Federal opioid package receives bipartisan support in the U.S. House On June 22, the U.S. House of Representatives passed HR 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. It includes more than 55 opioid-related bills intended to help combat the nation’s opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting our communities and bolstering our efforts to fight deadly illicit synthetic drugs. HR 6 also includes several Medicaid, Medicare and public health reforms to help combat the opioid crisis. The California Medical Association (CMA) aggressively advocated for more funding for prevention, treatment and alternative therapies and worked alongside the American Medical Association (AMA) to avoid legislation that interferes with the practice of medicine, such as mandating dosage and duration limits. CMA also secured an amendment (HR 58010) that prevents federal preemption of state laws that mandate physicians consult state prescription drug monitoring programs prior to prescribing. Unfortunately, HR 6 does include a mandate to e-prescribe controlled substances, despite opposition from CMA and AMA. Less than 25 percent of physicians currently e-prescribe controlled substances because of the antiquated DEA system. CMA and AMA will continue to urge Congress to require the DEA to update its program and reduce the costly burdens of e-prescribing controlled substances before mandating that physicians use it. The House also passed HR 6082, the Overdose Prevention and Patient Safety Act, expanding the circumstances under which medical records relating to substance use disorders can be securely disclosed to health care providers. The issue of opioid-related misuse, abuse and overdose remains a major policy issue at the federal, state and regional levels. CMA will continue to advocate to increase access and availability of medication-assisted treatment, opioid use disorder treatment programs, and non-opioid therapies, including mental health services and fight proposals that interfere with the practice of medicine and create barriers to care. Demonstrated Opioid Success in California and Across the Nation Like the nation as a whole, California is faced with a serious health care dilemma: how to prescribe controlled substances safely and effectively to relieve pain, while simultaneously reducing the risk of prescription medication misuse, addiction and overdose. California has been leading the way in efforts to reduce prescription drug abuse and drug diversion. From 2013-2017, there has been a 22 percent decline in opioid prescriptions, which shows that physicians and other health professionals are increasingly judicious when prescribing opioids. California’s rate declined by more than 24 percent, with an 8.6 percent drop 2016 to 2017. From 2013-2016, California had the second lowest per capita rate of filled opioid prescriptions, and that rate dropped even more in 2017 – California now has the lowest per capita opioid prescribing rate in the country. California has one of the lower overdose death rates in the country. Unlike other states, California has seen its prescription opioid overdose rate decrease over the last two years. Safe Prescribing Resources CMA supports a well-balanced approach to opioid prescribing and treatment that considers the unique needs of individual patients. CMA’s safe prescribing resource page includes the most current information and resources on prescribing controlled substances safely and effectively to relieve pain, while simultaneously reducing the risk of prescription medication misuse, addiction and overdose. There you will find: Resources on prescribing controlled substances safely and effectively to relieve pain, while simultaneously reducing the risk of prescription medication misuse, addiction and overdose CMA’s white papers on prescribing opioids Links to relevant documents in CMA’s health law library Continuing medical education courses and webinars Current information on the state's prescription drug monitoring database July 11, 2018 General Prescription Drugs, Drug Prescribing, Federal Legislative Advocacy 0 0 Comment Read More »
Saturday, April 28, is National Prescription Drug Take Back Day Saturday, April 28, 2018, is National Prescription Drug Take Back Day. On this day, hundreds of locations throughout California will be accepting and properly disposing of unused prescription drugs, including controlled substances. Proper disposal of unused prescription drugs helps prevent diversion and misuse associated with these medications. This one-day event will provide patients with free, anonymous collection of unwanted and expired medicines. The last National Take Back event collected 456 tons of unwanted prescription drugs at almost 5,500 collection sites nationwide. In addition to providing a safe, convenient and responsible means of disposal, the event also aims to educate the general public about the potential for abuse of these medications. A significant component of the prescription drug abuse and diversion problem stems from misuse of unused drugs. According to the Substance Abuse and Mental Health Administration, over 71 percent of prescription pain medications are obtained from family and friends, and 5 percent took the medication from a friend or relative without asking. Physicians can take action by encouraging their patients to participate in Take Back Day. To find a collection site near your practice, click here. This and other resources are available on CMA's safe prescribing webpage at www.cmanet.org/safe-prescribing. April 17, 2018 General Prescription Drugs 0 0 Comment Read More »
