California Passes First-in-Nation Law to Reduce Medication Errors, Address Pharmacy Staffing Concerns

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California's Stop Dangerous Pharmacies Act aims to improve patient safety by establishing new pharmacy staffing regulations and a medication error reporting system, arising from understaffed conditions.

The interview provided an overview of California's new Stop Dangerous Pharmacies Act (AB 1286), aiming to address understaffed chain pharmacies and reduce medication errors. Key aspects of the law included giving pharmacists more autonomy over staffing decisions, requiring reporting of unsafe conditions, and establishing a confidential medication error reporting system.

About The Guest

Ron Lanton has over 25 years of experience focused on government affairs and legal including 20 years dedicated to the healthcare sector. He is currently a Partner at Lanton Law and the President of Lanton Strategies. Ron has been an Executive Director & Senior Counsel for a national boutique health care law firm.

Prior to this, Ron founded the health care government affairs and lobbying firm True North Political Solutions. At True North, Ron lobbied and provided strategic consulting for retail/specialty pharmacies, HME, compounders, home infusion and device stakeholders throughout the country.

Ron is admitted to practice in Illinois, District of Columbia, Massachusetts and New York with New Hampshire pending.

Challenges in implementing the new provisions related to oversight, compliance from chains, and current staffing shortages were also identified. Overall, Ron Lanton, Esq, partner at Lanton Law, hopes it will improve the culture of safety in pharmacies and potentially influence other states as well.

Key Takeaways

  1. California passed the Stop Dangerous Pharmacies Act (AB 1286) to crack down on understaffed chain pharmacies and reduce medication errors through centralized EHR reporting and new staffing regulations.
  2. The new law gives pharmacists more autonomy over staffing decisions to prevent fatigue or unsafe conditions and requires reporting unsafe situations to management and the Board of Pharmacy if unresolved.
  3. Medication error reporting requirements were established, including confidential reporting to an approved entity within 14 days and analyzing errors to identify preventative measures.
Medicine law concept. Judges gavel with pills | Image Credit: Iren Moroz - stock.adobe.com

Iren Moroz - stock.adobe.com

Q: Could you just start by briefly elaborating on what the stop dangerous pharmacies act is?

Ron Lanton: This bill was actually signed into law in late 2023. It was sponsored by Assemblymember Haney. He's a Democrat from San Francisco. It was primarily negotiated with chain pharmacies, labor groups, and regulators. Now, [assembly bill (AB)] 1286 creates a first in the nation regulation, which actually cracks down on understaffed chain pharmacies that will be making medication errors. Essentially, this proposed law, which now is enacted, creates a centralized reporting system for errors for chains.

I know that I don't want to single out chains here. I mean, that's what the law primarily was in response to a lot of the things that we've been seeing in the news about understaffed chains. This does address some community pharmacy issues in here as well. But primarily, this law was aimed at understaffed chains.

Q: what are some of the specifics of the law?

Ron Lanton: The new law does a few things. First of all, it authorizes a pharmacist in charge to make staffing decisions, to ensure that the right personnel or at least enough personnel are present in the store, to prevent fatigue, distraction, or other conditions that may interfere with the pharmacist ability to practice. Second, it authorized as a pharmacist on duty if the pharmacist is charged is not available to make any staffing adjustments to workloads if needed, and that's very important.

It also requires a pharmacist in charge or the pharmacist on duty to immediately notify the store management if there's any conditions that are present, that may cause immediate risk of death, illness, or irreparable harm to patients, personnel, or staff. It also requires store management to take immediate and reasonable steps to address these issues and resolve these conditions, and if they're not resolved within 24 hours, it would require the pharmacist in charge or pharmacist on duty to actually notify or ensure that the board is notified of these issues. Lastly, it makes failure to comply with these with these regulations. There's a cease-and-desist order for unprofessional conduct or pharmacy corporation, so there are some deterrence protocols in here, if this law is not followed.

Q: How would this new bar potentially help with patient safety?

