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>Â 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“.
Jerry talks about the problem with storing medications in plastic syringes and potency loss. Recently the FDA notified ASHP that no plastic syringe is approved for use as a final storage device. Jerry discusses the issue and how it will impact pharmacies in the near future.
“Those who cannot change their minds cannot change anything.†― George Bernard Shaw …you people know who you are.
So much happens each and every week, and it’s hard to keep up sometimes. Here are some of the tabs that are open in my browser this morning along with some random thoughts…
As predicted, The Martian was #1 at the box office last weekend, pulling in a just over $54 million in its opening weekend. It’s a good movie. Highly recommended. I expect The Martian to hold the #1 spot for a bit longer. Who’s going to challenge it, Pan?
Speaking of movies, my younger brother came up to Fresno last Sunday and took me to see Everest. The movie recreates one of the worst climbing disasters in history. I don’t usually go in for movies like that, but Everest was really quite good. Another film I would recommend.
I’ve always been a drip coffee guy, probably because that’s how I got started drinking coffee. I’ve tried various methods – pour overs, coffee press, running by Dutch Brothers twice a day – but I always come back to drip. Recently my tried and true Mr. Coffee Coffeemaker took a turn for the worst and I had to replace it. Instead of simply getting another Mr. Coffee, I wanted to try something different. I did a little online research and finally decided on a Bonavita 8-Cup Original Coffee Brewer. While the Bonavita is still makes coffee via “drip”, the water comes down onto the grounds in a sort of showerhead fashion, and the “pot†is a carafe that keeps the coffee warm for several hours. There is no warmer under the carafe. It works very well. I’m quite satisfied with the coffee it brews. The only thing that’s a bit of a bummer is that you can’t pull the carafe out before it’s finished brewing when you just can’t wait five minutes for it to finish. I used to grab the carafe on my old Mr. Coffee as soon as I had enough black gold to warrant a cup. The price we pay for good coffee.
Microsoft had an epic event this week in New York. The company introduced some of the most exciting new products that I’ve seen in years. The company took their already class-leading line of Surface machines and introduced the new and improved Surface Pro 4. The Surface Pro 4 has updated internals, a slightly larger display, improved pen technology with a better inking experience, and a better detachable keyboard. And the best thing of all is that you can custom configure the device to your liking at the Microsoft Surface site. But that’s not all. Microsoft also introduced what I think is the most innovative piece of hardware that’s come along in a while, the Surface Book. The Surface Book offers a crazy new design, making it both a complete laptop and a full-fledged tablet. It also gives users the ability to configure the Surface Book to rival any 13-inch high-end laptop on the market. It’s what a modern ultrabook-tablet should be. Surface Book is quite literally my idea of the perfect machine torn from my brain and turned into reality. It’s the most excited I think I’ve ever been for a piece of new consumer technology. It’s beautiful, and I must have one.
Here’s an interesting website: http://easypcpicker.com/. “Easy PC Picker exists to simplify the process of buying a new computer. We ask you three simple questions (price, operating system, and features) and then provide a recommendation hand-picked by our staff of experts.†I played with it a little bit. It’s not perfect, but it kicks out some solid choices for anyone looking for a new machine.
Who would have thought that Velcro could be dangerous? I’ve managed to get a few nicks and cuts on my hands from unstrapping and re-strapping my leg brace several hundred times over the past few weeks. I’m theorizing that the little hooks on one side of the Velcro strap are able to grab tiny pieces of skin that are loose. And when they grab hold, they don’t let go.
