AB 2144: Pharmacy: prescriptions.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2016-03-18
The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law establishes requirements for the substitution of an alternative biological product when a pharmacist is filling a prescription order for a prescribed biological product. That law requires a pharmacist to inform the patient orally or in writing of harmful effects of a drug dispensed by prescription, if the drug poses substantial risk to the person consuming the drug when taken in combination with alcohol, or if the drug may impair a persons ability to drive a motor vehicle, whichever is applicable, and the board requires by regulation that warning is to be given. A knowing violation of the Pharmacy Law is a crime.
The Pharmacy Law requires a health facility to establish and implement a written policy to ensure that each patient receives information regarding drugs given to the patient at the time of discharge or under certain other circumstances, including the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions.
This bill would revise that patient information provision to require that a health facility require each patient to acknowledge in writing that the patient has received this information. Because a violation of this requirement would be a crime under certain circumstances, the bill would impose a state-mandated local program.
The Pharmacy Law establishes requirements for the substitution of an alternative biological product when a pharmacist is filling a prescription order for a prescribed biological product.
This bill would make nonsubstantive changes to those that substitution and warning provisions. provision.
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.
The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law establishes requirements for the substitution of an alternative biological product when a pharmacist is filling a prescription order for a prescribed biological product. That law requires a pharmacist to inform the patient orally or in writing of harmful effects of a drug dispensed by prescription, if the drug poses substantial risk to the person consuming the drug when taken in combination with alcohol, or if the drug may impair a persons ability to drive a motor vehicle, whichever is applicable, and the board requires by regulation that warning is to be given.
This bill would make nonsubstantive changes to those substitution and warning provisions.
(a)A pharmacist filling a prescription order for a prescribed biological product may select an alternative biological product only if all of the following apply:
(1)The alternative biological product is interchangeable.
(2)The prescriber does not personally indicate Do not substitute, or words of similar meaning, in the manner provided in subdivision (e).
(b)Within five days following the dispensing of a biological product, a dispensing pharmacist or the pharmacists designee shall make an entry of the specific biological product provided to the patient, including the name of the biological product and the manufacturer. The communication shall be conveyed by making an entry that can be electronically accessed by the prescriber through one or more of the following electronic records systems:
(1)An interoperable electronic medical records system.
(2)An electronic prescribing technology.
(3)A pharmacy benefit management system.
(4)A pharmacy record.
(c)Entry into an electronic records system as described in subdivision (b) is presumed to provide notice to the prescriber.
(d)If the pharmacy does not have access to one or more of the entry systems in subdivision (b), the pharmacist or the pharmacists designee shall communicate the name of the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, except that communication shall not be required in this instance to the prescriber when either of the following apply:
(1)There is no interchangeable biological product approved by the federal Food and Drug Administration for the product prescribed.
(2)A refill prescription is not changed from the product dispensed on the prior filling of the prescription.
(e)A selection shall not be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, Do not substitute, or words of similar meaning.
(1)This subdivision shall not prohibit a prescriber from checking a box on a prescription marked Do not substitute, provided that the prescriber personally initials the box or checkmark.
(2)To indicate that a selection shall not be made pursuant to this section for an electronic data transmission prescription, as defined in subdivision (c) of Section 4040, a prescriber may indicate Do not substitute, or words of similar meaning, in the prescription as transmitted by electronic data, or may check a box marked on the prescription Do not substitute. In either instance, it shall not be required that the prohibition on substitution be manually initialed by the prescriber.
(f)Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subdivision (e). A pharmacist who selects an alternative biological product to be dispensed pursuant to this section shall assume the same responsibility for substituting the biological product as would be incurred in filling a prescription for a biological product prescribed by name. There shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a biological product pursuant to this section. The pharmacist shall not select a biological product that meets the requirements of subdivision (a) unless the cost to the patient of the biological product selected is the same or less than the cost of the prescribed biological product. Cost, as used in this subdivision, includes any professional fee that may be charged by the pharmacist.
(g)This section shall apply to all prescriptions, including those presented by or on behalf of persons receiving assistance from the federal government or pursuant to the Medi-Cal Act set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code.
