Microneedle patch for monitoring drug levels

Medgadget: “A collaboration between researchers at the University of British Columbia and Paul Scherrer Institut in Switzerland has developed a microneedle device for drug monitoring. The device is in a form of a patch that’s stuck onto the skin, painlessly pushing microneedles through to sample the interstitial fluid…The proof-of-concept device reported by the team was used to measure the concentration of vancomycin.”

microneedle-optofluidic biosensor

This is something that has been sorely needed for a long time. As a pharmacist, I can confidently state that we spend entirely too much time looking at drug levels that are within normal limits versus evaluating those that are not. It would seem much more efficient, at least in the acute care environment, to ignore “normal” levels and spend our time investigating those that are out of whack.

In the outpatient environment this makes even more sense as a patient safety measure. Imagine never again having a patient urgently admitted to the hospital for a drug level that’s way too high. Think of all the medications that require at least intermittent drug levels: carbamazepine, phenytoin, digoxin, tacrolimus, and so on.

Side note, my mother was taking tacrolimus around the time of her liver transplant. An EHR charting error occurred that resulted in her receiving 10 mg orally twice a day instead of 1 mg orally twice a day; yep, a 10-fold error. True story. Almost killed her. The small-town hospital where she lived didn’t recognize the symptoms and failed to get a drug level when she was admitted for “dehydration”. Several days of pleading with physicians and calls to UCSF resulted in a level being drawn. It was off the charts. She was subsequently transferred to UCSF where she spent the next six weeks in the ICU. The entire ordeal could have been avoided with real-time drug monitoring. Just sayin’.

Sensor-enabled medication inhalers

I recall being really excited about sensor-enabled asthma inhalers several years ago. I even remember giving a presentation in 2013 on “the future of pharmacy” that included two such products: Asthmapolis and GeckoCap. Each was an add-on device for existing inhalers. They were marketed as tools for improving medication adherence, and by default helpful in controlling patient’s asthma symptoms. Each had a very different approach but were both pretty cool in their own way.

Asthmapolis is still around, as far as I can tell, but at some point, the product was rebranded as the Propeller Sensor by Propeller Health. The only reason I know this is because earlier this year the Propeller Sensor received FDA 540(k) clearance. I always thought the approach used by Asthmapolis was interesting because the product utilized crowed-sourced data to generate “Asthma risk maps” to help keep patients with asthma informed about potential hot zones in and around their area. It appears as though not much has changed. While the Propeller Health website doesn’t offer many details, a quick search of the web generated several articles that lead me to believe the mission remains the same. I’m still impressed with the Propeller Sensor and would love to see it in action sometime. It seems like it would be well suited for use by ambulatory care pharmacists.

Propeller

The other product, a little doohickey known as GeckoCap was a glowing “smart cap” that used a blinking light and gamification to remind patients when to use their inhalers. Data collected by the device was transmitted to a database via Bluetooth connection where family members and physicians could access it. I thought the use of gamification was rather clever, especially for kids. Parents could set goals with accompanying rewards to encourage kids to remain compliant. In this day and age, that made sense to me.

Similar to Asthmapolis, it appears that at some point GeckoCap became CareTRx [pronounced care-tracks]. However, it doesn’t appear that the product is actively being developed at this time. The last few reviews on the Google Play Store included complaints about server issues, and those were from December 2015. Based on information at the CareTRx website, the company was acquired by Teva in September of 2015. I’m not sure what that means. I don’t know if the product is dead or alive.

 

CareTRx

I wonder why these products never took off? Seems like these little devices would fit right into the up and coming Internet-Of-Things era.

Cool technology for pharmacy – Formulary Toolkit

Omnicell has been busy developing the IV automation and technology that they acquired from Aeysnt. Honestly, a couple of years ago I was ready to write off Aesynt’s presence in the IV room because of their tiny market share. This is when their current IV room products were still part of Health Robotics. With that said, the IV group has effectively reinvented themselves over the past couple of years and are doing some really neat stuff.

Two developments that I’m particularly excited about are REINVENT and Formulary Toolkit (FTK). I’ve written about REINVENT several times already, most recently just 6 days ago. I’ve mentioned FTK a couple of times in passing but have never really understood what it was, until now.

FTK

Aesynt website: “Said John Barickman, senior executive IV pharmacist consultant at Aesynt.  “With the Formulary Toolkit, we can now offer pharmacies data and services to better leverage automation technology and enable best practices in pharmacy like beyond use dating.”… Formulary Toolkit provides cost-effective access to cGMP quality gravity and drug stability data, in combination with established robust sterility protocols and testing services, that can be utilized to extend beyond use dates for compounded sterile preparations.”

