BILL ANALYSIS Ó AB 486 Page 1 Date of Hearing: April 28, 2015 ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS Susan Bonilla, Chair AB 486 (Bonilla) - As Introduced February 23, 2015 NOTE: This bill is double-referred, having been previously heard by the Assembly Committee on Health on April 21, 2015 and approved on a 19-0 vote. NOTE: This bill adds an urgency clause. SUBJECT: Centralized hospital packaging pharmacies: medication labels. SUMMARY: Requires labels on medications produced by centralized hospital packaging pharmacies (CHPP) to also include specific information on the label in human readable form. EXISTING LAW: 1)Provides for the practice of pharmacy and licensing and regulation of pharmacies and pharmacists by the Board of Pharmacy (Board) within the Department of Consumer Affairs (DCA). (Business and Professions Code (BPC) § 4001 et seq.) 2)Provides that a CHPP may prepare medications, by performing AB 486 Page 2 specialized functions, for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other. (Business and Professions Code (BPC) § 4128) 3)Defines "hospital pharmacy" as a pharmacy licensed by the Board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay. (BPC § 4029) 4)Provides that "hospital pharmacy" also includes a pharmacy that may be located outside of the hospital, in another physical plant that is regulated under a hospital's consolidated license issued by the California Department of Corrections or California Department of Youth Authority. (BPC § 4029) 5)Specifies that the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the hospital is located. (BPC § 4029) 6)Specifies that the pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. (BPC § 4029) 7)Requires any unit dose medication produced by a CHPP to AB 486 Page 3 display a readable barcode at the inpatients bedside. The readable barcode will display the following information: (BPC § 4128.4) a) The date the medication was prepared; b) The components used in the drug product; c) The lot number or control number; d) The expiration date; e) The National Drug Code Directory number; and, f) The name of the centralized hospital packaging pharmacy. 8)Requires the label for each unit dose medication produced by a centralized hospital packaging pharmacy contain the following information: (BPC § 4128.5) a) The expiration date; AB 486 Page 4 b) The established name of the drug; c) The quantity of the active ingredient; and, d) Special storage or handling requirements. 9)Permits a centralized hospital pharmacy to perform the following specialized functions: a) Preparing unit dose packages for single administration to inpatients from bulk containers; b) Preparing compounded unit dose drugs for parenteral therapy administration (e.g. by subcutaneous, intramuscular, intrasternal or intravenous injection) to inpatients; and, c) Preparing compounded unit dose drugs for administration to inpatients. 10)Requires all specialized compounding and packaging functions to be performed only in the licensed CHPP, and for the pharmacy to comply with all applicable federal and state statutes and regulations. (BPC § 4128.6) AB 486 Page 5 11)Specifies that the pharmacy and the pharmacists working in the pharmacy are responsible for the integrity, potency, quality, and labeled strength of any unit dose drug product prepared by the pharmacy. (BPC § 4128.7) THIS BILL: 1)Clarifies that any unit dose medication produced by a centralized hospital packaging pharmacy be barcoded to be machine readable at the patient's bedside using barcode medication administration software. 2)Specifies that barcode medication administration software permits health care practitioners to ensure, before medication is administered to an inpatient, that it is the right medications, for the right patient, in the right dose, and via the right route of administration. 3)Defines "barcode medication administration software" to mean a computerized system designed to prevent medication errors in health care settings. 4)Requires any label for each unit dose medication produced by a CHPP to display a human-readable label that contains all of the following: a) The date that the medication was prepared; b) The beyond-use date; AB 486 Page 6 c) The established name of the drug; d) The quantity of each active ingredient; e) Special storage or handling requirements; f) The lot number or control number assigned by the centralized hospital packaging pharmacy; and, g) The name of the centralized hospital packaging pharmacy. 5)Requires, for quality control and investigative purposes, a pharmacist be able to retrieve all of the following information using the lot number or control number: a) The components used in the drug product; b) The expiration date of each of the drug's components; and, c) The National Drug Code Directory number. AB 486 Page 7 6)Clarifies that CHPPs are preparing sterile compounded unit dose drugs. FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel. COMMENTS: 1)Purpose. This bill is sponsored by the California Society of Health System Pharmacists . According to the author, "In 2012, AB 377 was signed into law. This bill required that medications produced in [CHPPs] have a barcode which retrieves specific information, such as medication expiration date and lot number, which can be read when the barcode is scanned at the patient's bedside. There is also a requirement that patient information be scanned by barcode as well. In an effort to assist hospitals that do not have the technology infrastructure to provide certain patient information via barcode, the Board of Pharmacy has created a waiver that allows information to be listed in text form on the label. These waivers are only for a five year term. AB 486 creates a long-term solution while maintaining the intent of current law." 2)Background. Business and Professions Code § 4128.4 allows