### R u ssell F. Mankes, Ph.D. A ssociat e P r of essor, Center for Neuropharmacology & Neuroscience, and Center for Immunology & Microbial Disease Chemical Hygiene Officer & Responsible Facility Official
D EPARTMEN T O F E NV IR ONME NTA L H EALTH AN D S AF ETY H UN M EM O R I A L B UI LD I N G MC-96 

### (518) 262-5490/ (518) 262-8638 (FAX)/(518) 422-0593 (P AGE R 

### ) M A N KES 

### R@ MAI L



### . AMC



### . EDU 

## 29 October, 2009 Progress Report Project Title: “Source Reduc tion Demonstration Project” EPA-OPPT-06-008 / CDA 66.717 EPA Grant # X9-97256506-0 Project Period: 8/1/2007-7/31/2009 PI: Russell F. Mankes, PhD MankesR@mail.amc.edu

The project, ending July 31, 2009, evaluated strat egies for source reduction of pharmaceutical waste from a hospital into the env ironment, primarily though waterborne disposal (flushing) of drugs, reduction in use and wastage of hazardous medica tions (such as propofol), development of educational tools of improve compliance by patient care staff, and finally to disseminate this information and lessons learnt to the 550 hospitals in New York State and to the regulatory community. The project was an unqualified success. We were able to develop a training program which was embraced by patient care staff. We significant ly reduced maldisposals and initiated a “no-flush” policy. We collected unique data on dispensing as well as wasting practices, noting a wide variation in “wasting” percentages of drugs. Some drugs having 0 waste yet others exceeding 50% of all drug dispensed. These data provide unique opportunities fo r process improvement as well as healthcare cost containment. We provided onsite tours for facilities from Canada to Puerto Rico to see and touch the program as well as talk to nursing staff regarding the acceptance of the program. These tours were extremely well received (85% posit ive) and sixty-one percent indicat ed the tours were an impetus for change at their institutions. As indicated in our initial grant application, we intended to use this knowledge gained in the pilot project as an entryway into the program expans ion to the main (631 bed) hospital campus. As noted in the attached final report, we have begun the ro ll out at the main hospital, with interesting results. This roll out would not have been possi ble without the knowledge gained from the present pilot project.

## Slide 1

10/13/2009 

# Albany Medical Center

P h armaceuti c al w a ste management:
A 2 y e ar pi l o t proj ect

R u ss ell F

. M ankes, PhD Asso ciate Prof essor , C enter for N europharmacol ogy and N euroscience and C enter for Imm unology and M i cr obi al D i sease



## Albany Medical Center Pharmaceutical waste management: A 2 year pilot project Funded by US EP A

grant X9-97256506-0 In collabor ation with HANYS (Healthcare Associati on of New Y o rk S t ate) and the New Y o rk S t ate Dep a rtment of Environment al Conservation Russell F

. Mankes, PhD Associate Professor

, Center for Neurophar macology and Neurosc i ence and Center for Immunology and Microbial Disease

Slide 2



# Participants

• A l bany Medi cal C enter

– A l bany Medi cal C o l l e g e

• R ussell F. M ankes, PhD Associate Pr ofessor

, PI

• T i m othy D u ff ey , H o spi t al D i r e ctor Al bany M edical C enter South C l i n ical C a mpus

• M i c hael M u rphy

, R N D i r e ctor of Pat i ent C a r e South C l ini c al C a m pus

• E lena C i oppa, R P H D i rect or of Pharmacy South C l i n i c al C a m pus

• B r enda St reet er, C I H D i rect or Env i ronmental H eal t h & Safet y

• Laur i e D e W e e r dt, C hem ical H y giene O f f i cer AM C

• P et er G o rman, A sst C hem i c al H y giene O f fi cer A M C

• H eal thcar e Associ ati on of N e w Y o r k State

• K ar en R oach, D i rect or gov ernmental Aff a i r s

• N ew Y o rk State D epartment of Env i ronmental C onser v a ti on

• A l a n W o od ard

, P h D

• D en ni s L u c i a



## 2

## Particip ant s: Albany Medical Center – Albany M edical College - Russell F

. Mankes, PhD Associat e Professor

, PI, T i mothy Duf f ey , Hospit al Direc to r Albany Medical Center South Clinical Campus. Michael Mu rphy , RN Director of Patient Care S outh Clin ical Campu s , Elena Ciopp a, RPH Director of Pharmacy South Clinical Campus, Brenda S t reeter

, CIH Director Environment a l Health & Safety

, Laurie DeW eerd t, Chemical Hygiene Of ficer AMC, Pe ter Gorman, Asst Chem ical Hygiene Of ficer AMC Healthcare Association of New Y o rk S t ate - K a ren Roac h, Directo r government a l Af fairs New Y o rk S t ate Dep a rtment of E n vironment al C onserv a tion - Alan W oodard, PhD, Dennis Lucia, Resa Dimino New Y o rk S t ate Dep a rtment of H ealth, Bureau of Narcotic Enforcement – Paula Grogan; V i ctoria Hanson, RPH New Y o rk S t ate Dep a rtment of E ducation S t ericycle Inc (Contractor) – Mau r een Guice Major Account Exec utive, Dan Fadgen Rx Formulary

Slide 3



# Planning

• M aldis posals of Pharmaceuticals from OR

– “ Hous ton w e hav e a problem”



## Pharmaceutical maldis posals bec ame a signific ant issue for AMC in 2005. As shown abov e, controlled drugs and regulated s ubst ances were haphazardly dis p osed in cardboard boxes and regulated medical waste (white bu cket s ) making drug diversion lik e ly

. Additionally , many of the regulated d r ugs were no handled in accord wit h S t ate or federal regulations (RCRA). No consist ent guidance for pharmacist s or medical pr actitioners was available and st af f were pretty much “lef t on their own”. Regulat ory control and guidance from the US EP A

and NY DEC was focused upon the professional waste managers for healthcare fa cilities (Environment al Health & Safety) and st atewide enforcement inspections of hospit a ls by both EP A

and DEC in 2003 had resulted in signific ant penalties. This had not translated into gui dance or process improvement s to handling of pharmaceutical waste by the ultimate car egivers (pharmacy / p a tient care st af f).

3

## Slide 4



## Pharmaceutical Waste

• G oals

– C ompliance

– A void w a ter w a sting and disc harge.

– R educ e drug div e rsion

– I mprov e medic a tion management

prac tic e s

– N ew regulations on pharmaceutic al

w a ste (univ e rsal w a stes).



## Goals: Improve compliance with Joint Commission, S t ate, Federal and Local r e strictions on discharge of pharmaceutical was t e to water supplies. Improve compliance with Controlled Subst a nc e (Narcotics) regulations and avoidanc e of diversion. Improve medication management practices in collaboration with HANYS (AMC - National Model). Position AMC for compliance with new S t ate and federal regulations on limiting waste water discharge of pharmaceutical wa s t e (Universal wastes).

Slide 5

What’s Changed?

• N ew Joint Commiss i on standards.

• I ncreas ed c o mplianc e 274 c u rrently regulated drugs.

• A ntic ipated new regulations on

dis c harge of pharmaceuticals to w a s t e

w a ters affec t ing 2,426 not c u rrently regulated drugs.

• P ublication of CCL3 (Third drinking

w a ter Contaminant Candidate List).



## New Joint Commission st andards.

4

## (EC.02.20.01; MM.02.01.01; MM.03. 01.01; MM.05.01.1 1 ; MM.05.01.19) Increased complianc e action on 274 currently regulated pharmaceuticals by OSHA; US EP A; NYS DoH; NYS DEC and Albany County Sewe r District e.g.., Chemotherapy drugs, epinephrine, fent anyl, aerosol cont ainers. Anticip a ted new federal and st ate regulations on discharge of pharmaceuticals to waste waters af

fecting 2,426 not currently regulated drugs. M ood altering drugs – prozac, antiviral drug, endocrine drugs, heart medications digoxin and antiinflammatory drugs – ibuprofen and cholesterol lowering drugs – lipitor

. Publication (September , 2009) Third Drinking W a ter Cont aminant Candidate List (CCL3) including estrogens, formaldehy de, et hylene glycol and nitroglycerine.

Slide 6

2009 Joint Commission Standards

En v i ro nm ent of C a r e St and a rd ( E C

. 02.02.01): manag e

r i sks
Elem ent s o f Perf or man ce:

• M i n i m i z e r i sk di sposi n g of haz ar dous medi cati o n s.

• M i n i m i z e r i sk manag i n g haz ar dous medi cati ons. Med i catio n Man a gem e nt St and a rd (M M.02.01.01) : select, pr ocure medi cati ons. Elem ent s o f Perf or man c e

• M ai ntai n f o r m ul ary ( s treng th and dosag e)

.

• F ormul a r y readi l y av ai l abl e.

• R ev i e w ed at l east annual l y

.



