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«18 November 2015 EMA/606103/2014 Pharmacovigilance Risk Assessment Committee (PRAC) Good practice guide on risk minimisation and prevention of ...»

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18 November 2015

EMA/606103/2014

Pharmacovigilance Risk Assessment Committee (PRAC)

Good practice guide on risk minimisation and prevention

of medication errors

Final

Draft finalised by Project and Maintenance Group 2 of Member States

5 December 2014

and EMA pharmacovigilance governance structure

Draft consulted with the European Commission’s Patient Safety Quality of

11 February 2015

Care Working Group (PSQCWG)

Draft agreed by Pharmacovigilance Risk Assessment Committee (PRAC) 12 February 2015 Draft agreed by the Implementation Group (IG) of Member States and 18 February 2015 EMA pharmacovigilance governance structure Draft circulated to the Committee for Human Medicinal Products (CHMP) and the Co-ordination group for Mutual recognition and Decentralised 19 February 2015 procedures – human (CMD-h) Draft adopted by the European Risk Management Strategy Facilitation 17 March 2015 Group (ERMS-FG) Draft released for public consultation 14 April 2015 End of public consultation (deadline for comments) 14 June 2015 Revised draft agreed by Project and Maintenance Group 2 of Member 15 August 2015 States and EMA pharmacovigilance governance structure Draft consulted with CHMP Quality Working Party (QWP) and Biologics 4 September 2015 Working Party (BWP) Revised draft consulted with Committee for Human Medicinal Products (CHMP) and Co-ordination group for Mutual recognition and 4 September 2015 Decentralised procedures – human (CMD-h) 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

Revised draft agreed by Pharmacovigilance Risk Assessment Committee 10 September 2015 (PRAC)

–  –  –

Table of contents Executive summary

1. Introduction

2. Scope

3. Legal basis

4. Definitions

5. Structure and processes

5.1. General principles of risk management planning and the tools used

5.1.1. Reporting and Coding of medication errors

5.1.2. Root cause analysis

5.1.3. Use-related risk analysis and Human Factor/Usability Engineering

5.2. Assessing the potential for medication errors during the product life-cycle................. 10 5.2.1. General considerations for potential sources of medication error

5.2.2. Typical errors during the clinical trial programme

5.2.3. Defects and device failure (pre-authorisation)

5.2.4. Medication errors resulting in harm during post-authorisation use

6. Risk minimisation

6.1. Risk minimisation measures

6.1.1. Error prevention through naming, packaging and labelling (including name review activities and use of colour)

6.1.2. Risk minimisation tools and activities

6.1.3. Criteria to assess effectiveness of error prevention during post-marketing.............. 20

6.2. Specific considerations in high risk groups

6.2.1. Paediatric patients

6.2.2. Elderly patients

6.2.3. Patients with visual impairment

6.3. General principles of good communication in relation to medicines information.......... 23

7. Operation of the EU regulatory network

7.1. Competent authorities in Member States

7.2. Pharmacovigilance Risk Assessment Committee

7.3. Patients and healthcare professionals

7.4. Marketing authorisation applicant or holder

7.5. European Medicines Agency

List of acronyms

Annexes

Annex 1 – Potential sources of medication error in medicinal product design

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Good practice guide on risk minimisation and prevention of medication errors EMA/606103/2014 Page 4/41 Executive summary Medication errors present a major public health burden and there is a need to optimise risk minimisation and prevention of medication errors through the existing regulatory framework. The European Medicines Agency (EMA) in collaboration with the EU regulatory network was mandated to develop regulatory guidance for medication errors, taking into account the recommendations of a stakeholder workshop held in London in 2013. This guidance is intended to support the implementation of the new legal provisions regarding the reporting, evaluation and prevention of medication errors and is intended mainly for the pharmaceutical industry and national competent authorities. Healthcare professionals (HCP) are expected to consult national clinical guidance on reducing the risk of medication errors.

This good practice guide is one of the key deliverables of the Agency’s medication error initiative and offers guidance on risk minimisation and prevention of medication errors. The guidance includes population-specific aspects in paediatric and elderly patients, as well as guidance on the systematic assessment and prevention of the risk of medication errors throughout the product life-cycle.

The key recommendations:

• The potential for medication errors should be considered at all stages of the product life-cycle but particularly during product development.





• To minimise the risk of medication errors o careful consideration should be given to the name and pharmaceutical design of a medicinal product (including its type of dosage form, appearance and other formulation characteristics, packaging and labelling) in order to minimise the risk of mix-ups between different products;

o the product information should inform HCPs, patients and caregivers of the most appropriate use of the product.

• Where medication errors result in adverse outcomes, corrective actions should be taken.

1. Introduction 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. This includes the prescribing, storing, dispensing, preparation for administration or administration of a medicinal product. Examples of common medication errors include giving a medication to the wrong patient, the wrong dose of a medication being given to a patient or forgetting to give a patient a medication that had been prescribed for them. Competent authorities in EU Member States, marketing authorisation holders (MAHs) and the Agency have a number of obligations as detailed in Title IX of Directive 2001/83/EC, Regulation (EC) 726/2004, chapter 3, Article 28 and (for those medicinal products supplied with CE marked devices, Directive 93/42/EEC, Article 10 and Annex I). These relate to the recording, reporting and assessment of suspected adverse reactions (serious and non-serious) associated with an error in the prescribing, storing, dispensing, preparation or administration of a medicinal product for human use authorised in the European Union (EU), including scientific evaluation and risk minimisation and prevention.

