DRUG-CONTAINING DEVICES

To recognize that use of drug-containing devices (also known as combination devices) has important clinical and safety implications for patient care; further,

To advocate that use of such devices be documented in the patient's medical record to support clinical decision-making; further,

To encourage pharmacists to participate in interprofessional efforts to evaluate and create guidance on the use of these products through the pharmacy and therapeutics committee process to ensure patient safety and promote cost-effectiveness; further,

To advocate that the Food and Drug Administration (FDA) and device manufacturers increase the transparency of the FDA approval process for drug-containing devices, including access to data used to support approval; further,

To encourage research that evaluates the clinical and safety implications of drug-containing devices to inform product development and guide clinical practice.

Rationale

As defined by the FDA, a combination product is “a product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity” or “two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products.” Examples include, but are not limited to, antibiotic-loaded bone cement (ALBC), drug-eluting catheters and stents, and hemostatic sponges and other products used for wound care. Drugs in these products have a therapeutic effect, impact overall patient care, and in some instances may result in drug interactions and adverse drug events. For these reasons, ASHP advocates for documentation of the use of these products in patients’ medical records.

Pharmacists usually are not involved in decisions about how these products will be used within the health system but often end up playing a role in the set-up, programming, maintenance, and education of patients and providers in the use of devices. In addition to patient safety concerns, other shortcomings of this approach include lost revenue because these products are frequently not accurately billed or tracked as inventory. ASHP encourages pharmacists to participate in interprofessional discussions concerning use of these products and suggested that the pharmacy and therapeutics committee may provide the ideal mechanism to conduct these evaluations.

The FDA provides recommendations for drug-device development in Guidance for Industry and Staff: Early Development Considerations for Innovative Combination Products, including a suggestion that additional preclinical or clinical studies may be needed to evaluate “the potential for change in the established or understood safety, effectiveness, and/or dosing requirements” when a previously approved drug product is incorporated into a combination device. However, these studies are recommended, not required, by the FDA, and even when these studies are completed, information from these studies is not widely available or easily accessible. Finally, it is not always apparent why a specific combination product receives a primary product assignment as a device or drug, which is important because this assignment can impact the approval pathway. ASHP advocates that the FDA and manufacturers of drug-containing devices improve the transparency of the approval process and access to information.

There is often little research concerning the interplay of drugs and devices (e.g., the rate and extent of drug release from the device) or pharmacodynamics once these devices are administered, applied, or implanted in the patient. Further, little is known about the contribution of ALBC or antibiotic beads and spacers to antimicrobial resistance. Therefore, ASHP encourages research that could inform product manufacturers during the development process and provide information to clinicians about use of these products in patient care.