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Policy Advocacy

Group 1

Welcome Dr. Cathy and fellow FNP Students. We are group 1. We will be presenting a policy advocacy regarding the safe administration of anesthetic agents specifically Propofol by registered nurses in oral surgery. I’m Resel Casimiro and I will be presenting the objectives, the policy challenge, and the introduction to Propofol. Melissa Salazar will then discuss Caleb’s Law, our interview with our selected nurse leader, and the key stakeholders involved in the policy challenge. Iris Molina will conclude the presentation with legislative and non-legislative strategies and the legislative process.

Objectives

Describe the policy challenge and the nursing association identification

Describe the agenda

Key Stakeholders

Legislative Strategies used to inform/lobby legislators

Non-legislative strategies to support the initiative

Legislative Process

The objectives of our presentation are to:

Describe the policy challenge and nursing association identification

Describe the policy challenge agenda

Identify the key stakeholders: The supports and the oppositions and their goals.

Describe the legislative strategies used to lobby with the legislators

Identify the non legislative strategies to support the initiative

Lastly, will describe the legislative process used to attain the passing of the law.

Policy Challenge

Nurse Administered Sedation

Section 2725 (b)(2) of the California Nurse Practice Act places no limits on the type of medication or route of administration (Board of Registered Nursing, 2013).

American Association of Nurse Anesthesiology

Whenever Propofol is used for sedation or anesthesia, it should be performed by professionals trained in the administration of general anesthesia, who are not currently involved in the procedure to minimize the risk for injury or death (American Association of Nurse Anesthesiology, 2013)

Our policy challenge started after the registered nurses were advised that the oral surgeon would be ordering administration of IV push Propofol during wisdom teeth extractions under conscious sedation. However, the facilitie’s current moderate sedation program only allows for administration of IV push Fentanyl, Versed and Ketamine, after completion of moderate conscious sedation online training, hands on training and examination.

California Nurse Practice Act has an unclear statement stating that, there is no limits on the type of medication or route of administration administered by registered nurses, the only requirement is that the the drug must be ordered by a lawfully authorized prescriber.

During research in an attempt to find a clear policy regarding administration of Propofol by registered nurses, AB 2235, aka Caleb’s Law was discovered.

Upon discovery of Caleb’s law the registered nurses consulted a nurse leader, Department Head, Main Operating Room, Lieutenant Commander Erin Gagliano, a Certified Registered Nurse Anesthetist and member of the American Association of Nurse Anesthesiology.

The Warnings section of the drug’s package insert (Diprivan®, AstraZeneca) states that propofol used for sedation or anesthesia “should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure” (American Society of Anesthesiologists, 2019).

Propofol

Procedural sedation with the use of Propofol is safe and effective when performed by appropriately trained and credentialed health care professionals. These types of medications including, but not limited to, etomidate,ketamine, fentanyl, and midazolam are used to painful conditions and can extend to the maintenance of sedation to moderate-deep sedation for painful procedures. Compared to other types of medications that cause sedation, Propofol does not have a reversal drug that can counteract it’s sedative effects. This is one of the reasons why some states are against administration of Propofol by registered nurses. These states include Georgia, Texas, New York, Illinois, and Arizona. The only exception that allows the administration of Propofol by registered nurses is when the patient is intubated with mechanical ventilation in place (Sedation Certification, 2021). For example, the Texas State Board of Nursing’s position in administration of anesthetic agents (eg, propofol, methohexital, ketamine, and etomidate) is outside the scope of practice for RNs and non-CRNA advanced practice registered nurses (Buppert, 2018).

Caleb’s Law

California AB 2235

Effective January 1, 2017

Describe the “agenda.” How the policy issue was identified

In March 2015, 6 yr old Caleb Sears stopped breathing after receiving dental sedation comprised of versed, fentanyl, propofol, ketamine and nitrous oxide. He did not receive reversal meds, nor received CPR when paramedics arrived. The surgeon attempted to intubate but was unsuccessful. As only the oral surgeon and a dental assistant were there, this is called the single operator model.

Caleb’s Aunt, a general surgeon and his parents lobbied legislative changed, resulting in Assembly Bill 2235, Caleb’s law.

This bill established a committee to study safety of sedation and general anesthesia, appropriate consent for administration, and an epidemological study regarding adverse effects (Vlessides, 2020).

