BILL ANALYSIS Ó ----------------------------------------------------------------------- | Hearing Date:April 29, 2013 |Bill No:SB | | |493 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Curren D. Price, Jr., Chair Bill No: SB 493Author:Hernandez As Amended:April 24, 2013Fiscal: Yes SUBJECT: Pharmacy practice. SUMMARY: Updates Pharmacy Law to authorize pharmacists to perform certain functions according to specified requirements, including: administer physician prescribed injectable medications; furnish immunizations for people ages three and up if the pharmacist has completed training and follows specified procedures; furnish self-administered hormonal contraceptives, based on a statewide protocol, similar to the existing authority for pharmacists to furnish emergency contraceptive drug therapy; furnish smoking cessation drugs and devices if the pharmacist has completed training and follows specified procedures; furnish travel medications approved by the U.S. State Department; and, order and interpret tests to monitor drug safety. Establishes "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 physician protocol or as part of an integrated system and; participate in the evaluation and management of health conditions in collaboration with other providers. Existing law, the Business and Professions Code (BPC): 1) Establishes the Pharmacy Law which provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board of Pharmacy (Board) within the Department of Consumer Affairs (DCA) and establishes a scope of practice for pharmacy as a profession. 2) Defines "furnish" as supply by any means, by sale or otherwise. SB 493 Page 2 (BPC § 4026) 3) Defines "dispense" as the furnishing of drugs or devices upon a prescription from a physician, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor or upon an order to furnish drugs or transmit a prescription from a certified nurse-midwife, nurse practitioner, physician assistant, naturopathic doctor, or pharmacist acting within the scope of his or her practice. Dispense also means and refers to the furnishing of drugs or devices directly to a patient by a physician, dentist, optometrist, podiatrist, or veterinarian, or by a certified nurse-midwife, nurse practitioner, naturopathic doctor, or physician assistant acting within the scope of his or her practice. (BPC § 4024) 4) Declares the practice of pharmacy as a profession which is dynamic, patient-oriented health service that 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. Provides that pharmacy practice is continually evolving to include more sophisticated and comprehensive patient care activities. (BPC § 4050) 5) Permits a pharmacist to initiate a prescription according to certain requirements. Permits a pharmacist to provide clinical advice, information or patient consultation if as follows: (BPC § 4051 (b)) a) The advice, information or consultation is provided to a health care professional or patient. b) The pharmacist has access to prescription, patient profile or other relevant medical information for purposes of patient and clinical consultation and advice. c) Access to the information is secure from unauthorized use. 6)Permits a pharmacist to: (BPC § 4052) a) Furnish a reasonable quantity of compounded drug product to a prescriber for use in his or her office. b) Transmit a valid prescription to another pharmacist. c) Administer, orally or topically, drugs and biologicals pursuant to a prescriber's order. d) Perform certain procedures or functions in a licensed health care facility. e) Perform certain procedures or functions as part of the care provided by a health care facility, licensed home health agency, licensed clinic in which there is a physician SB 493 Page 3 oversight, provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that plan or a physician. f) Manufacture, measure, fit to the patient or sell and repair dangerous devices or furnish instructions to a patient or patient's representative concerning the use of those devices. g) Provide consultation to patients and professional information, including clinical or pharmacological information, advice or consultation to other health professionals. h) Furnish emergency contraception drug therapy. i) Administer immunizations pursuant to a protocol with a prescriber. 7) Provides that a pharmacist authorized to issue an order to initiate or adjust a controlled substance therapy shall register with the federal Drug Enforcement Administration (DEA). (BPC § 4052 (b)) 8) Permits pharmacists to perform the following procedures under physician protocols in licensed health care facilities: (BPC §4052.1) a) Order and perform routine drug therapy-related patient assessment procedures. b) Order drug therapy-related laboratory tests. c) Administer drugs and biologicals by injection pursuant to a prescriber's order. d) Initiate or adjust a patient's drug regimen pursuant to authorization or order by the patient's prescriber. 9)Permits pharmacists in a number of specified settings to do the following: (BPC § 4052.2) a) Order and perform routine drug therapy-related patient assessment procedures. b) Order drug therapy-related laboratory tests. c) Administer drugs and biologicals by injection pursuant to a prescriber's order. d) Initiate or adjust a patient's drug regimen pursuant to authorization or order by the patient's 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. e) Specifies that a patient's treating prescriber may SB 493 Page 4 prohibit pharmacists from making any changes or adjustments to patients' drug regimens. f) Requires the governing policies, procedures and protocols to be developed by specified health professionals and established minimum requirements for those policies, procedures and protocols. g) Requires pharmacists performing procedures authorized by this section to have successfully completed clinical residency training or demonstrated clinical experience in direct patient care delivery. 