## Joint Commission S t andards 2009 Applic able to Pharmaceuticals W a ste Management Environment of Care S t andard (EC.02.02.01) The [organization] manages risks relat ed to hazardous materials and waste. Element s of Performance for EC.02.02.01 The hospit a l minimizes risks associated wit h di sposing hazardous medications. (See also MM.01.01.03, EP 4). MM.01.01.03 (4): A

, 3 The hospit a l minimizes ri sks associated wit h managing hazardous medications. (See also EC.02.02.01, EP 8)

5

## Slide 7

Me di cation Management Standar d (MM.03.01.01): safe s t orage

• M a i nt ain in te gr ity

• P rom o te av ailability

• R ed uc e div e r s io n a n d d i sp en sin g er ro rs

.

• A w r it te n p o lic y t o co nt ro l me dic a t i on s fr o m receipt to adm i nist ration.

• L ab el a ll me dication s an d co mp on en ts w i th

con t e n ts, ex piration da te

, an d w a rn ing s

.

• E x p ired , d a m a g e d

, an d/or co ntam ina t e d

me dic a t i on s a r e r e mov e d an d st or ed s e pa ra te ly

.

• P e r io dically inspe c t me dication sto r a ge area s.



## Medication Management S t andard (MM.03.01.01) The [organization] safely stores medications. Rationale for MM.03.01.01 Medication storage is designed to assi st in maint a ining medication int egrity

, promote t he availability of medications when needed, minimize the risk of medication diversion, and reduce potential dispensing

errors. Law and regulation and manufacture rs' guidelines further define t he [organization]’ s appr oach to medication storage. Element s of Performance for MM.03.01.01 The hospit a l stores controlled (scheduled) medication s to prevent diversion, in accordanc e with law and regulat ion. The hospit a l has a written policy addressing the control of medication between receipt by an indiv i dual health care provider an d administration of the medication, including safe storage, handling, security , disposition, a nd return to storage. All stored medications and the com ponent s used in their prep aration ar e labeled with the content s, expiration date, and any applic able warnings

. The hospit a l removes all expired, damaged, and/or cont aminated medicati ons and stores them
sep a rately from medications av ailable for administration. The hospit a l periodically inspect s all medication storage areas.

6

## Slide 8

M e di ca ti on M a na ge m e n t S t an da r d (M M

. 05 .0 1.1 1 ) : d i sp en se m e d i ca ti o n

• P racti c es and recor d keepi ng i n cl ude antidi v ersi on str a tegies.

• M edi cati ons di spensed i n ready -to- admi n i s ter or uni t doses. Med i catio n Man a gem e nt St and a rd (M M.05.01.19): manag e retur n s.

• M edi cati ons are retur ned w hen al l o w ed.

• R etur ns are accounted, cont rol l ed, and di spose d to keep pati ents saf e and prev ent di v e rsi on.

– T he hos pital deter m i nes if and w hen outs i de s our c e s ar e us ed f o r

des t r uc tion of m edic a tions

.

– T he hos pital im plem ents it s pr oc es s f o r m anaging unus ed,

ex pir ed, or r e t u r ned m edic a t i ons



## Medication Management S t andard (MM.05.01.1 1) The [organization] safely dispens es medications. Element s of Performance for MM.05.01.1 1 The hospit a l dispenses medications and maint a ins records in accordance with law and regulation, licens ure, and professional st andards of practice. Note: Dispensing practices and recordkeepi ng include antidiversion strategies. Medications are dispensed in the most ready-to-administer forms co mmercially available, and, if feasible, in unit doses that have been rep a ck aged by the pharmacy or licensed rep a ckager

. Medication Management S t andard (MM.05.01. 19) manages returned medications. Rationale for MM.05.01.19 Medications may be returned to the [organiz a tion] w hen allowed by law or r egulation and organization policy

. Previous ly dispens ed but unused, expired, or retu rned medications in the [organization] must be accounted for

, controlled, and disposed of in order to keep p a tient s safe and prevent diversion. The hospit a l determines under what circumst ances unu sed, expired, or retu rned medications will be managed by the pharmacy or the hospit a l. When the hospit a l acc ept s unused, expired, or retur ned medications, it has a process for returning medications to the pharmacy’ s c ontrol, that includes procedur es for preventing diversion. The hospit a l determines if and when out side source s are used for destruction of medications. The hospit a l implement s it s process for managing unused, expired, or returned medications

7

## Slide 9



# Implement

G r ant Aw arded

• S tage 1: Months 1-6; Baseline Data Collection, Educ ation & Roll O u t.

• S tage 2: Months 7

– 18: Program Implementation, Refinement and Data Collection

• S tage 3: Pos t Mortem Analy s is & Decis i on Mak i ng for Full Scale Roll O u t



## Grant A w arded S t age 1: Months 1-6; Baseline Dat a Collection, Education & Roll O u t. S t age 2: Months 7 – 18: Program Implement ation, Refinement and Dat a Collection S t age 3: Post Mortem Analysis & Deci sion Making for Full Scale Roll Out

Slide 10



# Stage 1

• B as eline Metric s (s ee attac hed graphs )

• A w a rd Contrac t for Pharmaceutical Waste Serv ices

9 Stericy c le

• T riu m vira t e

• P harmEcol o g y



## • D esign Education Program



## S t age 1: baseline dat a on weight and cost of pharmaceutical waste disposal was collected from AMC’ s Main campus and South Clini cal Campus. Additional dat a from the A M C Pharmacies returns program was collected. The AMC Formulary (some 2,700 items) was asse mbled by NDC in prep ar ation for formulary characterization by an out side contractor

.
8

## Three out side contractors were solic ited to provi de bids for a subcontract under the EP A

Grant. The sub contractor would provide formulary charac terization and supp ort, supplement a ry training, reusable waste cont ainers and labels, and dispos al of Non-RCRA Regulated pharmaceuticals. PharmEcology Inc requested not to be consi dered as a subcontractor for business reasons. S t ericycle Inc., was awarded the sub contra ct by AMC. The AMC Dep a rtment of Education and Dev e lopm ent designed an educatio nal program focused upon the AMC caregiver

. During this time, popular pr ess report s of drinking water cont ami nation by pharmaceuticals were appearing daily , so advant age wa s made of this confluence of event s and flyers & Posters touting “What’ s in Y our W a ter” were distributed to the AM CH South Clinical p a tient care st af f w e ll in adv ance of the program’ s kic k of f. In addition to AMC’ s education pr ogram, S t er icycle provided a num ber of handout s and flyers t a rgeting Environment al Services S t af f and Nurs ing S t af f based on other operating programs. AMC modified these for use at the South Clinical Campus. S t ericycle also pr ovided a 4 day train the trainer program just prior to placement of the pharmaceutical c ont ainers. AMC Facilities Maintenance had mounted the distinctiv e carriers a nd posters but had not placed any c ontiners until the trainin g was completed.

Slide 11



# Overview of Pharmaceutical Waste Management at AMC

• M a n a g e m e n t fr ag me nt ar y an d dr iv e n b y

com p e t in g re gu lation s a n d practices

• C o n tro lled su bsta nces (C S)

• V ac cin e s , bio l og ica l s an d mix e d w a st es (r eg ula t e d me dic a l w a st e

– R MW )

• A n t in eo pla s tic an d cy to to x i c drug w a stes

• R a d io ph arma ce utica l s

• D y e s an d co ntra st ag en ts (Barium )

• S hie l din g f o r r a d i ot he ra py



## Controlled substances (CS) Bedside wasting vs drug destruction Most common toilet or sink wasting Fentanyl patches must be put in sharps containers Some CS a r e RCRA regulated ( C hlora l Hy drate / Paraldehy de) Vaccines, biologicals and mixed wastes (regulated medical waste – RMW) Red bag vs sharps containers Sharps are not always incinerated! Reusable sharps container systems. Autoclave and shredding of sharps. Sterile chemical wastes which are land filled! Preservatives for vacci nes, biological s, human insulin.are hazardous wastes Antineoplastic and cytotoxic drug wastes

9

## Special handling and i dentification due to risk to em ployees (OSHA / NIOSH) during administration and clean up Trace vs Residual waste Radiophar maceuticals Decay in storage vs RCRA time limits Mixed (radioactive – chemical) wastes Dyes and contrast agents (Barium) TCLP? Shielding for radiotherapy Heavy metal molding for directed beam procedures.

Slide 12



# Point of Generation?

• W hen draw n up?

• W hen partially adminis tered?

• W hen returned to pharmac y ?

• F loor s t oc ks vs unit dosing?

