Community pharmacy has long been a crucial point of care, providing not just medications, but also ready and broad access for patients to answers while supporting physicians’ practices by taking work out of their offices. Here we’ll learn about the current state of opportunity at the point of care in two areas: immunizations and CLIA (Clinical Laboratory Improvement Amendments)-waived testing. Find out how, with the right tools, data, and workflow, pharmacies are making a difference by addressing public health issues, building care-based relationships with patients, and ensuring that medications are effective and side effects minimized.
Immunizations are a common offering in pharmacy today, and that’s a very good thing. But what if pharmacy could easily check a patient’s immunization status at the point of care and have the chance to act immediately to provide missed immunizations? That’s a question the American Pharmacists Association Foundation’s Project IMPACT Immunizations initiative addressed, and one that pharmacies are addressing in practice.
Gary Petruzzelli, Pharm.D., for example, has been leading the charge to make a greater impact with immunization programs as the manager of healthcare for the Pharmacy Services department of Retail Business Services. Retail Business Services is the services company of Ahold Delhaize USA, providing services to grocers Food Lion, Giant/Martin’s, Giant Food, Hannaford and Stop & Shop. Those companies operate roughly 750 pharmacies in their stores. Personally, Petruzzelli has been a bench pharmacist and has overseen the pharmacy immunization program. His current focus is on supporting quality and outcomes as a service to the local brands’ pharmacies.
“As a profession, we’re challenged to improve immunization rates,” says Petruzzelli. “Pharmacy has done a good job so far, offering an alternative to physicians and clinics as the go-to immunization source for many people. But even with the success to date, there’s still plenty of room for the pharmacy industry to help improve the overall immunization rate for adults.”
|The American Pharmacists Association Foundation’s Project IMPACT Immunizations Pilot Summary of Key Findings|
|• For every study patient who requested an influenza vaccination from the pharmacy, an additional 1.45 vaccines were forecasted as due at the point of care.|
|• 33.5% of the identified unmet vaccination needs were resolved during the six-month study period.|
|• 95.3% were administered by the pharmacist at the point of care.|
|• 4.7% were resolved at a patient-initiated follow-up visit.|
|• There was a 41.4% increase in the number of vaccines administered as a result of this innovative model of care.|
Providing services for the local brands it supports, Retail Business Services saw an opportunity: If a pharmacist could easily identify with a high level of accuracy people who need immunizations and then provide the shots on the spot, there would be a wide range of benefits. First there’s the sheer convenience for the patient – there’s no appointment needed and pharmacy-based immunizations are usually the most cost-effective option, notes Petruzzelli. In fact, for many immunizations, there’s no copay. “In our experience, we’ve seen great success with this approach,” says Petruzzelli. “Pharmacies have really improved their vaccination rates, but as industry, we still have room to improve.”
This led Petruzzelli and his team to evaluate OmniSYS’ Vaccine Management Solution (VMS), which is a software-as-a-service that uses a data-driven rules engine and smart messaging to help pharmacies identify and engage patients eligible for pharmacy-administered vaccines.
VMS generates alerts using such elements as claims data, known patient data points, CDC guidelines, and perceived gaps in immunization history.
“VMS is an excellent example of the kind of intelligent solutions Retail Business Services looks for when sharing best practices with local brands,” says Petruzzelli. Alert fatigue is a real issue in pharmacies, with edits and halts popping up throughout the prescription filling and claims submission process. Ignoring an alert can be dangerous, but it can also mean losing an opportunity to good for the patient. “VMS is accurate to the point where, when pharmacists see an immunization opportunity alert come up, they have real confidence that this is in fact a patient who needs, for example, a pneumonia shot,” explains Petruzzelli.
The easiest people to reach with this program are existing pharmacy patients, of course. But Petruzzelli notes that pharmacies can also use VMS to leverage the opportunities that come from their location within grocery stores. “The local brands we serve have folks who are in their grocery stores every day who are not pharmacy customers. We see this as a chance to draw their attention to immunization services and then have a tool like VMS available to the local brands’ pharmacies to ensure that they can offer the immunizations their customers may need. This helps keep communities protected from preventable diseases.”
For example, Petruzzelli says, flu shots can serve as a trigger to check for immunizations gaps. “We’ve heard from the local brands we support that they see a huge influx of folks – both their existing pharmacy patients and their grocery customers – coming to them ahead of flu season,” he says, “and that’s proven to be a great opportunity for them to use VMS to check the consumers’ immunization history. At that point it’s really easy for the local brand pharmacists to talk to consumers about other recommended vaccines, and offer those immunizations during that same visit,” says Petruzzelli. “In terms of best practices, this is best time to ensure consumers get a vaccination , since we know that when somebody leaves, it can be hard to get them to come back in a timely manner.”
