A patient’s involvement in their own healthcare helps create more positive outcomes – better health at a lower cost – is now “conventional wisdom,” a conclusion based on solid and growing research.
But “conventional wisdom” has not always been so wise. As Janet Woodcock, the director of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), said during a public workshop in 2000:
“A century or more of a professional model that didn’t trust patients with information has created much inertia to be overcome.”
Dr. Mark McClellan, former Commissioner of the FDA, talks about consumers needing “information they can trust to make smart decisions.”
The better the information patients can access, the better their involvement becomes, and the better are individual health results.
Information is the key. Access for all is the lock. Understanding is the open door.
Using Drugs Safely
Drug research by the pharmaceutical industry contributes life-changing benefits to patients worldwide. This progress continues as drugs and treatments still emerge. The industry continues to learn about not only individual drugs but also entire classes of treatments, such as antibiotics, and how they can be used more effectively and safely.
“Compliance” (or “adherence”) is the word often used to mean whether patients take medication as directed. However, surveys have shown that the low level of compliance in America is stunning, with staggering implications for cost. For example, patients who are supposed to take blood pressure medicine, but do not, often unnecessarily wind up in the hospital, a poor outcome in terms of both health and dollars.
- 32 million Americans use three or more medicines daily
- 75% of adults taking prescription drugs are non-adherent in one or more ways (don’t take drugs when and how they should, don’t take drugs at all, don’t refill prescriptions)
- $100 billion / year is a bottom line estimate of the cost that non-adherence adds to the healthcare system
- The rate of non-compliance for taking prescription drugs can be 50% or higher, even for certain chronic conditions, such as blood pressure or diabetes that can be managed with drugs – avoiding costly and painful hospitalization
The Importance of Information
We know that medication errors result in huge costs to the healthcare system in the United States. The Institute of Medicine (IOM) identifies poor labeling as a critical reason for those errors. Improving drug labeling is not an academic issue; it is critical to keeping American patients safe.
Studies consistently document that patients want information; information is necessary for involvement in the health care process. The kind of information delivered by Patient Inserts – clear, consistent, and on paper – is a model for what will benefit a patient – our parents, grandparents, and families – the most.
Adverse Drug Effects
A serious type of medication error is called an “adverse drug event” (ADE) by the Institute of Medicine (IOM). In a 2006 study, the IOM estimated that at least 1.5 million ADEs occur each year in the U.S. Medical labeling is considered a factor in up to 20% of occurrences.
For patients to take a drug safely, they need the following scientific, unbiased, information:
- What are the contraindications, the warnings that this drug might not be the right choice for the patient?
- What warnings and precautions about the drug are important?
- What are some common adverse reactions?
- What other drugs might interact with the prescribed drug?
- How is it used in specific populations such as pregnant women, nursing mothers, young children or older citizens?
- What should you do in case of an overdose?
The IOM cited studies estimating that more than 500,000 preventable ADEs occur among outpatient Medicare patients alone. Having correct, concise, easily accessible scientific information is key to avoiding these errors, the pain and suffering they cause, and the costs incurred.
Enhancing Drug Effectiveness
The better the information patients can access, the more effectively they can follow through on their responsibilities in the patient involvement model of healthcare.
Here are some of the impacts that drug research by the pharmaceutical industry has quantified:
- $100 billion annually is the low estimate of the total costs non-adherence adds unnecessarily to the healthcare system.
- Recent research shows patients who did not consistently take their diabetes medicine were 2.5 times more likely to be hospitalized than were patients who took their medicine as directed more than 80% of the time.
- Non-adherent patients were more likely to develop coronary heart disease, cerebrovascular (brain and blood vessels associated with strokes), and chronic heart failure by 7%, 13% and 42% respectively, than patients who took their antihypertension (blood pressure) medicine as directed.
A recently completed study by the University of Maryland School of Pharmacy calculates that poor medication adherence costs an extra $49 to $840 per month, per Medicare beneficiary. With more than 49 million beneficiaries of Medicare on the rolls, that translates into a range of costs of from $29 billion to almost $500 billion per year.
Improving patient adherence requires patient involvement; involvement requires the best information delivered in the most convenient manner.