Should Hydrocodone be reclassified?
Pharmacy groups are voicing their opposition to an amendment in the Senate's FDA user fee reauthorization bill that would reclassify all medications containing hydrocodone as Schedule II drugs.
The Senate provision, drafted by Sen. Joe Manchin (D-W.Va.), would reclassify hydrocodone-containing combination products as Schedule II controlled substances, a category reserved for drugs with medical uses that have a high potential for abuse and may lead to severe psychological or physical dependence.
Both houses of Congress have passed similar versions of the user fee bill; now they must agree on one final version to be sent to the president for his signature. The House version of the bill does not contain a provision similar to Manchin's, which has two Senate co-sponsors, Sen. Mark Kirk (R-Ill.) and Sen. Kirsten Gillibrand (D-N.Y.).
Methadone and oxycodone are Schedule II drugs, and so is hydrocodone in pure form and any formulations of hydrocodone combination products containing more than 15 mg hydrocodone per dose. Prescriptions for Schedule II drugs cannot be phoned in, and patients need a new prescription for each refill.
However, hydrocodone is generally used in combination with other ingredients, such as acetaminophen (Vicodin). Those combination products are currently classified as Schedule III drugs, which are defined as drugs that have a lesser potential for abuse than the drugs or other substances in Schedules I and II, and also carry a lower risk of addiction.
Hydrocodone-containing products don't need to be reclassified, according to a May 30 letter sent to Manchin and congressional leaders by five groups: the American Pharmacists Association, the Food Marketing Institute, the International Academy of Compounding Pharmacists, the National Association of Chain Drug Stores, and the National Community Pharmacists Association.
"While we share your concerns regarding the abuse and diversion of these prescription drugs, and we appreciate your leadership on this unfortunate situation, these concerns must be balanced with the impact on patients who legitimately need access to these products," wrote the groups.
They said there are numerous hydrocodone-containing combination products that are needed by patients, including cancer patients, and stricter regulations might impede access.
"As a result of needing a new prescription for each fill, there is a greater chance that patients with a legitimate clinical need would be unnecessarily forced to endure symptoms of pain for a longer period of time," the groups wrote.
In addition, the groups said the reclassification would be costly for pharmacies who would have to implement additional storage procedures, record-keeping, and inventory management for the many different doses and formulations of hydrocodone-containing products carried by pharmacies.
The groups also said that the provision is unnecessary because states have the authority to place tougher restrictions on prescribing and dispensing of controlled substances by reclassifying medications into a more strict drug class.
The group said it understands concerns about diversion of opioids and the widespread abuse of the drugs.
"Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation's healthcare costs with no assurance of a reduction in diversion and abuse."
According to the Drug Enforcement Agency, hydrocodone is the second most abused pharmaceutical, behind oxycodone. ~DEA.com~