chemotherapy/hazardous drugs precautions, preparation, ordering 3... · chemotherapy/hazardous...

CHEMOTHERAPY/HAZARDOUS

DRUGS PRECAUTIONS,

PREPARATION, ORDERING Naser Z. Alsharif, PharmD, PhD

Professor, School of Pharmacy and Health Profeesions

Creighton University, Omaha, NE

1

Selected Slides Courtesy

Karen K. O’Brien, B.S. Pharm, Pharm.D. Associate Professor, Pharmacy Sciences

School of Pharmacy & Health Professions

Creighton University

The 20th Congress of the Scientific Association of Colleges of Pharmacy in the Arab World

November 8th, 2017

OUTLINE Define hazardous drugs and identify healthcare areas

and personnel where hazardous drugs are encountered

Discuss the different types of exposure

Identify activities that may result in exposure

Discuss guidelines for handling hazardous drugs

Discuss best practices in ordering chemotherapy

Identify ethical considerations in chemotherapy

Discuss implications for Jordan

2

WHAT ARE HAZARDOUS DRUGS?

Drugs that pose a potential health risk to workers who

may be exposed to them

This can include chemotherapeutic, cytotoxic,

antiviral, immunosuppressant, hormonal and

bioengineered drugs.

Not all hazardous drugs are cancer

chemotherapeutic agents!

3

WHAT ARE HAZARDOUS DRUGS?

The National Institute for Occupational Safety and Health (NIOSH) defined hazardous drugs as those that exhibit one or more of the following characteristics:

Carcinogenicity: cancers usually develop after many years; often occurs as a type of leukemia

Teratogenicity: damages developing fetus

May be related to increased miscarriages & birth defects

Reproductive toxicity

A concern for women and men of child bearing age

Organ toxicity

Genotoxicity

New drugs with structure and toxicity profiles that mimic existing hazardous drugs

4

11/28/2017 5

WHERE DOES ALL OF THIS APPLY TO?

Protection against hazardous drugs apply to facilities where they are used and to personnel who may become in touch with them:

Facility Examples

Hospitals

Pharmacies

Physician’s offices

Patient treatment clinics

Wholesalers

Other health care facilities and institutions

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WHO DOES ALL OF THIS APPLY TO?

Workers may be exposed to a drug at any point throughout

its life cycle:

receipt, transport, storing, preparation, administration, or disposal

Personnel Examples:

Shipping & receiving personnel

Pharmacists, Interns, Technicians

Physicians

Nurses

Custodial staff, Environmental services personnel

Delivery Personnel

Any one involved in preparing , handling , or, stocking hazardous substances

TYPES OF EXPOSURES

Inhalation (frequency unresolved)

Skin contact/absorption (may be a primary route)

Ingestion : unintentional exposure from hand to mouth

contact/ingestion of contaminated foodstuffs

Injection: unintentional exposure through a needle stick

or sharps injury (less common)

“The likelihood that a worker will experience adverse effects from

hazardous drugs increases with the amount and frequency of

exposure and the lack of proper work practices.”

Source: NIOSH Alert 2004

ASHP Guidelines on Handling Hazardous Drugs

7

ACTIVITIES THAT MAY RESULT IN

EXPOSURES Reconstituting powdered drugs; further dilution of

reconstituted drugs/concentrated liquids

Expelling air from syringes filled with hazardous drugs

Administration of hazardous drugs by IM, SQ or IV routes

Contacting measurable concentrations of drugs present on drug vial exteriors, work surfaces, floors & final drug products (Bottles, bags, syringes, cassettes)

Generating aerosols during administration of drugs (IV push/IV infusion)

Priming the IV set with a drug-containing solution at the patient bedside (should be done in Pharmacy)


8

ACTIVITIES THAT MAY RESULT IN

EXPOSURES Handling contaminated wastes generated at any step of

the preparation or administration process

Handling unused hazardous drugs or hazardous-drug-

contaminated waste

Decontaminating and cleaning drug preparation areas

Transporting hazardous waste containers

Removing and disposing of personal protective

equipment (PPE) after handling hazardous drugs or waste


9

HANDLING CHEMO

DRUGS

COMPONENTS

10

BEFORE PREPARING AN ORDER

What are key things to put in place

before preparing a chemo order?

