I received an email yesterday from the International Journal of Pharmaceutical Compounding. The email contains a link to the IJPC’s Compounders’ Resource Directory. There’s a lot of good information on the list. It’s worth a look.
Both the IJPC and CompoundingToday.com are great resources for anyone doing extemporaneous (non-sterile) or sterile compounding.
Enjoy!
Here’s an interesting article from the January 13 issue of the Journal of Medical Internet Research (JMIR): Digital Pills To Measure Opioid Ingestion Patterns In Emergency Department Patients With Acute Fracture Pain: A Pilot Study (1)
A group of researchers out of Boston utilized digital pills (eTectRx, Newbury, FL, USA) to observe the ingestion patterns of oxycodone for patients discharged from the hospital following an acute extremity fracture.
Eighteen patients met inclusion criteria for the study, but only ten consented and were enrolled. Of the ten, eight had usable data. Not exactly a large number, but you gotta’ start somewhere.
Study drug was dispensed in capsule form. The digital pill was compounded with oxycodone tablets using a standard capsule-filling machine by the hospital’s investigational drug services pharmacy. Compounded digital pills were dispensed in blister packages.
When ingested, the gastric chloride ion gradient in the stomach activates the digital pill, transmitting a unique radiofrequency signal that is captured by a hip-worn receiver. The ingestion data is then transmitted to a cloud-based server where it can be viewed and analyzed. Because each digital pill emits a unique frequency, the system can record multiple simultaneous ingestion events, which is very cool.
It turns out that the digital pill did a pretty good job of recording the patient’s ingestion of their pain meds. It wasn’t perfect, and they had some technological issues along the way, but overall it results look promising. Imagine being able to see how your patients are taking their medication in real-time. You could even use the data coming from the digital pill to determine if a patient had ingested too many capsules at once.
The use of digital pills definitely has potential.
From the abstract:
Results: We recruited 10 study participants and recorded 96 ingestion events (87.3%, 96/110 accuracy). Study participants reported being able to operate all aspects of the digital pill system after their training. Two participants stopped using the digital pill, reporting they were in too much pain to focus on the novel technology. The digital pill system detected multiple simultaneous ingestion events by the digital pill system. Participants ingested a mean 8 (SD 5) digital pills during the study period and four participants continued on opioids at the end of the study period. After interacting with the digital pill system in the real world, participants found the system highly acceptable (80%, 8/10) and reported a willingness to continue to use a digital pill to improve medication adherence monitoring (90%, 9/10).
Conclusions: The digital pill is a feasible method to measure real-time opioid ingestion patterns in individuals with acute pain and to develop real-time interventions if opioid abuse is detected. Deploying digital pills is possible through the ED with a short instructional course. Patients who used the digital pill accepted the technology.
Pharmacy Practice News: “The National Institute for Occupational Safety and Health (NIOSH) held a meeting today in Cincinnati to discuss a universal closed-system drug-transfer device (CSTD) testing protocol, which is being developed… The new protocol will test both physical barrier systems, which block the intake of environmental contaminants or the unintended release of hazardous drugs into the environment; and air-cleaning systems, which clean or filter vapors to prevent the unintended release of drug or the intake of environmental contaminants… NIOSH released a draft test protocol last year to evaluate the efficacy of physical barrier–type CSTDs to see whether they prevented hazardous drugs from escaping the closed system. After hearing from the public and meeting with various stakeholders, NIOSH was asked to develop a new performance test protocol for air-cleaning CSTDs. Instead of developing a completely new protocol, NIOSH decided to develop a universal one that addressed both types of systems.”
NIOSH and the CDC game out with guns blazing back when USP <800> was drafted. Here’s the section on CSTDs from USP <800>:
5.4 Containment Supplemental Engineering Controls
Containment supplemental engineering controls, such as CSTDs, provide adjunct controls to offer an additional level of protection during compounding or administration. Some CSTDs have been shown to limit the potential of generating aerosols during compounding. However, there is no certainty that all CSTDs will perform adequately. Until a published universal performance standard for evaluation of CSTD containment is available, users should carefully evaluate the performance claims associated with available CSTDs based on independent, peer-reviewed studies and demonstrated containment reduction.
AÂ CSTDÂ must not be used as a substitute for a C-PEC when compounding. CSTDs should be used when compounding HDs when the dosage form allows. CSTDs must be used when administering antineoplastic HDs when the dosage form allows. CSTDs known to be physically or chemically incompatible with a specific HD must not be used for that HD.
Around the same time, the CDC and NIOSH released a “Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugsâ€. The idea is admirable, but the testing method adopted by the protocol left some CSTD manufacturers on the outside looking in, and they let the CDC know about it. Feel free to drop by the protocol comment site for clarification.
Apparently the comments made an impact because NIOSH is going back to the drawing board to try and come up with a universal protocol to meet the testing needs for all CSTD systems. However, one has to wonder if the damage is already done. For the past several months pharmacies have been making decisions on which CSTD to use based on information in the draft vapor containment protocol. Right or wrong, that’s the truth of the matter. I have to believe that some of the companies in this space have been irreparably harmed. Only time will tell.
Management of controlled substances(1) inside acute care pharmacies is a mess. It’s difficult for me to stress how utterly disappointed I am by this area of pharmacy technology.