Speaking of Velcro, it “is the brainchild of Georges de Mestral, a Swiss engineer who, in 1941 went for a walk in the woods and wondered if the burrs that clung to his trousers — and dog — could be turned into something useful. After nearly eight years of research (apparently it’s not so easy to make a synthetic burr), de Mestral successfully reproduced the natural attachment with two strips of fabric, one with thousands of tiny hooks and another with thousands of tiny loops. He named his invention Velcro, a combination of the words “velvet” and “crochet,” and formally patented it in 1955. Though the first Velcro was made out of cotton, de Mestral soon discovered that nylon worked best because it didn’t wear with use.†And the moral of the story? Take time to go for a walk in the woods. (source: Time)
Have I ever told you how awesome 3D printing is? There’s a lab at the University of California San Francisco (UCSF) –  <cough>… my alma mater – that’s using living cells as the substrate to 3D print human tissue. “Zev Gartner, PhD, has focused on the next best thing: His lab is building fully functioning 3-D human tissue, cell by cell. It sounds straight out of a Frankenstein novel, but Gartner is working to grow the milk-producing tissues of the human breast to create a living, working model of the human mammary gland that grows, ages and responds to hormone signals just like the real thing. This means growing the ducts, arteries and connective tissue in the same environment.†Crazy.
How long before we all have 3D printers in our houses to print everything from our breakfast cereal to a new spray nozzle for our hose? It’s not as far off as one would think. It could even happen before I decide to checkout for good.
This week the FDA told ASHP that it has “not cleared or approved any syringes for stand-alone use as ‘closed container systems.’†Oh boy, that’s a biggie. You can read my initial thoughts about the announcement here, but I think it’s going to cause some problems for pharmacies.
Variety: “Consumers are now using mobile phones more often to search Google than desktop PCs…“We are getting over 100 billion searches every month,†Singhal said. Mobile overtook the desktop as the number one source of traffic this summer, he said.†– I talked about this a few years ago during a presentation I gave at a SoCal HIMSS Meeting. Those things in your pocket aren’t phones, they’re computers. My thought is that there has to be a way for pharmacy to leverage that knowledge to improve patient care. Really hasn’t happened yet.
You really should stop whining about your commute. Take a look at what happens when people return from vacation in China. Dude, that’s some traffic right there.
And just like that the Cardinals broke my heart. I said last week that the Rams defense was good, and they gave Palmer fits all afternoon. The Cardinals play the Lions tomorrow. I think it’s a winnable game, but the Lions have nothing to lose, which makes them dangerous. Expect the Cardinals secondary to have their hands full with the Lions long-ball.
Ugh, the Bruins took one in the shorts last Saturday night. Hats off to Arizona State, they punched UCLA in the throat. No game for the boys in baby blue this weekend. Good thing, as they have Stanford up next on the schedule. They’ve had trouble with the Stanford running attack and defense over the past few years. Fingers crossed.
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:
Reorganization of existing sections and placement of procedural information in boxes
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.
Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings
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].
The Vaccine Smart-Fridge is an interesting concept for ambulatory care. It appears to be a consignment vaccine distribution system. Reminds me of a refrigerated single-point automated dispensing cabinet (ADC).
There’s a lot to like here.
By using a consignment model, the vendor offers an ambulatory care clinic low cost, low risk access to vaccines. It also decreases the chance of something sitting in the cabinet beyond it expiration date, or going bad because the temperature is out of range. The company supplying the items has a vested interested in making sure that everything inside those refrigerators is ready for use, and that waste is kept to a minimum.
I believe that the consignment model for pharmaceuticals will only continue to grow. The largest budget item in many pharmacy is inventory, by a wide margin. Refrigerated medications seem to be the main target for consignment, but it’s possible that the model could creep into other spaces as well, especially with the introduction of biosimilars.
The system provides real-time alerts on inventory shortages and temperature. Automated temperature monitoring ensures that things stay within their appropriate temperature range. Heat is bad for lots of medications, especially vaccines. This information can be viewed from a computer or mobile device. I like that it’s proactive.
Single-item access is a great concept for an ADC. This style of distribution is frequently used for controlled substances – morphine, fentanyl, etc. It provides better security than open access trays, drawers, and bays, thus minimizing opportunity for diversion. Does it make sense for everything? No, not really, but in this case it fits.
The system provides access to real time analytics and historical dispensing data. This information could be linked to other systems for easy access to vaccination records.
Pharmaceutical refrigeration is in need of a little disruption, so when I see something like this I’m encouraged that someone is thinking about it. There’s nothing new about this technology, but it does provide a new paradigm to think about.