Immunization Messaging Tips for Success from OmniSYS’s Todd Fisher, R.Ph., Pharmacy Innovation • Workflow is an important factor. Programs that require pharmacists to take extra steps or alter their normal workflow are unlikely to be successful. • Messaging should be targeted, and both patient and vaccine specific. • Establish confidence by educating staff that alerts mean vaccines are both clinically necessary and covered by the patient’s insurance. • Train staff to recommend the appropriate vaccine, and avoid asking if the patient has already received the vaccine.
VMS works right within the pharmacy management system as well, without requiring pharmacy staff to have yet another app open. “The last thing we want is to provide the local grocery bands we serve with another system that a pharmacist has to log into,” says Petruzzelli. “It’s really critical that systems integrate into existing workflow and the alert hits right on the adjudication screen. This allows pharmacists to more easily interact with their patients, and make proper recommendations.”
So what’s the impact been on the conversion rate, or the rate at which pharmacists are able to successfully address patients’ gaps in immunizations? “The companies we serve have seen roughly a 30 percent pneumonia conversion rate, which is really incredible,” says Petruzzelli. This means that three out of 10 patients who come into the pharmacy for some other reason and are lacking a pneumonia immunization end up leaving with one. What’s key here is focusing the pharmacists on asking just those patients VMS has identified as highly likely to need the immunization. It may not always be right – the data showing that a patient has in fact been immunized already may not have been recorded yet – but this targeted approach is much more efficient than asking everyone over 65 and creates an effective positive feedback loop that motivates pharmacy staff.
A good conversion rate is also a valuable data point for proving value to managed care plans, which Petruzzelli says are starting to look more and more at immunization rates as quality measures. “Pharmacies can use these rates to differentiate themselves and show the kind of care they are able to provide,” says Petruzzelli.
This ends up being a case study in what pharmacy can do for patients. “The companies we serve are some of the best out there from a clinical perspective,” says Petruzzelli. “They really focus on helping patients be healthy.”
It’s also worth pointing out that there’s a real financial benefit to improving immunization rates as well. It’s absolutely in the health plan’s best interest to pay for that pneumonia shot as opposed to paying for the pneumonia visit to the hospital. “It’s very rare these days to have a situation in healthcare where everybody wins,” says Petruzzelli. “But this is one. Pharmacists are able to give a pneumonia shot that might not have happened otherwise, and at zero cost to the patient. They then get reimbursed from the health plans, and the health plan’s finances are strengthened because people are staying out of the hospital. It may sound cliché, but I always think of my grandmother. She was able to be at my wedding, because she had dedicated healthcare providers who were focused on keeping her well. There’s a grandmother or grandfather that can be identified as a candidate for an immunization using VMS, and she or he may be able attend a grandchild’s wedding because of a renewed drive for immunization. An immunization program makes business sense for those businesses that administer them; but, for there’s such an impact on patient health too.”
The pneumonia immunization requires two shots one year apart to be fully effective. So, the immediate point-of-care opportunity is literally just half the battle. Pharmacies that use VMS can send targeted HIPAA-compliant mailers to patients. “We find that older patients really appreciate this reminder,” says Petruzzelli. “People genuinely appreciate getting something in the mail that says, ‘Hey, we care about you. We want to make sure you’re healthy.’ The companies that we’ve worked with on VMS have gotten a lot of positive feedback on these reminders and they’re able to track the conversions on these mailers as well. We find that the mailers more than pay for themselves.”
As Easy as 1, 2, 3
Community pharmacies also have a great opportunity at the point of care for providing a range of CLIA-waived tests, according to Steve Hoffart, Pharm.D. Hoffart opened Magnolia Pharmacy in Magnolia, Texas, almost 16 years ago, and he describes his independent pharmacy as a hybrid. “We do traditional retail pharmacy along with compounding, immunizations, and MTM [medication therapy management],” says Hoffart. “We are a clinically integrated pharmacy, and we do a lot of point-of-care testing.” This is a service that supports Magnolia Pharmacy’s appointment-based model for health and wellness, weight loss, nutritional, and hormone therapy programs.