Are your prescription pads compliant with the law? The California Medical Association (CMA) has received numerous calls from physicians whose prescriptions are being turned away by pharmacies for being non-compliant with state law. Specifically, the forms in question do not have checkboxes to indicate refills. California law requires 14 elements that must appear on California security prescription forms, including "check boxes that shall be printed on the form so that the prescriber may indicate the number of refills ordered." Security forms that lack the check boxes, even if they indicate refills in a different way, are deemed non-compliant. This requirement took effect in 2007. In recent weeks, some pharmacies have begun to refuse to fill prescriptions written on non-compliant forms. The California Board of Pharmacy also recently reminded licensees that will it cite and fine pharmacists/pharmacies who dispense controlled drugs with non-compliant forms. According to the Board of Pharmacy, physicians who are using non-compliant forms should educate themselves on the required elements of the security prescription forms, order compliant forms from a Department of Justice-licensed security printer and consider using e-prescribing for controlled substances. In the meantime, if you do not have compliant forms, remember that Schedule III-V controlled substances may be filled as an oral prescription if the pharmacist verifies verbally with the prescriber the number of any refills ordered and notes it on the security form. For Schedule II medications—where there are no alternatives, such as the availability of compliant forms or e-prescribing—the Board of Pharmacy allows use of a non-compliant form on a temporary basis to allow patients to receive any Schedule II medications in a timely manner. There are further exemptions to the security form requirements for a prescription for controlled substances for use by a patient who has a terminal illness. For more information on the California security prescription form requirements and exceptions, see CMA On-Call document #3201, “Controlled Substances: Prescribing.” CMA On-Call documents are available free to members in CMA's online health law library at www.cmanet.org/cma-on-call. Nonmembers can purchase documents for $2 per page. CMA members also receive 15 percent off all orders of compliant California security prescription pads and electronic health record printer paper from RxSecurity. Contact: CMA legal information line, (800) 786-4262 or legalinfo@cmanet.org December 28, 2017 General Drug Prescribing, Prescription Drugs 0 0 Comment Read More »
Saturday, Oct. 28, is National Prescription Drug Take Back Day Saturday, October 28, 2017, is National Prescription Drug Take Back Day. On this day, hundreds of locations throughout California will be accepting and properly disposing of unused prescription drugs, including controlled substances. Proper disposal of unused prescription drugs helps prevent diversion and misuse associated with these medications. This one-day event will provide patients with free, anonymous collection of unwanted and expired medicines. The last National Take Back event collected 450 tons of unwanted prescription drugs at almost 9,700 collection sites nationwide. In addition to providing a safe, convenient and responsible means of disposal, the event also aims to educate the general public about the potential for abuse of these medications. A significant component of the prescription drug abuse and diversion problem stems from misuse of unused drugs. According to the Substance Abuse and Mental Health Administration, over 71 percent of prescription pain medications are obtained from family and friends, and 5 percent took the medication from a friend or relative without asking. Physicians can take action by encouraging their patients to participate in Take Back Day. To find a collection site near your practice, click here. The California Medical Association (CMA) has produced a flyer to educate patients about proper disposal of prescription medication and National Prescription Drug Take Back Day, which can be placed in offices and waiting rooms. This and other resources are available on CMA's safe prescribing webpage at www.cmanet.org/safe-prescribing. October 19, 2017 General Opioids, Prescription Drugs 0 0 Comment Read More »
