Overview of Draft Pharmacovigilance Protocol

Transcription

1 Overview of Draft Pharmacovigilance Protocol

2 Identifying ADRs in Africa Special Challenges Malaria - pan-systemic clinical features Life-threatening condition Real-world trial AS/SP and co-artem safety profile appears to be very good Limited access to health services Limited diagnostic capabilities Over-burdened health care system & staff Significant resource restraints Communication barriers 1-day (SP) to 3-day regimen (compliance)

3 Introduction Not used outside South East Asia until recently Different drug combinations in different countries These include: A-L, AS/SP, AS/AQ Safety in populations with high TB and HIV prevalence. Inadequate infrastructure in place in many early use countries to monitor safety

4 Definition: Adverse Event vs. Adverse Reaction Adverse Drug Reaction A noxious and unintended response to a medicine which occurs at doses normally used in man for treatment, prophylaxis, diagnosis or modification of physiological function. Adverse Event: untoward medical occurrence which does not necessarily have to have a causal relationship with the treatment

5 Adverse Drug Reaction vs. Adverse Event Adverse Event Diseases Diet Genetics Adverse Drug Reaction (event attributed to drug) All Spontaneous reports Other factors Other Drugs Events not attributed to drug Compliance Environment

6 Definition: Serious Adverse Event Any untoward medical occurrence that at any dose results in: Death Is life-threatening Requires or prolongs patient hospitalisation Results in permanent disability/incapacity or is A congenital anomaly/ birth defect Other medically significant event (e.g. blood dyscrasias, seizures) By definition Does not include NON-serious AE s that have the POTENTIAL to be SERIOUS if allowed to progress further

7 Objectives of a Basic P covig System Signal detection for Serious adverse reactions Assessment of signals to evaluate: causality, clinical relevance, frequency and distribution in certain population groups Communication and recommendations to authorities and public Appropriate response/action in terms of drug registration, drug use and/or training and education for professionals and the public Measurement of outcome of response/action taken (e.g. reduction in risk of signal, improved drug use, or improved outcome of patients with ADR)

8 Why Monitor ALL drugs? Create an awareness and culture of reporting Assess level of underreporting and contribution to lack of detection of signals Increase ability to detect a problem with ACT Minimise undue concern about safety of new ACT Allow for comparison of reporting rates among different therapeutic classes of medicines

9 Elements of the Basic P covig system SYSTEM COMPRISED OF 3 LEVELS Peripheral health facilities (spontaneous reporting base) Tertiary care facilities (Spontaneous reporting and SAEs investigated and intensive monitoring programmes introduced) Antenatal and delivery clinics (Pregnancy-related SAE s and congenital anomalies reported)

10 Peripheral Health Care Facilities E.g. health posts, clinics, outreach centres, dispensaries, outpatient departments Proper prescribing, counseling and administration of meds Inform patients to return in case of further or ongoing illness Counsel patients on how to take meds 1 hour observation post-medication Completion of SAE form in the event of suspected reaction Send form to district/state/national level co-ordinator (depending on infrastructure) Patients referral to hospital if necessary (with referral note informing of suspected ADR) Management of non-serious reactions

11 Investigation Team District, State or National level (?) May be comprised of only 1 person Follow-up all/specific SAEs Weekly review of all reports received Return to facility within 2 weeks for investigation Home and facility visit if warranted Review and complete ADR form and District Investigation Team report form Aggregation into Monthly District-wide report Aggregates and individual reports forwarded to national p covig co-ordinator

12 Secondary/Tertiary Care Facilities E.g. Hospitals, health centres (others?) Any patient attending tertiary care hospitals due to SAE (self-reported, detected in hospital or referred from peripheral health workers) should be investigated Intensive monitoring in specifically selected facilities DIT/co-ordinator may assist with completion of form and investigation. DIT co-ordinator/ pharmacovigilance nurse may be resident at secondary/tertiary level health centre

13 Antenatal Clinics and Delivery Services Report congenital anomalies using SAE reporting form Follow-up by DIT Collaboration with national Safe Motherhood programme of MOH Other methods to be discussed later.

14 Roles and Responsibilities Establish roles and responsibilities of Patient Clinic staff Traditional Healers and other informal providers District/state/national investigation team National pharmacovigilance co-ordinator Expert safety review panel Malaria control programme Drug regulatory authority Media International agencies (WHO, UMC, etc)

15 intensive Detection of serious drug reactions (if abnormal lab tests, eg agranulocytosis, interview patient for detailed history) Case-finding or cohort HOSPITAL HEALTH CENTERS PRIVATE CLINICS Laboratory and clinical investigations Generic form Follow-up with detailed report and causality rating, spontaneous DISPENSARIES Shops, traditional healers, CHWs

16 District Investigation Team (DIT) to confirm & report Serious Drug Reactions (SDR) Patient & public Dispensary & private clinic T H/DV Report Investigation Communication district investigation team District Hospital Expert Safety Review Panel National PV Coordinator UMC WHO MOH Ed. DCP NRA manufacturer media

17 The Denominators Dilemma Denominator: estimated figure of drug use Assists in estimating frequency of events Rate and not number of reports will allow riskbenefit assessment & comparisons Need a comparator/control drug within the system to determine whether lack of signals due to underreporting or real absence of signal

18 Examples of Denominators Drug procurement figures from central medical stores of MOH Drug distribution data from EDPs, national drug suppliers/distributors, or manufacturers Drug records at importation from customs Disease notification reports from disease surveillance programmes Drug procurement records from wholesalers in private sector Supplementary drug surveys (e.g. treatment seeking behaviour, drug utilisation, or surveys of drug vendors.)

19 Adopting and Adapting the forms ADR report form Investigation form Intensive Surveillance: Laboratory Report form

20 Issues for discussion and consideration (I) Is this system feasible in your country? If not, how can it be modified/simplified? Should we be encouraging reporting of EVENTS or REACTIONS? Should we encourage reporting of Serious Events/Reactions only or include non-serious as well? (I.e. this initiative does not discourage non-serious reports) Based on resources and size of country is a DIT needed? Could a national-level or state-level investigation team suffice? Can the proposed reporting flow be adapted to your country setting?

21 Issues for discussion and consideration (II) Should the forms be printed in single or duplicate? If duplicate who will each copy go to? What should be the timelines for submitting initial reports, investigations reports, aggregate reports? And to whom I.e supervisor, national co-orindator, district investigation team etc. Which reports to be investigated? All SAE s Clusters only, unexpected SAEs, unusual SAEs, AEs significantly affecting compliance?

22 Issues for discussion and consideration (III) Can you consider the functions and activities of each individual/organisation in your proposed reporting flow What would be an accurate denominator for drug use for ACT and a comparator/s What do you think are the critical success factors to achieve the system and its objectives? How can these critical success factors be achieved in your country?

23 Critical Success Factors Literacy of reporters Clearly defined responsibilities Adequate training and education Public awareness of the new medicine Public awareness on reporting safety problems of all medicines Awareness of p covig system within informal sector Community & religious leaders, shopkeepers, traditional healers, community health workers and school teachers Quality control of laboratories Open communication between public, health care providers and policy makers Presence of a national co-ordinator/s