While Magnolia offers a wide range of tests, Hoffart points to two relatively new tests that not only happen in the pharmacy but also return results while the patient waits: rapid strep and flu testing. “These are valuable tests to offer our patients, and for pharmacies that aren’t offering them yet, it’s super easy to get going,” says Hoffart. Think about it. Every pharmacy has people walk into the store, looking pretty under the weather and headed for the cough-and-cold section. Can you ask these people if they’d like to be screened for the flu? “We have the ability to do that,” says Hoffart.
Hoffart makes use of screening tools and forms that are provided by the test manufacturer, and which make training staff and implementing the program into the daily workflow really easy.
Here’s how it works at Magnolia Pharmacy. Patients complete a screening form for flu symptoms that uses a points system. If the person has enough points to make it possible that he or she has the flu, a staff member collects some basic information and uses a nasal swab to take a sample for the test. Hoffart reports that the process provides a rapid result with a very high level of accuracy, and identifies if it’s type A or B flu.
|Which Pharmacies Have A CLIA Waiver?|
|Percentage of Pharmacies with CLIA Waivers|
|Supermarkets – 43%|
|Traditional Chains – 24%|
|Independents – 5%|
|Mass Merchants – 4%|
Magnolia Pharmacy staff can then show confirmed flu patients the best over-the-counter and ancillary products to treat the symptoms. This includes a specialty at Magnolia Pharmacy: pharmaceutical-grade supplements that work to bolster the immune system during the flu season. “We’ve carried these products for many, many years during cough, cold, and flu season — especially during the flu season. If somebody has the flu during it, they’ll come in, and we start them on these products just like we would start them on a prescription medication,” says Hoffart. “We’ve found that the time for symptom relief is just as good, if not better.”
Hoffart has had great success alleviating flu symptoms with this combination of testing and OTCs, and reports that a lot of local physicians would really rather his pharmacy do the screening for the flu. “This is something they know we do accurately, and they know that we help patients feel better,” he says. “It also helps to keep flu patients out of the doctor’s waiting room, where they may make other patients or even staff sick, too.”
There are times when it’s important to refer a flu patient to his or her doctor, Hoffart notes. “You use your clinical knowledge,” he says. “Some patients come in, and upon screening you find out that they have diabetes, hypertension, asthma, or COPD, and those high-risk patients must go to their physician.” But the great thing about offering the initial screening and testing in the pharmacy is the easy access point for patients. “They don’t have to make an appointment with us,” says Hoffart. “It’s a quick test, and we either get them going on OTCs or we confirm they need to visit the doctor with the result of our screening.”
Bacteria or Virus? It Matters
Magnolia Pharmacy also offers rapid strep testing, which is very similar to the flu test in its implementation and is just as critical, in Hoffart’s view. Here’s another group of people who aren’t feeling well: They’ve got a sore throat and are miserable, and they want to know if it’s strep. “When we started offering this test, I spoke to a lot of our local elementary schools,” says Hoffart. Certainly, it’s not unusual for a child to end up in the school nurse’s office with a sore throat, which then necessitates a strep test. “I wanted schools to know that these kids didn’t have to wait for a doctor’s appointment or sit in an urgent-care waiting room, but instead a parent could bring them right into Magnolia Pharmacy. We do the same throat swab as the doctor’s office completes, and within a matter of minutes we know whether it’s strep or not.”
Hoffart has found that local doctors still want to be the ones to prescribe antibiotics for strep, but the testing at Magnolia Pharmacy helps ensure that only people with confirmed cases of strep go in to see the doctor. “I understand that prescribers don’t want to do a protocol to allow us to prescribe antibiotics,” says Hoffart, “especially with something like strep, which can have serious clinical outcomes if not treated properly. But what I have done is work with our local physicians to ensure that they will accept our strep test results and not retest at added cost and time.”
Amina Abubakar, Pharm.D., runs a very forward-thinking operation at Rx Clinic Pharmacy in Charlotte, N.C. She’s offering flu and strep testing as well. In her view, there’s an important public health aspect to the ease and speed of pharmacy flu testing.
“Patients only have a 48-hour window to really respond to antiflu medications,” she says. “That’s why pharmacy accessibility is the key. People can just walk in, and we can find out if they have the flu or a cold right now.” North Carolina law requires pharmacies like Rx Clinic Pharmacy to have collaborative practice agreements with specific providers, rather than a blanket protocol, and Abubakar has found that a number of physicians are interested in creating these agreements, which permit the pharmacy to prescribe and dispense Tamiflu based on a positive test result. “Taking action to provide Tamiflu as soon as possible, once we have that first encounter with a flu patient and get a positive test result, is helping us prevent further spread of the flu and prevent deaths and complications. We do have occasions when we don’t have that agreement, and then we will call the prescriber and let them know we have a positive test and can ask for a phone or faxed prescription. But it’s best when we can close the gap and provide treatment immediately,” says Abubakar.
