Legal Challenges to Immunization and Data-Sharing Sites

SEPTEMBER 21, 2018


Troy Trygstad, PharmD, MBA, PhD; Ned Milenkovich, PharmD, JD; John Beckner, BSPharm, RPh; and Mindy Smith, BSPharm, RPh, discuss the legal challenges to immunization and the concerns with state-to-state variations in requirements.

Transcript:

Troy Trygstad, PharmD, MBA, PhD:
You work for a firm?

Ned Milenkovich, PharmD, JD:Yes.

Troy Trygstad, PharmD, MBA, PhD:Would you say though, by and large, that we’ve mostly gotten past, as a health care system or as a society, the idea that we should question the pharmacist vaccinating?

Ned Milenkovich, PharmD, JD:It’s interesting, because historically, obviously, at the very beginning, it was the biggest challenge for a pharmacy and pharmacist to get going on immunizations. Back in the day, even when it started, the pharmacist typically had to have a prescription from a prescriber in order to go ahead and immunize. We then saw a natural progression to collaborative practice and standing orders, where there wasn’t an identifiable patient but there was a delegation by a prescriber to a pharmacist or a pharmacy and they would basically follow a protocol or a collaborative practice agreement, as we call it. And then we have the third variation on the theme, where states are actually going forth and allowing pharmacists to independently prescribe to administer the vaccine. So, we’ve seen quite an evolution. Are we past it? I believe so. Will there be limitations on individual immunizations? I believe Brian mentioned at one point earlier today, when we were talking, that there are some drugs that still require a physician prescription before the pharmacist can go forth and immunize. But I believe, by and large, pharmacists have demonstrated that they are up to the task and challenge of immunizing patients, and I believe most of that is in the rearview mirror.

John Beckner, BSPharm, RPh:And I think patients have become more accepting of pharmacists providing that service.

Troy Trygstad, PharmD, MBA, PhD:Mindy, I want to get back to decision support, data sharing, reducing the practitioner energy associated with information gathering and administration, so they’ve got time to care for the patient and develop that relationship or that conversation. What do you think are the most important data sharing mountains we need to climb as a pharmacy sector in the vaccination space?

Mindy Smith, BSPharm, RPh:Good question. So, part of a challenge that we have heard from our pharmacy clients is some health insurance does not cover the vaccine. They even go through all this effort to recruit, make calls out to your patients who come in and then there’s no coverage. That’s a barrier. So, providing that type of information is not readily available and difficult, but that would really help because you’re creating awareness. Then you need to tell them how they can get those vaccines or solve the solution on contracting with those companies, so they can.

Troy Trygstad, PharmD, MBA, PhD:But I can also use my health savings account if I had one of those, right?

Mindy Smith, BSPharm, RPh:They could. They actually could, yes.

Troy Trygstad, PharmD, MBA, PhD:So, that’s an important counseling point. It’s not covered by your insurance, but you have a health savings account, and I’m here to tell you that this vaccination is really important. I would do it for my own family.

Mindy Smith, BSPharm, RPh: Right, so that information. I also think just from leveraging community pharmacy, which has always been on kind of a siloed island outside looking in, and now with the pharmacist eCare plan and having that interoperability and that capability from an electronic system or standard now that can communicate to the health care team, we’ll now start bridging that communication data gathering that we need. So if you can infer a disease state, we need to have that disease state information. How do we share that the vaccines were given or side effects, etc? So, my daughter went to Uganda in May and had to get yellow fever. Thank goodness a community pharmacist in Virginia was able to provide her that vaccine. But that information needs to be shared—what she received and the side effects monitored that go into that before she ships off to Africa. I think there’s a lot from a data perspective that is still not obviously perfect in our system, but policy could help support and technology could also help solve those issues.

Troy Trygstad, PharmD, MBA, PhD:So, what I’m hearing you saying is we need to be part of the system, right?

Mindy Smith, BSPharm, RPh: Absolutely.

