Jerry Fahrni

Tag: Pharmacy Practice

  • Sensor-enabled medication inhalers

    I recall being really excited about sensor-enabled asthma inhalers several years ago. I even remember giving a presentation in 2013 on “the future of pharmacy” that included two such products: Asthmapolis and GeckoCap. Each was an add-on device for existing inhalers. They were marketed as tools for improving medication adherence, and by default helpful in controlling patient’s asthma symptoms. Each had a very different approach but were both pretty cool in their own way.

    Asthmapolis is still around, as far as I can tell, but at some point, the product was rebranded as the Propeller Sensor by Propeller Health. The only reason I know this is because earlier this year the Propeller Sensor received FDA 540(k) clearance. I always thought the approach used by Asthmapolis was interesting because the product utilized crowed-sourced data to generate “Asthma risk maps” to help keep patients with asthma informed about potential hot zones in and around their area. It appears as though not much has changed. While the Propeller Health website doesn’t offer many details, a quick search of the web generated several articles that lead me to believe the mission remains the same. I’m still impressed with the Propeller Sensor and would love to see it in action sometime. It seems like it would be well suited for use by ambulatory care pharmacists.

    Propeller

    The other product, a little doohickey known as GeckoCap was a glowing “smart cap” that used a blinking light and gamification to remind patients when to use their inhalers. Data collected by the device was transmitted to a database via Bluetooth connection where family members and physicians could access it. I thought the use of gamification was rather clever, especially for kids. Parents could set goals with accompanying rewards to encourage kids to remain compliant. In this day and age, that made sense to me.

    Similar to Asthmapolis, it appears that at some point GeckoCap became CareTRx [pronounced care-tracks]. However, it doesn’t appear that the product is actively being developed at this time. The last few reviews on the Google Play Store included complaints about server issues, and those were from December 2015. Based on information at the CareTRx website, the company was acquired by Teva in September of 2015. I’m not sure what that means. I don’t know if the product is dead or alive.

     

    CareTRx

    I wonder why these products never took off? Seems like these little devices would fit right into the up and coming Internet-Of-Things era.

  • Cool technology for pharmacy – Formulary Toolkit

    Omnicell has been busy developing the IV automation and technology that they acquired from Aeysnt. Honestly, a couple of years ago I was ready to write off Aesynt’s presence in the IV room because of their tiny market share. This is when their current IV room products were still part of Health Robotics. With that said, the IV group has effectively reinvented themselves over the past couple of years and are doing some really neat stuff.

    Two developments that I’m particularly excited about are REINVENT and Formulary Toolkit (FTK). I’ve written about REINVENT several times already, most recently just 6 days ago. I’ve mentioned FTK a couple of times in passing but have never really understood what it was, until now.

    FTK

    Aesynt website: “Said John Barickman, senior executive IV pharmacist consultant at Aesynt.  “With the Formulary Toolkit, we can now offer pharmacies data and services to better leverage automation technology and enable best practices in pharmacy like beyond use dating.”… Formulary Toolkit provides cost-effective access to cGMP quality gravity and drug stability data, in combination with established robust sterility protocols and testing services, that can be utilized to extend beyond use dates for compounded sterile preparations.”

    Basically, Omnicell (previously Aesynt) has taken it upon themselves to do CSP stability testing for a select group of drugs. They do this to offer extended beyond use dating (BUD) for sterile compounds. Why would they do that? Sit back and I’ll tell you.

    The BUD for a CSP identifies the time by which the preparation – once mixed – must be used before it is at risk for chemical degradation, contamination, and permeability of the packaging. In the absence of direct sterility and stability testing evidence that supports longer BUDs, USP <797> currently states that low-risk CSPs are good at controlled room temperature for 48 hours, at cold temperature (refrigerated) for 14 days, and frozen for 45 days. For medium-risk compounds, BUDs are 30 hours, 9 days, and 45 days, respectively.

    Given appropriate stability and sterility testing, BUDs can be extended, giving a hospital the ability to plan further ahead, reduce waste, and better allocate resources. FTK takes care of the stability testing, giving pharmacies one important piece of the puzzle they need to create large batches with extended BUDs. Once extended BUDs have been established by laboratory testing, facilities have only to test batches for sterility.