Basically, Omnicell (previously Aesynt) has taken it upon themselves to do CSP stability testing for a select group of drugs. They do this to offer extended beyond use dating (BUD) for sterile compounds. Why would they do that? Sit back and I’ll tell you.

The BUD for a CSP identifies the time by which the preparation – once mixed – must be used before it is at risk for chemical degradation, contamination, and permeability of the packaging. In the absence of direct sterility and stability testing evidence that supports longer BUDs, USP <797> currently states that low-risk CSPs are good at controlled room temperature for 48 hours, at cold temperature (refrigerated) for 14 days, and frozen for 45 days. For medium-risk compounds, BUDs are 30 hours, 9 days, and 45 days, respectively.

Given appropriate stability and sterility testing, BUDs can be extended, giving a hospital the ability to plan further ahead, reduce waste, and better allocate resources. FTK takes care of the stability testing, giving pharmacies one important piece of the puzzle they need to create large batches with extended BUDs. Once extended BUDs have been established by laboratory testing, facilities have only to test batches for sterility.

So let’s say your pharmacy services several facilities in your healthcare system and uses a ton of vancomycin 1250 mg in 250 mL D5W [Baxter bags]. According to USP <797> you can get 14 days in the refrigerator or 48 hours at room temperature. However, what if stability studies demonstrated that the same CSPs were stable for 90 days at room temperature? You would be able to make significantly larger batches. Prior to using the batch, it would need to be quarantined while sterility testing was performed, which usually takes a couple of weeks. But, when the sample returned negative results, the batch could be used for the remainder of the 90 days, effectively extending the BUD by more than four-fold. This is such an advantage for pharmacies that must prepare frequent, large batches of specific drugs.

I don’t know what drugs have been tested for inclusion in FTK, but I’ve been told that data for several drugs in currently available and more are being added each quarter. Very cool.

Mobile health apps not meeting expectations

I read with great interest a recent piece at FierceHealthcare. According to a study in the Journal of General Internal Medicine, health apps aren’t living up to the hype. To me, the entire field has been overblown from the beginning.

“A new UC San Francisco study … revealed nearly every participant who used health apps could not get to a productive point. The respondents also were able to complete just 51 percent of data entry tasks and just 43 percent of them could access data from the tools.”

Most of the problem stemmed from usability, or rather a lack thereof. This should come as a surprise to no one. Most of the health apps that I’ve tried haven’t been very good. In fact, I have yet to find a single health app that I consider anything more than a waste of time.

All this on the heels of other studies showing similar results. “A study released in mid-June noted very few apps providing high-quality heart failure symptom monitoring. Research earlier this month evaluated 40 fertility and pregnancy apps and found just six recorded a perfect score for accuracy.”

While I understand the desire for mHealth to be a success, at this point I believe it’s nothing more than over-hyped mediocrity. The worst part is the number of app developers and “researchers” taking advantage of the situation to further their own career, or in some cases their agenda. The mHealth movement is full of snake oil salesmen taking advantage of a population desperate for help.   As a healthcare provider myself, I find it hard to believe that other healthcare providers are putting so much stock in so little actionable information. Does that mean that all mHealth applications are useless? Probably not, but I think it’s time to step back and take a long, hard look at the entire ecosystem. The first thing we should be asking is whether or not the information being collecting provides any value to the patient or their provider. If not, I think it’s fair to question whether or not the application should even be available.

As a healthcare provider myself, I find it hard to believe that other healthcare providers are putting so much stock in so little actionable information. Does that mean that all mHealth applications are useless? Probably not, but I think it’s time to step back and take a long, hard look at the entire ecosystem. The first thing we should be asking is whether or not the information being collecting provides any value to the patient or the provider. If not, I think it’s fair to question whether or not the application should even be available.

Now I’ll sit back and wait for the onslaught of people telling me how wrong I am. Obviously I “just don’t get it”. Well, remember this, even homeopathy has supporters. Just sayin’.

Increased IV production means increased automation…and data

Interesting timing on this article at Healthcare IT News: “With an eye on improving safety, increasing compliance and reducing waste, an increasing number of hospitals and health systems are looking to insource and automate their IV compounding processes… Campbell said that the transition to robotic sterile compounding has resulted in a cost savings of $100,000…At the core of the technology is Omnicell’s REINVENT – Registry for Intravenous Technology in Pharmacy – global, multi-site data registry designed to collect compounded sterile preparation data from hospitals and health systems for evaluation, analysis and insight.”

