Summary of Module XVI Risk minimisation measures: selection of tools and effectiveness indicators

 Module XVI Risk minimization measures: selection of tools and effectiveness indicators

 

Continuing the series on Guideline on good pharmacovigilance practices, in this blog i will jump right into module VI having covered module I , II, III, IV, V, VI VII, IX, X and XV in previous blogs.

This module describes the measures taken for preventing or minimizing risks associated with product and their effectiveness. All products require routine risk minimization measures which are described in module module V and this module goes in details regarding additional risk minimization measures. 

Reference :https://ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-xvi-risk-minimisation-measures-selection-tools-and-effectiveness-indicators-rev-2_en.pdf

Definitions:

Risk minimization measures are interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur.

Why is it needed?

Risk minimization measures helps HCPs in clinical practice by supporting the provision of the right medicine, at the right dose, at the right time, to the right patient and with the right information and monitoring.

What are the factors that are considered ?

Routine and additional risk minimization measures are selected based on the risk /safety concerns and few factors that are taken into consideration are below.

• Ø  seriousness of the potential adverse reaction(s) 
• Ø  its severity (impact on patient), 
• Ø  preventability or the clinical actions required to mitigate the risk, 
• Ø  the indication, 
• Ø  the route of administration, 
• Ø  the target population and the healthcare setting for the use of the product
• Ø  safety concerns should be prioritized in terms of frequency, seriousness, severity, impact on public health and preventability
• Ø  Additional risk minimization measures should focus on the most important, preventable risks and the burden of imposing additional risk minimization should be balanced with the benefit for patients.

How ?

The additional risk minimization measures should have well defined objective, rationale/introduction, description, implementation and evaluation. 

1.Educational programmes> actionable information for prescribers, clear, concise and brief and well defined target audience

2. Controlled access programmes; very rarely used as puts a burden on healthcare system and may also limit availability of treatment.

• Ø  specific testing and/or examination of the patient to ensure compliance with strictly defined clinical criteria; 
• Ø   medicines made available for dispensing only by pharmacies that are registered and approved to dispense the product.
• Ø  prescriber, dispenser and/or patient documenting their receipt and understanding of information on the serious risk of the product; 
•      explicit procedures for systematic patient follow-up through enrolment in a specific data collection system e.g. patient registry; 

3. Other risk minimization measures

• Ø  Controlled distribution system
• Ø  Pregnancy prevention program            
• Ø  Direct health care professional communication (DHPC)
•  

    Measuring the effectiveness of risk minimization measures

T There are two types of indicators to measure effectiveness i.e. process indicators and outcome indicators.

    Process's indicators: If the educational material or information has reached the right audience, has it improved or added to their clinical knowledge and also has it impacted the clinical decisions for patients.

O  Outcome indicators: If the measures have impacted the reporting of the adverse events, clinical decisions in managing the risks, patient efficacy outcomes etc pre and post implementation needs to be measured.

     Overall the module offers a great insights in what is expected from each stakeholder to ensure implementation of right risk minimization measures that can ultimately contribute for patient safety.

Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook or Linkedin messages actively)

Support the cause of better rural education with me:ThinkSharp Foundation http://thinksharpfoundation.org/#home