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CLSA Wire

Sacramento At A Glance: July 27, 2018

California Life Sciences Association | 1201 K Street Suite 1840, Sacramento, CA 95814

July 27, 2018 |  Volume 1, Number 13

Thank you for your support of the California Life Sciences Association. Sponsorship opportunities are now open for CLSA’s Life Sciences Academy, which is an educational event for legislators held in Napa on December 6th and 7th this year. CLSA is also currently reviewing feedback on our proposed amendments for SB 212 (Jackson) and ideas on how to address AB 375. We will continue to work on measures impacting our industry during the rest of the legislative summer recess
– Team CLSA

Board of Pharmacy Meeting: July 24-25, 2018 

The Board of Pharmacy met on Tuesday, July 24th, and Wednesday, July 25th. During Tuesday’s meeting, it was announced that Virgina Herold, the Executive Officer since January 2007, will be retiring at the end of the year. In light of her retirement, the board will have a search committee, consisting of four board members, and will do a national search for this candidate. Ricardo Sanchez was reappointed to the Board of Pharmacy on July 19th and was sworn-in during Wednesday’s meeting.

Legislation for Discussion and Consideration

Board Sponsored/Originated Legislation

  • Board Position: Oppose Unless Amended (changed from a support position)
  • Version: As amended July 5, 2018
  • Amendments go far beyond the initial policy goal of the board. According to information received, this amendment is intended to allow insurers and PBMs to serve as another gatekeeper in the prescribing and dispensing of controlled substances. Staff noted that it is the role of the regulator to safeguard against inappropriate prescribing and dispensing habits and is a core function of the Board of Pharmacy mandate, as well as the mandate of prescriber board. As a result, the board voted to change its position from ‘support’ to ‘oppose unless amended’ to remove provisions that would expand access beyond what was originally envisioned.
  • AB 1752 (Low) Controlled Substances: CURES Database
    • Board Position: Support (no change in position)
    • Version: Introduced January 3, 2018
    • Recent Updates: Amendments to the measure do not indicate change in policy but rather provide clarification.
  • AB 2086 (Gallagher) Controlled Substances: CURES Database
    • Board Position: Support (no change in position)
    • Version: Amended April 3, 2018
    • Staff Comments: The board is the originator of this bill. During the July 2017 Board of Pharmacy Meeting, it was discovered that a statutory change was needed in order to allow prescribers to access reports in CURES.
  • AB 2789 (Wood) Health Care Practitioners: Prescriptions: Electronic Data Transmission
    • Board Position: Support (no change in position)
    • Version: Amended July 3, 2018
    • Staff Comments: The board is the originator of this bill. During the January 2018 Board Meeting, the board discussed how the abuse of pharmaceutical drugs has skyrocketed in the United States over the past decade, and has led to the current opioid epidemic. E-prescribing can address the opioid epidemic by substantially reducing the opportunities for persons to steal, alter, “doctor shop,” or use counterfeit prescriptions, thus decreasing unsupervised access to medication.

Legislation Impacting the Practice of Pharmacy or the Board’s Jurisdiction with a Board Established Position

  • AB 2859 (Caballero) Pharmacy: Safe Storage Products
    • Board Position: Neutral (changed from oppose unless amended)
    • Version: Amended June 21, 2018
    • The California Physicians Association (CPA) changed its position from ‘oppose’ to ‘neutral.’
    • Following recent amendments to the measure, the executive officer worked with committee chair to establish a neutral position on this measure.
  • AB 2863 (Nazarian) Pharmacy: Prescriptions
    • Board Position: Support (no change in position)
    • Version: Amended July 3, 2018
    • When this measure was brought to the board during the May meeting, the bill also included Pharmacy Benefit Manager along with a health care service plan and health insurer. This measure has been amended to only apply to a health care service plan and health insurer. This measure is consistent with the board’s consumer protection mandate by ensuring the consumer be charged the lesser amount for prescriptions.

Legislation Impacting the Practice of Pharmacy or the Board’s Jurisdiction without a Board Established Position

