Jerry Fahrni

Category: Pharmacy Practice

  • Webinar alert – The Missing Link: Practical Tips for Preparing for USP 800

    I mentioned previously that USP General Chapter <800> – Hazardous Drugs—Handling in Healthcare Settings has been approved and will be published February 1, 2016. Thankfully, the Compounding Expert Committee approved a delayed official implementation until July 1, 2018. Obviously, the committee felt that enforcing Chapter <800> sooner would create a hardship on systems that aren’t close to being ready and need the added time to make changes.

    There is going to be a lot of confusion around USP <800>, and for that reason, I will be proactively learning about its impact on healthcare systems and how it differs from the current version of USP <797>.

    First up on my learn-about-USP<800> list for 2016 is a webinar – The Missing Link: Practical Tips for Preparing for USP 800 – sponsored by Pharmacy OneSource. According to the webinar site: “In this webinar, Patricia C. Kienle, RPh, MPA, FASHP and Eric S. Kastango, MBA, BSPharm, FASHP will provide practical tips to assure compliance with upcoming USP Chapter 800 Hazardous Drugs: Handling in Healthcare Settings. Facilities, PPE, personnel training, and environmental monitoring will be discussed. The link between USP Chapters 795, 797, and 800 will be explained.”  Patricia and Eric are both leading experts in this field and typically have great insight into sterile compounding regulation. It’s definitely worth an hour of your time.

    The webinar is scheduled for on Wednesday, January 13.

    You can get more information on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings to be Published in USP 39–NF 34, First Supplement here.

  • Is nearly universal prospective order review (NUPOR) really necessary?

    Several years ago there was a group of pharmacists taking a serious look at the long-time practice of having pharmacists review virtually all drug orders, sometimes referred to as nearly universal prospective order review (NUPOR). The argument for NUPOR is that it is needed to ensure complete, accurate orders. The argument against NUPOR is that it’s expensive, time-consuming, and unnecessary in many instances. I fall into the latter category of pharmacists, i.e. NUPOR is an antiquated practice that needs to be done away with.

    There are those that argue that doing away with NUPOR is dangerous and removes the pharmacist from the medication use process. Nothing could be further from the truth. By making NUPOR a requirement you have taken pharmacists out of the healthcare discussion. NUPOR forces pharmacists to be tied to a terminal when they could be doing other things. 

    The introduction of Electronic Health Records (EHRs) and Computerized Provider Order Entry (CPOE) have created a perfect opportunity to change the concept of NUPOR.

    Here are some scenarios to think about:

    1. Setting, a large acute care hospital with a busy Emergency Department (ED). Physicians frequently order boluses of NS, or other fluid. Does a 1L bolus of NS ordered for an adult patient in the ED really require verification by a pharmacist prior to administration? Ask yourself, as a pharmacist, what set of circumstances would cause you to reject such an order and call the physician?
    2. Setting, hospital OB-GYN unit. Adult patient comes in for delivery. Physician orders 50 mg of IV meperidine x1 for pain. The patient is in good health, labs are normal, and has no allergies to the medication. Is there any reason that such an order needs verification? What would cause you to reject it and call the physician?
    3. Setting, general medicine floor of a hospital. Elderly patient admitted following a minor surgical procedure. The patient is experiencing constipation secondary to the procedure and medication for pain. Physician orders a bisacodyl suppository or MOM x1 to help get things moving. Labs are ok, the patient has no allergies to the medication, and there are no significant drug interactions. Is there any reason that such an order would require a pharmacist’s blessing?

    The list goes on and on. I suppose one could argue that there could be potential for a physician to blow through a catastrophic problem with the drug order that would harm the patient. Sure, that could happen. However, I would argue that a good system would allow the healthcare system to place hard stops in places where there is genuine concern or potential for a problem.

    I just don’t see NUPOR as necessary in today’s healthcare environment, especially for those healthcare systems using EHRs and CPOE. Don’t agree? That’s cool. Use the comment section below to convince me I’m wrong, but make sure you have a good reason, because if you don’t, I’ll mock you in front of the other children. 

  • Witnessing errors in the iv room

    I spent a short time observing iv preparation in two separate, distinctly different pharmacy environments in the weeks leading up to the new year.

    One was a traditional iv room in a large acute care pharmacy with multiple pharmacy technicians and pharmacists putting out hundreds of compounded sterile preparations (CSPs) per day. The second was a segregated compounding area in a satellite pharmacy with one pharmacy technician and one pharmacist using a glove box to prepare STAT and first dose CSPs to critical care areas.

