Tuesday, February 20, 2018

Compounding Task Force Meeting Minutes

Attendance:

Trip Hoffman (University Pharmacy), Chris Cox (Smith Rexall Drug), Rob Muellreck (Intermountain

Healthcare), Carrie Dunford (Intermountain Healthcare), Anita Freer (DOPL), Sharilee McIntyre (DOPL),

Travis Drebing (DOPL), Evan Vickers (Senator), Drew Favro, Casey Sayre, Brad Stapley (Stapley’s); Jeremy

Olsen (Moab Regional Hospital); Glen Carmody (Cardinal Health); Donelle Perez; Hali O’Malley

(Medquest); Karin Carestia (Alpine Apothecary); Daniel Barton (Taylor Drug); Senator Evan Vickers;

Mckinzi Hammon (Medicine Center); Matt Higley (IMC);

Carrie Dunford to take over the responsibility of Compounding Task Force Chair.

Co-chair (retail and hospital) nominees request are in the works, Survey monkey to be sent out

to take nominations.

Reminder of upcoming meetings as follows:

May 15, 2018

August 21, 2018

November 20, 2018

Times will be determined by survey monkey results

** UPHA Meeting May 3-5, 2018 One Task Force MBR & One DOPL MBR to attend to represent

Compounding task force. Also, set up with USHP annual meeting.

Roseman University Presenter: Casey Sayre PharmD, PHD

Mission of Pharmacy Compounding Research and Education.

See Attached Flyer

Drew Favero ;PharmD Candidate; Presentation on USP 800 Retail Application-

See attached presentation

Following Topics Discussed:

Bryan Prince MBA, with Lab-Red Consultants, See article titled- How to Perform A

Hazardous Drug Risk Assessment in the Compounding Pharmacy (can be found at

learn.nuaire.com

Trip wanting to see if pharmacies are preparing for December 2019?

Concern of being mindful of balance, safety and cost to smaller pharmacies trying to

prepare for USP 800.

*Trip discussed timeline of 800 in Utah:

-Implementation delayed-December 1, 2019 by USP -USP 800 is no doubt a Great standard an we appreciate the efforts of the USP 800 committee -----over-the-top in some regards

-what about amounts 5 vs 100 compounds per day -what about different risks associated with different meds

*cytotoxic vs hormones

-BOP allowed us to investigate what is best for UT--formed an 800 team -The team wanted to allow for 800; but at the same time be very mindful to a balance of ensuring safety but not to impede commerce. -1st the 800 team went through 800 and broke it down line by line in regards to musts or shoulds as well as best practice standards and the economic impact of each standard in the chapter. -800 team recommends removing all "shoulds" to clean up and allow for less grey areas -2 things we will do before considering how to adopt:

1. State funding to have an outside entity to review current literature of problems associated with exposure risk to certain group 2 and group 3 medications on the NIOSH 2018 list.

2. Set up mock compounding to look at exposure risk (are powder containment hoods enough with the right containment strategies and right PPEs??) Chris Cox working with Kash and Casey with Roseman University to facilitate this item.

-Another issue that is coming up------Who is going to enforce 800? State BOP; OSHA; FDA

-What will 800 team recommend? See recommendations *****Get started NOW----see NABP/Utah newsletter Feb edition*****

DOPL inspection form attached to August 16, 2016 Minutes if anyone wants to see the

criteria for inspections.

Kimberly-Clark N95-46727 air mask was the best air facial mask Trip (University

Pharmacy) and Kyle (MedQuest) has tested for N95 USP 800 standards.

Rob Muelleck gave a presentation on Guidance documentation for Deactivation,

Decontamination, Cleaning, Disinfecting processes.

Concern on how to get rid of waste used in sterile compounding of hazardous waste,

advised most places use third parties entity’s such as RCA waste/Stericycle.

Task Force would like input on DOPL inspection form, to work in conjunction with DOPL.

Zbigniew Ciupek gave input on HEPA filters and installation / testing of powder hoods.

To check with Baker on cleaning to report findings to task force.

Travis Drebing- Inspector DOPL; things he is finding in his inspections in regards to 795;

Improvement needed in documentation of training of compounding technicians.

Mailing out of medications in refrigerated containers with appropriate temperature

thermometers and cold packs in each container, as well as documentation on storing

and pharmacy phone number in case there are issues with the medication once it has

arrived.

Hazard drug training for all compounding employees documented, signed off by

supervisor with date of observed training.

