Hello Vladimir,
We face these same challenges in clinical trials too. I don't think there is anything you can do from labelling point of you. It is all down to the physicians and nurses and how they manage and support the patients. For example, in Alzheimer's studies it is normal to have relative supporting the patient in terms of taking their medications on time and attending appointments.
Alternatively, there are a lot of phone reminders and other technology options to remind patients.
Have a great week.
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
https://solutionsop.co.uk/United Kingdom
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Original Message:
Sent: 09-Nov-2023 22:17
From: Vladimir Penkrat
Subject: Are Medication Guides and Labelling the Answer to Non Adherence
In May of 2023 the FDA proposed the creation of simplified medication guides as a potential mechanism to fight patient adverse events and non adherence to prescriber information. For those in the labelling community there is extensive effort to ensure there is correct representation of the products prescribing information through localized labels, patient information leaflets, package inserts etc and there is some effort toward eLabelling and ePI to further advance label accessibility.
While there is a lot of talk about eLabelling and better label information, given the plethora of information in the public domain it has not solved the problem of adherence. The top 5 reasons patients surveyed respond as reasons for non adherence are 1) Disease fatigue, 2) Forgetfulness, 3) Running out of the drug, 4) Believing they are symptom free and 5) Cost. Will any of these be solved by more label content that is a flat file published as a PDF? Are there restrictions or concerns for a truly searchable and personalized eLabeling approach that is personalized to patients specific medical history and treatment consideration?
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Vladimir Penkrat
Associate Vice President
Princeton NJ
United States
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