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.

Man pleads guilty to relabeling drugs with bogus FDA codes

This is some crazy stuff right here. The length that people will go to pull off a scam in the name of making money continues to amaze me.

FDA.gov: “Arif Diwan, 60, owner of Lifescreen LLC, a Cranston, R.I., based company that labeled, advertised, and sold drugs and pharmaceutical products under the brand name “LifeLogic,” pleaded guilty in federal court in Providence today to conspiring with others to purchase drugs manufactured in India and other countries, repackaging and relabeling them making it appear that they were manufactured in the United States and Europe, and had been approved by the United States Food and Drug Administration (FDA), and then reselling them… According to court documents, between 2012 and 2015, Diwan received and filled numerous orders for high-cost pharmaceutical products, including a number of products used in the treatment of cancer. Diwan admitted that he rebranded and relabeled drugs manufactured in India, including adding bogus FDA codes and markings to make it appear that the drugs had been manufactured in the United States or Europe and were approved for sale by the FDA. The drugs were shipped by Diwan to customers in numerous countries. Diwan did not sell misbranded and mislabeled drugs in the United States.”

Two important things to note: first, this happened between 2012 and 2015, and second, nothing appears to have been sold in the United States.

When people wonder why we need something like the new Track-and-Trace legislation, all one has to do is point them to the article above. Hopefully, the ability to see a drug’s pedigree from the manufacturer to the patient will prevent this type of thing from happening, or at least make it significantly harder to do.

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.

USP Chapter <800> Terminology

USP <800> Hazardous Drugs – Handling In Healthcare Settings introduces not only new rules around hazardous drug compounding, but some new terminology/vocabulary as well. Most of the terminology doesn’t address unique items, but rather how items are described when handling hazardous drugs (HDs).

USP Chapter <800> refers to “containment” primary and secondary engineering controls (C-PECs and C-SECs). Think of C-PECs and C-SECs as the USP Chapter <800> equivalent of PECs and SECs found in USP Chapter <797>.

C-PECs are commonly referred to as “hoods” and C-SECs are synonymous with “buffer area” or “buffer room”. Simply put, C-SECs are the rooms where C-PECs must be placed to perform sterile HD compounding.

USP Chapter <800> introduces the concept of a containment segregated compounding are (C-SCA), which is an area where limitations are placed on compounding, such as what type of HD compounding may take place as well as maximum BUDs allowed.

As USP Chapter <800> covers nonsterile HD compounding as well as sterile compounding, most of you may not be familiar with the concept of a Containment Ventilated Enclosure (CVE).

When discussing USP Chapter <800> it’s important that we’re all on the same page. Sometimes new terminology can create confusion, so I recommend you educate yourself sooner rather than later.

Summary: 
C-PEC (Containment Primary Engineering Control) - A ventilated device designed and operated to minimize worker and environmental exposure to HDs by controlling emissions of airborne contaminants

C-SEC (Containment Secondary Engineering Control) - The C-SEC is the room in which the C-PEC is placed. It incorporates specific design and operational parameters required to contain the potential hazard within the compounding room, e.g., restricted access, barriers, special construction technique, ventilation, and room pressurization are components of the secondary control strategy

C-SCA (Containment Segregated Compounding Area) - A type of C-SEC with nominal airflow and room pressurization requirements related to HD compounding. HD compounding in the C-SA is limited for use with a BSC when preparing low- or medium-risk level CSPs with 12-hour or less BUDs, preparing CSPs in a CACI that meets <797> requirements, or preparing non-sterile HDs in a C-PEC.

CVE (Containment Ventilated Enclosure) - A full of partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants (through HEPA filtration) and prevent their release into the work environment.

Containment Supplemental Engineering Control - Containment Supplemental Engineering Control basically refers to  closed system drug-transfer devices (CSTDs*) and provide adjunct controls to offer an additional level of protection during compounding or administration.