And while she has focused on point-of-care (POC) testing that delivers immediate results, Abubakar feels strongly about another test she offers at Rx Clinic Pharmacy that may not provide immediate results, but makes a huge impact on a patient’s well-being. This is a cheek swab for pharmacogenomic testing. “We see patients all the time for whom therapy is clearly just not working,” says Abubakar. “The prescribers we work with will refer patients like this to us, and we’ll also find patients who start a new therapy and are back in the pharmacy a week later telling us that they still don’t feel right.” These patients immediately become candidates for Rx Clinic Pharmacy’s pharmacogenomic testing, which does have to go out to a lab for analysis, with results back in about a week. The panel that comes back is usually very enlightening, according to Abubakar. “A lot of times we find out exactly why the patient was having issues,” she says. “And we now have the blueprint we need to optimize care. We consider this test to be one of our most important services. It’s a cornerstone of our personalized medication review process, and it gives us key data we can use as part of our efforts to act as care coordinator with all of a patient’s providers.”
Preparing for the Test
What steps should you take if you want to get started with POC testing? Kevin Day, Pharm.D., has put in the work to find out, and he’s willing to share his experience. After serving as the executive resident at the National Community Pharmacists Association, Day returned to his father’s pharmacy, Day’s Miami Heights Pharmacy in Cincinnati, Ohio. The store has recently celebrated 28 years as a family-owned independent pharmacy, and Day has gotten going on the buyout process as he learns the ropes of running a pharmacy.
POC testing has been on his radar for some time. Day defines the opportunity very strictly as tests for which results can be generated at the point of care in the pharmacy. He’s been in the process of preparing Day’s Miami Heights Pharmacy to provide flu and strep testing this season, and offers some insight for pharmacists who are also looking to get their POC testing up and running. First of all, he notes that these are well-established tests, and that pharmacists have access to the same tests as doctor offices, minute clinics, ERs, and the like.
The fact that this same testing can be easily available at the pharmacy is significant, in Day’s view. “We see a combination of trends limiting patient access to care,” he says, “such as high-deductible plans and increasingly restricted networks that can mean patients only have access to a small selection of physicians, urgent cares, or ERs. In many cases community pharmacies can take on an important role by providing the access patients need and at a reasonable cost — certainly at a much lower cost than walking into an ER.”
And this tremendous access and cost-effectiveness impresses physicians, too, in Day’s experience. “We’re starting to see firsthand how much physicians really appreciate that we’re offering flu testing,” he says. “They really understand that ready access to testing in the community pharmacy is an excellent way to address a potentially very serious condition like the flu without overwhelming their offices.”
Rossi Pharmacy, in Brooklyn, N.Y., started an immunization program at the beginning of 2018 to meet patient expectations and stay competitive with large chains. Rossi Pharmacy was able to search the state immunization registry to find out, for example, that 200 of its patients were eligible for non-influenza-related vaccines, but there was no efficient way to notify them. Even with cold-calling, the pharmacy was averaging only four immunizations per month. “In New York City, everything has to be incredibly fast-paced, and we needed a faster way to service patients that didn’t involve taking time to access a separate system,” says Ambar Keluskar, Rossi Pharmacy’s supervising pharmacist. Then Keluskar got a solution in a new feature in the store’s BestRx pharmacy management software that integrates immunization registry access directly into the workflow via a partnership with Script Management Partners (SMP). SMP connects pharmacists with their state or local Immunization Information Systems (IIS) Registries and report immunizations in real-time, with no further intervention or communication required. “The BestRx immunization module has dramatically enhanced our immunization program,” says Keluskar. “The first day we went live with the BestRx immunization module, the pharmacy did more vaccinations than it had in the previous month.”
With this access, Rossi Pharmacy staff can see real-time data on a patient who should have a flu shot or a booster for a shot. A good example of how this is effective, says Sam Pizzo, co-founder of SMP, is Shingrix, a shingles vaccine from GlaxoSmithKline. “It requires two doses six months apart. Many patients would get the first vaccine and not think to get the second,” he says. “Through the SMP integration, independents can check to see if a patient has both doses and, if not, have a conversation right at the point of care.”
