On June 18, 2014, the Office of Controlled Substances issued
an emergency regulation imposing a number of conditions on prescribing extended
release hydrocodone that is manufactured without an abuse deterrent formulation
(ADF). The move is apparently Delaware’s
reaction to the FDA’s approval last year of Zohydro ER, which approval has
prompted concern among members of Congress and public health officials in a
number of states. According to those
officials, because Zohydro does not have an abuse resistant formulation, it can
be crushed and inhaled or injected, making the full dose of hydrocodone
available immediately, which some fear may lead to opioid addiction and
overdose fatalities. In April a federal
court blocked Massachusetts’ attempt to ban sales of Zohydro on the ground that
the state could not ban the sale of a federally-approved drug.
The new prescription requirements in Delaware are aimed at
minimizing use of Zohydro and, for those who are prescribed the drug,
minimizing the likelihood of abuse.
Effective as of June 18th, practitioners must do (and document)
the following prior to prescribing extended release hydrocodone that is
manufactured without ADF:
- conduct and document a
thorough medical evaluation and physical examination as part of the
patient's medical record
- evaluate and document
relative risks and benefits for the individual patient of the use of such
a hydrocodone.
- document in the medical
record that the prescription of a hydrocodone without an ADF is required
for the management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment, for which alternative
treatment options, including non-pharmacological treatments, are
ineffective, not tolerated, or would otherwise be inadequate to provide
sufficient pain management
- receive a signed informed
consent form from the patient, or if the patient is not competent to
provide informed consent, from the patient's legal representative.
The form must include information regarding the drug's potential for
addiction, abuse, and misuse and of the drug’s risks of
- life-threatening
respiratory depression
- overdose as a result of
accidental exposure, potentially fatal especially in children
- neonatal opioid
withdrawal symptoms
- potentially fatal
overdose when interacting with alcohol.
- receive a signed
Controlled Substance Treatment Agreement from the patient, which includes requirements
such as urine screening (no less frequently than every 120 days), pill
counts, safe storage and disposal, and other appropriate conditions as
determined by the practitioner to reasonably and timely inform the
practitioner if the patient is misusing the prescribed substance.
- query the Delaware
Prescription Monitoring Program (PMP) and review other controlled
substances prescribed to the patient. For any patient prescribed 40 mg or
greater per day, the practitioner must query the PMP no less frequently
than once every 120 days for as long as the patient possesses a valid
prescription for that amount.
- determine a maximum daily
dose or a "not to exceed value" for the prescription to be
transmitted to the pharmacy.
The prescription must be filled within seven days and
must not exceed 30 days in duration.
The emergency regulation also requires a practitioner to
schedule “periodic” follow up visits with a patient prescribed hydrocodone not
manufactured with ADF to evaluate and document whether to continue treatment or
if there is an available alternative, whether to refer the patient for pain management
or substance abuse consultation, and whether to implement a plan for
discontinuing the hydrocodone if the patient has failed to adhere to the
Controlled Substance Treatment Agreement.
Practitioners considering prescribing extended release
hydrocodone that is manufactured without an ADF, such as Zohydro, should review
the full text of the emergency regulation at http://dpr.delaware.gov/boards/controlledsubstances/documents/Emergency_Rule.pdf
Balick & Balick is prepared to assist practitioners with
putting procedures in place to meet the requirements of the emergency
regulation.
