BILL ANALYSIS Ó SB 493 Page 1 Date of Hearing: August 6, 2013 ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER PROTECTION Susan A. Bonilla, Chair SB 493 (Hernandez) - As Amended: August 5, 2013 SENATE VOTE : 34-4 SUBJECT : Pharmacy practice. SUMMARY : Expands the pharmacist scope of practice 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. 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. If the patient does not have a primary care provider, the SB 493 Page 2 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. 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. 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 SB 493 Page 3 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 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, 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; c) File an application and pay the applicable fee with BOP for recognition as an APP. 14)States that an APP recognition shall be valid for two years, coterminous with the certificate holder's license to practice pharmacy. SB 493 Page 4 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 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 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. 20)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. 21)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. 22)Requires an APP to personally register with the federal Drug SB 493 Page 5 Enforcement Administration (DEA) prior to initiating or adjusting a controlled substance therapy. 23)Permits a pharmacist to independently initiate and administer 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. 24)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. 25)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; SB 493 Page 6 b) The pharmacist notifies the patient's primary care provider of any drugs or devices furnished to the patient. 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. 26)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. 27)Authorizes an APP to practice advanced practice pharmacy inside or outside of a licensed pharmacy, as specified. 28)Makes a legislative declaration that pharmacists are health care providers who have the authority to provide health care services. 29)Makes other technical and clarifying amendments. 30)States that no reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution 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, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution. EXISTING LAW : 1)Establishes the Pharmacy Law which provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of SB 493 Page 7 dangerous drugs or devices by BOP and establishes a scope of practice for pharmacy as a profession. (Business and Professions Code (BPC) Sections 4000 et seq.) 2)Declares the practice of pharmacy as a profession which is dynamic, patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes, and further provides that pharmacy practice is continually evolving to include more sophisticated and comprehensive patient care activities. (BPC 4050) 3)Permits a pharmacist to initiate a prescription and provide clinical advice, information or patient consultation, as specified. (BPC 4051) 4)Permits a pharmacist to furnish emergency contraception drug therapy and administer immunizations pursuant to a protocol with a prescriber. (BPC 4052) 5)Requires a pharmacist who is authorized to issue an order to initiate or adjust a controlled substance therapy to register with the DEA. (BPC 4052 (b)) 6)Permits pharmacists to perform the following procedures under physician protocols in licensed health care facilities: a) Order and perform routine drug therapy-related patient assessment procedures including temperature, pulse, and respiration; b) Order drug therapy-related laboratory tests; c) Administer drugs and biologicals by injection pursuant to a prescriber's order; and, d) Initiate or adjust a patient's drug regimen pursuant to authorization or order by the patient's prescriber and in accordance with the policies, procedures, or protocols of the licensed health care facility. (BPC 4052.1) 7)Permits pharmacists in specified settings who act as part of a multidisciplinary group to initiate or adjust a patient's drug regimen pursuant to authorization or order by the patient's SB 493 Page 8 treating prescriber. Prohibits the substitution or selection of a different drug unless authorized by protocol and requires prescriber notification of initiated drug regimens to be transmitted within 24 hours. (BPC 4052.2) 8)Requires pharmacists performing specified procedures to have successfully completed clinical residency training or demonstrated clinical experience in direct patient care delivery. (BPC 4052.2) 9)Permits a pharmacist to furnish emergency contraception drug therapy in accordance with either standardized procedures or protocols developed by the pharmacist and an authorized provider or standardized procedures developed and approved by MBC in consultation with the American College of Obstetricians and Gynecologists, California Pharmacists Association and other entities. (BPC 4052.3) 10)Authorizes pharmacists filling prescription orders for drug products prescribed by their trade or brand names to substitute a generic drug product, as specified, unless the prescriber specifies that a pharmacist may not substitute another drug product by either indicating on the form submitted for the filling of the prescription drug orders "Do not substitute" or words of similar meaning or selecting a box on the form marked "Do not substitute." (BPC 4073) FISCAL EFFECT : Unknown 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 the recognition of and expanded scope for advanced practice pharmacists and establishes for. This bill is author-sponsored. 2)Author's statement . According to the author, "[SB 493] will establish 'advanced practice pharmacist' recognition, allowing such pharmacists to perform physical assessments; order and interpret medication-related tests; refer patients to other providers; initiate, adjust, and discontinue medications under SB 493 Page 9 physician protocol or as part of an integrated system such as an [accountable care organization]; and participate in the evaluation and management of health conditions in collaboration with other providers. This will align California law more consistently with federal programs such as the Department of Defense, the Veterans Administration, and Indian Health Service, where pharmacists have been practicing in this collaborative way for over 40 years." 8)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 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. 