Sharilee Mcintyre-Inspector DOPL; things in she findings of her inspections in regards to797;

SOP’s -staff need to know what is in them and be following them (reviewing them on

annual basis)

Training and cleaning of the hoods needs to be documented

Garbing standards, compounders that are sick should not be working in clean room,

fundamentals and interpretation of standards not being followed; watch jewelry, make-

up, and nails.

What is acceptable to clean, some agents are causing pitting, SOP’s should state

cleaning regimens. Epoxy based paints should be washable, advised to check with mfg.

or Sherwyn Williams to see if they meet the standards.

Pharmacies should be doing fingertip test, media test etc.

Sharilee to check with Critical Point on cleaning of the HEPA filter.

Changing of recipe of compounds needs to make sure you are doing a stability test.

Suppositories/syringes- labeling of individual doses unless in Rx bottle labeled.

Why safer in vial as opposed to mold? Clarification is that regardless all single use suppositories

or lollipops need to be labeled unless put in a medication container/bottle with a label

indicating lot #, expiration, name of active ingredients. For example, if suppositories are

wrapped in foil then each dose needs to be labeled properly. If placed in a bottle and not

wrapped individually in foil then the bottle can simply be labeled.

Important for pharmacies to attend meetings, utilize minutes on DOPL website to stay updated

to changes happening with compounding and USP standards, and proposed rule changes.

Concerns with Rx Pads: Give choice of utilizing another pharmacy and do not place controlled

substances with check boxes with set dosages. They must be filled in by the prescriber

completely.

Compounding Task Force Meeting Agenda Feb 20th, 2018

Heber M. Wells Bldg -DOPL Room 210 at 7 am

160 East 300 South SLC, Utah

AGENDA:

I. Introductions:

Members of task force: Chris Cox; Dean Jolley; Jim Ruble; Evan Vickers; Koby Taylor; Jake

Corsi; Christine Jacobsen; Adam Jones; Rob Muelleck; Kyle Kitchen; Mary Ellertsen; Jeremy

Olsen; William Black

New Chair for task force: Carrie Dunford

Elect new co-chair (hospital) and co-chair (retail): Nominations

Recognize 800 team:

II. Goals for 2018

Dates and Times of meeting: Feb 20; May 15, Aug 21; Nov 20 (all at 7 am)---Change?

Forums at UPHA and USHP meetings- Task Force member and DOPL member

III. Roseman University community outreach and potency testing for compounds- Kash

USP <800>:

ew

IV. HD Containment Strategies for Regular Retail- Drew Favro

V. USP <800> Direction/Timeline- Trip, Jim, and Chris

VI. USP <800> Cleaning, deactivating, decontaminating overview- Rob Muelleck

VII. USP 797 Inspection update- Sharilee

VIII. USP 795 Inspection Update- Travis

IX. Questions/concerns from Collegues

Dr. Rx pads

Unit dose labeling- suppositories, syringes

USP 80Q Reta ii Appli~aticin

Drew Favero University of Utah

PharmD Candidate 2018

Introduction - Interest in Topic

Midtown Clinic,

Ogden,UT

: Develop an USP ~ 800 adherence

plan for a retail harmac

2/19/2018

1

Background

"USP sets the standards that organizations must meet to ensure safe compounding, but it does not provide instructions or guidance for how organizations should meet these standards. 11

-Patricia C. Kienle, RPh, MPA, FASHP

Douglas K, Kastango ES, cantor P. USP <800>: Let's Get Started. Pharmaq, Purchasing & Products. December 2017; 14,12: 1. https://www.pppmag.com/article/2158

Objectives

• State the Hazardous Drug (HD) Compliance Officer's duties

• Review my process for creating an HD list

• Review examples of Assessments of Risk (AOR)

• Assess relevant Standard Operating Procedures (SOP)

2/19/2018

2

HD Compliance Officer

<800> Hazardous Drugs - Handling in Healthcare Settings. United States Pharmacopoeia Web Site. Accessed February 19, 2018. http://app.uspnf.com/uspnf/pub/index?usp=40&nf:35&s=2&official0n=December%201,%202017

HD Compliance Officer's Duty

USP 800 Compliance Practical Workplace Procedures & Policies

2/19/2018

13 I

AOR The Key

Kienle PC, Douglass K. Perform an Assessment of Risk to Comply with USP <800>. Pharmacy Purchasing and Products. March 2017; 14,3: 34. https://www.pppmag.com/article/2012

AOR- USP FAQ

FAQs: <800> Hazardous Drugs-Handling in Healthcare Settings. United States Pharmacopoeia Web Site. Accessed February 19, 2018. http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

2/19/2018

4

2/19/2018

HD List Requirements

• NIOSH HD Type • Group l(antineoplastics)

• Group 2(non-antineoplastics)

• Group 3(reproductive list only)

• Dosage form

• Packaging

• Risk of exposure

• Manipulation

Yuen C. USP 800 Safe Handling of Hazardous Drugs. Personal communication Feb 8, 2018.