10)Permits a pharmacist to furnish emergency contraception drug therapy (ECDT) in accordance with either standardized procedures or protocols developed by the pharmacist and an authorized provider or standardized procedures developed and approved by the Board and Medical Board of California (MBC) in consultation with the American College of Obstetricians and Gynecologists (ACOG), California Pharmacists Association (CPhA) and other entities. Provides that the Board and MBC have authority to ensure compliance and charges both boards with enforcing this provision for its licensees. Requires a pharmacist to complete a training program on emergency contraception that consists of at least one hour of approved continuing education on ECDT prior to furnishing emergency contraception drug therapy. Provides that a pharmacist, pharmacist's employer or pharmacist's agent may charge a patient an administrative fee of up to $10 above the retail cost of the drug but may not charge a patient a separate consultation fee for ECDT services. Prohibits a pharmacist from requiring a patient to provide individually identifiable medical information unless otherwise specified before initiating ECDT. Requires a pharmacist to provide ECDT recipients standardized factsheets developed in consultation with the State Department of Public Health (DPH), ACOG, CPhA and other health care organizations that include indications for use of the drug, appropriate method for use, need for medical followup and other appropriate information. Makes this inoperative if ECDT are reclassified as over-the-counter products by the FDA. (BPC § 4052.3) 11)Specifies certain requirements regarding the dispensing and furnishing of dangerous drugs and devices, and prohibits a person from furnishing any dangerous drug or device except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian or naturopathic doctor. (BPC § 4059) 12)Authorizes pharmacists filling prescription orders for drug products prescribed by their trade or brand names to substitute a SB 493 Page 5 drug product with a different form of medication with the same active chemical ingredients of equivalent strength and duration of therapy as the prescribed drug product when the change will improve the ability of the patient to comply with the prescribed drug therapy, subject to a patient notification and bottle labeling requirement, 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 § 4052.5) 13)Authorizes pharmacists filling prescription orders for drug products prescribed by their trade or brand names to substitute generic drugs for orders if the generic contains the same active chemical ingredients of equivalent strength and duration of therapy, subject to a patient notification and bottle labeling requirement, 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) 14)Specifies that dispensing of drugs in a non-profit community clinic or primary care clinic, as defined, shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations. (BPC § 4181) 15)Requires pharmacists to submit proof of completion of 30 hours of approved continuing pharmacy education (CE) prior to license renewal. (BPC § 4231) This bill: 1) Makes various technical and clarifying changes. 2) Defines "advanced practice pharmacist" (APP) as a licensed pharmacist who has been recognized as an advanced practice pharmacist by the Board. Specifies that a Board-recognized APP is entitled to practice advanced practice pharmacy as described in Section 4052.6, within or outside of a licensed pharmacy as authorized by this chapter. 3) Declares that pharmacists are health care providers who have the authority to provide health care services. SB 493 Page 6 4) Deletes the requirement that pharmacists only administer drugs and biological products orally or topically and instead permits pharmacists to administer drugs and biological products by other means including injection that have been ordered by a prescriber. 5) Permits an APP to perform specified procedures or functions. 6) Permits a pharmacist to provide consultation, training and education about drug therapy, disease management and disease prevention. 7) Permits a pharmacist to participate in multidisciplinary review of patient progress, including appropriate access to medical records. 8) Permits a pharmacist to furnish self-administered hormonal contraceptives, smoking cessation drugs and devices and prescription medications not requiring a diagnosis that are recommended by the CDC for individuals traveling outside of the U.S., in addition to ECDT. 9) Permits a pharmacist to administer immunizations pursuant to a protocol with a prescriber. 10)Permits a pharmacist to order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies. 11)Permits a pharmacist to furnish self-administered hormonal contraceptives in accordance with procedures and protocols developed and approved by the Board and the MBC in consultation with ACOG, CPhA and other appropriate entities. Specifies that procedures or protocols shall require the patient to use a self-screening tool based on the United States Medical Eligibility Criteria for Contraceptive Use developed by the federal Centers for Disease Control and Prevention (CDC) and that the pharmacist refer the patient to their primary care provider or to nearby clinics. Provides that the Board and the MBC have authority to ensure compliance and charges both boards with enforcing this provision for its licensees. Clarifies that this does not expand the authority of a pharmacist to prescribe any prescription medication. 12)Expands the requirements in current law for providing ECDT recipients standardized factsheets to include patients receiving self-administered hormonal contraception and requires contraindications of the drugs to be included on fact sheets. SB 493 Page 7 13)Provides that a pharmacist recognized by the Board as an APP is permitted 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 or management of diseases and health conditions in collaboration with other health care providers. e) Initiate, adjust or discontinue drug therapy pursuant to the authority established in current law for pharmacists to perform certain procedures in a licensed health care facility. 1) Provides that a pharmacist who adjusts or discontinues drug therapy shall promptly transmit written notification to the patient's diagnosing prescriber or enter the appropriate information into a patient record system shared with the prescriber. Provides that a pharmacist who initiates drug therapy shall promptly transmit written notification to the patient's diagnosing prescriber or enter the appropriate information into a patient record system shared with the prescriber. 2) Requires a pharmacist to register with the DEA prior to initiating or adjusting a controlled substance. 3) Permits a pharmacist to independently initiate and administer vaccines listed on the routine immunization schedules recommended by the federal Advisory Committee on Immunization Practices for persons ages three and older. 