Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker

Home-Study Continuing Pharmacy Education Modules for Pharmacy Technicians

Hazardous Drugs and USP 800 - Reducing Your Risk as a Healthcare Worker

January 2018 Volume 23 Number 1 Expires January 1, 2021 This module must be successfully completed

by December 31, 2020 (at 11:59PM CT)

to receive CPE Credit.

LAW

Pharmacy Tech Topics™ VOLUME 23 NO. 1 | JANUARY 2018

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker AUTHORS: Linda T. Carboni, RPh, BCPS Aryanah M. Carboni PEER REVIEWERS: Katie Gauen, PharmD Emily Wightman, CPhT EDITOR:

Patricia M. Wegner, BS Pharm, PharmD, FASHP

DESIGN EDITOR:

Leann Nelson

Pharmacy Tech Topics™ (USPS No. 014-766) is published quarterly for $50 per year by the Illinois Council of Health-System Pharmacists, 4055 N. Perryville Road, Loves Park, IL 61111-8653. Phone 815-227-9292.

Periodicals Postage Paid at Rockford, IL and additional mailing offices.

POSTMASTER: Send address changes to: Pharmacy Tech Topics™, c/o ICHP, 4055 N. Perryville Road, Loves Park, IL 61111-8653 COPYRIGHT ©2018 by the Illinois Council of Health-System Pharmacists unless otherwise noted. All rights reserved. Pharmacy Tech Topics™ is a trademark of the Illinois Council of Health-System Pharmacists.

This module is accredited for 2.5 contact hours of continuing pharmacy education and is recognized by the Pharmacy Technician Certification Board (PTCB). Cover image property of ©2018 Adobe Stock.

LEARNING OBJECTIVES Upon completion of this module, the subscriber will be able to: 1. Define how a hazardous drug is classified.

2. Describe the responsibilities of personnel handling hazardous drugs, and why reducing the risk of exposure is important.

3. Explain how the USP 800 standards decrease exposure risk in both sterile and non-sterile hazardous drug compounding.

4. Outline strategies and steps to be taken when compiling a hazardous drug list.

5. List at least five (5) common non-antineoplastic hazardous drugs found on the most recent NIOSH list of hazardous drugs and their therapeutic classifications.

ACCREDITATION Pharmacy Tech Topics™ modules are accredited for Continuing Pharmacy Education (CPE) by the Illinois Council of Health-System Pharmacists. The Illinois Council of HealthSystem Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The intended audience is pharmacy technicians.

This module will provide 2.5 contact hours of continuing pharmacy education credit for pharmacy technicians, in the area of law.

ACPE Universal Activity Number: 0121-0000-18-001-H03-T | Type of Activity: Knowledge-based Release Date: 01/01/18 | Expiration Date: 01/01/2021 (Must be completed by 12/31/2020 at 11:59PM CT)

PHARMACY TECH TOPICS — JANUARY 2018 TM

Meet the AuthorS

Linda T. Carboni, RPh, BCPS

Linda T. Carboni received her B.S. in Mathematics from the University of Massachusetts, Lowell and her B.S. in Pharmacy from the Massachusetts College of Pharmacy and Health Sciences in Boston, Massachusetts.

She started her career in pharmacy working in Ambulatory Care full time and home care per diem before transitioning to full time hospital pharmacy. She worked at the public hospital, Maricopa Integrated Health Systems (MIHS), as the inpatient pharmacy supervisor. Mrs. Carboni then worked as a Clinical Pharmacy Manager for HCA, and participated in the Making a Difference in Infectious Disease (MAD-ID) Certificate program in 2010. In 2011 Mrs. Carboni earned BCPS certification and became the first pharmacist to win the HCA Parkland Medical Center Clinical Excellence award. She then became the Pharmacy Regulatory and Compliance Supervisor at MIHS in 2012.

Mrs. Carboni has been an active member of the American College of Clinical Pharmacists (ACCP) since 2007 and served on several committees. Mrs. Carboni has been a reviewer for the Pharmacy Technician’s Letter since 2009. In 2013 she served on the Arizona State Board of Pharmacy Compounding Task Force. In 2014, Mrs. Carboni was a participant at the Institute for Safe Medicine Practice National Summit which led to publishing the Safe Practices for Injectable Drug Administration.

Aryanah M. Carboni

Miss Carboni is a full-time PharmD Candidate, with an anticipated graduation date of 2022 from Massachusetts College of Pharmacy and Health Sciences University in Boston, Massachusetts. Although born in Massachusetts, she moved to Arizona, but was accepted to Massachusetts College of Pharmacy and Health Sciences during her senior year in high school. She moved back to the East Coast, and to her home state, to pursue her educational goals of being a Pharmacist. Miss Carboni's goal after graduation is to do a residency and possible PGY-2 in either ICU or Emergency Medicine. She wants to be an integral part of the hospital team as well as become a teacher and preceptor for future healthcare students.

FACULTY DISCLOSURE. It is the policy of the Illinois Council of Health-System Pharmacists (ICHP) to ensure balance and objectivity in all its individually or jointly presented continuing pharmacy education programs. All faculty participating in any ICHP continuing pharmacy education programs are expected to disclose any real or apparent conflict(s) of interest that may have any bearing on the subject matter of the continuing pharmacy education program. Disclosure pertains to relationships with any pharmaceutical companies, biomedical device manufacturers, or other corporations whose products or services are related to the subject matter of the topic.

The intent of disclosure is not to prevent the use of faculty with a potential conflict of interest from authoring a publication but to let the readers know about the relationship prior to participation in the continuing pharmacy education activity. It is intended to identify financial interests and affiliations so that, with full disclosure of the facts, the readers may form their own judgments about the content of the learning activity.

The author’s submission has been peer reviewed with consideration and knowledge of these potential conflicts and it has been found to be balanced and objective. The author has no real or apparent conflict(s) of interest that may have any bearing on the subject matter of this continuing pharmacy education program.

NOTICE: Medicine is an ever-changing science. As new research and clinical experience broaden our knowledge, changes in treatment and drug therapy are required. The author and the publisher of this work have checked with sources believed to be reliable in their efforts to provide information that is complete and generally in accord with the standards accepted at the time of publication. However, in view of the possibility of human error or changes in medical sciences, neither the authors nor the publisher nor any other party who has been involved in the preparation or publication of this work warrants that the information contained herein is in every respect accurate or complete, and they are not responsible for any errors or omissions or for the results obtained from use of such information.

Readers are encouraged to confirm the information contained herein with other sources. For example and in particular, readers are advised to check the product information sheet included in the package of each drug they plan to administer to be certain that the information contained in this module is accurate and that changes have not been made in the recommended dose or in the contraindications for administration. This recommendation is of particular importance in connection with new or infrequently used drugs. Always refer to changes in federal law and any applicable state laws.

Pharmacy Tech Topics™ Steering Committee*

Laura Acevedo, PharmD Margaret DiMarco Allen, PhD Amanda D. Daniels, BS, CPhT Sandra Durley, PharmD

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Ana Fernandez, CPhT Clara Gary, CPhT Jo Haley

Elina Pierce, CPhT Jan Keresztes, PharmD, RPh Scott Meyers, RPh, MS, FASHP

Patricia Wegner, BS Pharm, PharmD, FASHP

*Acting committee for 2016, responsible for selecting 2018 module topics.

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker Introduction How Did USP 800 Come About?

In 1997 President Bill Clinton signed the Food Drug Administration Modernization Act1. Inside this law is a section, 503A, which gives information regarding pharmacy compounding. The law states that compounding needs to be done with ingredients that comply with standards from the United States Pharmacopoeia or National Formulary (USP-NF) monograph (if one exists) and the United States Pharmacopoeia chapter on pharmacy compounding1.

The United States Pharmacopeia Convention (USP) is a not for profit organization that sets standards for medications, food, and dietary supplements. The standards that they set are considered enforceable in the United States (US) by the Food and Drug Administration (FDA)2 and help ensure public and employee safety. It is important to know that when a manufacturer purchases a bulk supply of a medication and a “standard” amount is weighed out, it contains the exact amount of active drug that it should. Think of it in terms of baking. If a recipe calls for 15mg of baking soda, there needs to be some assurance that the box of baking soda purchased at the grocery store, when weighing out 15mg, will have the correct amount of baking soda, and not some other ingredient, like baking powder or flour, that does not belong there. If it does not have what it should, the recipe will be compromised and the end product will not come out as it should. In terms of medicine, if a drug does not have what it should, then patients who need to take this medication may be under-dosed or overdosed. Because the medication may be over or underdosed, the concentration can change with each batch of drugs that is made, making it unsafe for patients. The standards that USP set forth are legally recognized, and used by the FDA, as well as the state boards of pharmacy, and other accreditation boards, like Joint Commission.

The first publishing by USP regarding pharmacy compounding was USP 1206. This dealt with Sterile Drug Products for Home Use. In 2004, USP 797: Pharmaceutical Compounding – Sterile Preparations was published and USP 1206 was retired. Currently, the only published update to USP 797 was in 20083. USP 797 had a section that reviewed hazardous drugs as compounded sterile products and specifically states that preparation must be done under conditions that protect healthcare workers4.

Until recently, USP 797 was the only standard for sterile compounding. That changed when USP 800 Hazardous Drugs – Handling in Healthcare Settings was published in 20165 with an anticipated enforceable date of December 20196. Initially scheduled to be enforceable July 1st, 2018, this deadline has since been postponed to align with updates to the USP 797 chapter. The USP 800 chapter extracts what was already in USP 797 related to hazardous drugs and expands upon it. The purpose of USP 800 is to institute standards for the handling of hazardous drugs, which will protect the healthcare worker, patients, and the environment. The chapter is broken down into 19 sections; the ones that will be covered in this module include: List of Hazardous Drugs, Responsibilities of Personnel Handling Hazardous Drugs, Personal Protective Equipment, Personnel Training, Compounding, and Documentation and Standard Operating Procedures.

Hazardous Drugs How They Are Listed And Categorized

It would be a lot of work for USP to continuously remake a list of hazardous drugs. Instead of constantly reinventing the wheel, they look to the National Institute for Occupational Safety and Health (NIOSH), which falls under the oversight of the Center for Disease Control (CDC), because they review all drugs on the market and update their hazardous drug list every few years. The

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CDC and NIOSH are in charge of publishing, reviewing, and updating the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.” The first time it was published was 2004, and the latest version was released in 20167. The idea is to add in new drugs, as well as review older drugs for any changes based on studies, reports, industrial standard changes, etc. Because of the nature of this publication, and being that it is part of the CDC, each update must first be published in the Federal Register; a comment period is open for approximately two months and anyone may submit comments regarding the proposed changes.