I spent some time earlier this week speaking with Omnicell about their IV room automation and technology, including REINVENT. I’ve written about REINVENT before. Since that time, Omnicell has made big strides in connecting customers and collecting sterile compounding data.

It is my belief that most companies in this space fail to understand the value of all the data floating around in pharmacies. There is so much untapped potential there. Few vendors have given serious consideration to how best to deal with it, much less create a product that brings value to their customers. I’m pretty stoked about what Omnicell is doing with REINVENT and hope that other vendors will follow their lead. The future of pharmacies is in the data.

[Article] Pharmacist-provided medication management during transition of care

Medication management during transitions of care (TOC) has become a rather hot topic of late. The August 2016 issue of Annals of Pharmacotherapy has an article that describes the use of a dedicated inpatient TOC pharmacist to tackle the issue.(1) Seems like a no-brainer to me, but you don’t often see this in the wild.

Here’s the abstract:

Background: Medication management during transitions of care (TOC) impacts clinical outcomes. Published literature on TOC implementation is increasing, but data remains limited regarding the optimal role for the inpatient pharmacist, particularly in the community health setting.

Objective: To evaluate the impact of a dedicated inpatient TOC pharmacist on re-presentations following discharge.

Methods: This is a prospective study with historical control. All adult patients discharging home from study units were eligible. The TOC pharmacist (1) reviewed medication history and admission reconciliation, (2) met the patient/caregiver to assess barriers, (3) reviewed discharge reconciliation, (4) performed discharge education, and (5) communicated with next level of care. The primary outcome was 30 day re-presentation rate. Secondary outcomes included 60, 90, and 365 day re-presentation rates. IRB approval was obtained.

Results: Three hundred and eighty four patients met inclusion criteria. When compared to 1,221 control patients, the intervention had an 11% absolute and 50.2% relative reduction in 30 day re-presentation rate (OR 0.43, 95% CI 0.30-0.61, NNT 9). Reductions in re-presentations at 60, 90 and 365 days remained statistically significant. Utilization avoidance was $786,347. For every $1 invested in pharmacist time, $12 was saved. The TOC pharmacist made a total of 904 interventions (mean 2.4 per patient).

Conclusion: This study provides new information from previous studies and represents the largest study with significant and sustained reductions in re-presentations. Integrating a pharmacist into an interdisciplinary team for medication management during TOC in a community health system is beneficial for patients and financially favorable for the institution.

Pretty impressive results. “The intervention had an 11% absolute and 50.2% relative reduction in 30 day re-presentation rate… For every $1 invested in pharmacist time, $12 was saved.” Seems like a win-win. With that said, it seems like we keep repeating ourselves over and over again. At some point, someone is going to have to quit looking for more data and simply change the way pharmacists practice.

———-
(1) Ann Pharmacother August 2016 vol. 50 no. 8 649-655

Prescription bottle innovation

I was browsing for something the other day and got sidetracked by a link about prescription bottles. You know how it is, you start scouring the internet for information on antibiotic dosing in CRRT and end up looking at cat videos. It happens.

Anyway, I think it’s safe to say that everyone has seen a prescription bottle. Those cylindrical amber bottles with white caps that are almost universally used by pharmacies everywhere. Oh sure, there are minor variations here and there – like blue bottles, for example – but for the most part, they’re pretty standard across the board. In fact, you probably have a few strewn around the house in the “medicine cabinet”, in a handbag, or thrown in a drawer somewhere.

Rxbottle

Do you ever wonder why they look the way they do? I have, but never really cared enough to look into it. Until now, that is. Cat videos, remember?

Apparently, prescription bottles as we know them today were introduced sometime in the 19th century. They weren’t always cylindrical. Some of the early designs were actually rectangular. The rectangular brown wide-mouth bottle can still be found in the wild, but you don’t see them often. They’re really cool, but are made of glass and cost significantly more than a $0.01 amber plastic vial.