4) Requires a pharmacist, in order to initiate and administer vaccines, to do all of the following: a) Complete an immunization training program endorsed by the CDC or Accreditation Council for Pharmacy Education that includes hands-on injection technique, clinical evaluation of indications and contraindications of vaccines and recognizing and treating emergency reactions to vaccines. b) Be certified in basic life support. c) Comply with all federal and state 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 CDC. 1) Permits a pharmacist who has met the requirements for initiating SB 493 Page 8 and administering vaccines to also initiate and administer epinephrine or diphenhydramine by injection for the treatment of a severe allergic reaction. 2) Permits a pharmacist to furnish prescription smoking cessation drugs and devices, 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 provides the patient with a written record of the drugs or devices if the patient does not have a primary care provider 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 the Board. d) The pharmacist completes one hour of continuing education focused on smoking-cessation biennially. 21) Provides that in order to be recognized as an APP, a person must meet all of the following requirements: a) Hold an active license with the Board and be in good standing. b) File an application with the Board for recognition as an APP. c) Pay the applicable fee to the Board. 22)Provides that in order to be recognized as an APP, a person must satisfy two of the following criteria: a) Possess certification in a relevant area of practice, including but not limited to, ambulatory 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 other entity recognized by the Board. b) Complete a one year postgraduate residency through an accredited postgraduate institution where at least 50 percent of the experience includes a provision of direct patient care services with interdisciplinary teams. SB 493 Page 9 c) Have actively managed 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. 23)Provides that APP recognition is valid for two years. 24)Requires the Board to adopt regulations establishing the means of documenting completion of the requirements for an APP. 25)Requires an APP to complete 10 hours of continuing education (CE) each license renewal cycle for a subject matter in one or more areas relevant to a pharmacist's clinical practice, in addition to current CE requirements. FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by Legislative Counsel. COMMENTS: 1.Purpose. This measure is sponsored by the Author. According to the Author, pharmacists provide patient care that optimizes medication therapy and promotes health, wellness, and disease prevention. The Author states that pharmacists complete a four year post-graduate doctoral training program that includes extensive training in human anatomy and physiology, recognition and treatment of diseases and conditions, pharmacology, optimal medication use, as well as experience in direct patient care in multiple health care settings through clinical rotations. The Author further acknowledges that many pharmacists complete a residency program and obtain board certification in a specialized area of practice. According to the Author, this bill 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. The Author believes that "Californians deserve access to high quality primary care offered by a range of safe, efficient, and regulated providers. Physician assistants, nurse practitioners, pharmacists and optometrists have all significantly advanced their educational, testing, and certification programs over the past decade. They've enhanced clinical training, moved to graduate or advanced degrees, and upgraded program accreditation processes." 2.Background. SB 493 Page 10 a) The Patient Protection and Affordable Care Act. On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA) into federal statute. The ACA, which states will begin implementing in 2014, represents one of the most significant expansions and overhauls of the United States health care system since the passage of Medicare and Medicaid in 1965. The ACA is aimed at increasing the rate of health insurance coverage for Americans and reducing the overall costs of health care. It provides a number of mechanisms including mandates, subsidies and tax credits to employers and individuals in order to increase the rate of people with coverage. As a result of implementation of the ACA, anywhere from 4-7 million additional Californians will be eligible for health insurance beginning in 2014. It is anticipated that the newly insured will increase demand for health care on an already strained system. b) Primary Care Workforce Shortage. The Author provided a number of studies and reports highlighting a shortage in California of primary care physicians. According to a report commissioned by the California Health Care Foundation, Fewer and More Specialized: A New Assessment of Physician Supply in California, the number of primary care physicians actively practicing in California is at the very bottom range of, or below, the state's need. The report found that the distribution of these physicians is also poor and that rural counties in particular suffer from low physician practice rates and a shortage of primary care physicians. According to the report, in 2008, there were 69,460 actively practicing physicians in California (a figure which includes Doctors of Medicine and Doctors of Osteopathic Medicine), but only 35 percent of these physicians reported practicing primary care. This equates to 63 active primary care physicians in patient care per 100,000 persons. According to the Council on Graduate Medical Education, which provides an ongoing assessment of physician workforce trends, training issues and financing policies, and recommends appropriate federal and private sector efforts on these issues, a range of 60 to 80 primary care physicians are needed per 100,000 in order to adequately meet the needs of the population. When the same metric is applied regionally, only 16 of California's 58 counties fall within the needed supply range for primary care physicians. Less than one third of Californians live in a community where they have access to the health care services they need. c) Pharmacists. According to a recent report by the Center for the Health Professions at the University of California, San SB 493 Page 11 Francisco, California's Health Care Workforce: Readiness for the ACA Era., as of February 2011, there were 29,245 individuals with a California address in possession of a current and valid license to practice as a registered pharmacist in the state. The report found that pharmacists are generally concentrated in the belt of counties stretching from the Bay Area eastward across the state and that several counties have very low license per 100,000 population rates, including Imperial, Kings, San Benito, Merced, Mariposa, Yuba, and Tehama