• P Y X IS® automated dis pensing – r eturn

draw er

• R esearc h , Inves t igational and patient’s

ow n medic a tions



## When drawn up? When p a rtially administered? When returned to pharmacy? Floor stocks vs unit dosing? PYXIS® a u t omated dispensin g – return draw er All transactions for all drugs recorded or just some? Controlled subst ance wasting, returned to stock, etc. Out dated stock Research, Investigational and p a t i ent’ s own medications

10

## Slide 13

Me t r i c s
Phar m a c eutic al W a s t e G ener ation

– “ T r ac e” vs “ R es idual”



## S t age 1: baseline dat a on weight and cost of pharmaceutical waste disposal was collected from AMC’ s Main campus and South Clini cal Campus. Additional dat a from the A M C Pharmacies returns program was collected. “T race” pharmaceutical waste refers to materials charac teristic of regulated m edical waste that have come into cont act with regulated pharmaceuticals during administration. T he most common example is trace cont aminated materials from the admini stration of antimet abolit e – antineoplastic drugs “Chemo”. These are labeled “CHEMO INCINERA TE ONL Y ” “Residua l” pharmaceu t ical waste refers to both RCRA a nd Non-RCRA pharmaceutical wa stes shipped for disposal by a commercial hazar dous waste hauler

. Despite the increased focus on pharmaceutical waste manageme n t and disposal, AMC exp e rience d very modest increases in weight and cost of disposal of pharmaceutical wast es from January 2007 to the present. AMC’ s pharmacy returns program also ma int a ined a s t able return for credit weig ht and cost. This program accounted for the bulk of returned medications.

11

## Slide 14

“Trace” v s “Residual” Pharmac e utic al W a s t e

G e n e rated at Alba ny M e d i ca l C e nter (lb s ) 20 07 - 2 00 9

532

cen su s 536

cen su s

532

cen su s 533

cen su s

A

v er age

w e i ght per patient- y ear = 23. 7 pounds



## Graphical display of baseline dat a for “trace” and “residual” pharmac eutical waste generated at the Albany Medical Center ’ s Main Campus and S outh Clinical Campu s from 2007 through 2009. The above amount s do not include pharmaceuticals re turned for credit under AMC’ s guaranteed returns program. D u ring the project period, residual pharmace utical waste (e.g., recognizab le drug waste,
p a rtial vials

, t ablet s, etc) doubled from about 500 pound s / year to over 1,000 pounds, yet overall waste generation was not signific antly changed. Ho spit al occup anc y levels remained relatively const ant at 532, 536 and 532 p a tient s per day

. These dat a also provide some expect a tions for other facilities wh ich wish to embark on pharmaceu t ical waste collection p r ograms, al lowing for rough projection of 23.7 pounds (21.6 pounds “trace” and 1.9 pounds “residual”) of drug waste generated
per p a tient-year

.

Slide 15

“ T r a ce ” v s “ R es idu a l” Ph ar ma ce ut ica l W a st e

G ene ra te d at Alba ny M e d i ca l C e nter ($) 20 07 - 2 00 9

532

cen su s 536

cen su s 532

cen su s 533

cen su s A v erage cost
per

pat i ent - y ear= $1 1.61



## 12

## As noted earlier

, the cost per pound of disposal of “resi dual” (RCRA) pharmaceutical waste is markedly higher than for “trace” (RMW) cont aminat ed d r ug waste for incineration only

. Current RMW rates avera ge between $0.26 - $ 0 .45 per pound, depending on contractor . R CRA (“residual”) disposal rates may range as high as $156 per pound fo r acutely toxic (P –listed) drug wastes. The above graph clearly indicates the necessity for care ful waste segregation int o appropriate streams as a small increase in RCRA waste can translate into a large increas e in cost with no significant environment a l benefit . Per p a tient-year cost s for drug waste disposal over the baseline period 2007 – 2009 were $1 1.61 ($5.67 “trace” and $5.94 “residual” – RCRA).

Slide 16



# Metrics

AMC

- SC C F o rmul ar y char acteri z a ti on

*Ni ne dr ugs rem o v ed fr om RCRA Haz a rdous by US E P A & NY DE C:
1. C y cl ophospham ide i n jec t ion

- U 058; 10019095701
2. C y tox an ® i n jec t ion - U 058, 00015050641
3. E p inpehrine i n jec t ion

- 1 m g /m L

- P 042, 66860002001
4. E p inpehrine H C L - 1 m g /m L - P 042, 00548331600
5. E p inephrine H C L

- 1 m g /m L

- P 042, 00409724101
6. M i tom y c i n inj e cti on 40m g

- U 010

- 55390045301
7. M i tom y c i n inj e cti on 5m g- U 010

- 55390045101
8. P h y s osti gm i ne s a li cy cl ate inj e c t ion 1 m g /m L

- P 188, 11098051002
9. T r is enox - P 012, 1459060010



## The formulary for AMC is represent ative of most hospit a ls whic h have between two and three thousand individual it ems. If a drug is not on the formulary

, it is normally not available unless by specia l order . Characterization of the hospit a l formulary is the first step in RCRA and Joint Commissio n complian c e. A facility without a formulary (or “drug list”) will not know what medication s are either available for administrati on or what solid wastes are generated, thus failing the first test in “cradle to grave” RCRA complian c e. Furthermore, the facility is unable to determine it s generator st atus under RCRA, any manifesting, notifica t ion or training require ment s which may apply

. AMC’ s South Clinical Campus maint a ined it s st atus as a Condit i onally Exempt Small Quantity Generator (CESQG) despite generating small amount s of the P lis ted waste - epinephrine. In April, 2009, The New Y o rk S t ate Dep a rtment of E n vironment al C onserv a tion concurred with an earlier determination by the US EP A

to delist epinephr ine salt s (epinephrine is insoluble in water so medical epinephrine for drug use is converted to the hydroc hloride salt for admi n istration). This ruling also af fected other P and U (but not characteristic – D) listed wast es in syringes and nee dles. Because of this recent clarification and the rather st andardized formularies in use, most healthcare facilities sh ould now find themselves as CESQG st atus.

13

## Slide 17



# AMC Formula 

# ry

• A l bany Medi cal C enter ’ s F o rmul ar y i s 2,700 i t ems

• N i nety ( 90%) percent not

re gu la t e d

• F i v e ( 5 %) percent contr o l l ed substances.

• F our ( 4 %) percent haz ardous chemi c al s

• T hr ee ( 3 %) percent

cancer drug s.

• T hr ee ( 3 %) percent medi cal w a ste and

• T hr ee tenths ( 0 .3%) per cent aer osol s

.



## Of the 2,700 pharmaceuticals (unique NDC’ s ) whic h comprise the Albany Medical Cente r ’ s Formulary , ninety percent are not currently regulated (e.g., endocrine di srupto r s, steroids, antibiotics, mood altering drugs, heart & blood pressure medicati ons, anti-inflammatory and cholesterol lowering drugs). Five percent are controlled s ubst ances, regulated by the US DEA or New Y o rk S t ate. Four percent (April, 2009) were regulated as hazar dous chemical wastes (N.B. the US EP A

and New Y

o rk S t ate have since deregulated epinephri ne salt s and syringes with listed wastes). Three percent are OS HA / NIOS H regulated cytotoxic drugs. Three percent are medical waste (biohazardous); and three tenths of a percent are aerosols regulated by the US De p a rtment of T r ansport a tion.

Slide 18



# RCRA Pharm a ceut i c al Wast es D’ s

• 7 2 Cha r a c t e r i s t ic w a s t es of 2, 70 0 NDC’s

• I gn ita b le

, corro s iv e, re activ e or to x i c

• I g n it ab le ( a lc oh ol)

– D 00 1 (3 8/ 72 )

• C or ro siv e s – D 00 2 (2 /7 2) • T o x i c s ( T C L P )

– C resol (pr e serv ati v e)

– D 024, D 026 ( 12/7 2 )

– M er curi al s ( p reser v ati v e)

– D 009 ( 11/7 2 )

– S el eni um – D 010 ( 5 /72)

– S i l v er – D 011 (4/72)

– C hromi u m – D 007 ( 2 /72)



### “ C ha ra ct er ist i c” w a s t e s n o t af fe ct ed by NY DEC Ap ril, 20 09 le tter.



## 14

## Examples of characteristic drug wastes: Ignit able – Aromatic ammonia, ar gatroban, benzoin tinct u re, clinda m ycin, collodion, dexamethasone, etoposide, iodine tincture, kaletra, mastisol, nitroglycerine injecti on, norvir , p a clit axe l , trilept al; Corrosive – T r ichlor liquid; Reactive – none; and T

o xicity (D004 – D043) – Multitrace-4 inject able c oncentrate, T ab-a-vite, Thera vit a min (D007); Bio Glo, flurbiprofen, Genesal solution, nasal decongest ant , neomycin/polymyxi n/ gramacidin ophthalmic solution, Neo-synephr ine spray

, oxymet azoline so lution, trifluridine ophthalmic solution (D009), Adqadeks liquid, selenious acid injection, seleni um sulfide lotion/shampoo (D010), silver nitrate applicator , SSD cream, thermazine cr eam (D 01 1); Apidra inject able, Humalin®, lantus, Novolin N inject able (D024), and clobet asol cream, Hu malog, Novolin 70/30, Novolog (D026). TCLP – T o xic constituent leaching potentia l as express ed as mg/L (40 CFR 261.24)

Slide 19



# RCRA Pharm a ceut i c al Wast es P’s (A cu te l y T o xi c)

• 31 of 2,700 NDC’s

• G ener ator status

– 1 kg

, i n cl udes contai ner w e i g ht

• I ncl uded:

– W ar fari n / C oumadi n

– P 001- sol i d (tabl et) dosag e f o r m onl y

.

