Jerry Fahrni

Category: Pharmacy Practice

  • Time to revisit gravimetrics in the IV room 

    Summary: if you’re preparing compounded sterile preparations (CSPs) in a pharmacy IV room, you should be using gravimetric analysis to determine the appropriate dose/volume.

    Pharmacy practice is easy. Our job is to provide the right drug, at the right dose, to the right patient in the safest, most efficient, cost-effective manner possible. Simple.

    Currently, the only method for ensuring that the correct drug is used during sterile compounding is barcode scanning. The future may hold other methods — I’ve read promising things about real-time solution concentration and drug identification using Raman spectroscopy — but for now, barcode scanning is it.

    There are three basic methods for ensuring the correct dose/volume: traditional volumetrics using the pull-back method or using a pharmacist step-check process; photo-assisted volumetrics where the pharmacist views a photo of the drug drawn up in the syringe (1); and gravimetrics.(2)

    Figure 1 from Terkola et al. J Clin Pharm Ther. 2017

    The Volumetric method is limited by human error. In a situation where the pharmacy utilizes the pull-back method, there’s nothing to prevent a wrong dose from accidentally being injected into a bag only to have the technician pull the empty syringe back to the correct volume. The pull-back method of IV preparation is universally panned by organizations like ASHP and ISMP. Any pharmacy still using the pull-back method to prepare CSPs should be considered criminally reckless as they are endangering the lives of their patients every time they make an IV. It is unconscionable to be using the pull-back method for IV preparation in this day and age.(3)

    Using either a step-check process or photo-assisted volumetrics is significantly better than the pull-back method, but not without their pitfalls. I’ve seen errors resulting from both methods where the technician pulled the wrong dose and the pharmacist verified it. It is unclear how this happens. It may result from checking bias, simple “slips”, or even laziness on the part of the pharmacist. It’s difficult to know for certain.

    Gravimetric analysis utilizes the specific gravity of a solution to quantitatively determine the analyte, i.e. the drug found in the solution. In the case of an i.v. preparation, the method can be used to determine the accuracy of a dose drawn into a syringe, removed from a vial, injected into an i.v. bag, and so on. The assumption is that if you know the weight of an object – syringe, i.v. bag, a vial of medication, etc – before and after adding or removing a substance, then you know exactly how much drug was added or removed.

    Gravimetrics acts as a forcing function, i.e. you can’t continue the compounding process until you have the correct weight. It’s also incredibly accurate. The only thing I’m uncertain about at this moment is how low the weight can be and still be accurate. This is important as small volumes in small syringes can be problematic.

    Overall, syringes as a measuring device are accurate, but variable.(4) Tolerances for sterile graduated plastic single-use hypodermic syringes are defined by the International Organization for Standardization (ISO), specifically ISO 7886-1. ISO standards vary by syringe size and volume of fluid drawn and expelled. The commonly accepted definition for an accurate disposable syringe below 5 mL nominal capacity is +/-­ 5% when measuring volumes at or above 50% nominal volume. Accuracy increases slightly to +/- 4% when measuring volumes at or above 50% nominal volume for syringes greater than 5mL nominal capacity.

    Figure 2 from Terkola et al. J Clin Pharm Ther. 2017

    There are several semi-automated IV workflow management systems available today. They range from low-end, lightweight systems to high-end, feature robust systems. Pick your poison, as they say. However, I encourage anyone looking for one of these systems to give serious consideration to those that offers a fully integrated scale, i.e. gravimetrics. Doing otherwise could potentially be tragic.

    Left to right: i.v.SOFT from Omnicell, BD Cato from BD, DoseEdge from Baxter. Image Source: Jerry Fahrni, Pharm.D.

