At a time of ever-ratcheting concern about the safety of our food and the appropriate, safe use of prescription drugs, the Food and Drug Administration (FDA) has moved forward in the past with a number of initiatives to better protect public health. Among them are efforts that are likely to impact how pharmaceutical companies help manage some of the risks associated with their products. One such initiative: the Agency’s effort to make information about medications more accessible, comprehensible, and useful to consumers.
In December 2008, the FDA released a study1 showing that Consumer Medication Information documents (CMIs), distributed voluntarily by pharmacies, did not consistently provide patients with useful, understandable information regarding the risks and benefits of medications. Specifically, the study found that while 94% of consumers received CMI with their new prescriptions, only 75% of this information was considered useful falling well short of the Congressional mandate of 95%.
In late February 2009, the FDA’s Risk Communication Advisory Committee held a public meeting to discuss the findings of the study and explore changing the way the Agency addresses the dissemination of information about medication risks and benefits to the public. Perhaps the single most important take away from the FDA’s meeting was that it wasn’t only about improving CMIs; it was about changing the way we communicate about the risks and benefits of medications, period.
As it stands, there are three standard forms of communication used to convey important medication information to patients:
- – The CMI
- – The Patient Package Insert (PPI)
- – The Medication Guide (MG)
Each contains facts about medications: risks, benefits, the potential side effects and how to recognize them. But they’re regulated, created, and distributed in different ways.
Consumer Medication Information documents (CMIs) are typically created by the fulfilling pharmacy or an outside vendor, and routinely distributed voluntarily by pharmacies (often, stapled to the outside of the bag when medication is delivered). Format can vary dramatically, and a CMI can sometimes include advertising information that is totally unrelated to the medication itself.
The Patient Package Insert (PPI), on the other hand, is created by the drug manufacturer as the result of a mandate by the FDA. It contains information that is similar, if not identical, to parts of the drug label, and is often attached to the medication package (bottle or box) itself.
Finally, the Medication Guide (MG), also created by the manufacturer under FDA mandate, is required when the Agency determines that: providing specific information is necessary to prevent serious adverse effects; patients should have information about a known serious side effect to aid in decision-making; or patient adherence to directions for the use of the product is essential to its effectiveness.
The problem here is fairly self-evident. In some circumstances, a patient could get all three documents. The sheer amount of information alone could be overwhelming. Redundancy has the potential to further muddy the waters. In addition, people have varying levels of health literacy the ability to obtain, process, and understand the basic health information and services needed to make appropriate health decisions.
There are other complicating factors as well. The core concern here is that balancing risk and benefit, which is of paramount importance, but that’s often a different endeavor for different medications. A study found that the majority of drug-related overdose deaths in West Virginia in 2006 were associated with non-medical use and diversion of pharmaceuticals, primarily opioid analgesics. The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) collected data that show that people are often getting these drugs through family and friends. How do we ensure that patients who need these medications are using them safely and appropriately without sharing them with others? If we change the way we communicate about the risks and benefits of these medicines, what’s the best way to measure the impact?
Like all other aspects of healthcare, there is no obvious “silver bullet.” But at the Advisory Committee meeting in 2009, consensus emerged that when it comes to communicating about risks and benefits, less may be more. Among the Committee’s core recommendations was the adoption of a single standard document for communicating essential information about pharmaceuticals, which would replace the PPI, CMI, and MG, and be regulated and approved by the FDA. The Agency would also be responsible for creating a process to ensure that:
- – The most relevant information is included
- – The appropriate populations receive the information
- – There is ongoing evaluation and research into ways to further improve communication about medication information
In addition, the Committee considered the benefits of a two-tiered system of information dissemination, where a patient is provided with the most important basic facts, but also has the option of receiving more information if desired. Finally, it made clear that written medication information – regardless of the format – would serve to complement, not replace, the information doctors and pharmacists convey to patients face-to-face.
How might these changes have impacted drug manufacturers? With so many factors still unknown, it’s hard to say. For some companies, it might mean that the process for communicating the benefits and risks of their products becomes simpler. For others, such as those that have not been required to produce a MG in the past, it might become more complex.
Five years have passed, and a number of new challenges have surfaced that impact risks and benefits of prescription pain medications and conveying that information to patients in a meaningful way that results in less unintended negative consequences (e.g., overdose, death).
It might be fair to say that not as much progress has taken place in the past 5 years as the FDA would have hoped. Ultimately, however, with education of healthcare providers about informed consent and shared decision-making, ongoing measurement of impact and adjustments as necessary, we are moving towards a communication system that effectively enhances the benefit of medications, minimizes risk, and save lives. It might be a good idea to ask yourself what your role as a healthcare provider plays in this story.
1. Expert and Consumer Evaluation of Consumer Medication Information-2008. Final Report to the U.S. Department of Health and Human Services and the Food and Drug Administration. November 2008. Available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM163783.pdf. Accessed 2/14/14.