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 »
DOJ certifies CURES: Physicians must check database prior to prescribing effective October 2, 2018 The California Department of Justice (DOJ) has certified that as of April 2, 2018, the Controlled Substance Utilization and Evaluation System (CURES) – California’s prescription drug monitoring database – is ready for statewide use. The certification starts a six-month implementation period for the duty to consult requirements enacted by the Legislature in SB 482 (Lara, 2016). Effective October 2, 2018, physicians must consult CURES prior to prescribing Schedule II, III or IV controlled substances to a patient for the first time and at least once every four months thereafter if that substance remains part of the patient’s treatment. Physicians must consult CURES no earlier than 24 hours or the previous business day prior to the prescribing, ordering, administering or furnishing of a controlled substance to the patient. This law provides, however, that the requirement to consult CURES would not apply if doing so would result in the patient’s inability to obtain a prescription in a timely manner and adversely impact the patient’s conditions so long as the quantity of the controlled substance does not exceed a five-day supply. Physicians are also not held to this duty to consult when prescribing controlled substances to patients who are: Admitted to a facility for use while on the premises; In the emergency department of a general acute care hospital, so long as the quantity of the controlled substance does not exceed a seven-day supply; As part of a surgical procedure in a clinic, outpatient setting, health facility or dental office, so long as the quantity of the controlled substance does not exceed a five-day supply; or Receiving hospice care. In addition, there are exceptions to the duty to consult when access to CURES is not reasonably possible, CURES is not operational or the database cannot be accessed because of technological limitations that are beyond the control of the physician. As of July 1, 2016, the law mandates that all California licensed physicians authorized to prescribe scheduled drugs and registered with the Drug Enforcement Administration be registered to access CURES. For more information on CURES and the upcoming duty to consult, see CMA On-Call document #3212, “California’s Prescription Drug Monitoring Program: The Controlled Substance Utilization Review and Evaluation System (CURES)” or visit the DOJ’s website and CURES user guide. CMA will continue to provide educational resources and work with the DOJ to ensure a smooth implementation of the new requirement. April 9, 2018 General Department of Justice, DOJ, Drug Prescribing, CURES 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 »
Help save lives: Co-prescribe naloxone to patients at risk of opioid overdose For more than 40 years, the life-saving opioid overdose antidote naloxone has been used to reverse the effects of opioid overdose. Timely administration of naloxone has saved tens of thousands of lives. The American Medical Association Opioid Task Force, of which the California Medical Association (CMA) is a member, recently issued updated guidance encouraging physicians to consider co-prescribing naloxone when clinically appropriate for patients who are at risk for opioid overdose or might be in a position to help someone else at risk. The updated guidance includes several important questions that physicians should consider to help determine whether they should co-prescribe naloxone to a patient—or to a family member or close friend of the patient. Is the patient receiving a high dose of opioids? Does the patient also have a prescription for a benzodiazepine? Does the patient have a history of substance-use disorder? Does the patient have an underlying mental health or other medical condition that makes him or her more susceptible to overdose? The document also includes links to multiple resources for physicians to use in their practice, such as recommendations for use in different settings, best practices and product comparisons. The task force guidance is available on CMA's safe prescribing webpage at www.cmanet.org/safe-prescribing. October 19, 2017 General Drug Prescribing, Opioids 0 0 Comment Read More »
FDA says harm of untreated opioid addiction outweighs risks of concomitant benzodiazepine use Medication-assisted treatment (MAT) for opioid addiction is an important tool that has the potential to help millions of Americans with an opioid use disorder. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. However, health care providers and patients face significant challenges when determining how best to treat opioid use disorder, especially when the MAT drugs contain methadone or buprenorphine – which are also opioids. The U.S. Food and Drug Administration (FDA) recently issued a statement saying that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). However, the agency is requiring changes to MAT drug labels to help decrease the risks of combining these drugs. The new labeling recommends that health care providers develop a treatment plan that closely monitors any concomitant use of these drugs, and carefully taper the use of benzodiazepines, while considering other treatment options to address mental health conditions that the benzodiazepines might have been initially prescribed to address. The FDA’s Drug Safety Communication recommends that health care providers take steps such as: Educating patients about the serious risks of combined use, including overdose and death, that can occur with CNS depressants even when used as prescribed, as well as when used illicitly. Developing strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants when starting MAT. Tapering the benzodiazepine or CNS depressant to discontinuation if possible. Verifying the diagnosis if a patient is receiving prescribed benzodiazepines or other CNS depressants for anxiety or insomnia, and considering