USP Chapter <800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS is organized into the following main sections:

1. Introduction and Scope
2. List of Hazardous Drugs
3. Types of Exposure
4. Responsibilities of Personnel Handling Hazardous Drugs
5. Facilities and Engineering Controls
6. Environmental Quality and Control
7. Personal Protective Equipment
8. Hazard Communication Program
9. Personnel Training
10. Receiving
11. Labeling, Packaging, Transport, and Disposal
12. Dispensing Final Dosage Forms
13. Compounding
14. Administering
15. Deactivating, Decontaminating, Cleaning, and Disinfecting
16. Spill Control
17. Documentation and Standard Operating Procedures
18. Medical Surveillance

And of course the glossary and appendices.

Section 6 – Environmental Quality and Control covers wipe sampling for HD surfaces. According to Section 6, wipe sampling of HD surfaces should be performed initially to establish a baseline/benchmark and then at least every 6 months, or more often as needed, to verify containment.

Areas that should be sampled include:

• Interior of the C-PEC and equipment contained in it
• Pass-through chambers
• Surfaces in staging or work areas near the C-PEC
• Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)
• Areas immediately outside the HD buffer room or the C-SCA
• Patient administration areas

Emphasis is mine.

For the interior of C-PECs and equipment contained in it, that means that pharmacies using an IV robot or IV workflow management system (IVWMS) for sterile HD compounding must sample inside the robot as well as all the hardware tied to the IVWMS. This includes cameras, scales, barcode scanners, and even touchscreen computers both inside and adjacent to the hood. I don’t think most pharmacies are doing this.

As far as pass-through chambers go, this includes refrigerators and dual-sided carousels attached to HD compounding areas. Again, I don’t think most pharmacies are doing this.

There is currently no standard for acceptable limits for HD surface contamination. However, USP <800> lists the following common marker HDs that can be assayed: cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-containing drugs. I don’t think I’ve ever been in a hospital pharmacy larger than 100 beds that doesn’t have a patient receiving at least one of thsse drugs.

If any measurable contamination is found, the facility must identify, document, contain the cause of contamination, and come up with a way to fix it, which may include something as simple as re-evaluating work practices, re-training personnel, performing thorough deactivation, decontamination, and cleaning, or something as difficult as improving engineering controls, i.e. hoods and buffer rooms.

So remember folks, make sure you’re performing appropriate surface sampling on your technology in and around your hoods.

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.”

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.

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.

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 19^th 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.

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.

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?

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

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.

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.

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.

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.

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.

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.

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.”

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’.

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

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.

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]

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 “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.

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

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.

—–

(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.

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

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

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.

• The technology has been around for a long time. The controlled substance area of the pharmacy was one of the first areas to start using technology as part of routine medication distribution.
• More pharmacies use technology to manage controlled substances than any other area of the pharmacy. It’s probably considered “best practice” to use technology in this area of the pharmacy.
• There’s a fair amount of technology being used to deal with controlled substances: inventory management software, barcode scanning, biometrics, analytics and reports, remote access refrigeration and “vaults”.
• It’s the worst technology in the pharmacy, hands down.

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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1. The term ”controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of the Controlled Substances Act http://www.fda.gov/regulatoryinformation/legislation/ucm148726.htm . This includes medications like morphine, fentanyl, hydromorphone, etc.

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.

1. Chai, Peter R et al. “Digital Pills To Measure Opioid Ingestion Patterns In Emergency Department Patients With Acute Fracture Pain: A Pilot Study”. Journal of Medical Internet Research1 (2017): e19.

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!

The differences between stability, beyond-use date (BUD), and expiration for compounded sterile preparations (CSPs) causes a lot of confusion. I’m not even certain that I fully understand their roles in day to day pharmacy operations. With that said, I think the key is for everyone to at least understand and agree that the BUD of a CSP is not the same as the expiration date.

Here’s how I understand it:

Stability is based on the chemical stability of the solute in solution, i.e. ingredients alone or in combination. This is what the Handbook on Injectable Drugs is all about, i.e. loss of drug potency/activity in solution.

Expiration date is defined by the FDA and identified by the product manufacturer.  Basically, it’s the shelf-life of the drug when properly stored. The expiration date no longer applies once the manufacture’s container is opened and the drug product is transferred to another container for dispensing or repackaging. Pharmacy uses “expiration date” loosely as we are not manufacturers. Most often I see pharmacies use expiration date in place of stability, i.e. the drug is good in solution for “this long”.

Beyond-use date (BUD) is assigned by the pharmacy for a CSP and is an arbitrary date/time found in USP <797> and adopted by many boards of pharmacy. BUD is based on sterility, stability. The BUD identifies the time by which a preparation – once mixed – must be used, i.e. “hung”. Once the CSP is hung on a patient, the BUD goes out the window and no longer applies. USP <797> does not address what to do with a CSP once it is hung on a patient. So something can have a BUD of 12-Hours, but be stable much longer. Pharmacies can extend BUDs, but only after independent sterility testing performed according to USP <71>, or in some cases when appropriate literature sources are used.