    Syringe pull-back method

    Neither area utilized technology for CSP preparation, instead opting for the good ole fashioned syringe pull-back method (1). In the case of the traditional iv room, I observed instances of up to twenty different CSPs with empty vials and syringes laid out awaiting pharmacist verification. In the segregated compounding area with glove box, CSPs were typically prepared one at a time or in small batches.

    During my short time observing CSP preparation in the two areas I witnessed errors that would have easily been caught with the use of readily available technology.  Here are two examples:

    Wrong drug selection – This may be the most common error seen in iv rooms. In this particular case, the technician used a vial of potassium phosphate (KPhos) for a CSP that called for sodium phosphate (NaPhos). The use of bar code scanning for verification during the compounding process would have prevented this error.

    Calculation error resulting in an incorrect dilution – A patient-specific order called for 20 mg of hydrocortisone in a total volume of 2 mL to be placed in a syringe for iv administration. The technician started by first making a stock hydrocortisone syringe from which to draw the dose. This is a common practice. The resulting stock syringe should have contained 100 mg of hydrocortisone in 10 mL of solution, i.e. final concentration of 10 mg/mL. Instead, the technician calculated the final volume as 25 mL, resulting in a final concentration of 4 mg/mL in the stock syringe. So when the patient-specific dose of 2 mL was drawn into the syringe the final dose was only 8 mg. The pharmacist almost let it go, but something made him take a second look. It was only when he asked the technician to explain the process that the error was discovered. The use of bar code scanning for verification during the compounding process would not have prevented this error. But, the use of step-by-step instructions with intermediary step checks during the stock syringe prep, or the use of gravimetrics, would have.

    The number of CSPs prepared in iv rooms daily in the United States is unknown, at least to me, but has to be somewhere in the neighborhood of a million. (2) Combine that with published literature that puts sterile compounding errors around 11%, (3) and that’s some scary stuff. With numbers like these, I wonder how many mistakes make their way to the patient?

    The iv room is a busy place with a lot of dangerous medications. It’s also a place where a lot of errors occur.  With the availability of commercially available products that can easily prevent these types of errors, there’s really no excuse for continuing to use a completely manual process.

    ———————

    (1) Syringe pull-back method is when the empty syringe used for each drug or electrolyte is left alongside the item with its plunger pulled back to the volume that was added. The pharmacist looks at the empty syringe with plunger pulled back and compares volume to the volume necessary to accurately prepare the CSP. This is common practice in many pharmacies even though it has been declared unsafe. I continue to be surprised that pharmacies use the syringe pull-back method.

    (2) Using a number of 1.5 CSPs per patient, per day in acute care hospitals, and using 795,603 licensed Community Hospital beds in the United States (1999 – 2013 AHA Annual Survey, Copyright 2015 by Health Forum, LLC, an affiliate of the American Hospital Association), the number of CSPs produced per day in the United States exceeds 1 Million.

    (3) Am J Hosp Pharm 1997;54:904-912

  • USP General Chapter <800> has been approved

    I’m sure that most of you are aware, but just in case, I thought I would pass this little tidbit along.

    The Compounding Expert Committee announced on November 20, 2015, that USP has approved a new General Chapter USP <800> – Hazardous Drugs—Handling in Healthcare Settings. The revised chapter will be published February 1, 2016, in the first supplement to USP 39-NF 34. USP standards typically become official 6 months after publication, but the Expert Committee approved a delayed official implementation date of July 1, 2018 to prevent any undue hardship on systems that need to make major changes.

    You can get more information on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings to be Published in USP 39–NF 34, First Supplement here.

    Good luck, people.

  • Prepping for #ASHPMidyear15

    Tomorrow morning I’ll catch a flight from LAX to New Orleans for the 50th ASHP Midyear Clinical Meeting and Exhibition. The annual ASHP Midyear Meeting is the largest gathering of pharmacists in the country. Over a period of five days, more than 20,000 pharmacists from all over the world will gather to discuss everything from new approaches to therapy, to trending topics like IoT, wearables, and new technologies. It’s a great opportunity to learn a great many things.