– N i c oti ne – P 075 ( g um, patches)

• E x c l uded:

– E pi nephr i ne (sal ts)

– J ul y 15, 2009

– P hy sosti g mi ne Sal i c y l ate –i nj ecti on r e si dual

– T ri senox ® arseni c tri o x i de

– i nj ecti on r e si dual



## Examples of non-excluded P li sted pharmaceutical wastes: Coumadin t ablet s 2-10 mg, Jantoven t ablet s 2-10 mg, W a rfarin t a blet 2-10 mg (P001); and Nicorelief, nicotine transdermal (P075) Affects generator status – 1 kg (2.2 pounds) generat ed in any one month or accumulate 1 kg (2.2 pounds) of P waste at any time. FULLY REGULATED - LARGE QUANTITY GENERATOR!! 2.2 POUNDS INCLUDES WEIGHT OF EMPTY CONTAINER!!!!!!! Exc l uded: Epinephrine (salt s ) – Delisted by New Y o rk, July 15, 2009 for salt s of epinephrine and injection residuals (s yringes, vials, sharp s , etc). Physostigmine Salicy late – P188 injection residuals (syringes, vials

, sharp s , etc). T r isenox ® arsenic trioxide – P012 injecti on residual (syringes, vials

, sharp s , etc).

15

## Slide 20



# RCRA Pharm a ceut i c al Wast es U’ s

• 1 0 o f 2, 70 0 NDC’s

• D iscarde d v i rgin prod uct no t in sy rin g e / ne ed le

• S ole a c tiv e in gred ien t

• C he m o / C y to to x i c
3⁄4 M i tomy ci n C

– U 010
3⁄4 C y cl ophosphami de – U 058



### • S ha mp oo – S e l en ium Su lfid e U 2 05

• T h r o a t Sp ra y

– P he no l U 1 88

• W a r f a r i n / Co umad in – U 24 8 (1 mg t a b l et )



## Examples of non-excluded U list ed pharmaceutical wastes (virgin discarded product, sole active ingredient only

, not in sharp s or syringe - inject able): Sore throat spray cherry (U205), selenium sulfide lotion and shampoo (U205); coumadin 1 mg t abl et, Jantoven t ablet 1 mg, W a rfarin t a blet 1 mg (U248)

Slide 21



# An tin e o p l a s tic / C y to toxic D r ug s

• 5 f l uor o Ur ac il

• A r s enic tr iox i de • A z a s e r i n e

• A z a t h iopr im

• B leom y c in

• B us ulf a n • C a r m u s t i n e

• C hlor am buc il

• C y c lophos ph am ide

• C hlor naphaz in

• C is platin

• C y t ar abine

• D ic ar baz ine

• D ac tinom y c in • D anor ubc in

• D aunom y c in

• D ox or ubic i n

• Lom us tine

• M ec hlor etham ine

• M elphalan

• M er c aptopur ine

• M ethot r e x a te

• M ithr am y c in

• M itom y c in

• M itom y c in C

• P ro ca rb a z i n e

• U r a c il Mus t ar d



## In 1987, an EP A

policy letter clarifi ed that waste cont aminated with trace residues of chemotherapy agent s would be considered non-hazardous waste if it meet s the “ em pty cont ainer” criteria. OSWE R Directive 9441.1987(45) (policy dire ctive from J. Sales, Chief, Regulation Dev e lopment Section, EP A), U.S. Environment a l Protection Agenc y , June 16, 1987; cited in W

. L. T u r nberg, loc. cit. “ Empty cont ainers” are cont ainers from which chemotherapy agent s hav e been removed and no more than 1

16

## inch of residue or no more than 3% by weight of residue remains in the cont ainer

. The EP A recommends that materials such as vials, syringes, glov es, etc. cont aminated with these chemicals not be handled af ter use to minimize exposur e.

Slide 22

Not Currently Regulated Drugs (2,426)

• A nti b i o ti c/anti v i r al dr ug s

– 250 ( 10.3%)

– E x a m p les: am ox icillin, ketoconaz ole, m i conaz ole,

l e v o fl ox aci n

• A nti p sy choti c /anti depr essant drug s

– 109 ( 4 .5%)

– E x a mpl e s: hal operi dol , cl oz api ne. i m i p r a mi ne

• E ndocri ne di sr uptors/hor mones

– 100 ( 4 .1%)

– E x a mpl e s: bromocr i pti ne, estradi ol

, me g e strol

,

tamox i f e n

• H ear t/bl ood pr essure dr ug s – 71 ( 2 .9%)

– E x a mpl e s: ami odarone, propr anol ol

• A nti a rthr i t i c / anti n fl ammatory dr ug s

– 55 (2.9% )

– E x a mpl e s: al l opuri nol

, aspi ri n, ketopr of en



## Non-regulated does not mean not harmful. In Dece mber 2008, The US EP A

pr oposed to extend the universal waste rule to hazardous (RCRA regulat ed) pha rmaceuticals “Amendm ent to the Universa l W a ste Rule: Addition of Pharmaceuticals” 73 FR 73519-73544 Dec 2, 2008. The EP A

spec ifically
encourage d (but did not mandate) healthcare fac ilities to manage all pharma ceutical wa stes (hazardous and non-hazardous) as universal wastes under this new proposed rule. An area lef t unresolved was the handling of RCRA regula t ed c ontrolled subst a n c es. Neither RCRA nor the proposed rulemaking supersede the requirement s of the Controlled Subst anc es Act and DEA regulations for the disposal of controlled subst ances. Thus, any ent ity generating, collecting, handling or managin g a RCRA hazardous pharmaceu t ical wast e that is also a controlle d subst ance in Schedule II-V \43\ must abide by RCR A as well as the requirement s of the Controlled Subst ances Act and DEA regulations. Three examples of listed hazardous wastes that are also controlled subst ances are phentermine (alpha, alpha-dimethyl- benzenethanam ine, P046), chloral hydrate (U034), and
p a raldehyde (U182). Additional pharmaceuticals were listed by the US EP A

t o the Cont aminant Cand idate List 3 (CCL3) on September 22, 2009. These inclu ded 9 endocrine disruptors/hormones: 17 alpha estradiol, 17 bet a estradiol; 17 alpha ethynyl estradiol, estriol, estrone, mestranol, equilenin, eq uilin, 19 norethisterone, and 1 antibiotic: erythromycin.

17

## Slide 23

Exampl es of Env i ronment a l l y Harmf u l but Non- Regul ated Drugs of Concern*

P h ar m a ceu ti ca l P B T Ri sk of P h a r maceu t i cal P B T Ri sk of

( p er s i s t en ce , bioa ccu mu l a t i o n , t oxici ty) B i oa ccu m u lat i on ( p er s i s t e n c e , bi oa ccu m u la ti on , t oxici ty) B i oa ccu mu l a ti o n aci t r et i n 9 N / A d i azepa m * * 6 N / A
al l o pu ri n o l 6 m o d e rat e d o cet ax el 9 can n o t be ex cl ud ed

am

i o d a ro n e 9 N / A d r o s pi r e n o n e 8 can n o t be ex cl ud ed

a m

o x i c illin * * 6 m o d e r a t e d u t a s t e ri de 8 c a n n o t b e e x c l u d e d

at o v aq uo n e 9 N / A ef avi

r e n z 9 i n s i g n i f i c a n t
b ecl o m et haso n e 9 can n o t b e ex cl u d ed es ci t a l o p r a m 9 i n s i g ni f i ca n t
b r om oc r i p t i n e 9 N / A e s t r a d i ol 9 h i g h

bu d e so ni d e 8 i nsi g n i f i c a nt e t hi n y l e s t r a d i o l 9 hi g h

c a r v e di l o l 9 i n s i g n ific a n t e t o n o g e st r e l 8 i n si g n if ic a n t
ci t a l o p r am 9 i n s i g n i fi ca n t f e l o di

p i n e 9 l o w cl em

a s t i n e 9 N / A f e n t an y l * * 7 N / A
cl o zapi n e 9 i n s i g n i f i c a n t h al o p eri d o l 8 i n s i g ni f i ca n t

cy p r o t ero n e 8 can n o t b e ex cl u d ed i m i p ra mi n e 9 N / A
d a sa t i n i b 9 i n s i g n ific a n t i sra d i p in e 9 i n si g n if ic a n t
deso gest r e l 8 i n s i g n i f i c a n t k et o c o n azo l e 9 m o d er at e d e xt r o p r o p o x i p he ne 8 c a nno t be e x c l u d e d k e t o t i f e n 9 N / A dy dr o g est e r o n e 8 can n o t b e ex cl u d ed l e f l u n o m i d e 8 N/ A

l e vo f

l o x a c i n 8 i nsi g n i f i c a nt m e g e s t r o l 9 N / A

m i c o n a z o l e 9 N /A o f l o x a c i n 9 i n si g n if ic a n t

p r op of ol 9 N / A p r op r a n o l o l 3 m o d e r a te

t a m o xi f e n 9 N / A t e l i t hr o m yc i n 9 i ns i g n i f i c a nt

* T hos e w i th a PB T (per s i stenc e, bi oacc u m u l a ti on and tox i c i ty) sc or e of 8/9 or 9/9 and/or a m oder ate or hi gh ri sk (hi gh producti on /use or hi gh env i r onm ental m eas ur em ent) as repor ted by “ E nvi r onm ental C l as si fi c a ti o n of P har m a c euti c al s in w

w w .fas s .s e ”

. * * Inc l uded i n l i s t due to hi gh pr oduc ti on, usage and envi r onm ental rel ease.



