Substantial changes in these regulations have occurred in recent years and so clinicians should review both state and federal policies to fully understand their responsibilities (Chou et al, 2009).
|Did you know?: Only 0.1% of active patient care physicians had criminal and/or administrative charges and sanctions against them related to prescribing opioid analgesics between 1998 and 2006 (Goldenbaum, et al, 2008).|
Federal laws concerning the possession, use, and prescription of controlled substances are defined by the Controlled Substances Act (CSA) and Federal Food, Drug, and Cosmetic Act (FDCA). Five schedules or levels of drugs and chemical are based upon the substance's medical use, potential for abuse, and safety or dependence liability. The Act also provides a mechanism for substances to be controlled, or added to a schedule; decontrolled, or removed from control; and rescheduled or transferred from one schedule to another. The procedure for these actions is found in Section 201 of the Act (21 U.S.C. 811).
Examples of opioid scheduling are the following:
States may place a substance in another schedule, for example tramadol is unscheduled by the DEA but is schedule IV in some states. The lowest schedule on either the federal or state list applies.
Prescriptions for controlled substances must:
Some Federal regulations regarding controlled substances address unique scenarios a physician may encounter while others are only applicable in certain situations. Examples of such regulations are discussed here and on the following pages.
This section discusses the laws and required physician certifications concerning the treatment of pain for currently or previously narcotic-addicted patients.
The Drug Enforcement Administration (DEA) is revising its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These regulations are in addition to, not a replacement of, the existing rules. The regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery. The regulations will also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they will help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which may increase efficiency, and potentially reduce the amount of time patients spend waiting to have their prescriptions filled.
Healthcare professionals must comply with both federal and state lawas and regulations that govern prescribing scheduled controlled substances (Federation of Medical Boards, 2004).
States attempt to maintain a balance with Federal regulations in order to prevent abuse and diversion of controlled substances and to ensure their accessibility for genuine medical purposes. Both Federal and State governments should establish a system of controls to prevent abuse, trafficking, and diversion of controlled substances and at the same time ensure medical availability (Joranson, 1990).
States have the ability to schedule or reschedule a drug depending on its use within a particular state. Usually, an unscheduled substance is placed on a schedule for that state or a scheduled substance is placed on a higher schedule. In an attempt to increase control over the use of certain controlled substances, some states have limited dosage size or required the use of government-issued prescribing forms in specific situations.
(Pain & Policy Studies Group, March 2008)
(adapted from Goldenbaum, et al, 2008)
The prescription can be filled according to federal regulations. Federal law 21 CFR 1306.22 authorizes a schedule III or IV medication to be dispensed up to 6 months after the date of issuance (maximum of 5 refills). State limits may vary.
No. Although US federal regulations provide no time limits on dispensing schedule II drugs after the prescription is issued in these circumstances, the state of Hawaii has a 7 day time limit.
Healthcare professionals must comply with both federal and state laws and regulations that govern prescribing scheduled controlled substances. When federal laws or regulations differ from state laws or regulations, the more stringent rule applies. (Fed. State Med. Boards, 2004).
The primary objective of Federal and state regulations may be identical, but frequently, the laws contradict one another. However, a physician should acknowledge this fact and understand which law he or she is obliged to follow. The ensuing pages offer examples of such circumstances and how a physician should respond.
Prescriptions for schedule II have no specific time limitations on dispensing after the prescription is issued other than 60 days if the patient is in a long term care facility or has a medical diagnosis documenting a terminal
State specific limitations vary on dispensing time from date of issuance for schedule II: e.g., Virginia's is 6 months and Hawaii's is 7 days.
The FDA is considering requiring Risk Evaluation and Mitigation Strategy (REMS) for certain opioids in order to decrease rates of misuse, abuse, overdose and death (FDA, 2010a). A REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required for long-acting and extended release opioids if FDA finds that it is necessary to ensure that the benefits of the drugs or biological products outweigh the risks of the products. Some drug and biological products that were previously approved/licensed with risk minimization action plans may now be required to have a REMS.
July 2010: The FDA proposal released in July 2010 for opioid risk evaluation and mitigation strategy (REMS) did not require physician and patient training; however, this plan was highly criticized by an advisory panel and the agency is working to review recommendations.The FDA says it will closely monitor the proposed REMS and responses to it, and reserves the right to make further restrictions, including mandatory prescriber education and patient registration, if the more limited REMS fails to curb serious adverse outcomes (FDA, 2010b). The FDA plans on releasing final guidelines in 2011.