Table 2. Definitions Related to Prescription Drug Use and Misuse
Term
Definition
Physical dependence • Not the same as addiction
• Occurs because of physiological adaptations to chronic exposure to a drug • Withdrawal symptoms occur when medicine is suddenly reduced or stopped or when antagonist is administered • Symptoms can be mild or severe and can usually be managed medically or avoided through slow drug taper
Tolerance
• Same dose of drug given repeatedly produces reduced biological response • Higher dose of drug is necessary to achieve initial level of response • Taking medication in a manner or dose other than prescribed • Taking someone else’s prescription, even if for a medical complaint like pain • Taking medication to feel euphoria (i.e., to get high) • Nonmedical use of prescription drugs refers to misuse
Misuse
Addiction
• Primary, chronic disease of brain reward, motivation, memory, and related circuitry • Dysfunction in circuits leads to characteristic biological, psychological, social, and spiritual manifestations as individual pathologically pursues reward and/or relief by substance use and other behaviors • Characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one’s behaviors and interpersonal relationships, and dysfunctional emotional response • Involves cycles of relapse and remission • Without treatment or recovery activities, is progressive and results in disability or premature death
Opioid-use disorder
• A problematic pattern of opioid use leading to clinically significant impairment or distress • Defined in DSM-5* • Previously classified as “opioid abuse” or “opioid dependence” in DSM-4 • Also referred to as “opioid addiction”
*DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; diagnostic criteria given later in this activity
Registration Requirements to Prescribe Controlled Substances The cornerstone of CS regulation is that all handlers of CS must register with the DEA. The registration requirement extends to HCPs, drug manufacturers, wholesale distributors, hospitals, pharmacies, and scientific researchers. 24 One person or the institution itself (for example, a hospital) may serve as the registrant, and nonregistered agents may write prescriptions under that registration. 22 If an HCP has more than one practice, each location must have its own DEA registration to prescribe CS. 22 This applies to a business location and not to HCPs who practice at multiple locations within the same state. The DEA may act to suspend or revoke a prescriber’s registration, for example, if the prescriber has: 22 • Falsified any application • Been convicted of a felony related to a CS • Had a state license or registration suspended, revoked, or denied • Committed an act that would render DEA registration inconsistent with public interest • Been excluded from participation in a Medicaid or Medicare program Considerations in determining the public interest include recommendations of state licensing boards, compliance with CS law at the state, federal, or local level, conviction record pertaining to CS, experience with respect to CS, and “such other conduct” that may threaten public health and safety. 22 The registrant takes responsibility for compliance with the CSA and for ensuring CS are distributed only to those authorized to receive them. 22
A registrant must notify the local DEA Diversion Field Office in writing within a business day of discovery of a theft or significant loss of a CS. 19 The DEA may also move to investigate a prescriber for alleged criminal acts. The agency assures HCPs that investigation and prosecution are reserved for instances where “conduct is not merely of questionable legality, but instead is a glaring example of illegal activity,” and that cases “typically involve facts that demonstrate blatant criminal conduct;” however, the agency does not set a clear standard or signify a basis for prosecution. 24 The DEA does provide some examples of prescribing in violation of the CSA (i.e., for other than a legitimate medical purpose or outside the usual course of professional practice). 24 While there are no set criteria, some recurring patterns cited by the DEA that might indicate inappropriate prescribing include: 22 • An inordinately large quantity of CS or numbers of prescriptions in comparison to other area HCPs (while also recognizing that some practitioners, for example, those who treat cancer, may prescribe more than others) • Lack of physical exam • Warnings to the patient to fill prescriptions at different pharmacies • Prescriptions issued that are known to be delivered to others • Prescriptions issued in exchange for sex or money • Prescribing intervals inconsistent with legitimate medical treatment • Use of street slang for medical drugs • No logical relationship between prescribed drugs and alleged medical condition
The DEA further clarifies that the existence of any of the foregoing factors does not automatically mean a prescriber has acted improperly. For example, some patients require doses that would be considered large for other patients, and the DEA asserts that each case is individually considered. 24 Information on Prescriptions CS prescriptions must be dated and signed on the day when issued and include the patient’s full name and address as well as the registrant’s full name, address, and registration number. 22 In addition, the prescription must include: 22 • Drug name • Quantity prescribed • Directions for use • Number of refills (may be 0) CS prescriptions must be written in indelible ink or pencil or else be typewritten. 22 Federal Restrictions Regarding Refills Schedule II prescription orders must be written and signed by the HCP and may not be phoned into the pharmacy except in an emergency. If phoned in under emergency circumstances, the HCP must present the written and signed prescription to the pharmacy within 7 days. 19,22 One further exception is that a fax may serve as the written prescription for residents of long-term care facilities, hospice patients, or compounded IV opioids. 22 Prescriptions for Schedule III-IV drugs may be written or phoned in and may be refilled up to 5 times within 6 months of issue. 19 Schedule V drugs have no refill limits but are restricted in that the patient must be at least 18 years old and must offer some form of identification to fill a prescription. 19 • Drug strength • Dosage form
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