Controlled Substances Face Regulatory Barriers in California
    Regulatory barriers to prescribing Schedule II controlled substances are greater in California than in any other state.  One group of pain specialists, the Southern California Cancer Pain Initiative (SCCPI) -- along with 32 other pain organizations -- is working to eliminate those barriers.  Together, they propose to eliminate triplicate forms and to incorporate the use of an electronic monitoring program for controlled substances.
    California, the only state requiring triplicate prescription forms, is one of eight states that still mandate state-issued prescriptions, said Barbara A. Hastie, PhD, Executive Director of the SCCPI, at the 2002 annual meeting of the International Association for the Study of Pain.
    The use of triplicate forms is the most salient of the regulatory barriers to prescribing controlled substances, she said.  Triplicate forms are "an obsolete, antiquated system."
    "We don't understand the opposition" of law enforcement to switching to an electronic system, continued Dr. Hastie.  Triplicate forms do not efficiently deter drug diversion and are a serious impediment to patient care, she told Pain Medicine News.
    In 2001, legislation to switch to the electronic monitoring system passed unanimously in the California senate and state assembly, but was vetoed by Gov. Gray Davis.  The SCCPI responded by stepping up educational efforts and formulating a statistical fact sheet [see below].
    The statistics reveal that triplicate forms are both a real and perceived barrier to physicians' ability to prescribe Schedule II controlled substances.  Many physicians and nurses do not have access to triplicate forms, and a majority of pharmacies do not fill them.  Physicians often take alternative actions to avoid writing a triplicate.
    Also, only a small percentage of triplicate forms are actually reviewed; by comparison, an electronic monitoring system captures 99.5% of all prescriptions.  "An electronic monitoring system is equally - if not more - effective," suggested Dr. Hastie.
    The electronic monitoring system proposed by the SCCPI, the Controlled Substance Utilization Review Evaluation System (CURES), has been proven an effective monitoring system in 23 states, Dr. Hastie said.  For Illinois, which switched from triplicate forms to CURES stand-alone electronic monitoring 1999, the transition was a smooth one.  However 33 states do not have a monitoring program for Schedule II controlled substances. 
    Ironically, a pilot CURES program was established in California in 1997 to evaluate its efficacy.  "Every year, it is funded again," noted Dr. Hastie, "with no recommendations nor subsequent actions to make it permanent.  And the same company that processed the electronic date for CURES processes the triplicate forms for California, but law enforcement argues that it is an "unproven and unsafe system" despite its use in 23 other states.
    The SCCPI has made some legislative headway toward better pain management.  Recent laws (1998) include an exemption from triplicate forms for terminally ill patients.  Beginning in 1999, every California medical school required students to take courses in pain management and end-of-life care.  As of 2002 a one-time, 12-unit continuing medical education (CME) course in pain management and end-of-life care was required of every licensed physician in California (excluding pathologists and radiologists).  This last achievement was aided by the landmark California lawsuit Bergman vs. Eden, noted Dr. Hastie.
    In 2001, a jury awarded $1.5 million to the relatives of William Bergman, a lung cancer patient who spent the end of his life in severe pain.  Toward the end of his life, Bergman was hospitalized for one week and was discharged with severe pain.  His charted pain levels ranged from 7 to 10 (0-10 scale), and he was discharged from the hospital with a score of 10.  The suit was won as an elder abuse case.
    The work of the SCCPI is "very appropriate" and overdue, Farshad Ahadian, MD, told Pain Medicine News.  Undertreatment and lack of opioid availability for chronic pain sufferers "have helped bring pain management to the forefront of media attention and medical education," he continued.
    But the problem is larger than simple regulatory barriers and has existed for decades.  "Many physicians in practice today received no training in management of pain or chronic opioid therapy when they were in training," said Dr. Ahadian.  "They are thus uncomfortable prescribing opioid analgesics."
    What commonly happens is that a patient's analgesic regimen is optimized by the pain specialist, then the patient is transferred back to the referring physician for care.  A few months later, the patient returns to the pain specialist back at square one, said Dr. Ahadian, Assistance Clinical Professor of Anesthesiology and Pain Management, University of California, San Diego (UCSD) Medical Center,.  The UCSD Center for Pain and Palliative Medicine is a referral center for southern California and beyond. 
    "There are not enough pain specialists to take care of all chronic pain patients," said Dr. Ahadian.  "Ultimately, the referring physician needs to pick up where the pain specialist left off."
    An old dictum in medicine says: To cure sometimes, to relieve often, to comfort always.  Dr. Ahadian said that in recent times, the focus has been reserved: To cure always, to relieve often, to comfort sometimes.  The recent attention to chronic pain has "Put us back on track," he said.  Article by Elizabeth Douglas for Pain Medicine News Jan/Feb 2003.

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Last modified: 03/16/08