In November 2014, the Medical Board of California published a guideline for physicians on how and when to prescribe prescription opioids. The 90-page document covers topics ranging from understanding different types of pain—acute, chronic, nociceptive and neuropathic—to treating different special patient populations—end-of-life, older, pregnant, pediatric, psychiatric and patients with a history of substance abuse—to compliance—specifically, compliance monitoring and compliance with controlled substances law. These latter topics are the focus of this blog.
The report recommends three methods for physicians to monitor patients’ adherence to prescription medicine dosage instructions:
- CURES/PDMP Report. CURES stands for Controlled substance Utilization Review and Evaluation System; PDMP stands for Prescription Drug Monitoring Program. CURES is a database maintained by California’s PDMP. At present, every state except for Missouri has a PDMP. The CURES database keeps track of every Schedule II through IV controlled substance prescribed in the state. California’s PDMP allows physicians, pharmacists and other healthcare professionals who are licensed to prescribe prescription opiates access to patients’ records to ensure patients are not receiving prescriptions from multiple doctors—also known as doctor shopping.
- Drug testing. This is the most difficult and controversial method for establishing patients’ compliance. First, a patient must consent to testing. Physicians have no legal leverage to compel a patient to undergo a drug test. Second, urinalysis, which is the most widely used test for drug detection, cannot determine which drug was taken, how much or when. A urinalysis only proves the presence of opioids. Cost is also a prohibitive factor. Over-the-counter drug tests are inexpensive and practical when they return negative result. But positive test results must be confirmed by a physician and licensed lab. This can result in hefty out-of-pocket expenses for the patient.
- Pill counting. The guideline simply mentions that this method can be an effective strategy to ensure compliance and to eliminate diversion. But pill counting involves patients’ consent to bring prescriptions to their physicians in order for the counting to take place.
Compliance with controlled substances laws
The report includes hyperlinks to California Health and Safety Code section 11000-11033. These are known as the California Uniform Controlled Substances Act; providing an extensive glossary for drugs, substances, narcotics, opiates and more. The Act also clearly identifies agents, distributors, practitioners among others. But beyond providing a list of definitions, the Act does not contain provisions that address compliance in any practical sense.
The report also contains a link to the Drug Enforcement Agency’s Office of Diversion Control’s website. The site contains the text of Title 21 United States Code Controlled Substances Act. This is a huge piece of legislation with subchapters, sub-subchapters and nearly 100 sections that link to thousands of pages of text. With respect to Schedule controlled substances, the DEA defines these as “substances that are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.”
Substances, chemicals used to make drugs and drugs themselves, are classified into five schedules to categorize laws appropriately, depending upon the drug’s medical use and the dependency potential. Schedule I being the most dangerous.
Under Subchapter I – Control and Enforcement, Part C – Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances, §829. Prescriptions, (a) Schedule II substances, the section reads, in part, “Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without the written prescription of a practitioner…” Sections (b) and (c) address Schedule III and IV substances and Schedule V substances, respectively, and repeat the statutory language regarding prescribing practices and practitioners.
According to the Centers for Disease Control and Prevention, prescription drug abuse in the U.S. has reached the level of an epidemic. If you are addicted to prescription painkillers, call 866-450-1557. We can help.