Comments may include agreement, disagreement, or concern with any piece of the recommendations, and why. The comments are taken into consideration before publication.

The list of antineoplastic and hazardous drugs is quite extensive and is broken down into three groups8.

You need to understand why items are listed as hazardous before you can understand the grouping.

All medications listed are considered hazardous, but handling precautions may be different. To understand why medications are grouped as they are, you need to look at how NIOSH defines what a hazardous drug is.

The original definition of hazardous drug was developed in 19908, but since then, the industry has changed. In this day and age, there are drugs that have been engineered and that do not exactly fit the definitions, but still need to be considered hazardous. Instead of just having a flat definition, like one you would find in the dictionary, NIOSH looks more at the characteristics of hazardous drugs. If any drug has even one characteristic, then it is considered hazardous. These characteristics are as follows8: 1. Carcinogenicity – the drug is known to cause cancer.

2. Teratogenicity – the drug causes birth defects.

3. Reproductive toxicity – the drug interferes with normal reproduction, including causing problems with normal sexual function as well as fertility.

This toxicity may be seen in males, females or both.

4. Organ toxicity at low dose – although all medications have toxic side effects, this is specifically looking at medications that require a

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few milligrams or less to cause organ damage.

5. Genotoxicity – the drug damages the cell’s genetic (DNA, RNA) material.

6. Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria – if a new drug is approved and it works similarly to a drug that is already known to have one or more of the characteristics (1-5) above, then it will be considered hazardous.

Based on the six above criteria, NIOSH has taken all hazardous medications and put them into one of the following three groups: Group 1, antineoplastic drugs (drugs that are used to treat cancer); Group 2, nonantineoplastic drugs, but meet one of the six criteria listed above; or Group 3, drugs that pose reproductive risks to those men and women trying to conceive, to women who are already pregnant, or to women who are breast feeding.

It is important to understand how NIOSH has grouped medications because one requirement for USP 800 is that each facility must maintain their own list of hazardous drugs (HDs), and review the list at least annually. The review will help the facility look at any new drugs or dosage forms they have brought into their facility. An example of a new dosage form is when you have already done the analysis of a drug on your list, and it came in tablet form, but now the FDA approved a liquid form. You may already have the liquid on your shelf, now you just need to ensure that liquid was added to your list of HDs. For the purposes of this module, investigational drugs will not be discussed even though they may be subject to the rules of being a hazardous drug and fall under USP 800.

How To Make Your Own List Of Hazardous Drugs Assess Exposure To Drugs Where do you start to make this list? First you need to consider all aspects of how a person may be exposed to HDs. Think about the acts of receiving drugs, dispensing, compounding, transporting, administering, and other patient care activities (e.g. staff that may have

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker

Test Your Knowledge #1

Crossword Puzzle on Hazardous Drugs

ACROSS 2. The Hazardous Drugs list should be reviewed at least ______.

5. The category of drug which damages the cell's genetic material.

7. The category of drug which causes organ damage at a low dose.

8. The category of drug which causes birth defects.

DOWN 1. NIOSH looks at the ______ of hazardous drugs, instead of giving a flat definition.

2. The category of drug used to treat cancer.

3. The category of drug which interferes with normal reproduction.

4. The category of drug known to cause cancer 6. There are _____ groups NIOSH puts Hazardous Drugs into.

Answers on page 24.

to handle urine, sweat, or vomit). Think of each step and really take apart each step and what could happen.

What happens when drugs come into the pharmacy?

How are the boxes or totes brought in? What if a vial of a HD breaks during shipment? How are they put away? Where are the possible risks? Now that the drug is put away, what about dispensing? If it is a tablet, how is the risk for exposure different than a powder that may require reconstitution? In regard to compounding, each step in the compounding process must be carefully considered. Is it a tablet you are crushing to make a suspension? Is it a powder you are reconstituting to make a Compounded Sterile Product (CSP)? These are just some of the many factors that must be put into consideration while making a HD list.

Inventory and Assessment Of Drugs Next, you need to do an inventory and assessment.

Consideration for how a person may be exposed is part of the assessment. Look at each drug you have on hand, the type of HD it is (as grouped by NIOSH), what the dosage form is (tablet, liquid, injectable), how it is manipulated before being dispensed, and finally, what the risk of exposure is for all the healthcare workers involved. Medications that come in a tablet form packaged by the manufacturer, where the only thing required for dispensing is to count out the correct number of tablets needed, will be easy to assess. If you think about it, how could a healthcare worker be exposed to the drug? If there is dust from the tablets, then you

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have a risk of inhaling or having skin contact with the dust. How could you prevent accidental exposure to this drug? Using gloves, long sleeves, and a mask would help protect the person counting out these tablets, and then subsequent cleaning of the counting tray. Now think of something that requires more manipulation before it is given to the patient. What if you have to compound a suspension from tablets? Now you are crushing tablets and causing more dust that you can inhale or have skin contact with. On top of that, what if someone else is in the area? The drug powder, from crushing the tablets, does not just hang in limbo. It can be moved by the heat or air conditioner, or the movement of air just from someone walking. Now the dust is not contained in the bottle it came in and the small surrounding area; while you are crushing the tablets, it can go just about anywhere. How do you contain it? To minimize this risk, tablet crushing of HDs should be done in a hood that will carry the particles out and away from people.

More information about hoods will be given later; for now, the assessment and exposure risk, in order to aid in understanding how to generate a hazardous drug list, will be reviewed.

is on the floor, and you have to dispose of it properly.

More detailed information regarding spills and how to handle them will be given later on, in the section that details personnel’s responsibilities.

Drug Preparation

Once items are put away in inventory, they will then have to be either compounded or dispensed, depending on how the drug is given to the patient. Dispensing, as stated earlier, may generate powder while counting out the drug for final dispensing. Compounding has more risks. Non-sterile compounding, as stated above, may be risky because of the need for crushing of tablets; sterile compounding has another set of risks. Both sterile and non-sterile medications may require reconstitution before further preparation. If the drug is in a vial, the contents will have to be withdrawn and injected into a bag, and there may be air in syringes that needs to be expelled. Once compounding is complete, there may be residue on the compounder’s gloves, gown, or on any other Personal Protective Equipment (PPE), if the drug was in the air. If a needle and syringe were to be used, there is the added risk of a needle exposure, and this is Think of all the ways someone can be exposed to why a closed-system transfer device (CSTD) should be hazardous drugs. The most logical way is to track how used. This module will explain closed-system transfer a drug comes into the facility and then moves through devices a little later when training is addressed. it until it is dispensed to the patient, or administered by Drug Administration another healthcare worker (nurse or physician).

Procurement and Storage Starting at the beginning, the drug comes into the facility from a wholesaler or manufacturer. It is possible there is some drug residue on packages, on boxes, on shipping containers, etc. There is also the possibility that a bottle opened or a vial broke during transportation to the facility, or while inside the facility. How can exposure be avoided? Personnel should be bringing the shipping containers as close to the storage areas as possible. This way they are not walking with glass vials or loose caps with a risk of items slipping out of their hands or tripping and dropping the hazardous drug, causing a spill. Spilling of hazardous drugs is another source of possible exposure. You now have the risk of hazardous drug in the air, you have to clean up what

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Finally, once the drug is all ready for the patient, there is the risk to a nurse if the drug is being administered in a clinic or hospital. There may be an issue with the patient’s IV line, causing a spill. If administering something orally, the nurse may have to open a unit dose blister package and there is the risk of touching the tablets. Think of other ways drugs can be administered and what the risks are. What if the drug is to be injected by a provider during surgery? What about if the drug is administered into the bladder? What about an IV bag that needs to be primed prior to administration?

What about the patient’s bodily fluids? What about the patient’s clothing and linen?

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker Figure 1. Hazardous Drug Assessment Chart Generic Name

Dosage Form Brand Name (Tab, Cap, Susp, Inj)

Compounding Required

Documentation Tool It may be easier to understand if a chart is used to look at each drug and assess the possible areas of exposure for all healthcare workers. Figure 1: Hazardous Drug Assessment Chart is a chart that can be used for assessment. It takes into account how the drug is received (dosage form), if compounding is required before dispensing, if it is on the NIOSH list, the risk level (low, medium or high), PPE that should be used (for example: gloves, mask, gown, hair bonnet and booties), if it must be compounded in a hood, and finally a column for any added notes.

Review Package Inserts

Listed in NIOSH

Risk (L,M,H)

PPE

Hood

Notes

and review the pregnancy, lactation, and reproductive sections. In 2014, the FDA released labeling requirements for human prescription drugs and biological products.

These requirements became enforceable in June of 201510. Each product must contain information to help physicians and allied health providers assess the risk versus benefit of a drug being given to men or women who are trying to conceive, those who are pregnant, and those who are lactating. Any drug that was on the market prior to this ruling was assigned a letter.

Since it takes time for data and other information to be updated, some package inserts may still have these letter designations appear. If the package insert you are reviewing has a letter for pregnancy category, Table 1 lists what they mean11.

A quick way to assess possible issues with a drug is The problem is that many health care professionals to review the package insert or labeling information, misunderstood the system, and just thought it was Table 1. FDA Pregnancy Categories11 CATEGORY FDA CLASSIFICATION OF SAFETY

EXAMPLES

A

"Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters)."

pyridoxine (vitamin B6)

B

"Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women."

diphenhydramine (Benadryl)

C

"Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks"

guaifenesin (Mucinex, Humibid LA)

D

"There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."

aspirin

X

"Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits."

leflunomide (Arava)

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a ranking system of “good” to “bad”. It was not fully understood that Category C does not mean it is “worse” than Category B, but that there were true differences based on published case reports or studies. This is the reason the FDA wanted to move away from a letter system and require sections in the package insert that discuss the true risk, based on studies, to those wishing to conceive, those who are pregnant, or those who are nursing. Understanding the categories can at least help with understanding the hazardous drug classifications, because if a drug is labeled as category D or X, it should be present on the NIOSH list.

Review Common Drugs Instead of assessing easy examples of medications, like chemotherapy (antineoplastic) drugs, which are already known to be inherently hazardous, start to review some of the common drugs that typically make appearances in the top 200 dispensed drugs and see how the assessment is done.

