Regulatory Requirements for Safe Non-Opioid and Opioid Prescribing Paper
Prescription drug abuse is widely considered to be an epidemic in many states across the United States including California. According to the Centers for Disease Control and Prevention (2018), drug overdose as remains one of the key causes of morbidity and mortality in the United States, and hence safe opioid prescribing remains one of the most viable means to mitigate or reduce overdose risks among some of the most vulnerable populations. The State of California has over the years adopted a range of comprehensive legislative, institutional and regulatory measures aimed at tackling opioid dependency or addiction as a serious healthcare crisis affecting social and economic welfare as well as public health. Against this backdrop, this analytical paper examines the prevailing regulatory requirements for safe non-opioid and opioid prescribing in California State.
The Medical Board of California (MBC) is the state regulatory agency tasked with the noble mandate of protecting consumers through the appropriate licensing and regulation of healthcare practitioners including surgeons, physicians, Advanced Practice Registered Nurse (APRN) and others. The MBC regulates or oversea APRN prescribing in California by promoting greater access to quality medical care through the agency’s regulatory, disciplinary and licensing functions and also enforcement of the Medical Practice Act (Department of Consumer Affairs, n.d.). As the State’s health protection agency, the MBC can pursue disciplinary action against physician’s license in California based on the standards of care offered by the practitioner to a given patient/service user. Over the years, the Board as assumed an active role in the development and enforcement of guidelines aimed at providing proper direction to physicians and other practitioners who prescribe controlled substances for different health conditions including chronic pain (Medical Board of California, 2014). Therefore, the agency seeks to promote evidence-based decision-making and peer-expert review when it comes to prescribing practices and to uphold the appropriate standard of care with the intention of ensuring prevention of overdose morbidity and mortality due to opioid use and improvements in patient care outcomes.
Educational Requirements for Prescribing
As an APRN, certification by the California Board of Registered Nursing (BRN) is considered an important requirement for those who have already participated in formal education program in nursing or related field. Duensing et al. (2020) noted that the State of California require completion of a master’s, post-graduate or doctoral degree from an accredited institution or Nurse Practitioner (NP) program and subsequently, certification from a nationally-recognized certifying body such as the American Nurses Credentialing Center and the American Academic of Nurse Practitioners. In California, APRNs can receive the NP certification by successfully completing an NP education program in line with the standards set by the Board of Registered Nursing. With more than 23-approved NP programs in the State of California, the APRN must possess a BRN certification prior to practicing in the state, with some of the key areas where APRNs can be prepared and certified being pediatrics, family practice, acute care, psychiatry, public/community health (California Health Care Foundation, 2017). In the case of new applicants without proper certification or qualification to practice as an APRN in California, the possession of a master’s degree in nursing or related clinical area or a graduate degree in nursing is required alongside successful completion of an NP education program approved by the California Board of Registered Nursing (CDPH, 2020). One of the recent developments related to the educational requirements in the State of California is the introduction of the Doctor of Nursing Practice (DNP) degree, and this is becoming increasingly available in many nursing schools and attracting a growing number of NPs in these programs.
Overview of Regulations in Other States
California is among the 28 states that place restrictions on APRNs to pursue physician oversight prior to engaging in practice and prescribing. There are significant variations in state regulations on the APRN scope of practice. Nevertheless, recent developments have witnessed to withdrawal of these restrictions, and hence APRNs will have the full authority to practice and prescribe without physician collaboration or supervision at the start of 2023 after having under the supervision of a physician for at least three years. The American Medical Association (2020) established that in 22 states and the Distribute of Columbia, Nurse practitioners can prescribe and practice without physician supervision and/or collaboration (such as Arizona, Hawaii, New Hampshire, North Dakota, South Dakota, Washington, Nebraska, Maine, Iowa, Maryland, Montana and Washington). This is contrary to the case in California where numerous regulations have so far been introduced to guide physician collaboration and supervision. Moreover, whilst the physician is required to conduct a comprehensive review of patient records when it comes or prescribing or furnishing pharmaceuticals, at least twenty-six states mandates APRNs to practice independently and around four of these calls for the use of a collaborative agreement (such as Michigan,, Wisconsin, Arkansas and Oklahoma). Other findings indicated that the existence of differences in the features regarding the APRN scope of practice with some of the key ones being physician proximity (such as 75 miles in Mississippi), consultation frequency (annually in Ohio and every 30 days in Tennessee), and supervision rules (transitional supervision period of 1,000 hours in mentorship with APRN or physician in Colorado) (CDPH, 2020). With regards to recent changes, other states such as Rhode Island, Nevada, Vermont and others allow APRNs to practice autonomously through granting them complete authority to practice and prescribe without oversight from a physician or nurse practitioner (California Health Care Foundation, 2018).
