Final answer:
The prescriptions of pharmaceutical agents require detailed information ranging from drug name and strength to safety instructions and refill policies. The FDA ensures the safety and efficacy of these drugs through strict regulations and approvals.
Step-by-step explanation:
When prescribing pharmaceutical agents, especially new prescription drugs, there is a comprehensive set of requirements that must be met, which often includes clinical trials and regulatory approvals. The detailed explanation of these requirements would depend on whether the drug is categorized as a new drug, a generic drug, or an over-the-counter drug. As per the Center for Drug Evaluation and Research, a drug is considered new if it involves a new manufacturer, different inactive ingredients, a new purpose, or any substantial change. Here are the general items required for prescription of pharmaceutical agents:
- A clear indication of the drug name and strength
- Dosage form and dosage instructions
- Quantity to be dispensed
- Route of administration
- Duration of therapy
- Specific instructions for use
- Refill information
- Prescriber’s signature
- Patient’s name and address
- Date of prescription
- Warnings and precautions for the drug
- Possible side effects and interactions
- Storage instructions
The Food and Drug Administration (FDA) also plays a crucial role in ensuring safety and efficacy by regulating medicines through a rigorous process before they are allowed on the market. Drugs categorized under pain relievers, cold and allergy medicines, treatments for infectious diseases, cancer chemotherapy agents, hormone regulators, cardiac drugs, psychiatric drugs, and their impact on society are all scrutinized for their safety and therapeutic effectiveness.