Table 2 shows how each drug should be reviewed. Many drugs in the top 200 do not appear on the NIOSH list, so the facility may decide to do their own assessment of the drug. For example, lisinopril, oxycodone, sumatriptan,

Table 2. Assessment Examples GENERIC NAME

BRAND NAME

DOSAGE FORM (TAB, CAP, SUSP, INJ)

COMPOUNDING REQUIRED

LISTED IN NIOSH

RISK (L,M,H)

levothyroxine

Synthroid

Tablet

No

No

Low

estrogens, conjugated

Premarin

Tablet

No

Yes

Low

paroxetine

Paxil, Brisdelle

Tablet

No

Yes

Low

fluconazole

Diflucan

Tablets, Suspension

Liquid requires reconstitution

Yes

Low

phenytoin

Dilantin

Tablets, Suspension

No

Yes

Low

azathioprine

Imuran

Tablet

No

Yes

Medium

azathioprine

Imuran

Suspension

Yes

Yes

High

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Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker carisoprodol, and bupropion do not appear on the NIOSH list. Other examples of non-chemotherapy (non-antineoplastic), oral agents that appear on the list (and why) are included in Table 3 on page 10.

tablet in a single blister (unit dose), other medications come in a bottle with the correct number of tablets for a month’s supply (unit of use). Then there are birth control pills, which are both unit dosed and unit of use.

Other examples include: an injectable in a vial, prefilled Review Types of Dosage Forms syringe, or injectable pen form that the pharmacy does not draw up or manipulate in any way before dispensing; Although many medications appear on the NIOSH or a bottle comes in the exact number of tablets for a list, a facility may stock them in a blistered, single dose one-month supply and the entire bottle is dispensed as packaging, or what is called “unit of use” and may not is without opening. Since these items are secured in a require any precautions while handling, as the drug is way that prevents contact with staff for preparation and not touched by the person dispensing. For example, dispensing, no PPE would be needed by pharmacy staff. some medications come in a blistered package with each If the medication is being administered by a member of

PPE

HOOD

NOTES

N/A

N/A

It is not listed on NIOSH, there's no need to handle as hazardous

No

This particular brand of tablets is coated and therefore there is low risk of powder. If another estrogen is being reviewed, and it is an uncoated tablet that tends to break, then a mask may be needed. If you are dispensing in a self-contained blister pack, like those oral contraceptives come in, then gloves are not needed because there’s no risk of touching the tablets

Estrogens are listed in NIOSH 8 because the drugs have a black box warning regarding risk of endometrial cancer and long-term use may cause cancer, and they are classified as Pregnancy Category X. Therefore, they are considered carcinogenic.

No

Mask may be optional, depending on the tablets.

If there is a particular brand/generic that breaks often, it may be needed.

Paroxetine is listed in NIOSH because there is a risk of congenital abnormalities when taken in the first trimester of pregnancy and may cause complications if taken during the third trimester.

This drug is a pregnancy Category D, because it is considered teratogenic.

Gloves, Mask for reconstitution

No

Fluconazole is a pregnancy category D (when used Some fluconazole comes in unit dose packages; in high doses only; otherwise, it is still category C) therefore, no gloves or mask would be required as and there have been case reports of teratogenicity there is no risk of touching the medication. when taken during the first trimester.

Gloves

No

Phenytoin's suspension does not require reconstitution, if a large stock bottle is used must be properly wiped down after each dispensing

Phenytoin is classified as possibly carcinogenic to humans and pregnancy category D.

Gloves mask

No

Tablets tend to break and powder, therefore gloves and mask are needed.

Pregnancy Category D, carcinogen

Full

Yes

Not commercially available. Tablets must be crushed to a fine powder before adding liquid to make a suspension

Gloves

Gloves, Mask

ADDITIONAL NOTES

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Table 3. Non-Antineoplastic Drugs on NIOSH List11 DRUG REASON risperisone Evidence of tumors at low dose (Risperdal) in laboratory studies progestins They are pregnancy category X There is a black box warning carbamazepine including congenital malforma(Tegretol) tions and pregnancy category D There is a risk of congenital abclonazepam normalities in the first trimester, (Klonopin) and it's a pregnancy category D There is a black box warning liraglutide for thyroid cancers and labora(Victoza) tory studies showed teratogenic nature

PPE based on the formulation of the drug and what is being done, from receiving to administration. For example, if an intact hazardous drug is a tablet, and is being administered, then the only PPE needed would be a single set of gloves. If an oral liquid is being compounded with a hazardous drug, then PPE needs to include two sets of chemotherapy-rated gloves and a protective gown; it must be compounded in a hood with proper ventilation. If compounding is not able to be done in a Compounding Aseptic Containment Isolator (CACI), then eye, face, and respiratory protection will also be needed9. Any time a new drug is brought into the facility; this full review should be done before purchasing. It is important to know what risks are associated with the medication, and what PPE is required, before the drug gets to the shelf.

the nursing staff, they should always wear at least gloves when removing medications from packaging.

Personnel

Review Patient Populations

What are the Responsibilities of Personnel Handling Hazardous Drugs?

The next thing to assess relates to the patient population that the facility serves and the kind of compounding of both sterile and non-sterile products that may be needed. Those facilities with a high population of pediatric patients may require special oral dosing, or intravenous chemotherapy that is patient and dose specific. Look at specific items that are compounded and check the NIOSH list for precautions that will be needed. For example, if a patient needs a ganciclovir suspension then a compound will have to be made. It is ideal if the intravenous formulation can be used orally to avoid compounding, but if that is unavailable, then the capsules will have to be opened, and a suspension must be compounded. For this, PPE should at least include gloves, a mask, and a gown. Additional requirements may be specified at each pharmacy. Since the capsules must be opened and crushed, it must be done in a hood, to ensure any powder that is made during crushing is properly vented and removed from the area. After compounding, the bottle must be properly cleaned and labeled.

Once you have assessed each drug, you need to think about each person who handles HDs, as well as each step in the process from receiving to dispensing, or administration. Each facility needs to designate a single point of contact person who will be responsible for all pieces of USP 800. There should be a single person who is developing and reviewing policies and procedures, coordinating the generation of the list of hazardous drugs, and ensuring all personnel who touch HDs have been educated and understand all aspects of their job in relation to these HDs. It is vital for this person, who understands all the policies and procedures, to be able to communicate every aspect of their program. This person needs to understand where to find Safety Data Sheets (SDS), which used to be called Material Safety Data Sheets (MSDS), and ensure employees know where to find these in case of a spill or exposure. There should be a written plan that can be shared with everyone on how the standards, policies and procedures are being implemented, and a timeline for implementation. It should explain how personnel will be educated, trained, and signed off before working with hazardous drugs.

NIOSH has provided information in a table at the end of All this work may seem tedious. Breaking down each the hazardous drugs list. The table reviews recommended step in the HD handling process and working out what

10

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker the risks are can seem overwhelming. To make it easier, The Occupational Safety and Health Administration (OSHA) has a process called a Job Hazard Analysis (JHA)13. The JHA helps the person filling out the form to think about steps in a process and then decide what can be done to remove or reduce the hazards that are identified. An example of a JHA is something as simple as counting out a hazardous drug. Identify the risk – the stock bottle is opened and broken tablets are found. The potential hazard is the powder making contact with skin or being inhaled. To control this, the person dispensing should wear long sleeves, gloves, and a mask. Next, look at the tray used to count out the medication; it may contain traces of a previous drug on it, and should be cleaned prior to use. The process can be broken down to the smallest steps. It can be stated that if there is residue on gloves after counting, residue may be transferred to the outside stock bottle or prescription bottle. Personnel should wipe down the prescription vial before labeling, and the stock bottle should be wiped down before returning it to the shelf, so the next person is not exposed to the residue. Next, what is the risk due to the last person failing to wipe down the stock bottle? Gloves should be donned before retrieving the stock bottles from the shelf. It is always better to be safe than sorry.

It is easy to forget steps, which is why the JHA is helpful.

Once the drug is received, what is the risk associated with the storage of HDs? Where is the risk? What if the items are placed on a shelf above the average employee’s head? There is a risk of items falling during retrieval.

What if boxes of medications are stacked on the shelf?

There is a risk they could topple over and break. Figure 2 on page 12 is a blank JHA that you may use to help you with this process. There is even a spot to have personnel sign the JHA. This can be used to ensure each person who handles HDs has acknowledged their role and risk when handling JHAs. Each person would sign a JHA for each step they perform. For example, if they only receive HDs they would sign that one. If they compound, that is another JHA. If they deliver HDs to other personnel for administration, it is another, etc. See Figure 3 on page 13 on how to complete a JHA. Once complete, the USP 800 coordinator can use the JHAs as part of orientation

of new employees or for annual review and competency.

The other part of the JHA that should be addressed is how to deal with any of the risks that have been identified. For example, how are broken shipping containers handled? What if broken items go unnoticed and the shipping container is opened? How should these exposures be handled? USP discusses these issues in the training section of USP 800 and this module will do the same.

How Do You Protect Yourself?

Personal Protective Equipment (PPE) PPE, or personal protective equipment, is exactly what it sounds like. It is any equipment used to protect a person from whatever activity is being performed. In the case of USP 800, PPE is specifically used to reduce exposure of any HD that may have gone into the air or residue on surfaces such as packages, boxes, and shipping containers, etc. If your facility does any kind of sterile compounding, you already are aware of the requirement of gloves, gowns, head/hair coverings, and shoe coverings. Going back to each step in the process (receipt, storing, transporting compounding, administering, general cleaning or spill cleaning), what do you think may be needed?

Gloves Gloves are the most common PPE used and are needed for every step when working with HDs. Check the box of gloves. If you are working with chemotherapy medications, the box should be marked that they have been tested with chemotherapy drugs. When you put gloves on, do not just put them on and begin your task.

Inspect them. Make sure there are no holes or issues, and if personnel are compounding chemotherapy, then gloves must be changed every 30 minutes or if they become contaminated, torn or punctured9. Depending on the activities being performed, USP 800 requires chemotherapy gloves tested to meet the American Society for Testing and Materials (ASTM) standard D697813.

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PHARMACY TECH TOPICS — JANUARY 2018 TM

Figure 2. Job Hazard Analysis Worksheet JOB HAZARD ANALYSIS WORKSHEET Job / Task: Job/ Location: PPE Required:

Date: Completed By:

Sequence of Basic Job Steps [Part 1]

Potential Hazards of Each Job Step [Part 2]

Plan to Control or Eliminate any Hazard(s) [Part 3]

1.

2.

3.

4.