Updates to prior authorization form for prescription medications and new timelines for response now in effect On July 1, 2017, two new laws affecting the standardized prescription drug prior authorization form took effect. SB 282 required the Department of Managed Health Care (DMHC) and the Department of Insurance to create a standard electronic prior authorization request form. A second related law (AB 374) required the agencies to include on the updated form the option for physicians to request an exception to the plan/insurer’s step therapy process. Previously, SB 866 had required use and acceptance of a paper uniform prior authorization form. The form was updated in December 2016 and effective July 1, 2017, prescribers and payors are now required to use and accept this uniform prior authorization form, available on the DMHC website. Step therapy exception requests are to be submitted in the same manner as a request for prior authorization for prescription drugs, and would require the plan or insurer to treat, and respond to, the request in the same manner as a request for prior authorization for prescription medications. SB 282 also modified the timeframes in which plans/insurers are required to respond to the prior authorization/step therapy requests. Previously, plans/insurers were required to respond within two business days. SB 282 now requires plans/insurers to respond within 72 hours for nonurgent requests and within 24 hours for urgent requests. If a plan or insurer fails to respond within those timeframes, the request is deemed approved. The new law does not expand the list of medications that require a prior authorization. Delegated physician groups do not have to use the standardized form if they have been delegated the financial risk for prescription drugs and do not use a prior authorization process. September 25, 2017 General Drug Prescribing, Preauthorization, Prescription Drugs 0 0 Comment Read More »
CSAM Webinar: How to Build a Controlled-Substances Review Committee in Your Primary Care Clinic The California Society of Addiction Medicine (CSAM) is hosting a webinar, "How to Build a Controlled-Substances Review Committee in Your Primary Care Clinic," to help physicians navigate chronic pain and opioid management. The webinar will take place on Friday, July 28, from 12-1 p.m. Using a case-based format, the webinar will review the basic structure, operations and benefits of creating an internal peer-review committee for complex pain cases. From this event, physicians will understand how to implement, how to interact with and when to use such a committee in their clinics. The webinar will be led by Soraya Azari, M.D., an associate professor at the UCSF School of Medicine. For attending the webinar, physicians can receive 1.0 AMA PRA Category 1 Credit™ toward their continuing medical education requirement. To register or find more information about this upcoming event, click here. This is the 10th in a series of 12 monthly webinars created by CSAM on medication assisted treatments (MAT) for substance abuse disorders in primary care settings. Recordings of past MAT webinars have been archived by the California Health Care Foundation. July 26, 2017 General Continuing Medical Education, Drug Prescribing, Prescription Drugs, Webinars 0 0 Comment Read More »
NASEM issues major report on pain management and opioid use The National Academies of Science, Engineering, and Medicine (NASEM) issued a report last week, "Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use," detailing the dual public health challenges of undertreated pain and opioid use disorder. The report, requested by the U.S. Food and Drug Administration (FDA), highlights actions health care professionals and government agencies could take to stem the prevalence of opioid misuse without denying access to opioids for patients suffering from pain. The 18-member committee that worked over a year on the report recommended actions that include expanding access to treatment for opioid use disorder, weighing societal impacts in opioid-related regulatory decisions and investing in research to better understand the nature of pain and development of treatment alternatives. The report also urged public health agencies to work toward universal access to evidence-based interventions for pain management and substance abuse, including comprehensive pain management treatment programs and full coverage of medications approved to treat opioid use disorder. “This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing,” said committee chair Richard J. Bonnie, Harrison Foundation Professor of Medicine and Law and director of the Institute of Law, Psychiatry, and Public Policy at the University of Virginia in Charlottesville. “We also wanted to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel.” The committee also recommended that the FDA develop a systems approach for opioid approval decisions that incorporates the public health consequences into its existing risk-benefit model. Download the report here. For more information about opioid safety, see the California Medical Association's safe prescribing resource page at www.cmanet.org/safe-prescribing. July 24, 2017 General Drug Prescribing Opioids, Opioids, Pain Medicine, Prescription Drugs 0 0 Comment Read More »
