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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to help older adults with cancer manage their medications during chemotherapy. One group will have a pharmacist review their medications to suggest stopping any that might not be necessary (pharmacist-led deprescribing). The other group will receive a brochure with general information about medication management. Participants aged 65 and older, who are starting chemotherapy and taking more than 10 different medications, are eligible. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group. Participants have the opportunity to contribute to early-stage cancer care advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that when pharmacists help reduce medications, it is generally safe. Studies involving older adults with cancer have demonstrated positive outcomes. For instance, one study found that 65% of patients had at least one successful medication change after three months, and 57% reduced unnecessary medications. This indicates that the process is well-tolerated and effectively manages medication use.

In another program focused on reducing opioid use, pharmacists safely and effectively helped decrease these medications. This supports the idea that pharmacists can safely adjust medications.

Overall, these findings suggest that when pharmacists assist in reducing medications, it is safe for individuals, including those with cancer, and helps eliminate unnecessary medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pharmacist-led deprescribing intervention because it introduces a unique approach to managing medications for cancer patients. Unlike the standard of care, which typically involves regular prescriptions and adjustments by doctors, this method involves pharmacists performing detailed medication reviews via telemedicine. They tailor recommendations for stopping potentially unnecessary medications, which can reduce side effects and improve overall health. Additionally, this approach emphasizes continuous follow-up, with pharmacists reaching out after the initial consultation to support adherence and monitor any new symptoms, ensuring a more personalized and attentive care experience.

What evidence suggests that this trial's treatments could be effective for older adults with polypharmacy and curable cancers?

Research has shown that pharmacist assistance can effectively help older adults with cancer reduce their medications. In one study, 65% of older cancer patients reduced their medications with a pharmacist's help. In this trial, participants in one arm will receive a pharmacist-led deprescribing intervention, where pharmacists conduct a comprehensive medication assessment and provide tailored recommendations. Another study found that this approach not only reduced unnecessary medications but also saved money. Pharmacists have successfully contributed to cancer care by lessening the medication load. This method has also proven safe and effective in other areas, such as reducing opioid use, suggesting its usefulness in many situations. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

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Pharmacist-led deprescribing interventions for cancer ...

This study underscores the benefits of pharmacist-led deprescribing in inpatient palliative care, resulting in cost savings and reduced medication burden.

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Impact of Clinical Pharmacists' Interventions on Medication ...

Deprescribing-related interventions, primarily drug therapy discontinuations, resulted in substantial direct cost savings. These findings ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1879406823005842

Decreasing polypharmacy in older adults with cancer

In our pilot study of 26 older adults with cancer referred for geriatric oncology consultation, pharmacist-led deprescribing was shown to be feasible, ...

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jpsmjournal.com

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Pharmacist-led Opioid Deprescribing Pilot Clinic within ...

Our pharmacist-led opioid deprescribing pilot program was safe and effective in the initiation of opioid tapering plans and reducing OMEs for a ...

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Recommendations to deprescribe GORD medications had a significantly lower rate of implementation (26.7%) compared to all other medications (p< ...

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Pharmacist-Led Opioid Deprescribing Is Safe, Effective

Pharmacist-led opioid deprescribing was deemed safe and effective based on results from a pilot program consisting of palliative care ...