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  • Does tall man lettering work?

    First of all, is it tall man, tall-man, or tallman? And why is it called “tall man lettering” when none of the letters are actually taller than the others? Heck if I know. Just more questions in a mountain of questions piling up around tallMAN lettering.

    Pharmacy Practice News: “[The study] found that there hasn’t been a substantial drop in drug name mix-ups since use of tall man lettering became widespread around 2007… “We saw no reassuring trend of declining rates of errors,” said study author Chris Feudtner, MD, PhD, MPH, a pediatrician at the University of Pennsylvania’s Perelman School of Medicine, in Philadelphia…If tall man lettering were working, the researchers expected to see a significant decrease in these types of errors after 2007 when the JC began recommending that hospitals implement tall man lettering and other typographic drug safety measures. No such drop was seen.”

    The entire use of TaLlMaN lettering has always seemed odd to me. I could never understand how it would keep anyone from grabbing the wrong medication. I mean seriously, who in their right mind would confuse SUMAtriptan with ZOLMitriptan, or ARIPiprazole with RABEprazole. Crud, they’re not even remotely close when one considers the alphabet. When searching for the drug within a CPOE system one types “sum…” or “zol…”, not “…triptan. C’mon, people!

    One classic mix up is hydrOXYzine and hydrALAzine. They definitely have similar names, but the former is an antihistamine used to treat itching, while the latter lowers blood pressure by exerting a vasodilating effect through a direct relaxation of vascular smooth muscle, i.e. it’s a blood pressure medication. Why the heck would anyone want to use a blood pressure medication to treat itching? They wouldn’t.

    Perhaps it would make more sense to simply put the drug class or use on the packaging. You know, hydroxyzine [antihistamine/itching] or hydralazine [vasodilator/blood pressure]. Better yet, let’s require prescribers to place an indication on all orders: hydroxyzine 25mg PO Q6H PRN ITCHING versus hydralazine 25mg PO Q6H FOR BLOOD PRESSURE. Might even be educational for some prescribers.(1)

    How about we spend a little time creating smart EHR’s that know when something is amiss?(2) A system that won’t let the provider select a medication for an inappropriate indication without jumping through some hoops. Something like “You sure about this, bruh? Hydralazine isn’t typically used for itching. Were you trying to prescribe hydroxyzine?”(3)

    Now combine smart prescribing practices like those above with safety measures in the pharmacy like barcode scanning for verification. Selecting the wrong medication in the pharmacy is always possible and happens for a host of reasons, regardless of t.a.l.l.m.a.n lettering. Barcode scanning is a pretty good way to help ensure that you have the prescribed medication in hand.

    Overall, I’m not surprised that T-A-L-L-M-A-N lettering didn’t make much of a difference in the study. Even though it’s become a standard of practice, I don’t know that I’ve ever bought into it. My preference would be to use better technology with a little common sense.

    If you’re interested in reading the article (BMJ Qual Saf 2016;25[4]:213-217; BMJ Qual Saf 2015 Dec 16. [Epub ahead of print]), it can be found here.

     

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    (1)    You might be surprised to find out how little some practitioners know about the medications they prescribe. I constantly appalled by the prescribing practices that I see in the acute care setting.

    (2)    Something like AI or ML, perhaps. Hmm…

    (3)    That’s kind of how the call goes when you have to let a prescriber know they may have inadvertently selected the wrong drug.

  • Can “a computer” take over for a pharmacist?

    Two things happened to me recently that have pushed this question to the front of my mind.

    IBM_Watson

    The first is by way of some comments that were left in response to something I wrote in June about Google’s new symptom search. The comment is as follows:

    “...I have to question your closing statement: The idea of such a vast amount of knowledge at one’s fingertips is mind boggling, to say the least. Google, like any reference, has “information”, but I’m not sure if I would classify it as a “vast amount of knowledge”. Actually, knowledge on the part of the reader is what is required to make sense of the information that a source like this provides. The ability to interpret drug literatures only comes with education, training, and experience…

    The second item comes from a Reddit thread that I got involved with a few days ago. In the thread a user asks whether or not a pharmacist could be replaced “by a computer” in another 20 years. I argued that it could certainly happen. Someone countered by saying that it couldn’t happen because “the evaluation side, the interpretation of a patient, taking it’s [sic] history into account” couldn’t be done by decision-making software.

    Depending on which side of the fence you’re on, there is potential for some good discussion here.

    As I see it, information by itself holds little value. Having the skills to apply information to a given situation, i.e. “having knowledge”* makes all the difference in the world. Many think that it is this that makes humans indispensable in certain roles, like pharmacists. However, don’t be too quick to dismiss the ability of artificial intelligence (AI) and machine learning (ML) to mimic the actions of a human, especially in healthcare. Both AI and ML are powerful tools that can be used to appropriately apply information to any given situation. If a piece of software is able to use ML and AI to apply information to a situation based on past experience, doesn’t this become “knowledge”? I think it does.

    This is what pharmacists do throughout their career – take what they’ve learned, add it to what they’ve experienced, and apply it to a given situation – and why seasoned veterans are so valuable. It’s not that they’re smarter than their younger counterparts; it’s that they’ve been around longer and seen more. The knowledge gained by veteran pharmacists is often the difference between making average decisions and making great decisions. As pharmacists practice, they gain more knowledge.  As time goes by it becomes increasingly rare to see new situations. I’m sure that computers can take information and combine it with previous actions and outcomes to make decisions. They do it all the time.