    —————————————

    1. The photo can be viewed before or after the drug is shot into the final container, depending on the workflow. Obviously, viewing a photo of a syringe containing drug after the CSP has been made has its limitations.
    2. The image does a good job of showing the difference between volumetric and gravimetric preparation. Source: Terkola R, Czejka M, Bérubé J. Evaluation of real-time data obtained from gravimetric preparation of antineoplastic agents shows medication errors with possible critical therapeutic impact: Results of a large-scale, multicentre, multinational, retrospective study. Journal of Clinical Pharmacy and Therapeutics. 2017. doi:10.1111/jcpt.12529.
    3. I’m of the opinion that state boards of pharmacy should begin fining pharmacies that still use the pull-back method for IV prep. Administrators should be held professionally and personally responsible for allowing the method to continue. It simply shouldn’t be allowed. It’s dangerous, reckless, and lazy.
    4. Poppe L, Savage S, Eckel S. Assessment of final product dosing accuracy when using volumetric technique in the preparation of chemotherapy. Journal of Oncology Pharmacy Practice. 2016;22(1):3-9. doi:10.1177/1078155214549489.

  • Compounding Today: state board of pharmacy concerns with USP <800>

    Each Friday the CompoundingToday Newsletter faithfully appears in my inbox. The newsletter features commentary by Lloyd V. Allen, Jr., Ph.D., RPh, Editor-in-Chief of the International Journal of Pharmaceutical Compounding. Dr. Allen is a legend in the pharmacy compounding world for both sterile and non-sterile products. He was someone that I looked up to during my early years as a pharmacist; still do, as a matter of fact.

    Long before USP <795> and <797> existed, he was preaching the gospel of proper compounding technique and the need for specialized training. Truly a visionary man ahead of his time. I hope to meet him in person someday.

    So it should come as no surprise that I take seriously every thought and opinion he has. In last week’s Compounding Newsletter, Allen tackled an interesting topic with some thoughtful commentary.

    From the newsletter:

    Numerous state boards of pharmacy have concerns about United States Pharmacopeia (USP) Chapter <800> Hazardous Drugs-Handling in Healthcare Settings.

    – The official chapter goes beyond the walls of the pharmacy and into healthcare settings, including physician offices, clinics, hospitals, treatment centers, etc. where state boards of pharmacy don’t generally have authority for enforcement.

    – The requirements of <800> are very strict and extremely costly; many smaller pharmacies will no longer be able to serve their patients who depend upon compounded medications so they will simply cease compounding patient-specific medications, including some hospitals.

    – There are some aspects of <800> that should be the burden of manufacturers and distributors, not pharmacies. As an example, no package should be delivered to a pharmacy contaminated with hazardous drug (HD) contents on the package surfaces that exposes pharmacy personnel upon opening. This is the responsibility of the manufacturer and distributor…

    – Many of the requirements of <800> are based upon “opinion” and not necessarily upon science as demonstrated by documented, prospective studies.

    It’s interesting to note that USP <800> extends into all areas where HD’s may be used, including physician offices. Where will that oversight come from? Will pharmacies be held accountable?

    Dr. Allen has always been an advocate for “the little guy” and been cognizant of the balance between practical regulation and overbearing regulation. This is clear in his assessment of many areas within USP <800>. While I don’t necessarily agree with everything he says, I believe that his commitment to pharmacy practice and patient care deserve our attention. As he states, it is possible that the new regulation will simply be too much for some, resulting in the closure of compounding facilities. The greater concern, at least for me, is what impact the new requirements will have on hospital pharmacies where budgets drive change. A shift in budgetary requirements will likely mean that important projects will be postponed or canceled in favor of meeting USP <800>. The untoward consequences could be felt for years to come.(2)

    Dr. Allen’s zinger about the lack of science is understandable and shared by many, but I don’t believe that prospective studies are always necessary to begin a process. For example, would you really want a 10-year pilot study showing that healthcare workers in the U.S. exposed to HDs are 10 times more likely to die of cancer than those that don’t before implementing these guidelines?(1) No, of course not. As I’ve said many times before, some fields – clean room procedure and pharmacy technology, for example – cannot be studied and scrutinized in the same manner as therapeutics. We simply can’t wait 5-10 years to change operational practices. With that said, USP <800> probably goes too far too fast in certain aspects of the regulation. Only time will tell whether the new guidelines will have the same impact as USP <797> did back when they were introduced.

