Key Clinical and Operational Considerations in Practice-Based Dispensing of PARP Inhibitors and Other Oral Oncology Agents

Web Exclusives - Ovarian Cancer

A Discussion with Matthew Schulz, PharmD

Patient-centered standards adopted by the National Community Oncology Dispensing Association (NCODA) and endorsed by the American Society of Clinical Oncology have been shown to improve the quality and safety of oral oncology drugs, including poly (ADP-ribose) polymerase (PARP) inhibitors, in the medically integrated dispensing (MID) pharmacy setting.

MID is an alternative dispensing model wherein patients’ prescriptions are processed and dispensed through a pharmacy located within the oncology clinic. NCODA has established patient-centered standards for the MID delivery model, including standards for patient relationships and education, adherence, safety, collection of data, and documentation. The level of care and the amount of multidisciplinary communication that must occur for patients with cancer, many of whom experience treatment-related side effects requiring dose modifications, is difficult to deliver outside of an MID model, according to Matthew Schulz, PharmD, Manager, Clinical Initiatives, NCODA. Patient care is often disjointed when prescriptions must be filled by insurance-mandated pharmacies.

The patient with cancer “requires a very high-touch environment that can only be best handled and accommodated by an MID model,” Dr Schulz said. “When a prescription does have to go outside, these patients often fall through the cracks when it comes to prior authorization, financial assistance, education, follow-up, and monitoring.”

In terms of patient monitoring, “I’ve found that patients with ovarian cancer will get through those first 6 cycles of chemotherapy, at which point there seems to be a fairly wide gap in both knowledge and practice,” Dr Schulz said. “A team effort is required to ensure that patients remain adherent to treatment, and any care team member—schedulers, technicians, nurses, pharmacists, advanced practice providers, and physicians—may play a pivotal role at any given point in time. At NCODA, Positive Quality Interventions [PQIs] are one of our foundational resources. The intervention allows for an overlapping safety system to ensure that nothing is overlooked.”

Dr Schulz recommends creating reminders in the electronic medical record to review the records of all patients with ovarian cancer, including time to response, whether they have undergone genetic testing, and appropriate timing for initiation of maintenance treatment. Genetic counseling should also be a mainstay of ovarian cancer management. “It helps us to tailor our treatments to the most effective ones,” he said.

The Oncology Pharmacist’s Role

A huge role for the pharmacist is to ensure adequate dosing of PARP inhibitor therapy, said Dr Schulz. With niraparib (Zejula; GlaxoSmithKline), for instance, a subset of patients can reap the benefit of enhanced tolerability without compromising effectiveness if the starting dose is lowered from 300 mg to 200 mg. NCODA has built a PQI specific to PARP inhibitor eligibility to help guide medically integrated pharmacy teams to deliver quality care to patients with ovarian cancer.1 The PQI is available online at www.ncoda.org/wp-content/uploads/2019/11/NCODA-PQI-in-Action-PARP-I-Ovarian-copy.pdf.

In the setting of PARP inhibitor therapy for ovarian cancer, within the MID model, the oncology pharmacist plays a key role in educating the patient about their treatment journey, from chemotherapy to targeted therapy, evolving to PARP inhibitor maintenance therapy, said Dr Schulz.

When therapy is initiated, providers typically consult with patients regarding their treatment plan. This consultation is followed by a visit from a nurse provider or advanced practice provider dedicated solely to education on the drug therapy.

“The third education comes from the pharmacy team that’s dispensing the drug, hitting the key points, and reinforcing the principles explained by the other disciplines,” Dr Schulz said. “A fourth opportunity exists in providing materials for the patient to read over themselves, be it a starter kit, Oral Chemotherapy Education [OCE] sheets,2 or other informational materials. The frequency and quality of that education is the key.”

A key component of patient education is routine follow-up soon after educational resources have been distributed and treatment has been initiated. Follow-up for all oral oncolytics should be standard of care; this is already in place for intravenous therapy because patients return weekly or every other week for treatment.

“In the oral world, you may not hear from the patient for months if you’re not doing your due diligence,” said Dr Schulz. “I challenge individuals out there to do more for their patients and cater to their needs throughout the process. It’s really those first few cycles that are so critical to success.”

The oncology pharmacist’s role in ensuring adherence goes beyond counseling patients on how to take their medications, providing instructions on proper drug storage, and explaining what to do about missed doses. Patients must also be informed about anticipated side effects, how to prevent them, how to manage them if they occur, and what factors would trigger a call to the oncology office or a visit to urgent care, he said.