HD List Examples

• Figure 1 • Methimazole

• Figure 2 • Finasteride

5

AOR Components

• Medication

• HD NIOSH Category

• Product • Dosage Form • Packaging • Dispensing

• Risk

• Exposure

• Containment Strategies

• Documentation

Kienle PC, Douglass K. Perform an Assessment of Risk to Comply with USP <800>. Pharmacy Purchasing and Products. March 2017: 14 3: 34. httos://www.nnnmaa.com/article/2012

AOR Examples

• AOR: Methimazole

• AOR: Finasteride

2/19/2018

i6

2/19/2018

~ Yuen C. USP 800 Safe Handling of Hazardous Drugs. Personal coml'Jlunication Feb 8, 2018.

Kienle PC, Douglass K. Perform an Assessment of Risk to Comply with USP <800>. Pharmacy Pur!=hasing and Products. March

7

SOP • Designation of HD areas

• Ar.d equipment

• Receipt • 9elivery from suppliers • Wiping down products on receipt

• Hanb hygiene and use of PPE based on activity (e.g., receipt, tran~port, compounding, administration, spill, and disposal)

• Ehsure appropriate equipment is available

• Deahivation, decontamination, cleaning, and disinfection • Determine appropriate agents to use

• Spill control • Create a spill kit

Conclusions

• There is no set of instructions for how to comply with USP 800 in a retail settfng

• The best procedures are still being defined

2/19/2018

8

\

References

USP 800 Retail Application

Drew Favero

University of Utah

PharmD Candidate 2018

• Kienle PC, Douglass K. Perform an Assessment of Risk to Comply with.USP <800>. Pharmacy Purchasing and Products. March 2017; 14,3: 34. https://www.pppmag.com/article/2012

• Douglas K, Kastango E~ Cantor P. USP <800>: Let's Get Started. Pharmacy Purchasing & Products. Decemoer 2u17; 14,12: 1. https://www.pppmag.com/article/2158

• Yuen C. USP 800 Safe Handling of Hazardous Drugs. Personal communication Feb 8, 2018. • <800> Hazardous Drugs - Handling in Healthcare Settings. United States Pharmacopoeia

Web Site. Accessed February 19, 2018. http://aJ>p.uspnf.com/uspnf/pub/index?usp=40&nf=35&s=2&officia10n=December°,1,20l, %202017

• FAQs: <800> Hazardous Drugs-Handling in Healthcare Settin_gs. United States Pharmacopoeia Web Site. Accessed February 19, 2018. httl)://www.usp.org/frequently­asked-questions/hazardous-drugs-handling-healthcare-settings

2/19/2018

9

/

Figure 1 NIOSH Medication

Methimazole

NIOSH category

Group 2(non-antineoplastic)

Medication Product

Methlmazole 5mg Meth'imazole 10mg

- Tapa:zole(methimazofe) 10mg Refernces: UpToDate accessed on 09/20/2017. Drug lnforrilation: Methimazole

)

Dosage Form

tablet tablet tablet

Packaging Manipulation

100 count bottle counted/packaged 100 count bottle counted/packaged 100 count bottle counted/packaged

Risk of Exposure

"~DA Pregnancy Category D; appears in human breast milk".

HD considerations: "Use appropriate precautions for

receiving, handling, administration, and disposal.

Gloves (single) should be worn during receiving, unpacking, and

placing In storage. NIOSH\ recommends single gloving for administration of Intact tablets

or capsules. NIOSH recommends double gloving, a protective gown, and preparation In a controlled device or use of

ventilated engineering controls (a class II biological safety cabinet

or a compounding aseptic containment isolator) for

compounding; If not prepared in a controlled device, respiratory

and eye/face protection are recommended (NIOSH 2016)".

Figure 2 NIOSH Medication N IOSH Category Medication Product Dosage Form Packaging Manipulation

Finasteride Group 3(reproductive-risk)

Finasteride 5mg tablet 30 count bottle unit of use Refernces: UpToDate accessed on 09/20/2017. Drug Information: Finasteride

Risk of Exposure

"FDA Pregnancy Category X;

Women should not handle

crushed or broken

finasteride tablets when

they are pregnant or may

potentially be pregnany,

due to potential risk to a

male fetus". HD

considerations: "Use

appropriate precautions for

receiving, handling,

administration, and

disposal. Gloves (single) should be worn during

receiving, unpacking, and

placing in storage. NIOSH

recommends single gloving

for administration of Intact

tablets or capsules (NIOSH

2016)".

