In the News

4.27.2016

USP <800> Press Release

April 25, 2016
Media Contact:
J. Andrew Maddigan
(919) 785-1214 ext. 351, amaddigan@achc.org
For all other inquiries:
(919) 785-1214, (855) 937-2242, customerservice@achc.org
  

Compounding industry leaders to offer USP <800> webinars in May 
ACHC/PCAB join with VGM, Attentus to discuss newest standards for compounding pharmacies

Cary, NC- Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), along with Attentus Medical Sales, Inc., a pharmacy and medical products manufacturer, and VGM and Associates, a member services organization serving the home medical equipment industry, will host a series of FREE webinars to discuss the implications of recently-released hazardous drug safety standards by the United States Pharmacopeial convention--USP <800>.   

‘‘The pharmacy compounding industry is undergoing some significant regulatory changes,’’ said José Domingos, ACHC CEO, referring specifically to the newly-released USP <800> as well as revisions to the existing standard for sterile compounding, USP <797>. ‘‘I applaud Attentus and VGM for coming forward to recognize the need and support the information needs of compounding pharmacies.’’  

‘‘Our home infusion and compounding pharmacies are under continuous regulatory and pricing pressures today so they are asking for direct answers and solutions for these changes to USP <800>,’’ said Tom Tucker V.P. Sales and Marketing, Attentus Medical Sales. ‘‘We see these webinars as a way to help our pharmacies break down these changes to manageable tasks.’’  
  
‘‘VGM seeks out solutions to address challenges that its membership faces,’’  said Frank Geiger, VGM Director Home Infusion. ‘‘USP <800> is going to be a complex change in the way business is conducted. VGM will take a leadership role in making sure our members have the information and support they need to be successful.’’ 

The webinars will feature instruction by leading industry experts:


Jon Pritchett, Pharm.D., R.Ph., Associate Director of Pharmacy for PCAB
Dr. Pritchett has a diverse pharmacy background, most recently as Pharmacy Manager of a PCAB-accredited compounding pharmacy. During this time, he specialized in sterile and non-sterile compounding, and focused on men’s health and veterinary medicine. Dr. Pritchett earned his Doctor of Pharmacy (PharmD) from Campbell University College of Pharmacy & Health Sciences, and is a Registered Pharmacist in the state of North Carolina.

Rad Dillon, R.Ph., ASQ CQA, ASQ CMQ/OE, ACHC Certified Accreditation Consultant 
Mr. Dillon is a pharmacist whose career has focused on sterile compounding and pharmacy operations in the home infusion and long term care pharmacy sectors.  Having worked for a variety of regional and national providers from coast to coast, he has recently turned to the challenges faced by sterile and nonsterile ‘‘traditional’’ compounders. Currently Mr. Dillon divides his time between PCAB/ACHC surveys and consulting. 

For more detail regarding the implications of USP < 800 >, listen in as Pharmacy Podcast interviews the webinar sponsors and instructors. 

USP < 800 > Webinar Registration links: 
• May 3, 2016 --  4pm EST (Sterile): https://attendee.gotowebinar.com/register/7738522639425900546
• May 5, 2016 --  4pm EST (Non-Sterile): https://attendee.gotowebinar.com/register/3425517855232742657
• May 9, 2016 --  1pm EST (Non-Sterile): https://attendee.gotowebinar.com/register/561009689566529284               
• May 10, 2016 --  4pm EST (Sterile): https://attendee.gotowebinar.com/register/5060977630030503940

Additionally, Accreditation University (AU), a division of ACHC will hold a one-day USP <800> Compliance workshop at its headquarters in Cary, NC on May 19, 2016.  The workshop, hosted by PCAB, will give an overview of USP <800> and discuss practical steps for implementation. To register for the USP <800> Compliance workshop, please visit, http://www.cvent.com/events/usp-800-compliance-workshop or contact crigsbee@achc.org, or call 919-228-6559

As a leading accreditation organization, ACHC is committed to providing educational resources that facilitate continuous compliance. Through its educational division, Accreditation University, ACHC offers a range of resources designed to help pharmacies achieve and maintain compliance, including workbooks, workshops, and compliance checklists as well as customized consulting options.