    Dr. Allen goes on to state: “As state boards of pharmacy have options other than accepting USP <800> in its entirety… The purpose of this document is to simply provide a resource from which state boards of pharmacy can “pick and choose” items to include for their respective state.” While this may be true, it is one area where I disagree with Allen. Giving each state the ability to “pick and choose” how to implement and use USP <800> makes things incredibly difficult. California, for example, has made a complete mess out of their new regulations. Other states will do the same, creating chaos. In Allen’s scenario, moving ten feet across a state boundary could mean following a completely different set of rules. How does that make sense? I recommend developing USP <800> to a point that everyone can live with and use it. Period.

    I encourage you to read through the most recent issue of the CompoundingToday Newsletter. I also recommend that you “click subscribe” as well. The information is good and thought-provoking.

    ———

    • This is a fictitious example.
    • As my friend and colleague, Ray Vrabel likes to say, the clean room is “clean, but deadly”, referring to the fact that we spend all our money on regulation and virtually nothing on technology to improve safety.

  • Automated detection of LASA medication errors

     

    Look-alike/sound-alike (LASA) medications – also referred to as sound-alike, look-alike drugs (SALAD) (1) — have been a thorn in the side of healthcare professionals for as long as I’ve been a pharmacist.

    Many solutions to the LASA problem have been proposed, including Tall Man Lettering (2), physical separation of look-alike drugs, printing of both brand and generic names on packaging and storage bins, use of colorful warning labels, and so on and so forth. The problem with all these solutions is that they involve humans. Working in acute care pharmacy has taught me over and over again that as long as humans are involved there will be errors.

    Technologies can help. Automated carousel technology and robotics can help manage physical separation of the medications and eliminate visual bias generated by human eyes. Bar-code scanning can certainly aid in identifying medications correctly. Bar-codes don’t care that medications have similar names, they’re either right or wrong.

    In a recent article by Rash-Foanio (3) et al. the authors use an algorithm to flag potential errors from LASA drugs when an order meets the following criteria:

    1. a medication order is not justified by a diagnosis documented in the patient’s record
    2. another medication whose orthographic similarity to the index drug exceeds a specified threshold exists
    3. the latter drug has an indication that matches an active documented diagnosis.

    In the study the authors perform a retrospective analysis to identify errors that involved cyclosporine and cycloserine. The algorithm wasn’t perfect. Sixteen orders involving unique patients were found. Additional chart review of the errors discovered that 5 (31%) identified by the algorithm did not involve a medication error, i.e. the intended medication was correct. However, the algorithm correctly identified 11 (69%) LASA errors.

    While it may not catch all LASA errors, it seems that EHRs should give AI and some deep learning serious considerations for items like this. Preemptively catching greater than 50% of LASA errors is better than catching zero. (5)

    ——-

    1. I came out of pharmacy school having learned the phrase “sound-alike, look-alike drugs” (SALAD). At some point it changed to look-alike/sound-alike (LASA). Not sure when, how, or why it changed, but them’s the breaks. Just go with it. Adapt or die, I suppose.
    2. I’ve never been a fan of tall-man lettering, and it isn’t even clear that it works to reduce errors.
    3. Rash-Foanio, Christine et al. “Automated Detection Of Look-Alike/Sound-Alike Medication Errors”. American Journal of Health-System Pharmacy7 (2017): 521-527. Web.
    4. Kondrak, Grzegorz, and Bonnie Dorr. “Automatic Identification Of Confusable Drug Names”. Artificial Intelligence in Medicine1 (2006): 29-42. Web. 28 Apr. 2017.
    5. Honestly, one of the simplest things we can do is force providers to select an indication when ordering LASA medications. That simple act has the potential to significantly reduce these errors.

