BILL ANALYSIS Ó SB 493 Page 1 SENATE THIRD READING SB 493 (Ed Hernandez) As Amended September 6, 2013 Majority vote SENATE VOTE : 34-4 BUSINESS & PROFESSIONS 14-0 HEALTH 18-0 ----------------------------------------------------------------- |Ayes:|Bonilla, Jones, |Ayes:|Pan, Ammiano, Atkins, | | |Bocanegra, Campos, | |Bonilla, Bonta, Chesbro, | | |Dickinson, Eggman, | |Gomez, | | |Gordon, Hagman, Holden, | |Roger Hernández, | | |Maienschein, Mullin, | |Lowenthal, Maienschein, | | |Skinner, Ting, Wilk | |Mansoor, Mitchell, | | | | |Nazarian, Nestande, V. | | | | |Manuel Pérez, Wagner, | | | | |Wieckowski, Wilk | ----------------------------------------------------------------- APPROPRIATIONS 16-0 ----------------------------------------------------------------- |Ayes:|Gatto, Harkey, Bigelow, | | | | |Bocanegra, Bradford, Ian | | | | |Calderon, Campos, Eggman, | | | | |Gomez, Hall, Holden, | | | | |Linder, Pan, Quirk, | | | | |Wagner, Weber | | | |-----+--------------------------+-----+--------------------------| | | | | | ----------------------------------------------------------------- SUMMARY : Expands the scope of practice of a pharmacist to recognize an "advanced practice pharmacist"; permits pharmacists to furnish certain hormonal contraceptives, nicotine replacement products, and prescription medications for travel, as specified; and authorizes pharmacists to independently initiate and administer certain vaccines and treatments for severe allergic reactions. Specifically, this bill : 1)Permits a pharmacist to provide clinical services if the clinical services are provided to a health care professional or to a patient. SB 493 Page 2 2)Permits a pharmacist to provide consultation, training, and education to patients about drug therapy, disease management, and disease prevention. 3)Permits a pharmacist to participate in a multidisciplinary review of patient progress, including appropriate access to medical records. 4)Permits a pharmacist to furnish the following medications: a) Self-administered hormonal contraceptives, as specified; b) Nicotine replacement products, as specified; and, c) Prescription medications not requiring a diagnosis that are recommended by the federal Centers for Disease Control and Prevention (CDC) for individuals traveling outside of the United States. 5)Requires a pharmacist to notify the patient's primary care provider of any drugs or devices furnished to the patient, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist must provide the patient with a written record of the drugs or devices furnished and advise the patient to consult a physician of the patient's choice. 6)Permits a pharmacist to order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies, and requires a pharmacist who orders and interprets tests to ensure that the ordering of those tests is done in coordination with the patient's primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient's diagnosing prescriber or entering the appropriate information in a patient record system shared with the prescriber, when available and as permitted by that prescriber. 7)Requires a pharmacist to dispense self-administered hormonal contraceptives legally prescribed or ordered for a patient unless certain circumstances exist, including the absence of stock, objection on personal religious grounds, or belief of the pharmacist that a harmful drug interaction would result. SB 493 Page 3 8)Permits a pharmacist to furnish self-administered hormonal contraceptives in accordance with standardized procedures or protocols developed and approved by both the Board of Pharmacy (BOP) and the Medical Board of California (MBC) in consultation with the American Congress of Obstetricians and Gynecologists, the California Pharmacists Association, and other appropriate entities. The standardized procedure or protocol shall require that the patient use a self-screening tool that will identify patient risk factors for use of self-administered hormonal contraceptives, and that the pharmacist refer the patient, as specified, upon furnishing a self-administered hormonal contraceptive, or if it is determined that use of a self-administered hormonal contraceptive is not recommended. 9)States that BOP and MBC are both authorized to ensure compliance with the administration of hormonal contraceptives by pharmacists, and each board is specifically charged with the enforcement with respect to its respective licensees. States that a pharmacist's ability to furnish self-administered hormonal contraceptives does not expand the authority of a pharmacist to prescribe any prescription medication. 10)Requires a pharmacist to provide the recipient of self-administered hormonal contraception with a standardized fact sheet that includes, but is not limited to, the indications and contraindications for use of the drug, the appropriate method for using the drug, the need for medical follow-up, and other appropriate information. Requires BOP to develop this form in consultation with the State Department of Public Health, the American Congress of Obstetricians and Gynecologists, the California Pharmacists Association, and other health care organizations. States that the use of existing publications developed by nationally recognized medical organizations is not precluded. 11)Clarifies that this bill does not expand the authority of a pharmacist to prescribe any prescription medication. 12)Defines an "advanced practice pharmacist" (APP) as a licensed pharmacist who has been recognized as an advanced practice pharmacist by BOP, as specified. 