11

I. GUIDELINES FOR HANDLING

HAZARDOUS DRUGS American Society of Health-System Pharmacists (ASHP)

National Institute for Occupational Safety and Health (NIOSH)

National Occupational Research Agenda (NORA)

Occupational Safety and Health Administration (OSHA)

Environmental Protection Agency (EPA)

Stated goals vary somewhat from source to source, but the

general purpose is to protect health care workers by providing

recommendations for the safe handling of hazardous drugs.

12

What is the equivalent in Jordan?

II. SAFETY PROGRAM

Whose Responsibility?

Every institution that works with hazardous drugs should

have a comprehensive safety program in place.

This covers ventilation controls, training and monitoring

staff for safe handling of hazardous drugs, and personal

protective equipment (PPE).

The goal is:

These programs should help to keep the workplace safe.

Chemo room set up

13

III. PRE-PRINTED ORDERS

(PPO)

14

HANDLING CHEMO

DRUGS

COMPONENTS

15

IN THE PROCESS OF

PREPARING AN ORDER

What are key things to put in place in

the process of preparing a chemo

order?

16

I. STORAGE AND LABELING

Wear PPE when unpacking hazardous drugs in case

damaged containers are found.

Hazardous drugs should be stored separately from

other drugs.

All hazardous drugs must be labeled to identify them

for special handling.

17

II. PERSONAL PROTECTIVE

EQUIPMENT Gloves

18

Only gloves that have been tested against the American

Society for Testing and Materials (ASTM) standard for

resistance to chemotherapy should be worn.

Includes latex, nitrile, neoprene, and polyurethane gloves

Gloves need to be worn at all times when handling

hazardous drugs.

Double gloving is required; change gloves a minimum of

once every 30 minutes when compounding hazardous

drugs.

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&docid=axAevyJZ836liM&tbnid=yCgToGBbjT037M:&ved=0CAcQjRw&url=http%3A%2F%2Fwww.massgeneral.org%2Fabout%2Fnewsarticle.aspx%3Fid%3D2102&ei=dMwRVPKcLcSe8AHRy4CYDw&bvm=bv.74894050,d.b2U&psig=AFQjCNHrcD01yfRcK9_Nsi5RqctDVFRHGg&ust=1410538892503732


EQUIPMENT Gloves

Place inner glove under the knitted cuff of chemo gown; place outer glove over the cuff. There should be no exposed skin.

The outer pair of gloves should be removed after compounding is complete and the final preparation has been wiped off.

The inner gloves should be worn while the labels are affixed and the preparation is placed into a sealable containment bag for transport.

When gloves are removed, only touch the outer uncontaminated surface of the gloves.

Gloves should be placed in a sealable plastic bag for disposal.

19


EQUIPMENT Gowns

Use disposable gowns made of materials tested to be

protective against hazardous drugs.

Coated gowns should not be worn longer than 3 hours

during compounding.

Remove gowns carefully and contain and dispose of gowns

as hazardous waste.

Always wash hands after removing gowns.

20


EQUIPMENT Eye and Face Protection

Should be used whenever splashing or aerosolization of

hazardous drugs is possible

A face shield provides better skin protection than safety goggles/

glasses.

A surgical mask only protects the preparation ; a respirator fit to the

individual is needed to protect both the worker and the preparation.

21

This worker is wearing a face shield, but not a respirator


EQUIPMENT Shoe and Hair Coverings

These should be worn

Gloves should be used to remove shoe and hair coverings and

the contaminated coverings should be discarded as hazardous

waste.