## The table was abstracted from “Environmental Class ification of Pharmaceuticals in www.fass.se”. Additional pharmaceuticals with lo wer PBT scores were includ ed be cause of high production, usage and environmental release (e.g., am oxic illin, diazepam, fentanyl). PBT (persistence, bioaccumulation, toxicity) were assigned as 1 to 3 individually and multiplied to give an overall ranking from 1 to 9. Risk of Bioa ccumulat i on was as sessed as the drug concentration in the environment compared to the expected dr ug concentration based on drug production / usage (e.g. a drug with a moderate score would hav e a gr eater than expec ted envir on mental concentration as compared to a drug with an insignific ant sco re whic h would have a lower than expected concentration in the environment). Antibiotic/antiviral drugs – 250 (10. 3%): amoxic illin - PBT 6, modera te bioaccumulation; atovaquone – PBT 9, no data available for bioaccumulation; efav irenz - PBT 9, i n significant bioaccumu lation; levofloxac in - PBT 8, i n significant bioaccumula tion; miconazole – PBT 9, no data available for bioaccumulation; ketoconazole – PBT 9, moderate bi oaccumulation; ofloxacin – PBT 9, insignificant bioaccumulation; telithromycin – PBT 9, insignificant bioaccumulat i on. Antipsychotic/antidepressant drugs – 109 (4.5%): cita lopram - PBT 9, insignificant bioacc u mulation; clozapine - PBT 9, insignificant bioaccumulat i on; e scitalopram - PB T 9, insignif i cant bioac cumulation; haloperidol – PBT 8, insignificant bioaccumulation; imipr a mine – PBT 9, , no data available for bioaccumulation; Endocrine disruptors/hormones – 100 (4.1%): cyp roterone - PBT 8, cannot be excluded from bioaccumulation; desogestrel - P B T 8, insignificant bioaccumulation; dydrogesterone - PBT 8, cannot be exc l uded from bioaccumulation; tamoxifen - PBT 9, no data available for bioaccumulation; drospirenone - PBT 8, cannot be exc l uded from bi oaccumulation; dutasteride - PBT 8, cannot be

exc l uded from bioaccumulation; estradiol – PBT 9, high bioaccumulation (CCL3 listed); ethinyl estradiol – PBT 9, high bioaccum u lation (CC L3 listed); etonogestrel – PBT 8, insignificant bioaccumulation; megestrol – PBT 9, no data available for bioaccumulation; Heart/blood pressure drugs – 71 (2.9%): ami odarone - PBT 9, no data available for bioaccumulation; carvedilol- PBT 9, insignificant bioaccumulat i on; fe lodipine – PBT 9, low bioac cumulation; isradipine – PBT 9, insignificant bioaccumulat i on; propr anolol – PBT 3, moderate bioaccumulation;

18

## Antiarthritic/antinflammatory drugs – 55 (2.9%): allopurinol – PBT 6, moderate bioaccum u lation; leflunomide - PBT 8, no data available for bioa ccumulation; beclomethasone – PBT 9, cannot be

exc l uded from bioaccumulation; ketoprofen – PBT 7, cannot be excluded from bioaccumulation.

Slide 24



## AMC P h armacy Reverse Distribution

• V endor: Guaranteed R e turns, H o l b rook, N Y

• Q uar terl y pi ckups.

• 539 i t ems w e re retur ned ( M ar ch 10, 2009) f o r a cr edi t of $89,375.19

• 487 i t ems w e re sent to v endor and not cr edi ted due to

v a ri ous r easons

– c harg ed $35,105.34

• 50 “ H az ar dous Mater i al s” w e r e retur ned for a cr edi t of $1,868.92

• 8 C ontr o l l ed substances w e r e retur ned for a credi t of $283.99

• N et cr edi t to AMC $56,422.76

- M ar ch 10, 2009.



## AMC Pharmacy Reverse Distribution V

endor: Guaranteed Returns, Holbrook, NY ; Quarterl y pickup s . Represent ative dat a from March, 2009. 539 items returned (March 10, 2009) for a credit of $89,375.19. These were quite varied. Only 4 drugs had from 7 to 9 returns each. The most fr equently returned w e re flumazenil ( 9 items - $3,924); Abilify® - 8 items – $95.12; Coreg® t ablet s – 8 items - $1,293.89; Cef t in suspension – 7 items - $456.42; 487 items were sent to vendor and not credited due to various reasons – Guaranteed Returns charged $35,105.34 for these non-returnable items. 50 “Hazardous Materials” were retu rned for a credit of $1,868.92. Thes e included insulin (21 returns – Humulin®, Novolin® - $1,583.79) ; epinephrine (8 re turns - $50.10); influenza vaccine (2 returns - Fluarix® - $86.13) and one each physostigmine ($36. 45), alcohol (98% - $81.25), nicotine transdermal ($25.99) and am yl nitrate ($5.21). 8 Controlled subst ances were re turned for a net credit of $283.99

19

## Slide 25

What Hav e We Done?

• R ec eived 2 y ear gr ant f r om US E P A f o r phar m a c eut ic al w a s t e pilot pr ogr am at South Clinic al Cam pus

.

• P r ogr am im plem ented at S CC & ex t ended to all of f s ite and pr ac tic e s i t e s

.

• C ollec t ion of A LL phar m a c eutic al w a s t e and on s i te

s o r t ing.

• A MC P har m a c y us es r e ver s e dis t r i but or and tak e bac k o f unopened or out dated dr ugs

.

• P ar tic i pat ed in f o r m ation of a S t ate pr ogr am “ D o Not Flu s h Y our Dr ugs ”

• S tat e Pr ogr am ex pands t o dr ug t a k e bac k day s in eac h r egion.

• M ain c a m pus pilot pr ogr am im plem ent ed.

• A uthor iz ed f o r 4 patient c a r e ar eas

.

• F oc us ed on c ontr o lled s ubs t anc es ( nar c o t i c s ) w a s t ing.

• C ult u r e c hange f r om beds ide w a s t ing into t o ilets and

s i nk s by patient c a r e s t af f

.



## What Have W e Done? Receiv ed 2 year grant from US E P A

for pharmac eutical waste pilot progr am at South Clinical Campus. Program implemented at S CC & extended t o all of fsite and practice sites. Collection of ALL pharmaceutical waste and on site sorting. AMC Pharmacy uses reverse distributor and t a ke back of unopened or out dated drugs (NO W ASTES ACCEPT ED). Particip ated in formati on (http://w ww .dec.ny

. gov/p ress/45813.html) of a S t ate program “D o Not Flush Y

our Drugs” http://www .dec.ny

. gov/do cs/administration_pd f/0409dont flush.pdf S t ate Program exp a nds to drug t a ke back days in each region S t atewide Hous ehold Pharmaceutical Collections -- October 19 -24, 2009 http ://www .dec.ny

. gov/chemical/45083.html AMC’ s pilot project provided model for protection of New Y o rk City W a tershed – Of fice of the NYC W a tershed Inspector General. Main campus pilot program implemented. Authorized for 4 p a tient care areas. Focused on controlled subst ances (narcotics) wasting. Culture change from bedside was t ing into toilet s and sinks by p a tient care st af f.

20

## Slide 26



## Results - A MC South Clinical Campus

• P r o jec t per iod r uns May 9, 2008

– A ugus t 27, 2009 ( 475 day s )

• 226 c ontainer s f r om 8 OR’s P o s t

- O p; Pr e- Op, MRI, Patient c a r e f l oor and a Sur g ic al pr ac tic e s i te

• 0

. 008 lbs / c ontainer / d a y

• T ot al w e ight 851.7 pounds

• 17.2 pounds (2.0%) RCRA

• 717.2 pounds (84%) Non-RCRA

• 191. 4 pounds of pr opof ol, t he m o s t c o m m on ( 27%

- b y w e ight inc l udes c ontainer w e ight) non-RCRA m edic a tion.

• 662 s har ps

• 760 antibiot i c s ( 30.1 pounds

– 4 .2%)

• 178 c ontr o lled s ubs tanc es ( 2

. 2 pounds – 0 .3% )

• C os ts per pound (RCRA c ontrac t or):

– RCRA pharm a c eutic al w a s t e $156 - $3.52;

– RCRA c hem otherapeutic w a s t e $6.07;

– N on-RCRA pharm a c eutic al w a s t e f o r inc i neration only $4.37

– $2.23.

• S ter i c y c l e = $0.36/ lb ( I nc iner ate only )

.