Medication: HD Drug Category:

Product

Assessment of Risk: Methimazole Methjmazole

Group 2(non-antineoplastic) Dosage form Packaging Dispensing

Methimazole 5mg tablet 100 count bottle . counted/packaged Methimazole 10mg tablet 100 count bottle counted/packaged Tapazole(methimazole) 10mg tab1et 100 count bottle counted/packaged Risk:

"FDA Pregnancy Category D; appears in human breast milk". HD considerations: "Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules. NIOSH recommends double gloving, a protective gown, and preparation in a controlled device or use of ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator) for compounding; if not prepared in a controlled device, respiratory and

eye/face protection are recommended {NIOSH 2016)". Exposure:·. Counting manufactured tablets with no further manipulations. Containment Strategy: Products will be received and stored as documented in the HD SOP. Employees that are or may become pregnant or who are nursing will not handle this medication. Employees will wear approved gloves whenever handling/working with tablets or tablet

powders/residues. Tablets will only be counted and bottled and not manipulated in any way. Tablets will be counted using designated HD equipment. HD equipment will be cleaned according to HD SOP after counting is completed.

Based on Assesssment of Risk will proceed as follows: [x} Follow alternative strategies documented above

[] Follow all USP<800> requirements

Assessment of Risk written by: Reviewd by Pharmacy Manager: Date Assessment of Risk(AOR) Initially Performed:

Date AOR Reviewed: references: https://www-uptodate-com.ezproxy.lib.utah.edu/contents/methimazole-drug­information?source=search_result&search=methimazole&selectedTitle=l"'S3 Refemces: UpToDate accessed on 09/20/2017. Drug Information: Methimazole

Date: Date:

Medication: Assessment of Risk: Finasteride

Frnasteride HD Drug category: Group 3(reproductive-risk}

Product Dosage form Packaging Dispensing Finasteride 5mg tablet 30 count bottle unit of use

Risk:

"FDA Pregnancy Category X; Women should not handle crushed or broken finasteride tablets when

they are pregnant or may potentially be pregnany, due to potential risk to a male fetus". HD considerations: "Use appropriate precautions for receiving, handling, administration, and disposal.

Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH

recommends single gloving for administration of intact tablets or capsules (NIOSH 2016)". Exposure:

None. Tablets are unit dose packaged and employees are not exposed directly to the medication.

_q,~,!1~~!1_t_!t!c'~~gy: -- . Products will be received and stored as documented in the HO SOP.

Tablets will. not be removed from unit dose packaging(bottle).

Based on Assesssment of Risk will proceed as follows: [x] Follow alternative strategies documented above

[ ] Follow all USP<800> requirements

Assessment of Risk written by;

Reviewd by Pharmacy Manager:

Date Assessment of Risk(AOR) Initially Performed:

Date AOR Reviewed: Refernces: UpToDate accessed on 09/20/2017. Drug Information: Finasteride

Date:

Date:

Sponsored by

How to Perform a Hazardous Drug Risk Assessment in the Compounding Pharmacy There is a looming deadline on July 1, 2018 and that is the implementation of USP chapter <800>-Hazardous Drugs, Handling in Healthcare Settings. State Boards of Pharmacy (SBOP) are forming task forces and committees to determine if their state will fully implement the chapter or if they will only implement certain components of the chapters. And yet there are other states that are unsure what to do and may push the enforcement further down the timeline. Regardless of what your SBOP has determined regarding USP <800> enforcement, it is still wise to examine the risks associated with hazardous drug chemical handling in your entity. Mitigating risk may not be at the forefront of your mindset, but like the USP <800> deadline, the issue of chemical exposure risk is looming in all healthcare facilities that handle hazardous drugs (HDs). A comprehensive risk assessment of every single hazardous drug (HD) on the NIOSH hazardous drug list is not absolutely required, yet you will need to review the list and identify those drugs and dosage forms that you handle in your pharmacy.2 In the absence of the assessment of risk, you must implement all containment strategies defined in the chapter. Full implementation of the engineering controls necessary to maintain negative pressure can be an expensive endeavor with residual energy costs, so taking the time to perform a risk assessment may prove to be financially advantageous. What we will outline and explain in this paper is the process of risk assessment is relatively simple and the process will surely uncover truths about our current workflow habits. The introduction section of the USP <800> chapter reveals the non-defined terminology of “occupational safety plan.” There is not a clear-cut definition of “occupational safety plan” because it is a broad scope term. It can be summed up as “physical activities” and the risk of exposure from those activities. The physical activities defined in the chapter are a series of singular activities such as (but not limited to), unpacking, cleaning, and HD’s, storing HDs, compounding and mixing HDs, manipulating dosage HD dosage forms, administering HDs, and cleaning up spills and handling waste. All the defined singular activities form a comprehensive workflow process and are worthy of dissection because each activity could reveal one or multiple risks of exposure. The term “risk” is important to conceptualize because it is “defined as the combination of the probability of occurrence of harm and the severity of that harm.”1 A compounding pharmacy must devise an occupational safety plan and to adequately do so requires a risk assessment. 1 Source: Guidance for Industry. Q9 Quality Risk Management. U.S. Department of Health and Human Services Food and Drug Administration. June 2006 ICH 2 Source: Kienle, P. The Chapter <800> Answer Book, Bethesda, MD: ASHP: 2017.

