BILL ANALYSIS

 

 

Senate Research Center                                                                                              C.S.H.B. 1924

81R34935 NC-F                                                                                                  By: Heflin (Seliger)

                                                                                                                  Health & Human Services

                                                                                                                                            5/19/2009

                                                                                                        Committee Report (Substituted)

 

 

AUTHOR'S / SPONSOR'S STATEMENT OF INTENT

 

A new rule issued by the Texas State Board of Pharmacy requires on-site supervision of pharmacy technicians by a licensed pharmacist.  According to this rule, a licensed pharmacist must be on-site during a hospital's regular hours of business.  This rule is problematic for Class C pharmacies in rural hospitals, as changing hospital operations to include a full-time pharmacist would be very costly.  Such increased costs would burden rural hospitals and impair their ability to provide the services they already struggle to provide.

 

Historically, hospitals defined as rural hospitals have safely operated in-house pharmacies through a pharmacy technician or nurse.  There are fewer licensed pharmacists in rural areas and the pharmacists available are already spread very thin trying to meet demand for their services without being attached to a rural hospital.  Requiring a licensed pharmacist to be on hospital staff is a detriment to other rural residents who are not patients of the hospital and depend on that pharmacist's services, and is unreasonably burdensome to rural hospitals functionally and financially.

 

C.S.H.B. 1924 amends current law relating to the performance of pharmacy services in certain rural areas.

 

RULEMAKING AUTHORITY

 

Rulemaking authority is expressly granted to the Texas State Board of Pharmacy (TSBP) in SECTION 1 (Section 562.1011, Occupations Code) and SECTION 2 (Section 568.008, Occupations Code) of this bill.

 

Rulemaking authority previously granted to TSBP is modified in SECTION 1 (Section 562.1011, Occupations Code) of this bill.

 

SECTION BY SECTION ANALYSIS

 

SECTION 1.  Amends Subchapter C, Chapter 562, Occupations Code, by adding Section 562.1011, as follows:

 

Sec.  562.1011.  OPERATION OF CLASS C PHARMACY IN CERTAIN RURAL HOSPITALS.  (a)  Defines "nurse" and "rural hospital."

 

(b)  Authorizes a nurse or practitioner, if a practitioner orders a prescription drug or device for a patient in a rural hospital when the hospital pharmacist is not on duty or when the institutional pharmacy is closed, to withdraw the drug or device from the pharmacy in sufficient quantity to fill the order.

 

(c)  Requires the hospital pharmacist to verify the withdrawal of a drug or device under Subsection (b) and perform a drug regimen review not later than the seventh day after the date of the withdrawal.

 

(d)  Authorizes a nurse or practitioner, in a rural hospital that uses a floor stock method of drug distribution, to withdraw a prescription drug or device from the institutional pharmacy in the original manufacturer's container or a prepackaged container.

 

(e)  Requires the hospital pharmacist to verify the withdrawal of a drug or device under Subsection (d) and perform a drug regimen review not later than the seventh day after the date of the withdrawal.

 

(f)  Authorizes a rural hospital to allow a pharmacy technician to perform the duties specified in Subsection (g) if the pharmacy technician is registered and meets the training requirements specified by TSBP, a pharmacist is accessible at all times to respond to any questions and needs of the pharmacy technician or other hospital employees, by telephone, answering or paging service, e-mail, or any other system that makes a pharmacist accessible, and a nurse or practitioner or a pharmacist by remote access verifies the accuracy of the actions of the pharmacy technician.

 

(g)  Authorizes the pharmacy technician, if the requirements of Subsection (f) are met, to, during the hours that the institutional pharmacy in the hospital is open, perform certain duties in the pharmacy without the direct supervision of a pharmacist.

 

(h)  Requires the pharmacist-in-charge of an institutional pharmacy in a rural hospital to develop and implement policies and procedures for the operation of the pharmacy when a pharmacist is not on-site.

 

(i)  Authorizes the Texas State Board of Pharmacy (TSBP), on or after September 1, 2011, to establish by rule, a requirement for prospective and retrospective drug use review by a pharmacist for each new drug order.  Provides that a drug use review is not required when a delay in administration of the drug would harm the patient in an urgent or emergency situation, including sudden changes in a patient's clinical status.

 

(j)  Authorizes rural hospitals to establish standing orders and protocols, to be developed jointly by the pharmacist and medical staff, that may include additional exceptions to instances in which prospective drug use review is required.

 

(k)  Provides that this section does not restrict or prohibit TSBP from adopting a rule related to authorizing the withdrawal of a drug or device by a nurse or practioners from, or the supervision of a pharmacy technician in, an institutional pharmacy not located in a rural hospital.  Requires TSBP, as part of the rulemaking process, to consider the effect that a proposed rule, if adopted, would have on access to pharmacy services in hospitals that are not rural hospitals.

 

(l)  Requires TSBP to adopt rules to implement this section, including rules specifying the records that must be maintained under this section; the requirements for policies and procedures for operation of a pharmacy when a pharmacist is not on-site; and the training requirements for pharmacy technicians.

 

SECTION 2.  Amends Chapter 568, Occupations Code, by adding Section 568.008, as follows:

 

Sec. 568.008.  TECHNICIANS IN HOSPITALS WITH CLINICAL PHARMACY PROGRAM.  (a)  Defines "clinical pharmacy program."

 

(b)  Authorizes a Class C pharmacy that has an ongoing clinical pharmacy program to allow a pharmacy technician to verify the accuracy of work performed by another pharmacy technician relating to the filling of floor stock and unit dose distribution systems for a patient admitted to the hospital if the patient's orders have previously been reviewed and approved by a pharmacist. 

 

(c)  Requires the pharmacist-in-charge of the clinical pharmacy program to adopt policies and procedures for the verification process authorized by this section.

 

(d)  Requires a hospital to notify TSBP before implementing the verification process authorized by this section.

 

(e)  Requires TSBP to adopt rules to implement this section, including rules specifying the duties that may be verified by another pharmacy technician; the records that must be maintained for the verification process; and the training requirements for pharmacy technicians who verify the accuracy of the work of other pharmacy technicians.

 

SECTION 3.  Effective date: upon passage or September 1, 2009.