PHARMACOVIGILANCE AND CLINICAL TRIALS

DIVISION20 August 2015

Victoria Falls

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Activities Of The PVCT Division

• Pharmacovigilance Activities

• Regulation Of Clinical Trials Involving Medicines And Medical Devices

PHARMACOVIGILANCE

Pharmacovigilance: is the science and activities relating to the detection

collectionassessmentmonitoring, andprevention

of adverse effects related to pharmaceutical products and communication in a way that improves therapeutic outcomes (W.H.O)

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Adverse Drug Reactions (ADRs)

• Any response to a drug which is noxious and unintended, including lack of efficacy, which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function

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Spontaneous report

(ICSR - individual case safety report)

‘an unsolicited communication by healthcare professionals or consumers that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organised data collection scheme’

Targeted spontaneous report

‘a spontaneous report from a healthcare professional or consumer within a defined cohort that describes one or more adverse drug reactions in a patient who was given one or more medicinal products’

Importance of reporting

• generation of “signals”• influence drug labelling • Documentation of previously unknown ADRs• Withdrawal of drugs e.g dextropropoxyphene (Doxypol)• Ultimately, improved therapeutic outcomes

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What is a signal?

CHALLENGE QUESTION (Adapted from the FDA)

A safety “signal” is defined as:A. New, previously unknown, adverse eventB. New drug interactionC. An observed increase, either in quantity or severity, of a known

adverse eventD. All of the above

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Importance of reporting

There are differences in ADRs among people from different countries or regionsUsually due to differences in • diseases and prescribing practices;• genetics, • diet, • traditions of the people;• drug manufacturing processes

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Importance of reporting

• Data derived from within the country or region may have greater relevance and educational value and may encourage national regulatory decision-making.

• Information obtained in one country (e.g. the country of origin of the drug) may not be relevant to other parts of the world, where circumstances may differ.

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Barriers to ADR Reporting

• We already know the ADR• What benefit is it?• Scared to report• Failure to recognise ADR• All approved medicines are safe notion

Barriers to ADR Reporting

• Not aware of regulations• attitude• Odd reactions• ADRs may mimic a common natural disease• Long delay in the appearance of the Adverse effect• Disease complexity clouds drug-related issues

TSR of anti-TBs and ARVs- Pilot PhaseBackground:

•Adverse drug reaction monitoring is essential in achieving the goals of

anti-retroviral (ARV) and anti-tuberculosis (anti-TB) treatment, and is

an important element in promoting rational medicine use principles and

promoting patient safety.

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TSR of anti-TBs and ARVs- Pilot PhaseObjectives:

The pilot phase of the Targeted Spontaneous Reporting (TSR) system

for monitoring adverse drug reactions pilot phase research was carried

out to strengthen pharmacovigilance activities in the National ART and

TB programmes in Zimbabwe; and to understand and characterize

adverse drug reactions (ADR’s) or individual case safety reports

(ICSRs) due to ARV and anti-TB medicines.

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TSR of anti-TBs and ARVs- Pilot PhaseResults:

Age range was 0.9-76 years (median = 38 years)

In 83% of the reports, one ADR was reported per patient

In 11% of the reports, two ADRs were reported per patient

In 6% of the reports, three ADRs were reported per patient

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TSR of anti-TBs and ARVs- Pilot PhaseResults: The majority of ADR’s reported were mainly cutaneous in nature

Cutaneous (44%)

CNS (27%)

metabolic in nature (11%)

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TSR of anti-TBs and ARVs- Pilot PhaseResults: Efavirenz vs Nevirapinelower odds of cutaneous reactions compared to those on Nevirapine containing regimens (OR=0.07, p-value<0.0005)

higher odds of CNS type of reactions compared to those on NVP (OR=6.0; p-value<0.0005).

gastrointestinal reactions which were more frequent in those on Efavirenz containing regimens (OR=3.3, p-value=0.03).

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TSR of anti-TBs and ARVs- Pilot PhaseConclusion:

Pharmacovigilance activities need to be strengthened and included as part of clinical care especially for patient on ART and anti-TB treatment including essential medicines.

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TSR of anti-TBs and ARVs- Pilot PhaseConclusion:The TSR pilot phase demonstrated significant increase in ADR reporting and considered relatively a feasible cost effective method hence TSR was scaled up to the main phase program.

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TSR of anti-TBs and ARVs- Pilot PhaseConclusion:

Further in depth analysis of ICSRs of medicines reported such as tenofovir in combination with other anti-retrovirals is required.

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Resources

• Drug Information Bulletin (MCAZ website)• ADR reporting form (MCAZ website, email, request for hard copies)• Product defect reporting form(MCAZ website, email, request for hard

copies)• TSR protocol

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THANK YOU!!!

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