Michael Crowe, PharmD, MBA, CSP, FMPA

In past articles, some of the leading smart bottle products and their features were covered. Now, we will turn to considerations for implementing a smart bottle offering in your pharmacy. It may seem like a simple 'use the smart bottle instead of a regular bottle' process, but there a many variables, processes, and protocols to consider before going live with a smart bottle offering.

We will group these considerations under the headings of pre- and post-implementation, and start with pre-implementation in this article. Pre-implementation considerations include decisions to be made before going live, such as who will fund the cost of the smart bottle program and how will staff be trained. There are also decisions around recruitment and distribution of bottles to participating patients.

The first step to take before implementing a smart bottle offering at your pharmacy is to determine how it will be funded. Being new technology, these bottles are relatively expensive. If only bottle cost and the return on investment from increased medication adherence were considered, we would likely conclude that the offering comes at a loss. Furthermore, because these bottles can range from $75 to $200 per patient, per month (which may not include the supporting software costs), the pharmacy’s drug margins alone probably will not support a smart bottle program.

Today, most programs are set up as 3-party arrangements involving the pharmacy, the bottle company, and pharma, for 1 specific drug. This arrangement, for the right drug, becomes a win-win-win situation; pharma gets novel patient medication-taking behavior data, the bottle company gets business, and the pharmacy can demonstrate its progressiveness. All 3 parties also see benefits from bolstered patient adherence.

In considering how your program may be funded, be aware that the arrangement between pharma, pharmacy, and bottle company can vary. In some cases the bottle company may have a relationship with the pharma company, and the bottle company sets up agreements with 1 or more pharmacies to supply the patients. In other cases, pharma may approach the pharmacy about getting involved in a smart bottle program. And last, the pharmacy may try to gain pharma’s support in offering a bottle program for their drug. In all these scenarios, all 3 stakeholders may work together simultaneously, or there may be 2 sets of negotiations taking place.

When we get to patient enrollment, 2 important areas to consider are what patients are offered with the smart bottle program and how, if at all, does your software system facilitate the process. In some arrangements, patient inclusion and exclusion criteria may already be set for you (e.g., you are one of many pharmacies recruiting patients into a bottle company’s program for a specific drug). In other cases, you will get to set the inclusion or exclusion criteria independently or collaboratively with another stakeholder. If you are able to have a hand in setting this criteria, it can be helpful to run historical reports to understand how many patients might qualify. This is important because the number of patients you recruit and manage within the program will impact your staff’s time involved.

Some specific questions to consider around patient inclusion, include:

Will your smart bottle program be for new patients, refilling patients, or both? 

Will patients have to be of a certain age or geographic location? 

Are there certain regimens not compatible, such as multidose regimens? 

Does the patient have to possess a certain diagnosis?

Will you target patients at risk for poor adherence, such as those with a history of late refills?

Once you’ve set your inclusion criteria, it has to be conveyed to your staff communicating with patients. The simplest and lowest-cost means of doing this is to provide a paper checklist; however, that may not be practical for larger programs, and can even result in missed opportunities as staff has to remember to reference that checklist when interacting with potential candidates. This is where using your pharmacy system could be helpful. Depending on the level of control you have of your patient care software, it may be advisable to implement a reminder or even a questionnaire based on patient characteristics that serves as a reminder to your staff to screen patients and offer the program if they qualify. Integration of this questionnaire can also help with data collection, and, if you’re working with a bottle company with an application programming interface (API), you could even pass patient data from your system to theirs, streamlining enrollment and minimizing transcription errors. When it comes to system integration, while it is nice to have, it will come at a cost. Be sure to factor that into your program budget.

