institute of Pharmacology, Polish Academy of Sciences.


PubMed | Pharmacovigilance Unit, University of Bristol and University of Nottingham
Type: Journal Article | Journal: Veterinary journal (London, England : 1997) | Year: 2015

This study aimed to analyse UK pharmacovigilance data to quantify adverse events (AEs) associated with the non-steroidal anti-inflammatory drug (NSAID) molecules found in veterinary medicines authorised for use in dogs and cats. It was hypothesised that the frequency of AEs would be lower when associated with cyclo-oxygenase-2 selective (coxib), compared to non-selective (non-coxib) NSAIDs. The UK Veterinary Medicines Directorate (VMD) supplied frequencies of AEs derived from Periodic Safety Update Reports subdivided by formulation and species for each NSAID molecule. Frequencies of AEs were similar between species. The five most reported AEs were emesis, death, anorexia, lethargy, and diarrhoea. Reported frequency of emesis, renal insufficiency and death was higher with injectable compared to oral NSAIDs (P=0.043). Reported frequency of emesis, lethargy and death was higher with coxib, compared to non-coxib NSAIDs (P=0.029). Median (range) interval since authorisation was shorter for coxibs at 5 (2.5-9) years compared to non-coxibs at 15 (12-25) years. A negative correlation between time elapsed since authorisation and the frequency of AEs was identified (rs=-0.11 to -0.94). Higher frequency of reported AEs with injectable NSAIDs may be related to perioperative administration. The AE frequency associated with coxib and non-coxib NSAIDs may be confounded by changes in reporting habits over time. This study highlights the value of interrogating passive surveillance data to identify low frequency AEs and the need to facilitate improvement in recording and collecting AEs in small animal practice.


PubMed | Pharmacovigilance Unit
Type: Journal Article | Journal: The Veterinary record | Year: 2016

The following article has been produced by the pharmacovigilance unit at the Veterinary Medicines Directorate (VMD) to provide a summary of some of the results from its surveillance work carried out in 2014.

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