UNITED STATES - The increased restrictions on hydrocodone combination products that go into effect on Monday, October 6, are having a major impact on chronic pain patients seeking their monthly refill on a currently-valid prescription.
When the Drug Enforcement Agency announced that hydrocodone combination products, or HCPs, would move from Schedule III to Schedule II of the Controlled Substances Act, the 22-page rule allowed for pharmacies to recognize refills authorized on pre-October 6 prescriptions.
The rule states that those refills were to remain valid through April 8, 2015. But in a clash between DEA intentions, state pharmacy laws, and insurance companies, we have learned that nearly all pharmacies will be requiring a new, written prescription for hydrocodone combination products tomorrow, regardless of whether you have refills remaining on a current prescription.
If you have refills remaining on your currently-valid HCP prescription, you must get this month’s refill today (Sunday 10/5), or be required to submit a new prescription tomorrow, Monday 10/6. If you are fortunate to have your pharmacy open on Sundays, call ahead to be sure you can get this refill today.
I spoke earlier this week with DEA spokesperson, Barbara L. Carreno, as to the question of whether currently-remaining refills can indeed be fulfilled on or after October 6. She replied later in an email, saying, “DEA has made provision for legitimate scripts written before the new rule goes into effect on October 6 to be honored until April 8. Again, DEA is no hindrance to that. However, a pharmacy can choose to not honor such a script, perhaps because it wants to start clean with all its record-keeping on October 6 and isn’t willing to make any exceptions. (Schedule II records have to be kept separate from other records. That is one of two things that pharmacies have to do different with Schedule II drugs, the other being that they use a different form to order Schedule II drugs than other drugs. Pharmacies already have these forms, because they use them to order other Schedule II drugs they carry, like Percocet, Adderall and Ritalin.) If a pharmacy chooses to do that, that is the pharmacy’s call, and DEA has no authority to override their business practice.”
In response to the DEA allowance, the National Association of Chain Drug Stores has said, “‘However, state law, insurance limitations and some pharmacy quality and safety operations and processes may not allow for these prescriptions to be refilled. Citing efforts to work with healthcare stakeholders, including prescribers and patient groups, to help prevent any potential disruptions to healthcare delivery, NACDS expressed concern in its comments stating, ‘Most states have not provided clarity with respect to whether such refills will be valid under state law. Moreover, most pharmacies will not be able to process such refills due to existing quality and safety operations and processes; such pharmacy operations and processes cannot be modified in a mere 45-day time frame,” NACDS said in its statement.’”
I’ve written at length on this so-called upscheduling of hydrocodone combination products. The intent by regulators was to decrease the amount of HCPs available for diversion or abuse – non-medical use of the painkiller. However, many chronic pain patients are being inconvenienced by the rapid and erratically-coordinated implementation of the upscheduling.
By David Kroll - Forbes, Oct. 6, 2014
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