3rd International Symposium on Veterinary Pharmacovigilance Berlin, 13-14th December 2010

Transcription

1 Veterinary Pharmacovigilance Centres: the French experience 3rd International Symposium on Veterinary Pharmacovigilance Berlin, 13-14th December 2010 Xavier Pineau*, Florence Roque*, Stéphane Queffélec*, Christophe Hugnet** *Veterinary Pharmacovigilance Centre of Lyon VetAgro Sup - Veterinary Campus of Lyon **Clin vét. des Lavandes, La Bégude de Mazenc

2 Veterinary Pharmacovigilance in France: current organisation Legislative background decree 99/553, amended 2003/760 and 2004/802 ( : effect in 2011) Included in Public health codex, Rural affairs codex Actors CA = ANMV: French Agency of VMPs, under responsibility of ANSES (French Agency for Food, Environmental and Occupational Health&Safety ) / Ministry of Agriculture, Ministry of Health Veterinary Pharmacovigilance Center (formerly 2 VPCs, currently 1) National Veterinary Pharmacovigilance Commitee Representatives of CA, VPC, veterinarians, pharmacists, pharmaceutial companies trade union Reporters MAHs Reporting Scheme adapted from Human PV 29 Regional PV Centres, National PV Committee, PV technical Committee VPC of Lyon Created 2001, but in close cooperation with National Animal Poison Control Center (CNITV) created in 1976 Contract between ANSES and VetAgro Sup (formerly Vet School of Lyon)

3 Pharmacovigilance reporting: French legislation Veterinarians (and pharmacists) (Art. R of public health codex) must report immediately to a Veterinary Pharmacovigilance Centre (VPC) any serious or unexpected suspected adverse reaction to a Veterinary Medicinal Product (VMP), or to a human medicine in animal (used under the «cascade») ; regardless VMP prescribed or not by reporter, and regardless adverse reaction observed directly by vet or not may report other adverse events (non-serious SAR, off-label use, withdrawal period issue, lack of expected efficacy) Health care professionals may report suspected adverse reaction to a VMP to a VPC Poison Control Centres and (human) Regional Pharmacovigilance Centres must report immediately to a VPC any suspected adverse reaction to a Veterinary Medicinal Product (VMP) occuring in humans

4 the French Veterinary Pharmacovigilance Reporting Scheme Health Care Professionals Regional Pharmacovigilance Centres Poison Control Centres e-reporting (web) Veterinarians (Pharmacists) ANMV SARs PSURs MAH National Committee of Veterinary Pharmacovigilance information -reports -newsletter National Marketing Authorisation Committee Corrective measures -SPC modifications -MA suspension

5 VPC: an interactive interface between reporters and CA (1) 1/ phone contact (85%) round the clock hotline (shared with Poison Control Centre) immediate answer to reporter first estimation of causality therapy, prognosis Vets Physicians Pharmacists also questions related to asymptomatic (accidental) exposures in animals/humans drug use in particular species, breed, physiological status, interaction

6 VPC: an interactive interface between reporters and CA(2) Vets Physicians Pharmacists 2/ in writing spontaneous report form (15%) report form received after phone contact (46% returned back) VPC letter to the reporter, including: final VPC causality assessment comment exception: BTV cases managed directly by the Agency

7 VPC: an interactive interface between reporters and CA(3) Vets Physicians Pharmacists 3/ VPC and the Agency report form (from phone call/written report) recorded in database (Sentinelvet ) causality assessment performed (literature, comparison with db) electronic reporting to the Agency (secure web) serious SAR within 10 days non-serious SAR within 3 months

8 VPC: inside Veterinary Campus round the clock service: involvement of selected trained students practical teaching exercise: students are faced «real-life cases» learn autonomy (senior pharmacovigilance vet always available) know-how (reporting, bibliographic search) highlighted in international audits of the Vet Campus AEEV AVMA first line for promoting pharmacovigilance for future vets in cooperation with teachers basic course (all students) end-study (e.g horse medicine)