Potential Benefits of Performing a Risk Assessment: 1. Set Quality Assurance Processes

(ref. USP 797, 795, 1163) 2. Set Internal Standards (ex: PPE; workflow processes) Additional Resource Article: Workflow Strategies to Minimize Exposure to Hazardous Drugs in the Compounding Pharmacy 3. Decision making gets better. (learning curve; establish corp. policy and Standard Operating Procedures) 4. Regulatory Assurance (documentation makes them happy) 5. Reputation (Patients and Providers) 6. Competitive Advantage (use as a marketing tool)

Stakeholders Each person in the pharmacy has a different perspective on the matter of risk and under the umbrella of “risk management” each of those persons are considered “stakeholders.” The Pharmacist in Charge (PIC) and the business owners have obvious reputable and equitable stakes, but what about the technicians? Technicians are actively opening chemical containers, scooping, weighing, and manipulating active chemicals that have occupational exposure limits (OELs). Many years ago, after speaking at a conference education session on Quality and Safety in the Compounding Lab, a young lady in her late twenties approached me and asked, “Do you think the reason why I have had three miscarriages is because I work in a compounding pharmacy?” That young lady’s story should not be interpreted as an incrimination on the industry, but instead should be considered as a potential hazard in the absence of a thorough risk assessment and implementation of mitigation strategies such as consistent training on good lab practices and active monitoring of personnel proficiency. The take away here is every employee at the pharmacy has a perspective and stake that should be considered during the risk assessment process and it is almost a guarantee that soliciting those perspectives will reveal valuable information. Risk Assessment- The Process

Step 1: Risk Identification A compounding pharmacy, which is qualified as an “entity” in the USP chapter “must maintain a list of HDs, which must include any items on the current NIOSH list that the entity handles.” This identification process can be easily achieved by printing off the NIOSH hazardous drug list and highlighting those HDs on hand and posting in the compounding room, or alongside the other important “readily available” documents, and safety data sheets (SDS). Recently during a site visit we discovered the SDS three ring binder to be readily available, but completely empty, meaning no hard copies of the SDS sheets were available. After inquiring of the lab manager, she boldly proclaimed the SDS documents were digital and therefore “readily available” and the technicians knew how to access them. To validate her claim, I challenged a technician to produce an SDS. The technician proceeded to walk over to the bright yellow SDS

three ring binder to discover it was void of content. The lab manager reminded the technician that she was told the documents were digital. We completely agree that removing as much paper from a compounding room is a good idea, but the main point here is, consistency is key with training, even if it seems repetitive. To further validate this point, consider that in instances of severe weather or a power outage that may disrupt internet service, SDS paper copies should be available. Step 2: Risk Analysis This is an important step because we now get into the workflow process and examine the series of singular HD handling activities as defined in the USP <800> chapter. The Appendix 1 Hazardous Drug Worksheet is a simple and useful tool that sequentially walks through the HD handling processes and is provided at the end of this article. The worksheet was developed by an industry collaboration called the Hazardous Drug Consensus group and can be downloaded by clicking this link at Compounding Today.