“Sophistication is demonstrated when the patient experience is brought back to the provider to further tailor the care and individualize it to make sure that patients are being offered the right dose, and that they’re being given the right instructions for dealing with their side effects…just high-level care,” Dr Schulz said.

Supporting Adherence

An MID model that incorporates elements to which Dr Schulz referred is key to containing costs and improving outcomes, as evidenced by a systematic review on patient-centered best practices for the delivery of oral anticancer and supportive care drugs.

For instance, in one study, adherence to laboratory parameter monitoring, which is used for early identification and management of adverse effects, improved significantly after intervention with a pharmacist-led oral anticancer drug monitoring program.3

In a separate multi-institution case-control study, investigators reported a significant improvement in daily adherence to oral anticancer therapy when patients received an initial educational session with a pharmacist and ongoing counseling.4

Improved adherence rates were also reported in a program in which patients were contacted by pharmacists and nurses on days 10 and 20 during the first month of oral anticancer therapy, and monthly thereafter.5

In addition, a case-control study found that pharmacist-led education on adverse events and ongoing adherence counseling resulted in increased detection of drug-related errors and an improvement in adherence, as determined by a medication possession ratio >90%.6

PARP Inhibitors: Dispensing Considerations

Insurance mandates requiring that drugs be dispensed through mail-order pharmacy are a limiting factor to practice-based dispensing of PARP inhibitors, said Dr Schulz. “When the insurance doesn’t allow the patient to pick up their prescription at the oncologist’s office, opportunities for intervention are limited,” he said.

Often, practice-based dispensing of PARP inhibitors is discouraged by insurers in favor of mail-order pharmacies, making it more difficult for providers to educate and follow the patient appropriately.

“I would suggest and advocate that patients call in and try and reason with their plan as to why they want to receive care at their oncologist’s office…why they think that is a superior way to be treated. The patients are going to have far more success than the pharmacies or the providers in that argument,” Dr Schulz stated.

Another barrier to practice-based dispensing is identifying appropriate patients with ovarian cancer for PARP inhibition. According to Dr Schulz, many patients who could benefit from PARP inhibitor maintenance therapy, as identified through genetic testing, are not being offered it.

The PQI process calls for identifying and tracking all patients with ovarian cancer by using the electronic medical record, as Dr Schulz stated, and determining the patient’s BRCA status. PARP inhibitors should be considered as maintenance therapy for patients with relapsed platinum-sensitive ovarian cancer following partial or complete response to platinum-based chemotherapy and as first-line or maintenance therapy in patients with BRCA-associated advanced ovarian cancer.7

References

  1. National Community Oncology Dispensing Association. NCODA’s positive quality intervention in action: multidisciplinary management of advanced ovarian cancer patients within medically integrated pharmacy practices. www.ncoda.org/wp-content/uploads/2019/11/NCODA-PQI-in-Action-PARP-I-Ovarian-copy.pdf. Accessed February 28, 2020.
  2. National Community Oncology Dispensing Association. Oral chemotherapy education sheets. www.oralchemoedsheets.com. Accessed February 28, 2020.
  3. Patel JM, Holle LM, Clement JM, et al. Impact of a pharmacist-led oral chemotherapy-monitoring program in patients with metastatic castrate-resistant prostate cancer. J Oncol Pharm Pract. 2016;22:777-783.
  4. Simons S, Ringsdorf S, Braun M, et al. Enhancing adherence to capecitabine chemotherapy by means of multidisciplinary pharmaceutical care. Support Care Cancer. 2011;19:1009-1018.
  5. Khandelwal N, Duncan I, Ahmed T, et al. Oral chemotherapy program improves adherence and reduces medication wastage and hospital admissions. J Natl Compr Canc Netw. 2012;10:618-625.
  6. Ribed A, Romero-Jiménez RM, Escudero-Vilaplana V, et al. Pharmaceutical care program for onco-hematologic outpatients: safety, efficiency and patient satisfaction. Int J Clin Pharm. 2016;38:280-288.
  7. Fraga M. Ovarian cancer: PARP inhibitor eligibility. Updated November 9, 2019. www.ncoda.org/ovarian-cancer-parp-inhibitor-eligibility/. Accessed February 26, 2020.
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Last modified: April 27, 2020