Consistent attention to processes is vital to the practice of specialty pharmacy, with medication safety procedures playing a key role in the mitigation and reduction of adverse events.
Numerous studies have documented the significant clinical and economic consequences related to adverse effects of medication administration. The prevention of adverse events (AEs) remains a significant challenge to the health care system. Medication safety is of major concern to specialty pharmacy as well. In fact, patients using specialty pharmaceuticals may be at increased risk of AEs due to a diverse set of factors, which may include but are not limited to polypharmacy, immune system suppression, use of multiple physicians, and concomitant illnesses.
The specialty pharmacy care team plays a key role in the prevention of adverse drug reactions and in contributing to successful treatment outcomes through vigilant monitoring, reporting, and communication with other health care professionals on the patient care team.
Medication Safety Processes
Specialty pharmacies adopt a range of strategies designed to assure the safety of drug treatment regimens and apply these consistently in patient care. For all new patients referred to a specialty pharmacy for drug therapy, specialty pharmacists will obtain a full patient health history and a medication history with particular attention to medication allergies and sensitivities, and assess for potential drug—drug interactions that will affect treatment. This is especially a concern for patients seeing multiple physicians. It is not uncommon for physicians to have incomplete or inaccurate medication records and consequently prescribe medication treatments with issues that will require attention before therapy is initiated. In the event that therapy issues are identified, specialty pharmacists routinely consult with prescribing physicians, provide therapy recommendations, and collaboratively work to adjust medication therapy to result in a safer regimen.
Two real-life case examples from our pharmacy’s medication event reporting files will help to illustrate ways in which Aurora specialty pharmacists, working within an integrated health care system, have used established medication safety procedures to reduce the possibility of AEs and contributed to successful treatment outcomes for patients.
Case #1: Oral Oncologic Medication Interactions
A new patient was referred to the pharmacy for treatment with an oral oncologic agent for treatment of renal cell carcinoma. Review of the patient’s full medication profile and concomitant illnesses revealed that the patient was also being treated with an antidepressant that had the potential to interact with the oncologic agent and result in prolongation of the patient’s QT interval. Knowing that the oncologic therapy had the potential to induce cardiac arrhythmia, a prolonged QT interval could result in treatment discontinuation and ultimately in treatment failure. In this case, the pharmacist consulted the patient’s primary physician and obtained approval for an alternative and safer antidepressant.
Case #2: Hepatitis C Regimen Dosage Adjustment
The pharmacy received a new referral for a patient to be treated with antivirals for hepatitis C virus (HCV). Upon assessment and initial counseling of the patient, the pharmacist learned that the patient had markedly reduced renal function. The antiviral regimen prescribed for the patient was inappropriately dosed based on the patient’s renal status. Incorrectly dosed antiviral therapy has a high potential for significant AEs and, therefore, for potentially reduced treatment efficacy. Consultation with the prescribing physician resulted in a more appropriately dosed regimen. It should also be noted that although emerging treatment regimens for HCV require weight-based dosing, these regimens also may require adjustment for renal status.
An underappreciated way in which specialty pharmacists are expected to contribute to greater overall understanding of medication safety is by reporting AEs via the FDA’s MedWatch reporting system. Reporting can be done via the FDA’s online application or by submission of a written report to the agency. While reporting through the MedWatch system is considered voluntary, the FDA uses the data obtained for routine drug safety surveillance and communicates important new data to health care professionals. Since most specialty drugs are used by relatively small populations, reporting is a crucial way for new safety information to be made more widely known to the medical community.
It is also important to recognize how accreditors such as URAC hold specialty pharmacy accountable for the safety of the medication process through establishment of several safety and quality standards. Consistent attention to processes is an element of pharmacy practice that distinguishes a specialty pharmacy from other pharmacies, and this is made evident in accreditation standards that address drug intake, processing, and dispensing. Additionally, all specialty pharmacies will be expected by accreditors to develop, implement, and measure quality activities designed to address and improve the medication safety process. Accredited pharmacies will usually conduct 1 or more quality improvement projects that focus specifically on medication safety issues.
Specialty pharmacists may wish to investigate and utilize some of the tools developed by the Agency for Healthcare Research and Quality (AHRQ) to assess their pharmacy’s medication safety processes and use the data obtained to implement meaningful improvements. Aurora Specialty Pharmacy uses the AHRQ Pharmacy Survey on Patient Safety Culture to engage all staff members in the medication safety process and to help identify areas in need of improvement. It should be noted that the AHRQ tools aren’t specific to specialty pharmacy—medication safety processes in all pharmacy practices can benefit from implementation of AHRQ tools.
An Integrated Approach
As discussed here, all specialty pharmacies have a responsibility to monitor and follow through on issues affecting the safety of medications dispensed to their patients. Aurora Specialty Pharmacy, working as part of an integrated health care system, is uniquely positioned to deliver on the promise of clinical outcomes while reducing the impact of AEs for patients using specialty drugs. A key advantage of the integrated system approach to specialty practice is the extensive availability of clinical data and a seamless health care provider communication channel through use of the systemwide electronic medical records. Leveraging the accessibility of clinical data and the ability to exchange information with physicians in a preferred and secure format allows for efficiencies not typically available to other pharmacies.
Strict attention to reducing adverse outcomes and improving medication safety efforts is a necessary focus for specialty pharmacies. With the ever-increasing cost of drug therapies and the degree to which all stakeholders expect value from specialty medications, attention to safety-related quality improvement activities will remain an area in which specialty pharmacists will demonstrate their importance to the health care system. SPT
About the Author
Jim Motz, RPh, is the specialty pharmacy program manager for Aurora Health Care in Milwaukee. Aurora is an integrated health system and operates an Accountable Care Organization in Wisconsin.