Nelfinavir: Barbados Experience

Transcription

1 Nelfinavir: Barbados Experience By Maryam Hinds Director, Barbados Drug Service

2 Presentation At a glance Background of Barbados and BDS Background of BDS in PV efforts Background of HIV/AIDS Program Recall of Nelfinavir Reinstatement of Nelfinavir Any Signal? Or did we miss something? Disclaimer:

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5 Pride of Barbados National Flower

6 BDS BACKGROUND BDS established in 1980 by an Act of Parliament Operations governed by Drug Service Act and Financial (Drug Service) Rules both of (1980) Designated WHO Collaborating Center in Drug Supply Management in 1983

7 AREAS OF RESPONSIBILITY OF THE BDS The Barbados National Drug Formulary The Supply Service The Special Benefit Service (SBS) The Barbados Drug Service Pharmacy Service The Drug Inspectorate (DI) The Drug Information Centre (DIC)

8 PV BACKGROUND WHO conducted a CARICOM regional training in Pharmacovigilance in Barbados in Sept 2006 DBDS participated in UMC pharmacovigilance training course in 2007 Ministry of Health applied for membership in the WHO programme

9 Membership In July 2008, qualified for membership by submitting the required number of reports to UMC through VigiFlow Waiting to be a full member of the WHO Drug Monitoring Programme (Hopefully)

10 PMTCT & ARVs PMTCT started in 1995 using zidovudine (AZT) At the time, no other anti-retroviral agent was used routinely in the public sector for the prevention or treatment of HIV/AIDS AZT was given to the mother at 14 wks of pregnancy and to the baby from birth to six weeks. All other forms of treatment were haphazard, no standardised policy as was the case with PMTCT

11 National HIV/AIDS Program Haphazardly done prior to 2002, except for the PMTCT that was routine In 2002, a national HIV/AIDS program was expanded to mitigate the impact of the epidemic Multisectoral in nature Ministry of Health responsible for Care and treatment of patients ARVs were introduced including Nelfinavir

12 NFV Expenditure before and after Year Expenditure 2002 $ 29, $138, $ 133, $108, $165, $79, $0.0

13 NFV Expenditure before and after Year

14 Recall of Nelfinavir Initial observations and comments - First World June , informed of recall of all batches of Viracept film-coated tablets 250mg, Viracept tablets 250mg and Viracept Oral Powder June , received correspondence from Roche Regulatory Affairs Director regarding recall of Viracept due to contamination of API with methane sulfonic acid ethyl ester

15 Alternative Source of NFV Recall was for API manufactured at Roche Basel Switzerland Since Roche was unable to limit the issue to defined individual API batches, all Viracept batches on the market were recalled Tried to source Viracept from USA and Canada with no success. No attempt was made to source from Japan

16 Withdrawal from Barbados The BDS issued a national recall notice All patients on nelfinavir were contacted and switched to other ARV s,, not only PI s Roche delivered correspondence to all key healthcare providers regarding recall and suggestions for alternative PI s All stock were returned and refunds were made for quantities returned

17 Before and After recall Before the recall, there were 25 known patients on Nelfinavir Currently, there are 0 known patients on Nelfinavir Physicians are aware of recall and reinstatement, but the drug was used as 2 nd line treatment only No Nelfinavir has been procured and/or distributed since its recall and reinstatement.

18 After Recall Persons on Nelfinavir had it replaced by other PI s: - (LPV/r (Kaletra( Kaletra); ATV/r (boosted Reyataz); SQV/r) (Possibility of the use of NNRTI to replace Nelfinavir in a few patients)

19 After Reinstatement of NFV No NFV was prescribed, hence no procurement The lack of reinstitution of nelfinavir had nothing to do with recall issues Lack of use has more to do with the literature, which suggests more rapid development of resistance to nelfinavir than any other PI Resistance was initially to the signature D30N mutation but rapidly involve cross class muta- tion,, thus compromising future PI regimens

20 WHO Definition of Signal Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously -Note: (Usually, more than one report is required to generate a signal, depending on the seriousness of the event and the quality of the information)

21 Signal Index No submitted report on hepatic failure or liver fatty from Barbados ADRs (there are more reports to be processed) Reported to UMC an increase in fasting blood sugar in a patient, patient did not recover neither did it resolve upon stoppage of the drug Several reports of nausea, vomiting and diarrhea which usually resolved after stoppage

22 Future Use Don t t know Probable Possible Unlikely

23 Disclaimer All the information contained in this presentation were as far possible obtained from as reliable sources as can possibly be. All the views expressed are solely those of the author.

24 Acknowledgement Mrs. Rosemund Lovell (LRU) Dr. Nicholas Adomakoh (LRU) Dr. Anton Best (MOHNISS) Dr. Timothy Roach (LRU/QEH) Ms. Safiya Moore (UWI student) BDS Staff and MOHNISS Staff

25 Thank you for your attention.