Actions required to Prescribe in California
Action 1: Apply for APRN Licensure and a Furnishing License
The first step required for prescribing in California is the demand on the new NP or APRIN to make an application for his/her advanced practice nursing license. Equally, the submission of a Furnishing Number application is another key requirement that must be fulfilled prior to prescribing in the state of California (California Medical Association, 2021). Strong focus with regards to the Furnishing number is placed on ensuring whether the pharmacologic content of the practitioner’s NP education fulfills California’s state requirement for prescribing Schedule II drugs (in this case, 3 hours of Schedule II pharmacologic content) (Swartz, 2019). Moreover, advanced nursing practitioners without accreditation from an NP education program in the state of California or without proper educational qualifications are expected to advance to actions 2-4.
Action 2: Secure a DEA Number
Whilst having a furnishing number is enough for nurse practitioners to prescribe in California, it is important to make an application for a DEA Number to enable the APRN to prescribe other medications, besides Schedule II drugs. Practitioners identified to possess proper educational requirements for prescribing Schedule II substances can avoid proceeding to the next step since they are identified as full prescribers (TAP, 2017). In the event the NP program undertaken by the practitioner fails to meet the established educational requirements, one is advised to advance to the next step.
Action 3: Complete an Approved Continuing Education Prescribing Course
Another important action that must be pursued by the APRN is completion of a minimum 3-hour approved Continuing Education (CE) course. One of the most notable CE courses that strictly fulfill the curriculum requirements set by the State of California is currently provided through the California Association for Nurse Practitioners and can be bought and completed online at an estimated cost of around $250 (TAP, 2017).
Action 4: Apply for a Schedule II Furnishing License
The APRNs who have successfully completed the established educational requirements for Schedule II prescribing are expected to inform the Board of Nursing about their achievement. Alongside providing a copy of their CE completion certificate, it is highly important to make a written submission requesting for schedule II prescribing privileges amidst the existence of bureaucracies that may significantly undermine the speed and simplicity of receiving approval to prescribe in California State (Chartier, 2017).
Summary of the Controlled Substances Regulations in California
A set of regulations have so far been developed and implemented in the State of California to ensure safe prescribing. Reynolds (2020) asserted that adherence to the MBC guidelines and regulations on Controlled substances is integral to ensuring prescribers, pharmacists and other key practitioners are involved in proper prescribing practices. The first regulation is on the greater need for physicians, prescribers, APRNs and other key healthcare professionals to understand the type and severity of pain (acute and chronic pain, nociceptive and neuropathic pain, and cancer and non-cancer pain) that should be managed or treated using controlled opioids and non-opioids. Similar sentiments are shared by Swartz (2019) who pointed out that physicians and other relevant practitioners must understand the relevant clinical and pharmacologic issues in the utilization of opioids, and to develop a clear treatment plan outlining the benefits and risks of such analgesics for each individual patient placed under long-term opioid therapy.
Another key regulation identified on the MBC Prescriber guidelines for opioids touches on the special patient populations under which the MBC recommendations are based upon. Some of the special patient populations that must be considered when prescribing opioids include Urgent care clinics, emergency departments, end-of-life pain, acute pain, patients with history of use disorder, pregnant women, psychiatry patients, older adults, cancer pain, patients covered by Workers’ compensation, and patients prescribed Buprenorphine or methadone for treatment of a Substance Use Disorder (SUD) (American Medical Association, 2020). Chartier (2017) indicated that implementation of the MBC guidelines is essentially focused on improving patient care outcomes and mitigating complications or accidental deaths associated with the chronic use of opioids by the identified special patient populations. Therefore, the APRNs and other involved practitioners must make proper treatment considerations for varying scenarios or patient populations as the fundamental basis for ensuring the proper prescription of opioids for each of the drug-seeing patient (California Health Care Foundation, 2017). It is highly recommended to consider additional safe prescribing guidelines and relevant information on the proper use of controlled substances for the various patient populations in order to avoid some of the complications and problematic situations associated with the use of opioids in these special populations of patients.
