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  • 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?

  • Compounding Resource Directory from IJPC

    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!

  • Use of digital pills to measure opioid ingestion [article]

    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.
  • NIOSH puts the brakes on the CSTD vapor containment protocol

    Pharmacy Practice News: “The National Institute for Occupational Safety and Health (NIOSH) held a meeting today in Cincinnati to discuss a universal closed-system drug-transfer device (CSTD) testing protocol, which is being developed… The new protocol will test both physical barrier systems, which block the intake of environmental contaminants or the unintended release of hazardous drugs into the environment; and air-cleaning systems, which clean or filter vapors to prevent the unintended release of drug or the intake of environmental contaminants… NIOSH released a draft test protocol last year to evaluate the efficacy of physical barrier–type CSTDs to see whether they prevented hazardous drugs from escaping the closed system. After hearing from the public and meeting with various stakeholders, NIOSH was asked to develop a new performance test protocol for air-cleaning CSTDs. Instead of developing a completely new protocol, NIOSH decided to develop a universal one that addressed both types of systems.

    Image taken from EQUASHIELD marketing document obtained at ASHP Midyear 2015
    Image source: EQUASHIELD marketing document obtained at ASHP Midyear 2014

    NIOSH and the CDC game out with guns blazing back when USP <800> was drafted. Here’s the section on CSTDs from USP <800>:

    5.4 Containment Supplemental Engineering Controls

    Containment supplemental engineering controls, such as CSTDs, provide adjunct controls to offer an additional level of protection during compounding or administration. Some CSTDs have been shown to limit the potential of generating aerosols during compounding. However, there is no certainty that all CSTDs will perform adequately. Until a published universal performance standard for evaluation of CSTD containment is available, users should carefully evaluate the performance claims associated with available CSTDs based on independent, peer-reviewed studies and demonstrated containment reduction.

    A CSTD must not be used as a substitute for a C-PEC when compounding. CSTDs should be used when compounding HDs when the dosage form allows. CSTDs must be used when administering antineoplastic HDs when the dosage form allows. CSTDs known to be physically or chemically incompatible with a specific HD must not be used for that HD.

    Around the same time, the CDC and NIOSH released a “Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs”. The idea is admirable, but the testing method adopted by the protocol left some CSTD manufacturers on the outside looking in, and they let the CDC know about it. Feel free to drop by the protocol comment site for clarification.

    Apparently the comments made an impact because NIOSH is going back to the drawing board to try and come up with a universal protocol to meet the testing needs for all CSTD systems. However, one has to wonder if the damage is already done. For the past several months pharmacies have been making decisions on which CSTD to use based on information in the draft vapor containment protocol. Right or wrong, that’s the truth of the matter. I have to believe that some of the companies in this space have been irreparably harmed. Only time will tell.

  • Someone please disrupt controlled substance storage technologies

    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.

    ——————-

    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.
  • Cool Technology for pharmacy – Linked Visibility Inventory System (LVIS)

    The Intelliguard® Linked Visibility Inventory System™, or LVIS for short, is an RFID-enabled anesthesia cart designed for use by anesthesiology providers in the OR. I spoke about this briefly in my last podcast.

    LVIS is a free-standing cart with three drawers – one large and two small. The cart looks quite different from any of the current anesthesia carts on the market. Take a look at the image below taken at the ANESTHESIOLOGY 2016 conference for a better understanding of what I’m talking about.

    Intelliguard LVIS Cart

     

    LVIS utilizes RFID technology to track medications in real-time. Items placed inside the cart are labeled with RFID tags – attached by the pharmacy or pre-tagged from some third parties like PharMEDium – and placed in a drawer. Once the cart is unlocked via one or a combination of locks – RIFD reader, biometric scanner, keypad for PIN (see image below) – the user has access to any medication in any of the drawers. Each time a drawer is closed, the system scans the contents and captures data on every medication, including item, quantity, user identification and time stamp. That’s it. If you take something out, the system knows. If you place something back in the drawer, the systems knows. The user is not required to debit or credit any item or scan the drug on removal or return. That’s a win for anesthesia providers and for the pharmacy. The provider gets access to medications without interring with their workflow, and the pharmacy gets real-time inventory numbers and complete transparency for what’s being used.

    LVIS Access

    I like how the system was designed. There are several little things that show how much thought went into the product. For example, offering three different methods to log into the cart, or giving users the ability to configure access to each drawer individually, or offering an “in process” area to track items that have been removed but not documented as used (little green area on top of the machine), and so on. I also like how the system was designed with minimal impact on workflow in mind. Because LVIS uses RFID technology, most of what’s happening is transparent to the user, i.e. their workflow remains intact.

    Not all is perfect, however. I’m not completely sold on the physical design of the system. I would like to speak to others that have seen the unit to get their feedback. The other questions I have are around integration with existing systems, especially EHRs and AIMS. That’s the elephant in the room with every small company trying to play with the big boys. Only time will tell, but I am encouraged by LVIS. I like the technology and I’m impressed with the thought that went into the product’s design.

    I’m looking forward to learning more at ASHP Midyear in Las Vegas.

    Couple other random images below:

     

    MEPS LVIS Keypad

    20161023_141315

  • JerryFahrni.com Podcast | Episode 14: Update from ASA 2016

    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

  • The Future of Pharmacy: Using Technology to Drive Practice Change [presentation]

    Below is the presentation that I gave at Health Connect Partners 2016 in Chicago, IL. I’ve had a few requests to publish the slides so I uploaded them to SlideShare. With that said, I have issues with SlideShare like the loss of animations, timed transitions, and a couple of minor formatting problems.

    If you would like to view the presentation as it was meant to be viewed, you may do so here at the Microsoft Mix site. However, there is a log-in wall. I would have preferred that it not be there, but it is. The choice was to require a log-in to view or allow the presentation to be listed as Creative Commons. I am not prepared to do that. So, if you happen to have a Microsoft account – Hotmail, outlook, Office 365, etc – or you prefer to sign in with Google of Facebook, you will be able to view the presentation as it was intended, including the two embedded videos. However, if that’s not your thing, feel free to view it below or directly on the SlideShare site realizing that it’s missing some of its pizzazz.

    Enjoy!

  • JerryFahrni.com Podcast | Episode 13: HCP Chicago

     

    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