ACHC is a non-profit accreditation organization that has stood as a symbol of quality and excellence since 1986. The organization has CMS Deeming Authority for Home Health, Hospice, and DMEPOS and a Quality Management System that is certified to ISO 9001:2008. ACHC is the provider’s choice for accreditation because of its personal Account Advisors, relevant and realistic standards, competitive pricing, and a friendly, consultative approach to accreditation. Accreditation by ACHC reflects an organization’s dedication and commitment to meeting standards that facilitate a higher level of performance and patient care.  As a service of ACHC, PCAB is currently the only comprehensive
accreditation solution for compounding pharmacies wishing to demonstrate compliance with USP standards.

For more information on ACHC’s accreditation programs, or to download ACHC Accreditation Standards, please visit achc.org or contact customerservice@achc.org or 855-937-2242.

VGM Home Infusion is powered by the VGM Group, Inc., a national leader in providing business solutions for diverse industries including health care, insurance and golf. VGM provides a complete line of business solutions and purchasing contracts to more than 25,000 companies throughout the United States and Canada. From group purchasing contracts to continuing education; from audit, appeals and medical review consultation to market data, patient referrals and marketing services, VGM Home Infusion can help members grow revenue, manage expenses and remain compliant.  

Attentus Medical Sales, Inc., based in Houston TX, is a leading nationwide manufacturer and distributor of medical products specializing in cold chain packaging, USP <797> & <800> compliance products, infusion pumps and supplies, back packs and fanny packs for portable infusion pumps, and various other medical supplies.  Attentus Medical services the compounding pharmacy, home infusion, specialty pharmacy, and HME markets.  Founded in 2003, Attentus has experienced tremendous growth every year with a continuous focus on developing solutions for our customer's ever changing needs in this dynamic marketplace.   We strive to provide the highest levels of personal attention and consideration to the client.  Each client will have a dedicated sales rep and customer service rep as well as have their phone call answered by a live person every time.  We are dedicated to providing a high level service and the consultative support for all your business needs. www.attentusmedical.com

3.7.2016

Sterile Gowning

Sterile gowning has become a hot topic in the compounding pharmacy industry since the release of Drug Quality and Security Act established in 2013.  This opened the door for different interpretations of what regulations the 503B space will follow in regards to sterile gowning.  USP <797> was the traditional source of information which set lenient standards for the sterile compounding industry, however, many companies are following more strict guidelines of 21 CFR 211.28 while the 503B guidance is in draft form.  This more lenient guideline practice, while adopted as the industry norm, produced less than favorable results as seen with the NECC incident in 2012.  As seen with many FDA warning letters issued to compounding pharmacies, the industry standard is now moving towards full coverage.  Essentially this means no skin exposure in the sterile cleanroom space at any time, with the use of sterile, nonshedding, latex free components.  Top-down gowning methodology should be applied to create the most aseptic gowning process.


The following sterile gowning components are expected for all 503B sterile manufacturing operations:


Mask

Bouffant

Hood with eye opening

Coveralls

Boot Covers

Goggles

Gloves


These products can be found under the USP <797> & <800> Compliance section of our Product Catalog. 


Additionally, in accordance with implementation of the new tighter standards, the following cleanroom behaviors shall be followed to avoid microbial contamination of the cleanroom space.  The elimination of the use of nail polish, perfume, make-up, sunless tanner, etc. shall be practiced as external substances cause the body to produce excess oils and shed skin more rapidly to naturally remove the foreign substances on the surface, allowing for a higher potential of cleanroom contamination.