    Not all knowledge requires depth of logic and “freedom of thought”. Take for example a pharmacist that gains knowledge by reading through a new set of treatment guidelines, or a journal article, or by attending a conference lecture. After digesting the information – use drug x in this situation – the pharmacist is ready to apply it. This is one of the things that make pharmacists better as clinicians over time, i.e. learning new things from others. Can’t a computer use the same information and be given parameters from which to apply it? Sure. How is that different from a human pharmacist? On the surface it’s not.

    So while I understand the desire for pharmacists to push back on the idea of being taken over by computers, I fundamentally disagree. I believe that 80% of what pharmacists do right now could be successfully emulated by a combination of technologies. Decisions made by pharmacists rarely require some special power of observation. Most are actually pretty cut and dry. What about those times that require a judgement call? That’s the other 20%. And while I think you need a pharmacist to make those calls today, I don’t think it will be long before technology can do the same thing. After all, most judgment calls are simply something learned plus experience. Computers may not be able to think on their own, but they can certainly take information, search for a previous encounter, and “make a decision”.

    Obviously this is just my opinion, take it for what it’s worth.

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    *one definition of knowledge – “facts, information, and skills acquired by a person through experience or education; the theoretical or practical understanding of a subject.”

  • ISMP releases new medication safety best practices document

    I quite literally stumbled across this the other day while doing research for another project. I heard that ISMP had updated their best practices document, but didn’t see an official announcement. It’s possible I just missed it.

    ISMP_Best_Practices

    The document contains some great new safety recommendations. All in all there are eleven best practices listed. Most of the recommendations are what I would consider minor, but there are a couple that I think are worth highlighting:

    Dispensing vinCRIStine in a minibag instead of a syringe. This is one of those ideas that seems so simple, yet brilliant. When you read it, you instantly say to yourself “why didn’t I think of that?”. VinCRIStine is commonly dispenses in a syringe and given via short IV push. However, being dispensed in a syringe has led to the accidental administration of the drug via the intrathecal route. The result is devastating neurological damage, up to and including death. By simply putting the drug in a minibag, you effectively eliminate the possibility of it being administered intrathecally.

    Performing independent verification of ingredients during sterile compounding. This includes a recommendation to use technology to “assist in the verification process (e.g., barcode scanning verification of ingredients, gravimetric verification, robotics, IV workflow software) to augment the manual processes.” I believe this is the first official document from an organization to include such a recommendation. Congratulations to ISMP for having the resolve to do this. ASHP needs to follow suite.

    More information can be found here: 2016-2017 Targeted Medication Safety Best Practices for Hospitals [PDF]

  • Deactivation, Decontamination, Cleaning, and Disinfection of sterile HD compounding areas

    USP <800> has an entire section dedicated to deactivation, decontamination, cleaning, and disinfecting areas that are used for compounding sterile hazardous drugs (HDs).

    The chapter calls for:

    • Establishing written procedures
    • Training personnel
    • Using appropriate personal protective equipment (PPE) resistant to cleaning agents. This includes the use of two pairs of chemo gloves and impermeable disposable gowns
    • Using eye protection and face shields required if splashing is likely
    • Using respiratory protection if warranted
    • Using wetted wipes and not spray bottles to deliver agents for deactivation, decontamination, and cleaning
    • Proper disposal of all materials used

    Deactivation – Renders the compound inert or inactive. Residue from deactivation must be removed through decontamination (see below). There is no single method for deactivating all known compounds.

    Decontamination – Inactivating, neutralizing, or physically removing HD residue from non-disposable surfaces via wipes, pads or towels. This includes work surfaces and under work trays where residue may collect.

    Cleaning – Process to remove contaminants – organic and inorganic material – from objects and surfaces using water, detergents, surfactants, solvents, and/or other chemicals. Cleaning may not be performed while compounding activities are occurring.

    Disinfection – Process of inhibiting or destroying microorganisms. Required for surfaces where sterile compounding occurs.

    Most of the above is common sense. While it may seem complicated, most pharmacies will simply purchase kits designed to walk them through the process. An example of a kit used to meet USP <800> requirements is WipeDown 1-2-3 by Valtek Associates. I’m sure there are others as well.

    The WipeDown 1-2-3 product description can be seen below. Notice that the kit contains numbered packets designed to walk you through the process, i.e. Packet #1 – deactivation, Packet #2 – decontamination, Packet #3 – disinfecting/cleaning. Pretty straightforward.

    WipeDown 1-2-3 is a sterile 3 step application wipe kit, that when used in sequence, provides deactivation, decontamination, and disinfection/cleaning of sterile compounding surfaces from most hazardous drugs. WipeDown 1-2-3 satisfies both USP compounding sterile preparations and USP hazardous drugs – handling in healthcare settings.
    Each Sterile WipeDown 1-2-3 kit includes:

    • Packet #1 – HYPO-CHLOR®, 5.25% Sodium Hypochlorite for deactivation
    • Packet #2 – THIO-WIPE, 2% USP Thiosulfate for decontamination
    • Packet #3 – ALCOH-WIPE®, 70% USP Isopropyl Alcohol for disinfecting/cleaning
  • 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.

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