  • AB 1753 (Low) Controlled Substances: CURES Database
    • No position taken.
    • Version: As amended April 18, 2018
    • Staff Comments: The author arrived at the number of printers based on the input from the Department of Justice.
  • AB 1998 (Rodriguez) Opioids: safe prescribing policy
    • No position taken.
    • Version: As amended July 2, 2018
    • Recent Updates: Recent amendments to this measure now include a hospital pharmacy and therapeutics committee as an entity required to develop a safe prescribing protocol.
  • AB 2486 (McCarty) Opioid Prevention and Rehabilitation Act
    • Assemblymember McCarty does not wish to move the bill forward at this time.
    • Version: Amended June 18, 2018
  • SB 212 (Jackson) Solid waste: pharmaceutical and sharps waste stewardship
    • No position taken.
    • Version: Amended June 18, 2018
    • The CA Pharmacists Association had an ‘oppose unless amended’ position, with the belief that the Sharps issue should be addressed separately.
    • Staff Comments: Staff has worked with the authors and CalRecycle and continues to provide technical assistance. As written, staff believes compliance with the board’s drug take-back regulations would still apply and the board would remain responsible for enforcement of those provisions.
    • During public comment on July 24, individuals sought clarification regarding preemption of county ordinances.
  • SB 1021 (Wiener) Prescription Drugs
    • Board Position: Support (upon the recommendation of the subcommittee, the board adopted this position on July 25)
    • Version: Amended June 14, 2018
    • Staff Comments: Amendments made in Senate Health Committee added language similar to AB 2863 capping the copay amount at the retail price if it is lower than the copay. This measure was brought to the board in May and no position was established.
  • SB 1254 (Stone) Hospital Pharmacies: Medication Profiles or Lists for High-Risk Patients
    • Board Position: Support (upon the recommendation of the subcommittee, the board adopted this position on July 25)
    • Version: Amended June 28, 2018
    • Staff Comments: This measure was brought to the committee to seek input on the policy of the measure. The board previously heard a presentation on a study underway at Cedars Sinai regarding high risk patients. This measure was brought to the board in May and no position was established. The subcommittee made a recommendation to support the bill on July 24.

Regulation Status Update

Proposed Regulations to Amend Title 16 CCR Section 1735.2 to Update the Compounding Self‐Assessment Form 17M-39

  • Summary of Regulation: This regulation updates the Self‐Assessment form 17M‐39. Additionally, this regulation updates section 1735.2 with clarifying language as to the completion and certification requirements of the self-assessment form.
  • Board staff recommended that this regulation be put on hold pending action by the USP and the board’s statutory proposal that would incorporate relevant chapters of USP into board regulation.
    • Committee will not pursue at this time. They previously voted to incorporate by reference and struck most of the rules. They want to see what USP action looks like before they proceed.
    • Copy of the Community Pharmacy & Hospital Outpatient Pharmacy Compounding Self-Assessment can be found here as Attachment 6.

 Enforcement and Compounding Committee Update

Implementation Strategy for Anticipated Statutory Changes to Incorporate USP Compounding Chapters

The Board discussed the statutory proposal to incorporate USP compounding chapters into the board’s requirements for compounding drug preparation. As part of its discussion, the board noted that two of the compounding chapters, <795> and <797>, are in the revision process by USP, and that USP <800> has been finalized but is not yet in effect. As the revisions for the representative chapters are finalized, it’s anticipated that staff will complete a comprehensive review of the new requirement, provide recommendations to the board about necessary changes in regulations, and the requirements related to drug compounding will be reassessed to determine if any action is necessary. Based on public comments, it appears that the independent retail sterile compounding pharmacies will be compliant with USP 800 requirements by December 1, 2019. The committee requested that information on readiness by other sterile compounding pharmacies be provided at future meetings. Their next meetings will be on September 5 and December 13.

  • Chapter 795: The proposed revisions for USP <795> were formally published in the Pharmacopeial Forum for public comment in May 2018, and will close on July 31. Its intended publication date is June 1, 2019 with an implementation date intended to be December 1, 2019.
  • Chapter 797: The proposed revisions to USP <797> will be pre-posted by USP on July 27, 2018 and will be formally published on September 4, 2018.
  • Chapter 800: This chapter is in its final form, with an expected implementation date of December 1, 2019.

For more information on the Implementation Strategy for Anticipated Statutory Changes to Incorporate USP Compounding Chapters, click here. (Please scroll down to page 7 section (f) on Compounding for background).

In addition, it was announced that board inspectors are completing a three-day in-person training on compounding. Pharmacy consultants in the Department of Public Health have been given the opportunity to also take the training.

Administrative Case Process: The Role of the Attorney General in the Disciplinary Process

The Supervising Deputy Attorney General, Joshua Room, gave a three-hour presentation on the administrative cases process and case resolution times for matters referred to the office of the Attorney General. For the PowerPoint presentation given to the board, click here.

Report on the 2018 USP Workshop on Safe Compounding

Ms. Harold reported to the board a presentation she did as a state representative at the “Advancing Quality Compounding, the State Perspective” workshop. She discussed California’s experience with compounding, what they learned, and how difficult it is to be compliant with chapter 800 due to the high expense.