Training is important when providing a new smart bottle service. First, you don’t want to mess up what is reaching the patient. Second, you don’t want staff not being familiar with the project, and your pharmacy appearing disorganized to your patients. So training is necessary, but who should be trained? The answer to this will depend on the breadth of your patient population. If you’re expecting hundreds of patients to be involved, more of your staff needs to be trained on the offering. Of course, training requires time and money, so you do not want to pull everyone from their daily duties if it can be avoided. Instead, a starting point would be to ensure all patient-facing staff are aware of the program and know to whom to direct questions. Beyond that, your training decisions are related to the live trainings:

What training content is used; is everyone training on everything, or do you train 1 group on enrollment, 1 group on bottle set up, and 1 group on interventions? 

Where does training take place? Does your pharmacy have more than 1 distribution site? Will all sites distribute the smart bottle? 

How will training be provided? Do you have an internal training department or will you be leveraging the bottle company’s trainers? 

And last, and probably the most important aspect of training is providing an explanation to staff as to why a smart bottle program is being offered at your pharmacy. If possible, staff should also be involved in the project planning phase. Providing this engagement and context will greatly contribute to their buy-in and the success of the program.

Hopefully, these 3 areas of consideration will help you and your staff as you determine how to implement a smart bottle offering at your pharmacy. 

Articles

What to consider when considering a smart bottle program.

Smart Bottles: Implementation Considerations

There are many smart bottle companies competing today. In a 

, the most common features of smart bottles were covered. In this article, a glimpse into 4 specific products (GlowCap, AdhereTech, CleverCap, and SMRxT) is given. These 4 aren’t the only ones available, but they do represent the varied means by which smart bottles record medication adherence and are some of the most well-known products in the space.

Glowcap is probably better defined as a smart cap than a smart bottle. The cap provides visual and auditory reminders when it is time for the patient to take his or her dose. The action of removing the cap at the dosing time is equated to a taken dose. GlowCap has a companion mobile app, as well as an adherence portal. The patient can decide with whom to share their adherence record, whether it be prescribers, pharmacies, or caregivers. Within the cap, there is a button that can be pushed to trigger a refill request to the pharmacy, if so configured.

Compared to GlowCap, the Adheretech bottle moves the technology from the cap to the actual container. Cellular functionality is incorporated into each of its bottles, meaning patients don’t have to pair the bottle with a wifi hub, or app on a mobile device. However, there is a portal where healthcare providers can view their patients’ adherence levels. Like GlowCap, Adheretech equates a dose to removal of the cap at dose time; however, it also incorporates something called capacitance, which is similar to how your smartphone’s screen registers touch. In the same way that your phone can detect two fingers on the screen, the AdhereTech bottle can sense an approximate number of doses remaining based on the capacitance at the floor of the bottle’s interior. This smart bottle stands out in that it can hold a six-month battery life, several months longer than many of the other smart bottles. The AdhereTech bottle also requires no patient setup. It is ready to go when the patient receives it.

With CleverCap, the technology is all in the cap, as it was with GlowCap. However, rather than cap removal equating to a dose, the CleverCap device has a door on the device, and internal mechanics that can be calibrated to track precisely how many dosage units were removed and when. This is helpful as we know that patients don’t solely open their bottles to take a dose; they might remove the cap to determine if they need a refill or to confirm the color or imprint on the dosage unit. Like AdhereTech, the cap does have cellular capabilities built in, so patients are not required to do anything, unless they want to pair it with the companion app for personal management. A feature of the CleverCap, not seen in other bottles, is the option to lock the dosing door between dosing windows, which can be helpful to prevent patients from inadvertently taking extra doses.

Like AdhereTech and CleverCap, SMRxT incorporates cellular connectivity into its bottles so patients are not required to connect the bottle with wifi or pair the bottle with a hub or device. It can also communicate with the patient, caregivers, or healthcare providers. What is unique about the SMRxT system is the 'way'—no pun intended&mdash;in which it measures a dose taken. Each bottle sent to a patient is precalibrated with the weight of each unit (tablet or capsule) and the patient’s dosing schedule. Each time the patient sets the bottle down on a level surface, the bottle weighs the contents. If it detects a weight reduction, it will record that as a dose. Depending on the time and amount, it may be categorized as an on time dose, a partial dose, an extra dose, or a late dose. Missed doses are also recorded. These dosing trends can be monitored over time and, if helpful to the patient, the dosing window can be adjusted remotely by the pharmacy. Besides its method of measuring adherence, a differentiator for SMRxT is its robust companion software, Nomi, which combines the best of data collection and actionable data.  

