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Reviewing concomitant medications for participants in oncology clinical trials
Kayla E McGahey1, Glen J Weiss2
1Cancer Treatment Centers of America at Western Regional Medical Center, Goodyear, AZ. kayla.mcgahey@ctca-hope.com.
Purpose:
The importance and key components of clinical medication reviews for participants in oncology clinical trials are described, and drug- drug interactions (DDIs) associated with new oncology drug classes are discussed.
Summary:
Use of investigational drugs is a mainstay of adult oncology clinical trials and has led to discovery of new oncology drug classes, including immunotherapy agents and oral targeted therapies, as well as novel chemotherapy delivery methods. As sponsor-supplied DDI information on investigational drugs and drug classes is typically limited and often inconsistent, a clinical medication review to assess the potential for DDIs is recommended for all patients enrolling in oncology clinical trials. A simplified approach to performing such reviews includes (1) evaluating the trial protocol for DDI risks, (2) meeting with the patient face-to-face to perform the review, (3) making medication-related recommendations based on the findings of the patient encounter, and (4) documenting review findings in the medical record. Pharmacists can create a personalized "concomitant-medication review guide" listing key medication-use information in table format to assist other clinicians in preventing and assessing DDIs during a patient's clinical trial participation.
Conclusion:
Each investigational drug and new drug class in oncology has a unique DDI profile. It is essential that patients be screened for DDI risks prior to clinical trial participation and that pharmacists and clinical investigators have clear guidelines for managing DDIs. Performing a clinical medication review is one approach to simplifying this process and ensuring patient safety.
Insights
Clinical medication reviews are crucial for oncology trial participants to prevent drug-drug interactions (DDIs). A simplified review process, including patient consultation and protocol evaluation, ensures safety when using investigational cancer drugs.
Area of Science:
- Oncology
- Clinical Pharmacology
- Drug Safety
Background:
- Investigational drugs are central to oncology clinical trials, leading to new drug classes like immunotherapies and targeted therapies.
- Information on drug-drug interactions (DDIs) for investigational oncology drugs is often limited and inconsistent.
- Managing DDIs is critical for patient safety in clinical trials.
Purpose of the Study:
- To describe the importance and components of clinical medication reviews for oncology trial participants.
- To discuss DDIs associated with new oncology drug classes.
- To recommend a systematic approach for managing DDIs in this population.
Main Methods:
- A simplified clinical medication review process is proposed.
- Key steps include evaluating trial protocols for DDI risks.
- Face-to-face patient encounters are essential for comprehensive review and recommendations.
- Documentation of findings in the medical record is critical.
Main Results:
- A structured approach can simplify the assessment and prevention of DDIs.
- Pharmacists can develop personalized guides to aid clinicians in managing DDIs.
- This process aids in identifying and mitigating potential risks associated with concomitant medications.
Conclusions:
- Clinical medication reviews are essential for all patients in oncology clinical trials.
- A proactive approach to screening and managing DDIs is vital.
- Pharmacists play a key role in ensuring patient safety through medication reviews and DDI management.