By: Vasantha Kolluri, PharmD Candidate c/o 2019
With the recent advancement of oral oncology drugs, there has been an ever-growing need for specialty pharmacy services. Although these oral agents allow for patients to receive therapy at home, clinical outcomes heavily depend upon patient adherence and management. Specialty pharmacy is a niche area of pharmacy practice that has recently received major attention in the healthcare system. It strives to achieve high quality clinical services by utilizing value-based patient care and patient-centered management.
An online survey conducted by North Star Opinion Research of 400 physicians with specialties in oncology, infectious diseases, hematology, and other fields who prescribe specialty medications to their patients, showed high levels of satisfaction with specialty pharmacies. Physicians commented that specialty pharmacies have the expertise to provide a range of clinical services for patient care management. Approximately thirty-eight percent of oncology patients receive their specialty medications from specialty pharmacies.1 Specialty pharmacy teams are expanding their role by creating patient focused care plans, providing patient education, increasing accessibility and affordability of oral oncology drugs, and monitoring for patient safety. They have ongoing training to ensure their staff adheres to patient care protocols and provide remediation training when necessary. They also have to meet the terms and conditions of payers in order to be included in their preferred network.2
Specialty pharmacies build relationships with physicians and their staff through consultations regarding drug-specific patient care. The operations of specialty pharmacies set a benchmark for the highest degree of quality for patients and healthcare providers. Clinical outcomes are measured on a patient-to-patient basis through patient care programs. In the oncology specialty, patient outcomes can be improved by utilizing pharmacy services as listed in Table 1.3
|Table 1: Oncology specialty pharmacy strategies to improve patient outcomes|
|Patient-specific drug utilization strategy to optimize drug therapy and cost for the patient|
|High standards of storage, shipping and handling services to ensure the drug product is delivered in optimal conditions to the appropriate patient|
|Care coordination between healthcare providers, infusion services, and skilled nursing services|
|Patient counseling that focuses on patients as a whole and addressing their concerns|
|Cancer education and oncology drug information for patients|
|Pharmacist to physician consultations to address patients’ gaps in care, side effects, safety and adherence to drug regimens|
|Medication review and record keeping that is critical during transitions of care|
Patient education is a huge component of the specialty pharmacy team’s expanded role in patient care. Medication adherence and adverse event management can be challenging for cancer patients. Non-adherence directly results in poor outcomes and higher total healthcare costs.3 These patients go through rigorous treatments that may involve surgery, chemotherapy, radiation, and adjuvant medication therapy. The costs and side effects of the specialty drugs, drug-drug interactions, co-morbid conditions, moderate to severe pain, socioeconomic status, cultural barriers, and lack of support and knowledge can contribute to non-adherence.4 Specialty pharmacies have come up with different drug adherence strategies as a part of patient care management like screening for side effects, assessing for drug administration difficulties through monthly evaluations, and reminder calls. Patient-centered care management programs lower the risk of cancer relapse and progression of disease as pharmacists monitor patient adherence as a component of the program.4
During my advanced community patient care rotation in the summer of 2018 at a Walgreens community pharmacy in Florida, under the guidance of Randy Mehlhop, RPh, Pharmacy Manager, I learned how specialty pharmacists actively identify at-risk patients who are non-adherent and engage them in care planning and goal setting. They notify the prescribers of patients who are having trouble adhering to therapy. They provide personalized intervention by performing a complete medication review to identify the root cause of non-adherence and provide recommendations to patients and their providers. If necessary, specialty pharmacists are also able to look at lab data and adjust medication therapy. Specialty pharmacies establish home deliveries with tracking ability to ensure patients who have transportation barriers can still get their therapy and that there are no delays in treatment.
Making sure patients receive their medications on time each month is one of the top priorities for specialty pharmacies. With costs in the tens of thousands at times, new medications can be overwhelming for patients who are newly diagnosed with cancer, especially when they discover that they cannot afford drug therapy. In an already difficult time, this can add much stress and anxiety to the patient and their loved ones. Specialty pharmacies have expanded their role in breaking down financial barriers by utilizing specialists to obtain methods of payment for patients. Navigating through insurances and getting financial assistance by themselves can be overwhelming to patients so they usually depend on pharmacy staff and their caregivers to get access to medications. Specialty pharmacy teams have extensive experience in expediting prior authorizations from prescribers, and third-party payers, since they are aware of all the requirements to successfully obtain approvals. As a result, they reduce the time between diagnosis and medication initiation, which offers excellent patient and provider satisfaction. Specialty pharmacists work with manufacturers, third party financial programs, private non-profit foundations, and co-pay assistance programs to personalize the financial assistance of each patient through copay cards and coupons. They also obtain consent and enroll eligible patients into patient assistance programs from a range of sources. Specialty pharmacies that help lower out of pocket costs have substantial effects on patient fill and adherence rates.