FDA wants opioid pulled from market due to risk of abuse Last week, the U.S. Food and Drug Administration (FDA) requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is concerned that the benefits of the drug may no longer outweigh its risks. This is the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. The FDA’s decision is based on a review of all available data and follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks. Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012 in an attempt to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. Postmarketing data has shown, however, a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.” The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval. In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product. For more information about preventing opioid abuse, see the California Medical Association's safe prescribing resource page at www.cmanet.org/safe-prescribing. June 21, 2017 General Food and Drug Administration, Prescription Drugs, Drug Abuse, Opioids 0 0 Comment Read More »
Pharmacy board announces rules for pharmacy drug take-back services The California State Board of Pharmacy has finalized rules for pharmacy prescription drug take-back programs. The proposed regulations are part of statewide efforts to combat prescription drug misuse by making it easier for patients to safely dispose of old and unwanted drugs. A significant component of the prescription drug abuse and diversion problem stems from misuse of unused drugs. According to the Substance Abuse and Mental Health Administration, over 71 percent of prescription pain medications are obtained from family and friends, and 5 percent took the medication from a friend or relative without asking. The California Medical Association (CMA) believes that increasing opportunities for the public to safely dispose of their unused prescription drugs will help prevent the misuse and diversion associated with these medications. Under the new regulations, pharmacies are not required to provide drug take-back services. However, for those pharmacies that do, the regulations establish requirements that are based upon U.S. Drug Enforcement Administration (DEA) requirements. Besides using pharmacy take-back services, the public can take unwanted prescription drugs – including controlled substances – to collection sites authorized by the DEA, which maintains an online search page of public disposal locations. The DEA also sponsors biannual drug take-back days at locations nationwide. More information about take-back services is available on the pharmacy board's drug take-back page. The American Medical Association Task Force to Reduce Opioid Abuse, of which CMA is a member, has also released a new resource that physicians can use to promote safe use, storage and disposal of opioids and other medications. This and other resources are available on CMA's safe prescribing webpage at www.cmanet.org/safe-prescribing. June 21, 2017 General Prescription Drugs 0 0 Comment Read More »
DHCS gets federal grant to increase access to opioid treatment in California The California Department of Health Care Services (DHCS) has received a $90 million grant from the federal government to expand drug treatment services in California, primarily in counties and tribal communities that have higher rates of opioid-related overdose deaths. One key initiative will target those areas with an innovative approach to increase access to medications used to treat opioid addiction. DHCS will use a large portion of the grant from the U.S. Substance Abuse and Mental Health Services Administration to expand Californians’ access to medication-assisted treatment for opioid use disorders, particularly using buprenorphine. With more than 2.2 million people nationwide in 2015 who met the diagnostic criteria for an opioid use disorder, increasing appropriate access to life-saving addiction treatment services is one component of a balanced approach to addressing opioid-related morbidity and mortality rates. Treatment of opioid use disorder with medication-assisted treatment has been shown to be cost-effective, safe and successful when used appropriately. The California Medical Association (CMA) strongly supports efforts to increase access to much-needed medication-assisted treatment for opioid use disorders. DHCS also will use the grant to fund additional approaches to reduce opioid misuse, such as enhancing the wider distribution of naloxone, which can reverse the toxic effects of an opioid overdose; coordinating local coalitions to act together to reduce opioid abuse; and providing education and training to help reduce the stigma associated with addiction. For more information, visit CMA's safe-prescribing resource page at www.cmanet.org/safe-prescribing. There you will find: Resources on prescribing controlled substances safely and effectively to relieve pain, while simultaneously reducing the risk of prescription medication misuse, addiction and overdose. CMA’s white papers on prescribing opioids Links to relevant documents in CMA’s health law library Continuing medical education courses and webinars Current information on the state's prescription drug monitoring database May 22, 2017 General Drug Abuse, Medical Solutions to Drug Abuse, Opioids, Prescription Drugs 0 0 Comment Read More »
