National Pain Strategy: Assessing the Early Impact of FDA's Proposed Changes in Classification of Opiod Derivatives
Have you been affected by the reclassification of Opiods from Schedule III to Schedule II?
Since 2009, the U.S. Food and Drug Administration (FDA) has been carefully evaluating and weighing the appropriate use of opioid analgesic drug products. For the millions of American patients experiencing an acute medical need or living with chronic pain, opioids, when prescribed appropriately, can allow patients to manage their pain as well as significantly improve their quality of life.
In recent years, FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States. While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.
In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which would increase the controls on these products.
Due to the unique history of this issue and the tremendous amount of public interest, the FDA announced the agency’s intent to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule. This determination came after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which input was received from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.
HHS reclassified hydrocodone combination products into Schedule II. Schedule II drugs are a category of drugs considered to have a strong potential for abuse or addiction but that also have legitimate medical use. Included are opium, morphine, and cocaine. Schedule III. drugs are a category of drugs that have less potential for abuse or addiction than Schedule I or II drugs and have a useful medical purpose. Included are short-acting barbiturates and amphetamines.
The National Institute on Drug Abuse (NIDA) concurred with this recommended action, beginning a process that led to a final decision by the DEA on the appropriate scheduling of these products.
The ensuing months have yielded a variety of patient experiences. Public agencies have committed publicly to continue to work with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most. By some reports, this has been an uneven process and patients have reported a variety of experiences.
The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lortab. Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems. The change would reduce the number of refills patients could get before going back to see their doctor and impose new restrictions on access to and use of these medications.
The following drugs are now all reclassified from Schedule III to Schedule II: • Hydromorphone (any brand, any dose) • Oxycodone (any brand, any dose) • Morphine (any brand, any dose) • Oxymorphone (any brand, any dose) • Methadone (any brand, any dose) • Transdermal fentanyl (any brand, any dose) • Transdermal buprenorphine (any brand, any dose) • Ritalin (any brand, any dose) • Adderall (any brand, any dose