{"id":48281,"date":"2020-08-11T16:20:07","date_gmt":"2020-08-11T15:20:07","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=48281"},"modified":"2020-08-19T15:29:06","modified_gmt":"2020-08-19T14:29:06","slug":"patients-emotions-matter-in-the-regulation-of-medicines","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2020\/08\/11\/patients-emotions-matter-in-the-regulation-of-medicines\/","title":{"rendered":"Patients\u2019 emotions matter in the regulation of medicines"},"content":{"rendered":"

Regulatory decisions about medicines need to be informed by the emotional as well as the physical impact of living with<\/span><\/i> medical conditions and having to balance the risks and benefits of treatment<\/span><\/i><\/p>\n

Over the past twenty years, patients and carers have been involved in the regulation of medicines at EU level. This has completely changed the European regulatory environment; we now talk of the \u201cpatients\u2019 perspective\u201d as not only an integral part of the process, but an <\/span>essential<\/span><\/i> part of it. <\/span>\u00a0An example of this is how patients’ direct reporting of suspected side effects<\/span><\/a> is now an indispensable part of safety monitoring of medicines once they are authorised for use.\u00a0<\/span><\/p>\n

The input given by patients and carers at all stages of the European Medicine Agency\u2019s regulatory procedures, via various engagement methods, has been invaluable in helping, for example, the Pharmacovigilance Risk Assessment Committee (PRAC) conduct balanced, well-rounded assessments on the safety of medicines. It also informs the benefit-risk assessments made in EMA\u2019s other scientific committees, including the committee that makes recommendations concerning marketing authorisation of new products (CHMP). To support patient\u2019s involvement, the EMA, and many of the patient organisations it works with provide specific support and training to ensure patients understand the environment and <\/span>their role within the process<\/span><\/a>.\u00a0<\/span><\/p>\n

Patients are very aware of the importance of their input, and spend considerable time preparing their participation, aiming to provide relevant, constructive contributions. Their involvement ultimately results in more meaningful regulatory outcomes, for all.<\/span><\/p>\n

Yet despite a well-established way of working with patients we still occasionally hear comments that their views have limited validity because they are put over with a degree of emotional overlay.\u00a0 We consider this to be unfair and short-sighted. Emotion has a clear place in the patient experience, which is inevitably personal and not infrequently stressful. To reduce the patients\u2019 experience to an agglomeration of fears and tears and assume it is purely anecdotal is misplaced, especially as it does not reflect the current situation whereby regulators today progressively support and value patient engagement.<\/span><\/p>\n

There is no need to be wary<\/span> of the fact that the patients\u2019 experience contains an emotional component. Indeed, we should recognise that emotions make it all the more real. Patient and carer perspectives cannot be separated from the emotional burden of having a medical condition and receiving treatment for it\u2014they come hand in hand.<\/span><\/p>\n

After being diagnosed with a condition, particularly a long-term condition, the patient begins a lifelong journey through which he or she has to accept, learn, understand, and manage a new situation and to make important treatment choices. We believe that this “emotional” journey <\/span>enhances<\/span><\/i> the validity of patients\u2019 contributions to regulatory discussions, often related to the benefit\/risk balance of a medicine, because it reflects the real patient experience. Understanding these emotions can be a goldmine for regulators; regulatory assessments are not only about reading numbers and data, but are also an interpretation exercise to understand what those numbers and data correspond to in real life.\u00a0<\/span><\/p>\n

Several studies have compared the patients\u2019 and physicians\u2019 views on treatment preferences and quality of life. [3-7] When there is a difference, and it often happens, this is due in most cases to the fact that physicians tend to focus on clinical outcomes, whereas patients focus on the impact in their everyday life (QoL), which includes emotions. Neither are wrong; for optimal decision-making, both points of view need to be considered and merged.\u00a0<\/span><\/p>\n

Public hearings<\/span> at the EMA illustrate the importance of obtaining the input of patients. [1] Public hearings are convened by the PRAC to gain insights from the public on specific medicines safety reviews. The information received during the public hearing on Valproate, a medicine for epilepsy, bipolar disorder and migraine, was at the core of the safety review of the risks to the unborn child during pregnancy. Twenty-eight patient representatives participated, and their experience and suggestions were instrumental in shaping the PRAC\u2019s recommendations on additional risk minimisation measures to reduce the risks of using valproate during pregnancy. This included new restrictions on the use of the medicine, a pregnancy prevention programme, and education materials: a guide for prescribers, patient card and guide, risk acknowledgment form, and <\/span>warning on the medicine packaging<\/span><\/a>.<\/span><\/p>\n

As confirmed by the PRAC chair, \u201cevery input was valuable and each point, spoken and written, ultimately helped strengthen the outcomes of the scientific review\u201d. It was clear that the participants and the PRAC shared a simple common goal; to ensure that patients receive the best possible risk minimisation, now and into the future. Patients\u2019 interventions were understandably passionate and “emotional” (as can be seen from the recording [<\/span>2]<\/span>) but rather than reducing their legitimacy, the emotional aspects reinforced the impact for patients and the seriousness of not being fully aware of the risks.\u00a0 Patients highlighted how the risk minimisation measures at the time were not effective enough and gave tangible suggestions on how they could be improved to <\/span>increase awareness of the risks<\/span><\/a>. It was a similar story for the second public hearing on quinolone\/fluoroquinolone antibiotics whereby patients\u2019 testimonies helped the committee appreciate the serious, long-lasting nature of the side effects affecting muscles, tendons, joints and the nervous system and the <\/span>devastating impact on some patients\u2019 lives<\/span><\/a>.\u00a0<\/span><\/p>\n

