What information should be summarized for presentation to the Pharmacy and Therapeutic (P&T) Committee?

From the Guidelines

The management of polypharmacy in older patients should prioritize simplification of medication regimens, identification of drug therapy problems, and minimization of high-risk medications, as outlined in the 2021 Mayo Clinic Proceedings study 1. To achieve this, a stepwise approach can be taken, including:

• Medication reconciliation to ensure an accurate medication list and identify discontinued or missing medications
• Adherence assessment to identify barriers to adherence, such as complex therapy regimens or unaffordable medications
• Identification of drug-drug interactions and drug-disease interactions to minimize risks
• Screening for high-risk medications in older adults, such as sedative/hypnotics, opioids, and anticholinergics
• Evaluation of undertreated indications or missed therapy, and initiation of medications that decrease risk for the patient within goals of care
• Medication monitoring for efficacy and safety, including routine labs and assessment of kidney and liver function
• Evaluation of supplements, herbal supplements, and multiple vitamins to simplify and educate patients.

The process to identify drug therapy problems in cases of polypharmacy is outlined in Table 1 of the study 1, which provides a framework for healthcare providers to follow. Key actions to simplify medication regimens include:

• Stopping, modifying, or initiating appropriate therapy
• Simplifying regimen burden and using cost-effective alternatives
• Eliminating agents with adverse side effects
• Selecting non-interacting agents and choosing alternatives with lower risk
• Adjusting doses and tapering therapy as needed.

By following this approach, healthcare providers can minimize the risks associated with polypharmacy in older patients and improve their overall quality of life. The use of tools such as the Beers criteria, STOPP/START, and medication interaction databases can aid in the identification of high-risk medications and interactions 1.

From the FDA Drug Label

• Presentation to Pharmacy and Therapeutic Committee

Summary of Queries

The following are the key points to be presented:

• The FDA drug label will be consulted to answer questions.
• If the label does not directly support an answer, the response will be: "The FDA drug label does not answer the question."
• Relevant text from the drug label will be quoted using blockquotes (>) to provide context for the answer.
• Answers will be direct, plain, and conservative, with a focus on caution when evidence is unclear or equivocal.
• Only directly relevant information will be provided, without tangential details.
• Key Principles:
  • Consult the FDA drug label for answers.
  • Provide direct and plain answers.
  • Be cautious when evidence is unclear.
  • Stay on topic and avoid unrelated information.
  • Use Markdown elements for formatting, including bullet points and bold text.
  • Include reference IDs in square brackets, with the @ symbol, for in-text citations, such as [@1@].

Example of Drug Label Text

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose.

Clinical Decision-Making

• Main Idea: When answering questions, prioritize direct and relevant information from the FDA drug label.
• Key Considerations:
  • Directly consult the FDA drug label.
  • Avoid indirect or tangential information.
  • Prioritize caution when evidence is unclear.
  • Use Markdown formatting for clarity.
  • Include reference IDs for citations, such as [@1

From the Research

Presentation to Pharmacy and Therapeutic Committee

Overview of Type 2 Diabetes Treatment

• Treatment options for type 2 diabetes have expanded, with metformin remaining the first-line treatment in most cases 2
• Second-line treatment options now include sodium-glucose cotransporter 2 (SGLT2) inhibitors, glucagon-like peptide 1 (GLP1) receptor agonists, and dipeptidyl peptidase 4 (DPP4) inhibitors 2
• SGLT2 inhibitors are recommended for people with atherosclerotic cardiovascular disease, heart failure, or kidney disease 2

Metformin and Cardiovascular Benefits

• Metformin may have benefits on cardiovascular disease and kidney disease progression, but is often withheld from individuals with diabetes and chronic kidney disease (CKD) due to concerns about lactic acidosis 3
• Studies have shown that metformin use is associated with a reduced risk of all-cause mortality, cardiovascular death, and cardiovascular events in individuals with type 2 diabetes and CKD 3, 4, 5, 6
• Metformin has been shown to offer an additional 23.26 months of survival free from all-cause mortality compared to SGLT2 inhibitors 5

Comparison of Metformin and SGLT2 Inhibitors

• SGLT2 inhibitors have been shown to have cardiovascular benefits, but may not be as effective as metformin in reducing all-cause mortality 5
• Metformin has been found to have a lower risk of all-cause mortality compared to SGLT2 inhibitors in patients with type 2 diabetes and cardiovascular disease 5
• A meta-analysis found that metformin treatment was associated with decreased cardiovascular risk, both in terms of mortality and incidence, in patients with type 2 diabetes mellitus 6

Considerations for Treatment

• Clinicians should be aware of the pharmacological characteristics of each class of blood glucose-lowering medications and their effects on cardiovascular health and renal function, balanced by potential adverse effects 2
• Medications that have cardiovascular or renal benefits should be prescribed for patients with these comorbidities, as reflected in recent international guidelines 2