 

To review observations and warning letters, please visit the FDA website for registered outsourcing facilities:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm

 

Melissa Stefko, MBA, ASQ CQA


MelissaStefko@Gmail.com


Melissa Stefko is an experienced Pharmaceutic and Biotechnology professional with a background in Quality Assurance and Quality Control in sterile processing.  She is an active member of the American Society for Quality as a Certified Quality Auditor and is currently completing her second Masters in Biotechnology and Regulatory Affairs.

2.15.2016

USP <800>

The final, official version of USP <800> governing hazardous drugs was published several weeks ago. Below are some questions (and answers) that many compounders are likely asking:

 

Q: How much does the final version differ from the last revision?

A: Not much; USP did most of its compromising from the first to final draft. Most importantly, the requirement for the external venting of negative pressure rooms within which hazardous drugs are to be compounded was not removed.  (You can in some cases still get away with this with biological safety cabinets and other “C-PECs,” but this is not preferred.)

 

Q: Where can I obtain a free copy of the final version?

A: Well, there aren’t any! Your best bargain is to purchase a year’s subscription to the Compounding Compendium from USP, which includes copies of <800>,  <795>, <797> and dozens of other great chapters of help to the compounder for $150.

You can however obtain a free copy of a comprehensive gap analysis for <800> on Compounding Today’s website; click on “Compliance” and then "IJPC's USP <795>, <797> and <800> Gap Analysis Surveys" under the “FDA” section.

 

Q: What is the “effective date” for the chapter?

A: Officially it is July 1, 2018 – but don’t let this lull you into complacency! Upon “good authority” we hear that many state boards of pharmacy and other regulatory entities are going to expect “substantial” compliance on everything but difficult facility changes like external venting a lot sooner than this.

Thus, the best bet is to plan full compliance as soon as possible.

 

Q: What if I need help with implementing <800> after using the gap analysis?

A: That’s easy; Attentus Medical's employed consultants are ready to assist you every step of the way, including:

·        Selecting “C-PECs” such as powder hoods and biological safety cabinets

·        Designing the “C-SECs” within which such equipment is placed

·        Advising on workflow

·        Environmental testing and quality control

·        Cleaning supplies and equipment

·        Waste handling and disposal



L. R. Dillon, R.Ph., ASQ CMQ/OE, ASQ CQA, ACHC / PCAB CAC

5.27.2015

A Path Out of the Jungle: Guidance for Selecting and Using Disinfectants in Sterile Compounding

The topic of disinfectant use continues to be a complex and confusing one for many of those involved in sterile compounding. Even a brief scan of the Internet and published resources reveals literally hundreds of commercially available products that are grouped into between six to eleven classes, depending on your source. Additionally, one will find over a dozen traits by which these substances can be evaluated.


Unfortunately, most of these materials in the final analysis leave it to the end user to choose and use products.


While this is of course a technically correct approach, there is a widely expressed desire among end users for a "Reader's Digest" document that makes this final step as simple as possible. This white paper is an attempt to provide such guidance - but is not an end-all to your process.



For our purposes we can condense the number of traits by which to evaluate these substances to the following:

·        Spectrum - ability to kill bacteria, fungi, viruses and spores.

·        Speed / Dwell Time - length of time a disinfectant needs to reside on a surface to be effective.

·        Mechanism(s) of Action - the number of different ways the disinfectant attacks microbes.

·        Robustness - ability to work in a wide range of temperatures, levels of "soiling" and pH.

·        Residue - does the disinfectant completely evaporate, or leave a residue?

·        Corrosiveness - likelihood to interact with and damage surfaces such as stainless steel or plastic that are commonly encountered in compounding environments.

·        Irritation / Safety - does the disinfectant irritate the user's eyes, skin or lungs or, worse yet, pose a potential long term health risk?

·        Convenience / Cost:

o   is dilution or other preparation needed prior to use?

o   is it commercially available the way we want it - spray bottles, bulk containers, etc.?

o   what is its shelf life?

o   cost per prepared volume

o   labor cost involved in preparing and using"

·        Miscibility - ability of the disinfectant to dissolve dried spills and residues.