Troy Trygstad, PharmD, MBA, PhD:Now, John, when we look at the ACIP [Advisory Committee on Immunization Practices] guidelines and we start to get to the noninfluenza vaccines, all of the economic opportunity, all of the health opportunity associated with that, there’s a lot more nuance and clinical nuances as to whom, how, when, under what circumstances. I think Mindy is making the argument that with technologies, like the eCare plan or integrated data streams, interoperability, that really is important. You could make the argument from a pharmacy sector’s perspective that I need to know conditions because those conditions help inform what vaccinations I’m going to recommend or know about. Certainly this calls for a patient interview. All of us in the health care systems do patient interviews. We know how notoriously poor those all are. Even us, as health care professionals, do poor recall and poor reporting. So, I’m hearing a policy consideration here that has been prompted by immunizations, which is that this is a patient care activity. It’s a whole patient, we have a circumstance where we want to give access to a whole bunch of other vaccinations for other disease states, but I need to have some semblance of the medical record in order to do that in an informed way. What might an NCPA [National Center for Policy Analysis] or a policy maker advocate do to help advance that cause?

John Beckner, BSPharm, RPh:NCPA is first and foremost an advocacy organization. We advocate for our members on various issues. DIRs were mentioned earlier. That has been at the top of the list. But from an immunization standpoint, we think it’s very important that our members engage in that service. And we’ve done a better job over the past, I would say, 5 years in increasing the percentage of our members that are immunizing. The focus now needs to be on encouraging them to expand their portfolio, and part and parcel to that is making sure that the state laws and regulations are friendly toward pharmacists being able to administer really all ACIP-approved vaccines with appropriate age limitations. Some states are more liberal than others. I’m from Virginia. I’ve practiced in Virginia for a long time. We’re one of the first. The company I worked for earlier was one of the first companies to offer immunizations back in the late 90s. I think the state laws and regulations are really beginning to evolve to allow pharmacists to really expand and do much more than the traditional flu and pneumococcal vaccines. And that is very important for NCPA, APHA [American Pharmacists Association], NACDS [Nationwide Association of Chain Drug Stores], and all of the major pharmacy organizations to really advocate for expansion.
 


Troy Trygstad, PharmD, MBA, PhD; Ned Milenkovich, PharmD, JD; John Beckner, BSPharm, RPh; and Mindy Smith, BSPharm, RPh, discuss the legal challenges to immunization and the concerns with state-to-state variations in requirements.

Transcript:

Troy Trygstad, PharmD, MBA, PhD:
You work for a firm?

Ned Milenkovich, PharmD, JD:Yes.

Troy Trygstad, PharmD, MBA, PhD:Would you say though, by and large, that we’ve mostly gotten past, as a health care system or as a society, the idea that we should question the pharmacist vaccinating?

Ned Milenkovich, PharmD, JD:It’s interesting, because historically, obviously, at the very beginning, it was the biggest challenge for a pharmacy and pharmacist to get going on immunizations. Back in the day, even when it started, the pharmacist typically had to have a prescription from a prescriber in order to go ahead and immunize. We then saw a natural progression to collaborative practice and standing orders, where there wasn’t an identifiable patient but there was a delegation by a prescriber to a pharmacist or a pharmacy and they would basically follow a protocol or a collaborative practice agreement, as we call it. And then we have the third variation on the theme, where states are actually going forth and allowing pharmacists to independently prescribe to administer the vaccine. So, we’ve seen quite an evolution. Are we past it? I believe so. Will there be limitations on individual immunizations? I believe Brian mentioned at one point earlier today, when we were talking, that there are some drugs that still require a physician prescription before the pharmacist can go forth and immunize. But I believe, by and large, pharmacists have demonstrated that they are up to the task and challenge of immunizing patients, and I believe most of that is in the rearview mirror.

John Beckner, BSPharm, RPh:And I think patients have become more accepting of pharmacists providing that service.

Troy Trygstad, PharmD, MBA, PhD:Mindy, I want to get back to decision support, data sharing, reducing the practitioner energy associated with information gathering and administration, so they’ve got time to care for the patient and develop that relationship or that conversation. What do you think are the most important data sharing mountains we need to climb as a pharmacy sector in the vaccination space?