counties. Based on the report findings, the range of 18 - 30 licenses per 100,000 population ratio would mean there are between .9 - 1.5 pharmacists for every 5,000 people. The number of pharmacists in California is only likely to grow. For a number of years, California had only three schools of pharmacy. Since the early 1990s, that number has increased to eight schools today, with plans underway for eight additional entities to open new schools of pharmacy in California in the next few years. This change alone would double the current number of schools, and presumably the number of California graduates which would in turn result in growing numbers of pharmacists eligible for licensure and ready to work. Pharmacists are already well placed in every community throughout the state to provide medication therapy management services; including in rural and inner city communities where primary care access is particularly impacted. Pharmacists provide patient care with a goal of optimizing medication therapy and promoting health, wellness, and disease prevention. Pharmacists complete a four year post-graduate doctoral training program that includes extensive training in human anatomy and physiology, recognition and treatment of diseases and conditions, pharmacology, optimal medication use, as well as experience in direct patient care in multiple health care settings through clinical rotations. Many pharmacists complete a residency program and obtain board certification in a specialized area of practice. Throughout the U.S., since 2003, all schools of pharmacy now only offer a doctorate in pharmacy (Pharm D) which includes course study on: Basic Life Support, Diagnosing & Disease State Management of Diabetes, Infectious Diseases, Hypertension, Heart Disease, Oncology; Immunization Training, Medication Management, Pharmacy Law/Administration, Pharmacy Practice, Therapeutic Drug Monitoring, Therapeutics. The Pharm D, which has been the sole degree awarded in California since the 1970s, includes over 1000 hours in pharmacology as well as clinical rotations, specifically one-two ambulatory rotations, SB 493 Page 12 one-three inpatient rotations, one or more retail rotations and one or more elective rotations in either geriatrics, long-term care or medication therapy management. Pharmacists may also choose to complete certificate programs focused on the management of specific disease or other certification to demonstrate competency and expertise in a certain area. In addition to meeting educational and experience requirements, an applicant for licensure as a pharmacist must take and pass both the North American Pharmacist Licensure Examination (NAPLEX) and the California Practice Standards and Jurisprudence Examination for Pharmacists (CPJE). A December 2012 New York Times editorial, part of a continuing examination by the paper of ways to cut medical costs while improving quality, highlighted using pharmacists to provide medical care as a sensible solution to the primary care shortage crisis and as a means of ensuring health care delivery to millions of new patients under ACA. Specifically, the editorial noted a report by the chief pharmacist of the U.S. Public Health Service who argued that pharmacists are underutilized given their education, training and closeness to their communities except for in the Department of Veterans Affairs (VA), Department of Defense (DOD) and Indian Health Service (IHS) where they deliver health care with minimal supervision. These federal pharmacists manage the care of patients when medications are the primary treatment and can start, stop or adjust medications, order and interpret laboratory tests and coordinate follow-up care. d) Scope of Practice and Access. Numerous entities have explored amending scope of practice laws at the state level as a means of meeting the overall goal of providing quality care and controlling long-term health care costs. A report from the Brookings Institution recommended creating incentives for states to amend scope of practice laws to allow for greater use of certain professions like nurse practitioners, pharmacists, physician assistants and community health workers. A 2010 white paper by the Citizen Advocacy Center in Washington D.C. addressed the role of states like California in addressing scope of practice, writing that scope of practice laws restrict health care professionals from "performing the full range of skills for which they have been trained" which in turns limits access to care and inflates health care costs. The paper also cited data from the National Practitioner Data Bank and Health Integrity and Protection Data Bank where no trends or observations suggesting increased liability for offices employing physician assistants or advanced practice nurses and that the inclusion of these SB 493 Page 13 professionals has been a safe and beneficial undertaking. 1.Specific Practices Authorized by SB 493. a) Permits pharmacists to administer physician prescribed injectable medications. Biological products are generally derived from living material, human, animal, or microorganism and FDA regulations specify that biological products include blood-derived products, vaccines, in vivo diagnostic allergenic products, immunoglobulin products, products containing cells or microorganisms, and most protein products. These treatments are not widespread but rather used as specialty drugs to treat serious conditions and diseases. In some instances, patients undergoing treatments for serious diseases receive biological injections, in addition to other infusion therapies and could access those drugs directly from a pharmacist under this bill. b) Permits pharmacists to furnish immunizations for people ages three and up if the pharmacist has completed specified training and follow specified procedures. Immunizations stand as a useful, cost-effective measure in promoting public health and preventing the spread of disease. According to the Institute of Medicine, more than 50,000 adults and 300 children die annually in the United States from diseases or complications arising from diseases that are considered vaccine-preventable. Studies show that immunizations assist in preventing an estimated 14 million cases of vaccine-preventable diseases and 33,000 cases of death. Vaccines against influenza have been especially useful in preventing the spread of that virus and have recently been at the center of a larger national and international vaccination conversation. While CDC recommends vaccination against influenza for over 70% of the population, actual rates of immunization are much lower. CDC estimates that 36,000 people die each year