22

III. VENTILATION CONTROLS Hazardous drugs should be stored in a negative pressure environment

Cleanroom should be separate from other preparation areas &

possess negative pressure

Access to areas where hazardous drugs are stored & prepared should

be limited to protect persons not involved in drug preparation

All transfers of hazardous drugs should be carried out in an ISO Class

5 BSC or (Compounding Aseptic Containment Isolator (CACI)

Optimally 100% vented to outside air via HEPA filtration

23

Source: USP Chapter <797> Revision Bulletin, 2008

http://www.dynamicdesignpharma.com/Chemosafe_classic.html

III. BIOLOGICAL SAFETY

CABINETS (BSCS) Class II BSC use vertical flow HEPA filtered air

Inward airflow for personal protection

HEPA-filtered laminar airflow for product protection

HEPA-filtered exhaust air for environmental protection

OSHA, ASHP, and NIOSH recommend Class II BSCs for

compounding sterile preparations of hazardous drugs

Four types of Class II BSCs

Type A1, Type A2, Type B1, and Type B2

24

25

Work surface of BSC

Note Glass Shield

Note intake grills in

front and back of

cabinet

BSC certification is

required once every 6

months, or with each

physical move… whichever is shorter

III. CLASS II BIOLOGICAL SAFETY CABINET

III. BSCS CLASS II Type B2

Image from: http://www.bakerco.com/resources/intro.php

26

11/28/2017 27

HORIZONTAL AIR FLOW HOOD:

DIFFERENCE

Note placement of the HEPA filter

Note filtered intake vents in front

Venting directly at the operator

Horizontal laminar airflow workbenches

(LAFWs) must not be used to compound

hazardous Compounded Sterile Products

Note:

Protective metal grid in front of HEPA filter

Note white filter material beneath metal grid

Supported by corrugated metal strips between the HEPA filter material

III. WORK PRACTICES IN BSCS

CLASS II Appropriate PPE should be worn

A plastic-backed absorbent preparation pad can be used

It should not block airflow and should be replaced and discarded after each

batch.

Avoid leaving and reentering the work area of the Class II BSC, NO

DISTRACTION

Wipe down all vials with moist gauze after placing them in the BSC

Discard the gauze as hazardous waste.

A small waste/sharps container may be placed towards the back

corner of the BSC

Wipe the final preparations with a moist gauze

Remove your outer gloves before labeling the final preparation 28

IV. ASEPTIC TECHNIQUE

29

USP 797, Control for contamination from:

Personnel

Materials

Environment


30

Fingernail Pickings

Uncovered hair “head shake” Coughing

Blood agar cultures courtesy of Dr. O’Brien.

Blood agar cultures courtesy of Dr. O’Brien.

11/28/2017 31


Medication Vial


BASIC CLEANROOM RULES Keep hands and face clean

Keep fingernails trimmed and clean

Never comb your hair in the room

Never wear makeup or jewelry

Never carry personal items into the room

No eating or chewing gum in the room

Wear specified clothing/gloves AS SPECIFIED

Don’t walk around unnecessarily

Wipe down items with isopropyl alcohol before placing in the ISO Class 5 environment

Use good aseptic technique

11/28/2017 32


Closed-system vial-transfer devices (CSTDs) are

preferred

Vial-transfer systems that allow no venting or exposure of

hazardous substance to the environment

33


When drawing out the contents of the vial small, amounts of

air should be exchanged for small amounts of drug solution

to avoid creating a high positive pressure in the vial.

Maintain a small negative pressure to avoid accidental

dribbling or aerosolization of hazardous drug from the

vial

The exact volume of drug required should be measured out

before the syringe is removed from the vial

After the drug is measured, turn the vial upright and pull back a

small amount of air before removing the needle

34


Do not re-cap needles

Dispose of needles and syringes in a specially

marked Chemo Sharps Container

The CSP must bear proper labels for use and a

warning CHEMO label

35

V. PREPARATION FOR DELIVERY TO

THE NURSING UNIT OR PATIENT

All chemo preps should be by pharmacist and doubled

checked by a pharmacist before it goes up to the floor

To supply chemo in LVPs or IVPBs:

