Pharmacist-Led Medication Review for Cancer

Overseen By Lauren Mitchell

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Rochester

Disqualifiers: Targeted therapies, Hormonal therapies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-site cluster-randomized trial to assess efficacy and implementation outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP) and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll 6 patients each and will be randomized to either a pharmacist-led deprescribing intervention or patient education intervention. Initial focus groups with oncologists, nurses, pharmacists, primary care physicians, and patients will provide data for initial adaptations to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial cohort to further refine and adapt the pharmacist-led intervention.

Will I have to stop taking my current medications?

The trial involves a pharmacist-led review to potentially reduce the number of medications you take, especially if you are on more than 10 medications or some are considered inappropriate. It doesn't specify if you must stop all current medications, but changes might be recommended.

What data supports the effectiveness of pharmacist-led medication review and deprescribing for cancer patients?

Research shows that deprescribing, which involves stopping unnecessary medications, can improve the quality of life for cancer patients by reducing side effects and healthcare costs. Additionally, a collaborative approach between pharmacists and doctors has been shown to reduce inappropriate medication use in patients with multiple conditions. ^{1 2 3 4 5}

Is pharmacist-led medication review for cancer safe?

Pharmacist-led medication reviews, including interventions to address drug-related problems and deprescribing, have been shown to improve medication safety by resolving adverse reactions and reducing drug interactions. These reviews are generally safe and well-accepted by patients and healthcare professionals. ^{1 2 6 7 8}

How is pharmacist-led deprescribing different from other treatments for cancer?

Pharmacist-led deprescribing is unique because it involves a pharmacist reviewing and discontinuing medications that are no longer necessary or potentially harmful for cancer patients, focusing on improving quality of life and reducing side effects. This approach is patient-centered and considers the individual's overall health and treatment goals, unlike standard treatments that may not address the complexities of multiple medications. ^{1 2 3 4 9}

Eligibility Criteria

This trial is for adults aged 65 or older with certain types of curable cancers (like aggressive lymphoma, breast, colon, pancreas, or lung cancer) who are starting chemotherapy and take more than 10 medications. They must be able to read/write English and give consent. Excluded are those planning surgery/radiation within 3 months or referred to a specific clinic soon.

Inclusion Criteria

Be able to read and write English

I am 65 years old or older.

I can make my own medical decisions or have someone legally appointed to do so.

Exclusion Criteria

I cannot make decisions for myself and do not have someone to do this for me.

I will visit a senior cancer care clinic within a month of starting treatment.

My cancer treatment plan does not include traditional chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-pilot

A pre-pilot cohort of 8 patients undergoes a pharmacist-led deprescribing intervention with iterative adaptations

Not specified

Treatment

Participants receive either a pharmacist-led deprescribing intervention or a patient education intervention during chemotherapy

12 weeks

Follow-up

Participants are monitored for changes in functional status, chemotherapy toxicity, and other outcomes

12 weeks

Implementation Follow-up

Barriers and facilitators of the intervention are assessed

2 years

Treatment Details

Interventions

• Patient education
• Pharmacist-led deprescribing

Trial Overview The study compares two approaches: one where pharmacists help reduce the number of medicines patients take ('deprescribing'), and another focused on educating patients about their medications. Oncologists will randomly assign patients to either group to see which method is more effective during chemotherapy.

Participant Groups

Group I: Arm 1: Pharmacist-led deprescribing intervention Experimental Treatment 1 Intervention

Pharmacists will complete a comprehensive medication assessment with the participant via telemedicine and discuss tailored recommendations for discontinuations of potentially inappropriate medications. The pharmacist will document the evaluation and recommendations and communicate to the participant and care team members. The pharmacist will telephone each participant at least one time after the initial intervention to assess adherence to instructions and recommendations, and to assess any symptoms potentially related to medication discontinuation.

Group II: Arm 2: Patient education brochure Active Control 1 Intervention

Participants will receive a brochure discussing medication appropriateness and deprescribing in general terms

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a pilot study involving 96 patients with cancer and chronic conditions, 57% received a comprehensive medication review (CMR) by a primary care pharmacist, demonstrating the feasibility of this intervention.

The CMR identified medication-related problems in 27% of patients and led to 40% being referred for further care, indicating that such reviews can improve patient management and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a comprehensive medication review to improve medication use for patients with cancer and comorbid conditions. Mackler, ER., Azar, MK., Johengen, E., et al.[2023]

In a 6-month study involving 33 oncology pharmacists in Alberta, Canada, a total of 3,474 prescriptions were made, with a median of 7 medications prescribed per month, highlighting the significant role of pharmacists in managing cancer patient care.