Mindy Smith, BSPharm, RPh:Good question. So, part of a challenge that we have heard from our pharmacy clients is some health insurance does not cover the vaccine. They even go through all this effort to recruit, make calls out to your patients who come in and then there’s no coverage. That’s a barrier. So, providing that type of information is not readily available and difficult, but that would really help because you’re creating awareness. Then you need to tell them how they can get those vaccines or solve the solution on contracting with those companies, so they can.

Troy Trygstad, PharmD, MBA, PhD:But I can also use my health savings account if I had one of those, right?

Mindy Smith, BSPharm, RPh:They could. They actually could, yes.

Troy Trygstad, PharmD, MBA, PhD:So, that’s an important counseling point. It’s not covered by your insurance, but you have a health savings account, and I’m here to tell you that this vaccination is really important. I would do it for my own family.

Mindy Smith, BSPharm, RPh: Right, so that information. I also think just from leveraging community pharmacy, which has always been on kind of a siloed island outside looking in, and now with the pharmacist eCare plan and having that interoperability and that capability from an electronic system or standard now that can communicate to the health care team, we’ll now start bridging that communication data gathering that we need. So if you can infer a disease state, we need to have that disease state information. How do we share that the vaccines were given or side effects, etc? So, my daughter went to Uganda in May and had to get yellow fever. Thank goodness a community pharmacist in Virginia was able to provide her that vaccine. But that information needs to be shared—what she received and the side effects monitored that go into that before she ships off to Africa. I think there’s a lot from a data perspective that is still not obviously perfect in our system, but policy could help support and technology could also help solve those issues.

Troy Trygstad, PharmD, MBA, PhD:So, what I’m hearing you saying is we need to be part of the system, right?

Mindy Smith, BSPharm, RPh: Absolutely.

Troy Trygstad, PharmD, MBA, PhD:Now, John, when we look at the ACIP [Advisory Committee on Immunization Practices] guidelines and we start to get to the noninfluenza vaccines, all of the economic opportunity, all of the health opportunity associated with that, there’s a lot more nuance and clinical nuances as to whom, how, when, under what circumstances. I think Mindy is making the argument that with technologies, like the eCare plan or integrated data streams, interoperability, that really is important. You could make the argument from a pharmacy sector’s perspective that I need to know conditions because those conditions help inform what vaccinations I’m going to recommend or know about. Certainly this calls for a patient interview. All of us in the health care systems do patient interviews. We know how notoriously poor those all are. Even us, as health care professionals, do poor recall and poor reporting. So, I’m hearing a policy consideration here that has been prompted by immunizations, which is that this is a patient care activity. It’s a whole patient, we have a circumstance where we want to give access to a whole bunch of other vaccinations for other disease states, but I need to have some semblance of the medical record in order to do that in an informed way. What might an NCPA [National Center for Policy Analysis] or a policy maker advocate do to help advance that cause?

John Beckner, BSPharm, RPh:NCPA is first and foremost an advocacy organization. We advocate for our members on various issues. DIRs were mentioned earlier. That has been at the top of the list. But from an immunization standpoint, we think it’s very important that our members engage in that service. And we’ve done a better job over the past, I would say, 5 years in increasing the percentage of our members that are immunizing. The focus now needs to be on encouraging them to expand their portfolio, and part and parcel to that is making sure that the state laws and regulations are friendly toward pharmacists being able to administer really all ACIP-approved vaccines with appropriate age limitations. Some states are more liberal than others. I’m from Virginia. I’ve practiced in Virginia for a long time. We’re one of the first. The company I worked for earlier was one of the first companies to offer immunizations back in the late 90s. I think the state laws and regulations are really beginning to evolve to allow pharmacists to really expand and do much more than the traditional flu and pneumococcal vaccines. And that is very important for NCPA, APHA [American Pharmacists Association], NACDS [Nationwide Association of Chain Drug Stores], and all of the major pharmacy organizations to really advocate for expansion.
 
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