  • EHRs are an untapped, but almost impossible to use, health resource

    We’re all familiar with the promise of “big data” in healthcare. Crud, I’m a huge fan of using data. I think the amount of information inside an EHR has the potential to do a lot of wonderful things, not only for healthcare in general but specifically for a pharmacist. How many kinetic consults have been done by hand, tracked manually, and refined by voodoo magic? Thousands, I can assure you. The number of things pharmacists still do manually is staggering. “Monitoring” should no longer involve rummaging through charts — electronic or otherwise — looking for tidbits of information that need to be “fixed”. The days of dosing medications like vancomycin, warfarin, phenytoin, and aminoglycosides — just to name a few — should be long gone. We can contemplate building a Hyperloop, but we can’t figure out how to get someone’s INR to a therapeutic level within five days? Seriously, think about that for a second.

    FierceHealthcare: “For public health agencies, tapping into EHR data could augment the costly and time-consuming process of surveys….Data analytics has emerged as a key tool for providers to target high-risk populations with chronic conditions, although some have argued that health IT systems are still ill-equipped to adequately manage population health.” There’s the crux of the matter, data is valuable, but it’s tough to get. I’ve only recently started to request specific data from the EHR to look at some things I find interesting. Unfortunately, I’ve run into roadblocks. Apparently, the data inside an EHR — at least inside this particular EHR — isn’t easy to retrieve. At least that’s what I’ve been told. How hard can it be? Dude, just dump the raw data somewhere and I’ll build the queries myself. Again, apparently not that easy. 

    In a nutshell, all patient data, from demographics and notes to labs and medication use should be easily accessible to anyone with appropriate credentials, i.e. a pharmacist that works for the hospital where an EHR is used, for example. Only when we, as healthcare professionals, can access data at will, and use that data to answer questions, will EHRs become valuable to patient care. At present, EHRs are full of potentially valuable information that no one can get. It’s like having a savings account that only allows deposits, no withdrawals. The balance might look great, but what do you do when you need a little money and the bank says “sorry, there’s no way to take your money out”? Throw in the fact that EHRs are a usability nightmare and you realize that we have a long way to go.

  • A cautionary tale for healthcare. A lesson for pharmacy.

    A couple of days ago I read an interesting piece by John Halamka over at healthsystemCIO.com. In it, Halamka shares two stories about purchasing parts for some projects. One part required a lot of legwork and took a month to secure. The other required a quick Amazon search and less that 24 hours to obtain.

    “It’s clear [the people running the company have] been asleep since 1985. When it comes time to replace the windows in my buildings, I would never consider Marvin Windows products, since it’s clear they care more about preserving an ancient business model and less about their customers’ modern expectations and experiences”. I feel that this accurately describes today’s pharmacy model.

    The pharmacy practice I returned to after nearly a 10-year absence appears to have been frozen in time. Yes, things have changed here and there, like the introduction of EHRs, but the distribution model feels the same as the one I left around 2006. It’s a model that relies heavily on humans to perform manual tasks, which isn’t terrible per se. Unlike others, Amazon, for example, there has been a failure in pharmacy to introduce and integrate automation and technology into the distribution process. While pharmacy continues to rely heavily on people and very little technology, Amazon has designed a system that uses people plus strategically chosen technology to improve efficiency and accuracy.

    In today’s pharmacy model, medication orders are manually pulled, stocked and counted. Manual “double” and “triple” checks are used in place of simple technologies like barcode scanning and robotics; often leading to slips and lapses. Medications are frequently lost due to the inability to accurately track them once they leave the pharmacy. This in turn results in medications being re-dispensed and often given late. Stickers identifying medications as high-risk, high-alert, STAT, sound-alike-look-alike, “note dose”, “rectal use only”, “neuromuscular blocker”, and a slew of others, decorate the shelves turning them into a Jackson Pollock painting.  Buyers still walk the shelves and manually evaluate stock levels. Paper logs are filled with information that is often redundant and available elsewhere in digital form. Legacy software sits on desktop computers while the cloud begs to be used. “Mobile pharmacy” means the pharmacist is walking around. If you didn’t know better, you’d think I was joking. I’m not.

