HHS is very concerned with prescription drug abuse. In July they released a plan on hhs.gov to combat abuse of opioid painkillers: "The opioid crisis is affecting communities across the country. Deaths from drug overdose have risen steadily over the past two decades and have become the leading cause of injury death in the United States. Prescription drugs, especially opioid analgesicsa class of prescription drugs such as hydrocodone, oxycodone, morphine and methadone used to treat both acute and chronic pain have increasingly been implicated in drug overdose deaths over the last decade. From 1999 to 2013, the rate for drug poisoning deaths involving opioid analgesics nearly quadrupled Given these alarming trends, it is time for a smart and sustainable response to prevent opioid abuse and overdose" (HHS.gov bulletin 7.28.15)
How does this trend manifest in your practice?
Imagine you are working at a busy medical practice that often helps patients with pain management. One day you receive a call from an agitated patient demanding a refill of his pain medication. The patient tells you he recently ran out of his medications and needs them prior to the weekend. He also said he is standing at the pharmacy because he thought he had a refill available. After reviewing the patient's medical record you notice the patient just had a 30 day schedule 2 (II) pain medication refilled within the past two weeks. You kindly let the patient know he recently had a refill and according to his medical record, and he should have another two weeks of medication left. The patient begins screaming at you and demands to speak to the physician who prescribed his pain medication. You let the patient know you will give the physician the message to call him back because he is currently seeing another patient. He then screams, curses and threatens you informs you he is on your way to the practice then he hangs up.
What does the law say about pain medication and refills? How would you handle this situation?
Schedule 2 (II) Drugs
According to the U.S. Drug Enforcement Administration (DEA) "Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, less abuse than Schedule I drugs, with use potentially leading to severe psychological or physical dependence." Examples of these Schedule II drugs include:
Did you know that just under one year ago (August 2014), the Administrator of the DEA rescheduled hydrocodone combination products (i.e. Vicodin and Norco) from schedule
- III to schedule II of the Controlled Substances Act? The final rule went into effect October 6, 2014 and for good cause: according to the International Narcotics Control Board, hydrocodone products are among the most commonly prescribed drugs in the United States Americans consume approximately 99% or the hydrocodone produced worldwide. Moreover, these drugs contribute to more than 16,000 deaths annually more than heroin and cocaine combined.
Prescription and refill requirements
In our scenario above, it's easy to see why the patient may have been agitated the patient may not be aware of the change from schedule III to schedule II for hydrocodone combination products, and the prescription and refill requirements for those medications.
- However, this doesn't explain why the patient is already out of his medication (more on this later).
The DEA Practitioner's Manual includes some valuable information for your organization to consider regarding scheduled controlled substances:
Schedule II Substances
- Schedule II drugs require a written prescription which must be signed by the practitioner.
- For schedule II controlled substance, an oral order is only permitted in an emergency situation.
- The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.
- A prescriber may transmit a Schedule II prescription to pharmacy by facsimile. However, the original Schedule II prescription must be presented to the pharmacist for review prior to the actual dispensing of the controlled substance.
- If certain requirements are met, an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance.
Schedule III V Substances
- A prescription for controlled substances in Schedules III, IV, and V issuedby a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.
- Schedule III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date on which the prescription was issued. After five refills or after six months, whichever occurs first, a new prescription is required.
- Prescriptions for Schedules III-V controlled substances may be transmitted by facsimile from the practitioner or an employee or agent of the individual practitioner to the dispensing pharmacy. The facsimile is considered to be equivalent to an original prescription.
Because the primary responsibility to regulate and enforce prescription drug practices is handled on the State level, your organization must be aware of what your State laws say regarding prescription and refill requirements. Additionally, your practice should have a policy and procedure in place regarding prescription medications especially for schedule II substances. Your state will have laws in place for emergency verbal prescription of schedule II controlled substances and most states allow for a quantity to dispensed for a defined emergency period (i.e. not to exceed 72 hours). It is critical for your policy to follow your State Laws, and the DEA Practitioner's Manual.
Finally, perhaps the most important practice your organization can implement is to provide patient education regarding prescription drugs. This education provides opportunities to both ensure your patient is compliant with their treatment regimen and to explain your prescription drug policy. We would recommend requiring the patient to sign an acknowledgment form stating their understanding of the policy, and when necessary, a patient contract stating their willingness to be compliant with the provider's prescribed treatment plan.
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