(h)When a selection is made pursuant to this section, the substitution of a biological product shall be communicated to the patient.
(i)The board shall maintain on its public Internet Web site a link to the current list, if available, of biological products determined by the federal Food and Drug Administration to be interchangeable.
(j)For purposes of this section, the following terms shall have the following meanings:
(1)Biological product has the same meaning that applies to that term under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262(i)).
(2)Interchangeable means a biological product that the federal Food and Drug Administration has determined meets the standards set forth in Section 262(k)(4) of Title 42 of the United States Code, or has been deemed therapeutically equivalent by the federal Food and Drug Administration as set forth in the latest addition or supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations.
(3)Prescription, with respect to a biological product, means a prescription for a product that is subject to Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
(k)This section shall not prohibit the administration of immunizations, as permitted in Sections 4052 and 4052.8.
(l)This section shall not prohibit a disability insurer or health care service plan from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for any biological product.
SEC. 2.Section 4074 of the Business and Professions Code is amended to read:4074.(a)A pharmacist shall inform a patient orally or in writing of the harmful effects of a drug dispensed by prescription if both of the following apply:
(1)The drug poses substantial risk to the person consuming the drug when taken in combination with alcohol or the drug may impair a persons ability to drive a motor vehicle, whichever is applicable.
(2)The drug is determined by the board pursuant to subdivision (c) to be a drug or drug type for which this warning shall be given.
(b)In addition to the requirement described in subdivision (a), on and after July 1, 2014, if a pharmacist exercising his or her professional judgment determines that a drug may impair a persons ability to operate a vehicle or vessel, the pharmacist shall include a written label on the drug container indicating that the drug may impair a persons ability to operate a vehicle or vessel. The label required by this subdivision may be printed on an auxiliary label that is affixed to the prescription container.
(c)The board, by regulation, may require additional information or labeling.
(d)This section shall not apply to a drug furnished to a patient in conjunction with treatment or emergency services provided in a health facility or, except as provided in subdivision (e), to a drug furnished to a patient pursuant to subdivision (a) of Section 4056.
(e)A health facility shall establish and implement a written policy to ensure that each patient shall receive information regarding each drug given at the time of discharge and each drug given pursuant to subdivision (a) of Section 4056. This information shall include the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions. The health facility shall require each patient to acknowledge in writing that the patient has received this information. This information shall be given by a pharmacist or registered nurse, unless already provided by a patients prescriber, and the written policy shall be developed in collaboration with a physician, a pharmacist, and a registered nurse. The written policy shall be approved by the medical staff. Nothing in this subdivision or any other law shall be construed to require that only a pharmacist provide this consultation.
SEC. 3.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)A pharmacist filling a prescription order for a prescribed biological product may select an alternative biological product only if all of the following: following apply:
(1)The alternative biological product is interchangeable.
(2)The prescriber does not personally indicate Do not substitute, or words of similar meaning, in the manner provided in subdivision (d). (e).
(b)Within five days following the dispensing of a biological product, a dispensing pharmacist or the pharmacists designee shall make an entry of the specific biological product provided to the patient, including the name of the biological product and the manufacturer. The communication shall be conveyed by making an entry that can be electronically accessed by the prescriber through one or more of the following electronic records systems:
(1)An interoperable electronic medical records system.
(2)An electronic prescribing technology.
(3)A pharmacy benefit management system.
(4)A pharmacy record.
(c)Entry into an electronic records system as described in subdivision (b) is presumed to provide notice to the prescriber.
(d)If the pharmacy does not have access to one or more of the entry systems in subdivision (b), the pharmacist or the pharmacists designee shall communicate the name of the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, except that communication shall not be required in this instance to the prescriber when either of the following apply:
(1)There is no interchangeable biological product approved by the federal Food and Drug Administration for the product prescribed.
(2)A refill prescription is not changed from the product dispensed on the prior filling of the prescription.
(e)In no case shall a A selection shall not be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, Do not substitute, or words of similar meaning.
(1)This subdivision shall not prohibit a prescriber from checking a box on a prescription marked Do not substitute, provided that the prescriber personally initials the box or checkmark.