other treatment options for these conditions. Recognizing that patients may require MAT medications indefinitely and that their use should continue as long as patients are benefiting and their use contributes to the intended treatment goals. Coordinating care to ensure other prescribers are aware of the patient’s buprenorphine or methadone treatment. Monitoring for illicit drug use, including urine or blood screening. Patients taking MAT drugs should continue to take these medicines as prescribed, and should stop taking other prescribed medicines without first talking to their health care professional. Physicians are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, available online at www.fda.gov/MedWatch/report. You can also call (800) 332-1088 to request a paper reporting form. For more information about opioid safety, see the California Medical Association's safe prescribing resource page at www.cmanet.org/safe-prescribing. October 13, 2017 General Drub Abuse, Drug Prescribing, Medical Solutions to Drug Abuse, Opioids 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 »
National Prescription Drug Take Back Day April 29, 2017 Saturday, April 29, 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. 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. 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. These and other resources are available on CMA's safe prescribing webpage at www.cmanet.org/safe-prescribing. April 19, 2017 General Drug Abuse, Drug Prescribing, Prescription Drugs 0 0 Comment Read More »
Court hears oral arguments in Oregon prescription drug monitoring database case The Ninth Circuit Court of Appeals heard oral arguments earlier this month in a patient privacy case involving law enforcement access to Oregon’s Prescription Drug Monitoring Program (PDMP). The California Medical Association (CMA) joined the American Medical Association and other western state medical associations in 2015 to file an amicus brief with the appeals court challenging the authority of the U.S. Drug Enforcement Administration (DEA) to obtain patients' private prescription records without a court order. In this case, the DEA sought patient-specific information from Oregon’s PDMP through the use of a federal administrative subpoena, which does not involve judicial review or a showing of probable cause. The Oregon PDMP, however, refused to comply with the DEA’s subpoena on the ground that doing so would violate Oregon state law, which requires a court order based on probable cause before patient data in the PDMP can be disclosed to any federal, state or local law enforcement agency. A coalition of plaintiffs that include Oregon’s PDMP, the American Civil Liberties Union (ACLU), patients and physicians filed a lawsuit in federal court against the DEA challenging the use of administrative subpoenas to access PDMP information. The plaintiffs argued that information in the PDMP is protected under the Fourth Amendment of the U.S. Constitution and that the DEA must show probable cause and obtain a warrant prior to accessing such information. The federal trial court sided with the State of Oregon and concluded that the Fourth Amendment prohibits the DEA from issuing administrative subpoenas for the database records. The court held that patients have an expectation of privacy in their prescription information contained in the PDMP stating that it “is difficult to conceive of information that is more private or more deserving of Fourth Amendment protections.” The DEA appealed this ruling to the Ninth Circuit Court of Appeals, whose jurisdiction includes California. The brief filed by the medical associations urges the court to recognize the profound interests that this case places at issue in the areas of patient privacy and the integrity of the patient-physician relationship. The protection of patient privacy “is essential for a patient-physician relationship built on trust … so that patients will seek care and so that doctors may provide the most efficacious health care for the patient’s benefit,” the brief states. It advocates for the strongest possible protections for patient prescription data collected by state prescription drug monitoring programs so that data is used by doctors and pharmacists for responsible treatment and prescription practices and to protect public health and safety, not for the enhancement of federal law enforcement without stringent legal safeguards. Click here to read the medical associations’ brief. A decision from the Ninth Circuit is expected in early 2017. Contact: CMA legal information line, (800) 786-4262 or legalinfo@cmanet.org. November 28, 2016 CMA, General CURES, Drug Prescribing, Privacy 0 0 Comment Read More »
Pharmacy board warns of fraudulent prescriptions for controlled substances The California State Board of Pharmacy recently warned pharmacies of an uptick in fraudulent California security prescription forms for controlled substances. The pharmacy board is encouraging pharmacies to take appropriate precautions to verify the legitimacy of prescriptions written by prescribers who have been identified as victims of this fraud. The pharmacy board maintains a list by county of prescribers who have reported stolen or fraudulent California security prescription forms. Pharmacies that receive prescriptions from a provider on this list have been advised to verify the prescription by contacting the provider's office using a phone number obtained from a source other that the prescription form itself. If you believe you are a victim of prescription fraud, see California Medical Association (CMA) On-Call document #3202,"Drug Prescribing: Unauthorized," which will walk you through the steps for reporting the incident to Federal and State agencies. On-Call documents are free to members in CMA's online health law library at www.cmanet.org/cma-on-call. Nonmembers can purchase On-Call documents for $2 per page. November 16, 2016 General Drug Prescribing, Fraud and Abuse 0 0 Comment Read More »
