Some perspectives on a draft pharmacovigilance protocol reference to hiv aids
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Some Perspectives on a Draft Pharmacovigilance Protocol-reference to HIV/AIDS. I Ralph Edwards. Identifying ADRs in Africa – Special Challenges: general . Limited access to health services Limited diagnostic capabilities Over-burdened health care system & staff

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Some perspectives on a draft pharmacovigilance protocol reference to hiv aids l.jpg

Some Perspectives on a Draft Pharmacovigilance Protocol-reference to HIV/AIDS

I Ralph Edwards

Identifying adrs in africa special challenges general l.jpg
Identifying ADRs in Africa – Special Challenges: general Protocol-reference to HIV/AIDS

  • Limited access to health services

  • Limited diagnostic capabilities

  • Over-burdened health care system & staff

  • Significant resource restraints

  • Communication barriers

Identifying adrs in africa special challenges hiv aids l.jpg
Identifying ADRs in Africa – Special Challenges: HIV/AIDS Protocol-reference to HIV/AIDS

  • Patients need to continue drugs

    • ADRs common and troublesome

  • Need to treat ADRs

  • Combinations of drugs

    • Which drug?

  • Disease and complications and ADRs affect multiple overlapping body systems

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Introduction Protocol-reference to HIV/AIDS

  • Much information and experience in USA/EU, but

    • Different drug combinations used

    • Population and disease burden varies

  • Inadequate infrastructure in place in many 3x5 roll-out countries to monitor safety

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Definition: Protocol-reference to HIV/AIDSAdverse 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

Adverse drug reaction vs adverse event l.jpg
Adverse Drug Reaction vs. Protocol-reference to HIV/AIDSAdverse Event

Adverse Event

Adverse Drug Reaction

(event attributed to drug)






All Spontaneous


Other Drugs

Events not attributed to drug



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Definition: Protocol-reference to HIV/AIDSSerious 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)

    • Does not include NON-serious events that have the POTENTIAL to be SERIOUS if allowed to progress further, nor SEVERE events

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Objectives of a Basic System Protocol-reference to HIV/AIDS

  • Signal detection for concerns about the safety of drugs

  • 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)

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The pharmacovigilance process Protocol-reference to HIV/AIDS

Follow up

Case reports



Case database

Signal analysis

Signal detection

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Why Monitor ALL drugs? Protocol-reference to HIV/AIDS

  • Create an awareness of safety issues and drugs

  • To encourage health professionals to share concerns about drugs

  • To determine the concerns health professionals have over drugs and their best use

    • Including interactions

  • To react to with helpful information to improve therapy

  • Minimise undue concern about safety of therapies known to cause ADRs

    • Eg. Anti-retrovirals

  • Allow for comparison of reporting rates among different therapeutic classes of medicines

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Elements of the Basic system Protocol-reference to HIV/AIDS

  • Possible general system:

    • Peripheral health facilities

      • (spontaneous reporting of drugs used in general medical practice)

    • Tertiary care facilities and ADR Centre

      • (Spontaneous reporting and SAEs investigated and intensive monitoring programmes. Special investigations)

    • Antenatal and delivery clinics

      • (Pregnancy-related SAE’s and congenital anomalies reported)

    • Public health Programmes

      • HIV/AIDS, Malaria etc.

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Peripheral Health Care Facilities: Protocol-reference to HIV/AIDSE.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 coordinator (depending on infrastructure)

  • Patients referralto hospital if necessary (with referral note informing of suspected ADR)

  • Management of non-serious reactions

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Evaluation/Investigation Team Protocol-reference to HIV/AIDS

  • General or special or geographical (??)

    • May be comprised of only 1 person

  • Weekly review of all reports received

    • Follow-up all/specific SAEs

      • Home and facility visit if warranted

      • Return to facility within 2 weeks for investigation

  • Review ADR forms and Investigation Team report forms

  • Aggregation into monthly report

  • Aggregates and individual reports forwarded to national co-ordinator

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Secondary/Tertiary Care Facilities Protocol-reference to HIV/AIDSE.g. Hospitals, health centres (others?)

