Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.ages.at

Dr. Susanne Wolf Dept. Assessment Pharmacovigilance

AGES-Gespräche

Vienna, 15.09.2016

Wissenswertes aus dem Bereich PHV

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Requirements for PHV renewal documents:

Irrespective of the “CMDh BEST PRACTICE GUIDE ON THE PROCESSING OF RENEWALS IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES” submission of the following data is required for a renewal procedure in Austria:

AT=RMS: An “Addendum to the clinical overview“ should be submitted

AT=CMS: An “Addendum to the clinical overview“ currently only required if requested by the RMS.

Nationally approved: An ACO is required, irrespective of a generic, well-established use, traditional herbal or homeopathic application.

The “Addendum to the clinical overview “ should cover the period from the date of approval to the date of submission of the renewal.

„Apothekeneigene Zulassungen“ are exempted from PSUR submission. However, identification of safety relevant aspects requires the submission of pharmacovigilance data.

Addendum to the Clinical Overview

Addendum to the Clinical Overview = ACO

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Focus on:

• current benefit/risk balance taking account of PSUR data

• suspected adverse reaction reports

• additional pharmacovigilance activities

• effectiveness of risk minimisation measures contained in the RMP

• any relevant new information e.g. literature, clinical experience, new treatments available

ACO

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• History of pharmacovigilance system inspections

• Worldwide marketing approval status

• Actions taken for safety reasons during the period

• Significant changes to the SmPC

• Estimated exposure: cumulative exposure of subjects in clinical trials and from marketing exposure pattern of use of the medicinal product

• Data in summary tabulations (serious AEs from clinical trials, adverse reactions from post-marketing, safety and efficacy findings from clinical trials and non-interventional studies

ACO - strucutre

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• Literature

• Risk evaluation

• Benefit evaluation

• Benefit/risk balance: a discussion on the benefit/risk balance for the approved indication should be presented, based on the above information.

MAHs are advised to consider GVP Module VII on PSURs as guidance for preparation of the ACO.

ACO - strucutre

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The Clinical Expert should:

• Confirm that no new clinical data (or pre-clinical data in the absence of a non-clinical overview) are available

• Confirm that the product can be safely renewed after 5 years for an unlimited period, or any action recommended should be specified and justified.

• Confirm that the authorities have been kept informed of any additional data significant for the assessment of the benefit/risk balance

• Confirm that the product information is up to date with current scientific knowledge

ACO

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An adverse reaction is a response to a medicinal product which is noxious and unintended. This includes adverse reactions which arise from:

• use of a medicinal product within the terms of the marketing authorisation;

• use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors;

• occupational exposure.

Medication Error

Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/2014

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• A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to harm to the patient.

• A failure in the drug treatment process does not refer to lack of efficacy of the drug, rather to human or process mediated failures.

Medication Error

Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/2014

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The term potential medication error refers to all possible mistakes in the prescribing, storing, dispensing, preparation for administration or administration of a medicinal product by all persons who are involved in the medication process and may lead to

a) a medication error with harm, but without knowing the actual cause

b) a medication error without harm and without knowing the actual cause

c) a medication error without harm, but with the awareness of the actual cause.

Medication Error

Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/2014

www.ages.at 10 Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/2014

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Medication Error

Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/2014

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Medication Error

With kind permission of Dr. Kayser, BfArM

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•Update still ongoing, consultation closed (02/2016)

•Final expected ???

•http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp

GVP Module V Risk management systems