If the list of disinfectant types are evaluated in light of these traits, two things happen:


1. Many disinfectant types appear far less favorable than others based on one or more of these traits. Specifically:

·        Aldehydes - very irritating and highly corrosive

·        Amphoteric Surfactants - not sporicidal; only "fair" antifungals; leave residues

·        Biguanides - not sporicidal; only "fair" antifungals; leave residues

·        Hypochlorites - only sporicidal at high concentrations; highly corrosive and irritating, leave residues

·        Phenolics - not sporicidal; highly irritating

·        Quaternary Ammonium Compounds - not sporicidal; leave residues


2. Assuming we eliminate these classes of disinfectants from further consideration based on this evaluation, the number of traits we need to continue considering drops down to only:

·        Spectrum - specifically, the ability to kill bacterial spores

·        Residue

·        Convenience / Cost

o   Cost per volume

o   Availability as:

§  Presaturated wipers

§  Spray bottles

§  Large volume containers


The good news is, this only leaves us with three excellent disinfectant types:


·        Sterile 70% Isopropyl Alcohol (SIPA) - only "flaw" is not being sporicidal

·        NaDCC (sodium dichloroisocyanurate) - a chlorine-based substance with none of the disadvantages of sodium hypochlorite

·        Peroxides:

o   Hydrogen Peroxide + Peractic Acid

o   Accelerated Hydrogen Peroxide


Let’s take a closer look at each of these “finalists:”

·        Isopropyl alcohol has of course been a mainstay disinfectant for decades.

§  However, it does not kill microbial spores

§  Among its positives are its availability in its sterile form in many convenient forms, from individual “prep pads” to spray bottles to bulk containers

·        Peroxides

o   Hydrogen Peroxide + Peracetic Acid (PeridoxRTU®)

§  This combination kills everything, and does do rapidly

§  Available in spray bottles or bulk containers

§  Spray bottles containing sterile solution are available

o   Accelerated Hydrogen Peroxide ( Oxivir®)

§  This product has all the advantages of hydrogen peroxide + peracetic acid, but is significantly less expensive

§  Only one drawback; it leaves a residue

·        NaDCC (Bru-Clean®)

o   The main advantage of this wide-spectrum disinfectant is compactness and convenience; one small tablet will create a gallon of disinfectant solution when added to water

o   It is however not available as a sterile product, preventing its use as a final disinfectant on interior primary engineering control (PEC) surfaces


When Are Sterile Disinfectants Required?

As per USP <797>, four specific times:

·        As the only or final step of cleaning the interior or a PEC

·        Immediately after donning sterile gloves, and periodically thereafter

·        To treat “critical sites” just prior to entry

·        To disinfect the exterior of materials being introduced into the clean room. (Note: this is not a particularly rational requirement. Overwraps will be removed and critical sites again disinfected prior to aseptic entry.)


SIPA is not required for the cleaning of the exteriors of PECS or any surface or object found in SECs (secondary environmental controls such as ante rooms and clean rooms). This often misunderstood fact can drastically increase the cost of cleaning compounding facilities through the use of much more costly sterile disinfectants.


Must Disinfectants Be Rotated?

Assuming one uses a disinfectant capable of killing all classes of microbes, the short answer is, “No.” Viable microbes within PECs or SECs will not become resistant to disinfectants in a manner analogous to the development of resistant pathogens within humans or animals, because to do so would require their growth and replication, which is extremely unlikely within these environments based on the lack of nutrients and the very high concentration of disinfectants typically used.


Sole reliance on SIPA, since it is not sporicidal, however, suggests the need of alternating or “layering” disinfectants – that is, using one disinfectant that is sporicidal followed by SIPA.


There may be some merit in the occasional rotation of disinfectants based on the fact that some contaminants might be more miscible in one such solution than another, but this is probably not necessary. 



