Consumer Medication Information

Regarding the second part of the program-that useful written patient information (CMI) accompany every new prescription-the agency proposed distribution goals and performance standards for patient information and left it up to the private sector to accomplish them. If the private sector failed to reach these goals and meet the standards, the agency indicated that it would then become necessary to federally establish a comprehensive patient information program.

The program proposal generated considerable controversy, especially among pharmacy organizations and pharmaceutical manufacturers who resented the FDA's intrusion. Shortly thereafter, Congress enacted legislation that established a voluntary private sector process under which national organizations of healthcare providers, consumers, pharmaceutical companies, and others could collaborate to achieve the program's goals but without the threat of a federally mandated program (P.L. 104-180, Sept. 30, 1996). The law required that 95% of patients receiving new prescriptions receive useful written information about their medications by 2006. Failure of the private sector to implement a program within 4 years of the law's passage would result in reinstatement of the original FDA-mandated proposal. Pursuant to this requirement, private sector stakeholders met to assess the effectiveness of current oral and written patient information, developed guidelines based on this assessment, and developed a process to continually evaluate the quality and frequency of the information provided to patients. This collaboration program was completed and its plan accepted by the FDA prior to the deadline.

Assessing the progress of the private sector plan, an FDA-commissioned study in 2001 found that although 89% of patients with new prescriptions received written information, the information was useful to patients only about 50% of the time In order to assist the private sector in meeting the 95% goal, the FDA published a guidance titled, "Guidance: Useful Written Consumer Medication Information (CMI)" in July 2006 (https://www.fda.gov/media/72574/download). The guidance provided recommendations on what information should be provided and how it should be provided. The FDA noted that failure of pharmacies and others to meet these CMI standards voluntarily could result in the FDA resorting to mandatory measures. In December of 2008, the FDA released the results of a follow-up study showing that although more consumers were receiving CMI (94%), only about 71% of this information met the minimum standard criteria for usefulness. (Remember that the law required 95%.) An FDA official remarked, "The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely" (Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, FDA News, December 16, 2008). Flaws found in CMI include formatting that is too small and crowded, inconsistent word counts with some CMI being extremely lengthy and repetitive, lack of clear action steps patients should take in the result of an adverse event, lack of clear organization and prioritization of information, and cluttering of important information with unnecessary verbiage. Nonetheless, CMI remains unreviewed and unregulated by the FDA.

Medication Guides

After passage of the 1996 law, the FDA acknowledged that the law had stripped it of its authority to establish a comprehensive private sector patient information program for all drugs. However, it felt that it retained the authority to mandate the Medication Guide program for drugs posing a "serious and significant concern" and, therefore, enacted a final regulation to this effect in 1998 (63 Fed. Reg. 66378; 21 C.F.R. parts 201, 208, 314, 601, and 610). The regulation specified that Medication Guide requirements primarily apply to outpatients who are not under the direct supervision of a healthcare professional and apply to both new and refill prescriptions. Under the final regulation, patient labeling for a product is required if the FDA determines that one or more of the following circumstances exists regarding a drug product: (1) that patient labeling could help prevent serious adverse effects; (2) that the product has serious risks relative to its benefits of which the patient should be aware in order to decide whether to use or continue to use the product; and (3) that patient adherence to directions is crucial to the drug's effectiveness. The FDA acknowledged that the MedGuides would be required for very few products, "no more than 5 to 10 products per year."

In November of 2011, the FDA published a guidance document titled, "Guidance for Industry: Medication Guides-Distribution Requirements and Inclusion in REMS" explaining when the FDA will require that a MedGuide be provided to a patient and when a MedGuide will be required as part of risk evaluation and mitigation strategy (REMS) (https://www.fda.gov/media/79776/download). The guidance articulates that, in general, a MedGuide need not be provided when the drug is dispensed to a healthcare professional for administration to a patient in an inpatient setting or in an outpatient setting such as in a clinic or dialysis or infusion center. However, the guidance then lists exceptions and other situations where the MedGuide is mandatory, including:

• When the patient or patient's agent requests a MedGuide

• When the drug is dispensed in an outpatient setting and the patient will use the drug without direct supervision of a healthcare professional (e.g., community or hospital ambulatory care pharmacy)

• The first time a drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting such as in a clinic or infusion center

• The first time a drug is dispensed in an outpatient setting of any kind after a MedGuide is materially changed

• When a drug is subject to a REMS that includes specific requirements for reviewing or providing a MedGuide

Pursuant to the regulation, MedGuides must be written in nontechnical language and in a uniform format, containing the approved uses for the product, circumstances under which the product should not be used, serious adverse reactions, proper use, cautions, and other general information. The manufacturer of the drug product for which a MedGuide is required must obtain FDA approval before the guide is distributed with the product. Manufacturers must provide directly or supply the means to provide sufficient numbers of the MedGuides to the distributor or dispenser of the product. The dispenser, in turn, must provide the guide to the patient each time the medication is dispensed when required. It is important to note that other written drug information the pharmacy may distribute does not replace the MedGuide. A study conducted by the FDA in 2004 of 5,000 pharmacists determined that 29% of pharmacists were not familiar with medication guides (from transcripts: https://www.fda.gov/drugs/drug-safety-and-availability/public-hearing-use-medication-guides-distribute-drug-risk-information-patients-june-12-13-2007).

The FDA has significantly increased the number of drugs subject to MedGuides over the past few years, now requiring nearly 902 drug products to have MedGuides. A list of those drugs can be accessed at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=medguide.page. The number of MedGuides has raised concerns from pharmacy organizations over the administrative burdens and distribution difficulties MedGuides cause pharmacies and their impact on pharmacy workflow. Because of the concern over MedGuides and the fact that Congressional goals had not been met for CMI, the FDA convened the Risk Communication Advisory Committee in February of 2009 and encouraged public participation. The FDA also held a public workshop in September of 2010 seeking answers regarding the best ways to provide useful prescription information to consumers. The FDA announced a goal that envisioned a single, easy-to-read document incorporating the most important information from PPIs, CMI, and MedGuides that the FDA now collectively terms "patient medication information" or PMI. Although this vision has yet to materialize, in February of 2017 the FDA discussed, and in 2023 proposed a rule that would require manufacturers to produce a one-page document highlighting for patients the most important information about the drug (88 Fed. Reg. 35694). PMI would also be required to follow standardized format and content requirements. Additional details regarding PMI can be found on the FDA website (https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information).

Medication Guides and REMS

The Food and Drug Administration Amendments Act (FDAAA) of 2007 authorized the FDA to require REMS when necessary to ensure that a drug's benefits outweigh its risks and MedGuides are an important component. The FDA can require a REMS both prior to NDA approval and postmarket. The compliance guide stipulates that since the FDAAA was enacted in 2007, the FDA has considered every new MedGuide to be part of a REMS. However, as the FDA states in the 2011 compliance guidance, it has the discretion to determine that a new MedGuide should be required as labeling only, not part of a REMS.