I haven’t been in a pharmacy in years that wasn’t using technology to manage these drugs. This is likely due to the amount of fear and regulation swirling around controlled substances. These drugs have the highest level of control and are more regulated than any other drug class; at least until USP <800> goes live. The paranoia around these medications is crazy. The man hours dedicated to their management is obscene.
Based on my observations, the technology is outdated, difficult to use, and has failed to improve the process in any appreciable way. It remains unclear to me what advantage these systems offer. I don’t think it would be difficult for someone to argue in favor of ditching the technology in lieu of replacing it with two people locked inside a room using pen and paper. Crud, it might even be more efficient.
Consider that in a majority of instances the inventory management system used to manage controlled substances is separate from the system used for other inventory, and almost never tied directly to the EHR. Yes, it means you have to maintain a separate database for one area within the pharmacy.
Also consider that at least one of the major players in this area cannot handle partial doses, i.e. half-tablets or increments of mL’s. That’s right, software designed to keep detailed records for controlled medications chokes on something as simple as 7.5 mL.
This is an area of the pharmacy that needs an enema. Someone out there must have a better way. If you have any ideas, please give them up.
And for the companies playing in this space, you really need to do a better job. Go sit in a pharmacy for a day or two and observe how utterly terrible these systems are to use.
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The Intelliguard® Linked Visibility Inventory System™, or LVIS for short, is an RFID-enabled anesthesia cart designed for use by anesthesiology providers in the OR. I spoke about this briefly in my last podcast.
LVIS is a free-standing cart with three drawers – one large and two small. The cart looks quite different from any of the current anesthesia carts on the market. Take a look at the image below taken at the ANESTHESIOLOGY 2016 conference for a better understanding of what I’m talking about.
LVIS utilizes RFID technology to track medications in real-time. Items placed inside the cart are labeled with RFID tags – attached by the pharmacy or pre-tagged from some third parties like PharMEDium – and placed in a drawer. Once the cart is unlocked via one or a combination of locks – RIFD reader, biometric scanner, keypad for PIN (see image below) – the user has access to any medication in any of the drawers. Each time a drawer is closed, the system scans the contents and captures data on every medication, including item, quantity, user identification and time stamp. That’s it. If you take something out, the system knows. If you place something back in the drawer, the systems knows. The user is not required to debit or credit any item or scan the drug on removal or return. That’s a win for anesthesia providers and for the pharmacy. The provider gets access to medications without interring with their workflow, and the pharmacy gets real-time inventory numbers and complete transparency for what’s being used.
I like how the system was designed. There are several little things that show how much thought went into the product. For example, offering three different methods to log into the cart, or giving users the ability to configure access to each drawer individually, or offering an “in process” area to track items that have been removed but not documented as used (little green area on top of the machine), and so on. I also like how the system was designed with minimal impact on workflow in mind. Because LVIS uses RFID technology, most of what’s happening is transparent to the user, i.e. their workflow remains intact.
Not all is perfect, however. I’m not completely sold on the physical design of the system. I would like to speak to others that have seen the unit to get their feedback. The other questions I have are around integration with existing systems, especially EHRs and AIMS. That’s the elephant in the room with every small company trying to play with the big boys. Only time will tell, but I am encouraged by LVIS. I like the technology and I’m impressed with the thought that went into the product’s design.
I’m looking forward to learning more at ASHP Midyear in Las Vegas.
Couple other random images below:
Show Notes:
Host: Jerry Fahnri, Pharm.D.
Just a quick update from Jerry’s visit to Chicago for ANESTHESIOLOGY 2016, October 22-25, 2016.
Items discussed in podcast:
Intelliguard Linked Visibility Inventory System (LVIS)
BD Intelliport (I’ve written about this before here)
Codonics
ePosters
Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones
Below is the presentation that I gave at Health Connect Partners 2016 in Chicago, IL. I’ve had a few requests to publish the slides so I uploaded them to SlideShare. With that said, I have issues with SlideShare like the loss of animations, timed transitions, and a couple of minor formatting problems.
If you would like to view the presentation as it was meant to be viewed, you may do so here at the Microsoft Mix site. However, there is a log-in wall. I would have preferred that it not be there, but it is. The choice was to require a log-in to view or allow the presentation to be listed as Creative Commons. I am not prepared to do that. So, if you happen to have a Microsoft account – Hotmail, outlook, Office 365, etc – or you prefer to sign in with Google of Facebook, you will be able to view the presentation as it was intended, including the two embedded videos. However, if that’s not your thing, feel free to view it below or directly on the SlideShare site realizing that it’s missing some of its pizzazz.
Enjoy!
Show Notes:
Host: Jerry Fahnri, Pharm.D.
This is actually Episode 13. My apologies, but the volume is very low for some reason.
A brief discussion of Jerry’s presentation at Health Connect Partners (HCP) in Chicago on October 18, 2016, followed by a brief overview of some of the products he saw while at the conference.
Items discussed in podcast:
Swisslog
BD Cato
DoseEdge
MEPS Real-Time Inc Intelliguard LVIS
Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones
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…â€, 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?â€(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)Â Â Â 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.
Two things happened to me recently that have pushed this question to the front of my mind.
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 “informationâ€, but I’m not sure if I would classify it as a “vast amount of knowledgeâ€. 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 knowledgeâ€* 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 “knowledgeâ€? 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 thoughtâ€. 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 decisionâ€.
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.â€