9 graduation veterinary thesis VPC: inside Veterinary Campus (2) Delhaye D. Side effects and poisoning due to the use of medicines containing permethrin on cats. Epidemiological study (2008): (in French) Gedoux F. Problem of drug residues in food of vultures, especially anti-inflammatory drugs, antibiotics and euthanasia drugs used in livestock (2010) (in French) postgraduate education : Pharmacovigilance-Toxicovigilance Master to be conducted again? cooperation with colleagues of various teaching/research areas (inside Campus / other Vet Schools) Several teachers/researchers involved in National PV Committee over the last 9 years Pr Keck (Lyon), former Chairman Dr Alvinerie (Toulouse), current Chairman helpful for scientific evaluation, where necessary e.g toxicological analysis lab of Lyon, Pharmacology Unit of Toulouse provide some valuable case reports e.g Cardiology Unit of Alfort Vet School

10 VPC: key figures. 1/ reporting way, yearly distribution BTV I AsE WR* NV-tel* V-tel* Most reports by telephone over 85% (except BTV) Vets: near 90% of reports; pharmacists 0.3%; owner 6.5% Continuous increase until plateau phase BTV excepted V-tel*: phone call, veterinary reporters (BTV excluded) NV-tel*: phone call, non-veterinary reporters (BTV excluded): owner, physician, PCC WR*: spontaneous written report (BTV excluded) AsE: Asymptomatic exposure I: general information BTV: Bluetongue vaccination adverse events

11 VPC: key figures. 2/ Species - yearly distribution Other Rabbit Ovine Equine Human Bovine Canine Feline Companion animals: over 85% Livestock increase of ruminants: BTV only (cattle 3% for other classes of VMPs) pigs and poultry: negligible numbers

12 VPC: key figures. 3/ VMP category - yearly distribution (ATC-vet) Others Dermatologicals&Sensory organs Hormones&Corticoids Alimentary Musculo-skeletal Neurological Antibiotic Vaccine Internal Parasiticide Endectocide Majority of parasiticides 30-60% decrease of external parasiticides (mainly: permethrin spot in cats) Vaccines increase = BTV vaccines other vaccines#3-5% External Parasiticide

13 VPC: involved in national committees National Veterinary Pharmacovigilance Committee 3 vets of VPC members of this Committee ( ) , the Committee released 19 public reports (in French) ce/rubrique%20lettre.htm Summarized in 7 PV newsletters sent to all vets and pharmacists Toxicovigilance network (human safety scheme) contribution to reports e.g clenbuterol misuse in humans (2010) buterol_2010.pdf (in French)

14 VPC: international cooperation VPC: participation to EMA-PhVWP 1 vet as expert ( ) contributions regarding causality assessment, signal detection, Veddra VPC: informal contacts with other countries Switzerland Italy Spain

15 Advantages of the French Reporting System / VPC Advantages for Reporters round the clock service for emergency situations (e.g overdose): availability pharmacovigilance reporting as easy as a phone call other options available (mail, , fax, and since early 2010 web reporting directly to the ANMV) feed-back tailored answer (oral/in writing) newsletter from Committee Advantages for Reporting scheme Direct contact increases quality of data (spontaneous written reports usually less informative)

16 Drawbacks of the French Reporting System / VPC Cost round the clock service 3 full-time vets (cost supported by ANSES) 0.5 secretary (cost supported by ANSES) 0.75 librarian (cost supported by ANSES) 45 students (equivalent to 1 full time vet; cost supported by Poison Control Centre) at start (2001) network of 2 VPCs Dec 2008,VPC of Nantes closed

17 Perspectives of the French Pharmacovigilance Scheme 2011 Committee of Marketing Autorisation of VMPs and Veterinary Pharmacovigilance Committee merge into a Committee of VMPs (come into effect January 2011) 5 representatives of CA, 18 nominated members (pharmacologists, vets, ) expected benefit: quicker implementation of recommendations (e.g modifications of SPC) Network of «sentinel veterinarians» in the field of pharmacovigilance, for targeted surveillance (e.g for BTV vaccines or any rising issue) Postmarketing studies case-control studies (e.g mammary tumours and progestins; report of the PV Committee estimated a high level of underreporting)

18 Thank you for your attention Vielen Dank zu Cornelia Ibrahim und zum BVL