    So let’s say your pharmacy services several facilities in your healthcare system and uses a ton of vancomycin 1250 mg in 250 mL D5W [Baxter bags]. According to USP <797> you can get 14 days in the refrigerator or 48 hours at room temperature. However, what if stability studies demonstrated that the same CSPs were stable for 90 days at room temperature? You would be able to make significantly larger batches. Prior to using the batch, it would need to be quarantined while sterility testing was performed, which usually takes a couple of weeks. But, when the sample returned negative results, the batch could be used for the remainder of the 90 days, effectively extending the BUD by more than four-fold. This is such an advantage for pharmacies that must prepare frequent, large batches of specific drugs.

    I don’t know what drugs have been tested for inclusion in FTK, but I’ve been told that data for several drugs in currently available and more are being added each quarter. Very cool.

  • Increased IV production means increased automation…and data

    Interesting timing on this article at Healthcare IT News: “With an eye on improving safety, increasing compliance and reducing waste, an increasing number of hospitals and health systems are looking to insource and automate their IV compounding processes… Campbell said that the transition to robotic sterile compounding has resulted in a cost savings of $100,000…At the core of the technology is Omnicell’s REINVENT – Registry for Intravenous Technology in Pharmacy – global, multi-site data registry designed to collect compounded sterile preparation data from hospitals and health systems for evaluation, analysis and insight.”

    I spent some time earlier this week speaking with Omnicell about their IV room automation and technology, including REINVENT. I’ve written about REINVENT before. Since that time, Omnicell has made big strides in connecting customers and collecting sterile compounding data.

    It is my belief that most companies in this space fail to understand the value of all the data floating around in pharmacies. There is so much untapped potential there. Few vendors have given serious consideration to how best to deal with it, much less create a product that brings value to their customers. I’m pretty stoked about what Omnicell is doing with REINVENT and hope that other vendors will follow their lead. The future of pharmacies is in the data.

  • [Article] Pharmacist-provided medication management during transition of care

    Medication management during transitions of care (TOC) has become a rather hot topic of late. The August 2016 issue of Annals of Pharmacotherapy has an article that describes the use of a dedicated inpatient TOC pharmacist to tackle the issue.(1) Seems like a no-brainer to me, but you don’t often see this in the wild.

    Here’s the abstract:

    Background: Medication management during transitions of care (TOC) impacts clinical outcomes. Published literature on TOC implementation is increasing, but data remains limited regarding the optimal role for the inpatient pharmacist, particularly in the community health setting.

    Objective: To evaluate the impact of a dedicated inpatient TOC pharmacist on re-presentations following discharge.

    Methods: This is a prospective study with historical control. All adult patients discharging home from study units were eligible. The TOC pharmacist (1) reviewed medication history and admission reconciliation, (2) met the patient/caregiver to assess barriers, (3) reviewed discharge reconciliation, (4) performed discharge education, and (5) communicated with next level of care. The primary outcome was 30 day re-presentation rate. Secondary outcomes included 60, 90, and 365 day re-presentation rates. IRB approval was obtained.

    Results: Three hundred and eighty four patients met inclusion criteria. When compared to 1,221 control patients, the intervention had an 11% absolute and 50.2% relative reduction in 30 day re-presentation rate (OR 0.43, 95% CI 0.30-0.61, NNT 9). Reductions in re-presentations at 60, 90 and 365 days remained statistically significant. Utilization avoidance was $786,347. For every $1 invested in pharmacist time, $12 was saved. The TOC pharmacist made a total of 904 interventions (mean 2.4 per patient).

    Conclusion: This study provides new information from previous studies and represents the largest study with significant and sustained reductions in re-presentations. Integrating a pharmacist into an interdisciplinary team for medication management during TOC in a community health system is beneficial for patients and financially favorable for the institution.

    Pretty impressive results. “The intervention had an 11% absolute and 50.2% relative reduction in 30 day re-presentation rate… For every $1 invested in pharmacist time, $12 was saved.” Seems like a win-win. With that said, it seems like we keep repeating ourselves over and over again. At some point, someone is going to have to quit looking for more data and simply change the way pharmacists practice.