    In the article, Halamka states that “The lesson learned is that in the near future, healthcare organizations that offer an Amazon approach will displace this [sic] which do not.” I wonder if this applies to the pharmacy as well as healthcare organizations. I think not. Time has shown that pharmacy is an often forgotten part of the healthcare system. Pharmacists get promoted to move up and out of the pharmacy. No one ever moves “down” into the pharmacy. As the saying goes, it’s a good place to be from.

    Halamka describes the progressive nature of Beth Israel Deaconess Medical Center (BIDMC). It’s impressive, to be sure. But even so, I’ve never heard of the BIDMC pharmacy. I’m sure it’s a fine pharmacy, but it’s never come up in any conversation or discussion of “the best” or the “most progressive”. I hear about BIDMC and Halamka all the time. Why not the pharmacy? Is the department as forward thinking as the rest of BIDMC? I don’t know. Perhaps someday I’ll find out.

    Companies that provide technology to pharmacies are partly to blame. Their products often lack proper functionality and are woefully inadequate for the tasks at hand. With that said, it’s unfair to hold them responsible for our lack of progress. After all, pharmacy administrators are cheapskates, unless of course, they can make a lot of money – 340B, specialty pharmacy, etc – and then they’re all over it. But for the average, desperately needed technology, those in charge are unwilling to invest even when the technology has demonstrated improved patient safety and workflow.

    It’s difficult for me to take a Pharmacy Director seriously when they say “we don’t have the money” only to take a stroll through the pharmacy and see inefficiency compounded with bloated drug budgets and out-of-control overtime numbers. Fixing even one of those would free up enough money to implement any number of additional technologies.

    More often than not, I find that I’m speaking to myself when attempting to engage others in this conversation. Most want to discuss “clinical pharmacy” and “patient safety”(1) initiatives, all the while missing the bigger picture in favor of the minutia. It’s this clear lack of strong leadership and forward thinking(2) that will continue to plague pharmacy for the foreseeable future.

    In the best interest of healthcare systems everywhere, I think it’s time to turn all pharmacy operations over to Amazon. I jest, but only a little.

    —–

    • Strange that many pharmacists don’t see the connection between using automation and technology and patient safety. True story.
    • There’s a whole nother blog post in there.

  • Thoughts on my time with DoseEdge Pharmacy Workflow Manager 

    Yesterday, I had a great opportunity to spend the day using DoseEdge in its native environment. That is to say, I staffed at a facility that was using DoseEdge in its cleanroom to prepare CSPs, including patient-specific products as well as stock bags, TPNs, etc. I’ve used DoseEdge for brief periods in the past. I’ve also spent time with the engineers that have worked on the product, product managers, sales people, marketing folks, and various other Baxter employees at conferences like ASHP midyear. But, this is only the second time that I have worked an entire  “staff pharmacist” shift using the product. And as one might imagine, using a system in its native environment can often provide a new perspective.

    DoseEdge System at Boston Children’s Hospital

    I’ve written about DoseEdge, and systems like it, extensively on this site over the years.  A quick search of jerryfahrni.com revealed several articles mentioning DoseEdge, dating back to 2010. I’ve also written about DoseEdge and similar products extensively elsewhere.

    With over 300 installs in the U.S., DoseEdge is one of the most popular IV workflow management systems on the market and is still the most widely implemented product of its kind in the U.S. It’s a very good system, certainly in my top five. There are several things that I really like about the system, such as how it controls labels, its ability to track partial vials, and the fact that it talks. Seriously, it speaks to the user. Pretty cool.

    However, there’s always room for improvement. For example, after using the system, I found that I don’t really care for the user interface (UI). I found it to be rather unintuitive and a bit clumsy. The UI is stuck somewhere between a legacy system and a modern web-based system. It’s not good. Too many clicks, things in weird places, naming conventions that simply don’t make sense in my mind, just to name a few. With that said, it’s still quite usable, and honestly, it’s likely as good as any other UI on any other product that I’ve used in the pharmacy.

