Risk Minimisation. Maarten Lagendijk Pharmacovigilance Coordinator Medicines Evaluation Board (CBG-MEB) The Hague, The Netherlands
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2 Maarten Lagendijk Pharmacovigilance Coordinator Medicines Evaluation Board (CBG-MEB) The Hague, The Netherlands
3 Outline of the presentation 1) Introduction 2) Risk Minimisation Plan 3) Educational Material 4) Effectiveness of Risk Minimisation Measures
4 Introduction Approval Decision = Critical Juncture Beginning of lifecycle pursue and manage emerging knowledge about risk benefit uncertainty
5 Introduction New pharmacovigilance legislation in 2005 The definition of a Risk Management Plan (Volume 9A): A risk management system is a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assessment of the effectiveness of those interventions.
6 Introduction The Risk Management Plan contains arrangements to: 1. identify and evaluate (spontaneous reporting, PASS) 2. reduce (Risk Minimisation Plan) the risks of the medicinal product
7 Introduction PART I Safety specification Pharmacovigilance plan PART II Evaluation of the risk and the need for risk minimisation Risk Minimisation Plan
8 Evaluating the need for Risk Minimisation Determine acceptable level of risk Varies according to perceived benefit, drug class, risk Define the process (i.e. likely treatment pathways and stakeholders) This may vary per market Anticipate real world usage Identify desired behaviour and potential failure modes Failure Modes and Effects Analysis (FMEA) Evaluate potential for risk mitigation and identify potential tools Rationale for additional activities outside of SPC and PIL Describe tools and assessment of them
9 Risk Minimisation Plan Details the risk minimisation activities Should include both routine and additional risk minimisation activities A safety concern can have more than one risk minimisation activity Should include details how the effectiveness will be assessed
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11 Risk Minimisation Plan If Risk Minimisation Measures are needed, the requirements are laid down in Annex II (
12 Risk Minimisation Plan Routine Risk Minimisation Summary of Product Characteristics (SPC) Patient Information Leaflet (PIL) Legal status of a medicine Additional Risk Minimisation Provision of information (educational material) Control at pharmacy level Control of prescription size Restricted access Registries Additional Risk Minimisation Measures can be complex, and are context dependent.
13 Risk Minimisation Plan What kind of products need Risk Minimisation? 1) Serious adverse drug reactions E.g. immune system disorders 2) New (difficult) method of administration New patch in neuropathic pain 3) High potential for abuse / off-label use Risk for addiction
14 Risk Minimisation Plan Abseamed Aclasta Arava Arcalyst Arepanrix Atripla Benefix Binocrit Celvapan ChondroCelect Cimzia Ecalta Effentora Efient Epoetin alfa Evoltra Exjade Fablyn Firmagon Focetria Gliolan Humira Ilaris Increlex Instanyl Ionsys Leflunomide Lucentis MabCampath Macugen Mircena Multaq Mycamine NovoSeven NPlate Nymusa Onbrez Opgenra Optimark Pandemrix Photobarr Prevenar Qutenza Ranexa Refacto Remicade Renvela Retacrit Revatio Revlimid Revolade RoActemra Scintimun Siklos Silapo Silodyx Simponi Soliris Stelara Tasigna Thalidomide Thelin Thymanax Tysabri Urorec Valdoxan Volibris Zypadhera
15 Risk Minimisation Plan Centrally authorised new active substances in the period January 1995 till January 2010: 391 Active substances with additional risk minimisation activities (of the 391): 57 15% 15
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17 I.M. Zomerdijk, MSc. Medicines Evaluation Board, Erasmus University Rotterdam Risk Minimisation Risk Minimisation Plan Additional risk minimisation activities No active substance [n=57] Provision of educational material 57 * To health care professional 56 * To the patient 31 Patient monitoring/screening 18 Controlled distribution 9 Pregnancy Prevention activities 5 Special packaging / extra label 7 Others 6
18 Educational Material Who needs to be educated? 1. Health Care Professionals Prescribers (specialists, general practitioner) Pharmacist Nursing staff 2. Users Patients Parents, care-givers Depending on the audience, different ways to communicate
19 Educational Material Advantages of Educational Material? Additional focus on the key messages Information more accessible than in SPC/PIL (due to pictures, different lay-out) As a check-list To give detailed instructions on how to administer
20 Educational Material Disadvantages of Educational Material? Advertisement in disguise Lot of repetition Important information can still be missing Documents can be very voluminous
21 Educational Material Readability / language Length Clear key message SPC contains ALL information Educational Material only the key message(s) Message of reference product and of generic product should be the same No advertisement (or suggestion thereof) Will it be effective as Risk Minimisation Measure?
22 Risk Minimisation Plan Current Challenges in additional risk minimisation activities Additional risk minimisation Guidance not always clear If no additional Risk minimisation activities deemed necessary this should be discussed and supported by evidence Differences in perception between MAHs and Regulators National implementation Differences in interpretation between MSs MSs requesting additions to agreed RMP Practical issues with implementations due to national legislation Evaluating effectiveness difficult Additional work: should have added value
23 Effectiveness New Pharmacovigilance legislation (2012): Measurement of effectiveness of the additional risk minimisation measures will be mandatory New legal requirement: EMA /Member States shall monitor the outcome of risk minimisation measures contained in risk management plans and of conditions. As part of the pharmacovigilance system, the MAH shall monitor the outcome of risk minimisation measures which are contained in the risk management plan or which are laid down as conditions of the marketing authorisation (Annex IIB) pursuant to Articles 21a, 22 or 22a ; 23
24 Effectiveness How well does the Risk Minimisation Measure work in minimising the risk? 1. Show that a risk has been minimised (direct outcome) 2. Measurement of the implementation (performance measurement, surrogate outcome) Important!: Performance measurement will never replace the need for assessment of the direct outcome! Successful implementation is no guarantee for effectiveness.
25 Effectiveness Examples of effectiveness measurements: Cognitive testing of the educational material Testing of knowledge Surveys (patients, pharmacists, physicians) Audit in a pharmacy Web-panels Use of medical databases Use of claims databases Drug utilization studies 25
26 Effectiveness How to keep the healthcare professionals motivated? Baseline-measurements are lacking (how do you know that your results are a sign of success?) How do you know the healthcare professional/patient is using the Risk Minimisation Activities? Internet (social media) and smart phones are booming can we use them in the Risk Minimisation Plan? Can spontaneous reporting be an indication of success? (if the adverse event is reported less, is it a success?)
27 Risk Minimisation: Work in progress
28 Questions?
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