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

  • Prescription bottle innovation

    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.

    Rxbottle

    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 19th 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.

    Adheretech

    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.

    ClearRx_bottle

    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?

  • Electronic alert overload

    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.”

    alert_overrides

    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.

  • Surface sampling for equipment used for preparing sterile HDs

    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 scope of IV room errors

    There’s an interesting article in Pharmacy Practice News this month (In the IV Room, Robots Come to the Rescue). While the title of the article is a bit misleading – I think ‘rescue’ is a bit strong – it does contain quite a bit of good information.

    The article discusses some of the technology being used at Brigham and Women’s Hospital (BWH) in Boston, and the University of California, San Francisco (UCSF) Mission Bay pharmacy. I’ve been in both pharmacies. BWH and UCSF both make extensive use of technology, but believe me when I say that they have very different approaches. Anyway, the article is worth a few minutes of your time.

    Deep in the article, the author, Rajiv Leventhal spends a few paragraphs discussing the scope of the problem in the IV room, and some of the challenges of using robotics. Rajiv acknowledges that the iv room is a dangerous place for a host of reasons.

    Regardless of the technology chosen, the need to automate IV compounding to at least some degree is hard to dispute, given the relatively high rate of errors that occur when technology is limited. In 1997, when many of the recent advances in robotics were not available, the error rate for IV compounding was 9%—or one mistake in every 11 medications coming out of the IV room.

    As for the main cases [sic] of those errors, many factors have been identified, including sterility and other drug safety issues, according to a safety alert released last year by the Institute for Safe Medication Practices. The alert identified five core causes: 1) depreciating importance of the compounding and dispensing processes in pharmacy practice; 2) lack of knowledge and standardization around best practices; 3) training based on traditions handed down from one pharmacist to the next; 4) learned workplace tolerance of risk and routine practice deviations that persist; and 5) a reluctance to learn from the mistakes of others.

    It seems intuitively obvious that the use of technologies like iv workflow management software, barcode scanning, gravimetrics, imaging, and even robotics can potentially decrease errors described in the article referenced above (Am J Health Syst Pharm1997;54[8]:904-912 ). However, of the causes identified in the second paragraph, only #2 can really be addressed with the use of technology alone. The rest of the items listed are symptoms of a deep-seeded problem growing in pharmacies today, and that is the failure to understand the need for our profession to provide patients with medications in the most efficient, safe, and economical way possible. Sounds ridiculous, I know, but it’s true nonetheless.

    Most (all?) pharmacies I visit these days tout initiatives to improve patient care through increased ‘clinical activities’ of pharmacists, including electronic chart review, ADE follow-up, rounding with the medical team, monitoring and adjusting medications, antibiotic stewardship, and so on. However, I rarely, if ever hear directors talk about efforts to improve operations through streamlined processes, automation and technology, standardization, and heaven forbid, increased use of technicians and non-pharmacist personnel.

    Examples of this can be found within open job listings at various healthcare systems. Recently I visited an acute care pharmacy with a large budget for several open ‘clinical pharmacist’s positions’ but no budget for improving operations or automating processes. In this particular case, a fraction of the money being allocated for open clinical pharmacist positions could be used to make significant improvements to the medication distribution process.

    It’s an interesting dilemma for pharmacy directors. While spending tens of thousands of dollars on automation and technology to improve operations may not seem sexy, it goes without saying that a vast majority of care for a hospitalized patient involves getting the right drug at the right time. A majority of that falls to nursing staff, but the pharmacy owns a piece of the medication distribution/administration process. Nurses can’t administer medications if they’re not readily available, or wrong.

    Regardless of what direction the profession wants to go, it is important that we understand that pharmacy is, at this time, tied to distribution. We must find ways to extricate ourselves from the medication distribution process first before we can begin to truly realize the benefits of pharmacists in patient care. Each time an error occurs for lack of focus, training, or sheer disinterest, the profession suffers. Preventable medication errors involving the pharmacy causes both the public and other healthcare practitioners to lose trust in our ability to get the job done. It’s difficult to recover from lack of trust. Think about it.

  • JerryFahrni.com Podcast | Episode 12: Pharmacy IV room discussion with Ray Vrabel, PharmD

    Show Notes:
    Host: Jerry Fahnri, Pharm.D.