In summary, the BUD is not the expiration date, nor the stability of a preparation. Nurses must hang a CSP before the BUD is reached. The CSP can continue to hang on the patient until the “Expiration Date” is reached.

I would love to hear how facilities are dealing with these three concepts. Does your facility use a BUD and expiration on CSP labels?

I’ve been thinking about writing this post for quite some time. The concepts and thoughts presented here have been on my mind since I re-entered the workforce in a traditional sense over a year ago. I’ve alluded to some of my thoughts on Twitter, but decided it was time to put something in long form.

The thing that finally put me over the top was an article sent to me by my good friend and colleague, Mark Neuenschwander. Mark and I have been going back and forth for a long while on the pros and cons of self-driving cars. I’m all for it. He’s a bit more cautious with the concept. The article Mark sent – Crash: how computers are setting us up for disaster – contains a short paragraph supporting one of his main objections, mainly that humans may not be ready for self-driving vehicles.

With that said, the article goes way beyond a paragraph or two about self-driving cars. The author of the piece presents great insight into how humans are losing the ability to think and act for themselves as a result of automation. This is something the author refers to as the paradox of automation.

This problem has a name: the paradox of automation. It applies in a wide variety of contexts, from the operators of nuclear power stations to the crew of cruise ships, from the simple fact that we can no longer remember phone numbers because we have them all stored in our mobile phones, to the way we now struggle with mental arithmetic because we are surrounded by electronic calculators. The better the automatic systems, the more out-of-practice human operators will be, and the more extreme the situations they will have to face. The psychologist James Reason, author of Human Error, wrote: “Manual control is a highly skilled activity, and skills need to be practiced continuously in order to maintain them. Yet an automatic control system that fails only rarely denies operators the opportunity for practicing these basic control skills … when manual takeover is necessary something has usually gone wrong; this means that operators need to be more rather than less skilled in order to cope with these atypical conditions.”(1) –emphasis is mine

At this point, you’re probably wondering what this has to do with pharmacy. I’m getting to that.

I’ve been a pharmacist for the past 20 years, but have only been involved on the periphery for the past ten. I was an IT pharmacist from 2007 to 2010, a product manager at Talyst from 2010 to 2013, and an independent pharmacist consultant from 2013 to 2016. Recently I re-entered the pharmacy workforce as a staff pharmacist. Besides realizing that the day-to-day operations of an acute care pharmacy are basically unchanged, I noticed that new pharmacists – those that are fresh out of school with less than two or three years of acute care experience – are risk averse, lack creativity, don’t think outside the box, and lack the willingness to make expert judgment calls. In a nutshell, they are missing the very qualities necessary to qualify them as professionals in the healthcare field.

Pharmacists are relied upon, and paid well, to make tough decision, take on risk and responsibility, and come up with creative solutions to difficult medication-related problems. A trained monkey can perform most pharmacist-related work tasks when things are going exactly as planned.(2) It is only when things get complicated that pharmacists are there to apply a unique skillset to the problem. Unfortunately, I have witnessed a decline in the ability of new pharmacists to apply these skills to complex situations.

The cause of this decline is a bit of a mystery to me. I’ve speculated often as to the cause. It’s certainly not for a lack of intelligence. The new pharmacists I have met over the past year are certainly bright enough. It’s not the schools, or at least I hope it’s not the schools. The curriculum’s I’ve seen are more than adequate.  Is it a lack of experience? I’m sure that plays a part, but it doesn’t explain the lackluster willingness to problem solve. Could it be my age? I mean, every pharmacist I’ve ever met thinks their generation did it better than the current generation. Maybe there’s a little bit of truth to that, but I don’t think that explains everything I’ve seen.  No, it’s something else.

It wasn’t until I read the Guardian article cited above that things started to come together in my mind. It’s clear that the paradox of automation is playing a role. Better systems and more technology have led to fewer opportunities to practice basic skills that are necessary for pharmacists to perform at a high level. Smartphones and computer software have taken the place of a pencil and calculator. Strict protocol-driven care has taken the place of common sense and logic. But that doesn’t explain everything, especially when you consider how unautomated pharmacies are. It’s no exaggeration when I say that pharmacy practice is at least ten years behind in the technology race. No, the problem cannot be blamed entirely on the paradox of automation. There’s more to it.  Something more insidious. Something hidden in plain sight, but unseen. And that is the ever increasing number of pharmacy regulations and the proliferation of complex policies and procedures heaped on pharmacy practice.

Our overreliance on data and algorithms is eroding away at pharmacist’s ability to judge things for themselves and depriving them of decision-making opportunities.

