Improvements In Understandability Of Medication Label and Warnings Needed To Empower Patients

Reports about side effects of medications like one reported today in the article Common Heartburn Medications Linked To Greater Risk Of Heart Attack and disclaimers in advertising and labels of drug advertisements are supposed to help patients make more informed decisions about medications. Intended presumably to help patients be better informed about their choice and use of medications, the disclaimers and warnings alert patients that every “cure” has a side effect or effects.

Media reports about research studies and disclaimers on medication labels present a challenging conundrum for patients.  Media reports about risks associated with medications already in the marketplace create heartburn for most patients already taking the medication even when prescribed by a physician for treatment of a known condition.  Meanwhile, lengthy and often confusing lists of known or potential side effects contained in warnings on medication labels and the disclaimers on advertised medicines in television and other advertising often make the cure sound worse than the disease. As a patient, it becomes more and more impossible to tell what medicine is appropriate, with or without a doctor’s advice.  Excessive Tylenol can cause kidney damage.  Heartburn medicine is linked to heart attacks.  Certain antibiotics taken with grapefruit can be deadly. When these seemingly simple remedies for common conditions carry such risks, imaging the challenges for cancer or other patients facing life threatening illnesses where all of the treatments carry significant or even life threatening side effects and the medical evidence is less settled.

As these alerts and warnings proliferate, it becomes increasingly apparent that most present information to the patient in a manner that creates awareness of potential risks in a manner which provides the patient with little or no realistic ability to evaluate the potential benefits and risks of the medication in light of the patient’s particular medical circumstance in any meaningful way.  In most cases, the complexity of the information and its lack of meaningful tailoring to the particular medical status and situation of the particular patient create real challenges for patients and their families to understand, much less properly use, this information.  In most cases, a patient and his or her family realistically cannot be expected meaningfully and reliably to evaluate this data for purposes of making a reliable decision about whether and how to use the particular medication prior to commencement of the treatment, particularly where the same side effects often are associated with all reasonably acceptable treatment options.

As confusing and disempowering as these alerts and warnings can be before the patient begins treatment, patient are even more disempowered by warnings based on new research findings announced when or after the patient is undergoing treatment with the medication prompting the alert.  Evolving medical research often presents challenges for even the most educated and talented physicians and other medical professionals.  Emerging science often supports broader use of medications initially only to reveal the additional side effects as the medication is used in the broader population. While the medical community generally understands this dynamic, patients and their families often do not.   The American public as a whole tends to view Federal Drug Administration (FDA) approval of a medication or other treatment as certifying its safety and appropriateness.  Patients and their families often are confused and frightened when the FDA subsequently requires the removal of a medication from the market or new restrictions or warnings on its treatment.  Even with the aid of the most competent physician and other medical team, these alerts and warnings bear out that some patients will lose the side effect lottery.

In the worst – and often most widely publicized – of situations, patients unfortunately live the reality that the cure in fact was worse than the disease for which class action litigation or settlements provides unsatisfactory recompense.

The reality is that a patient and his or her family realistically cannot be expected, without the assistance of a physician or other competent medical professional, to evaluate and determine in any meaningful and reliable way the suitability of particular medications or other treatments based on these warnings or alerts without the aid assistance of a competent physician or other medical professional knowledgeable about the patient’s overall condition and needs and the medication or other contemplated treatment.  While the collection and dissemination of this information remains important to help ensure that patients in conjunction with their treatment team make the most reasonable informed decision possible in light of the currently available medical evidence, however, it is critical to keep in mind its limitations and the limitations on the ability of the average patient and his or her family to grasp and properly use this information to determine the proper course of treatment and properly use the medication to achieve the desired outcome with the minimum risk of side effects.  Like most diseases, the lack of clear solution for the conundrum doesn’t mean we should abandon these warnings.  However, it is critical we acknowledge that while patients need to be informed, evolving medical evidence and the technical nature of the findings of the moment limit the ability of most patients to properly assimilate the evidence and its associated warnings without the help of qualified medical professionals.  Even when a patient understands the potential benefits and risks, the patient and their family often fail to properly grasp how best to use the medication to maximize its benefits.  At best, the warnings should prompt patients and their physicians to discuss more fully the possible benefits and risks of particular treatments and how best to use the medications chosen to enhance the potential for the most desirable outcome with a minimum of side effects.  Understanding and using the warnings and other information from research and medication labels can offer meaningful opportunities to enhance communication between patients and providers and educate patients about their choices and the steps to properly use the medication can help improve outcomes.    To best promote this goal, however, Americans need to accept that the current manner in which warnings are provided in medication labels and advertising is unsuitable to achieve this goal in most instances and to make improving the understandability of this information and its proper use by patients in consultation with their physicians as a priority in their health care reform efforts.