The pharmacist-patient care process uses principles of evidence-based practice. Specialty pharmacists are the epitome of this dynamic pharmacy service. Patients are assessed upon initiation of therapy and asked a series of questions regarding their medication. Pharmacists then collect patient information and information regarding history of medication use including prescription medications, non-prescription medications, herbal products, vitamins and supplements. They then assess the clinical outcomes of each patient by evaluating medication appropriateness, efficacy, and safety. Drug safety depends on several factors and is unique to each cancer patient which makes it imperative to assess adverse events regularly. In order to maintain a continuous care process, monitoring cancer patients at regular intervals once they are initiated on oncology drugs is necessary.5 Specialty pharmacists document adverse events when encountered and notify providers. In most cases, specialty pharmacies collaborate with drug manufacturers and are obligated to report drug-specific adverse events. They play an integral role in post-marketing surveillance programs for an increasing number of specialty drugs approved for new indications. One such program is the Risk Evaluation and Mitigation Strategies (REMS) program which is a United States Food and Drug Administration drug safety program that is required for certain medications with serious adverse event concerns. The REMS program protects patients who may benefit from therapy which poses risks of adverse events. Specialty pharmacists are trained to triage patients who present with previously undiscovered adverse events and notify prescribers and manufacturers. They also follow up and re-assess those patients proactively. As a result, patient satisfaction and healthcare outcomes are improved, and hospitalization costs are reduced.6
With specialty pharmacy’s expanding role, there is a greater demand for specialty pharmacy-specific accreditation. One of the accreditations specialty pharmacies can obtain is from the Utilization Review Accreditation Commission (URAC). URAC was originally founded in 1990 as an independent non-profit third-party healthcare quality validator. The goal of URAC accreditation is to advocate for the highest standards of practice in the pharmacy profession. This includes providing high quality and value, continuous quality improvement, and safeguarding patient health.7 Although there are many ways to provide high quality care to patients and advance specialty pharmacy practice, the URAC accreditation process is likely the most important step. Specialty pharmacy accreditation is being recognized by payers and pharmaceutical manufacturers as a major validation factor. Many times, payers and manufacturers look at URAC accreditation before they do business with specialty pharmacies. URAC accreditation provides clinical oversight while complementing national professional standards of care, which interests providers. It provides competitive advantage with operational efficiency and reduced liability, which is acknowledged by insurance companies. URAC accreditation also offers great value to other stakeholders, including regulators and legislators, because it allows specialty pharmacies to keep up with changes in healthcare, provides transparency and accountability, and reflects the best practices due to impartial evaluation. The validation of specialty pharmacy clinical services is critical because they serve patients with complex chronic diseases where outcomes are of the utmost importance. A URAC accredited specialty pharmacy has the proper policy and procedures to make sure patients have access to specialty medications and adheres to drug safety protocols. A patient who gets their medications at a specialty pharmacy can be assured of ongoing procedures for quality management, maintenance, and reporting. URAC accredited specialty pharmacies meet specific performance standards for timeliness and accuracy of dispensing medications and providing customer service.2,8
Specialty pharmacies have become a crucial part of the therapeutic management of patients receiving oral oncology drugs. The role the specialty pharmacy team plays is expanding and includes complete patient-centered care which involves building a rapport with patients and physicians, breaking down financial barriers, and becoming URAC accredited for continuous quality improvement. This all leads to great strides towards the ultimate end goal – increasing patient care and improving patient outcomes.
- North Star Opinion Research. Key findings from the survey of New York physicians regarding specialty medications. Pharmaceutical Care Management Association. Published on 05/18/2015. Accessed on 12/14/2018.
- Anderson J. The importance of accreditation for specialty pharmacy organizations. Pharmaceutical Commerce. Published 04/30/2014. Accessed on 12/14/2018.
- PBM specialty pharmacies improve patient outcomes and reduce costs. Pharmaceutical Care Management Association. Published 04/2017. Accessed on 12/14/2018.
- Powers J. The role of the pharmacist as part of a multidisciplinary cancer care team. Specialty Pharmacy Times. Published 05/15/2018. Accessed on 12/14/2018.
- Joint Commission of Pharmacy Practitioners. Pharmacists’ patient care process. Published 05/29/2014. Accessed on 12/14/2018.
- Cast K.G and Berger A. Maintaining compliance in the global pharmacovigilance landscape. Specialty Pharmacy Times. Published 10/09/2013. Accessed on 12/14/2018.
- Pharmacy quality management programs: specialty pharmacy accreditation. URAC. Accessed on 12/14/2018.
- Davis LE and Jessee Q. Competitive advantages of accreditation. Specialty Pharmacy Times. Published 12/05/2011. Accessed on 12/14/2018.