    Jerry and Ray talk about the pharmacy IV room, specifically where we’ve been, where we’re at, and where we’re headed. Topics include workflow, the impact of USP <797> on pharmacy iv room operations, and thoughts on currently available iv workflow management system technologies.

    You can learn more about Ray at his LinkedIn Profile here.

    Items discussed in podcast:
    Current setup:
    Blue Microphones Yeti USB Microphone – Blackout Edition
    Dragonpad Pop Filter
    Sony MDR-V150 Headphones

  • Frequency of and risk factors for med errors during order verification

    error

    A friend and colleague of mine and I were talking about pharmacy order verification and errors the other day.

    Many (all?) acute care pharmacies use the number of orders entered/verified by pharmacists per unit of time as a performance metric. The theory being that the more orders you verify the busier you are and therefore the more work you do. Sounds logical. And it is. And it also isn’t. It is because more orders typically equates to a heavier patient load and/or sicker patients, which in turn results in more work. It isn’t because some orders – and the associated distribution of medications associated with those orders – are significantly more complex than others. Chemotherapy is a good example of this. The amount of work required to verify and dispense your average chemotherapy order is several orders of magnitude greater than an order for, oh I don’t know, a saline-lock.

    So in theory, a pharmacist verifying more chemotherapy will certainly have lower numbers than a pharmacist verifying routine medication orders. However, when evaluating the number of orders verified over an entire year, one would expect the number of complicated orders handled per pharmacist to average out over the long haul. That’s not complicated math, just common sense.

    Assuming that every pharmacist is on equal footing, and that the number of orders verified is a reasonable performance metric, what then is a reasonable number of orders to be verified per hour, per shift, or per year to be considered good, bad, or average? It’s impossible to say. One would think that the higher the number the better the productivity. Here’s the thing, during periods of high volume order verification, pharmacists make more mistakes. Not just mathematically more, i.e. 1% of 300 is more than 1% of 200, but a higher percentage of mistakes.

    From a blog post at the American Pharmacist Association (APhA) website: “the number of medication errors increased with the number of orders verified per pharmacist per shift” … According to the findings, the verification of more than 400 orders per shift per pharmacist was associated with the highest risk of errors…“Once we got to the 400 mark, meaning 400 orders verified per pharmacist, [we] started to reach a higher number of errors,” said Christy Gorbach, PharmD, coauthor of the study“. The study referred to in the APhA post is this one.

    So it would appear on the surface that using volume of orders verified as a performance metric is actually driving pharmacists to make more mistakes, thus leading to less productivity, not more. (1)

    With the increased adoption of EHRs, the number of orders verified per pharmacist is only going to grow. EHRs have made order entry quick and easy. Physicians create lists – favorites, order sets, etc. – that allow them to simply check a box and put patients on multiple medications in a matter of seconds. This is especially true for what I refer to as “don’t-call-me” orders. Don’t-call-me orders consist of multiple PRN medications to cover everything from fever to constipation; all designed to prevent the physician from receiving a phone call at 3 o’clock in the morning, i.e. don’t call me. Most of these orders go unused and simply complicate the medication profile and medication administration record.(2) Verifying such a large number of redundant, benign orders creates alert fatigue and selective blindness which ultimately leads to something important getting missed.

    All in all, the results are increased verification numbers, more work, and as it turns out, more errors. Unfortunately, I have no answer to the problem. And make no mistake, it is a problem. Orders have to get verified and released, and patients must receive their medications in a timely manner. With that said, safety must also be a top priority. Medication errors are unacceptable.

    Overall, it appears that using volume of orders verified by a pharmacist as a performance metric is a bad idea. I think it’s time to slow down, pay attention, and create an environment that rewards pharmacists for the quality of their work, not for the speed at which they perform it.

    ———————————————————–

    1. Medication errors can lead to all kinds of problems, among them wasted time.
    2. All the pharmacists reading this are shaking their head and grinning because they know exactly what I’m talking about. What pharmacist hasn’t seen a post-op C-section order with 15 to 20 PRN medication orders, including half a dozen different pain meds that never get used? It happens all the time.