13)Requires a pharmacist seeking recognition as an APP to meet SB 493 Page 4 the following requirements: a) Hold an active license to practice pharmacy issued pursuant to this chapter that is in good standing. b) Satisfy any two of the following criteria: i) Earn certification in a relevant area of practice, including, but not limited to, ambulatory care, critical care, geriatric pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric pharmacy, from an organization recognized by the Accreditation Council for Pharmacy Education or another entity recognized by BOP; ii) Complete a one-year postgraduate residency through an accredited postgraduate institution where at least 50% of the experience includes the provision of direct patient care services with interdisciplinary teams; or, iii) Have provided clinical services to patients for at least one year under a collaborative practice agreement or protocol with a physician, APP, pharmacist practicing collaborative drug therapy management, or health system; and, c) File an application and pay the applicable fee with BOP for recognition as an APP. 14)States that APP recognition shall be valid for two years, coterminous with the certificate holder's license to practice pharmacy. 15)Requires BOP to adopt regulations establishing the means of documenting completion of the requirements in this section. 16)Requires BOP to adopt regulations setting the fee for the issuance and renewal of APP recognition at the reasonable cost of regulating APPs, which shall not exceed $300. 17)Requires an APP to complete 10 hours of continuing education each renewal cycle in a subject matter relevant to the pharmacist's clinical practice. 18)Permits a pharmacist recognized by BOP as an APP to do all of SB 493 Page 5 the following: a) Perform patient assessments; b) Order and interpret drug therapy-related tests; c) Refer patients to other health care providers; d) Participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers; and, e) Initiate, adjust, or discontinue drug therapy, as specified. 19)Requires an APP who orders and interprets tests to ensure that the ordering of those tests is done in coordination with the patient's primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient's diagnosing prescriber or entering the appropriate information in a patient record system shared with the prescriber, when available and as permitted by that prescriber. 20)Requires an APP who initiates, adjusts, or discontinues drug therapy to promptly transmit written notification to the patient's diagnosing prescriber or enter the appropriate information in a patient record system shared with the prescriber, as permitted by that prescriber. 21)Requires an APP who initiates drug therapy to promptly transmit written notification to, or enter the appropriate information into, a patient record system shared with the patient's primary care provider or diagnosing provider, as permitted by that provider. 22)States that an APP's abilities shall not interfere with a physician's order to dispense a prescription drug as written, or other order of similar meaning. 23)Requires an APP to personally register with the federal Drug Enforcement Administration (DEA) prior to initiating or adjusting a controlled substance therapy. 24)Permits a pharmacist to independently initiate and administer SB 493 Page 6 vaccines listed on the routine immunization schedules recommended by the federal Advisory Committee on Immunization Practices (ACIP), in compliance with individual ACIP vaccine recommendations, and published by the CDC for persons three years of age and older if the pharmacist: a) Completes an immunization training program endorsed by the CDC or the Accreditation Council for Pharmacy Education that, at a minimum, includes hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines, and maintains that training; b) Is certified in basic life support; and, c) Complies with all state and federal recordkeeping and reporting requirements, including providing documentation to the patient's primary care provider and entering information in the appropriate immunization registry designated by the immunization branch of the State Department of Public Health. 25)Permits a pharmacist to initiate and administer epinephrine or diphenhydramine by injection for the treatment of a severe allergic reaction either pursuant to protocols, or under the requirements for administering vaccines to persons three years of age and older. 26)Permits a pharmacist to furnish nicotine replacement products approved by the federal Food and Drug Administration for use by prescription only in accordance with standardized procedures and protocols developed and approved by both BOP and MBC in consultation with other appropriate entities and provide smoking cessation services if all of the following conditions are met: a) The pharmacist maintains records of all prescription drugs and devices furnished for a period of at least three years for purposes of notifying other health care providers and monitoring the patient; b) The pharmacist notifies the patient's primary care provider of any drugs or devices furnished to the patient, or enters the appropriate information in a patient record system shared with the primary care provider, as permitted SB 493 Page 7 by that primary care provider. If the patient does not have a primary care provider, the pharmacist provides the patient with a written record of the drugs or devices furnished and advises the patient to consult a physician of the patient's choice; c) The pharmacist is certified in smoking cessation therapy by an organization recognized by BOP; and, d) The pharmacist completes one hour of continuing education focused on smoking cessation therapy biennially. 