Employee Comments:

Signatures of Employees Verifying the Review for Potential Hazards Print Name

Signature

Print Name

Signature

All employees performing the above task have been trained on this JHA. Manager’s Name (print)

Signature

Date

Attachment A - Page 1 of 2

Reviewed: March 2016

Source: Maricopa Integrated Health System. Reprinted with permission. March 2017

Gowns

requirement for shoe covers is slightly different than with USP 797 (for sterile compounding). For USP 800, a second pair of shoe covers must be used before entering the buffer room and removed when exiting the buffer room for any HD compounding. Shoe covers worn in any HD handling area must not leave the area as there is a risk of HD residue being on the shoe coverings and therefore spread the HD contamination.

Gowns should also be checked to ensure they were tested to be used when working with HDs. Coats or other gowns should never be substituted for disposable HD gowns. Cloth can absorb HDs and hold it against the skin. Disposable, long sleeve gowns that are coated, have elastic cuffs, and close in the back are best and should never be worn out of the HD handling area.

These gowns must be changed every 2-3 hours or if it Goggles

becomes soiled or contaminated9.

Anyone compounding HDs needs to ensure their face and eyes are protected from any kind of dust, particles, Hair And Shoe Covers splashes, or any other type of possible exposure.

Head and hair covers (masks and bonnets) include Hazardous drugs may be irritating and if any drug covering for beards and moustaches, if applicable. The splashes or spills, it can get in the eyes or on facial skin.

12

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker Figure 3. Instructions for Completing Job Hazard Analysis Worksheet JOB HAZARD ANALYSIS WORKSHEET INSTRUCTIONS FOR COMPLETING JOB HAZARD ANALYSIS WORKSHEET Sequence of Basic Job Steps [Part 1] Break the job task(s) down into steps. Each of the steps of a job should accomplish some major task.

The task will consist of a set of movements. Look at the first set of movements used to perform a task, and then determine the next logical set of movements. For example, the job might be to move a box from a truck in the receiving area to a shelf in the storage area. How does that break down into job steps? Picking up the box from the truck and putting it on a hand truck is one logical set of movements, so it is one job step. Everything related to that one logical set of movements is part of that job step.

The next logical set of movements might be pushing the loaded hand truck to the storeroom. Removing the boxes from the truck and placing them on the shelf is another logical set of movements. And finally, returning the hand truck to the receiving area might be the final step in this type of job.

Be sure to list all the steps in a job. Some steps might not be done each time – checking the casters on a hand truck, for example. However, that task is a part of the job as a whole, and should be listed and analyzed.

Number the steps. The number will provide a reference point for the hazards and procedures developed.

Potential Hazards of Each Job Step [Part 2] Identify the hazards associated with each step. Examine each step to find and identify hazards - actions, conditions and possibilities that could lead to an accident.

Number hazard list to correspond with your steps.

It is not enough to look at the obvious hazards. It’s also important to look at the entire environment and discover every conceivable hazard that might exist.

Be sure to list health hazards as well, even though the harmful effect may not be immediate. Ex: the harmful effect of inhaling a solvent or chemical dust over a long period of time.

It’s important to list all hazards. Hazards contribute to accidents, injuries and occupational illnesses.

In order to do Part 3 of a JHA effectively, you must identify potential and existing hazards. That’s why it’s important to distinguish between a hazard, an accident and an injury. Each of these terms has a specific meaning: HAZARD: A potential danger. (E.g. oil on the floor is a hazard).

ACCIDENT: An unintended happening that may result in injury, loss or damage. (E.g. slipping on the oil is an accident).

INJURY: Damage or harm done. (E.g. a sprained wrist from the fall would be an injury).

Plan to Control or Eliminate any Hazard(s) [Part 3] Using the first two columns as a guide, decide what actions are necessary to eliminate, minimize or monitor the hazards that could lead to an accident, injury or occupational illness.

List recommended safe operating procedures on the form, and also list required or recommended personal protective equipment for each step of the job.

Be specific. Say exactly what needs to be done to correct the hazard such as “lift” using your leg muscles”. Avoid general statements like, “be careful”.

Give a recommended action or procedure for every hazard.

If the hazard is a serious one, it should be corrected immediately. The JHA should then be changed to reflect the new conditions.

Some people find it easier to identify possible accidents and illnesses and work back from them to the hazards. If you do that, you can list the accident and illness types in parentheses following the hazard. But be sure you focus on the hazard for developing recommended actions and safe work procedures Attachment A - Page 2 of 2

Reviewed: March 2016

Source: Maricopa Integrated Health System. Reprinted with permission. March 2017

Clean room hoods that are meant to be used during HD compounding have a glass shield, but personnel administering these compounds to patients should have a splash shield and goggles to avoid exposure in case of an issue during infusion9.

Respiratory Masks

Respiratory protection has several components. During compounding in a negative pressure environment, and in a hazardous drug hood with a face shield, a surgical mask is adequate protection. If there is a spill and there are particles, then a NIOSH certified N95 mask may be needed9. There are other requirements for respiratory protection in case of a spill or if personnel are unpacking hazardous drugs that are not contained.

For in depth information, the occupational health department at your facility should be consulted. Under normal circumstances in a health care facility, these kinds of masks are not usually required14.

Environmental Controls

Environmental controls are anything that controls the area you work in. These can be items as simple as the heating and cooling systems, but also include design features meant to limit the risk of on the job injuries.

There are certain environmental controls that are part of USP 797 that are meant to limit the risk to patients by keeping products sterile, and in USP 800 to limit the risk to healthcare workers. Compounding rooms and hoods are a very important part of safety and are

13

PHARMACY TECH TOPICS — JANUARY 2018 TM

Test Your Knowledge #2

Do You Know Your Acronyms?

TERM

ACRONYM

1. American Society for Testing and Materials

A. OSHA

2. Safety Data Sheets

B. JHA

3. Closed-System Transfer Device

C. NIOSH

4. Material Safety Data Sheets

D. PPE

5. High Efficiency Particulate Arrestance

E. HD

6. Biological Safety Cabinet

F. CSTD

7. Compounding Aseptic Containment Isolator

G. HEPA

8. Hazardous Drug

H. CACI

9. The National Institute for Occupational Safety and Health

I. BSC

10. Personal Protective Equipment

J. ASTM

11. Job Hazard Analysis

K. MSDS

12. The Occupational Safety and Health Administration

L. SDS Answers on page 24.

considered part of environmental controls.

Hoods Both USP 797 and 800 refer to two different kinds of hoods: a Biological Safety Cabinet (BSC), and a Compounding Aseptic Containment Isolator (CACI), which is also referred to as a glove box (because you put only your hands and arms in the box). The BSC is a hood that is placed inside a sterile room and is open with a glass shield that slides up and down.

Rooms

There are two different sterile room pressures that can be used. Positive pressure rooms have an air flow that pushes the air out of the room into surrounding rooms.

This keeps particle contamination from entering the room to a minimum. Negative pressure rooms allow the air to flow into the room but not out to surround-

14

ing rooms. The air is removed from the area, or hood, and then pulled through to outside air, or it is filtered and then can be returned to the room. In the case of hazardous drugs, they are to be compounded in a negative pressure room where the air is evacuated through special high efficiency particulate arrestance filters, called HEPA filters and vented to the outside. In USP 797, if a CACI is being used, it can be placed in a nonpressurized or positive pressure room, because all of the compounding is done in a controlled environment. For HDs and USP 800, that is not the case. Even if all compounding is being contained in a CACI, and the air is being properly vented through HEPA filters to outside air, the CACI must still be in a negative pressure room.

These pressure controls protect sterile compounds from cross contamination, because the air is moving and being pulled out of the compounding area, as well as protecting healthcare workers from accidental exposure to any HDs that wind up in the air during compounding.

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker

Closed-System Transfer Devices

drug to the bag, should spike the bag and run the plain IV fluid through the lines before starting to compound.

Other than the pressured rooms and PPE, there is one This way, when a nurse is attaching the IV line to the other item that is essential in protecting the healthcare patient, if a few drops spill, it is plain fluid, not the drug. worker from accidental exposure to hazardous drugs.

It is referred to as a Closed-System Transfer Device There are multiple vendors who supply CSTDs. To (CSTD). These devices may also be referred to as view images of various devices, type in “closed-system transfer devices” in the search box of your web needless systems, but that is not completely accurate. browser, then click on “Images” to view various A CSTD mechanically prohibits the transfer of products. Vendors include, but are not limited to, environmental contaminants into the system and the BD Medical Inc, BBraun Medical Inc, Equashield LLC, ICU Medical Inc and Teva Medical Ltd. You escape of hazardous drugs or vapor concentrations may also put these vendor names in the search field outside the system. USP 800 recommends the use of to learn more about their products.

CSTDs for compounding, but it is not a requirement14.

A CSTD is a system that is used instead of a traditional needle and syringe to transfer a drug from a vial to Training its final container; for example: IV bag, continuous infusion cassette or syringe. The system has several Training of staff is very important and the process of how pieces; each one works so that, unless the system is staff must be trained to reduce the risk of HD exposure properly engaged, the drug cannot move from one needs to be reviewed by each health care facility. part to another. NIOSH originally discusses the use of closed-system drug transfer devices in its 2004 version Shipping And Receiving of Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Healthcare Settings15. Drugs are ordered from a wholesaler or manufacturer The closed-systems come with pieces that attach to and received in the pharmacy. There is usually a the drug vial, the syringe used for drug transfer or designated receiving area in a pharmacy for all supplies. administration, the IV bag, and the connection to the Items that are hazardous should be properly labeled and patient. There are various companies that make CSTDs, identified on the shipping containers to ensure they are and each has its own way of engaging or disengaging the handled carefully. Hazardous drugs should be received system. The purpose of the entire system is to remain and stored in a separate and designated area. In this closed so no particles or vapors escape. When air is HD area, there should be PPE for the person receiving needed in the system to ensure the drug can flow out of the shipment. Now, take a moment to think about what the vial, it must be added before any compounding can may have happened during shipping. What if there start. The system locks and you cannot pull or push the were broken vials or bottles opened? Hazardous drugs plunger on the syringe once the system is in place. With may be removed from their containers in a normal CSTDs, priming the bag at the outset is important. pressure or negative pressure area, but not in sterile

compounding areas. USP 800 spells out exactly how to One potential risk for exposure for staff is during the handle any containers that were broken during shipping. administering of a drug. If an IV bag is not primed, the It delineates how staff must handle the shipment if the nurse must do this prior to attaching the medication to outer container is damaged. There is always a risk that the patient. If the drug is mixed in the bag, this means items may be damaged in shipping, so it is best if the you may cause a spill, as usually several drops of fluid designated HD area is in a room that is under negative spill from the end of the line before attaching to the pressure. Again, this area should not be the same area patient. If a closed-system is properly attached, it is for sterile compounding, and any damaged items should impossible to open and free-flow the fluid through the be handled the same as if it were a hazardous drug spill. line, therefore, the pharmacy staff, prior to adding any See Table 4.