Another key regulation in the State of California is the enforcement of the Electronic prescribing mandate from January 1, 2022 onwards. Sullivan (2021) observed that the enforcement of a bill passed by the California State Legislature in 2018 placed the mandate on prescribers and physicians to ensure nearly all prescriptions (including for controlled medications) written in California are electronically transmitted. However, numerous exceptions to the rule include: environments where electronic prescribing is not available as a result of electrical or technological failure; prescription of controlled drugs for utilization with terminally-ill patients; the prescription is provided by a veterinarian; the prescription is provided at a moment when a patient’s preferred or regular pharmacy is probable to be padlocked or not operational. Others include: prescriptions that are provided in an urgent care clinic, hospital emergency departments and those that meet a number of requirements such as those issued to patients situated outside the geographical zone of the healthcare facility, the patient is not currently a resident of California State and the patient faces certain vulnerability including indigence or homelessness (Swartz, 2019). Moreover, the implementation of the Controlled Substance Utilization Review and Evaluation System (CURES) can also be considered an important regulatory measure aimed at boosting the ability of physicians and prescribers to share and access patient information and data of Scheduled II through IV controlled medications and substances. Precisely, this updated database acts an important digital platform where the providers can access key information or data prior to writing a prescription for controlled drugs in the state of California. Equally, the prescribing of controlled drugs in the state of California must be duly reported to the CURES within one working day following the release of the medication to the identified patient or his/her representative (Department of Consumer Affairs, 2022). Prior to the revised reporting requirements for controlled substances, the deadline to report was placed at seven days after dispensation of a controlled substance.
Other key regulations are related to the initiation and continuation of opioids for chronic pain as experienced by the specific patient populations. It is stated that prescribing opioid medications is only allowed in the event other non-opioid pain medications are considered to provide insufficient pain relief, particularly when the patient is identified to suffer from acute or chronic pain. Active collaboration between the physician or prescriber and the patient is highly recommended in the event long-term utilization of chronic, non-cancer pain is considered in the treatment plan (California Health Care Foundation, 2017). There are also some regulatory requirements on the selection, dosage, duration, follow-up and discontinuation of opioids. The Centers for Disease Control and Prevention (2018), mentioned that opioids should be prescribed on a short duration and within the required doses for treatment of acute pain, and hence strong focus must be placed on assessing the risks and complications associated with the long-term usage of opioids through comprehensive patient assessment and evaluation. The appropriate referral of patients to a psychiatry, pain and/or mental health specialists as required as well as consultation by the treatment physician can help to enhance patient outcomes and ensure proper treatment options for opioid abuse or addiction are applied when it comes to the prescription of long-term opioid therapy (Swartz, 2019). The utilization of Prescription Drug Monitoring Programs (PDMP) and CURES as well as periodic pill counting and drug testing are also recommended to improve the therapeutic outcomes as well as ensure successful implementation of the treatment plan.
Other regulations are related to the discontinuation or tapering of opioid therapy (Bonta, 2022). Reynolds (2020) established the need for including an “exit strategy” in the overall treatment for patients provided with controlled substances at the commencement of the treatment process. A number of reasons including the healing or resolution of the painful condition; evidence of non-medical or improper use; intolerable side effects; failure to comply with pain management agreement; failure to attain projected functional enhancement or pain relief, display of drug-seeking behaviors; and failure to comply with monitoring efforts (e.g. urine drug screening). Other key regulations mandates that every prescriber, physician and APRN must keep proper, comprehensive, accurate and updated medical records of all patients.
Main Concepts for CDC Module 1 and Module 4
Module 1 offers key stakeholders including public health practitioners with key data and information related to the CDC for Toxic Substances and Diseases Registry (ATSDR), and the various methods for tackling the opioid crisis. In the United States, opioid use disorder is steadily emerging as a serious public health pandemic with significant impact on individuals, communities and the society at large (CDC, 2022). In this module, training is provided on how the CDC Guidelines for prescribing opioids have been extensively employed with the core purpose of ensuring effective and safer prescribing of opioids and non-opioids for different forms of chronic pain in patients aged 18 years and over in different healthcare settings. Module four is primarily focused on some of the mechanisms that can be employed to reduce the risks of opioids. The module provides vital training on the CDC-recommended interventions and strategies to addressing the risks of opioids among patients (CDC, 2022). Therefore, both modules provide relevant information and data aimed at equipping APRNs and other healthcare professionals on some of the evidenced-based, patient-centered strategies that can be employed to ensure safer and more effective prescribing of controlled substances.