One of the HD workflow processes that is undoubtedly the physical activity with greatest exposure risk occurs during the compounding workflow. Inspection of the lab area during the risk analysis step should be scrutinized. This will require some literal hands to reveal some truths on how clean or how dirty your lab really is. This inspection is even more effective with a UV flashlight that can be purchased for less than $15.00. One approach we commonly engage in is wiping a finger (it’s probably better accomplished wearing gloves) or shining the UV flashlight over the top of door jambs, behind hoods, and on shelving where dry chemicals are stored. Eight out of ten labs we visit will reveal a similar result to the Reference-1 picture revealing environmental exposure. No matter how many times you think you have reinforced good behavior, or reprimanded unacceptable behavior, this simple qualitative test is effective. Now the risk analysis step incurs a couple of risk questions such as, “why is powder residue present on surfaces outside the containment primary engineering controls (C-PEC)?” With each risk discovery, a follow-up question of “What are the potential harms?” should be strongly considered. In the above Reference-1 picture scenario, the environmental contamination is present due to inconsistent safe workflow habits and an absence of good lab practices. The potential harm is environmental contamination, which is a good indication of personnel exposure and a leading cause of cross contamination with other formulations.

Step 3: Risk Evaluation Risk evaluation compares the identification and analysis against the “risk criteria.” The risk criteria are a set of industry standards and/or defined quantitative benchmarks. The problem with performing a comprehensive risk evaluation is that there are no established risk criteria or

Reference-1: Environmental Exposure

acceptable levels of environmental exposure in the compounding industry. Depending on what SDS is referenced, there may or may not be a defined OEL in “Section 11. Toxicological Information” which may or may not reveal a guideline of daily exposure limits.

With the absence of true benchmarks, we would advise to start your own by performing a Gap analysis. A Gap analysis is a simple tool that evaluates the current state versus a desired future state. Using another example from a client site visit, we discovered that the container used to dispense anticipatory stock of progesterone capsules contained a distinctive powder residue as evident in Reference-2 picture. Again you should interject the risk analysis question of “why” this occurred. The potential risks are inhalation and dermal exposure during dispensing, which may be occurring outside of a negative pressure room. The mitigation is a corrective action that defines a thorough de-dusting of capsules prior to removing from the C-PEC which is written in the pharmacy’s Standard Operating Procedures (SOP).

It is recommended that the current state risk discoveries be photographed as benchmarks and compared against future results. After implementing new SOPs as part of a “risk control” solution, the quarterly, bi-annual, or annual observations will be compared against the benchmarks and prove important during the risk evaluation step. Risk Control: Reduce the Risk Risk control is to fix the problems discovered during risk assessment by reducing the risks to an acceptable level. We have determined the effectiveness of visual observation of the HD processes as a qualitative assessment method. Process mapping brings a visual component to the gap analysis and can also be used as an SOP supplement and employee training tool. An example of a process map defining the HD receiving process can be found in Appendix-3. The Apendix-3 process map could hypothetically portray a current state with chemical parcels being delivered via USP or FedEx through the front door, received by the front retail staff, and the outer shipping box opened in that general space. Receiving and opening a damaged chemical container in a general area outside the negative pressure room could result in an environmental and personnel exposure, so we consider that path to be the wrong model. The corrective future state for receiving HD’s essentially reroutes the receiving process by mapping the chemical parcel to a controlled area of “neutral or negative pressure” per USP <800> guidelines. The process map is solid visual personnel training supplement to the written SOP process. To reinforce an earlier point, all future processes of handling HD’s from to receiving, all the way through dispensing, really need to be examined, observed, and possibly rewritten and retrained.

Reference-2: powder residue

Risk Review: The Case for Establishing a Medical Surveillance Program Establishing a Medical Surveillance program in your facility is a “should” and not a “must” in the USP <800> chapter. While it is a recommendation and not a requirement, your organization may have specific policies you are required to follow. Medical surveillance’s purpose is to minimize adverse effects for personnel exposed to HDs. To determine if a worker has been exposed or is exhibiting symptoms associated with exposure, one must do an assessment of the worker, including physical assessment and documentation of symptoms, physical findings, and laboratory studies to determine if there is deviation from expected norms.1,2 Consistent medical screening is a great risk management strategy and one that could prevent long term repercussions to years of hazardous drug chemical exposures. One question often asked is: “Should all employees have to sign forms acknowledging the risks of handling HDs?” This has been a requirement since Chapter <797> was updated and is required by <800>. Personnel of reproductive capability must confirm in writing that they understand the risks. Whether or not an employee is required to share information about their personal health has not been established, yet we would encourage personnel to refer to their employee health policies or risk management department for further guidance. Even though USP <800> does not require a pharmacy establish a medical surveillance program, there are consistencies between the chapter language and the parameters of a medical surveillance program. Elements of a medical surveillance program for workers exposed to hazardous drugs should include the following:

- Establishes hazardous communication to personnel (required by USP <800> under Section 8)

- Evaluates engineering controls (required by USP <800> under Section 5) - Identifies hazardous drug exposure process (evaluated during risk assessment) - Availability of Personal Protective Equipment (PPE) and appropriate use of PPE - Reproductive and general health questionnaire (completed at time of hire and

periodically thereafter) - History of drug handling (estimate of prior and current exposure, including dates of

duty assignment) - Plan to provide initial baseline clinical evaluation, including appropriately targeted

medical history, physical examination, and laboratory testing for workers identified as being potentially exposed to hazardous drugs.

