BILL ANALYSIS Ó AB 486 Page 1 Date of Hearing: April 14, 2015 ASSEMBLY COMMITTEE ON HEALTH Rob Bonta, Chair AB 486 (Bonilla) - As Introduced February 23, 2015 SUBJECT: Centralized hospital packaging pharmacies: medication labels SUMMARY: Clarifies existing law regarding medication labeling requirements for centralized hospital packaging pharmacies by requiring any label for each unit dose medication produced by a centralized hospital packaging pharmacy to include certain information on a human-readable label. Contains an urgency clause to ensure that the provisions of this bill go into immediate effect upon enactment. Specifically, 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 medications administration software permits health care practitioners to ensure, before medication is administered to a patient, that it is the right medications, for the right patient, in the right dose, and via the right route of administration. AB 486 Page 2 3)Requires any label for each unit dose medication produced by a centralized hospital packaging pharmacy 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; c) The quantity of each active ingredient; d) Special storage or handling requirements; e) The lot number or control number assigned by the centralized hospital packaging pharmacy; and, f) The name of the centralized hospital packaging pharmacy. 4)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, AB 486 Page 3 c) The National Drug Code Directory number. 5)Clarifies that centralized hospital packaging pharmacies are preparing sterile compounded unit dose drugs. EXISTING LAW: 1)Provides for the practice of pharmacy and the licensing and regulation of pharmacies and pharmacists by the Board of Pharmacy (Board) within the Department of Consumer Affairs. 2)Allows that a hospital pharmacy license to include a centralized hospital pharmacy physically located outside of the hospital or at a separate facility that is located within a 75-mile radius and is under common ownership. 3)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 AB 486 Page 4 to inpatients. 4)Specifies that a centralized hospital pharmacy may perform the functions in 3) above only if the following information is barcoded to be readable at the patient's bedside and the following information is retrievable: the date the medication was prepared, the components used in the drug product, the lot number or control number; the expiration date; the National Drug Code Directory number; and, the name of the centralized hospital packaging pharmacy. 5)Requires the label for each unit dose medication produced by a centralized hospital packaging pharmacy to contain the expiration date, the established name of the drug, the quantity of the active ingredient, and any special storage or handling requirements. 6)Requires all specialized compounding and packaging functions to be performed only in the licensed centralized hospital packaging pharmacy, and for the pharmacy to comply with all applicable federal and state statutes and regulations. 7)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. FISCAL EFFECT: This bill has not been analyzed by a fiscal committee. AB 486 Page 5 COMMENTS: 1)PURPOSE OF THIS BILL. According to the author, this bill is a clean-up measure to AB 377 (Solorio), Chapter 687, Statutes of 2012, which requires specific data to be contained within barcodes on medicine labels for use within centralized hospital packaging pharmacies. The author states that the goal of AB 377 was to make it easier for hospitals to set up, and invest in, high-tech central pharmacies in order to reduce medication errors. Unfortunately, hospital technology development and procurement has not moved as quickly as anticipated. The author notes that, additionally, the Board has opined that wording in current law requires that only barcodes now be used on medication and this has resulted in the Board spending staff time and money issuing waivers to hospitals to allow them to operate while technology catches up. The author concludes that this bill clarifies that data are allowed to be contained both within the barcode and in human readable form, and includes much needed definitions that will allow the Board to continue to provide oversight and regulation in this area. 2)BACKGROUND. In 2012 the Governor signed AB 377 into law, which allowed hospitals to create centralized hospital packaging pharmacies (CHPPs) that can serve multiple institutions under common ownership. AB 377 also requires that medications produced in a CHPP be barcoded and that the barcode retrieve specific information, such as the expiration date and lot number, which can be read when the barcode is scanned at the patient's bedside. However, as noted by the author, the Board's new legal interpretation has suggested that certain specific information required on the barcode, also be immediately viewable on a screen. This is problematic because current technology does not allow for this, making it difficult for hospitals to establish CHPPs. The Board has subsequently created a waiver for which hospitals can apply that allows the required information to be physically listed on the label rather than being accessible in AB 486 Page 6 electronic, barcode format. These waivers are only for a five year term. 3)SUPPORT. The California Society of Health-System Pharmacists (CSHP), the sponsor of this bill, states it will address the gap between current healthcare technologies and the new law afforded by AB 377, improving patient safety and ensuring the optimal use of medication. CSHP notes that AB 377 was a positive policy change in that it allowed hospitals to establish these special pharmacies offsite of the main hospital campus, allowing for the purchasing and placement of large robotic packing and filling tools, which often are not useable in hospitals simply due to space restrictions, and that these tools dramatically decrease medication errors and save lives. The California Hospital Association (CHA) states in support that this bill ensures that centralized hospital packaging pharmacies can continue to operate and serve their member hospitals efficiently. CHA notes that a new legal interpretation has suggested that the specific retrievable information from the barcode be immediately viewable on a screen upon scanning the barcode is problematic because current technology does not allow for this function. By requiring the information to be displayed on a human-readable label, CHA concludes that this bill provides a long-term solution while maintaining the original intent of the law. 4)PREVIOUS LEGISLATION. a) AB 2757 (Bocanegra) of 2014, was substantially similar to this bill. AB 2757 passed the Senate Business, Professions and Economic Development Committee, but was not heard in any other policy or fiscal committee. b) AB 377 authorizes a centralized hospital packaging pharmacy to prepare medications, performing specified AB 486 Page 7 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. c) AB 2077 (Solorio) of 2010, in its final version, was virtually identical to AB 377. AB 2077 was vetoed by Governor Arnold Schwarzenegger. In his veto message, the Governor expressed concern that the bill could result in "a greater likelihood of product mix-up, loss of product identity, contamination and cross-contamination, and lack of adequate control systems." d) AB 1370 (Solorio) of 2009 was similar to AB 377 but would have created a separate licensing category for centralized hospital pharmacies. AB 1370 was held in the Assembly Committee on Business, Professions and Consumer Protection. e) SCR 49 (Speier), Chapter 123, Statutes of 2005, creates 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. f) SB 1875 (Speier), Chapter 816, Statutes of 2000, requires hospitals to adopt a formal plan to eliminate or substantially reduce medication-related errors. 5)DOUBLE REFERRAL. This bill is double referred; upon passage in this Committee, this bill will be referred to the Assembly Business & Professions Committee. REGISTERED SUPPORT / OPPOSITION: Support AB 486 Page 8 California Society of Health-System Pharmacists (sponsor) California Association of Physician Groups California Hospital Association California Pharmacists Association Providence Health & Services, Southern California Region Opposition None on file. Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097