Gary Klein, a psychologist who specializes [sic] in the study of expert and intuitive decision-making, summarises [sic] the problem: “When the algorithms are making the decisions, people often stop working to get better. The algorithms can make it hard to diagnose reasons for failures. As people become more dependent on algorithms, their judgment may erode, making them depend even more on the algorithms. That process sets up a vicious cycle. People get passive and less vigilant when algorithms make the decisions.” – emphasis is mine

This is what is happening to pharmacists. New grads, or those with limited practical experience, are relying too much on policies and procedures as a way to skirt tough decision. Instead of thinking logically about the problem and applying their deep understanding of pharmaceutical care, they are hiding behind page after page of arbitrary guidelines, sometimes to the detriment of the patient. In a sense, pharmacists have stopped working to get better and their judgment is fading.

There are times during the care of a patient when the right answer may not be written into a policy. In a worst-case scenario, the right thing to do for the patient may go against what’s written in the policy. During those times, a pharmacist in cooperation with other healthcare providers need to work together to make decisions based on expert judgment and experience. Sometimes these decisions can be tough and often times fall outside “the norm”. I’ve been involved in a few tough calls during my 20 years, and none of them were simple black-and-white matters.

Pharmacists practicing today cannot shy away from tough decisions. They can’t pass the buck. They can’t point to rules and regulations as a reason not to do something that they know should be done.(3) What I’ve observed is a serious problem. It threatens the credibility and the future of pharmacists as medication experts. When a pharmacist can’t think outside the box and apply their skills to complex problems in unique ways, they become no better than a reference book.

Think about it.

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1. If you’ve been in healthcare for any amount of time, you will recognize the name James Reason. He’s basically the father of the “Swiss Cheese model” of how errors occur. Every patient safety expert I’ve ever met uses the Swiss Cheese model to explain how errors occur in hospitals.
2. My thoughts on this are well documented throughout my website. I stand by my opinion that a majority of what a pharmacist does on a routine basis requires no specialized knowledge or skill. See this video for a pharmacist verifying orders in an EHR/CPOE system.
3. I’m not saying there isn’t a place for rules, because there is. I’m saying that regulatory requirements and policies cannot cover every scenario. It’s not possible. There will be times when the best, most thoughtful policy won’t cover what’s happening to a patient.

ACP Hospitalist: “About 10% of patients in the United States report a penicillin allergy, but most of these patients are not currently allergic, meaning that they could safely take drugs in the beta-lactam class. “The vast majority of patients who think they have penicillin allergies actually don’t when they undergo penicillin allergy skin testing,” said Emily Heil, PharmD, of the University of Maryland School of Pharmacy in Baltimore…. In fact, 96% of patients at one acute care facility who self-reported penicillin allergy had a negative skin test in a recent study by Dr. Heil and colleagues.”

I wrote about the problems surrounding patient allergies in the medical record several years ago. One would think that things have improved over time. Not even close. The proliferation of Electronic Health Records (EHRs) has only made things worse. The inaccuracy and incomplete nature of drug allergy information located in EHRs is causing more problems than ever before.

It might surprise you – or perhaps not – to find out that most patients don’t know whether or not they’re allergic to a medication, much less what the details are surrounding the allergy. Many perceived allergic reactions can be classified as an adverse reaction, intolerance, or simply an expected side effect.

Many of the allergies I see recorded in EHRs could easily be classified as intolerance, which in my mind means they shouldn’t be listed as an allergy. Having codeine listed as an allergy in the EHR because it causes GI upset is wrong. GI upset is not an allergy. GI upset to codeine does not preclude a patient from using any number of opioid analgesics. However, that little entry in the EHR will follow that patient around until the end of time, repeatedly rearing its ugly head whenever an opioid analgesic is prescribed. Each time a provider enters an order for an opioid analgesic, or a pharmacist verifies that order, or a nurse administers that order, they will have to contend with an allergy alert. The alert will fire, the provider will acknowledge it, quickly realize that it’s not really an allergy, and truck on. Not only does the alert provide worthless information with no value to the provider, it contributes to alert fatigue, which we all know is a very real and dangerous thing in today’s EHR-driven healthcare world.

Allowing poorly defined allergy information to appear, and remain, in the EHR should not be allowed. Facilities that allow it should be reprimanded. Providers that enter it should be educated. Improving the quality of allergy information found in EHRs benefits everyone. It should be a priority.

According to the ACP Hospital article cited above, accurate allergy information can lead to optimized therapy, decreased use of broad-spectrum antibiotics, and decreased costs. Is there anyone in healthcare that doesn’t want all of that?

Here’s the thing: it’s such a simple thing. Collecting better allergy information is so easy that it makes my brain hurt. It’s low-hanging fruit that often gets ignored. It requires no special education, training, or skill. No technology required. It cost nothing. This is one of those rare instances when a little common sense goes a long way.