31 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. 9)The Affordable Care Act (ACA) . The federal Affordable Care Act (ACA) was passed in March 2010 to provide quality, 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 SB 493 Page 10 Patient and Health System Outcomes through Advanced Pharmacy Practice, A Report to the U.S. Surgeon General," in which it was demonstrated that "though 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 by: a) Performing patient assessments and developing therapeutic plans; b) Utilizing authorities to initiate, adjust, or discontinue medications; c) Ordering, interpreting, and monitoring appropriate laboratory tests; d) Providing care coordination and other healthcare services for wellness and prevention; and, e) Developing partnerships with patients for ongoing and follow-up care. 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. 1)Arguments in support . The California Pharmacists Association writes, "Health experts agree that team-based delivery models such as Patient Centered Medical Homes, and payment models like Accountable Care Organizations, represent our best opportunities at achieving the ACA triple aim of improving quality and patient satisfaction, improving health outcomes, and reducing per capita cost. "SB 493 seeks to hold true to these principles by including pharmacists as members of the care team with authorities consistent with their education and expertise. Pharmacists are the foremost experts in medications and more than 80% of health conditions are treated with prescription medications. SB 493 Page 11 Many chronic diseases like hypertension, diabetes, and high cholesterol require ongoing management to ensure the maximum efficacy of the medications. The model that SB 493 promotes is consistent with models that have been shown to be effective and with the CDC's recommendation for incorporating pharmacists into team-based strategies for preventing and managing chronic disease. "To be clear, pharmacists are not looking to replace other healthcare providers or fragment the delivery of care. Rather, they are looking to expand their current statutory authorities into new systems of care, which will allow them, as community-based providers, to assist physicians and other healthcare practitioners in expanding access and improving care. SB 493 ensures pharmacists are able to participate in team-based care consistent with their level of training." 2)Arguments in opposition . The Union of American Physicians and Dentists write, "UAPD/AFSCME applauds the author of SB 493 in attempting to expand health care access to residents of California. SB 493 is not, however, a step in the right direction. The legislation does not expand health care access for residents of the State. Instead, SB 493 rolls out an uncertain and untested health care delivery system? with patients subject to adverse side effects resulting from prescribing pharmacists. Moreover, physicians are trained to respond in the event of such adverse side effects to medications. Pharmacists lack the medical training to respond to these patient crises. Medical collaboration with pharmacists remains critical to safe patient outcomes!" 3)Related legislation . SB 491 (Hernandez) of 2013 permits a nurse practitioner (NP) to practice independently after a period of physician supervision if the NP has national certification and liability insurance. SB 491 is pending in the Assembly Business, Professions and Consumer Protection Committee. SB 492 (Hernandez) of 2013 would expand the scope of practice for optometrists. SB 492 is pending in the Assembly Business, Professions and Consumer Protection Committee. 4)Previous legislation . AB 1711 (Strickland) Chapter 58, Statutes of 2005, authorized a registered nurse or licensed pharmacist to administer influenza and pneumococcal SB 493 Page 12 immunizations without patient-specific orders, as specified. AB 2660 (Leno) Chapter 191, Statutes of 2004, authorized pharmacists to register with the DEA and initiate or adjust controlled substance drug therapy under specified conditions. SB 490 (Alpert) Chapter 651, Statutes of 2003, authorized a licensed pharmacist to initiate emergency contraceptives in accordance with a standardized procedure approved by BOP and MBC. REGISTERED SUPPORT / OPPOSITION : Support American Society of Health-System Pharmacists Bay Area Council Blue Shield of California California Association for Nurse Practitioners California Association of Physician Groups California Association of Public Hospitals and Health Systems California Chronic Care Coalition California Family Health Council California Hospital Association California Immunization Coalition California Korean American Pharmacists Association California Northstate University, College of Pharmacy California Optometric Association California Primary Care Association California Pharmacists Association California Retailers Association California Society of Health-System Pharmacists California State Board of Pharmacy Californians for Patient Care Cedars-Sinai Medical Center Indian Pharmacists Association of California Kaiser Permanente Loma Linda University School of Pharmacy Medical Board of California National Asian American Coalition National Association of Chain Drug Stores Pharmacy Choice and Access Now Private Essential Access Community Hospitals Safeway SB 493 Page 13 Sharp HealthCare The United Nurses Association of California/Union of Health Care Professionals The University of California Touro University California, College of Pharmacy United Nurses Associations of California/Union of Health Care Professionals University of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences University of California, San Francisco University of Southern California School of Pharmacy Western University of Health Sciences 211 individuals Opposition Blind Childrens Center California Academy of Eye Physicians and Surgeons California Academy of Family Physicians California Chapter of the American College of Emergency Physicians California Psychiatric Association California Right to Life Committee, Inc. California Society of Anesthesiologists California Society of Plastic Surgeons Canvasback Missions, Inc. Diabetes Coalition of California Here For Them, Inc. Latino Physicians of California Let's Face it Together Lighthouse for Christ Mission Minority Health Institute, Inc. The Dream Machine Foundation Time for Change Foundation Union of American Physicians and Dentists (UAPD/AFSCME) Ventura County American Chinese Medical Dental Association 207 individuals Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916) 319-3301 SB 493 Page 14