    Over the years, my focus at the Midyear Meeting has changed. When I was a practicing clinician, I spent all my time in sessions trying to pick up every last little clinical crumb. However, I’ve become less interested in clinical content and more interested in pharmacy operations and technology. As a result, I attend fewer and fewer educational sessions each year, instead opting for more time in the exhibit hall. That trend will continue this year. I will slowly wind my way through the exhibit hall evaluating products, looking for new technologies, and sniffing out new practice trends. I will attend a few sessions on topics covering things like USP <797> and USP <800>, automation and technology, practice changes, etc., and I will be following up with all the companies covered in In The Clean Room to see if there have been any significant changes from a year ago, but for the most part the exhibit hall will be my primary focus.

    I will do my best over the next several days to keep you up to date as to what I’ve seen and my thoughts on anything “new”.

    Some links of interest:

    • ASHP Midyear
    • Exhibit Hall layout
    • Midday Symposia – There are some good CE opportunities here.
    • Cardinal Health educational programs – I mention this here because there are two programs that I’m interested in attending: 1) Hazardous Drugs: USP, NIOSH, and OSHA Oh, My! on Tuesday, December 8 at 3:00 – 5:00 PM; and 2) Preparing for USP Chapter <800> Now is the time to get ready on Wednesday, December 9, at 11:30 AM – 1:00 PM.

  • Medication non-adherence, is more technology the proper response?

    EMR & EHR: “Of all the things that irrationally inflate health costs, one of the top concerns is people who just don’t take their prescribed medications. Medication adherence doesn’t sound like a high-tech issue, but a lot of interesting technologies are being thrown at the problem…. At the recent Connected Health Conference I talked to several companies taking on the difficult adherence problem from different angles. Medisafe aids patients in self-monitoring, Insightfil creates convenient packaging that groups pills the ways patients take them, and Dose doles out medication at prescribed times.”  – The author goes on to describe some of the technology. The content is worth a few minutes of your time.

    Here’s the thing, technology may not be the solution.

     

    There’s no question that medication adherence is a problem. How big is the problem? Well, according to an article in The American Journal of Medicine, 28% of new prescriptions never get filled, and among patients who do fill their prescriptions,  adherence rates are less than 50%. The New England Healthcare Institute NEHI in 2009 [PDF] estimated that the cost of non-adherence was about $290 billion annually. It’s probably well over $300 billion now, but the number I see in most presentations is $290 billion. Hey, it’s a good, scary number.

    Medication adherence, or non-adherence as the case may be, not only complicates things for patients but for the entire healthcare system.

    The problem is well defined, i.e. people aren’t taking their medications properly, but the solution has eluded healthcare for a long time. That’s likely because the reasons for non-adherence vary widely and have been debated and discussed as long as I’ve been a pharmacist. Have we made progress? It’s hard to say. I suppose it all depends on your definition of progress. We have lots of medication adherence tools at our disposal; reminder systems, mobile applications, smart medication organizers, alert systems for medication bottles, and so on. I suppose that could be considered progress.

    All these toys have a place in medication adherence, but the fundamental problem goes well beyond their scope. Medication adherence is a multi-faceted problem with roots in psychological behavior, socioeconomic background, and demographics.

    However, one thing that people seem to overlook is that the contact point for most patients and their medications is a pharmacist. According to a recent report published by the National Community Pharmacy Association (NCPA), “the biggest predictor of medication adherence was patients’ personal connection (or lack thereof) with a pharmacist or pharmacy staff.”

    A patient’s introduction to medication use should begin by developing a relationship with a pharmacist at the point of care, whether that’s a hospital or a community pharmacy. In hospitals, patients should speak with a pharmacist upon admission, and again upon discharge. No patient should ever leave the hospital without speaking to a pharmacist or without medications in hand.

    This is an oft-overlooked opportunity within healthcare systems. For hospitals that don’t have the resources to speak with every incoming and outgoing patient, look to your local community pharmacies. Find community pharmacies in the area that are willing to partner with the healthcare system to provide bedside medication delivery and consultation, thus beginning the process of building a working relationship between patient and pharmacist. As the patient moves from the hospital back into their daily routine, the relationship with their pharmacist will continue to grow. The payoffs are huge, especially for those patients with chronic diseases like diabetes, asthma, hypertension, hypercholesterolemia, and so on.

    Not all patients are willing or able to be compliant, but some are, and those are the ones we hope to reach. Using a cost for non-adherence of $300 billion annually, a conservative positive impact of 10% could add up to more than #30 billion a year in savings, not to mention the positive impact on a patient’s quality of life.