About Project COPE: The Coalition On Patient Empowerment &  Coalition on Responsible Health Policy

Do you have ideas about how to improve the understandability of medication warnings or research findings for patients or other ideas about how to improve healthcare or health care policy?  Share your ideas in the  PROJECT COPE: Coalition On Patient Empowerment LinkedIn Group.  If you have knowledge, experience or other resources that could help patients, families, communities, or the government better understand or cope with  Asperger’s or other health care conditions, costs of care, or other challenges affecting Americans and the American health care system, we encourage you to get involved and share your insights.

As American leaders continue to struggle to deal with these and other mounting problems impacting the U.S. health care system, the input of individual Americans and businesses and community leaders is more critical than ever.  Get involved in helping to shape improvements and solutions to the U.S. health care system and the Americans it cares for by sharing your ideas and input through the Coalition For Responsible Health Care Policy  and exchanging information and ideas for helping American families deal with their family member’s illnesses, disabilities and other healthcare challenges through PROJECT COPE: Coalition On Patient Empowerment.

Sharing and promoting the use of practical practices, tools, information and ideas that patients and their families, health care providers, employers, health plans, communities and policymakers can share and offer to help patients, their families and others in their care communities to understand and work together to better help the patients, their family and their professional and private care community plan for and manage these  needs is the purpose of PROJECT COPE.

The Coalition and its PROJECT COPE arise and run on the belief that health care reform and policy must be patient centric and patient empowering.  The best opportunity to improve access to quality, affordable health care for all Americans is for every American, and every employer, insurer, and community organization to seize the opportunity to be good Samaritans.  The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch.  Americans can best improve health care by not waiting for someone else to step up:  Step up and help bridge the gap when you or your organization can. Speak up to help communicate and facilitate when you can.  Building health care neighborhoods filled with good neighbors throughout the community is the key.

The outcome of this latest health care reform push is only a small part of a continuing process.  Whether or not the Affordable Care Act makes financing care better or worse, the same challenges exist.  The real meaning of the enacted reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye.  Americans individually and collectively clearly should monitor and continue to provide input through this critical time to help shape constructive rather than obstructive policy. Regardless of how the policy ultimately evolves, however, Americans, American businesses, and American communities still will need to roll up their sleeves and work to deal with the realities of dealing with ill, aging and disabled people and their families.  While the reimbursement and coverage map will change and new government mandates will confine providers, payers and patients, the practical needs and challenges of patients and families will be the same and confusion about the new configuration will create new challenges as patients, providers and payers work through the changes.

We also encourage you and others to help develop real meaningful improvements by joining PROJECT COPE: Coalition On Patient Empowerment and by sharing ideas, tools and other solutions and other resources. The Coalition For Responsible Health Care Policy provides a resource that concerned Americans can use to share, monitor and discuss the Health Care Reform law and other health care, insurance and related laws, regulations, policies and practices and options for promoting access to quality, affordable healthcare through the design, administration and enforcement of these regulations.

You also may be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, and/or our HR & Benefits Update electronic publication available here.

You also can get details about how to arrange for your employees or other communities to participate in training on “Building Your Family’s Health Care Toolkit,”  using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here.

NOTE:  This article is provided for educational purposes.  It is does not provide legal advice, establish any attorney-client relationship or provide or serve as a substitute for legal advice to any individual or organization.  Readers must engage properly qualified legal counsel to secure legal advice about the rules discussed in light of specific circumstances.ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, or (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.  ©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.