- A follow-up for workers who have shown health changes suggesting toxicity or who have experienced an acute exposure

Summary Even though the risk assessment has been defined in a process map showing a linear progress through risk identification, risk analysis, and risk evaluation, understand that your actual process may not be as linear. We can’t stress enough that taking pictures of the current state is a beneficial first step towards documenting and implementing mitigation strategies for risk control. One of the steps not defined under risk control on the process map is called “risk acceptance.” Risk

acceptance comes after implementing well designed engineering controls, training employees, and writing SOPs and is an understanding that there is no level of perfection. Unfortunately risk is present wherever healthcare facilities handle HDs. However, an entity handling HDs should continuously strive for process improvement to minimize personnel and environmental exposures to HDs.

Author: Bryan Prince, MBA is the owner and lead consultant at Lab·Red Pharmacy Consultants (website: http://pharmacyworkflow.com/). His early career in containment technology allowed him access to pharmaceutical labs around the U.S. where he gleaned extensive knowledge of chemical handling techniques and safety strategies. Since 2012, Bryan has had the unique experience of observing and advising compounding pharmacies on industry specific best practices relating to workflow habits and technologies. Bryan has published numerous articles on compounding pharmacy workflow design and containment; to include the International Journal of Pharmaceutical Compounding. Bryan has been the invited speaker at conferences on workflow and USP <800> throughout the U.S. and Canada for several compounding related companies, groups, and associations. email: bryankprince@gmail.com

Contributing Author: Ann Barlow Oberg, BS, CPhT is the owner and CEO of Pharmacy Technician Consulting, specializing in the education and training of pharmacy technicians, and preparation of programs for ASHP accreditation. Spending the majority of her career in health-system pharmacy and long-term care infusion pharmacy allowed her to develop strong technical skills and extensive knowledge of sterile compounding. Ann’s background includes information she has gleaned over her 30 years in the profession, including more than a decade of instruction and comprehensive training experience in ASHP accredited pharmacy technician programs. Her expertise as a Certified Instructor in Sterile Compounding and Aseptic Technique (SCAT) has made her a frequent presenter at meetings across the country for pharmacy technicians. She has sat on advisory groups and committees for the American Pharmacists Association (APhA), and American Society of Health-Systems Pharmacists (ASHP), and contributed to the content development for various textbooks and laboratory manuals. Email: obergptconsulting@gmail.com

Appendix-1: Hazardous Drug Worksheet

Appendix-2: Example of a Hazardous Drug Worksheet

Appendix-3: Process Map for Receiving Hazardous Drugs

20-1430-W-D-EN-1-1017

NIVERS~ PHAR RE SEAR

OMPOUNDING EDUCATION CENTER

Mission: The Pharmacy Compounding Research and Educa­tion Center (PCREC) is dedicated to advancing the science and practice of pharmacy compounding by producing research and providing education to fulfill the need for safe, effective, and innovative compounded pharmaceuticals.

As the focus on personalized medicine intensifies and the de­mand for safe and effective personalized medications grows, there is a need for a corresponding advance in the research base, technology, and practice of pharmacy compounding. Pharma­cy compounding involves designing, formulating, and prepar­ing a non-commercially available medication specific to the needs of an individual patient. The Pharmacy Compounding Research and Education Center (PCREC) at Roseman Univer­sity in South Jordan, Utah educates students to meet this need by providing advanced pharmaceutical compounding educa­tion. Additionally, the PCREC is dedicated to advancing the art and science of pharmacy compounding by conducting cutting edge research, consulting on the formulation of complex dos­age forms and drugs on shortage, and offering quality testing of compounded preparations to regional pharmacies and health care institutions. Compounding pharmacies are required to abide by guidelines issued by the United States Pharmacopeial Convention (USP) for the quality assessment of their com­pounded preparations. Testing of compounded preparations is a required component of all quality assurance programs, ac­cording to USP Chapter 1163. Currently, many compounding pharmacies seek out quality testing of end products from con­tract laboratories to demonstrate their commitment to safety and accuracy for both patients and providers, and in anticipa­tion of future regulation. In addition, patient safety concerns spurred the passing of the Compounding Quality Act in No­vember, 2013. This act has led to increased scrutiny of com­pounding pharmacies by the FDA. In a regulatory environment that is rapidly evolving, an academic center to advance the sci­ence and practice of pharmacy compounding through quality testing of compounded pharmaceuticals is needed. In short, the PCREC elevates the quality of pharmacy compounding and thereby improves patient health and outcomes.