(2)To indicate that a selection shall not be made pursuant to this section for an electronic data transmission prescription, as defined in subdivision (c) of Section 4040, a prescriber may indicate Do not substitute, or words of similar meaning, in the prescription as transmitted by electronic data, or may check a box marked on the prescription Do not substitute. In either instance, it shall not be required that the prohibition on substitution be manually initialed by the prescriber.
(f)Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subdivision (e). A pharmacist who selects an alternative biological product to be dispensed pursuant to this section shall assume the same responsibility for substituting the biological product as would be incurred in filling a prescription for a biological product prescribed by name. There shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a biological product pursuant to this section. In no case shall the The pharmacist shall not select a biological product that meets the requirements of subdivision (a) unless the cost to the patient of the biological product selected is the same or less than the cost of the prescribed biological product. Cost, Cost, as used in this subdivision, includes any professional fee that may be charged by the pharmacist.
(g)This section shall apply to all prescriptions, including those presented by or on behalf of persons receiving assistance from the federal government or pursuant to the Medi-Cal Act set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code.
(h)When a selection is made pursuant to this section, the substitution of a biological product shall be communicated to the patient.
(i)The board shall maintain on its public Internet Web site a link to the current list, if available, of biological products determined by the federal Food and Drug Administration to be interchangeable.
(j)For purposes of this section, the following terms shall have the following meanings:
(1)Biological product has the same meaning that applies to that term under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262(i)).
(2)Interchangeable means a biological product that the federal Food and Drug Administration has determined meets the standards set forth in Section 262(k)(4) of Title 42 of the United States Code, or has been deemed therapeutically equivalent by the federal Food and Drug Administration as set forth in the latest addition or supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations.
(3)Prescription, with respect to a biological product, means a prescription for a product that is subject to Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
(k)This section shall not prohibit the administration of immunizations, as permitted in Sections 4052 and 4052.8.
(l)This section shall not prohibit a disability insurer or health care service plan from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for any biological product.
SEC. 2.Section 4074 of the Business and Professions Code is amended to read:4074.(a)A pharmacist shall inform a patient orally or in writing of the harmful effects of a drug dispensed by prescription if both of the following apply:
(1)The drug poses substantial risk to the person consuming the drug when taken in combination with alcohol or the drug may impair a persons ability to drive a motor vehicle, whichever is applicable.
(2)The drug is determined by the board pursuant to subdivision (c) to be a drug or drug type for which this warning shall be given.
(b)In addition to the requirement described in subdivision (a), on and after July 1, 2014, if a pharmacist exercising his or her professional judgment determines that a drug may impair a persons ability to operate a vehicle or vessel, the pharmacist shall include a written label on the drug container indicating that the drug may impair a persons ability to operate a vehicle or vessel. The label required by this subdivision may be printed on an auxiliary label that is affixed to the prescription container.
(c)The board may by regulation board, by regulation, may require additional information or labeling.
(d)This section shall not apply to a drug furnished to a patient in conjunction with treatment or emergency services provided in a health facility or, except as provided in subdivision (e), to a drug furnished to a patient pursuant to subdivision (a) of Section 4056.
(e)A health facility shall establish and implement a written policy to ensure that each patient shall receive information regarding each drug given at the time of discharge and each drug given pursuant to subdivision (a) of Section 4056. This information shall include the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions. This information shall be given by a pharmacist or registered nurse, unless already provided by a patients prescriber, and the written policy shall be developed in collaboration with a physician, a pharmacist, and a registered nurse. The written policy shall be approved by the medical staff. Nothing in this subdivision or any other law shall be construed to require that only a pharmacist provide this consultation.
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Date
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Status
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|---|---|
| Feb 17, 2016 | Read first time. To print. |
| Feb 18, 2016 | From printer. May be heard in committee March 19. |
| Mar 17, 2016 | Referred to Coms. on HEALTH and B. & P. |
| Mar 18, 2016 | From committee chair, with author's amendments: Amend, and re-refer to Com. on HEALTH. Read second time and amended. |
| Mar 28, 2016 | Re-referred to Com. on HEALTH. |
| May 31, 2016 | Read second time and amended. Ordered returned to second reading. |
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