Factual information is essential, but numbers alone are not enough to assess human health or to understand why a patient is not adherent to their treatment, or why a patient decides (or not) to accept a certain level of risk. Emotions represent a complementary \u201cset of data\u201d that can help include the \u201creal world experience\u201d within the regulatory process, and, although interpreting this information is not always easy, it is worthwhile, rewarding and ultimately results in more patient-relevant regulatory outcomes.<\/span><\/p>\n

Marco Greco<\/strong>, President of the European Patients\u2019 Forum.<\/span><\/em><\/p>\n

Competing interests<\/strong>: MG has no personal interests to declare. I am the President of the European Patients\u2019 Forum and I work on a voluntary basis. EPF accepts funding from a variety of sources, including the pharmaceutical industry. Details of EPF\u2019s funders, funding arrangements, and accounts are available on its website: <\/span>http:\/\/www.eu-patient.eu\/About-EPF\/Transparency\/<\/span><\/a><\/em><\/p>\n

Nathalie Bere, <\/strong>Patient Engagement, European Medicines Agency<\/em><\/p>\n

Competing interests<\/strong>: None declared<\/em><\/p>\n

References:<\/strong><\/p>\n

    \n
  1. https:\/\/www.ema.europa.eu\/en\/about-us\/how-we-work\/public-hearings<\/span><\/a><\/li>\n
  2. https:\/\/www.youtube.com\/watch?v=CzeJSzkrygM&feature=emb_rel_pause<\/span><\/a><\/li>\n
  3. Becky A. Purkaple<\/span><\/a>, BA, BS,<\/span>1<\/span>James W. Mold<\/span><\/a>, MD, MPH,<\/span>2<\/span>and\u00a0\u00a0<\/span>Sixia Chen<\/span><\/a>, PhD<\/span>3 \u201c<\/span>Encouraging Patient-Centered Care by Including Quality-of-Life Questions on Pre-Encounter Forms\u201d. In <\/span>Ann Fam Med<\/span><\/a>. 2016 May; 14(3): 221\u2013226.\u00a0<\/span><\/li>\n
  4. Levinson W, Gorawara-Bhat R, Lamb J. \u201cA Study of Patient Clues and Physician Responses in Primary Care and Surgical Settings\u201d.\u00a0<\/span>JAMA.<\/span><\/i>2000;284(8):1021\u20131027. doi:10.1001\/jama.284.8.1021<\/span><\/li>\n
  5. Srikrishna S<\/span><\/a>1<\/span>,\u00a0<\/span>Robinson D<\/span><\/a>,\u00a0<\/span>Cardozo L<\/span><\/a>,\u00a0<\/span>Gonzalez J<\/span><\/a>. \u201cIs there a discrepancy between patient and physician quality of life assessment?\u201d <\/span>Neurourol Urodyn.<\/span><\/a>2009;28(3):179-82. doi: 10.1002\/nau.20634.<\/span><\/li>\n
  6. Aurora Bortoli, Marco Daperno, Anna Kohn, Patrizia Politi, Stefano Marconi, Rita Monterubbianesi, Fabiana Castiglione, Ada Corbellini, Manuela Merli, Giovanni Casella, Renata D’Inc\u00e0, Ambrogio Orlando, Fabrizio Bossa, Patrizia Doldo, Pierenrico Lecis, Daniela Valpiani, Silvio Danese, Michele Comberlato, on behalf of Italian Group for the study of Inflammatory Bowel Disease (IG-IBD), \u201cPatient and physician views on the quality of care in inflammatory bowel disease: Results from SOLUTION-1, a prospective IG-IBD study\u201d,\u00a0<\/span>Journal of Crohn’s and Colitis<\/span><\/i>, Volume 8, Issue 12, 1 December 2014, Pages 1642\u20131652,\u00a0<\/span>https:\/\/doi.org\/10.1016\/j.crohns.2014.07.004<\/span><\/a><\/li>\n
  7. Eur J Intern Med.<\/span><\/a>2000 Aug;11(4):228-234. \u201dInfluence of quality of care on quality of life in inflammatory bowel disease (IBD): literature review and studies planned\u201d<\/span>. <\/b>van der Eijk I<\/span><\/a>1<\/span>,\u00a0<\/span>Stockbr\u00fcgger R<\/span><\/a>,\u00a0<\/span>Russel M<\/span><\/a>.<\/span><\/li>\n<\/ol>\n

     <\/p>\n

    The views expressed in this article are the personal views of the author and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

    Regulatory decisions about medicines need to be informed by the emotional as well as the physical impact of living with medical conditions and having to balance the risks and benefits […]<\/p>\n

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