  • Investigate any patient attending tertiary care hospitals due to suspected ADR (self-reported, detected in hospital or referred from peripheral health workers) should be investigated

  • Intensive monitoring in specifically selected facilities

    • Event monitoring and epidemiological studies

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Antenatal Clinics and Delivery Services Protocol-reference to HIV/AIDS

  • Report congenital anomalies using SAE reporting form

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Detection of serious drug reactions Protocol-reference to HIV/AIDS

(if abnormal lab tests,

eg agranulocytosis,

interview patient for

detailed history)


or cohort


Laboratory and clinical



Generic form

Follow-up with detailed report and causality rating,





Shops, traditional healers, other health professionals

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Roles and Responsibilities Protocol-reference to HIV/AIDS

  • 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)

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Some participants! Protocol-reference to HIV/AIDS

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From data to signal analysis: Protocol-reference to HIV/AIDSinternational

Follow up

National case reports



WHO database

UMC Signal detection

Signal analysis

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The Importance of Denominators Protocol-reference to HIV/AIDS

  • Denominator: estimated figure of drug use

    • for estimating frequency of events

  • Comparisons between drugs difficult and VERY problematic without rates

    • Often use a comparator/control drug within the system to determine whether lack of signals due to underreporting or real absence of signal

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Examples of Denominators Protocol-reference to HIV/AIDS

  • 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

  • Notification reports from disease surveillance programmes

    • ?e.g. HIV/AIDS

  • Drug procurement records from wholesalers in private sector

  • Supplementary drug surveys (e.g. treatment seeking behaviour, drug utilisation, or surveys of drug vendors.)

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Adopting and Adapting – the forms Protocol-reference to HIV/AIDS

  • ADR report form

  • Evaluation and follow-up form

  • Special investigations

    • Public health programmes e.g. HIV/AIDS

    • Congenital anomaly registers

    • Etc.

  • Study protocols

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Communication: General Protocol-reference to HIV/AIDS

  • All reports must be acknowledged

    • Reporters must feel a valued part of the system

  • Useful feedback must be given

    • Specific to the case if necessary

    • General, in the form of periodic reports

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Communication: HIV AIDS Protocol-reference to HIV/AIDS

  • Must allow treating health professionals best information on effectiveness v. risks

    • Globally and in own population

  • Give them, and patients, knowledge and confidence to continue therapy in spite of some ADRs

  • Give information on best avoidance, minimisation, and treatments for ADRs

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Issues for discussion and consideration (I) Protocol-reference to HIV/AIDS

  • Is this system feasiblein your country?

    • Should it be modified/simplified?

  • When should you be encouraging reporting of events or reactions

  • Should you encourage reporting of serious events/reactions only orinclude non-serious as well?

    • (This draft does not discourage non-serious reports)

  • Based on resources, size of country and nature of public health structures– is a special investigation team needed?

    • Could a ‘generic’ national-level or state-level investigation team suffice?

  • Can the proposed reporting flow be adapted to your country setting?

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Issues for discussion and consideration (II) Protocol-reference to HIV/AIDS

  • 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

    • supervisor, national coordinator, special investigation team etc.

  • Which reports to be investigated? All suspected ADRs, clusters ? Unexpected? Unusual? Significantly affecting compliance?

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Issues for discussion and consideration (III) Protocol-reference to HIV/AIDS

  • Consider the functions and activities of each individual/organisation in your proposed reporting flow

  • What would be an accurate denominator for drug use for HIV/AIDS treatments 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?

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Critical Success Factors Protocol-reference to HIV/AIDS

  • 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 pharmacovigilance 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

    • Judicious and pro-active use of the media, professional and general

  • Presence of national coordinator/s