from influenza or its complications. The H1N1 outbreak of 2009 resulted in a CDC recommendation that everyone receive the vaccine. Yet access to immunizations can be compounded by a growing uninsured population in the state who may lack the ability to be seen in a physician's office. Pharmacies and pharmacists are able to play a unique role in contributing to higher access to immunizations. CDC's ACIP SB 493 Page 14 recommendations for 2008 call for vaccinations to be provided in alternative settings like pharmacies to help make progress toward achieving national health objectives. According to an article in the Journal of the American Pharmaceutical Association, "Pharmacists and Immunizations," Gallup Polls have consistently named the pharmacist among the most trusted professionals. People in many communities, especially rural areas, look to their community pharmacist for medical advice. This respect can be pivotal in helping educate parents and other adults about the importance of timely immunization. When parents and elderly patients pick up prescriptions, pharmacists can take advantage of their accessibility and reputation to ask them about their immunization status and counsel them on the importance of immunization. Pharmacies are located in many neighborhoods throughout the state, have extended hours of operation and have existing infrastructure to properly store vaccines. c) Permits a pharmacist to furnish self-administered hormonal contraceptives like the pill, the patch and the ring, based on a statewide protocol, similar to the existing authority for pharmacists to furnish ECDT. Hormonal contraceptives are made up of female sex hormones: estrogen or progestin (a synthetic form of progesterone). Organizations like the World Health Organization (WHO), ACOG and Planned Parenthood Federation of America have developed evidence-based guidelines for hormonal contraceptive use based on a self-reported medical history and measurement of blood pressure. All of these guidelines acknowledge that hormonal contraception can be safely provided and utilized without requiring a pelvic examination. The Institute of Medicine Committee (IOM) on Women's Health Research recently reported a universal need for making contraceptives more available, accessible, and acceptable (IOM, 2010b). They indicate the several barriers that women often face that keep them from being able to successfully and correctly utilize their birth control method. Among these are expensive co-pays, insurance coverage limitations on prescriptions, and the difficulty or delay when scheduling an office visit. Under the Department of Health and Human Services, and with guidance from the WHO, the CDC created the U.S. Medical Eligibility Criteria for Contraceptive Use 2010 (USMEC) and finalized the recommendations after consultation with a group of health professionals who met in Atlanta, Georgia, in February of SB 493 Page 15 2009. The WHO's guidance includes recommendations for the use of specific contraceptive methods by women and men who have certain characteristics or medical conditions. The majority of the U.S. guidance does not differ from the WHO guidance and covers more than 60 characteristics or medical conditions. However, some WHO recommendations were modified for use in the United States, including recommendations about contraceptive use for women with venous thromboembolism, valvular heart disease, ovarian cancer, and uterine fibroids and for women who experience postpartum depression or are breastfeeding. Recommendations were added to the U.S. guidance for women with rheumatoid arthritis, history of bariatric surgery, peripartum cardiomyopathy, endometrial hyperplasia, inflammatory bowel disease, and solid organ transplantation. The recommendations are intended to assist health-care providers when they counsel women, men, and couples about contraceptive method choice. Although the recommendations are meant to serve as a source of clinical guidance, the CDC cautioned that health-care providers should always consider the individual clinical circumstances of each person seeking family planning services. d) Permits a pharmacist to furnish smoking cessation drugs and devices if they have completed specified training and follow specified procedures. According to the CDC, tobacco use can lead to nicotine dependence and serious health problems. CDC states that cessation, a process of evaluation, education and support to aid patients who desire to stop smoking can provide many health benefits like: lowering the risk for lung and other types of cancer; reducing the risk for coronary heart disease, stroke, and peripheral vascular disease; reducing respiratory symptoms, such as coughing, wheezing, and shortness of breath; reducing the risk of developing chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the United States; decreasing women's risk for infertility or having a low birth weight baby. According to CDC, cessation treatment options currently include brief clinical interventions (i.e., when a doctor takes 10 minutes or less to deliver advice and assistance about quitting), counseling (e.g., individual, group, or telephone counseling), behavioral cessation therapies (e.g., training in problem solving) as well as over-the-counter medications like a nicotine patch, gum, lozenge and prescription medications like a nicotine inhaler, nasal spray and drugs like bupropion SR (Zyban) and varenicline tartrate (Chantix). SB 493 Page 16 Safeway Inc. recently partnered with the UCSF School of Pharmacy whereby Safeway's pharmacists will be trained in smoking-cessation counseling techniques using a program developed by UCSF pharmacy faculty. The project will allow smoking cessation intervention to be applied systematically across a network of pharmacies. e) Permits a pharmacist to furnish travel medications approved by the CDC. Recommendations for the use of vaccines and other biologic products (such as immune globulin products) in the U.S. are developed by the CDC Advisory Committee on Immunization Practices (ACIP) and other groups, such as the American Academy of Pediatrics. These recommendations are based on scientific evidence of benefits (immunity to the disease) and risks (vaccine adverse reactions) and, where few or no data are available, on expert opinion. The recommendations include information on general immunization issues and the use of specific vaccines. Recommendations for travelers are not always the same as routine recommendations. CDC advises that individuals might benefit from shots or medications before traveling outside of the U.S. Recommended vaccines are those the CDC determines may