Speed and Dwell Time

We live in the Era of Immediate Gratification; there seems to be a belief that only a small amount of disinfectant rapidly applied to surfaces is “good enough.” This may work if your goal is simply to make your kitchen floor “look” clean and be reasonably free of microbes. Even the best disinfectants, however, require “dwell time” to work, meaning that they need to exist in a liquid state on a surface long enough to penetrate and destroy microbes. A good rule of thumb is, apply enough disinfectant to a surface to require five minutes to dry.


Spray Bottles

Spray bottles are an excellent way to preserve the sterility of sterile disinfectants. However, is it important to not spray the HEPA filter grid at the back of laminar flow PECs, as doing so may compromise the integrity of the filter. Disinfectants should be sprayed on non-shedding cleaning materials that are then used to wipe the grid.


The Final Analysis

Below is a diagram, with item numbers, of a reasonable solution to this disinfectant quagmire. It provides for some organizational autonomy, but drastically reduces the number of decisions.

Critical Sites: SIPA Wipes (contact us for item numbers and support)

PEC Interior: SIPA spray bottle (8316 or 8332), or PeridoxRTU® sterile spray bottle (AM10032-834), or Oxivir® spray bottle (DVY4277285) followed by SIPA

PEC Exterior and SEC: Bru-Clean® bulk (AMDT1772), or PeridoxRTU® bulk (AM10032-832), or Oxivir®.


Reading

http://www.cdc.gov/hicpac/disinfection_sterilization/6_0disinfection.html


http://electroiq.com/blog/2008/06/disinfection-begins-with-proper-selection/


Disclaimer

The author and Attentus Medical have made every effort to ensure the accuracy of the information herein. However, appropriate sources should be consulted for any change in process for verification in your state and under your specific regulatory agencies, especially for new or unfamiliar products or processes. The author and Attentus Medical expressly disclaim responsibility for any adverse effects or consequences resulting from the use of any of the information presented in this article.




L. Rad Dillon, ASQ CMQ/OE, ASQ CQA, ACHC / PCAB CAC ASQ CMQ/OE, ASQ CQA, ACHC / PCAB CAC has been involved in sterile compounding with a variety of regional and national home infusion and long term care pharmacy providers for decades. He currently surveys for the Accreditation Commission for Health Care (ACHC), consults for sterile and nonsterile compounding pharmacies, and writes policies and procedures and other guidance documents.




Post Test

1.        True or False: Even a good disinfectant must reside as a liquid on a surface for a certain amount of time to kill microbes


2.        True or False: Disinfectants vary in their ability to work when there is significant soiling or residue on a surface.


3.        True or False: All cleaning performed in clean and ante rooms must utilize sterile disinfectants.


4.        True or False: There is no need to use the most irritating and corrosive disinfectant types because "gentler" alternatives exist.


5.        True or False: The "weak link" for many disinfectants is that they are not sporicidal.


6.        As per USP 797, in which of the following cases is use of sterile isopropyl alcohol (SIPA) not required:

a.         As the only or final step of cleaning the interior or a PEC

b.        Immediately after donning sterile gloves, and periodically thereafter

c.         To treat “critical sites” just prior to entry

d.        Daily mopping of clean room floors


7.        True or False: Disinfectant rotation is not only required by USP 797, the concept is widely supported by microbiological theory and evidence.



8.        True or False: A good rule of thumb is to allow one minute of disinfectant "dwell time" on a surface.


9.        True or False: The main drawback of using spray bottles to apply disinfectants is that it is easy to wet HEPA filters durig their use.


10.      True or False: Which of the following antibiotic traits is not used to arrive at a “Final Three?”

a.         Spectrum

b.        Mechanism of action

c.         Convenience / Cost

d.        Residue





Answer Key

1.        True

2.        True

3.        False

4.        True

5.        True

6.        D

7.        False

8.        False

9.        True

10.      B







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