• 113 hr f o r labor in w a s t e s o r t ing ( 2 per s ons )



## Result s – A M C South Clinica l Ca mpus From May 9, 2008 – August 27, 2009 (475 days) 226 cont ainers were collec t ed from 8 operating rooms (8,00 surgical cases per yea r), Post-Op; Pre-Op, Post Anest hesia Care Unit (P ACU), Magnetic Resonance Imaging and Radiology

, one p a tient care floor (20 beds – 23 hour st ay) and a Surgical practice site. This averaged 0.008 lbs/cont ainer/day fr om a tot a l weight collec ted of 851.7 pounds, only 17.2 pounds (2.0%) was RCRA regulat ed pharma ceutical wa ste. Non-RCRA phar maceutical waste constituted 84% of the co llected materi al or 717.2 pounds. Pr opofol, a non-narcotic lipid solub l e ane sthetic was the most common (27% - by weight include s cont ainer weight) non-RCRA medication accounting for 191.4 p ounds of drug waste. During the course of the pilot program propofol waste management was t a r geted for a process improvement and propofol was t e declined from 43% of initial was t e collect ions from the operating rooms to less than 20% by weight. Other nonRCRA drug wastes included 760 antib iotics (30.1 pounds – 4.2%) and 178 controlled subs t ances (2.2 pounds – 0.3% ). 662 sharp s including broken glass vials, unc apped needles with or without syringes and ampoules were removed during sorting and resulted in maldis pos al report s to the Director of Patient Care Services. Cost s per pound (RCRA contractor): RCRA pharmaceutical waste $156 - $3.52; RCRA chemotherapeutic waste $6.07; Non-RCRA pharmaceutical wast e for incineration only $4.37 – $2.23. S t ericycle® provided disposal und er contract for Non-RCRA pharmace utical waste by incineration only at a cost of $19.00 for a 4.0 Cu.Ft. card board box (55 pounds Maximu m weig ht). Labor for sorting required 1 13 hr for 2 persons. Refer to t he sorting video for a more det ailed review of the process of drug waste sorting.

21

## Slide 27

C u m u lat i v e T o p 80 Per cent o f Phar maceu tical W ast es A l b a ny Medical C e n t er - S ou th C lin ical C a mp us



## Graphical represent ation of cumulati ve “80/20” dat a from pharmaceutic al was t es collected at the AMC South Clinical Campus from May

, 2008 – August, 2009. Of the 2,700 drugs in the AMC Formulary

, seven account for over 80% of t he drug wast age. Forty-five percent of the drug wast e collected was one drug - Propofol (Diprivan®) waste. This wast age was markedly decreased by restricting the size available for dispensing from 50 and 100 mL vials to only 20 mL vials. The other 6 drug w a stes were non-RCRA, non-controlled drugs used primarily in surgical proced ures (anesthetics – lidocaine, bupivac a ine, lidocaine/epi nephrine; pressors – ephedrin e; a neuromuscular blocker – succinylcholine; and a topical antimicrobial – benz oin swab sticks, 77% alcohol)

Slide 28

Ty pical drugs collec t ed:
1. propofol 2. lidocaine 3. succiny lcholine 4. bupiv a caine 5. lidocaine/epinephrin e 6. benzoin sw absticks (77% alcohol)-g 7. ephedrine 8. epinephrine 9. bupiv a caine/epi nep hri

ne 10. atracurium 11. proparacaine 12. atropine 13. omnipaqu e 14. lidocaine/m a rcaine 15. bacitracin-g 16. pheny lephrine 17. dy e 18. v ancomy c in -g 19. heparin 20. neostigmin e 21. gadodiam ide 22. lidocaine jelly 23. cefazolin 24. diatrizoate meglumine 25. ox y m etazo line 

### 81 %

95 %



## 22

## Listing of the top 25 (of 2,700 formulary drugs) wa sted drugs from the Sout h Clinical Campus from May

, 2008 through August, 2009. Note that RCRA regul ated drugs were a very minor component of the drug waste (epinephrine, dye, oxymet azoline – RCRA) and no c ontrolled subst ances were among the top 25 (95% cumulative percent).

Slide 29

Drugs Dispos ed in Pharmac eutic al Waste Containers (top 85%):



## Cumulative dat a t able for cumulative drug waste from May

, 2008 through August, 2009. C u mulative tot a ls based upon unit s (mL unless otherwise specif ied – e.g., benzoin swabs ticks –grams not mL). Note of 50,150 unit s tot a l waste collected only 854 mL of epineph rine was collected as waste.

Slide 30

Program Highlights

• S CC pr og ra m op er at ing 2 y e ar s.

– G ood compl i ance

– l ow mal d i s posal rate.

– D ev el oped educati onal materi al s.

– R educed opportuni ty for di v e rsi o n



### • P rocess Im prov em en ts & C o st Sa v i n g s – SCC

– P r opof ol w a sti n g from surg ery reduced.

– E st $100,000 i n annual sav i ng s (8,000 surg i c al

case/y r )



### • O f f s i te & Pract i ces.

– E x c el l ent compl i ance.

– M in im a l m a ld isp o s a l s.

– I ncreased compl i ance



## High lig ht s. SCC progr am operating 2 years.

23

## Good compliance low maldispos al rate. Devel oped educational materials. Significantly reduced opportunity for diversion of cont rolled subst ances (narcotics – morphine, fent anyl, midazolam) Process Improvement s & Cost Savings – SCC Propofol wasting from surgery reduced by changing siz e s dispens ed to 20cc only

. T r anslates to $100,000 in annual savings ba sed on 8,000 surgical case load. Of fsite & Pr actices. Exc e llent complianc e. Minimal maldisposals. Increased complianc e with hazardous waste laws and regulations. Main campus pilot program. Bedside wasting of liquid formulations common. Over 1⁄2 of drugs su ch as levofloxac in (antibiotic) or acet aminophen with codeine elix er (narcotic) are w a sted into toilet s and sinks. Eight y four percent of drugs di spensed at AMC (main campus) have a 0% wasting and are predominantly solid dos age forms dispensed as unit doses.

Slide 31

T o p 80% Ph arm aceut i cals D i spen sed at A M C So ut h Clinical Camp us A u g u st , 2008

– F ebr u ar y , 2009



## Graphical represent ation of cumulative dis p e n sing dat a from PYXIS® automated dispens i ng machines at the AMC South Clini cal Campus. Propofol, the most common waste, was also the most frequently dispens ed medication. It however account ed for but 10.5% of the drugs dispensed as
comp ared to 45% of the waste collected. Midazolam , a controlled dr ug, was next most frequently dispens ed. Four controlled subst ances were among the 80% most dis pens ed drugs. Epinephrine and oxymet azoline were the only RCR A regulated (at that time) drugs which c o ntributed to the top 80%.

24

## Slide 32

C u mu lativ e 80% Ph arm aceut i cals D i sp ensed at A M C So ut h Clinical Camp us
A u g u st , 2008

– F eb ruary , 2009



## Cumulative dispensing dat a from PYXIS® a u t omat ed dispensin g machines at AMC South Clin ical Campus collected from August, 2008 – February

, 2009. All dat a were downlo a ded week ly , stripped of
p a tient identifiers and summarized by drug using Micr osof t Excel and Microsof t Access. Out refers to number of drug unit s dispens ed from the PY XIS®. Ret refers to the nu mber of drug unit s recorded as returned to the PYXIS® machine. Ws t refers to the number of drug unit s recorded as was t ed in the PYXIS® re cords. Net refers to net drug unit s (out less returned and wasted). All un it s are the same for comp ari s on and may be thought of as individual prescriptions. Of the 2,700 drugs in the AMC Formulary , 26 accounted for 80% of the drugs dispens e d at the South Clin ical Campus. As noted above, propofol was the most commonly dispensed medication. Five controlled subst ances ( midazolam, hydrocodone/ap ap, ap ap/codeine, fent anyl and morphi ne); four local anesthetics (lidocaine, bupivac a ine, lidocai ne/epinephrine, tetracaine), th ree anti-inflammatory drugs (dexamethasone, ondansetron, keto rolac); vasopressors; muscle relaxant s; and antibiotics rounded out the 26 dispens ed medications

25

## Slide 33

Phar m a c eut ic al W a s t e as a Per c entage of Dr ug Dis pens ed Albany Medic a l Center

- S outh Clinic al Cam pus May

, 2008

- M ay , 2009



## Graphical represent ation of drug wasting as a percent age of drug dispens ed from PYXIS® automated dispens ing machines. Great variability was noted in the percent age of wasting which aver aged 18.05%. Ninety four percent of al l dyes (RCRA regulat ed) dispen sed were collected in the pharmaceutical waste. Neostigmine (90.3%), edet ate (69.9%), bupivacai ne/epinephrine (68.1%) exceeded 60% wasting. El even drugs exceeded 50% wasting. Re fer to next slide for det ails on indiv i dual drug wasting.