protect travelers from illnesses present in other parts of the world and prevent the importation of infectious diseases across international borders. Many pharmacies are already providing services to travelers to determine which vaccines they should receive and when they should receive them; the authority in this bill will allow those patients to receive those vaccines at the pharmacy. f) Permits a pharmacist to order and interpret tests to monitor drug safety. Permits APPs to perform physical assessments, order and interpret medication-related tests, refer patients to other providers, initiate, adjust and discontinue medications under physician protocol or as part of an integrated system and participate in the evaluation and management of health conditions in collaboration with other providers. A 2012 CDC program guide for public health, "Partnering with Pharmacists in the Prevention and Control of Chronic Diseases" outlines how the role of the pharmacist has expanded beyond just dispensing medications and is evolving into active participation in chronic disease management as a part of team-based care. At the federal agency level, the IHS has been engaged in an advanced SB 493 Page 17 practice pharmacy model whereby pharmacists deliver direct patient care services with physician collaboration since the early 1970s. Similarly, the VA implemented a similar program in 1995 that updated prescribing authority for clinical pharmacy specialists. These models have become a part of day-to-day care within hospitals, clinics and educational facilities with pharmacists performing many of the functions authorized in this bill. 2.Related Legislation. SB 352 (Pavley) of 2013 would authorize a nurse practitioner, physician assistant or certified nurse-midwife to supervise medical assistants without a physician present and according to standardized procedures and protocols created by the physician. This bill is currently pending on the Senate Floor. SB 491 (Hernandez) of 2013 Deletes the requirement that Nurse Practitioners perform certain tasks pursuant to standardized procedures and/or consultation with a physician or surgeon and authorizes a Nurse Practitioner to perform those tasks independently. Also requires, after July 1, 2016, that Nurse Practitioners possess a certificate from a national certifying body in order to practice. The bill is also up for consideration before the Committee today. SB 492 (Hernandez of 2013) Permits an optometrist to diagnose treat and manage additional conditions with ocular manifestations, directs the California Board of Optometry to establish educational and examination requirements and permits optometrists to perform vaccinations and surgical and non-surgical primary care procedures. The bill is also up for consideration before the Committee today. AB 2348 (Mitchell, Chapter 460, Statutes of 2012) authorized a registered nurse to dispense specified drugs or devices upon an order issued by a certified nurse-midwife, nurse practitioner, or physician assistant within specified clinics. The bill also authorized a registered nurse to dispense or administer hormonal contraceptives in strict adherence to specified standardized procedures. SB 1524 (Hernandez, Chapter 796, Statutes of 2012) deleted the requirement for at least 6 months duration of supervised experience by a physician before a nurse-midwife could furnish or order drugs. The bill authorized a physician and surgeon to determine the extent of the supervision in connection with the furnishing or ordering of drugs and devices by a nurse practitioner or certified nurse-midwife. SB 493 Page 18 AB 977 (Skinner) of 2010 would have authorized pharmacists to administer influenza immunizations, pursuant to standardized protocols developed and approved by the Medical Board of California (MBC), to any person 18 years or older, until January 1, 2015. The bill was never heard by a Senate policy committee. SB 993 (Aanestad and Calderon) of 2007 would have revised the Psychology Licensing Law to authorize a "prescribing psychologist," as defined, to prescribe and administer drugs, and requires the Board of Psychology to establish and administer a certification process to grant licensed psychologists the authority to write prescriptions. The measure failed passage in this committee. SB 1427 (Calderon) of 2008 was substantially similar to SB 993 and failed passage in the Senate Committee on Health. AB 1436 (Hernandez, 2007) would have allowed a nurse practitioner to perform comprehensive health care services according to his or her educational preparation. The bill would have authorized a nurse practitioner to admit and discharge patients from health facilities, change a treatment regimen, or initiate an emergency procedure, in collaboration with specified health practitioners. The bill failed passage on the Senate Floor. AB 2408 (Negrete McLeod, Chapter 777, Statutes of 2006) recasts various provisions of the Pharmacy Law for purposes of clarifying and updating the duties a pharmacist can perform, and makes other technical changes. At one point the bill authorized a pharmacist to adjust a prescription and provide cognitive services under specified conditions; however, those provisions were removed from the bill in the Senate. AB 1711 (Strickland, Chapter 58, Statutes of 2005) authorized a registered nurse or licensed pharmacist to administer influenza and pneumoccocal immunizations without patient-specific orders to patients age 50 years or older in a skilled nursing facility under standing orders when they meet federal recommendations and are approved by the medical director of the skilled nursing facility. AB 2660 (Leno, Chapter 191, Statutes of 2004) reinstated pharmacists authority to register with the DEA and therefore initiate or adjust controlled substance drug therapy under specified conditions. AB 2560 (Montanez, Chapter 205, Statutes of 2004) authorized a nurse practitioner to furnish drugs or devices under standardized SB 493 Page 19 procedures or protocols when the drugs and devices furnished or ordered are consistent with the practitioner's educational preparation or for which clinical competency has been established and maintained. SB 490 (Alpert, Chapter 651, Statutes of 2003) authorized a licensed pharmacist to initiate ECDT in accordance with a standardized procedure approved by the Board and MBC. SB 111 (Alpert, Chapter 358, Statutes of 2001) amended the Medical Practice Act to authorize a medical assistant to perform specified services in community and free clinics under the supervision of a physician assistant, nurse practitioner or nurse-midwife. The bill authorized a physician and surgeon in these specified clinics to provide written instructions for medical assistants, regarding the performance of tasks or duties, while under the supervision of a physician assistant, nurse practitioner or nurse midwife when the supervising physician and surgeon was not on site. SB 1169 (Alpert, Chapter 900, Statutes of 2001) authorized a pharmacist to initiate ECDT in accordance with standardized procedures or protocols developed by the pharmacist and an authorized prescriber acting within their scope of practice. AB 261 (Lempert, Chapter 375, Statutes of 1999) authorized pharmacists to dispense emergency contraception pills for patients who have a written authorization by the patient's physician. 