Information on DHCS Grant for Drug Take-Back Programs

The board’s executive officer is working with DHCS on a possible grant to provide reimbursement for drug take-back services. This project is in the early development phases; however, there was discussion about once completed, an alert will be sent out to licensees to notify them how they can get reimbursed for drug take-back collection bins and mail back supplies.

Report on the Certification of the CURES System by the CA Department of Justice and Resulting Changes

The Department of Justice (DOJ) certified the CURES 2.0 system on April 2, 2018, which also requires prescribers to check CURES before prescribing Schedule II, III, or IV drugs to a patient for the first time, and at least every four months thereafter if therapy with the controlled substances is ongoing after October 2, 2018. Data show that pharmacists check CURES at higher rates than prescribers. Updates will be made to CURES so that information is more recent and will have data from across state lines to allow users to see what patients are doing in other states.

The DOJ also released the following CURES data (this graphic can be found here on page 3):

 

Public Policy Institute of California Releases Poll

The Public Policy Institute of California(PPIC) lifted its embargo on its PPIC Statewide Survey on Californians and the Environment (found here) on July 25th. The findings in the report are based on a survey of 1,711 California adult residents, and took place between July 8-17, 2018. Listed below are the results:

2018 Gubernatorial Election and Environmental Issues

The poll found 56 percent of likely voters say the candidates’ positions on the environment are important in determining their vote in the Governor’s race, with 31 percent saying they are somewhat important. Looking across party lines, 67 percent of Democratic likely voters say the candidate’s environmental stances are very important, while 54 percent of independents and only 33 percent of Republicans hold this view. Mark Baldassare, PPIC president and CEO, summed up the findings: “Many Californians are concerned about the personal impact of global warming in the wake of a prolonged drought and in the face of fears that extreme weather may result in more severe wildfires.”

The poll gives Gavin Newsom, the Democratic lieutenant governor, an advantage over Republican businessman, John Cox, in the race for California’s governor. The poll found 55 percent of likely voters favored Newsom, compared to 31 percent who favored Cox, and 9 percent who were undecided. In true partisan fashion, 86 percent of Democratic likely voters favored Newsom and 84 percent of Republican likely voters favored Cox. Newsom led among independents, 41 to 33 percent. In terms of ethnicity, 64 percent of Latino likely voters favored Newsom and 49 percent of white likely voters did as well. “The electorate is so polarized,” Mark Baldassare said. “Cox has equally solid support among Republicans, but there are many more Democrats than Republicans in the electorate these days.”

US Senate Election

Dianne Feinstein leads state senator Kevin de Leon with a 46 to 24 percent advantage among likely voters. Only 9 percent of voters reported being undecided, denying De Leon a potentially winning margin, according to the poll. The poll found 47 percent of Republican likely voters and 24 percent of independents do not plan to vote in the Senate race.

Approval Ratings of State Candidates

The poll found 54 percent of likely voters approve of the way Jerry Brown is handling his job as governor of California. Across regions, approval is highest in the San Francisco Bay Area (59 percent) and Los Angeles (59 percent). Latinos (61 percent), Asian Americans (58 percent), and African Americans (53 percent) are more likely than whites (45 percent) to approve of Governor Brown’s job performance.

Looking at the California Legislature, 46 percent of likely voters approve of the way  it is handling its job. Today, Democrats (60 percent) are more likely than independents (42 percent) and Republicans (13 percent) to approve. Majorities approve of the state legislature in Los Angeles (53 percent) and the San Francisco Bay Area (52 percent).

In the News

California lawmakers to tackle key wildfire question: Who pays for damages?

Worst Poverty in California? Not Where You Might Think

California’s Costly, Inaccessible Healthcare System

Bay Area biotech firm chases medicine’s white whale: Alzheimer’s cure

Needles, feces still litter San Francisco. Could a Governor Gavin Newsom fix it?

Democrats spent 37 times the contribution limit on Nathan Fletcher. And it’s legal.

The law that led to soda tax blackmail is coming to cities. Is Sacramento’s rent control fight next?

San Diego median home price hits its highest ever: $575K

California funds new dams to protect against future drought

House votes to repeal medical device tax

House Passes Device Tax Repeal Bill, Industry Urges Senate To Follow Suit

Biotech Companies Are Investing Millions of Dollars in the Medical Marijuana Market to Develop Cannabinoid Products

A CAR-T bottleneck: Centers that collect patient cells feel crunch from growing demand

Paying for therapies that cure: innovative solutions needed

UCLA surpasses $4.2 billion fundraising goal, a boon for a public campus faced with diminished state aid

Digital Pills Could Help with Adherence to Prescription Drugs

California sues Trump administration over small-business health policy

New privacy law takes center stage

Cell phones, landlines would be taxed more to pay for 911 upgrade under Jerry Brown’s plan

August’s Legislative Deadlines

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