Improving drug safety through the patient voice

At PatientsLikeMe we’re interested in bringing the voice of our patients to the attention of those who make drug products and to the regulators that approve them. Since 2008 we have conducted a series of projects to collect safety information from some of our member communities. We’ve worked with our pharmaceutical partners to help them better understand the safety experiences of patients while they are using certain drug products.

I’d like to introduce you to a new acronym – P.R.O.S.P.E.R.  It stands for Patient-Reported Outcomes in Safety Event Reporting and it promotes the value of including patient experiences in monitoring the safety of drug products during clinical trials and after drugs are approved.

The PROSPER Consortium is co-led and supported by PatientsLikeMe and Pope Woodhead, a UK healthcare firm, with input from most global pharmaceutical companies, many clinical and academic groups, as well as regulators, researchers and patient advocates.

A report from the Consortium was recently published in the journal Drug Safety that provides guidance for using patient reported outcomes (PROs) for safety monitoring processes. These are just a few of the reports findings…

  • The patient perspective is an essential component of drug safety
  • Patient-centeredness and patient safety are emerging as core elements of any responsive health system
  • The potential clinical utility and value of real-world information obtained from real patients taking real drugs is great1

Although the U.S. Food and Drug Administration (FDA) has accepted safety reports from consumers for 20 years through its MedWatch program, other parts of the world only accept reports on adverse reactions to drugs from health professionals. While patient reporting has recently been encouraged there remain skeptics who doubt its value.

PatientsLikeMe is part of the PROSPER Consortium because we believe the patient voice – your voice – is essential to improving the safety of drugs and medical products. As we look ahead to 2014, we’ll be exploring opportunities to amplify your voice across all areas of health care to improve safety, starting with the FDA and the EU counterpart, the European Medicines Agency.

PatientsLikeMe member MollyCotter


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3 thoughts on “Improving drug safety through the patient voice”

  1. Ronnell E. Burks - PLM Research Ambassador

    Dear Sally,
    Nothing could be more important than prioritizing the importance of generating information to patients, no matter their particular diagnosis, as side effects are indicative of benefit versus risks in the ingesting of Doctor Prescribed Medication(s). Similarly is the importance of the patient’s understanding w/emphasis on translating of the ofttimes confusing collaboration of Medical Terms, which (more often than not) result in the patient’s ingesting of a medicine regardless of the risk or harmful result based on their (hopeful) misinformed remedied state of mind that it’s for their benefit despite their misunderstanding or the lack thereof regarding any life threatening or dire situation perhaps resulting in their Hospitalization, providing the host or patient will survive prior to a warranted Ambulatory state.
    My Personal Regards & Appreciation,
    Ronnell E. Burks – PLM Research Ambassador a k a lusciousblkmale0053

  2. Ronnell E. Burks - PLM Research Ambassador

    Dear Sally,
    Nothing could be more important than prioritizing what’s in the best interest of the patient, especially when it comes to risks versus benefits. Understandably if the host prescribed a medication can comprehend through the medical terms and jargon prior to ingesting a medicine, however for those hosts who don’t understand it is with gratitude that I express to you all I’be been communicating through the various research questionnaires and surveys, personally forwarded to me as Research Ambassador here at PatientsLikeMe. Though the questions were addressed at ideas of how patients should question their physicians and how physicians should formulate patient questionnaires so that the barrier of Medical Terms and Patient’s understanding can better be addressed.
    My Humble Thanks and Appreciation,
    Ronnell E. Burks…………….

  3. People of Prosper Consortium,
    It’s as much better as it is accomplished to express gratitude over attitude on behalf of other patients as myself, having just comprehended and fully accepted with open arms, the progress duly noted in the aforementioned briefing. Having been all but victimized via the use of a Pharmaceutical Drug to which a case is pending and on that basis shall remain confidential, I am nowhere from understanding the importance of being fully informed on the basis of drug interactions, contraindications , precautions etc; Communication and understanding being two separate but equal entities, it is with great promotional approval over apprehension that I accept this as a twofold, step in the right direction (again) on behalf of other patients, as myself.
    “Respectfully Yours,”
    Mr. Ronnell E. Burks (PLM Research Ambassador)

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