3.Arguments in Support. Supporters write that the concept of team-based care which is currently being utilized in hospital and other health care settings should be expanded to community settings in order to meet the demands of millions of Californians. The American Society of Health-System Pharmacies notes that this bill will allow pharmacists to use the full range of their education and training to meet the demands of a growing patient population in California. According to the Bay Area Council , the business community recognizes the importance of allowing highly-educated, well-trained professionals like pharmacists to perform primary care services that will improve efficiency, help control costs and create additional capacity in our state's increasingly overburdened health care system. Blue Shield of California writes that this bill will help alleviate SB 493 Page 20 the access challenge and the continued contribution of pharmacists will help control costs and reduce the strain in our overburdened health care system. Californians for Patient Care also supports this bill, stating that they are especially pleased with the language designed to ensure patients receive safe and high quality care when needed. California Northstate University, College of Pharmacy writes in support of this bill, stating that PharmD education consists of close to 6,000 hours of post graduate clinical education and training which extensively covers patient care, disease prevention and management and clinical rotations in a variety of health care settings. According to the California Optometric Association , this legislation is necessary to make the promise of ACA a reality. The California Pharmacists Association (CPhA) and California Society of Health-System Pharmacists (CSHP) state that California must look at improving efficiencies in how care is delivered and how the health care workforce is utilized. The organizations believe that pharmacists are trained and qualified to provide more services, pharmacists are one of the most accessible providers in the health care system and pharmacists provide safe care that will improve patient outcomes. CPhA and CSHP note that pharmacists will be working in close collaboration with physicians whenever modifying medication regimes and this bill will more fully integrate the pharmacy profession into the health care team, "an outcome that will strengthen interprofessional collaboration and boost patient outcomes." The California Retailers Association supports this bill, noting that the bill proposes a number of novel concepts that will fill in health care gaps and will not only better incorporate pharmacists into the health care system but will do so appropriately, resulting in significant cost savings for patients and the system as well as improved patient outcomes. According to the Indian Pharmacists Association of California , representing over 400 pharmacists, including 103 independent pharmacy owners, pharmacists are widely recognized as being the most overqualified and underutilized professionals. The group writes that pharmacists' formal education appropriately prepares them to successfully perform services related to the prevention and control of disease and that the passing of this bill would be an SB 493 Page 21 important milestone in health care reform signaling much needed empowerment of the pharmacy profession. Pharmacy Choice and Access Now writes in support of this bill, noting that to alleviate the congestion caused by increasing numbers of patients and the current primary care physician shortages, California should focus on utilizing highly trained pharmacists. According to the United Nurses Associations of California and Union of Health Care Professionals , this bill will allow for better utilization of our existing infrastructure of trainer medical providers to bridge the provider gap through expanded practice. Western University of Health Sciences (WU) notes the extensive hours of training in a PharmD education and states that pharmacists have been acting as direct care providers for decades in federal and managed care systems. WU writes that this bill will enable pharmacists to make more significant contributions to the care team to improve care for patients. 6.Support if Amended. The California of Physician Groups (CAPG) has adopted a support if amended position on this bill, writing that it can help to increase access to care but the group has concerns. Specifically, CAPG believes that APPs should be limited to current health system delivery models rather than have authority for independent, autonomous practice; that the training requirement in this bill is too low for the type of functions expected of an APP and unacceptable for independent practice; the CE requirements are too low and; including travel vaccines is very dangerous. The California Hospital Association (CHA) also writes that it supports this bill if amended, noting that CHA is extremely supportive of efforts to include pharmacists in the health care clinical delivery teams of the future and is committed to working with the Author to provide amendments to address "practice safeguards and quality mechanisms to ensure of coordinated care across the state". Kaiser Permanente writes that it will be in full support of this bill if the Author clarifies that an APP would be allowed to perform "patient" assessments rather than "physical" assessments as the bill currently provides. 