BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 1039 AUTHOR: Hernandez AMENDED: April 10, 2014 HEARING DATE: April 30, 2014 CONSULTANT: Moreno SUBJECT : Pharmacies: furnishing drugs. SUMMARY : Makes a number of changes to the tasks that a pharmacy technician is authorized to perform, under the direct supervision or control of a pharmacist, including permitting them to assist with emergency supply packaging for hospitals, and stock, replenish and inspect a hospital's emergency pharmaceutical supplies container. Adds an advance practice pharmacist to the list of those authorized to prescribe controlled substances under existing law. Existing law: 1.Permits a pharmacy technician (PT) to perform packaging, manipulative, repetitive or other non-discretionary tasks, only while assisting, and under the direct supervision and control of a pharmacist. Prohibits a PT from performing any act requiring the exercise of professional judgment by a pharmacist. 2.Requires that a pharmacy with only one pharmacist to have no more than one PT performing packaging, manipulative, repetitive or other non-discretionary tasks. Establishes a ratio of two PTs for each additional pharmacist, except in specified settings. 3.Defines "intern pharmacist" as a person licensed by the Board of Pharmacy for a period of one to six years if he or she is enrolled in a school of pharmacy recognized by the Board, two years if he or she is a graduate of a school of pharmacy recognized by the Board who has applied to become licensed as a pharmacist, two years if he or she is a foreign graduate, or one year if he or she has failed the pharmacist license exam four times and has remained enrolled in a school of pharmacy. 4.Authorizes an advanced practice pharmacist (APP) recognized by the Board to: Continued--- SB 1039 | Page 2 a. Perform patient assessments; b. Order and interpret drug-therapy related tests, ensuring 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. 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; and, 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.Establishes the California Uniform Controlled Substances Act (Controlled Substances Act) which regulates controlled substances. Permits only specified persons to write or issue a prescription for a controlled substance, including a: physician; dentist; podiatrist; veterinarian; naturopathic doctor; pharmacist in certain settings or acting within the scope of a health workforce pilot project authorized by the Office of Statewide Health Planning and Development (OSHPD); a registered nurse acting within the scope of a health workforce pilot project authorized by OSHPD; a certified nurse-midwife, if furnished or ordered incidentally to the provision of family planning services, routine health care or perinatal care, or care rendered consistent with the certified nurse-midwife's practice, as specified; a nurse practitioner, as specified; a physician assistant, as specified; an optometrist, as specified; and, an out-of-state prescriber in emergency situations, if his or her licensing classification is same as a license in California that would permit prescribing of drugs or devices. This bill: 1.Clarifies that PTs, in performing packaging, may perform emergency supply packaging and sealing in or for hospitals, hospital unit inspections, and other physical tasks, only while assisting and under the direct supervision and control of a pharmacist. SB 1039 | Page 3 2.Permits a pharmacy to furnish a dangerous drug or dangerous device to the emergency medical services system of a licensed general acute care hospital for storage in a secured emergency pharmaceutical supplies container maintained within the hospital in accordance with its policies and procedures. Permits a PT or intern pharmacist, under the direct supervision and control of a pharmacist, to stock, replenish, and inspect the hospital's emergency pharmaceutical supplies container. 3.Requires the hospital and the dispensing pharmacy to maintain records of each request by, and dangerous drugs or dangerous devices furnished to, the hospital's emergency medical services system, for at least three years. 4.Requires controlled substances to be furnished to the hospital's emergency medical services system under this section in accordance with the Controlled Substances Act. 5.Permits a pharmacy to furnish a dangerous drug or dangerous device to a hospital pursuant to preprinted or electronic standing orders, order sets, and protocols established under the policies and procedures of the hospital, as approved according to the policies of the hospital's governing body, if the order is promptly dated, timed, and authenticated in the medical record of the patient to whom the drug or device is dispensed by the ordering practitioner or another practitioner responsible for the care of that patient and authorized by the hospital's policies and procedures to write orders. 6.Requires the hospital to store and maintain drugs in accordance with national standards regarding the storage area and refrigerator or freezer temperature, and otherwise pursuant to the manufacturer's guidelines. 7.Requires a pharmacist, PT, or an intern pharmacist under the direct supervision and control of a pharmacist, to inspect the drugs maintained in the hospital at least once per month. Requires the hospital to establish specific written policies and procedures for inspections. Requires the person conducting the inspection to report any irregularities to the director or chief executive officer of the hospital, or other person holding an equivalent position, and in accordance with the hospital's policy. SB 1039 | Page 4 8.Requires the hospital to adopt policies and procedures regarding the responsibility for ensuring proper methods for repackaging and labeling of bulk cleaning agents, solvents, chemicals, and non-drug hazardous substances used throughout the hospital according to state and federal law and standards. 9.Adds an APP to the list of those authorized to prescribe controlled substances under the Controlled Substances Act. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1.Author's statement. According to the author, in response to the primary care shortage in California coupled with millions of newly insured individuals entering the health care market as a result of implementation of the Affordable Care Act (ACA), SB 493 (Hernandez), Chapter 469, Statutes of 2013, was enacted. SB 493 gives health care facilities greater flexibility to focus their pharmacist workforce on providing patient-centered services as part of a multi-disciplinary team. This is especially important given that previously uninsured patients entering the health care system under the ACA will likely suffer disproportionately from multiple comorbidities and have low health literacy rates. However, this flexibility is in conflict with existing regulatory requirements on pharmacists that have been in place for decades and that have long been outdated. Removing the burden of simple non-discretionary activities unrelated to professional judgment of pharmacists, such as checking expiration dates for drug stock or repackaging or labeling cleaning agents, will help redirect pharmacy resources where they are needed most - the patient. This bill makes more efficient use of pharmacy personnel in the facility setting expanding the types of non-discretionary tasks that pharmacy technicians are permitted to perform, freeing up pharmacists to focus on patient care. 2.The ACA. On March 23, 2010, President Obama signed the ACA into law (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law 111-152). The ACA greatly expands health insurance coverage in California. Beginning in 2014, millions of low- and middle-income Californians began gaining access to coverage under the expansion of Medi-Cal, and through premium and cost-sharing subsidies offered through the California Health SB 1039 | Page 5 Benefit Exchange (known as Covered California). As a result of the coverage expansions under the ACA, between 89 and 91 percent of non-elderly Californians are predicted to have health coverage, and the number of uninsured is projected to decrease by between 1.8 and 2.7 million by 2019. The newly insured will increase demand for health care on an already strained system. Furthermore, the ACA aims to change how care is delivered. It will provide incentives for expanded and improved primary care, which may affect demand for some health care professionals more than others, and create team-based models of service delivery. Research indicates that health care reform will place higher skill demands on all members of the health care workforce as systems try to improve quality while limiting costs. The scale of change with health care reform is unlike anything that the state has previously faced. Many newly insured Californians will have a pent-up demand for services and will create even more pressure on the already strained health care system, particularly in medically underserved areas. 3.Primary Care Physician Workforce Shortage. According to a report commissioned by the California Health Care Foundation, the number of primary care physicians actively practicing in California is at or below the very bottom range of the state's need based on Council on Graduate Medical Education estimates. The distribution of these physicians is also poor. In 2008, there were 69,460 actively practicing physicians in California (this includes Doctors of Medicine and Doctors of Osteopathic Medicine), and 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, 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. In other words, less than one-third of Californians live in a community where they have access to the health care services they need. 4.Pharmacy Technicians. According to the Board of Pharmacy, a PT is an individual who, under the direct supervision and control of a pharmacist, performs packaging, manipulative, repetitive, or other non-discretionary tasks related to the processing of a prescription in a licensed pharmacy, but SB 1039 | Page 6 excludes all functions restricted to a registered pharmacist. The Board's regulations related to PTs define "non-discretionary tasks" as removing the drug or drugs from stock; counting, pouring, or mixing pharmaceuticals; placing the product into a container; affixing the label or labels to a container; and, packaging and repackaging. To work as a PT in California, current registration is required. The Board may issue a license to high school graduates or a person with a general educational development (GED) certificate equivalent, and has obtained an associate's degree in pharmacy technology, has completed a course of training specified by the Board, has graduated from a school of pharmacy recognized by the Board, or is certified by the Pharmacy Technician Certification Board. PT applications are required to include a description of the applicant's qualifications, along with supporting documentation for those qualifications and applicants are required to undergo a criminal background and fingerprint check. PTs must wear identification clearly identifying themselves as a PT in a pharmacy and may only perform duties under the direct supervision of a pharmacist, ensuring that a pharmacist is fully aware of all activities involved in the preparation and dispensing of medications, including the maintenance of appropriate records. 5.Double referral. This bill was heard in the Senate Business, Professions, and Economic Development Committee on April 21, 2014, and passed by a vote of 9-0. 6.Prior legislation. SB 493 expands the scope of practice of a pharmacist to recognize an APP; 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. 7.Support. The California Society of Health-System Pharmacists states that this bill addresses several outdated regulations that have not been updated since the 1960s, and will free up hospital-based pharmacists to spend more time directly working with physicians and nurses to assure the safest and most effective care of the patient. The California Hospital Association and Providence Health & Services, Southern California writes that unnecessary use of health care personnel, such as those non-discretionary activities pharmacists are required to do now, drive inefficiencies and SB 1039 | Page 7 high costs, which is contrary to ensuring continued achievement of meeting the goals of the ACA to improve quality and limit costs. The California Pharmacy Technician Association states that when utilized appropriately in accordance with existing law, PTs increase the efficiency of the healthcare system by allowing pharmacists to focus their time and expertise on delivering direct patient care services. 8.Author's amendments. The author request that the Committee approve amendments to move language currently contained in Business and Profession Code 4119.7 (d) to an appropriate Health and Safety Code section and add language that states that any regulations promulgated by the Board of Pharmacy that are inconsistent with this bill are void and not enforceable. SUPPORT AND OPPOSITION : Support: California Chronic Care Coalition California Hospital Association California Pharmacy Technician Association California Society of Health-System Pharmacists Providence Health and Services, Southern California 48 individuals Oppose: None received. -- END --