Lieutenant Commander Erin Gagliano Certified Registered Nurse Anesthetist

Nurse Leader

As RNs assist with conscious sedation for oral surgery in the Ambulatory Procedure Unit, we were informed that the Department of Health Agency, overseer of Military policy, was allowing for oral surgeons to use Propofol. We were advised by our oral surgeon that he wished to use it almost immediately. As we were not comfortable with this, we spoke with the Department Head.

LCDR Gagliano is a nurse leader in Naval Medical Readiness Training Center Lemoore, CA. As the department head of the main operating room that oversees the conscious sedation program, she placed a hard stop on the oral surgeon’s request on having the registered nurses push IV propofol for conscious sedation during teeth extractions. She advocated for the safety of our patients and also helped protect our nursing licenses from potential malpractice. LCDR Gagliano recommended to have an established policy for the facility and have adequate training before proceeding with the new practice.

Key Stakeholders

*The California Dental Association

*American Academy of Pediatrics -

CA (Bill sponsor)

Opposition

*American Society of Dentist

Anesthesiologists

*California Society of

Anesthesiologists

Supporter

*The California Society of Pediatric Dentistry

*PDI Surgery Center

*Happy Bear Surgery Center

*The Family of Caleb Sears

(2008–2015)

*The California Association of Oral and Maxillofacial Surgeons

(Morain, 2017)

Oral surgeons should perform surgery, and anesthesiologists should administer anesthesia. Surgeons should not do double duty. Oral surgeons, also argue that if they must hire anesthesiologists, or specially trained nurses, patients will be priced out of dental care.

In 2002, the California Dental Association spent1.5 million to legislators. Again in 2004, the dentists made the largest single independent expenditure of $408,000, to elect one of their own. Since then they added another oral surgeon and a dentist to California legislators.

2015-2016 they spent 3.8 million on lobbying and campaigns

Legislative Strategies

Private/public communication with legislators

Personal meetings

Presentations in leadership forums

Political conferences, seminars and public meetings

Caleb’s Law advocacy involved various legislative strategies for legislators’ lobbying

(Agarwal et al., 2018)

There are various legislative strategies used in Caleb’s Law advocacy for lobbying and informing legislators about a bill for support. Direct legislative lobbying can involve influencing lawmakers through private communication with decision-makers. Personal meetings with legislators are a cost-effective and powerful tool for policy advocacy.Dr. Kaplan, who is Caleb’s aunt met with the California State Assemblymember Tony Thurmond to draft a bill and present it to the Assembly (Agarwal et al., 2018). Making a presentation about the policy issue, attending conferences, seminars, and public meetings where legislators are present can help influence them for support. Attending national and international political conferences can help influence political support toward certain policies. One can still lobby lawmakers by reaching influential legislators through writing, demonstrating the extent of a certain problem and its possible solution. Identifying an issue and gathering a team to push for changes is a key lobbying strategy.

Non-Legislative Strategies

Media Headlines

Provide Testimony

Chain E-mails

Opinion Pieces To Newspapers Editors

Testimonies

Newsletters

Online Discussions

Celebrity Endorsement

Media Partnerships With Film-makers And Journalists

Large-scale Advertisement Campaigns On The Policy

(Kaplan, 2016)

Many non-legislative strategies can be used to lobby legislators to support a particular policy like Caleb’s law. Writing to media editors to secure influential media headlines that mobilize support from legislators for a particular policy is an effective approach. The policy advocating team can use letters or chain e-mails, opinion pieces to newspapers editors, testimonies, newsletters, and online discussions. Dr. Kaplan and Caleb’s mother testimony, facebook group for Caleb’s law are just one of the examples used for the support of the Caleb’s Law (Kaplan, 2016) . Other policies influencing non-legislative strategies include celebrity endorsement to increase campaign awareness, media partnerships with filmmakers and journalists, and large-scale advertisement campaigns on the policy.

Non-Legislative Strategies

Six-year-old boy dies getting tooth extracted

Father pushes for new law after son dies during dental procedure

Legislative Process

80%

Group E

Dr. Anna Kaplan partnered with Assemblymember Tony Thurmond

AB 2235 introduced February 18, 2016

Amended three times, passed by House April 28, 2016

Moved to Senate, amended three times, passed August 24, 2016

Approved by Governor September 23, 2016

Caleb's Law was enacted January 1, 2017 (California Legislative Information, 2016)

Dr. Anna Kaplan partnered with Assemblymember Tony Thurmond to prepare and support the Caleb bill. Bill AB 2235 was introduced on February 18, 2016. AB 2235 Bill was amended three times and passed by the House of representative on April, 28th 2016. The bill was moved to the senate, amended three times, and passed on August 24, 2016. On September 23, 2016, California Governor Jerry Brown signed Assembly Bill 2235 into law. Caleb's Law was implemented on January 1, 2017.