Slide 34

C o l l e cti on of D i spe n sed Medi cati ons as Pharmaceuti c al W a st e at South C l i n i c al C a mpus
W e a r e c o l l e c t i ng an av era g e of 18 % (ran g e 0-1 1 2 6 % * ) of t h e m e di c a t i o n s di s p e n s e d an d
n o t r e t u r n e d a s ph ar m a c e uti c a l w a s t e ( n ot c o un t i ng p a c k a ging ) o r b e d s i d e w a s t ed. 3⁄4 9 1 % of n e o s t i gm i n e dis p e n s e d i s thr o w n o u t 3⁄4 6 9 % of b u p i v a c a i n e/ep i n ep hr ine dis p e n s e d i s thr o w n o u t 3⁄4 5 9 % ea c h o f k a n a m y c i n, li d o c a i n e/bu piva c a ine

, l i do c a ine / b u p i v a c a i n e/hy da s e /

, li d o c a i n e/ep i n ep hr ine / h y d a s e , li d o c a i n e/m a r c aine

, a n d li d o c a i n e/m a r c aine / h y d a s e di s p e n s e d i s t h row n ou t 3⁄4 49

. 9 % o f a c et am i n op he n/ c o d e i n e d i s p en s e d i s t h ro w n ou t 3⁄4 40 % o f pi l o c a rp i n e di s p e n s e d i s t h row n o u t 3⁄4 39 % o f ph en yl ep hri n e di s p e n s e d i s t h ro w n o u t 3⁄4 3 6 % of tes t os ter o ne d i s p en s e d i s thr o w n ou t 3⁄4 3 0 % of n e o m y c i n / p olym i x i n / b ac it r a cin d is pe ns e d i s t h r o w n o u t 3⁄4 2 3 % of p r op ar a c aine dis p e n s e d i s t h r o w n o u t 3⁄4 21 % o f s u c c i ny l c h o l i ne d i s p en s e d i s t h row n ou t 3⁄4 20 % e a c h of a t ro pi ne an d ep i n ep hri n e di s p e n s e d i s t h row n o u t 3⁄4 1 9 % of a t r a c u r i um dis p e n s e d i s thr o w n ou t 3⁄4 18 % o f et om ad at e d i s p en s e d i s t h row n o u t 3⁄4 1 7 % of p r op ofol dis p e n s e d i s t h r o w n o u t 3⁄4 1 6 % of n a lox o ne d i s p en s e d is t h r o w n ou t 3⁄4 15 % o f l i do c a i n e di s p e n s e d i s t h ro w n ou t 3⁄4 14 % o f al bu t e rol di s p e n s e d i s t h row n o u t 3⁄4 Fr om 1% t o 10 % of 3 5 d r ug s d i s p en s e d a r e t h r o w n ou t 3⁄4 Le s s t h an 1 % of 95 d r ug s d i s p en s e d are t h row n ou t 3⁄4 For t y tw o d r ug s , r a dio- c o ntr a s t ag en t s o r d r ug c o m b i n ati o ns w e r e fou n d du r i n g w a s t e so r

t i n g b u t n o t d i sp e n se d fr o m PY X I S® m a ch i n e s

. *N B: bec a u s e o f d i luti on an d

m i x i ng, totals

rec o vere d m a y

e x c eed

a m o unts di s p e n s ed



## Drug wasting as a percent age of drug dispe n sed from PYXIS® a u t omated dispensin g machines. W e are collecting an average of 18% (r ange 0-1 126%*) of the medications dispen sed and not returned as pharmaceutical waste (not counti ng p a ckaging) or bedside wasted.
26

## 3⁄4 91% of neostigmine dispensed is thrown out 3⁄4 69% of bupivacaine/epinephrine dispensed is thrown out 3⁄4 59% each of kanamycin, lidocaine/bupiva caine, lidocaine/bupivacaine/hydase/, lidoc aine/epinephrine/ hydase, lidocaine/marcaine, and lidocaine/marcaine/hy dase dispensed is thrown out 3⁄4 49.9% of acet aminophen/codeine dispensed is thrown out 3⁄4 40% of pilocarpine dis pensed is thrown out 3⁄4 39% of phenylephrine dispens ed is thrown out 3⁄4 36% of testosterone dispensed is thrown out 3⁄4 30% of neomycin/poly m ixin/bacitra cin dispensed is thrown out 3⁄4 23% of prop aracaine dispens ed is thrown out 3⁄4 21% of succinylcholine dispensed is thrown out 3⁄4 20% each of atropine and epinephrine dispensed is thrown out 3⁄4 19% of atracurium dispensed is thrown out 3⁄4 18% of etomadate dispensed is thrown out 3⁄4 17% of propofol dispensed is thrown out 3⁄4 16% of naloxone dispensed is thrown out 3⁄4 15% of lidocaine dis p ensed is thrown out 3⁄4 14% of albuterol dispensed is thrown out 3⁄4 From 1% to 10% of 35 drugs dispensed are thrown out 3⁄4 Less than 1% of 95 drugs dispensed are thrown out 3⁄4 Forty two drugs, radio-contrast agent s or drug combinations were found during waste sorting but not dispens ed from PY XIS® machines

Slide 35

B eds ide "W a s t ing" of Contr o lled Subs tanc es as a P e r c ent age of Dr ug Dis pens ed at Alban y Medic a l Center - S outh Clinic al Cam pus May

, 2008

- A pr il, 2009



## Graphical represent ation of contro lled subst ance wasting as a perc ent age of drug dispensed from PYXIS® a u t omated dispensin g machines. W a sti ng averaged 7.8% and was primarily due to acet aminophen/codeine liquid. T h is drug is normally dispensed in 12.5 mL bottles and is seldom fully dispens ed. Of the controlled subst ances disp ensed from the AMC S outh Clin ic al Campus Formulary

, only 7 drugs had any signific ant wasting. These were almost exclusively liqui d formulations, few solid dosage forms (t ablet, cap s ule) were found as waste or recorded as wasted in the PYXIS® records. Please refer to the following slide for more det a iled des cription of controlled s ubst ance wasting.

27

## Slide 36

Bed s i d e Wa st i n g vs Di s c a r di ng of Co nt r o l l e d Substances A M C-SCC data

A n aver ag e o f 7

. 8% ( r a n g e 0 t o 5 0 % ) o f c o nt r o lle d s u bs t a nc e s dis p en s e d f r o m au t o m a t e d dis p en s i ng m a c h in es ( P Y X I S ® )

a r e be dsi d e w a ste d

. 3⁄4 Ac e t am ino p h e n an d c o de ine dis p en s e d a s a liq uid is m o s t

f r eq u e n t ly be ds id e w a s t e d ( 5 0 % )

. 3⁄4 3 4 % o f mi da z o l a m di sp en sed i s be dsi d e w a ste d

. 3⁄4 31 % of hydr oc o d o n e / ac e t am ino p h e n t a ble t s d i s p e n s ed ar e be ds id e w a s t ed

. 3⁄4 18 % of hydr om or ph on e liq u i d dis p en s e d is be ds id e w a s t ed

. 3⁄4 1 2 % o f a c eta m i n op he n an d co de i n e tab l ets a r e bed si de

wa s t e d

. 3⁄4 2 % of m o r p hi n e i s be dsi d e w a ste d

. 3⁄4 1% o f h y d r o c od on e/ a c et a m in op he n liq uid dis p en s e d is be ds id e w a s t ed

. 3⁄4 12 c o nt r o lle d s u b s t a n c es dis p en s e d a r e no t r e p o r t e d as be ds id e w a s t ed

.



## An average of 7.8% (range 0 to 50%) of controll ed subst ances dispensed from automated dispensing machines (PYXIS®) a r e bedside wasted. Acet aminophen and c odeine dispensed as a liquid is most frequently bedside wasted (50%). 34% of midazolam dis pensed is bedside was t ed. 31% of hydrocodone/acet aminophen t abl et s dispensed are bedside wasted. 18% of hydromorphone liquid dis pensed is bedside was t ed. 12% of acet aminophen and codei ne t ablet s are bedside wasted. 2% of morphine is bedside wasted. 1% of hydrocodone/acet aminophen liqui d dispensed is bedside wasted. 12 controlled subst a nces dispensed are not reported as bedside wasted.

Slide 37



# Process Improvement

– Propofol (Diprivan®)

Pr opof ol i s an i n j e ctabl e anestheti c ag ent used f o r outpati ent

or i npati ent sur g i c al procedur es or to prov i de consci ou s sedati on. It i s a suspensi on i n l i q ui d suppl i ed i n 20, 50 or 100 mL v i al s. It i s consi dered a 9 of 9 for per si stence, bi oaccumul a ti on and tox i ci ty (Env i r onmental l y cl assi fi e d phar maceuti c al s, http://w w

. j anusi n f o .se ). Du rin g wa s t e seg r eg ati on, pr opof ol w a s f ound to compr i se 41% of the total w a ste g ener ated f r om the oper ati n g rooms as each

case r e q u i r ed a new v i al of propofol to be opened and al l pr opof ol f r om the precedi ng case to be di scar ded. Sol u ti on: 50 and 100 mL v i al s of pr opof ol w e r e r e mov ed

from AM C Phar macy i n v entor y

. Propofol w oul d onl y be

av ai l abl e i n the smal l e st si z e manuf actur ed to r educe

w a stag e.