Medication errors represent a significant public health burden, with an estimated global annual cost exceeding €4 1. Individual studies have reported inpatient medication error rates of 4.8% to 5.3% and http://www.who.int/patientsafety/information_centre/reports/Alliance_Forward_Programme_2008.pdf Good practice guide on risk minimisation and prevention of medication errors EMA/606103/2014 Page 5/41 in another study, prescribing errors for inpatients occurred 12.3 times per 1000 patient admissions 2. In most cases medication errors are preventable, provided that the potential risks of medication errors have been considered during the product development, appropriate measures put in place and reactive measures taken in response to documented reports of medication error. It is important that reports of medication errors and interventions are evaluated, and corrective and preventative actions considered, proportionate to the risk and in accordance with quality management systems, as described further in Good Vigilance Practices (GVP) Module I - Pharmacovigilance systems and their quality systems 3.

This good practice guide is complementary to the guideline on GVP and the scientific guidelines on quality, safety and efficacy of medicines published on the Agency’s website, including the position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures (EMA/CHMP/277591/2013) 4.

2. Scope This good practice guide outlines the key principles of risk management planning in relation to medication errors arising from the medicinal product and its delivery system (if applicable). This includes medication errors related to the name and the design of the product, with a special focus on the type of dosage form, the type of administration device (if applicable) and the packaging. This guidance describes the main sources and categories (types) of medication error which may need to be considered, provides real-life examples of such errors, the measures implemented to minimise the risk of medication errors occurring and suggests proactive approaches to risk management planning throughout the product life-cycle. This guidance should be read in conjunction with the latest version of

GVP Module V on risk management systems and GVP Module XVI on risk minimisation measures:

selection of tools and effectiveness indicators. The recording, coding, reporting and assessment of medication errors is covered in a separate document (see section 5.1.1.) Risk management planning in relation to events associated with intentional overdose, abuse, misuse, occupational exposure, off-label use and of medication errors occurring in the context of clinical trials conducted in accordance with Regulation (EU) No 536/2014, repealing Directive 2001/20/EC, are outside the scope of this guidance.

3. Legal basis Directive 2001/83/EC specifies that the definition of the term ‘adverse reaction’ covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product. The risk management system (described in Directive 2001/83/EC) documents the risks which may be associated with use of a medicinal product, including those which arise from medication errors and any measures which may mitigate these risks.

Commission Implementing Regulation 520/2012 defines the content and format of the risk management plan (RMP).

4. Definitions The definitions provided in Article 1 of Directive 2001/83/EC and those provided in chapter 4 of the good practice guide on recording, coding, reporting and assessment of medication errors (see section Medication Errors: An Overview for Clinicians Wittich, Christopher M. et al. Mayo Clinic Proceedings, Volume 89, Issue 8, 1116 - 1125 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129132.pdf http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144096.pdf Good practice guide on risk minimisation and prevention of medication errors EMA/606103/2014 Page 6/41 5.1.1.) should be applied for the purpose of this guidance; of particular relevance for risk minimisation and prevention of medication errors are the definitions provided in GVP Module V on risk management systems (Rev 1) which include the general principles presented in the ICH-E2E guideline, and GVP Module XVI on risk minimisation measures: selection of tools and effectiveness indicators (Rev 1).

5. Structure and processes

5.1. General principles of risk management planning and the tools used GVP Module V describes the general principles of risk management planning, which is a global process, continuous throughout the life-cycle of the product. It involves the identification of risk at the preauthorisation phase, during evaluation of the marketing authorisation application and postauthorisation phases. It also involves planning of pharmacovigilance activities to monitor and further characterise risks, planning and implementation of risk minimisation activities and measurement of the success of these activities.

Risk management planning in relation to medication errors should be proactive, beginning at an early stage in product development and continuing with the development of newly marketed products (which could be used with the concerned product) and with any changes to the use of the product in clinical practice. Medication errors can arise at any stage of the treatment process, including prescribing, storing, dispensing, preparation for administration or administration. Such errors can lead to over- or underdosing, incorrect application via the wrong route of administration or administration to the wrong patients. The consequences may include serious adverse reactions including death, an increased incidence and/or severity of adverse reactions and loss of effectiveness.

During the product development process, applicants should consider the various sources of medication error, their relevance for the product and the likely impact on the balance of risks and benefits. This should take into account relevant products in the same or similar indication(s) already on the market.

Once the product is marketed, MAHs should consider whether any significant changes to the marketing

–  –  –

product name, • concentration or strength, • pharmaceutical form, • composition, • method of preparing for administration, • route of administration, • administration device (or method of supply of administration device), • patient population or indication, • inbuilt distinguishing features in terms of appearance (e.g. appearance of insulin pen device).



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