hospitals to set up and invest in high-tech central pharmacies utilizing the latest in technological innovations, such as robotics, effectively lowering rates of medication errors and reducing unnecessary costs. The term "retrievable" within BPC § 4128.4 has caused confusion and different interpretations between the Board of Pharmacy and hospital chains. The intent of the word "retrievable" was not that the elements be immediately readable on the label, but instead that the data elements on the barcode be able to be linked to a database where the AB 486 Page 8 elements would be retrievable. Several hospitals approached the Board of Pharmacy and highlighted limitations in their software that would prohibit full compliance with the barcode requirements. According to the hospitals, hospital information technology vendors will have to reconfigure their systems to make all the elements listed in BPC § 4128.4 immediately readable upon scan. These medical groups requested that the Board of Pharmacy interpret the meaning of the provisions more broadly to allow for ample time following licensure to fully comply with the requirements. The Board of Pharmacy ultimately approved five-year waivers to organizations who have fallen out of compliance - allowing the requisite information elements to be physically listed on the label rather than having them in electronic barcode format. 3)Prior Related Legislation. AB 2757 (Bocanegra) of 2014, was substantially similar to this bill. NOTE: The bill passed the Senate Committee on Business, Professions and Economic Development but was not heard in any policy or fiscal committee in the Assembly. AB 377 (Solario), Chapter 687, Statutes of 2012, authorized a centralized hospital packaging pharmacy to prepare medications, by performing specified functions for administration only to inpatients within its own general acute care hospital, or one or more general acute care hospitals under the same ownership and located within 75 miles of each other. AB 2077 (Solario) of 2010, in its final version, was virtually AB 486 Page 9 identical to AB 377 (Solario). NOTE: This bill was vetoed by Governor Schwarzenegger due to concern that the bill would result in, "a greater likelihood of product mix-up, loss of product identity, contamination and cross-contamination, and lack of adequate control systems." AB 1370 (Solario) of 2009, was similar to AB 377, but created a separate licensing category for centralized hospital pharmacies. NOTE: The bill was held in the Assembly Committee on Business and Professions and Consumer Protection. SCR 49 (Speier), Chapter 123, Statutes of 2005, created a panel to study the causes of medication errors and recommend changes in the health care system that reduces errors associated with the delivery of prescription and over the counter medication to consumers. SB 1875 (Speier), Chapter 816, Statutes of 2000, required hospitals to adopt a formal plan to eliminate or substantially reduce medication-related errors. AB 486 Page 10 ARGUMENTS IN SUPPORT: The California Association of Health-System Pharmacists (sponsor) support the bill and write in their letter, "AB 486 amends [BPC] section 4128 to be less proscriptive than the original law - replacing the word "retrievable" with more clarifying language about barcode medication administration software capabilities and giving centralized hospital packaging pharmacies the flexibility to work with existing technology and adapt to new technology as it becomes available. AB 486 also clarifies that this technology can be used for multiple purposed and at multiple locations within the hospital, improving patient safety." The California Hospital Association echoes the expressed support for the bill and they write in their letter, "AB 486 provides a long-term solution while maintaining the original intent of the law." The California Pharmacists Association writes, "AB 486 creates and effective system for bar-coding medications while clarifying that this technology can be used for multiple purposes within a hospital in order to reduce the rates of medication errors and improve patient safety." Providence Health & Services of Southern California writes in their letter, "Providence appreciates this reasonable solution to assure that centralized hospital packaging pharmacies can continue to operate as intended and have essential elements for patient safety readily available." The California Association of Joint Powers Authorities supports the bill and writes, "Many public acute care hospitals in AB 486 Page 11 California participate in public entity risk pools. CAJPA believes that AB 486 provides clarity to existing law and provides centralized hospital packaging pharmacies the flexibility to work with existing technology and adapt to new technology as it becomes available." The California Council for the Advancement of Pharmacy supports the bill, "?because its long-term care pharmacy members have experienced similar challenges with the California State Board of Pharmacy's regulations regarding patient-centered labeling, where by exemptions from the regulation must be sought on an individual basis...AB [486] would remedy the onerous task of requesting waivers while still maintaining the security of a hospital patient's information and providing more efficient, safe and effective patient care." ARGUMENTS IN OPPOSITION: None on file. REGISTERED SUPPORT: California Society of Health-System Pharmacists (sponsor) California Association of Joint Powers Authorities California Association of Physician Groups AB 486 Page 12 California Council for the Advancement of Pharmacy California Hospital Association California Pharmacists Association Providence Health & Services Southern California REGISTERED OPPOSITION: None on file. Analysis Prepared by:Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301 AB 486 Page 13