Future Implication

Improved safety of pediatric dental patient

Better reporting of deaths and hospitalization

Better patient empowerment

Specific and standardized policy regarding nurse administration of Propofol

Passing Caleb’s Law Part 2

(Agarwal et al., 2018)

The law will significantly improve the safety of pediatric dental patient because the Dental Board are required to provide a report on the safety offered by the current pediatric dental anesthesia regulations for adequate protection. The law will guarantee proper data keeping and reporting as the dentist is required to report all pediatric deaths and cases of hospitalization associated with general anesthesia (Agarwal, 2018). Patients will be more empowered as the law requires written informed consent from patients that should involve a particular language.Caleb’s family is still set on Caleb’s Law Part 2 to include a separate anesthesia provider for young children undergoing deep sedation and general anesthesia. However, the California Dental Association and the California Association of Oral and Maxillofacial Surgeons continues to fiercely oppose such legislation arguing it would increase patient costs and decrease access to care.

References

Agarwal, R., Kaplan, A., Brown, R., & Cote, C. (2018). Pubmed. Retrieved from Concerns regarding the single operator model of

sedation in young children: https://pubmed.ncbi.nlm.nih.gov/29500294/

American Association of Nurse Anesthesiology. (2013). AANA-ASA joint position statement regarding Propofol administration.

Retrieved from American Association of Nurse Anesthesiology:

https://www.aana.com/docs/default-source/practice-aana-com-web-documents-(all)/professional-practice-manual/aana-asa-p

ropofol-joint-ps.pdf?sfvrsn=f80049b1_4

American Society of Anesthesiologists. (2019). Statement on safe use of Propofol. Retrieved from American Society of

Anesthesiologists: https://www.asahq.org/standards-and-guidelines/statement-on-safe-use-of-propofol

American Society of Anesthesiologists. (2021). Joint statement on pediatric dental sedation. Retrieved from

American Society of Anesthesiologists:

https://www.asahq.org/advocacy-and-asapac/advocacy-topics/office-based-anesthesia-and-dental-anesthe

sia/joint-statement-pediatric-dental-sedation

Board of Registered Nursing. (2013). Conscious sedation/moderate sedation. Retrieved from State of California

Department of Consumer Affairs: https://www.rn.ca.gov/pdfs/regulations/npr-b-06.pdf

Buppert, C. (2018). Can RNs bolus Propofol? Retrieved from Medscape:

https://www.medscape.com/viewarticle/890840#vp_2

Calebslaw.org. (2017). Calebs law. Retrieved from Caleb's law seeks to increase the safety of administering and

monitoring general anesthesia/deep sedation to children during dental procedures: www.calebslaw.org

California Legislative Information. (2016). AB-2235 Board of Dentistry: pediatric anesthesia: committee. Retrieved

from California Legislative Information:

https://leginfo.legislature.ca.gov/faces/billHistoryClient.xhtml?bill_id=201520160AB2235

Kaplan, A. (2016). Turning tragedy into advocacy: Caleb's Law. Retrieved from Feminem:

https://feminem.org/2016/10/24/turning-tragedy-advocacy-calebs-law/

Morain, D. (2017). How $3 million in political donations stands in the way of justice for this boy's death. Retrieved

from Centre Daily Times: https://www.centredaily.com/opinion/article147594484.html

Otto, M. (2017). What can we learn from the failed effort to pass 'Caleb's Law' in California. Retrieved from

Covering Health:

https://healthjournalism.org/blog/2017/09/what-we-can-learn-from-the-failed-effort-to-pass-calebs-law-in-california/

Rosenhall, L. (2020). A child's death and the power of the dental lobby. Retrieved from Calmatters:

https://calmatters.org/health/2016/04/a-childs-death-and-the-power-of-the-dental-lobby/

Sedation Certification. (2021). State sedation policy. Retrieved from Sedation Certification:

https://sedationcertification.com/resources/position-statements/postion-statements-by-state/clickable-map/

Vlessides, M. (2020). Disagreements persist over safety of dental anesthesia. Retrieved from Anesthesiology News:

https://www.anesthesiologynews.com/article/printarticle?articleID=59545