    Bottom line, get a pharmacist involved early and often. Medication adherence, it’s what we do.

  • Where to get information on compounding sterile preparations

    Someone asked me the other day where they could read up on what’s going on in the world of pharmacy sterile compounding. It’s a good question. The simple answer is to get your hands on a copy of the USP Compounding Compendium and read it over and over again. That’s where I started. Unfortunately, that will make you about $150 lighter in the wallet. Not to mention that it’s not the most entertaining of documents.

    ASHP offers several training courses that include written material as well as video. I’ve gone through many of them myself. They’re good, but expensive. You can see a list of them here.

    ASHP also offers a Sterile Compounding Resource Center. Lots of good content there, especially in the Policies, Best Practices, and Guidelines section. Some of the material may require you to be an active ASHP member, but I believe some (much?) of the content is free.

    I’ve found Pharmacy Practice News and Pharmacy Purchasing & Products to have lots of good, timely content pertaining to sterile compounding. The best part about these two publications is that they provide free access after a one-time registration process.

    If you’re just looking for general reading material, a Google search for sterile compounding, compounded sterile preparations (CSPs), primary engineering controls, beyond-use dating (BUD), USP <797>, or pharmacy compounding will give you more than you can handle.

    Anyone else have any recommendations for where to find information on sterile compounding? If you do, feel free to leave a comment below.

  • Major differences between proposed USP Chapter 800 and current USP Chapter 797

    USP <800> is still in draft form. The official date of the chapter has not yet been determined and is dependent on several factors, but expect it to become official some time in mid to late 2016. And while USP <797> is in the process of being updated, the current version is still the one everyone has to live with.

    Information contained in USP <800> is in addition to information found in USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations and USP Chapter <795>  Pharmaceutical Compounding – Nonsterile Preparations.

    In its current iteration, USP <797> and USP <800> requirements for hazardous drugs (HDs) differ.  However, HD compounding in the upcoming revision to <797> will be harmonized with Chapter <800>. Actually, it looks like USP will simply defer all HD compounding to USP <800>, which makes sense.

    Until all the USP Chapters are on the same page, here are some highlighted differences between Chapters <800> and <797>:

    • Requirement of compounding supervisor
    • Applies to sterile as well as non-sterile compounding
    • No longer allowed to store, unpack, or manipulate HDs in positive pressure areas
    • Elimination of exemption that allowed low volumes of HDs to be compounded in a non-negative pressure room. All quantities of HDs must be compounded in a separate, negative pressure room
    • C-SCAs may be used to compound low- and medium-risk HDs
    • CSTDs are recommended for compounding and required for administration

    Perhaps the greatest impact will come from elimination of the current USP <797> exemption for small volumes of HDs to be compounded in a positive pressure room. USP <800> handles this by allowing low- and medium-risk HDs to be compounded in a containment segregated compounding area (C-SCA). C-SCA is a new concept, and is defined as “a separate, negative pressure room with at least 12 air changes per hour (ACPH) for use when compounding HDs. Low- and medium-risk HD compounded sterile preparation (CSP) may be prepared in a BSC or compounding aseptic containment isolator (CACI) located in a C-SCA, provided the beyond-use date of the CSP does not exceed 12 hours“.

  • Initial reaction to FDA stance on syringes as standalone storage container

    This morning I woke to the news that No Syringe Is Approved as a Standalone Storage Container, FDA Says. This I’m sure is in response to the recent issue with BD syringes and drug stability. I need to think about this more, but my gut reaction is that this is huge and will have a significant impact on many acute care pharmacy practices across the country.

    There are three factors to consider when making and dispensing compounded sterile products (CSPs): accuracy, sterility, and stability.

    Accuracy. Self-explanatory. When you make a CSP you want it to be as accurate as possible. This is where I believe automation and technology come into the equation. My thoughts on the subject can be found in many essays/articles published on this site.

    Sterility is covered ad nauseam by USP General Chapter <797>. CSPs should be free of microbial contamination. This, of course, is for the safety of patients receiving treatment with CSPs. If you have any questions regarding how long something can be stored following compounding, and still be considered “sterile” then you should look no further than the beyond-use dating (BUD) guidelines found in <797>.

