California provider status bill heads to governor; compounding, track-and-trace bill passes House; APhA to FDA: Standardize, integrate REMS programs

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Jump ahead to: Compounding, track-and-trace bill passes House  Jump ahead to: APhA to FDA: Standardize, integrate REMS programs


California provider status bill heads to governor 

California’s pharmacist provider status bill (SB 493) passed the state Assembly in a unanimous vote on September 11. The state Senate completed final approval September 12. Gov. Jerry Brown of California has until October 13 to act on the bill. 

Introduced on February 21 by state Sen. Ed Hernandez, OD (D-24), SB 493 would declare pharmacists as health care providers with the authority to provide health care services.

“We are excited by the Legislature’s action [on September 11] to recognize pharmacists as integral members of the health care team and give them appropriate authorities consistent with their expertise,” Pat Person, BSPharm, President of the California Pharmacists Association (CPhA), said in a statement. “Thanks to Senator Hernandez’s leadership, California’s nearly 40,000 pharmacists stand ready to serve and provide greater access to quality health care.”

“We have high hopes that the governor will sign this important bill,” Jon R. Roth, CAE, CPhA CEO, told Pharmacy Today.

The state Senate approved the bill in May. All organized opposition to the bill was dropped after several amendments were made to the bill addressing some organizations’ concerns. The California Medical Association and other physician groups became “neutral” on the amended version.

The California pharmacist provider status bill is part of a package of bills introduced by Hernandez, an optometrist. Bills for nurse practitioners and optometrists did not pass out of Assembly committees, according to news reports.

SB 493 would authorize all licensed pharmacists to administer drugs and biologics by injection when ordered by a prescriber; provide consultation, training, and education about drug therapy, disease management, and disease prevention; participate in multidisciplinary review of patient progress, including appropriate access to medical records; and order and interpret tests to monitor and manage the efficacy and toxicity of drug therapies, in coordination with the patient’s prescriber. 

SB 493 would also authorize all licensed pharmacists to furnish self-administered hormonal contraceptives under a statewide protocol; furnish travel medications not requiring a diagnosis; furnish prescription-level nicotine replacement drugs for smoking cessation under a statewide protocol; and administer immunizations to patients 3 years and older without a physician protocol.

Further, SB 493 would establish an Advanced Practice Pharmacist (APP) recognition and authorize APPs to perform patient assessments; order and interpret drug therapy–related tests in coordination with the patient’s prescriber; refer patients to other health care providers; initiate, adjust, and discontinue drug therapy with an order by the patient’s prescriber and according to established protocols; and participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers.

In addition, SB 493 would require pharmacists seeking recognition as APPs to complete two of three criteria, including certification in a relevant area of practice, a postgraduate residency program, or 1 year of experience providing clinical services to patients under a collaborative practice agreement or protocol with a physician, APP pharmacist, collaborative drug therapy management pharmacist, or health system.

Compounding, track-and-trace bill passes House

The Drug Quality and Security Act (H.R. 3204) is a new name for a new bill addressing both compounding and track and trace on which agreement was reached by leaders of the House Energy & Commerce Committee and the Senate Health, Education, Labor, & Pensions (HELP) Committee. Introduced on September 27, the bill passed the House by voice vote on September 28.

House Energy & Commerce and Senate HELP staff had negotiated behind the scenes to reach agreement, according to APhA Senior Lobbyist Michael Spira. The Senate is expected to take up the bill soon.

In the wake of the ongoing fungal meningitis tragedy linked to the New England Compounding Center, Congress is moving quickly now to act on the Drug Quality and Security Act. Older bills include the Compounding Clarity Act (H.R. 3089) introduced September 12 by Reps. Morgan Griffith (R-VA), Gene Greene (D-TX), and Diana DeGette (D-CO); a Senate HELP Committee bill (S. 959); and a bill introduced by former House Democrat Sen. Ed Markey (D-MA) (H.R. 2186). 

The Drug Quality and Security Act would help ensure the safety of compounded drugs and would track all prescription drugs from the manufacturer to the pharmacy, according to a September 28 news release from the Senate HELP Committee. 

Related to compounding, the proposed legislation would distinguish compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions; would define FDA’s role in oversight of outsourcing facilities; would offer providers and patients information about compounded drugs; and would clarify current federal law regarding pharmacy compounding. 

More specifically, traditional pharmacies would continue to be primarily regulated by state boards of pharmacy. But compounders who wish to practice outside the scope of traditional pharmacy practice could register as outsourcing facilities that would be subject to FDA oversight in much the same way as traditional manufacturers. Providers and patients would have the option of purchasing products from outsourcing facilities that comply with FDA quality standards.

Related to track and trace, the proposed legislation would develop a pathway to unit-level tracing in 10 years; would strengthen licensure requirements for wholesale distributors and third-party logistics providers; and would establish nationwide drug serial numbers.

On September 26, when the Drug Quality and Security Act was a draft proposal being circulated to stakeholders for comments, APhA sent a comment letter to HELP Committee staff that (among other suggestions) recommended the legislation include an advisory council that would include pharmacists. In less than a day, the bill was introduced—and altered from the draft proposal version to reflect that particular concern.

“Up to the minute, [Government Affairs staff has] been talking, e-mailing, meeting with Senate and House staff,” Spira said. 

APhA to FDA: Standardize, integrate REMS programs

In September 13 comments to FDA (http://apha.us/18Fff42), APhA continued to advocate for a standardized, systems-based approach to Risk Evaluation and Mitigation Strategies (REMS) programs.

APhA’s comments were organized around standardization of REMS programs, educational tools and patient outreach, REMS tools in dispensing settings, and assessing the impact of REMS.

On REMS standardization, APhA recommended that REMS processes be integrated into regular operations by leveraging existing information technology systems, that front-line providers such as prescribers and pharmacists be involved early in the development of new REMS program protocols, that manufacturers begin the REMS education process with an information packet that includes clear identification of which provider is responsible for which requirement, that FDA consider centralizing all REMS information through the FDA website, and that FDA organize REMS programs based on risk-based levels similar to the schedules for controlled substances or to TIRF (Transmucosal Immediate Release Fentanyl) drugs.

On educational tools and patient outreach, APhA advocated that FDA simplify patient educational materials to a single information sheet, that FDA and stakeholders consider face-to-face and telehealth consultations as key elements of REMS programs with appropriate compensation, that FDA and REMS sponsors fold REMS patient education into medication therapy management (MTM) programs both to benefit patients and to present a way to collect data on REMS and medication use issues, and that FDA become familiar with the work of the Pharmacy e-Health Information Technology Collaborative’s work to create SNOMED codes to allow pharmacists to document their services in electronic health records (EHRs).

On REMS tools in dispensing settings, APhA suggested that REMS training be incorporated into required provider education related to licensure; that REMS requirements be accommodated by electronic prescribing platforms, EHRs, and prescription claims adjudication processing already in place; that every pharmacist be certified for REMS programs as is required for prescribers participating in REMS programs; and that National Provider Identifiers be used by pharmacists to access the centralized REMS clearinghouse and to track practitioner-specific REMS requirements.

On REMS assessment, APhA urged that FDA require assessment tools that generate usable data and build on information from previous assessments; that FDA streamline the process for making changes to REMS tools when such changes are prompted by assessment data; and that each REMS program assessment process involve input from prescribers, pharmacists, and patients.