ROSEMAN UNIVERSITY 0 F HEALTH SCIENCES

11 Sunset Way I Henderson, NV 89014 I 702- 990-4433

10530 Discover y Drive I Las Vegas, N V 8 913 5 I 70 2-802-2841

10920 S. River Front Parkway I South Jo rdan, UT 84095 I 801-302-2600

roseman.edu I @rosemanuhs ~ ~ IJ

W HAT IT O FFERS:

A. Quality Testing of Compounded Preparations

• Potency

• Beyond-Use Dating (BUD) - Stability

• Endotoxins and Pyrogen Testing

• Microbiological Detection and Sterility Testing

B. Pre-formulation and Formulation Services • Analytical method development and validation

• Drug compatibility with excipients

• Solubility profile, Dissociation constant (PKa), and Log P evaluation

• Dissolution profile in simulated biological fluids

• Particle size and Surface Charge

• Rheology/viscosity

• Oral permeability studies using Caco-2 cell monolayer and isolated tissue Ussing chamber models

• Transdermal permeability studies using Franz diffusion cell system

• Freeze-drying process optimization

• Characterization of drugs by differential scanning calorimetry (DSC), Fourier transform infrared (FTIR) spectroscopy and particle morphology by optical microscopy

CONTACT INFO: Venkata Yellepeddi, BPharm, PhD Co-Director, Pharmacy Compounding Research & Education Center (PCREC) Office: 801-878-1096 I vyellepeddi@roseman.edu

Casey L. Sayre, PharmD, PhD Co-Director, Pharmacy Compounding Research & Education Center (PCREC) Office: 801-878-1126 I csayre@roseman.edu

LOCATI O N: Pharmacy Compounding Research & Education Center (PCREC) Roseman University of Health Sciences 10920 S. River Front Parkway, South Jordan, UT 84095

800 recommendations to the Board of Pharmacy by the Compounding Task Force

State enforcement of 800 by December 2019;

By December 2018

All pharmacies:

Must have a designated HD representative

Must have a HD list for their facility

Must have at least a powder containment hood

Must follow all PPE requirements within the chapter (to be discussed in more detail)

Must follow the cleaning, disinfecting and decontamination steps within the chapter

Changes to 800: Recommendations deal only with Group 2 and 3 of the NIOSH list

Section 2: List of Hazardous Drugs

Box 1: Containment Requirements

*Drugs on the NIOSH list that must follow the requirements of this chapter:

-Any HD API with the exception of the approved risk analysis category list

-Any antineoplastic requiring HD manipulation

*Drugs on the NIOSH list that do not have to follow all the containment requirements of this

chapter if an assessment of risk is performed and implemented include:

-Final dosage forms of compounded …….

-HD API from group 2 or 3 of the NIOSH list that have been approved for a risk analysis

category list

This list includes the following medications:

Estradiol, medroxyprogesterone, methimazole, progesterone, finasteride,

fluconazole, oxytocin, tretinoin, clonazepam, colchicine; spironolactone, and (we as a task

force should go thru meds on the list one by one to determine the approved list). Outside entity

(drug information of IMC and U of U) to review issues related to exposure of the above

medications. Task force will make a proposal for a legislative bill to cover the cost of this

research.

**If an entity chooses to opt out of full 800 the facility must have a medical survelliance

program; Intial and every 2 years; questionnaire would be suffice to show trends; also

recommend we have a pilot study with certain parameters to report. Then we revisit 800 in

2020 for update.

**IF entity chooses to opt out of full 800 and perform a risk assessment for alternative

containment strategies certain items must be followed:

- Must follow all PPE requirements

- Must follow all cleaning, disinfecting, and decontamination steps

- Must have a powder containment hood (vented to outside?)

- Must have a medical survelliance program

- BPR would be to store all medications from the “inclusion list” in a clearly marked

area and to use the same utensils and equipment (including powder containment

hood if possible)

*****Goal to remove all shoulds and only have “Must” included in our Rules to establish clarity and

have less gray areas for pharmacies and inspectors.

*****After 800 Rules are established, task force would like to work with DOPL inspectors and

investigators to create an inspection form and discuss educational opportunities to enhance compliance

****USP has delayed the implementation date of USP 800 to December 1, 2019****