The smart bottle space is certainly one with many potential benefits and choices. Having a better understanding of the features of smart bottles and available products, you may be in a better position to implement a smart bottle offering in your pharmacy. 

Who are some of the key players in the smart bottle space?

Sampling of Available Smart Bottles

When it comes to promoting and tracking patient adherence, smart bottles are far more advanced than traditional prescription vials. These devices are precise and can monitor adherence over the duration of therapy. Before smart bottles, our best means of measuring adherence were rooted in patient reports, pills counts, and refill history. We know these methods are inherently flawed as they rely on patient recall and honesty. And who has the time to do pill counts? Smart bottles take us 2 steps forward in terms of monitoring adherence (and intervening on nonadherence).

The earliest smart bottles recorded a dose each time the cap was removed. Newer bottles use features such as scales, dose unit removal, and even something called capacitance. Listed below are some of the features that should be evaluated when considering smart bottle usage in your pharmacy.

The first is one that most bottle companies today like to tout. That’s understandable. If a patient isn’t willing to take steps on their own to maintain adherence, why would they take steps to set up a device that is intended to do the same thing? Earlier devices would require the patient to download an app, connect the device to a wifi network, or connect the device to a plug-in hub. Fortunately, as technology has advanced, most companies have integrated cellular connectivity directly into their bottles, meaning the patient does not have to do anything.

Another capability that can impact the 'requires-nothing' goal of the smart bottle is the battery life of these devices. Most bottle companies recognize that their bottle better last at least a month, and some have been able to go much longer than that. The issue with battery life is that as it declines, the burden on the patient goes up. Each time the battery life is depleted, the patient has to either recharge it or swap bottles. And if swapping, they may even be required to return their 'dead' bottle for refurbishment. So the longer the battery life, the better.

The types of alerts utilized by these bottles run the gamut—patients typically see some combination of light and auditory notifications on the bottle when it’s time for their dose and if they’ve missed a dose. Patients and caregivers, in most cases, can usually have text messages, emails, and automated phone calls configured for missed dose alerts as well. Pharmacies most often rely on alerts within the manufacturer’s portal, which may or may not include a corresponding email notifying the pharmacy staff that they have missed dose alerts within the portal.

There are many direct-to-consumer devices and mobile applications available to promote medication adherence. Recognizing patients may want to track their own adherence, smart bottle manufacturers often offer a patient app. Within these apps, patients can visualize their successful doses and missed doses, and in some cases, see their own personal medication adherence score.

In addition to not requiring the patient to do anything, it is also considered important for smart bottles to be fairly inconspicuous. Some adherence devices are rather bulky and hard to transport, thus eliminating some of their adherence-promoting benefits. Fortunately, most manufacturers’ products allow your standard amber vial to be used or they provide their own bottles that look similar to a standard vial.  

Last, since these devices are storing and transmitting protected health information, its important that they be FDA-approved and HIPAA-compliant if your pharmacy is going to get involved.

For more information on smart bottles, read 

 about the business side of pharmacies offering these products to patients.

Common Features of Smart Bottles

Medication non-adherence costs the health care system $300 billion about per year.  

Very few patients carry through with the full process of filling a prescription, picking it up, taking every dose, and repeating the process with refills until the prescriber says they can stop. Sometimes, that non-adherence is intentional, such as when the patient decides that the medication is not necessary or that the cons (eg, the adverse effects, cost, and inconvenience, etc.) outweigh the pros. And sometimes, it is unintentional, mostly showing up as forgetfulness, leading to missed doses. In either case, we know that this is a problem. What has been missing is a solution.