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PHARMACY TECH TOPICS — JANUARY 2018 TM

Table 4. Summary of Requirements for Receiving and Handling Damaged Hazardous Drug Shipping Containers - USP 40-NF35, General Chapters: <800> If the shipping container appears damaged • Seal container without opening and contact the supplier for instructions • If the unopened package is to be returned to the supplier, enclose the package in an impervious container and label the outer container "Hazardous" • If the supplier declines return, dispose of properly If a damaged shipping container must be • Seal the container in plastic or an impervious container opened • Transport it to a C-PEC and place on a plastic-backed preparation mat • Open the package and remove usable items.

• Wipe the outside of the usable items with a disposable wipe.

• Enclose the damaged item(s) in an impervious container and label the outer container "Hazardous" • If the supplier declines return, dispose of properly • Decontaminate/deactivate and clean the C-PEC (see Deactivation/Decontamination, Cleaning, and Disinfection) and discard the mat and cleaning disposables as hazardous waste Source: ©2016 U.S. Pharmacopoeial Convention. Reprinted with permission July, 2017.

Once items have been unpacked, they must be properly stored. When storing any hazardous item, the location must be carefully considered. If items are stored on a high shelf, they will be difficult to reach, and there is a risk of dropping and breaking the item during retrieval.

Multiple containers should not be stacked on each other as they may fall over and risk breakage. If at all possible, items should be stored close to where they will be used.

For example, items that must be compounded, either sterile or non-sterile, should be stored as close to the compounding area as possible. Sterile rooms should have a “pass-through” window, preferably in the storage area.

By reducing the transport distance, there is a reduction in the risk of the drug falling and causing a spill. This storage area must also be under negative pressure, so if there is a spill or problem, it will be contained and have a lower risk of contaminating surrounding rooms.

Labeling

Just as shipping containers should be properly labeled, all hazardous drug products should be properly labeled, regardless of where they are to be administered.

Patients, caregivers, and hospital staff who administer medications need to be aware if a medication is

16

hazardous and requires special handling precautions.

Compounded items should always be clearly labeled and properly packaged for transportation. Items being walked by staff from the pharmacy to an infusion suite or hospital unit must be done in a way to ensure they will maintain their integrity and sterility. There also should be training for personnel transporting medications in case an item falls, breaks or spills. Compounded hazardous drug products should be individually bagged in a zipped lock bag and transported in a rigid case that can accommodate liquid to reduce the risk of large contamination if any item spills. Ensure that the case is large enough to hold the compounded items comfortably and nothing is compressed and, ideally, can also hold a standard spill kit. A pneumatic tube system should never be used to transport hazardous drugs. It should always be carried to where it needs to go. This is because of how a pneumatic tube system works. Items in the pneumatic tube are under pressure, because the air movement is a vacuum. If a bag were to leak, it would lead the entire tube system to be contaminated.

The system would have to be shut down and properly cleaned by a certified company who specializes in decontamination

Hazardous Drugs and USP 800 â&#x20AC;&#x201C; Reducing Your Risk as a Healthcare Worker

Spills

intra-articular, etc.) or in the eye must be sterile.

Hazardous drugs must follow USP 800 and either USP

Anyone working with or around hazardous drugs 795 for non-sterile compounding, or USP 797 for sterile should be trained on how to use a spill kit. Spill kits compounding. USP 800 is not a replacement for the are commercially available and should be placed in all guidelines of compounding, it is meant to add a layer of areas where there are HDs. Spill kits have all items in protection for healthcare workers. them needed to clean up a spill. Each facility must have policies and procedures on how to handle a spill, when Location a respirator is required, and when escalation is needed.

Spill kits have several components, many have enough Non-sterile hazardous drug compounding needs to be items for two employees to clean the spill, but some only completed in a negative pressure area separate from have enough for one. Usually the kit contains: a sign where sterile compounding is performed. Equipment, warning of the spill to stay out of the area, a disposable such as mortar, pestle, and spatula, needs to be gown, a mask, shoe covers, goggles, sets of gloves rated dedicated for hazardous drug compounding and not to clean up hazardous drugs, an absorbent material to for non-hazardous compounding. Crushing of tablets sprinkle on the liquid to solidify the spill, some kind or opening capsules may cause particles to become of scraper/brush/pan to sweep up the now solid spill, a aerosolized and should be done in either a biological thick plastic bag to gather items, and a puncture proof safety cabinet or an aseptic containment isolator. Noncontainer for glass. Finally, the spill kit will contain sterile compounding should be kept to a minimum if instructions on exactly how to use it in the event of a possible, but if it cannot be avoided then using a liquid spill. Although there are a lot of components, the spill is preferred over crushing or opening capsules in order kit is usually quite compact and should easily fit in any to minimize exposure to the employee9. It is possible transport container that will contain HDs. Note that a to compound with the injectable formulation of a respirator may be required if the spill is large. Policies medication and administer it orally. For example, if a and procedures must be in place for employees to know patient is having trouble swallowing cyclophosphamide how to handle spills, large or small, and when it may tablets, it is preferable to reconstitute the injectable be required to call for backup hazardous personnel vials with saline and then mix with a sweetener for who can handle a large spill. All facilities should have palatability17. This prevents the risk of aerosolizing the a way to report any time a spill kit is used, why it was drug by crushing the tablet since the content of the vial needed, who was potentially exposed to the hazardous is self-contained and easily goes into solution. drug, and how it was handled. This report should go to management for review and analysis to see if there is a Sterile compounding should always be done in the negative pressure clean room, in the proper biological way to prevent the situation from happening again. cabinet, and with the use of the CSTD. USP 797 must be followed carefully as USP 800 does not replace Compounding these guidelines. An important piece of USP 797 is the

Most pharmacy personnel will say that the highest required validation of employeesâ&#x20AC;&#x2122; ability to manipulate risk of exposure to hazardous drugs, as well as the medications and ensure the sterility is maintained. most complicated process, is during the compounding During validation of aseptic technique, the employeeâ&#x20AC;&#x2122;s process. You will recall that there are two distinct use of CSTD should be evaluated to ensure there are no compounding areas: non-sterile and sterile. In essence, leaks or spills during the process. Kits are available to the administration route of the medication dictates if test compounding technique which contain a dye and the preparation must be sterile or not. Preparations require the use of a black light. The employee is to mix intended to be given orally, topically, in the ear, etc., the reagents in the kit within the closed-system as if it are not required to be sterile. Anything administered were a hazardous drug. The evaluator can then use the by injection (intramuscular, intra-arterial, intravenous, black light to check for any issues with connections or

17

PHARMACY TECH TOPICS — JANUARY 2018 TM

leaks. If there are no issues (nothing glows) then the compounder can be signed off as competent. If there are any leaks or issues, then this is the perfect time to check each connection and find the problem, re-train the compounder, and re-validate as needed.

with handling HDs, appropriate PPE must be worn, not just due to the risk of residual HDs but also to reduce the exposure of the cleaning agents to the healthcare worker.

Education on how cleaning should be performed, and how often, should be part of the facility’s policies and procedures and should be standardized. The purpose Disposal Of Waste of standardized procedures is so every person cleans

the same way each time. This ensures cleaning is done Once all compounding is completed, disposal of the un- correctly every time. It should be clear regarding the used hazardous drug is important. Federal oversight is use of PPE; which cleaning agent(s) is/are to be used; done by the Environmental Protection Agency (EPA), how to dilute them, if required; and how often each area but each state has their own regulations on how hazard- must be cleaned. There should be a way for employees ous drugs must be disposed. Many questions can be an- to physically sign off or electronically to track that all swered by going to the EPA’s site https://www.epa.gov/ cleaning was completed. If the area is used for sterile and looking up “hazardous waste.” There is information compounding, then USP 797 should be referenced for on the hazardous waste stream that refers to the RCRA, cleaning because it is of utmost importance that sterility Resource Conservation and Recovery Act. This act goes is maintained and that no cross contamination occurs into medical waste and tracking. It is out of the scope during the cleaning process. of this module, but should be known because facilities may handle their hazardous waste in different ways. All education surrounding cleaning of any compounding Each facility must ensure they are following federal, area, after showing the employee is competent, should state, and local rules regarding how they dispose of haz- be signed off by a manager. This way, if any surveyor ardous drugs. This will include the empty vials, syringes asks for proof of competency, all the education given or other containers used during compounding or after can be submitted as evidence. Employees need to administration since there may be trace amount of drug understand what the facility means by cleaning and left on anything used during the compounding process. why being meticulous is important. Cleaning must be done not only on a routine basis, but anytime there is a spill. Although cleaning to some implies removing any Cleaning material or debris from the surface, with hazardous drugs

After compounding, or anywhere else HDs may be and sterile compounds it is more than that. Hazardous handled or manipulated, the area must be properly and drugs must be deactivated and then the area must be routinely cleaned. Sterile areas must be properly cleaned decontaminated. Deactivating stops the activity of the and disinfected. Just like with any other activity involved hazardous drug and then decontamination removes Table 5. Summary of Cleaning Steps - USP 40-NF 35, General Chapters: <800> CLEANING STEP PURPOSE AGENTS Deactivation Render compound inert or As listed in the HD labeling or if no specific ininactive formation available, sodium hypochlorite or other Environmental Protection Agency (EPA) - registered oxidizer Decontamination Remove inactivated residue Sterile alcohol, sterile water, peroxide, or sodium hypochlorite Cleaning Remove organic and inor- Germicidal detergent and sterile water ganic material Disinfection Destroy microorganisms Sterile alcohol or other EPA-registered disinfectant appropriate for use Source: ©2016 U.S. Pharmacopoeial Convention. Reprinted with permission July 2017

18

Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker

Test Your Knowledge #3

Answer True or False for each statement below.

1. To properly wash your hands, you ap-

ply some soap, run your hands under the water, whistle a bit, dry your hands, and go back to work.

2. Sterile compounding should always be done in a negative pressure clean room.

3. It does not matter where non-sterile

drug compounding is done because of the fact that it is non-sterile compounding.