The most commonly prescribed medications were antiemetics (24.1%), and half of the prescriptions were for new medications, indicating that oncology pharmacists are actively involved in initiating and managing supportive care treatments for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribing practices of oncology pharmacists working in ambulatory cancer centers in Alberta. Hynes, K., Folkman, F., Dersch-Mills, D., et al.[2023]

Deprescribing, the process of stopping unnecessary medications, can significantly improve the quality of life for patients with incurable cancers by reducing the risks of adverse drug events and healthcare costs.

This approach not only addresses the challenges of polypharmacy in cancer patients but also aligns treatment with patients' values and goals, facilitating important discussions about advance care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deprescribing: A Prime Opportunity to Optimize Care of Cancer Patients. Chaput, G., Bhanabhai, H.[2023]

Deprescribing in oncology is a patient-centered approach that effectively reduces the use of potentially inappropriate medications (PIMs), which can range from 41% to 52% in older cancer patients, thereby improving their quality of life.

The study introduces an integrative algorithm for deprescribing that considers patient goals, life expectancy, and medication appropriateness, aiming to minimize polypharmacy and its associated risks, such as drug interactions and adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationalizing prescription via deprescribing in oncology practice. Raju, B., Chaudhary, RK., L, A., et al.[2023]

Patients with multiple myeloma in a collaborative physician-pharmacist clinic took fewer total medications on average (7) compared to those in a traditional physician-managed clinic (9), indicating a potential benefit of pharmacist involvement in medication management.

The collaborative clinic not only reduced the overall number of medications but also significantly lowered the rate of polypharmacy related to non-myeloma medications, which can help minimize the risk of adverse drug interactions and improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polypharmacy and potentially inappropriate medication use is highly prevalent in multiple myeloma patients and is improved by a collaborative physician-pharmacist clinic. Sweiss, K., Calip, GS., Wirth, S., et al.[2022]

A study involving 215 neoplasm patients over two years showed that a pharmacists-managed outpatient clinic effectively identified and resolved drug-related problems (DRPs), with 82.6% of issues confirmed as resolved after pharmacist interventions.

Pharmacists played a crucial role in improving patient care, as 90.3% of their planned interventions were accepted by patients or physicians, highlighting their importance in managing medication therapy for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of Pharmacists-Managed Oncology Outpatient Clinic on Resolving Drug-Related Problems in Ambulatory Neoplasm Patients: A Prospective Study in China. Zhao, X., Xu, R., Wang, Y., et al.[2021]

A follow-up program involving pharmacists for outpatients treated with oral antineoplastic agents (OAA) showed a reduction in severe adverse events (AEs) and major drug interactions compared to patients who were not monitored, indicating improved safety in the intervention group.

The study included 249 patients over a 6-month period, revealing that while AEs were still common, the intervention group experienced fewer severe AEs and had better monitoring of drug interactions, particularly with medications like erlotinib and gefitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents. Escudero-Vilaplana, V., Ribed, A., Romero-Jimenez, RM., et al.[2018]

Pharmacist-led deprescribing in primary care settings was found to be acceptable to both patients and healthcare professionals, indicating a positive reception for this approach.

The intervention successfully reduced the number of medications that were considered to pose more risk than benefit, highlighting its potential efficacy in improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of pharmacist-led deprescribing in collaborative primary care settings. Trenaman, SC., Kennie-Kaulbach, N., d'Entremont-MacVicar, E., et al.[2022]

Most cancer patients are over 65 and often have multiple chronic conditions, which complicates their care and can change their treatment goals.

Regularly reviewing and adjusting medication regimens for these patients is crucial to minimize risks like adverse drug reactions and drug interactions, ensuring that treatments provide more benefits than harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising Medications for Patients With Cancer and Multimorbidity: The Case for Deprescribing. Turner, JP., Kantilal, K., Kantilal, K., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of a comprehensive medication review to improve medication use for patients with cancer and comorbid conditions. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Prescribing practices of oncology pharmacists working in ambulatory cancer centers in Alberta. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Deprescribing: A Prime Opportunity to Optimize Care of Cancer Patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Rationalizing prescription via deprescribing in oncology practice. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Polypharmacy and potentially inappropriate medication use is highly prevalent in multiple myeloma patients and is improved by a collaborative physician-pharmacist clinic. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Impacts of Pharmacists-Managed Oncology Outpatient Clinic on Resolving Drug-Related Problems in Ambulatory Neoplasm Patients: A Prospective Study in China. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of pharmacist-led deprescribing in collaborative primary care settings. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Optimising Medications for Patients With Cancer and Multimorbidity: The Case for Deprescribing. [2021]