    Stability. When you store something in a container, i.e. a syringe, bag, bottle, etc. you want the drug to remain active for as long as necessary to administer to the patient. We know that some drugs are sensitive to light, temperature, type of storage device, etc. However, pharmacy has long used syringes as a method of distribution, and as long as the drug was considered unaffected by light and temperature, not much consideration was given to stability.(1) This is a holdover from the days when we, i.e. pharmacy used to draw everything up in glass syringes. Glass was an awesome storage medium, but we didn’t really change out practice when glass syringes became too expensive to be practical and we went to plastic. While addressed in USP General Chapter <797>, stability is not given the same detailed coverage as sterility. USP <797> was never meant to address stability in great detail.

    Recently I’ve seen an upward trend in pre-drawn syringes. I’ve spent the better part of the last three months immerging myself in what goes on with medication distribution and use in the O.R. That is to say I’ve been educating myself on processes and paradigms of how anesthesiologists and pharmacy work together to ensure safe, accurate and responsible medication use during surgery.

    One of the major trends I found in O.R.’s was the use of pre-drawn syringes. Pharmacy likes them because it gives them more control over drug usage and waste, and anesthesiologists like them because they don’t have to draw medications from vials prior to administration. Anesthesiologists are more concerned with monitoring the patient then they are with having to deal with medication labeling, etc.; and rightly so.

    This desire to supply anesthesiologists with pre-drawn syringes has created an interesting side effect in CSP automation – there is a renewed interested in CSP robots in the clean room. Robots are good at batch production. Pulling several hundred syringes filled with the same drug is an ideal use for a compounding robot.

    This of course, doesn’t include pediatric facilities that use pre-drawn syringes to stock their shelves to meet the needs of their patient population. I remember when I was a pediatric pharmacist back in the early 2000’s. We pulled thousands of syringes each and every day to replenish stock not only on our shelves in the pharmacy, but to place in ADCs for easy access to medication for nurses and physicians.

    Some pharmacies will use third party vendors like PharMEDium for their pre-drawn syringes. I bet companies like PharMEDium already have data on the stability of drugs stored in syringes. Will they share this information with the rest of the pharmacy world? My gut reaction is that they won’t. By sharing  information they’re basically cannibalizing their own sales. What’s this do for them? Uptake of customers and bigger sales in the immediate future. It’ll be interesting to see how they handle it. Not to mention potential liability snafus.

    Like I mentioned above, I need to think on this more deeply. However, at this moment I’m thinking that the FDA’s stance on syringes as stand-alone storage devices is going to create a lot of headaches for pharmacies across the country over the next several weeks. It’ll be interesting to see how organizations like ISMP, ASHP, USP, etc. respond to the FDA’s statement.

    Grab some popcorn folks, this should be good.

    ——-

    1. There’s much more to this statement, but for the sake of brevity let’s just leave it at that.

  • USP soliciting comments for proposed changes to Chapter <797> Pharmaceutical Compounding—Sterile Preparations

    The USP Compounding Expert Committee has published a Notice of Intent to Revise for General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.

    I knew this was coming. I’ve talked to several people this year that indicated that revisions to Chapter <797> were imminent, especially with the introduction of USP <800> Hazardous Drugs—Handling in Healthcare Settings.

    According the USP notice:

    The General Chapter has been under review since 2010 and has been significantly revised to clarify requirements, and reflect stakeholder feedback and learnings since the last revision became official in 2008.

    Major revisions of the General Chapter include:

    1. Reorganization of existing sections and placement of procedural information in boxes
    2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.
    3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings
    4. Introduction of the terminology “in-use time” to refer to the time before which a conventionally manufactured product used to make a CSP must be used after it has been opened or punctured, or a CSP must be used after it has been opened or punctured.

    Items #2 and #3 are significant.

    Most hospitals do not currently make CSPs that fall into the microbial high-risk category. Altering these categories could have significant impact on acute care pharmacies.

    The introduction of USP Chapter <800> Hazardous Drugs – Handling in Healthcare Settings will make any mention of hazardous drugs in the current Chapter <797> obsolete. I suspect that the Compounding Expert Committee will likely remove management of hazardous drugs from Chapter <797> and simply defer to USP <800>, which has yet to be published in anything other than draft form.

    I will be spending the next week or so going through the proposed changes to better understand what the USP Committee is thinking. Remember, these revisions aren’t final.

    Revisions to General Chapter <797> will be published for public comment in Pharmacopeial Forum (PF) 41(6) [Nov.–Dec. 2015] on November 2, 2015. You can view the proposed revisions with line numbers in advance of publication here [PDF].