Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. |
Recent patient-centric regulatory and related initiatives are transforming the form and function of the pharmacovigilance function within the biopharmaceutical industry. |
To meet this patient-centric imperative successfully, pharmacovigilance departments will need to develop a more patient-centered culture, use a framework-driven approach to patient engagement and become proficient in a range of patient-centered competencies. |
1 Introduction
2 Patient-Centric Trends Affecting Drug Safety
Drug safety domain | Title | Description |
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Adverse event reporting | Directive 2010/84/EU amending Pharmacovigilance Directive 2001/83/EC on the Community code relative to medicinal products for use | Implementation of EU pharmacovigilance legislation 2012 expanding direct patient reporting of suspected ADRs throughout the EU |
Regulation (EU) 1235/2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and Regulation (EC) 1394/2007 on advanced therapy medicinal products | ||
European Medicines Agency (EMA). Guideline on Good Pharmacovigilance Practices (GVP) Module VI: Management and Reporting of Adverse Reactions to Medicinal Products EMA/542040/2014 (2012) | Guidance outlines responsibilities for MAHs to: | |
(a) Monitor and screen internet sites and all forms of digital media under their management or responsibility for potential reports of suspected ADRs. The frequency of the screening should allow for potential valid individual case report forms to be reported to the health authorities within the appropriate reporting timeframe, based on the date on which the information was posted on the internet site/digital medium | ||
(b) Utilize their websites to facilitate the collection of reports of suspected adverse reactions | ||
Innovative Medicines Initiative (IMI) Web–Recognizing Adverse Drug Reactions (Web-RADR) Consortium (2014–2017) | The project’s goals are to: | |
(a) Develop robust text-mining techniques for analysis of social media data for patient reports of potential suspected ADRs to complement existing methods of adverse event signal detection | ||
(b) Develop and pilot a mobile app to facilitate patient reporting of suspected ADRs | ||
US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Initiative (2010) | The project goal was to develop a library of patient-reported outcomes to supplement CTCAE reporting to enable standard capture of patient-reported safety data in clinical trials | |
Benefit–risk assessment | Food and Drug Administration (FDA). Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling | The guidance describes scientific methods for sponsors to use in collecting patient preference data on medicinal devices, and how to submit such data in filing and labelling |
Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (May 18, 2015) | ||
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: M4E(R2) (effective 2016) | The guidance specifies inclusion of patient preference data in the Clinical Overview Section 2.5.6 of the Common Technical Document at the time of filing for marketing authorization | |
IMI-2 Consortium on Patient Perspective Elicitation on Benefits and Risks of Medicinal Products, Supplementing Benefit-Risk Assessments by Regulators and HTAs from Development through the Entire Life Cycle (2015–2020) | The project goal is to develop recommendations with the view of supporting the development of guidance for industry, regulators and HTA bodies on how and when in the product life cycle to consider patient perspectives on benefits and risks of medicinal products to inform the decision-making process by regulators and HTA bodies | |
Risk management, risk minimization and risk communication | EMA. Good practice guide on risk minimisation and prevention of medication errors (2015) | The guidance outlines the responsibilities of sponsor to conduct human factors testing during product development |
EMA. Good Pharmacovigilance Practices (GVP) Module V: Risk Management. EMA/542040/2014 (2012) | The guidance requires sponsors to develop a lay summary of the product Risk Management Plan for public posting | |
EMA Guideline on GVP Module XVI: Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 1) | The guidance outlines the responsibilities for sponsors to obtain patient input into the design and testing of risk minimization tools and programmes | |
EMA/542040/2014 (2012) | ||
Council for International Organizations of Medical Sciences (CIOMS) Working Group IX: Practical Approaches to Risk Minimisation of Medicinal Products (2014), Geneva | The guidance recommends that sponsors include patients throughout the cycle of risk minimization planning, implementation and evaluation |
3 Key Attributes of the Patient-Centered Drug Safety Department
Strategy | Tactics |
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Embed a patient-centered culture within the drug safety organization | Orient core drug safety functions towards understanding and addressing patient preferences, goals and priorities |
Communicate the value of patient-generated information across the department, as well as the larger organization | |
Support modifications in practice with changes in drug safety staff culture by: | |
Communicating a vision | |
Establishing accountability | |
Creating metrics to measure staff behaviour | |
Establishing a supportive governance structure and processes | |
Providing training | |
Develop a framework to engage with patients | Internally: integrate patient engagement efforts with those patient engagement initiatives occurring elsewhere in the larger organization |
Establish metrics to measure progress and the degree of transparency in reaching this goal, and to measure the quality and quantity of patient engagement | |
Externally: co-promote patient engagement with patient communities as a sustainable and scalable commitment | |
Become proficient in applying patient-centered engagement methods and other patient-centered competencies | Apply health literacy and numeracy principles in the development of labelling and other patient-targeted materials for communicating safe and appropriate use of medicinal drugs and devices, and benefit–risk information |
Use eHealth tools to engage with patients to communicate/educate | |
Develop patient-targeted benefit–risk decision aids |
3.1 A Culture of Patient-Centeredness
3.2 A Framework for Patient Engagement
3.3 Proficiency in Patient Engagement Methods
Competencies |
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Provide ongoing support for application of patient-centered processes and patient engagement methods (‘patient engagement framework’) across the organization as a whole |
Increase availability of understandable information about product benefits and risks for patients, including benefit–risk decision aids |
Foster an environment that encourages ongoing innovation in regard to developing and implementing patient-centered approaches to pharmacovigilance activities |
Have professional staff who have subject matter expertise in: |
Human factors study design and methods |
Patient engagement approaches |
Patient preference assessment methods |
Designing and implementing evidence-based, patient-centered risk minimization interventions |
Application of eHealth technologies for patient communication and other forms of patient interface |
Data-mining techniques for social media |
Risk communication, including health literacy and numeracy principles |
Incentivize staff to engage in cross-functional collaboration and teamwork so as to minimize ‘silo’ mentality and behaviours |
Establish robust processes for rewarding and acknowledging ‘patient-centered’ service orientation among staff |