Send to nursing unit with an administration set attached

Tubing of the administration set should be primed with non-

chemo containing fluid

Add chemo agent only after priming the administration

tubing with container fluid

36

V. DELIVERY TO THE NURSING

UNIT OR PATIENT Chemo product delivered to floor or home should be

contained in multi-layered, leak proof packaging

Never send through pneumatic tube system;

hazardous medications must be hand delivered

Should have a spill kit available at the pharmacy,

nursing unit, home, and with delivery courier to cover

any emergency spills

All individuals trained in clean-up and appropriate

disposal

All individuals trained and aware of risk of exposure to these

agents 37

VI. DECONTAMINATION AND

WASTE DISPOSAL Personal Decontamination

Immediately removing the gloves or gown

Immediately cleanse the affected skin with soap and water

Flooding an effected eye at eye wash fountain or with water or

isotonic eyewash for at least 15 minutes

Obtaining medical attention

Documenting the exposure in the employee’s medical

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VI. DECONTAMINATION AND

WASTE DISPOSAL Alcohol does not deactivate hazardous drugs

Strong oxidizing agents such as sodium hypochlorite bleach

are effective deactivators of many hazardous drugs.

Hazardous drug waste should be placed in thick

sealable plastic bags before being placed in an

approved hazardous-waste container.

Should not be mixed with biological waste

Waste containers should be puncture proof and have a

sealed lid.

39

Chemo Spill Kit

40

http://www.kendallhq.com/imageServer.aspx?contentID=

31229&contenttype=application/pdf

http://www.kendallhq.com/imageServer.aspx?contentID=31229&contenttype=application/pdf

http://www.kendallhq.com/imageServer.aspx?contentID=31229&contenttype=application/pdf

PRE-PRINTED ORDERS Safety

Includes dose amount and parameters (mg/m2, mg/kg, flat dose)

Lists infusion order for multi-drug regimens

Includes all pre- and post-drugs, labs and other testing

Key to eliminating errors

Consistency

Streamline the process of ordering for physicians

Addresses protocols based on diagnosis/physician

Eases understanding/communication for nursing

Supports practice guidelines for appropriate premeds and prn

drugs

PRE-PRINTED ORDERS

Best Practice

Regimens appropriate for disease state

Continuous modifications based on evidence based

practice

Maximizes patient well-being

Maximize cost control

Patient Education

Identifies key information to relay to patients

PHARMACOGENOMICS

Variations in the genome that affect drug activity

May cause abnormal activity of metabolizing enzymes

Tests are available (blood or cheek swab)

Oncology examples – results in dosage change

UGT1A1 metabolism of irinotecan

DPD metabolism of fluorouracil and capecitabine

Additional panel of 20 medications used for supportive care

ETHICAL ISSUES IN CHEMOTHERAPY Physicians are bound by

Respect for autonomy

Nonmaleficence (do not harm)

Informed consent

Justice – make standard of care available to all

Drug shortages

Shared decision making

Patients who select alternative care

(cultural competency)

Educate

Continue to communicate

Support (LEARN)

IMPLICATIONS FOR JORDAN

Guidelines and regulations

Best practices in handling chemo drugs

IV room set up, ordering, preparation, dispensing,

labelling, delivery, storage, decontamination

Safety guidelines and procedures.

Personnel training (KSA)

Chemotherapy knowledge

Patient Education

Cultural competency, Ethical Considerations, palliative care

45

SUMMARY Hazardous drugs are part of community and hospital

practice

Exposure to such drugs is a possibility

Safe handling guidelines should be followed to decrease

any possible exposure to such drugs

Pharmacist training plays a major role in preventing

exposure to themselves and others 46

SUMMARY

Establishing best practices in hazardous drugs:

Ordering

Preparation

Handling

Disposal

is essential to optimize patient care and address

ethical considerations.

47

QUESTIONS?

