Which program requires additional precautions to ensure drug safety?

Risk Evaluation and Mitigation Strategies (REMS) is a specific program designed to ensure that the benefits of certain medications outweigh their risks. This program is implemented when the FDA determines that additional measures are necessary to manage potential risks associated with a drug, particularly those drugs that have serious safety concerns.

REMS may include requirements such as restricted distribution, mandatory patient education, monitoring programs, and specific prescriber qualifications. The goals of REMS are to provide a strategy to mitigate risks while still allowing patients access to potentially life-saving therapies. By requiring these additional precautions, REMS helps ensure that prescribers and patients remain aware of the potential dangers related to certain medications, thereby enhancing overall drug safety.

The other choices represent important aspects of pharmaceutical regulations and safety, but they do not specifically require the tailored, risk-based approach that REMS embodies. For instance, the FDA approval process is focused on evaluating a drug's efficacy and safety before it can enter the market, while the Pharmacy Quality Assurance Program oversees operational standards in pharmacies. The DEA regulations primarily govern the handling of controlled substances to prevent misuse and abuse. However, they do not specifically indicate a structured risk management strategy like REMS.