27)Authorizes BOP and MBC to ensure that pharmacists are compliant with the requirements for furnishing nicotine replacement products, and states that each board is specifically charged with the enforcement of this section with respect to their respective licensees. States that nothing in the ability for pharmacists to furnish nicotine replacement products shall be construed to expand the authority of a pharmacist to prescribe any other prescription medication. 28)Authorizes an APP to practice advanced practice pharmacy inside or outside of a licensed pharmacy, as specified. 29)Makes a legislative declaration that pharmacists are health care providers who have the authority to provide health care services. 30)Makes other technical and clarifying amendments. 31)Adds language to avoid chaptering out issues with SB 205 (Corbett) of the current legislative session. 32)States that no reimbursement is required because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, changes the penalty for a crime or infraction, or changes the definition of a crime. FISCAL EFFECT : According to Assembly Appropriations Committee, all costs would accrue to the Pharmacy Board Contingent Fund. 1)One-time costs to BOP of $100,000 for regulations establishing APP recognition process, rules, and fees. In addition, SB 493 Page 8 one-time costs of $20,000 to modify information technology systems to accommodate a new licensure type. 2)Ongoing costs of approximately $300,000 annually for licensing and regulation of APPs. 3)Potential fee revenues of approximately $300,000 annually. 4)Unknown potential increase in enforcement costs. Since the activities permitted under this bill are newly allowed for pharmacists outside the supervision of a physician, it is unclear whether or how many increased complaints may occur. The Department of Justice (DOJ) and/or the BOP may experience increased enforcement costs; any DOJ costs would be reimbursed by the Pharmacy Board Contingent Fund. 5)The net effect on health care costs from expanding the role of pharmacists in delivery of care is unclear. Increased access to care may result in increased costs due to greater utilization, which could be counterbalanced by cost savings related to improved medication adherence, reduced hospital readmissions, and other benefits stemming from provision of care pharmacists would provide. COMMENTS : 1)Purpose of this bill . This bill further develops the pharmacists' role as part of a primary care team by expanding pharmacists' scope of practice to allow for more autonomy in furnishing certain drugs and devices pursuant to standardized procedures and protocols. It also provides for an expanded scope for, the recognition of, advanced practice pharmacists. This bill is author-sponsored. 2)The profession of pharmacy . California licensed pharmacists are required to have at least a baccalaureate degree in pharmacy from a specially accredited college of pharmacy program, have completed 1,500 intern hours of pharmacy practice experience, and have passed a national and state exam. There are 38,440 licensed pharmacists in California. Pharmacists consistently rank amongst the most trusted healthcare personnel in nationwide Gallup polls and have a broader knowledge of medicines, both prescription and over-the-counter, than any other member of the health care SB 493 Page 9 team. According to a 2012 report by the CDC, engaging pharmacists as members of the health care system can significantly improve treatment of diabetes, better control high blood pressure, improve management of cholesterol, and reduce overall health care costs. Thirty-one states, including California, have laws that allow physicians and pharmacists to collaborate in providing advanced services such as those authorized by this bill. This bill will permit APPs to perform patient assessments, order and interpret drug therapy-related tests, participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers; and initiate, adjust, or discontinue drug therapy in certain circumstances. 3)The Affordable Care Act (ACA) . The federal Affordable Care Act (ACA) was passed in March 2010 to provide affordable healthcare for all Americans and improve the quality and efficiency of that care. The January 2014 implementation date of ACA will result in millions more Californians entering the primary care market. The CDC argues that pharmacists are well positioned to augment primary care teams and help manage patient's medications and chronic conditions. The U.S. Department of Health and Human Services (HHS) authored a 2011 report, entitled "Improving Patient and Health System Outcomes through Advanced Pharmacy Practice, A Report to the U.S. Surgeon General," in which it was demonstrated that "through evidence-based outcomes, many expanded pharmacy practice models, implemented in collaboration with physicians or as part of a health team, improve patient and health system outcomes and optimize primary care access and delivery." The report recommended that pharmacists work in collaboration with physicians and primary care clinicians. This measure builds upon pharmacists' current scope of practice to more fully enable them to participate in a multidisciplinary patient management team, and provides for the recognition of APPs, who would be able to provide many of the advanced health management techniques recommended by the HHS report. SB 493 Page 10 Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916) 319-3301 FN: 0002550