In all likelihood, there never will be a magic bullet that solves the problem of non-adherence for all patients. However, there are a lot of companies out there trying to address non-adherence through the use of smart bottles, which are advanced prescription vials designed to promote adherence through the use of caregiver, health care provider, and patient alerts and reminders. The smart bottle companies also stand to improve medication persistence. Where adherence is defined as the percentage of doses taken as prescribed, persistence is the duration of time from initiation to discontinuation of therapy or to the time a patient exceeds a permissible gap.

But why do we care about improving adherence and persistence? Well, provided that the patient is prescribed the right drug, adherence is in the best interest of all stakeholders. The adage that “the most expensive drug is the one not taken" is true. Adherence is related to positive health outcomes, which obviously benefits the patient. But prescribers also want positive outcomes in order to rate well within their networks, among other reasons. And payors or insurance companies want positive outcomes, because, theoretically, medical costs should then decline. Although manufacturers and pharmacies also want positive health outcomes, it is much easier to measure how improved adherence correlates with improved revenue for payors and prescribers.

Let's look at both the costs and the data related to smart bottles.

Because smart bottles typically are best used in the specialty market, let's look at the drug tofacitinib (Xeljanz) an oral therapy for autoimmune disorders, such as rheumatoid arthritis and ulcerative colitis. Let's look at the relationship between adherence and profit for a pharmacy. Hypothetically, let’s say a pharmacy has 10 patients on tofacitinib. Here are some made-up figures for a 30 days’ supply: At an average wholesale price (AWP) of $4000, reimbursement of AWP, minus 10%, and a pharmacy cost of $3400, the pharmacy is looking at a gross profit of $200 per dispense. Because adherence measures look at things in terms of days medication is possessed or covered (see this article on 

), let's convert that to profit per day. Now, for every extra day that a patient has this medication, that translates to an extra $6.66 of gross profit for the pharmacy. Over a year’s time, a 10% improvement in adherence equates to an extra 36.5 days with medication or about an extra $250 of profit for the pharmacy per patient. Multiply this by 10 patients, and we are looking at a handsome incremental profit for helping those patients improve their adherence by 10%.

This example illustrates a starting point for evaluating return on investment (ROI) for devices geared toward improving adherence, such as smart bottles. It is helpful in answering the questions: How much can I expect intervention X to improve adherence; what does intervention X cost; and will the profit generated from improved adherence cover that cost? In the example, if the intervention were a smart bottle offering for patients taking tofacitinib and it was expected to improve adherence 10%, it could have an ROI and may be worth considering if the cost of that offering was less than $250 per patient per year.

That said, smart bottles are not cheap. Think “miniature cell phone” in terms of some of the capabilities of these bottles. By the time the cost of the bottles including the hardware and software is taken into account, the profit generated by increased adherence may not be enough to justify a smart bottle offering. This is where the value of the data must be considered.

Many bottles record the dose-by-dose, or, more importantly, the missed-dose-by-missed-dose, behavior of patients that can be extracted and reported on in aggregate. And, most bottle programs are drug-specific and involve the manufacturer of that drug. The manufacturer can use the data collected by smart bottles to better understand its drugs.

Let’s consider a new oral oncolytic that was just approved. Clinical trials were completed, and the manufacturer understands the rates of adverse effects reported. But remember that those clinical trials were conducted in a vacuum. The sample size was small and subject to strict inclusion criteria compared with the eligible population that could benefit from the drug post-approval. In real life, data collected by a smart bottle and solicited during interventions prompted by the bottle could pinpoint exactly when specific adverse effects are leading to non-adherence, with or without early discontinuation. The data might even show that a rare adverse effect observed in clinical trials is occurring much more frequently post-marketing. Those adverse effects could better be addressed proactively by the dispensing pharmacies and the manufacturers, in hopes of helping patients overcome them and remain on therapy.

If the data provided by a smart bottle program could allow a manufacturer to do this, then the ROI improves as a pharmacy can add this to the fair market value of the offering when a manufacturer is sponsoring the entire program. Alternatively, the pharmacy could sell the data a la carte to interested manufacturers.   

Here is why to consider the dollars and data behind such pharmacy offerings.