4. To clean a spill, use some paper towels.

5. A pneumatic tube system should never be used to transport hazardous drugs.

6. USP 797 spells out exactly how to handle any containers that were broken during shipment.

7. There is always a risk of exposure to healthcare workers.

8. Hazardous drugs boxes can be stacked.

Answers on page 24.

the inactive drug residue from the area. Sterile areas must then be disinfected to destroy microorganisms as required by USP 797. Think of the counter in a kitchen.

If raw chicken was cut on the counter, even if it was on a cutting board, it would not be sufficient to use a sponge with water and just wipe down surfaces. In order to ensure safety and that there is no salmonella on the counter, it must first be cleaned with water to remove any spills on the counter, and then it must be cleaned with a proper detergent or bleach. This cleans and disinfects so no one gets a food borne illness. See Table 5.

The nature of the cleaning agents must also be considered.

Some cleaners are corrosive to stainless steel and must be washed off with another agent that will not harm the surface. Each step must be carefully considered when writing the standard operating procedures. For example, when spraying cleaners, it should never be sprayed directly into the hood, as it may cause damage to the HEPA filters or cause residual hazardous drugs to be spread. Instead, spray the cleaning towel or pad. Ensure any trays or areas that may collect residue are properly removed and cleaned routinely; at least monthly.

Personnel responsible for cleaning must remember that there will be residue on the pads and wipes used during the cleaning process, so it is important that they are discarded properly. All items must be treated as if they are contaminated. If during cleaning a glove breaks, it must be replaced. If there is a splash from any of the cleaning solutions, then not only should the solution be cleaned off, but PPE should be changed to ensure the employee is not exposed. If while changing it is noted that the clothing got wet, then additional action is required. Personnel should know what to do if they have any kind of accident while cleaning or compounding and what to do if exposed to a hazardous agent.

Medical Surveillance – What And How?

As hard as everyone tries, because of the nature of hazardous drugs, there is always a risk of exposure for healthcare workers. While you can do your very best to minimize risks, by using standard operating procedures, educating all personnel who handle hazardous drugs, using JHAs to look at each step and minimize the chance of accidental exposure, using PPE, etc.; exposure can still happen. If at any time an employee has a sign, symptom or complaint of exposure, it must be taken seriously.

The hazardous plan coordinator must work with the facility’s occupational health department and/or human resources department to ensure there are procedures to address any symptoms or complaints of exposure. They should have a way to evaluate the employee, document any symptoms or complaints, draw blood, and review any laboratory findings, if needed, etc.

The point of the surveillance is that it can be used as another means to protect the employee, and it is the last guidance step from USP 80017. Some surveillance, like checking urine levels of certain drugs, may only need to be done if there is a documented exposure, like a spill, or if an employee is complaining of symptoms that seem to relate to hazardous drug exposure.

As with a spill, any sign and symptom of exposure must be reported to management and must be followed-up with an investigation. This investigation of exposure must include review of all policies and standard operating procedures. Did the employee follow

19

PHARMACY TECH TOPICS — JANUARY 2018 TM

policies and procedures? Was PPE properly worn?

Are environmental controls properly in place? Have environmental samplings been done to ensure they are working properly. Were CSTDs used and were there any product failures or leaks? Talk with the employee.

Ask what happened; could it be traced back to a single issue or failure? Perform an in-depth root cause analysis if possible. While a root cause may not be found, the steps may unmask an issue that management was not aware of. Documenting the investigation is a vital step in performance improvement.

Review of Policies and Standard Operating Procedures

The one theme that is present throughout the USP chapters is the understanding of what is needed in policies and Standard Operating Procedures (SOPs).

The difference between a policy and a SOP is simple.

The information regarding a regulation is a policy and the step-by-step instructions are SOPs.

• Closed-system transfer devices should be used during compounding and must be used during administration of hazardous drugs.

• All hazardous waste must follow all federal, state, and local regulations.

• All personnel with potential exposure to hazardous drugs will be trained on how to use a Spill Kit as part of their orientation.

This way, each item that is required can be thought of as a check list when you compare it to the USP guidelines.

SOPs however, need to be in order of how a process should be completed: 1. Competency in aseptic technique will be established before allowed to compound sterile preparations of hazardous drugs.

2. Personnel will be trained to use any equipment or devise, like a closed-system transfer device, before being allowed to use.

3. Food, drink and excessive talking are prohibited in sterile compounding areas.

4. Fingernails are to be kept shorter than ¼ inch beyond tip of finger.

5. Personnel with respiratory illness will be reassigned and not allowed to work in sterile preparation areas, if at all possible.

6. All jewelry will be removed prior to entering sterile compounding areas.

7. No makeup shall be worn in sterile compounding areas.

8. Booties, bonnet and mask shall be donned before proceeding to anteroom for hand hygiene.

9. Hand hygiene shall be performed as follows:

Think of it this way, the policy should be bullet points of required items, though not necessarily in any particular order compared with the guidelines17: • A list of hazardous drugs must be compiled and reviewed annually, consideration will be given to the hazardous nature of the drug, manipulation required by personnel before the drug is dispensed, and type of exposure that may occur for the healthcare worker.

• All personnel handling hazardous drugs must be properly trained and competency must be maintained. This includes the following personnel: • Those receiving hazardous drugs and how to a. Wet hands thoroughly with water. handle broken containers. b. Apply soap.

• Anyone involved in non-sterile or sterile c. If necessary, use a brush to scrub under nails or compounding. remove any substances on the skin.

• Delivering of hazardous drugs. d. With rotating frictional motion, rub hands togeth• Administration of hazardous drugs. er and wash at least 2-3 inches above the wrists.

• Hazardous drugs will never be stored where e. Interlace fingers and rub up and down to ensure personnel will have to reach high over their heads to each finger is properly washed. retrieve. f. Rinse well allowing water to drip from hands down elbows.

• Hazardous drugs will never be stacked in a way g.

Dry thoroughly with a lint-free towel or with pathat may increase the risk of tipping over, falling or perless hand dryers. breaking.

• Personal protective equipment must be used at all You can see the step-by-step procedure can be in-depth. times while handling hazardous drugs.

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Hazardous Drugs and USP 800 â&#x20AC;&#x201C; Reducing Your Risk as a Healthcare Worker This way it is always done the same way and anyone training can read the SOP and know exactly how they should be performing the task. Review of SOPs should be done by several people, this way you ensure no step is missing and each step is as clear as possible.

Policies and SOPs are critical because, if an outside agency asks how things are done and why, each question can be easily answered. Although USP does not enforce the guidelines, facilities may be subject to audits by the local Board of Pharmacy, Board of Medicine, the state or regional Environmental Protection Agency, OSHA, etc. If there is ever a patient, guest or employee who is inadvertently exposed to a hazardous drug, you may be asked to show policies and procedures as well as proof of training. This way, the auditor knows the risks of the hazardous drugs, how healthcare workers were carefully considered and what steps were in place to protect as many workers and patients as possible. â&#x20AC;&#x192;

Ensure the person in charge of purchasing and receiving reviews the JHA that analyzes those processes. If the same personnel put away the medications, then ensure they understand how to store hazardous medications in a way that there is less risk of any medications falling or breaking open. Remember, the purpose of the JHA is to stop and analyze each individual step in a task.

Look at it and see where there could be a problem, and then think of how to minimize this risk. Mitigation of risk may be something as small as using PPE, or as big as requiring the building to be modified for negative pressure areas. Pick at least one person who performs each task to review the JHA and empower employees to look at any task they perform as an opportunity to write a JHA. Once complete, then it should be singed off by management. Finally, each employee who performs that task needs to sign off on the JHA, the signature indirectly states that it is appropriate for this job, and file it so that if a board of pharmacy, or another accreditation body, asks about training, this can be presented to them.

There are many times you will hear about initiatives meant to ensure the safety of the patient. An example is when nurses, medical assistants, physicians, etc., ask for the name and date of birth of the patient, so they have two identifiers when performing anything on the patient. This makes sure the healthcare worker has the right patient each time and keeps someone safe by not accidently administering a medication that is meant for someone else. USP Chapter 800 has one purpose: to maintain the safety of healthcare workers who are dealing with hazardous drugs. There are so many different ways pharmacy and other personnel may be exposed to hazardous drugs. There could be a broken shipping container. Prior to USP 800, pharmacy staff could be crushing tablets or opening capsules to compound a suspension in a room without proper airflow, causing particles to go into the air. Nurses and physicians administer medications and could have a problem with the IV line, causing a spill. The important thing is to try to minimize and mitigate risk of exposure.

Taking on USP 800 seems like a daunting task. Break it down into pieces and be sure you have input from all staff along the way. Start with the Job Hazard Analysis (JHA).

Next is to take an inventory of all the medications in the facility. Once the inventory is completed, there must be a determination if each drug is hazardous, and how to handle it, if it is. Take care to look at how the medication is received, stored, manipulated, dispensed, and administered. This will take into consideration how high the risk of exposure is, and then steps can be taken to address it.

Finally, standard operating procedures, policies and training must occur. These are listed together because they are entwined together. Policies are needed on how to handle the regulatory aspect of USP 800 and standard operating procedures may be a part of the policy, though they could be separated. Training must be done to comply with the policies and procedures. Ensuring all healthcare workers, in every step of the process, are aware of their potential risk of exposure, and how to lessen that risk, is the reason for USP 800.

Taken step by step, USP 800 is not difficult, but is a lengthy process to work through. In the end, the reduced risk of exposure to healthcare workers is worth it. Safety is best when it is done first and not after someone has been harmed.

Conclusion

21

PHARMACY TECH TOPICS — JANUARY 2018 TM

Glossary of Terms Antineoplastic: Chemotherapy drugs; which means the drug acts to prevent, inhibit or halt the development of a tumor.

ASTM: American Society for Testing and Materials. They set the standard for chemotherapy rated gloves to help protect the healthcare worker from accidental exposure.

BSC: A Biological Safety Cabinet. Used to compound hazardous drugs.

CACI: Compounding Aseptic Containment Isolator. This is an isolator (also known as a “glove box”) that may be used to compound non-hazardous drugs.

C-SEC: Containment Secondary Engineering Controls: This is the room in which compounding occurs. For hazardous drugs it must be certified to be ISO 7 and negative pressure.

CSTD: Closed-System Transfer Device CSP: Compounded Sterile Product. Any item compounded in a sterile manner for administration (for example: for intravenous administration) EPA: United States Environmental Protection Agency (https://www.epa.gov/) HD: Hazardous drug HEPA: High Efficiency Particulate Arrestance filters.

