AB 486, as introduced, Bonilla. 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, but not limited to, the date that the medication was prepared and the components used in the drug product.
This bill would require that this information be displayed on a human-readable unit-dose label, and that the information be retrievable by the pharmacist using the medication lot number or control number.
This bill would require that the 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
11barcodedbegin insert pursuantend insert tobegin delete contain at least the information required byend delete
12 Section 4128.4.
13(2) Preparingbegin insert sterileend insert compounded unit dose drugs forbegin delete parenteral administration to inpatients, if each compounded unit
14therapy forend delete
15dose drug is barcodedbegin insert pursuantend insert tobegin delete contain at least the information Section 4128.4.
16required byend delete
17(3) Preparing compounded unit dose drugs for administration
18to inpatients, if each unit dose package is barcodedbegin insert pursuantend insert to
19begin delete contain at least the information required byend delete Section 4128.4.
20(b) For purposes of this article, “common ownership” means
21that the ownership information on file with the board pursuant to
22Section 4201 for the licensed pharmacy is consistent with the
23ownership information on file with the board for the other licensed
P3 1pharmacy or pharmacies for purposes of preparing medications
2pursuant to this section.
Section 4128.4 of the Business and Professions Code
4 is amended to read:
begin insert (a)end insertbegin insert end insert Any unit dose medication produced by a
6centralized hospital packaging pharmacy shall be barcoded to be
7begin insert machineend insert readable at the inpatient’sbegin delete bedside. Upon reading the begin insert bedside
8barcode, the following information shall be retrievable:end delete
9using barcode medication administration software.end insert
10(a) The date the medication was prepared.
end delete
11(b) Thebegin delete components usedend deletebegin insert barcode medication administration
12software shall permit health care practitioners to ensure that,
13before a medication is administered to an inpatient, it is the right
14medication, for the right inpatient,end insert in thebegin delete drug product.end deletebegin insert right dose,
15and via the right route of administration. The software shall verify
16that the medication satisfies these criteria by reading the barcode
17on the medication and comparing the information retrieved to the
18electronic medical record of the inpatient.end insert
19(c) begin delete The lot number or control number.end deletebegin insert For purposes of this
20section, “barcode medication administration software” means a
21computerized system designed to prevent medication errors in
22health care settings.end insert
23(d) The expiration date.
end delete24(e) The National Drug Code Directory number.
end delete25(f) The name of the centralized hospital packaging pharmacy.
end deleteSection 4128.5 of the Business and Professions Code
27 is amended to read:
begin deleteThe end deletebegin insert(a)end insertbegin insert end insertbegin insertAny end insertlabel for each unit dose medication
29produced by a centralized hospital packaging pharmacy shall
30begin delete containend deletebegin insert display a human-readable label that containsend insert all of the
31following:
32(a)
end delete
33begin insert(1)end insert Thebegin delete expiration date.end deletebegin insert date that the medication was prepared.end insert
34(2) The beyond-use date.
end insert35(b)
end delete36begin insert(3)end insert The established name of the drug.
37(c)
end delete
38begin insert(4)end insert The quantity ofbegin delete theend deletebegin insert eachend insert active ingredient.
39(d)
end delete40begin insert(5)end insert Special storage or handling requirements.
begin insert
P4 1(6) The lot number or control number assigned by the
2centralized hospital packaging pharmacy.
3(7) The name of the centralized hospital packaging pharmacy.
end insertbegin insert
4(b) For quality
control and investigative purposes, a pharmacist
5shall be able to retrieve all of the following information using the
6lot number or control number described in subdivision (a):
7(1) The components used in the drug product.
end insertbegin insert8(2) The expiration date of each of the drug’s components.
end insertbegin insert9(3) The National Drug Code Directory number.
end insert No reimbursement is required by this act pursuant to
11Section 6 of Article XIII B of the California Constitution because
12the only costs that may be incurred by a local agency or school
13district will be incurred because this act creates a new crime or
14infraction, eliminates a crime or infraction, or changes the penalty
15for a crime or infraction, within the meaning of Section 17556 of
16the Government Code, or changes the definition of a crime within
17the meaning of Section 6 of Article XIII B of the California
18Constitution.
This act is an urgency statute necessary for the
20immediate preservation of the public peace, health, or safety within
21the meaning of Article IV of the Constitution and shall go into
22immediate effect. The facts constituting the necessity are:
23To eliminate, at the earliest possible time, requirements that
24exceed the current technological capabilities of hospitals and that
25create overly burdensome administrative costs for the California
26State Board of Pharmacy, it is necessary this act take effect
27immediately.
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