• The training or experience of a prescriber.

check-act of REMS. Such systems are developed to confirm “how” the overall REMS is being implemented, and if the REMS can be improved at the practitioner level. Implementation systems provide the sponsor or manufacturer with the ability to monitor each step in the implementation of the REMS by downstream healthcare practitioners and facilities responsible for implementing the REMS. Proper use of the implementation system model afford the manufacturer access to data that can be rapidly used to change elements of the REMS that may not be meeting expectations.

TAblE 3

• The type of setting that dispenses the drug must demonstrate sufficient training.

Recommended FDA REMS-related sources

• The site of care may be specified (i.e., the patient must be admitted to a hospital).

Approved REMS

 

• The patient must show evidence or documentation of safe-use conditions (typically through laboratory measures).

Medication guides

Postmarket drug safety information for patients and providers

www.fda.gov/Drugs/DrugSafety/Postmar­ ketDrugSafetyInformationfor PatientsandProviders/ucm111350.htm www.fda.gov/Drugs/DrugSafety/ ucm085729.htm www.fda.gov/Drugs/DrugSafety/Postmar­ ketDrugSafetyInformationfor PatientsandProviders/default.htm

• The patient must agree to be appropriately monitored.

• In some cases, the patient must be enrolled in a registry in order to assess the longitudinal treatment cycle of the patient.¹

 

In each case above, ETASU places new challenges on the pharmacy practitioner. Often, the pharmacist is the last check in determining if the drug is to be made available to the healthcare practitioner for administration to the patient. Prior to the FDAAA, state laws and regulations governed this dispensing function; by making REMS more prevalent, the FDA has achieved soft authority to regulate the practice of pharmacy and the distribution of drugs in new ways through its powers over manufacturers and sponsors. In order for ETASU to be successfully introduced for any REMS drug, the supply chain must attest to meeting the requirements of the drug’s REMS. Thus, the role of the specialty market emerges in this area, as drugs requiring ETASU must be able to have the support of pharmacies and distributors to implement the clinical, risk and data needs of the drug’s REMS. Manufacturers must address the challenges to their drugs by addressing the negative effects on the commercial application of their drug through contracting for services provided by distributors and pharmacies. Without such services, it is unlikely that the requirements of REMS can be met.

The FDA may require implementation systems in conjunction with ETASU to provide mechanisms that allow the sponsor or manufacturer to more closely manage the supply chain. Through the use of the “prove it” method of process management, implementation systems bring the physical drug unit under closer scrutiny and control. Most often, implementation systems are associated with some limits on the distribution and availability of the drug under REMS. These limits most often are seen in 1-of-4 types of distribution models:

a system that is verifiable to prove the importance of pharmacists and their role in the safe use of medications. It is likely that more REMS programs will be required for drugs currently available in the U.S. market; many will require a medication guide and some a formal communication plan. Oral drugs pose their own unique challenges for REMS, as they often are indicated for conditions that affect large patient populations. The retail pharmacist must engage in new discussions with patients that are verifiable, as defaulting to the rules of OBRA-90 and basic patient counseling are not sufficient in the world of specialty drugs requiring REMS.

and avoiding behaviors that can contribute to their occurrence will all become more commonplace. However, with all the new responsibilities mandated through REMS, costs are likely to go up throughout the supply chain as they relate to providing access to drugs under REMS. Manufacturers, payers and practitioners, to maintain wide access to medications needed by patients, must embrace new compensation models if REMS is to remain true to its intentions of providing access to drugs that have the potential to cause severe adverse events if not safely used.

concluSIon

• Open distribution (generally for oral drugs used to treat ubiquitous conditions)

• Managed distribution ( generally for drugs that are used at specific types of sites of care)

Pharmacists must embrace the role of educating patients and healthcare practitioners as an extension of the manufacturer and the REMS program governing the drug in question. If the key tenets of good risk mitigation are evoked, pharmacists should:

• Controlled distribution ( generally for drugs used by a specific type or types of physicians, and generally at the same type of site of care)

• Proactively discuss REMS requirements with patients receiving such drugs

 

• Restricted distribution ( generally for drugs that require a patient registry or those used for rather rare or rare diseases)

• Explain the use of medication guides and their application within REMS

• Note a plan of action for the patient, if severe adverse events were to occur

Table 2 includes medications currently requiring levels of risk mitigation greater than medication guide alone.

• Reinforce the need to plan ahead for proper laboratory monitoring

Implementation system

Implementation systems are the backbone of the risk surveillance system for drugs with severe adverse event profiles. An implementation system must be developed by the sponsor or manufacturer to provide the ongoing evaluation of the healthcare marketplace offering with access to a drug requiring REMS. It effectively is the plan-do-

PHaRMacISTS cRITIcal RolE

• Identify any REMS-related activities that may delay prescription fulfillment

In REMS-REla TEd Pa TIEn T Educa TIon The roles of pharmacy and the pharmacist have never been greater when considering REMS. Through the use of medication guides, ETASU and other aspects of REMS, pharmacists have been placed in a leading role related to managing risks. REMS has created

• Develop a relationship with known healthcare practitioners referring patients treated with drugs under REMS

REMS and reduction of severe adverse events are becoming central parts of the specialty pharmaceutical industry. Since the FDAAA became effective in 2008, approximately one-third of all new drug applications have required some form of REMS.³ As specialty thera-pies become more targeted and focus on modification of biologic responses, one can only assume that the prevalence of REMS will increase. The FDA has issued guidelines to define the components of REMS programs, but pharmacists should expect that each drug requiring REMS would be tailored to the unique risk fingerprint of that drug. Table 3 contains some additional FDA REMS resources to consult for more information. While many components are likely to be similar, no drug — or, for that matter, patient — will present the same risk challenges. Reduction of risk and severe adverse events is fast becoming one of the most challenging issues facing the practice of pharmacy.

Helping patients understand the importance of recognizing potentially severe adverse events, reporting them to the prescriber

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