CHAPTER <800>

USP Chapter <800> (Feb, 1, 2016), extended official

implementation date for July 2018. Some states have elected to

require earlier compliance)

Focus on protecting healthcare workers and environments from exposure to

hazardous drugs in the healthcare settings where they are handled

State boards of pharmacy are in the process of being trained extensively on

this regulation

American Society of Health System Pharmacists

American Society of Clinical Oncology

National Institute for Occupational Safety and Health

Oncology Nursing Society

49

COMPLIANCE STUDY

Conduct a gap analysis to identify areas that require

improvement

2016 compliance Study

26% of the hospitals report using the “low volume” exemption contained in Chapter <797> relative to HD compound

Chapter <800> removes that exemption

27% of hospitals report they do not comply with the physical

plan requirements of Chapter <800> and have no plans to

comply

Containment Primary Engineering Controls (CPEC)

Containment Secondary Engineering Control

50

NATIONAL INSTITUTE FOR

OCCUPATIONAL SAFETY AND HEALTH

Designate a knowledgeable individual to be responsible for all

aspects of HD

Compile list of HD’s handled using the 2016 NIOSH HD list Consider performing an assessment of risk for those drugs (chemo

that need to be packaged or counter, non-chem and reproductive

only hazard) that may be eligible for alternative containment

strategies and work practices

Assess current physical plan (CPED, CSEC)

Evaluate current work practices and identify gaps between

required and desired work practices and actual work practices

Revise written standard operating procedures (SOPs); Changes to:

Hazardous PPE donning and doffing practices; HD inventory receipt and handling

Organization of compounding steps (improve containment of HD residues)

51

Develop staff training based on updated SOPs

Lowest score in the 2016 compliance study were with items within the SOP

Development Domain and Personnel Training Domain

Establish processes to monitor for compliance with new

procedures and use objective measures when possible to measure

outcomes

Only 10% of hospitals report performing HD environmental wipe sampling

and the vast majority of these perform it by sampling of the inside of the

CPEC only

Should monitor the flood directly outside of these areas

Keep seeking improvement, focus on moving forward

52

Compliance is a journey not a destination

Develop a compliance plan that is strategic based upon

your organization’s needs

Systemically evaluate the voyage travelled by HDs in

your facility

Verify current containment strategies and develop new

ones

Learn from the experience of others

53

http://www.usp.org/frequently-asked-questions/hazardous-drugs-

handling-healthcare-settings

A hazardous drug is any drug identified as hazardous or

potentially hazardous by the National Institute for

Occupational Safety and Health (NIOSH) on the basis of

at least one of the following six criteria: carcinogenicity,

teratogenicity or developmental toxicity, reproductive

toxicity in humans, organ toxicity at low doses in

humans or animals, genotoxicity, and new drugs that

mimic existing hazardous drugs in structure or toxicity.

NIOSH maintains a list of antineoplastic and other

hazardous drugs used in healthcare settings.

55

http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings













The purpose of the chapter is to describe practice and quality standards

for handling hazardous drugs in healthcare settings and help promote

patient safety, worker safety, and environmental protection. The chapter

defines processes intended to minimize the exposure to hazardous drugs

in healthcare settings. The chapter was developed by the USP

Compounding Expert Committee with the assistance of the USP

Compounding with Hazardous Drugs Expert Panel and government

liaisons from the U.S. Food and Drug Administration (FDA) and the U.S.

Centers for Disease Control and Prevention (CDC) including NIOSH.

The chapter was published for the first time for public comment in March

2014. Based on the public comments received, the chapter was revised

and proposed for another round of public comments in December 2014.

The chapter was revised again and published in the USP-NF in February

2016.

56

The public health need for developing <800> was based on published reports of

adverse effects in healthcare personnel from occupational exposure to

hazardous drugs.1 General Chapter <800> was developed based on existing

guidance documents published by the National Institute for Occupational Safety

and Health (NIOSH), American Society of Health-System Pharmacists (ASHP),

and the Oncology Nursing Society (ONS). ASHP published a Technical

Assistance Bulletin in 1986 and NIOSH published an alert on preventing

occupational exposure in 2004. There was a known risk of hazardous drug

exposure in healthcare settings from published medical reports, but there was no

enforceable standard to minimize the potential risk of exposure.

[1] Sessink PJ, Bos RP. Drugs hazardous to healthcare workers. Evaluation of

methods for monitoring occupational exposure to cytostatic drugs. Drug Saf.