    The other thing that hit me yesterday was just how terrible the process of using images is to verify the accuracy of compounded products. I don’t care for it. As good as the images are – and they’re quite good in DoseEdge – there are still shadows in strange places that make reading syringe volumes difficult at times. This is especially true for small volumes. There were times yesterday when I simply made educated guesses to the exact volume and assumed that the volume was accurate, as I couldn’t quite see the exact location of the plunger. Don’t get me wrong, this is still way better than the syringe-pullback method, but image-assisted verification isn’t optimal. I would have liked to have had the gravimetric option available to me yesterday. DoseEgde offers gravimetrics, although it isn’t widely used.

    So, good system, but not perfect. Better than the manual process, but room for improvement. Imaging better than pullback, but not great.

  • Does charge-on-chart hurt or help medication chain of custody?

    Historically, hospital pharmacies have used a charge-on-dispense (COD) model for medications. The model charges the patient for a medication when it is dispensed from the pharmacy and credits the medication if it’s returned to the pharmacy unused. Simple, but labor-intensive. The model itself has been around for a long time.

    The introduction of electronic health records (EHRs) and electronic medication administration records (eMARs) has pushed the COD model aside in favor of the charge-on-chart (COC) model; sometimes referred to as “charge on administration” (COA). In the COC model, the patient isn’t charged for a medication when it is dispensed from the pharmacy because the charge is captured when the medication is scanned by the nurse and administered to the patient. When the nurse scans the medication, the information is captured by the eMAR and charted, hence the name. There are several benefits to this model, including no need for the pharmacy to credit medications that go unused. Unused medications are simply returned to the pharmacy and folded back into the inventory.

    Put simply, the COC model eliminates the need for pharmacies to charge and credit medications as they are dispensed and returned to the pharmacy. But here’s a little untoward side effect of the COC model, it eliminates much of the pharmacy audit trail for medication movement into and out of the pharmacy.

    The old COD model wasn’t perfect, and there were plenty of discrepancies, but I wonder if the COC model has created even less transparency regarding inventory reconciliation and the movement of medications throughout the hospital.

    Inventory management systems like AutoPharm from Talyst and Pyxis Pharmogistics from Carefusion should, in theory, give pharmacies real-time inventory numbers. But the promise of these systems has fallen short. Both utilize barcode scanning to track inventory, which unfortunately requires humans to be diligent when scanning items in and out of inventory. Human laziness usually prevails, and numbers are frequently inaccurate.

    Medication tracking systems are available from a couple of companies, but also utilize barcode scanning, thus fall prey to the same weakness mentioned above. These systems also fall short when following medications throughout the medication distribution process as they typically stop as soon as the medication is delivered to the nursing unit, i.e. they don’t track the return of the medication.

    Track and trace regulation, which will require serialized barcodes and tracking from manufacturer to patient, could potentially help with this issue. However, that process has the same weaknesses as those mentioned above, namely human intervention.

    RFID technology would surely be better than barcode scanning, except that RFID tags are too costly for use on all medications and drug manufacturers are nowhere near ready to do anything like this.

    Currently, the only medications that receive enough scrutiny in a pharmacy to determine location and quantity at any given moment are controlled substances, i.e. morphine, fentanyl, oxycodone, and so on. And this falls short on some level once the medication leaves direct oversight of the pharmacy.*

    It’s interesting to think that as much time as we spend managing inventory in a hospital pharmacy, we still have a long way to go.

    ———–

    *This includes leaving the pharmacy itself as well as storage devices like automated dispensing cabinets (ADC). When a medication leaves the ADC we assume it has been administered to the patient once it has been charted. We cannot confirm this, however. For all we know, the healthcare provider that removed the medication and documented the administration, simply put it in their pocket and walked out with it. You never know for certain.

  • Allergies and Electronic Health Records, we’re doing it wrong

    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.

  • The overlooked impact of automation, regulations, and guidelines on pharmacy practice

    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.

    ——

    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.

  • Three concepts that create a lot of confusion: stability, beyond-use date, expiration

    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?