AB 2757, as amended, Bocanegra. Centralized hospital packaging pharmacies: medication labels.
The Pharmacy Law provides for the licensure and regulation of pharmacies, including hospital pharmacies, by the California State Board of Pharmacy, and makes a knowing violation of that law a crime. Existing law authorizes a centralized hospital packaging pharmacy to prepare medications for administration to inpatients within its own general acute care hospital or certain other commonly owned hospitals. Existing law requires that these medications be barcoded to be readable at the inpatient’s bedside in order to retrieve certain information, including the date that the medication was prepared and the components used in the drug product.
This bill would instead require that this information be displayed on a human-readable label or be retrievable using the lot number or control number of the medication, rather than by reading the barcode. The bill would require that a medication’s barcode be machine readable using medication administration software, and that the software compare the information contained in the barcode to the electronic medical record of the inpatient in order to verify that the medication to be given is the correct medication, dosage, and route of administration for that patient. Because a knowing violation of these provisions would be a crime, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
This bill would declare that it is to take effect immediately as an urgency statute.
Vote: 2⁄3. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.
The people of the State of California do enact as follows:
Section 4128 of the Business and Professions
2Code is amended to read:
(a) Notwithstanding Section 4029, a centralized hospital
4packaging pharmacy may prepare medications, by performing the
5following specialized functions, for administration only to
6inpatients within its own general acute care hospital and one or
7more general acute care hospitals if the hospitals are under common
8ownership and located within a 75-mile radius of each other:
9(1) Preparing unit dose packages for single administration to
10inpatients from bulk containers, if each unit dose package is
11barcoded pursuant to Section 4128.4.
12(2) Preparing sterile compounded unit dose drugs for
13
administration to inpatients, if each compounded unit dose drug
14is barcoded pursuant to Section 4128.4.
15(3) Preparing compounded unit dose drugs for administration
16to inpatients, if each unit dose package is barcoded pursuant to
17Section 4128.4.
18(b) For purposes of this article, “common ownership” means
19that the ownership information on file with the board pursuant to
20Section 4201 for the licensed pharmacy is consistent with the
P3 1ownership information on file with the board for the other licensed
2pharmacy or pharmacies for purposes of preparing medications
3pursuant to this section.
Section 4128.4 of the Business and Professions Code
5 is amended to read:
(a) Any unit dose medication produced by a centralized
7hospital packaging pharmacy shall be barcoded to be machine
8readable at the inpatient’s bedside using barcode medication
9administration software.
10(b) The barcode medication administration software shall permit
11health care practitioners to ensure that, before a medication is
12administered to an inpatient, it is the right medication, for the right
13inpatient, in the right dose, and via the right route of administration.
14The software shall verify that the medication satisfies these criteria
15by reading the barcode on the medication and comparing the
16information retrieved to the electronic medical record of the
17inpatient.
18(c) For purposes of this section, “barcode medication
19administration software” means a computerized system designed
20to prevent medication errors in health care settings.
Section 4128.5 of the Business and Professions Code
22 is amended to read:
(a) Any unit dose medication produced by a centralized
24hospital packaging pharmacy shall display a human-readable label
25that contains all of the following:
26(1) The date that the medication was prepared.
27(2) The beyond-use date.
28(3) The established name of the drug.
29(4) The quantity ofbegin delete theend deletebegin insert eachend insert active ingredient.
30(5) Special storage or handling requirements.
31(6) The lot number or control number assigned by the centralized
32hospital packaging pharmacy.
33(7) The name of the centralized hospital packaging pharmacy.
34(b) For quality control and investigative purposes, a pharmacist
35shall be able to retrieve all of the following information using the
36lot number or control number described in subdivision (a):
37(1) The components used in the drug product.
38(2) The expiration date of each of the drug’s components.
39(3) The National Drug Code Directory number.
No reimbursement is required by this act pursuant to
2Section 6 of Article XIII B of the California Constitution because
3the only costs that may be incurred by a local agency or school
4district will be incurred because this act creates a new crime or
5infraction, eliminates a crime or infraction, or changes the penalty
6for a crime or infraction, within the meaning of Section 17556 of
7the Government Code, or changes the definition of a crime within
8the meaning of Section 6 of Article XIII B of the California
9Constitution.
This act is an urgency statute necessary for the
11immediate preservation of the public peace, health, or safety within
12the meaning of Article IV of the Constitution and shall go into
13immediate effect. The facts constituting the necessity are:
14To eliminate, at the earliest possible time, requirements that
15exceed the current technological capabilities of hospitals and that
16create overly burdensome administrative costs for the California
17State Board of Pharmacy, it is necessary this act take effect
18immediately.
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