Drug Information Center

What medications currently have restricted access programs?

The first restricted access program in the United States was developed in 1972 to limit access to methadone.¹ Since that time the use of many other medications has been restricted due to concerns about serious adverse effects, teratogenicity, potential for abuse, and a desire to ensure appropriate prescribing that minimizes patient risk. Access to most of these products is limited as a joint effort between pharmaceutical manufacturers and the Food and Drug Administration (FDA).

The most recent FDA effort to manage medication risk is the Risk Evaluation and Mitigation Strategy (REMS) initiative.² The FDA may require manufacturers of drugs with safety concerns to submit a REMS program at the time a new drug is approved. These programs may contain any combination of 5 criteria (Medication Guide, Communication Plan, Elements to Assure Safe Use, Implementation System, and Timetable for Submission of Assessments). Restricted access programs are considered Elements to Assure Safe Use. A current list of medications with REMS programs is available via the following link:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Table 1 provides information about the medications that currently have a restricted access program. The scope of these programs varies greatly. Some programs require registration of the patient, prescriber, and pharmacy and require that the pharmacy confirm appropriateness of the prescription by calling the program before dispensing, while others are limited to a one-time training of the physician. While the requirements of some programs may be inconvenient, their aim is to encourage safe and appropriate medication use.

Table 2 provides information about the medications that are currently limited in their distribution. Limited distribution programs are generally not mandated by the FDA. These programs are developed by manufacturers to fulfill various functions including facilitating access to specialty pharmaceuticals, providing assistance with obtaining insurance coverage, and providing patient counseling services. Distribution of these medications is usually from select specialty pharmacies directly to the patient, caregiver, or institution.

Pharmacists in all practice settings should be familiar with medications that have restricted access and limited distribution programs in order to ensure safe medication use, access, and continuity of patient care.³

References

By Heather Ipema, PharmD