7. Neutral. The American Federation of State, County and Municipal Employees (AFSCME) has a neutral position on this bill due to SB 493 Page 22 differing positions taken by two of its impacted affiliates, the United Nurses Associations of California/Union of Health Care Professionals (AFSCME Local 1199) which supports the bill and the Union of American Physicians and Dentists (AFSCME Local 206) which opposes the bill. 8. Arguments in Opposition. Opponents of this bill support expanding access to health care but believe that its provisions put patients at risk. According to BayBio and BIOCOM , the bill creates the ability of pharmacists to perform therapeutic substitution of an agent prescribed by a physician and that in contrast to generic substitution where the product is chemically identical to that ordered by a physician, this allows for substitution within a broad general class, creating a conflict of interest for pharmacists who could be motivated to switch to cheaper but also less appropriate drugs strictly for financial considerations. The American College of Emergency Physicians, California Chapter (California ACEP) is concerned about the impact this bill will have on patient safety and the potential conflicts of interest it introduces. California ACEP believes that this bill undermines the corporate ban on the practice of medicine because pharmacists are not covered by the ban and it is foreseeable that a pharmacist working for a retail chain could be paid to prescribe a drug by the company profiting from the prescription. The California Academy of Eye Physicians and Surgeons write that pharmacists have no experience doing any of the things they are requesting and the bill raises the specter of a "two-tiered system where those who are less well-off make do with less trained providers while those with greater resources (i.e. money) go wherever they want." According to the California Academy of Family Physicians (CAFP) , California Medical Association and Osteopathic Physicians and Surgeons of California this bill puts patients at risk. The groups cite the expanded authority to administer immunizations as unsafe because safe administration requires extensive education, experience and training. The groups also believe that the bill's expanded authority to prescribe smoking cessation drugs could result in increased likelihood of patient harm, particularly because some of these drugs are associated with a substantial risk of depression and should be used only under close medical supervision. The groups write that allowing APPs to adjust or SB 493 Page 23 discontinue drug therapy allows the pharmacist to interfere with the physician-patient relationship and make treatment decisions based on their own judgment. They also state that APP qualification requirements in the bill are unclear and inconsistent with expanded practice authority and that the bill allows pharmacists to practice medicine without being subject to the Medical Practice Act. The California Psychiatric Association echoes the statements above about APP concerns, specifically stating problems with APPs having ability to initiate, adjust or discontinue drug treatments and the potential risks to the health and safety of patients who are taking powerful, sometimes dangerous psychotropic medications which often have serious side effects. The California Right to Life Committee, Inc. is opposed to this bill on the basis that the health of women using self-administered hormonal contraceptive services could be at risk without an attending physician and these drugs can act as abortifacients and end the life of a pre-born child. The California Society of Anesthesiologists believes that the provisions in this bill would diminish physician involvement essential for patient safety. The California Society of Plastic Surgeons is concerned about the expansion in the scope of services and the negative impact on patient safety, as well as the lack of resources and expertise at the Board which could lead to pharmacists being held to a lower standard of care than physicians providing the same service. Canvasback Missions, Inc. and Lighthouse for Christ Mission and Eye Center write that pharmacists play an important role in healthcare delivery but treating disease is not that role. The Osteopathic Physicians and Surgeons of America states that there is clear patient danger that exists by authorizing pharmacists to independently furnish drugs and are also concerned that the bill references oversight by MBC but makes no mention of the Osteopathic Medical Board of California. The Union of American Physicians and Dentists writes that this bill is not a step in the right direction and that it rolls out an uncertain and untested health care delivery system. 9. Recent Amendments. SB 493 Page 24 a) In response to concerns raised by organizations like PhRMA, BIOCOM, BayBio and others, the Author recently amended the bill to clarify that pharmacists cannot engage in therapeutic substitutions. PhRMA has taken a neutral position on this bill. b) In response to concerns raised by Kaiser, the Author recently amended the bill to clarify that an APP would be allowed to perform "patient" assessments rather than "physical" assessments. c) In response to concerns raised by multiple organizations about the qualification requirements for a pharmacist to be recognized as an APP by the Board, the Author recently strengthened the bill to specify the types of certification and specific areas of practice an APP must be certified in, and also added a requirement that an APP meet two of the eligible criteria for APP recognition rather than just one. SUPPORT AND OPPOSITION: Support: American Society of Health-System Pharmacists Bay Area Council Blue Shield of California Californians for Patient Care California Northstate University, College of Pharmacy California Optometric Association California Pharmacists Association California Society of Health-System Pharmacists California Retailers Association Indian Pharmacists Association of California Pharmacy Choice and Access Now Union of Health Care Professionals United Nurses Association of California Western University of Health Sciences Hundreds of individuals, including Pharm D students and numerous deans of schools of pharmacy Support if Amended: California Association of Physician Groups California Hospital Association Kaiser Permanente SB 493 Page 25 Neutral: AFSCME Pharmaceutical Research and Manufacturers of America (PhRMA) Opposition: American College of Emergency Physicians, California Chapter Bay Bio Biocom California Academy of Eye Physicians and Surgeons California Academy of Family Physicians California Healthcare Institute California Medical Association California Psychiatric Association California Right to Life Committee, Inc. California Society of Anesthesiologists California Society of Plastic Surgeons Canvasback Missions, Inc. Lighthouse for Christ Mission and Eye Center Osteopathic Physicians and Surgeons of California Pharmaceutical Research and Manufacturers of America (PhRMA) Union of American Physicians and Dentists Hundreds of individuals Consultant:Sarah Mason