Prescription vials are colored to prevent light from damaging light-sensitive drugs. Are all drugs light sensitive? No, but it doesn’t make sense to have different bottles for different drugs. Does it have to be amber? No, but I read somewhere that amber is the most cost-effective color. I don’t know if that’s true, but it would make sense as to why we don’t see more color options. Why not use a solid material, i.e. one you can’t see through, to prevent light from coming through the bottle? Fair question. My guess is because the semi-transparent nature of today’s prescription bottle allows you to see the contents without having to remove the lid. However, when looking at the contents of a prescription vial, I always remove the lid to evaluate the color and condition of the contents.

That’s the nuts and bolts of the modern prescription vial. There’s a lot more history if you’re interested. For those of you that crave a deeper, more detailed history of the prescription vial, I direct you to History of Drug Containers and Their Labels by George Griffenhagen and Mary Bogard. Real page-turner, that one.

Knowing that modern prescription bottles have been around for more than 100 years, one has wonder why we haven’t seen more innovation. Is it because they’re perfect? Doubtful. More likely the lack of innovation has been due to complacency.

With that said, there have been a couple of advancements in recent years. One high-tech solution, and one not so high-tech solution.

AdhereTech introduced a “modern” prescription bottle several years ago. I wrote about their bottle design back in 2013. Since that time, the company has introduced a new bottle design, which by the way is similar in size and shape to the brown wide-mouth bottles mentioned above. The new bottle can be seen in the image below. It’s unclear to me what made them alter the design. I’ll have to do some digging.

Adheretech

The second, more low-tech innovation comes from Target of all places. The retail giant introduced the ClearRx bottle more than ten years ago. You can read more about the ClearRx bottle/system at the ISMP site here. The bottle has a rather impressive design. It’s simple yet elegant. However, it’s unclear whether or not Target continues to use this bottle since being acquired by CVS. I guess I’ll have to venture out of the house and find out.

ClearRx_bottle

The prescription bottle has a long and rich history but it seems to me that it’s time for someone to come up with something new. With the advent of 3D printing, it shouldn’t be too hard to come up with several potential prototypes in a relatively short period of time. Crud, I have a 3D printer. Can’t be that hard, can it?

Electronic alert overload

The Washington Post: “Something similar is happening to doctors, nurses and pharmacists. And when they’re hit with too much information, the result can be a health hazard… It’s called alert fatigue… Electronic health records increasingly include automated alert systems pegged to patients’ health information… The number of these pop-up messages has become unmanageable, doctors and IT experts say, because of reflecting what many experts call excessive caution, and now they are overwhelming practitioners.”

alert_overrides

I had to laugh when I read The Washington Post article quoted above. Pharmacists have been dealing with this for years. We’ve been getting hammered with unnecessary alerts since electronic order entry became a thing. I don’t know exactly when it started, but it’s been an integral part of my career for the past 20 years.

It’s a problem to be sure. A vast majority of alerts, conservatively 90%, have absolutely no bearing on the job clinicians are asked to perform. The article mentions receiving alerts for pain meds when it’s obvious that the patient needs them, such as in a post-op situation. Even more ridiculous is getting an alert for a duplicate fluid, or my favorite, lactation warnings for an 80-year-old female.

It’s difficult to say what the impact of these alerts is on patient care, but I think it’s safe to say that they cause more harm than good. They pop up so often that most simply get ignored. I know that I’ve clicked through my fair share of alerts without more than a glance.

And here’s the thing, physicians see only a fraction of the alerts seen by pharmacists. Many hospitals minimize alerts so as not to irritate physicians. We wouldn’t want to irritate physicians now, would we?

With all that said, things have improved in the past few years. Usability is on the radar of hospitals and healthcare systems. We can thank consumers for that. Healthcare workers are consumers first and their experience with software and hardware in their day-to-day lives has spilled over into healthcare. Today’s software is much better than it was a decade ago, even in the Bizzaro World of healthcare.

I can recall my experience with pharmacy information systems during the early years of my career. They were terrible, and I do mean terrible. The things were barely usable. They were often functionally rich and usably poor. It wasn’t until quite recently that pharmacy systems became more user-friendly, in part because of the introduction of EHRs.

Physicians wield a disproportionate amount of power within healthcare systems, so when they are forced to use EHRs with poorly designed user interfaces and ridiculous alerts, the vendors hear about it. The result of all that complaining has been improvements in usability. As the pharmacy system is an integral part of many EHRs, pharmacists have benefited.

I dare say that we are nowhere near the user experience of consumer products, but the improvements are nonetheless welcome. Given time, and enough physician whining, we may live to see the day when alerts are useful rather than annoying. Until then, I say to my physician brothers and sisters, welcome to my world.