JHA: Job Hazard Analysis. A method of looking at a job, specifically the risks and hazards associated with the job, and mitigate any risk uncovered.

OSHA: The Occupational Safety and Health Administration (https://www.osha.gov) NIOSH: The National Institute for Occupational Safety and Health (https://www.cdc.gov/niosh/) PPE: Personal Protective Equipment. Items used to protect healthcare workers from work hazards and exposures.

PPE includes gowns, gloves, goggles, respirators, etc.

RCRA: Resource Conservation and Recovery Act (https://www.gpo.gov/fdsys/granule/USCODE-2011-title42/ USCODE-2011-title42-chap82-subchapI-sec6901) SOP: Standard Operating Procedure Spill Kit: A kit that contains all items needed to clean up a hazardous drug spill. Items contained include: warning sign, gloves, gown, goggles, absorbent material to solidify the spill, and any other items needed to clean a spill.

USP: The U.S. Pharmacopeial Convention (http://www.usp.org/about-usp) USP 795: United States Pharmacopeia General Chapter <795>: Pharmaceutical Compounding – Nonsterile Preparations USP 797: United States Pharmacopeia General Chapter <797>: Pharmaceutical Compounding – Sterile Preparations USP 800: United States Pharmacopeia General Chapter <800>: Hazardous Drugs – Handling in Healthcare Settings USP 1206: United States Pharmacopeia Chapter <1206>: Sterile Preparations - Pharmacy Practices

22

Hazardous Drugs and USP 800 â&#x20AC;&#x201C; Reducing Your Risk as a Healthcare Worker

References 1. FDA. Public Law 105-115; 105th Congress. FDA. November 21, 1997;:Section 503(b)(B). Available at: http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDAMA/ FullTextofFDAMAlaw/default.htm. Accessed February 09, 2017.

2. USP. About USP. USP (US Pharmacopeial Convention). Available at: http://www.usp.org/about-usp. Accessed March 23, 2017.

3. USP. Frequently Asked Questions: Pharmaceutical Compounding -Sterile Preparations. USP.org. Available at: http://www.usp.org/frequently-asked-questions/pharmaceutical-compounding-sterile-preparations.

Accessed February 09, 2017.

4. USP-NF General Chapter Pharmaceutical Compounding - Sterile Preparations: U.S. Pharmacopeia; 2012.

5. Frequenty Asked Questions: Hazardous Drugs - Handling in Healthcare Setting. USP. http://www.usp.org/ frequently-asked-questions Accessed Februrary 09, 2017.

6. General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. USP-NF. September 29, 2017. http://www.uspnf.com/notices/gc-800-hazardous-drugs-handling-in-healthcare-settings?_ ga=2.114384135.1099747711.1507757204-1087266609.1482187732 Accessed November, 13, 2017.

7. NIOSH - Hazardous Drug Exposures in Healthcare. CDC. Available at: https://www.cdc.gov/niosh/topics/ hazdrug/default.html. Accessed February 09, 2017.

8. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2016. CDC. September 2016. https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf. Accessed February 09, 2017.

9. USP-NF Chapter Hazardous Drugs - Handling in Healthcare Settings: U.S. Pharmacopoeia; 2016.

10. FDA. Pregnancy and Lactation Labeling (Drugs) Final Rule. U.S. Food and Drug Administration. December 14, 2014. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ Labeling/ucm093307.htm. Accessed March 30, 2017.

11. Drugs.com. FDA Pregnancy Categories. Drugs.Com. 2016. Available at: https://www.drugs.com/pregnancycategories.html. Accessed March 30, 2017.

12. OSHA. Five Basic Steps to Conducting a Job Hazard Analysis. The OSHA Advisor. Available at: http://www. the-osha-advisor.com/JHA.html. Accessed March 07, 2017.

13. USP technician suggestion from Kienle P. The Chapter <800> Answer Book. American Society of HealthSystem Pharmacists, Bethesda, MD: ASHP 2017.

14. Wolters Kluwer. Q&A from Complying with USP 800 Hazardous Drug Compounding Requirements Webinar.

Pharmacy OneSource. Available at: http://forums.pharmacyonesource.com/t5/Pharmacy-Practice/Q-amp-Afrom-Complying-with-USP-800-Hazardous-Drug-Compounding/td-p/12126. Accessed March 07, 2017.

15. NIOSH List of Antineoplastic and Other Hazardous Drugs in Health Care Settings 2004. CDC. 2014. https:// www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed March 13, 2017.

16. U.S. Pharmacist. Cyclophosphamide 10-mg/mL Oral Liquid. U.S. Pharmacist. March 19, 2010. Available at: https://www.uspharmacist.com/article/cyclophosphamide-10-mgml-oral-liquid. Accessed March 20, 2017.

17. Usp.org. (2017). USP 800. [online] Available at: http://www.usp.org/sites/default/files/usp/document/ourwork/healthcare-quality-safety/general-chapter-800.pdf [Accessed 18 Nov. 2017].

23

PHARMACY TECH TOPICS â&#x20AC;&#x201D; JANUARY 2018 TM

Test Your Knowledge Answer Key Test Your Knowledge #1

Crossword Puzzle on Hazardous Drugs Across: 2.

Annually 5.

Genotoxicity 7.

Organ Toxicity 8.

Teratogenicity Down: 1.

Characteristics 2.

Antineoplastic 3.

Reproductive Toxicity 4.

Carcinogenicity 6.

Three

Test Your Knowledge #2

Do you know your acronyms?

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

J L F K G I H E C D B A

Test Your Knowledge #3 True and False

1.

2.

3.

4.

5.

6.

7.

8.

24

FALSE TRUE FALSE FALSE TRUE FALSE TRUE FALSE

Hazardous Drugs and USP 800 â&#x20AC;&#x201C; Reducing Your Risk as a Healthcare Worker

USPS Statement of Ownership, Management, and Circulation - Mandatory Annual Statement

25

PHARMACY TECH TOPICS â&#x20AC;&#x201D; JANUARY 2018 TM

2018 MODULES

Tests must be received by their expiration dates to receive continuing pharmacy education credit.

Volume 23 #1 | January 2018

Hazardous Drugs and USP 800 Reducing Your Risk as a Healthcare Worker**

(Must be completed by 12/31/20 at 11:59PM CT)

Volume 23 #2 | April 2018

Type 1 Diabetes: Updates in Treatment and Technology

(Must be completed by 3/31/21 at 11:59PM CT)

Volume 23 #3 | July 2018

Autoimmune Disorders - What Are They?

(Must be completed by 6/30/21 at 11:59PM CT)

Volume 23 #4 | October 2018

Basic Principles of Transplant Thera- Expires 10/01/21 (Must be completed by 9/30/21at py: The Use of Immunosuppressants 11:59PM CT)

Expires 1/01/21 Expires 4/01/21 Expires 7/01/21

**This module provides 2.5 contact hours of law continuing pharmacy education credit for pharmacy technicians.

THE FOLLOWING 2016 AND 2017 MODULES ARE STILL AVAILABLE!

Tests must be received by their expiration dates to receive continuing pharmacy education credit.

Volume 21 #1 | January 2016

Medical Marijuana: Evaluating the Quality and Quantity of Evidence**

Expires 1/31/18

Volume 21 #2 | April 2016

Chemotherapy Symptom Management: Helping Each Patient with Their Journey

Expires 4/30/18

Volume 21 #3 | July 2016

Overview of Hyperlipidemia and Hypertension

Expires 7/31/18

Volume 21 #4 | October 2016

Health Literacy and Diversity

Expires 10/31/18

Volume 22 #1 | January 2017

Medication Safety in the Older Adult*

Expires 1/01/20

Volume 22 #2 | April 2017

The Eyes Have It! Update on Common Conditions Affecting the Eye

Expires 4/01/20

Volume 22 #3 | July 2017

Insurance and Billing Primer for Pharmacy Technicians

Expires 7/01/20

Volume 22 #4 | October 2017

New Drugs 2017

Expires 10/01/20

Expiring Soon!

(at 12:00AM CT)

(at 12:00AM CT)

(at 12:00AM CT)

(at 12:00AM CT)

*This module provides 2.5 contact hours of patient safety continuing pharmacy education credit for pharmacy technicians. **This module provides 2.5 contact hours of law continuing pharmacy education credit for pharmacy technicians.

26

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Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker

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4. Once you receive your Online Account User Name and Password, go to www.PharmacyTechTopics.com and Log In. 5. Click on My Modules (upper right corner under the Welcome), and you will see a list of the paper modules to which you have subscribed, but for which you have not yet taken the test. (You will have access to your subscriber modules ONLY.) 6. Once you see your module, you will see the Take the Pre-Test in a box to the left of the Module title. You may be required to take a 5 question pre-test prior to having access to the online module and the online post-test. This pre-test does NOT affect your final test results; it will be used to evaluate the effectiveness of the continuing education program.

Pharmacy technicians

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CHANGED Your Mind? Once you have established an Online Post-Test Account, you may still choose to mail or fax your post-test instead. This Online option simply provides you with more flexibility based on your circumstances.

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27

IN ORDER TO RECEIVE A CPE INFORMATION SHEET VIA MAIL, PLEASE READ THE FOLLOWING SUBSCRIBER REQUIREMENTS… 1. We must receive the Hazardous Drugs and USP 800 - Reducing Your Risk as a Healthcare Worker module’s completed EXAMINATION ANSWER SHEET AND EDUCATIONAL EVALUATION FORM by December 30, 2020 (at 11:59PM CT).

A score of 70% must be achieved in order to receive credit. Answers to the self assessment questions on pages 30-31 should be circled in the space on page 33. Participants scoring below 70% will be notified and permitted to retake the exam within the limits of the validation dates. This course is valid from January 1, 2018 to January 1, 2021 (December 31, 2020 at 11:59PM CT).

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PHARMACY TECH TOPICS â&#x20AC;&#x201D; JANUARY 2018 TM

SELF ASSESSMENT QUESTIONS Note:

If you purchase a paper subscription, but complete the Self-Assessment Test online at pharmacytechtopics.com, you will be required to take the Pre-Test first, then the final test and evaluation. This Pre-Test does not affect your final test results but will be used to evaluate the effectiveness of the continuing education program.