A little more than a week ago the most recent ASHP Section of Pharmacy Practice Managers Chair’s Message(1) landed in my inbox. I don’t typically read these messages carefully as they’re mostly full of the same old rhetoric. However, this particular message caught my attention because it included information on the ASHP Section of Pharmacy Practice Managers new strategic plan for 2015-2016.
According to the email:
“…the Executive Committee recently completed an extensive update to the Section’s strategic plan, which is now available on the Section webpage. Our intent was to set a structure that would help us continually remain focused on the most important needs of practice managers. We have worked to carefully align the Sections plan with the overall ASHP Strategic Plan. This alignment eliminated the need for separate Section goals, which greatly streamlined the plan. We also identified critical areas for practice managers. The critical areas identified for 2015-16 are:
Leadership Development
Innovation Management
Management of the Pharmacy Enterprise
Patient Care Quality
Multi-Hospital Health System Pharmacy Executives”
These are all great areas of focus.
Much more detail can be found the actual strategic plan document, which can be found here. I read through the document, much of which is what you’d expect, but there are some interesting items in the strategic priorities and goals section. Three bullet points caught my attention: 1) Expand pharmacy practice in ambulatory clinics and other primary pharmacy care settings, 2) Produce an Innovative and Timely Professional Journal, Website, Drug Information Compendium, and Other Publications that Meet the Needs of Members and Other Customers, 3) Improve the Discoverability of ASHP Digital Content Assets.
Expand pharmacy practice in ambulatory clinics – There was a time when I thought all pharmacists should practice in a hospital setting, but my views on that have slowly changed over the years. The most appropriate time for pharmacists to have a meaningful impact on patient care is before they’re hospitalized, i.e. in the ambulatory care environment. We are the medication experts, and nowhere is there more inappropriate medication use than in the outpatient setting. I think it is wise for pharmacy managers to spend more time focused on this practice area.
Produce innovative and timely information – Times have changed. The amount of readily available information is growing at an exponential pace. Unfortunately not all information is reliable. ASHP has made only small strides in the past several years in improving speed and access to information. Information affecting practice areas like operations, management, and technology should be made available at breakneck speed as it does not require the same rigorous vetting that clinical information does. It is no longer acceptable to wait a year for someone to present their findings at ASHP Midyear, or for AJHP to take months to publish something that is relevant now.
Improve discoverability of ASHP digital content – This would be a welcome change. ASHP has created a mountain of valuable information, but it’s scattered and difficult to find, cross reference, etc. I could go on and on about this, but suffice it to say I would love to see an improved content management style.
Let’s hope that Dr. Hoffman is able to make good on his promises. I’m going to hold him to his word.
——
The ASHP Section of Pharmacy Practice Managers new chair is James M. Hoffman, Pharm.D., M.S., BCPS, FASHP. With all those initials after his name he must be good.
Pondering the need for an IV workflow management system (IVWMS)? You’re not alone if you are. According the most recent PP&P State of Pharmacy Automation Survey, 15% of facilities have already implemented something and another 29% plan to do so in the next few years. The only surprise is the relatively low percentage of facilities planning on implementation in the near future. (more…)
Jerry talks about the use of RFID technology in pharmacies, specifically the use of RFID in refrigerated consignment programs and medication tray management.
Multi-dose packaging has been a part of pharmacy for longer than I’ve been a pharmacist. It’s mostly been limited to long term care (LTC), such as nursing homes, rehab facilities, etc. It’s not something that’s commonly used in acute care hospitals for a host of reasons, most notably medication regimens frequently change in acute care settings. Multi-dose packaging works best when the patient is stable and medications can be dispensed for multiple days, hence the popularity in LTC.
Recently articles have been cropping up for companies attempting to use multi-dose packing technology in the ambulatory care setting, i.e. outpatient pharmacy. The most recent of which is an article in the Tampa Bay Times, describing the M5000 robot (1) by MTS Medication Technologies, an Omnicell company. Check the video below.