Pharmacies often encounter two stumbling blocks when enrolling in the IIS registries: paperwork and state-specific requirements. Pizzo says that SMP streamlines this time-consuming process with expertise in what’s required in each state.
The support Day’s seen from doctors has been even greater for strep testing, in fact. Day notes that there’s actually very little strep that circulates through adults in this country. The majority of patients who go in to see a healthcare professional with a sore throat do not have a bacterial infection, but they still frequently leave with a prescription for antibiotics. “Antibiotic stewardship is critical,” he says. “We’re not in a world anymore where we can use just-in-case antibiotics for millions of patients who don’t need them.”
The first step to getting started with POC testing is applying for a CLIA waiver using the Centers for Medicare & Medicaid Services (CMS) form 116. “This is an incredibly easy process for pharmacy,” says Day. “The form is only 10 pages, including all of the instructions.” A pharmacy doesn’t even complete the entire form, since what you’re applying for is waiver status. Still, Day emphasizes that it’s important to plan ahead, since the process can take a couple of months from start to finish: You submit the form, get a coupon back with the fee you owe, submit that payment, and only then do you get your waiver. Again, it’s not hard, but you have to stay on the ball to ensure you’re prepared, for example, for flu season.
Another key piece of advice from Day is to be very clear on both federal and state laws. “These laws determine your scope of practice,” he says. “You can have collaborative practice agreements set up with prescribers and you also need to have documented protocols for your pharmacy.” This protects your pharmacy and allows you to ensure that your staff are following a strict set of rules when providing testing and taking any resulting actions.
“For example, let’s look at strep,” says Day. “Patients who have a sore throat often want antibiotics even if the test comes back negative. So even if you have the ability to provide those antibiotics through a collaborative practice agreement, for example, you want to have a protocol that clearly states you will not dispense when the test is negative — because you’re going to get pressured the same way that I think other practitioners do to write for antibiotics. You want to point to your protocols and say without doubt, ‘I’m sorry, that’s outside of my scope of practice.’”
Day further recommends putting a lot of work into being ready for that first patient who walks in and needs a flu or strep test. “These people aren’t feeling well and they’re coming to you for help,” he says. “If you aren’t 100% ready for how to quickly screen the patient, provide the test, answer questions, and provide recommendations for care, then you run the risk of losing that patient’s confidence. You can’t have her end up sitting in your pharmacy for two hours instead of 30 minutes because your staff isn’t well trained and doesn’t know the procedures.” Day suggests running mock cases to make sure you really have the whole process figured out, including how you’re going to document what you’ve done.
That’s a big number and represents a big opportunity for pharmacy, in Kevin Day’s opinion. That’s because 1,400 is the number of CLIA-waived tests out there.
“Not all of these tests are really appropriate for pharmacy,” says Day. “But there are many with very simple collection methods that are reasonable for pharmacies to consider. We’ve been doing whole blood tests for a long time, with glucose, A1c, and triglycerides monitoring.” Day takes a strategic view and sees these tests as more than just additional services at the pharmacy level. “Testing gives us a real opportunity to create our own patient data,” he says. “When I went to pharmacy school, we talked a lot about the need for pharmacists to access patient data, and the assumption was that we’d be given access to data other providers collected. But I say, why not flip that and collect the data ourselves, at pretty negligible cost and potentially great benefit to patients? In an outcome-driven world, if you’re going to treat a patient with an A1c of 10 differently from one with an A1c of 7, then why not do the test and be sure you have that data? I think there is a ton of opportunity there, especially for pharmacies that want to be a healthcare destination and really want to integrate with the rest of the healthcare team. Get the data that you need from the patient. If it means an extra nasal swab or a finger prick, so be it. That can be the standard of practice, and it will benefit pharmacy and our patients.”
There’s so much opportunity here that it might seem a little overwhelming at first. “I think a lot of pharmacists say, ‘How do we make this work in our busy day?’” says Steve Hoffart. “I think it’s like immunizations. When pharmacies start doing those, there’s a learning curve, and it takes a little effort to get the process down. But once you begin, then it becomes such an important part of your business, and you find out that some of your best clinical interactions with patients come when you immunize or complete a screening test.” Testing is all about creating another touch point with your patients, according to Hoffart, one in which you can show how pharmacy integrates with the healthcare system and makes a positive impact on patient lives. CT
Will can be reached at email@example.com