FDA Proposes Updates to Drug Labeling Regs to Include New Patient Medication Information (PMI) Guide for Prescription Drug Products

Patient Medication Information

This action, if finalized, will require applicants to create a new type of medication guide, referred to as Patient Medication Information (PMI). In this article, our Scientific Lead, Bernard Vrijens, unpacks the proposals and questions whether more is needed to help patients achieve the desired outcomes.

Let us be crystal clear. Poor communication is a significant issue in the strive towards ensuring greater levels of regimen adherence with patients. Indeed, a book of evidence suggests that poor communication by healthcare professionals may lead to life-threatening complications.

In one study, the clear conclusion was that communication problems with patients lead to increased preventable adverse effects, which were mostly drug-related[1].

It has also been estimated that 27% of medical malpractice is the result of communication failures[2] with one investigation reviewing 23,000 medical malpractice lawsuits and finding more than 7,000 of those lawsuits could be attributed to communication failures[3]. 

Perhaps as a consequence, the Food & Drug Administration (FDA) is proposing to amend its human prescription drug labeling regulations. It claims that the new one-page Patient Medication Information (PMI) would highlight essential information that patients need to know about the prescription drug product, including basic directions on how to use the product[4].

The Patient Medication Information (PMI) Guide is a step in the right direction, but more is required.

While the idea to improve medication guides is to be applauded, there are some concerns around the proposed execution.

There is evidence that shows patients are increasingly referring to patient information leaflets[5] at the outset of a new regimen, however, they can sometimes be regarded as a rather frightening read[6] as the section most often read is about side effects. We already know that the fear of such side effects often prevents people from taking their medication as prescribed.

And actually, the real challenge around adherence isn’t how but when. Taking an oral solid dose isn’t complicated for most people, notable exceptions being young children and people with certain disorders that make swallowing difficult. The real complication is knowing when to take the dose and what to do if the dose isn’t taken as prescribed.

Therein lies the problem with the current FDA proposals. Patients aren’t robots, they are busy living their lives, and sometimes, things get missed or forgotten about. While there is anxiety about forgetting where your mobile phone is, it usually isn’t life-damaging. Failing to take a medication where the dosing regimen is very strict can be. The Patient Medication Information needs to be focussed on the importance of consistent dosing, the level of flexibility allowed, and what to do if one is missed.

Most drugs in today’s pharmacopeia are prescribed to be taken once a day. While the expected interval between doses (i.e., 24 hours) is the same, there are major differences in the duration of drug action across medications. When the dosing of these drugs is delayed or briefly interrupted, the action of some drug may continue for a few days, while for others, the drugs’ actions will have fallen to unmeasurable levels or ceased altogether [7] For example, some ACE inhibitors, a widely used class of antihypertensive treatments, are prescribed once daily but have a duration of action of 24 hours. It, therefore, requires precise dosing every 24 hours to maintain continuity of drug action. On the other hand, a few other antihypertensive treatments like amlodipine, chlorthalidone, or aliskiren, also prescribed once daily, will continue to reduce blood pressure for several days after dosing stops. How can patients know the difference when they are only told that it is a once-daily dosing?   This is crucial information which is currently not communicated effectively to patients. Here at AARDEX Group, we would go as far as to say if it were, adherence would perhaps be a considerably less contentious and, thus far, better-resolved issue.

To the best of our collective knowledge, this kind of more robust guidance is only contained within contraceptive pills prescribed in the UK. To illustrate this point, the birth control pill, which was first approved for use in the United States in 1960, has undergone a transformation in formulation which has necessitated greater adherence.

Early formulations of oral contraceptives had higher hormone dosages compared to modern pills, and while effective, they also presented a higher risk of side effects such as blood clots and cardiovascular issues. Over time efforts have been made to reduce the hormone dosages in oral contraceptives. Today, women benefit from the many advancements in oral contraceptives, however, low-dose contraceptive pills typically require strict adherence to a daily dosing schedule. This regimen demands users to take the pill at the same time each day for maximum effectiveness. Low-dose contraceptive pills do, however, have a narrower margin of error. Missing even a single dose or deviating from the prescribed schedule can increase the risk of contraceptive failure. Adherence becomes crucial in maintaining the pill’s efficacy.

Another example is SSRIs, or Selective Serotonin Reuptake Inhibitors, a class of antidepressant medications commonly used to treat depression, anxiety disorders, and other mental health conditions. Categorized into short, intermediate, and long-acting, the duration of action can vary depending on the specific drug, dose, and factors personal to each individual. For example, while they are all prescribed once daily, drugs like fluoxetine (Prozac) and its active metabolite have long half-lives ranging from several days to a week or more. On the other hand, drugs such as Sertraline (Zoloft) and Escitalopram (Lexapro) have shorter half-lives of around one day and require timely intake of consecutive doses to maintain continuity in drug action. How would the patient know if it is not described in the Patient Medication Information (PMI)?

The FDA’s stated aim is to protect public health by ensuring the safety and efficacy of drugs. Therefore, we contend that it needs to be as robust in its guidance to patients as it is in its guidance to the pharmaceutical and drug delivery industries. The clarity and consistency of communication is paramount in addressing poor levels of adherence, and that clarity should come from the very top.

Indeed, as one paper cites, “The usual objective during long-term pharmacotherapy is, in large part, to maintain continuity of action of the prescribed drug(s). Continuity of action arises from the continuity of implementation of a prescribed dosing regimen that is pharmacologically sound in dose quantity and interval between successive doses. Interruptions in dosing can interrupt drug action, but the consequences vary according to length of interruption, drug, drug formulation, length of the patient’s prior exposure to the drug, and the disease being treated.” [8]

The 18th-century poet Thomas Gray clearly didn’t take any medications when he wrote ‘ignorance is bliss.’ Perhaps that’s why he died aged just 54.


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