Ron Lanton: I think it's going to help a lot. This is the first law like this that we've seen, so hopefully, this won't be in the last. I am told that in chains that pharmacists don't have a lot of autonomy, and speaking just specifically for California, this new law would actually give licensed pharmacy staff a lot more autonomy over staffing and working conditions. It also provides pathways for temporary pharmacy closure if necessary. In essence, all of these safeguards have now been put into place to ensure that the patient experience is much safer, and also for the staff and the pharmacists as well.

Q: AB 1286 introduces medication error reporting requirements. Could you discuss what pharmacists should know about reporting medication errors and the potential impacts of this provision on pharmacy practice?

Ron Lanton: If a pharmacist really needs to know about specific medication error reporting requirements, you need to look at your specific board of pharmacy regulations, because that's where that's going to be. But for this conversation, I know we're only talking California, so I just wanted to make sure that that point was clarified, at least with this new law and where it stands.

With this new law in California, the law requires that a licensed community pharmacist would report all medication errors to an entity approved by the board and maintain records as prescribed. I mentioned earlier in this interview how there are some provisions that do apply to community pharmacist but mostly this law is aimed at the chain pharmacies and how they run. That's why I'm talking community pharmacy right now. Just didn't want to make sure that everybody was confused.

Specifically on that point, community Pharmacy shall submit a report that's no later than 14 days following the discovery of any error. These reports are deemed confidential and they're not subject to discovery, subpoena, or disclosure pursuant to the California Public Records Act. This is straight from the law, not my personal advice or legal advice. If anybody does have questions, legally, I advise that you consult counsel, but this is strictly from the law. A medication error report made pursuant to this law shouldn't be subject to investigation, discipline, or any other enforcement action by the board. Outpatient hospitals are also mentioned too in this new law. They should not be required to report a medication error that meets the requirements have an adverse offense. I wanted to make sure that that was covered.

Lastly, the new law talks about the primary purpose of the medication error reporting. That's to advance error prevention by analyzing individually and collectively medication error data that occurs in a community pharmacy setting, and specifically, the law goes on to talk about how it identifies contributing factors to broadly disseminate information on preventative measures and best practices. They want to make sure that we learn from these mistakes, we see what's there, and the pressure is not on the store to conceal. That's why they want to try to make sure that the Public Health Records Act is used the way it is in the section. Because again, we want to make sure that patient safety is emphasized.

Q: In your opinion, what challenges could potentially arise when implementing the provisions that are related to staffing decisions, and unsafe pharmacy conditions?

Ron Lanton: The challenges that I foresee with any new law, notwithstanding this one, is how the oversight is going to be during the early stages of implementation, that's always a factor you're trying to figure out. Because these things are new, a specific person may need to be identified in order to handle the issue, how timely is that person put into place, all of those things are important.

Another question or challenge that I see is how will the chains comply with this? This is, on the surface, it looks like it should be something that's fairly easy to put in. But I don't work in a chain. I'm not chain management. I'm sure that there are some several protocols that do need to be changed in order to comply. My other challenge that I see with this is how will the current state of pharmacist and pharmacy tech shortages affect compliance? I mean, this is an issue with shortages that aren't going away for a lot of reasons, including the impact that we've seen with COVID. I'd like to see how that plays into how this law gets implemented, but that's just kind of a short-term challenge that I see right now, especially with getting the appropriate staff because that's what this law is about making sure that the staff is there in order to make sure that that patient is kept safe.

Q: how do you anticipate AB 1286 influencing the overall culture of safety within pharmacies, particularly around the reporting of unsafe conditions and medication errors?

Ron Lanton: I definitely think it's a help. I see more pharmacists and pharmacy techs that are going to speak out when there is an unsafe environment. I think this law empowers both the pharmacist in the pharmacy tech to make these observations and try to make sure that there is compliance because again, the pharmacist and pharmacy techs want to be safe in their workplace.

Obviously, the goal is to make sure that the patient is safe, overall, so that we don't have any of these errors that happen due to these extenuating circumstances that we've been talking about. So hopefully this law goes into other states. I mentioned how this is the first in the nation that we've seen. I think this is something that is a good thing. It's definitely needed, and both the pharmacist and pharmacy tech, and ancillary staff, they need to be empowered to make decisions to make sure that the patient is taken care of.

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