Final answer:
Retrospective drug regimen reviews for a class D pharmacy with an expanded formulary should be conducted regularly, and while specific frequencies can vary, quarterly reviews are a common best practice guideline. This is a crucial part of pharmacovigilance, which ensures long-term safety and effectiveness of medications monitored by healthcare providers and the FDA.
Step-by-step explanation:
If a class D pharmacy has an expanded formulary, the frequency of retrospective drug regimen reviews can vary based on specific state regulations and the policies of the pharmacy itself. However, in the interest of patient safety and in alignment with pharmacovigilance practices, these reviews should be conducted regularly. Pharmacovigilance systems are crucial as they continue to evaluate the long-term safety and effects of drugs on different subgroups of patients, especially after the drug has been released to a wider patient population post-approval. Additionally, the Food and Drug Administration (FDA) regulates the medicines that pharmacies can sell, and as part of the postmarketing risk management, may require phase IV clinical trials or other surveillance activities.
Regarding the retrospective drug regimen review specifically, best practice guidelines suggest that these reviews should be performed at least quarterly or more frequently if warranted by the clinical situation or as required by state regulations. The integration of direct patient care into pharmacy practices, as well as the expanded formularies, both necessitate diligent monitoring to ensure appropriate use, prevent medication errors, and to contribute to overall healthcare effectiveness and safety.