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*A closed system drug-transfer device (CSTD) is a device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. There’s still quite a bit of controversy around the definition of these devices.

Google improves symptom search

I’m sure most of you have Googled for medical advice at one time or another. I know I’ve performed quick Google searches for healthcare information, including specific drug information.

It turns out that a lot of people search for symptoms online, and the information isn’t always helpful. Sometimes a little information can send people’s minds cascading into full panic mode, i.e. get a tension headache, search for symptoms and end up thinking you’re dying from a brain aneurysm.

Google understands the problem and has improved symptoms search.

Roughly 1 percent of searches on Google (think: millions!) are symptom-related. But health content on the web can be difficult to navigate, and tends to lead people from mild symptoms to scary and unlikely conditions, which can cause unnecessary anxiety and stress.

So starting in the coming days, when you ask Google about symptoms like “headache on one side,” we’ll show you a list of related conditions (“headache,” “migraine,” “tension headache,” “cluster headache,” “sinusitis,” and “common cold”). For individual symptoms like “headache,” we’ll also give you an overview description along with information on self-treatment options and what might warrant a doctor’s visit. By doing this, our goal is to help you to navigate and explore health conditions related to your symptoms, and quickly get to the point where you can do more in-depth research on the web or talk to a health professional.

As I mentioned above, I’ve used Google to look for pharmacy specific drug information. Most of my colleagues do the same thing on a regular basis. It’s amazing what can be found with a few key words and the click of mouse.

We live in a digital world. Information has never been more accessible nor more overwhelming. Clinicians have unfettered access to information that one couldn’t have imagined just ten years ago. Information has become cheap, plentiful, and readily available to anyone with internet access. Journals, reference books, provider forums, clinical trial hubs, drug monographs, study data, and so on can be accessed anytime, from anywhere. This thanks to the development of cellular networks and mobile devices. Everything is simply a click away.

I still work an occasional per diem shift at a local hospital, and take my word for it when I say that it’s never been easier to access information. When I compare this to how I gathering information when I became a pharmacist some twenty years ago, my head spins.

I’ve always wondered what it would be like if one were to give Google access to all the currently available literature and reference material in real time. The idea of such a vast amount of knowledge at one’s fingertips is mind boggling, to say the least.

Cool technology for pharmacy – ProteXsure Safety Capsule System

Needle sticks happen. I’ve actually stuck myself a few times during my career while compounding in the IV room. Fortunately for me, it never involved anything hazardous. Still, it was a pain. No pun intended.

Over the years a lot of attention has been given to methods for preventing needle sticks in healthcare, ranging from things like procedures, i.e. “no-recapping” to physical barriers like safety syringes. The ProteXsure Safety Capsule System falls into the latter category.

ProteXsure

medGadget: “[The ProteXsure Safety Capsule System] prevents needle stick injuries by offering an easy way to snap on a protective cap to the tip of a needle. Once a syringe is finished with, the needle is simply pushed into a slot on the side of the ProteXsure. This can be done with one hand. A cap immediately grabs onto the needle, readying the syringe for safe disposal.”

The ProteXsure Safety Capsule System gets high marks for ease of use and design. It appears to be a simple, yet elegant solution to the problem of blunting the end of a needle to prevent accidental sticks. Check the video below to see how simple the product is to use.

 

From the ProteXsure site:

  • First device to safely address recapping the Front & Back end of all dental syringes
  • Fits all size needles and gauges in most medical and healthcare settings
  • Meets all OSHA guidelines of mandated “One Hand Recapping”
  • Accepts both “Bent & Straight” needles
  • Quick and easy to use
  • Non skid gel pads adhere to any surface without leaving marks or residue
  • 100 safety capsules inside every system
  • Fully automatic (Insert needle and remove)
  • Once completely dispensed, simply dispose in a normal waste bin & replace
  • Additional downstream needle protection should original needle cap come off (capsule covers needle tip in addition to the syringe cap)

No information on cost and availability in the U.S.