Legal and Data Barriers to Vaccination

Troy Trygstad, PharmD, MBA, PhD; Ned Milenkovich, PharmD, JD; Mindy Smith, BSPharm, RPh; Brian Hille, BSPharm, RPh; and John Beckner, BSPharm, RPh, address the legal barriers to vaccination and sharing patient information.


Troy Trygstad, PharmD, MBA, PhD: Ned, what are some of those barriers to flu and other types of vaccination information flows? So, we have the need to report to registries. We have the need to be able to do decision support and know what vaccinations they’ve already received even if they’re not recalling it. But also we need to know what conditions they might have and circumstances that require me to think about and think through which vaccinations and which circumstances, under what type of timing and follow-up. What might be getting in the way of all that from your perspective and your firm’s perspective?

Ned Milenkovich, PharmD, JD: Well, at the end of the day, as a pharmacist, I want access to all that information and I want all that information at my finger tips to make sure that I have a full-scope picture of that patient. And if I don’t have that information, then there’s risk, because as you said, there could be an immunocompromised patient and somehow I don’t get that information and I administer a live vaccine or I do something that’s going to harm that patient. That could potentially expose me to liability. And we could talk about liability at another interval, but the barriers to communication are really operational at this point.

There is some misinformation that HIPAA [Health Insurance Portability and Accountability Act] somehow inhibits the free flow of information. Well, it does, but not with respect to health care providers who are communicating with each other when it comes to patient treatment, when it comes to payment, and when it comes to health care operations. These are permitted uses and exposures that can occur between a pharmacy and a pharmacist on the one hand and a physician, a practice group, a hospital, or some other health care provider, so long as they’re all involved in the treatment of that patient. And the principle concern there is what we call PHI, or protected health information, and that is where you have an identifiable patient associated with a health care issue and those 2 together have limitations in terms of the free flow of information.

But at the end of the day, there shouldn’t really be an impediment to get access to that information except for perhaps technology barriers that might exist in the marketplace or there hasn’t been some coordination of efforts to create, like we talked about earlier, the repository of immunization services where people can access all of the data and perhaps health care records, too, that might be helpful. So, you’re really looking at privacy laws and security laws at both the federal and the state level. There might be a few other things to consider within specific pharmacy practice laws, but generally speaking, there shouldn’t be any inhibition on free flow of information at this day and age.

Troy Trygstad, PharmD, MBA, PhD: So, from your perspective, for the most part, it’s a friendly, environment legal exchange of this information. Mindy, technologically, and from a business-alignment perspective, where are we at with these types of information flows and what needs to happen next?

Mindy Smith, BSPharm, RPh: Great question. So, you have the HIEs [health information exchanges]. Each state has an HIE, which is another place you could plug into. I think it’s a matter of knocking on the doors of the EHR [electronic health record] vendors. There’s 90 EHR systems on the market today. Each of them consumes data differently. So, you have the dinosaur systems and the robust systems, and so it’s not as easy as connecting into for free flow of information. And there are always costs involved when you share data, and getting that data and access to that data do not come for free. But there are standards that exist that through understanding protections that are out there related to HIPAA, and especially if it’s patient approved, you could pull in the data. I think even within, we talked about a PDMP [prescription drug monitoring program]. But taking that model and being able to streamline that across systems doesn’t exist right now because you do have proprietary registry data. Some states only have the data, but they don’t allow a vendor to come in, which also leaves, I think, 7 states where we don’t have access to the data, including the city of San Diego—although California allows it. So, there are different areas that, from a policy perspective and data sharing perspective, there still are barriers even from a system perspective that need to be solved and conquered.

Troy Trygstad, PharmD, MBA, PhD: But there are products and capabilities in the marketplace with respect to decision support.

Mindy Smith, BSPharm, RPh: There is, yes.

Troy Trygstad, PharmD, MBA, PhD: And to reporting in to the registry.

Mindy Smith, BSPharm, RPh: Right.

Troy Trygstad, PharmD, MBA, PhD: And perhaps pulling from some registries in that decision support.

What are the 2, 3, 4 things that I need to be thinking about from risk mitigation with respect to I own a pharmacy business and I’m responsible for immunizations across 1 or more pharmacy sites? Two or 3 most important things to be keeping in mind at all times as far as regulations, laws, risk mitigation?

Ned Milenkovich, PharmD, JD: Have an intimate understanding of your Pharmacy Practice Act and the regulations that relate to immunization. Make sure that you have adequate clinical resources available to your pharmacists at all times, including programming so that they can stay on top of all of the new developments in immunizations. Make sure that your record keeping is square. You don’t want to have a sloppy book. If someone comes in for an audit, whether it’s a payer, whether it’s a board inspector, you want to make sure that you have all of that information available to you. Just generally understand the laws and the rules that are associated with your individual state. State-by-state laws will vary. They’re not uniform, obviously. If they were, things would be a lot easier, but they’re not. So, just understand. Make it a subpractice of your practice and devote your full attention to it and good things will happen.

Troy Trygstad, PharmD, MBA, PhD: Well, we’re nearing the end of our discussion. I always like to end the Peer Exchangewith a speed round, and so we’re going to go to each panelist with a quick fire answer. Most exciting development in vaccinations generally?

Brian Hille, BSPharm, RPh: Most exciting. Well, I think the new entries of new vaccines in the marketplace have been exciting, especially the new shingles vaccine that came out here recently.

Troy Trygstad, PharmD, MBA, PhD: So, new products.

Mindy Smith, BSPharm, RPh: I am really excited to see Idaho expand vaccination capability to technicians. I think it’s a game changer. We already game changed pharmacists, and now we can even bolster and even more so maximize these vaccination opportunities in community pharmacy.

Troy Trygstad, PharmD, MBA, PhD: John?

John Beckner, BSPharm, RPh: It’s a way to brand your pharmacy as a health care destination. The most exciting thing to me is the continued uptake in pharmacists providing a service.

Troy Trygstad, PharmD, MBA, PhD: Ned?

Ned Milenkovich, PharmD, JD: I love to see the independence of pharmacists, that independent prescribing authority, legislative enactments that give pharmacists full power and reign over their ability to deliver patient care.

Troy Trygstad, PharmD, MBA, PhD: Well, there you have it, folks. That was a terrific panel. Thank you all for your contributions to the discussion. On behalf of our panel and Pharmacy Times®, thank you for joining us, and we’ll see you on the next Peer Exchange.

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