April 1999; 20(4): 347-59. Venitt S, Crofton-Sleigh C, Hunt J, Speechley V,

Briggs K. Lancet, Monitoring exposure of nursing and pharmacy personnel to

cytotoxic drugs: urinary mutation assays and urinary platinum as markers of

absorption. Jan 1984;1(8368): 74-7. (See also

https://www.cdc.gov/niosh/topics/antineoplastic/default.html). 57

https://www.cdc.gov/niosh/topics/antineoplastic/default.html

Chapter <800> was written to protect all workers, patients and the general

public who may be accessing facilities where hazardous drugs (HDs) are

prepared. This includes but is not limited to pharmacists, technicians, nurses,

physicians, physician assistants, home healthcare workers, veterinarians, and

veterinary technicians. If any workers come in contact with HDs, they must

receive HD training, and be assessed for an understanding of the training. All

personnel who handle HDs are responsible for understanding the fundamental

practices and precautions and for continually evaluating these procedures and

the quality of final HDs to prevent harm to patients, minimize exposure to

personnel, and minimize contamination of the work and patient-care

environment.

58

The chapter applies to all healthcare personnel who handle HD preparations and

all entities that store, prepare, transport, or administer HDs (e.g., pharmacies,

hospitals and other healthcare institutions, patient treatment clinics, physicians'

practice facilities, or veterinarians' offices).

Yes, the chapter applies to administration of HDs. If non-antineoplastic or

reproductive risk HD dosage forms do require manipulation such as crushing

tablet(s) or opening capsule(s) for a single dose, alternative containment

strategies and work practices as defined in the assessment of risk must be used

(e.g. appropriate personnel protective equipment (PPE), use a plastic pouch to

contain any dust or particles generated). If antineoplastic HD dosage forms

require manipulation, the requirements of Chapter <800> must be followed.

59












60












61

From a compendial standpoint, a USP general chapter numbered below <1000>

becomes enforceable through reference in the General Notices, a monograph, or

another applicable general chapter numbered below <1000>. At this time,

<800> is not specifically referenced in the General Notices, a monograph, or

another applicable general chapter numbered below <1000>.

However, states may make their own determinations regarding the applicability

and enforceability of <800> to entities within their jurisdiction. Per question 8

above, USP has no role in enforcement. As a result, the specific enforceability

of <800> depends on the legal fram

No. USP encourages adoption and implementation of General Chapter <800> to

help ensure a quality environment and protection of healthcare workers and

patients when hazardous drugs are handled.ework that you are analyzing

62

Yes, there have been minimal editorial changes to the chapter. USP publishes

errata if it discovers erroneously published text that does not accurately reflect

the intended requirements as approved by the Council of Experts. In the errata

table, enter “800” in the field “Search by Monograph” to view errata associated with General Chapter <800>.

No. The only part of USP General Chapter <800> that is expected to change is

the official date, which is expected to be changed to December 1, 2019.

Yes, there are several studies demonstrating risks associated with handling

HDs. Some of references are included in the References section of USP General

Chapter <800>.

Yes, final dosage forms of commercially available HD oral liquids that do not

require any further manipulation other than pouring and repackaging may be

considered under an assessment of risk.

63

http://www.uspnf.com/official-text/errata-table

http://www.uspnf.com/official-text/errata-table

No. The assessment of risk must list each drug and dosage form

individually. Dosage forms of drugs within the same group might not have the

same risk of exposure. For example, priming an intravenous line may have

more risk of exposure than dispensing tablets without further

manipulation. HDs appear on the NIOSH list based on different characterizes,

such as specific reproductive risks. The facility may have the same information

for several drugs or dosage forms, but the facility’s list needs to be specific to the drug and dosage form.

http://www.usp.org/frequently-asked-questions/pharmaceutical-compounding-

sterile-preparations and

http://www.uspnf.com/notices/general-chapter-797-proposed-revision

http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-

healthcare-settings

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http://www.usp.org/frequently-asked-questions/pharmaceutical-compounding-sterile-preparations

































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