This paper examined the main regulatory requirements for safe and effective opioid and non-opioid prescribing in the state of California. The Medical Board of California is the sole state regulatory agency mandated with regulatory, licensing and disciplinary duties. Besides the requirement for a master’s, post-graduate or doctoral degree from an accredited university, other educational requirements in California State include completion of a certified NP education program. Regulations aimed at guiding the APRN scope of practice vary from one state to another. Whilst APRNs in California cannot prescribe or prescribe without physician collaboration or supervision, other states have different regulations related to the roles and responsibilities of APRNs. Numerous actions must be pursued by the APRN in order to meet the regulatory requirements for prescribing in California and they include: applying for APRN licensure and a furnishing license; Securing a DEA Number; completing a certified CE course; and Applying for a Schedule II furnishing license. The enforced regulations on controlled substances in the state of California touches on key areas namely: understanding pain, special patient population, medical records, e-prescribing, CURES for tracking and reporting opioid use, initiation and continuation of opioids, active stakeholder participation, selection, follow-up, duration and discontinuation of opioids. Module 1 and Module 4 provides useful tips on some of the strategies and efforts that can be applied by APRNs to help in reducing the risks of opioids and assisting patients to attain improvements in care outcomes and therapeutic response.
American Medical Association, (2020).State law chart: Nurse Practitioner Prescriptive Authority. https://www.ama-assn.org/system/files/2020-02/ama-chart-np-prescriptive-authority.pdf
Bonta, R. (2022).Controlled Substance Utilization Review and Evaluation System. https://oag.ca.gov/cures
California Health Care Foundation, (2017). Case Studies: Three California Health Plans Take Action Against Opioid Overuse. https://www.chcf.org/wp-content/uploads/2017/12/PDF-CaseStudiesHealthPlansOpioid.pdf
California Medical Association, (2021).Are you ready for California’s electronic prescribing mandate? https://www.cmadocs.org/newsroom/news/view/ArticleId/49517/Are-you-ready-for-California-s-electronic-prescribing-mandate-1
CDC, (2022).Module 4: Reducing the Risks of Opioids. https://www.cdc.gov/drugoverdose/training/reducingrisk/accessible/
CDPH, (2020).Introduction To Prescribing Guidelines Comparison. https://www.cdph.ca.gov/Programs/CCDPHP/DCDIC/SACB/CDPH%20Document%20Library/Prescription%20Drug%20Overdose%20Program/PrescribingGuidelines4.26.17Compliant.pdf
Centers for Disease Control and Prevention, (2018). Quality Improvement and Care Coordination: Implementing the CDC Guideline for Prescribing Opioids for Chronic Pain. National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention, Atlanta, GA. https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf
Regulatory Requirements for Safe Non-Opioid and Opioid Prescribing Paper.
The APRN must be knowledgeable of their state’s regulatory laws as it pertains to
prescribing non-scheduled and scheduled medications across the lifespan.
Review state regulations for APRN prescribers in the state in which you live or
the state where you plan to be certified. Review the CDC Interactive Training Series
for Healthcare Providers in Module 1 and Module 4
1. Summarize which agency/agencies regulate/oversee APRN prescribing in your
2. Summarize the educational requirements for prescribing as an APRN
3. Differentiate the regulations in your current state and state(s) you are considering
practicing in or a neighboring state.
4. Create an outline of the actions required to prescribe in your identified state.
5. Summarize the Controlled Substances regulations in your state and the process
for obtaining your DEA registration.
6. Summarize the main concepts for CDC Module 1 and Module 4.
7. Conclude the paper describing your plan for implementing safe prescribing
practices as an APRN addressing California state’s regulations and the CDC
8. Use APA format for your write up and cite any resources/evidence that you
have utilized. The paper is to be 2500-4500 words, excluding title page and
● Due: Monday, 11:59 pm PT, Week 6
● Length: 2500, excluding title page and references.
● Format: APA Style, including citations and references