1. What was the first publishing by USP regarding pharmacy compounding? a. USP <797> b. USP <800> c. USP <1206> d. USP <825>

2. What date is USP 800 expected to be enforceable? a. July, 2017 b. January, 2018 c. December, 2019 d. December, 2017

3. What does NIOSH look at to determine if a drug is hazardous?

a. They look at its name. b. They look at its shape. c. They look at the characteristics of the drug. d. They roll a 20-sided dice; a roll above a 10 is considered hazardous.

4. What are the six (6) different drug characteristics that make a drug considered to be hazardous?

a. Carcinogenicity, Teratogenicity, Hepatotoxicity, Genotoxicity, Organ Toxicity, Superplasticity. b. Carcinogenicity, Teratogenicity, Reproductive Toxicity, Organ Toxicity, Genotoxicity, Structure and Toxicity Profiles. c. Hepatotoxicity, Genotoxicity, Organ Toxicity, Oversensitivity, Susceptibility, Structure and Toxicity Profiles. d. There are no specific characteristics because all drugs are hazardous.

30

5. Based on the NIOSH definition, a carcinogenic drug is one that:

a. is known to cause birth defects b. is known to make it harder for a woman to become pregnant c. is known to suppress your immune system d. is known to cause cancer

6. How many different groups are there for the list of antineoplastic and hazardous drugs? a. Three (3) b. Five (5) c. Eight (8) d. None

7. The best way to compile a HD list is to:

a. read the OSHA list b. take an inventory of all drugs and how they are handled. c. treat everything like a hazardous drug; better safe than sorry d. mark everything in the chemotherapy infusion suite as hazardous.

8. According to USP 800, receiving drug shipments should be done:

a. as close to the drug storage area as possible. b. outside. c. while wearing a respirator when receiving and opening totes. d. outside on the loading dock.

Hazardous Drugs and USP 800 â&#x20AC;&#x201C; Reducing Your Risk as a Healthcare Worker

9. What is the quickest way to assess the possible hazardous nature of a drug?

a. Review the package insert/labeling information, and review the pregnancy, lactation, and reproductive sections. b. Look at it and decide that there is an issue because the drug looks funny. c. Review the package insert/labeling information, and review the active drug section. d. Review the package insert/labeling information, and review the â&#x20AC;&#x153;doctor warningâ&#x20AC;? section.

10. Which of the following is FALSE?

a. There are only 5 categories (A, B, C, D, X) under the labeling requirements for human prescription drugs by the FDA. b. A drug listed as Category B is always considered less hazardous than a drug that is listed as Category D. c. Many drugs in the top 200 dispensed drugs do not appear on the NIOSH list (ex. lisinopril, oxycodone, sumatriptan, carisoprodol, and bupropion) d. Estrogens are classified as Category X; therefore, they are considered carcinogenic.

11. Fluconazole is on the NIOSH list because:

a. it is an estrogen. b. it has a risk of congenital abnormalities. c. it is a pregnancy category D with reports of teratogenicity. d. it needs to be crushed and added to a liquid to make a suspension.

13. Which of the following non-antineoplastic drugs is considered hazardous? a. lisinopril b. clonazepam c. oxycodone d. carisoprodol

14. When a new drug is brought into the facility:

a. it should be reviewed for hazardous nature before purchasing. b. it should be reviewed at some point within the next year. c. it only needs reviewing if compounding is required. d. it only needs reviewing if being administered inside the facility.

15. What is the purpose of a Job Hazard Analysis (JHA)?

a. To stop and analyze each individual step in a task. b. To make more paperwork for hospital personnel. c. To inform hospital personnel that there was a spill. d. To show the other pharmacists that everyone knows how to clean up a hazardous drug spill.

12. Paroxetine is on the NIOSH list because:

a. it is an estrogen. b. it has a risk of congenital abnormalities (i.e. teratogenic). c. it is an immunosuppressant. d. it needs to be crushed and added to a liquid to make a suspension.

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PHARMACY TECH TOPICS â&#x20AC;&#x201D; JANUARY 2018 TM

16. How do the requirements for shoe covers differ from USP 797 to USP 800 (for sterile compounding)?

a. For USP 800, a third pair of shoe covers must be used before entering the buffer room and removed when exiting the buffer room for HD compounding. b. For USP 800, a second pair of shoe covers must be used before entering the buffer room and removed when exiting the buffer room for HD compounding. c. For USP 800, no shoe covers must be used before entering the buffer room and removed when exiting the buffer room for HD compounding. d. For USP 800, the bright orange shoe covers must be used before entering the buffer room and removed when exiting the buffer room for HD compounding.

17. Which of the following is NOT an environment control? a. Hoods b. Hair and Shoe Covers c. Closed-System Transfer Devices d. Negative Pressure Rooms

18. If a shipping container appears damaged

a. open the container and assess what may be broken or damaged. b. open the container and then place broken items in a zipped-lock bag. c. seal container without opening and contact supplier for instruction. d. seal the container, bring into the negative pressure sterile compounding area, open box, and then throw out what was broken.

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19. When transporting a compounded HD (e.g.

IV infusion) from pharmacy to a nursing unit, it is best to:

a. send it via pneumatic tube so that you know it will get to where it needs to be, fast. b. deliver it with any other medication that needs to be on that floor. c. place it in its own zipped-lock bag, in a rigid case. d. wrap it in bubble wrap to protect it, in case it falls on the floor.

20. What items are within a spill kit?

a. Hazmat/biohazard grade paper towels b. A hazmat suit, a warning sign for the floor, paper towels, and a gas mask. c. Instructions, a warning sign for the floor, PPE (a disposable gown, mask, shoe covers, goggles, gloves), an absorbent material to solidify the spill, some sort of brush and pan to sweep up the material, a thick plastic bag, and puncture proof container for glass. d. Instructions, a stop sign, PPE (a disposable gown, mask, shoe covers, goggles, gloves), a rag, disinfectant spray, and puncture proof container for glass.

Hazardous Drugs and USP 800 â&#x20AC;&#x201C; Reducing Your Risk as a Healthcare Worker

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PHARMACY TECH TOPICS â&#x20AC;&#x201D; JANUARY 2018 TM

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In order to receive your CPE information sheet, you MUST FILL OUT the Educational Evaluation Form Hazardous Drugs and USP 800 – Reducing Your Risk as a Healthcare Worker AND the Answer Sheet below OR follow the instructions for completing your Test online!

(Instructions for online test completion found on pg. 27 of this module.)

Educational Evaluation form PROVIDER: Illinois Council of Health-System Pharmacists DATE(S): 01/01/18 to 01/01/2021 (12/31/20 at 11:59PM CT) TITLE OF MODULE: Hazardous Drugs and USP 800 - Reducing Your Risk as a Healthcare Worker

ACPE Universal Activity Number: 0121-0000-18-001-H03-T TYPE OF ACTIVITY: Knowledge-based

COMPLETE THIS EVALUATION FORM USING THE RATING SCALE BELOW Use the following rating scale and circle the appropriate number: 5 - AGREE STRONGLY 4 - AGREE 3 - NO OPINION, NEUTRAL, DOES NOT APPLY 2 - DISAGREE 1 - DISAGREE STRONGLY As a result of this module, I feel I have achieved the following objectives: 1.

2.

3.

4.

5.

Define how a hazardous drug is classified....................................................................................................................................................................... 5 4 3 2 1 Describe the responsibilities of personnel handling hazardous drugs, and why reducing the risk of exposure is important......................... 5 4 3 2 1 Explain how the USP 800 standards decrease exposure risk in both sterile and non-sterile hazardous drug compounding..................................... 5 4 3 2 1 Outline strategies and steps to be taken when compiling a hazardous drug list..................................................................................................... 5 4 3 2 1 List at least five (5) common non-antineoplastic hazardous drugs found on the most recent NIOSH list of hazardous drugs and their therapeutic classifications......................................................................................................................................................................................................................... 5 4 3 2 1

Please use the rating scale above to answer the questions below: 1. Rate the relationship of the objectives to the overall purpose or goal of the module. ........................................................................................ 5 4 3 2 1 2. The information presented will be useful in my work. ............................................................................................................................. 5 4 3 2 1 3. This program presented information in a balanced and unbiased manner. ................................................................................................ 5 4 3 2 1

Rate the expertise of the author(s): Demonstrates knowledge of subject matter

Authors

Uses appropriate teaching strategies

Linda T. Carboni, RPh, BCPS

5

4

3

2

1

5

4

3

2

1

Aryanah M. Carboni, CPhT

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1

5

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2

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CONTINUING PHARMACY EDUCATION CREDIT REQUEST FORM

Hazardous Drugs And Usp 800 - Reducing Your Risk As A Healthcare Worker JANUARY 2018 VOLUME 23 NO. 1 ACPE Universal Activity Number: 0121-0000-18-001-H03-T PLEASE CIRCLE ONE LETTER FOR EACH QUESTION FROM THE EXAMINATION SHEET:

1. A

B

C

D

6. A

B

C

D

11.

A

B

C

D

16.

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B

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D

2. A

B

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D

7. A

B

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D

12.

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B

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D

17.

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B

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3. A

B

C

D

8. A

B

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D

13.

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C

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18.

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B

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D

4. A

B

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D

9. A

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14.

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19.

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B

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D

5. A

B

C

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10.

B

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15.

A

B

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D

20.

A

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C

D

A

Name _________________________________________________________________________________________________________ Address _______________________________________________________________________________________ Apt No. __________ City/State/Zip ___________________________________________________________________________________________________ Daytime Phone (_________)________________________ E-MAIL ADDRESS ________________________________________________ THIS IS A CHANGE IN MY: q LAST NAME q ADDRESS q PHONE q E-MAIL REQUIRED: NABP e-Profile ID # _______________________________ Birthday (MMDD): ________ (Requirement of CPE Monitor Project) Visit www.myCPEmonitor.net for information about the CPE Monitor Project and to obtain your NABP E-Profile ID #.

PLEASE NOTE: NO credit or CPE information sheets will be issued without an NABP e-Profile ID#.

FOR TECHNICIANS REGISTERED IN FLORIDA:

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MAIL FORMS TO: PTT; 4055 N Perryville Road; Loves Park, IL 61111 • FAX TO: 815-227-9294

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PHARMACY TECH TOPICS — JANUARY 2018 TM

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January 2018 | Volume 23 | Number 1 Hazardous Drugs and USP 800 - Reducing Your Risk as a Healthcare Worker Expiration Date: January 1, 2021 (Must be completed by 12/31/2020 at 11:59PM CT)

Published by the Illinois Council of Health-System Pharmacists