Final answer:
The Negative Formulary list includes drugs that cannot be substituted with generics due to potential differences in therapeutic effects. The FDA's ANDA process ensures generic drugs are equivalent to brand names. However, historical scandals have shown the importance of strict regulation and oversight in drug approval and substitution.
Step-by-step explanation:
Drugs on the Negative Formulary list are those that cannot be substituted with a generic equivalent if a brand name is prescribed. The concept here relates to generic drugs, which are chemical equivalents of brand-name drugs with expired patents. Generic drugs are typically less expensive and manufactured by different companies. The U.S. Food and Drug Administration (FDA) must verify that a generic drug is interchangeable with or therapeutically equivalent to the brand-name drug through an ANDA (Abbreviated New Drug Application). However, in the late 1980s, a generic drug scandal unfolded, revealing corruption in the FDA's approval process for generic drugs. This led to investigations, suspensions, and recalls of certain generic drugs after it was found that some manufacturers had submitted falsified data in their FDA applications.
When it comes to specific medications like opium, heroin, fentanyl, morphine, oxycodone, Vicodin, methadone, and other prescription pain relievers, careful supervision is necessary when prescribing and dispensing due to the potential for abuse and overdose. Overdoses can occur with both prescription or over-the-counter medicines if taken in excessive doses, as well as with illegal drugs.