## 28

## Propofol is an inject able anesthetic agent used for outp a tient or inp a tient surgical procedures or to provide conscious sedation. It is a suspension in liquid supplied in 20, 50 or 100 mL vials. It is considered a 9 of 9 for persistence, bioaccumula tion and toxic i ty (Environment a lly class i fied pharmaceuticals, http://ww .janusinfo.se). During wast e segregation, propofol was found to comprise 41% of the tot a l waste generated fr om the operating rooms as each case required a new vial of propofol to be opened and all pro pofol from the preceding case to be discarded. Solution: 50 and 100 mL vials of propofol were re moved from AMC Pharmacy inventory

. Propofol would only be available in the smallest size manufactured to reduce wast age.

Slide 38

Op p o rtu n ity fo r Imp r o v e m en t

T hese data on w a sti n g and di sposed dr ug s as a pr oporti on of phar maceuti c al s di spensed at a smal l surg i c al hospi tal

ar e i n l i ne w i th publ i c ati ons f r om the l i t er ature. 3⁄4 In 2001, i t w a s esti mated that ov er $13.00 of medi cati ons w e r e w a sted f r om each surg ery , thus for a f a cility that does 8,000 cases/y r it w ould repr es ent $104,000 i n costs due to w a sted dr ug s based on 2001 dr ug costs. 3⁄4 W e hav e al ready seen a mar k ed decrease i n p r opof ol

w a stag e caused by our r e mov a l of the l a rg er (50 and 100 cc) propofol v i al s. 3⁄4 Processes to reduce l i docai ne, succi ny l c hol i n e and bupiv a caine w a stage w ill be desig ned and im p l em ented.



## These dat a on wasting and dispos ed drugs as a propor ti on of pharmaceuticals dispensed at a small surgical hospit al are in line with p ublic ations from the literature. In 2001, it was estimated that over $13.00 of medications were wasted from each surgery

, thus for a facility that does 8,000 cases/yr it would represent $104 ,000 in cost s due to wasted drugs based on 2001 drug cost s. W e have already seen a marked dec rease in propofol wast age caused by our removal of the larger (50 and 100 cc) propofol vials. Processes to reduce lidocaine, succinylcholine and bupivacaine wast age will be designed and implement ed.

29

## Slide 39



# Tours and Dissemi nat i on of Knowledge Gai n ed

• S even, tw o-hour tours announced by HANYS.

• F ifty -one participants registered.

• T w e nty

- nine hosp ita l , go ve rnme nt,

w a ste management and consulting

o r ga ni za tio n s fro m Pu erto Rico to Canada.

• S urvey forms collected from each tour group.

Seven, two-hour tours of S CC pharmaceutical waste oper ations announced by HANYS. Fif t y-one p a rticip ant s registered: 26% safety or environment al services; 20% complianc e; 19% administration; 13% clinician; 1 1 % RPh; 4% scientist; and 7% other

. T

w enty-nine hospit a l, governmen t, waste management and consult i ng Organiz a tions from Puerto Rico to Canada: 62% hospit a ls; 21% government; 6% pharmacy and 12% other (waste management, services, journalism). Survey forms collected from each tour group.

Slide 40



# Survey Resul t s

• P ro gr am hig h ly ra te d - e ig ht y

- fiv e p e r c e n t

• W o u ld re co mm en d to p e e r s

- e ig hty

- fiv e pe rcen t

• P re se nt at ion s w e re of a lo t o r a gr ea t d e a l of he lp - e ig ht y

- th re e pe rc en t

• E d u cation al m a terials useful

- s e v e n ty -tw o pe rc en t

• T ou r an imp e tus for ch an ge at th eir institu t io n

-

six t y

- on e pe rcen t

• T o u r s a lot o r a g r e a t de al of as sis t a n c e t o un de rs ta nd ing t h e pr og ra m

- s ix t y p e r c en t

• O nly 9% felt the to urs w e re of so me or no he lp in

un de rs ta nd ing t h e pr og ra m.



## Eighty-five percent of respondent s rated the program highly overall..

30

## Eighty-five percent of respondent s would recommend the program to their peers. Eighty-three percent of respondent s fe lt the present ations were of a lot or a great deal of help. Seventy-two percent of res pondent s felt the educational mate rials were very useful. Sixty-one percent of the respondent s felt the t our was an impetus for change at their institution. Sixty percent of respondent s fe lt the tours w e re of a lot or a grea t deal of assist ance to underst a ndin g the program. Only 9% felt the tours were of some or no help in underst anding the program

Slide 41



# Model Education Plan

• Pu rp ose: Fi nd opti m al educati on pl an to support pharmaceuti c al w a ste manag ement pr og r a m

• Goal: Staff compl i ance w i th JC AH O and State and Feder al pol l u ti on pr ev enti on standar ds

• Plan : 1. A udienc e: Nur s ing, P A ’s

, T he A nes t hes ia Gr ou p, P C
2. S t af f Meeting P r es ent ations one m ont h pr ior to Stage 2. 3. P o s t er developm ent f o r m edic a t i on r oom s 4. Fly e r developm ent f o r m a ilbox dis t r i but ion
5. Manager f o llow up t o det er m i ne s t af f k now ledge 6. T r ainee f eedbac k to r e f i ne t r aining
7. Dev e lop & T e s t tr aining DV D



## Purpose: Find optimal educati on plan to support pharmaceutic al waste management program Goal: S t af f complianc e with JCAHO and S t ate and Federal pollution prevention st andards Plan: Audience: Nursing, P A

’ s , The Anesthesia Group, PC S t af f Meeting Present ations one month prior to S t age 2. Poster development for medication rooms Flyer development for mailbox dis t ribution Manager follow up to determine st af f knowledge T r ainee feedback to refine training Develop & T e st training DVD

31

## Slide 42



# Model Education Plan (c ont’d)



## • Outcome: Managers and Direc t ors hold

s t aff ac countable for inc o rporating c hange into practice.

• M e trics : 1. Po st te st – 8 0% m i nim u m pa ssing. C o m p l e t i on ra te s fo r e a c h j o b t i tl e, 9 9 % ta rg et ra te . New h i re s mu st re ce iv e tr ain i ng at hir e

. 2. R a nd om train e e follo w

- up s. C o rrect re sp on se rates be low 80 % trigg e r re train i ng.



## Outcome: Managers and Directors hol d st af f account able for incorporating change into practice. Metrics: Post test – 80% minimum p a ssing. Completion rates for each job titl e, 99% t a rget rate. New hires must receive training at hire. Random trainee follow-up s . Correct response rates below 80% trigger retraining.

Slide 43



# Education

Model education flyer developed by AMC Dep a rtment of Nursing Educ ation and Development for use in “T rain the T r ainer” sessions he ld before pilot project roll out.

32

## Slide 44



# Clinical Staff Handout (Cont’d)

Opportune timing due to widespread news report s of dri n king water cont amination by pharmaceuticals appearing in loc a l news out let s . Flyer was distributed to all nursing and p a tient care st af f on the South Clin ical Campu s prior to roll out of the pilot project. A laminated 1 1 ” x 14 ” color poster of the flyer was produced and placed near each pharmaceutical waste cont ainer and copies given to each nurse manager

.

Slide 45

Flow chart laminated and placed near each blue phar m a ceutical waste cont ainer . Other copies distributed to nursing st af f and placed at PYXIS® machines.

33

## Slide 46



# Education Activities:

• A pr i l 2, 2008: AM C N u rsing educat i on r ounds f o r nur si ng uni t s and

r adi ology f o r SC C

. 55 Staf f t r ained. 20 poster s and 65 handou t s di st ributed.

• A pr i l 24 & 25, 2008: Pr esentat i ons by AM C & St ericy c le st aff to Env i r onm ent al Serv i c e & C l ini c al Staf f . 4 pr esentat i ons, 24 at tendees.

• J une 11, 2008. Announcement and sum m ary of progr am by HAN Y S and

av ai labi li t y of tour s sent to all C E O ’ s and C o mpl i ance O f ficers of H A N Y S M e m ber H o spi t al s.

• J uly 14, 2008. Ster i c y c l e r e sends t he H A N Y S announcement to al l St ericy c le H eal t h care cust om er s.

• J ul y 25, 2008 R e sent H A N Y S announcem ent t o pharmw ast e li stser v at phar m w aste@ l i s t s

. dep

. sta te. f l

. us

• J uly 25, August 1, August 22, September 26 and O c t ober 24. T ours of t he Sout h C l i n ical C a mpus and educat i on sessions on pharmaceu t i c a l w a st e coll ect i ons scheduled. Jul y 25

– 8 (max i m um ) at tendees.

• D r R. M ankes - N EW M O A present ation. USEPA Regi on 2 Headquar ter s, N Y ,N Y M a y 7, 2008.

• D r R

. M ankes – R oundtable part i cipant, C o mm issi oner s’ R o undt abl e on Phar m a ceut i c al W a st e, N Y D E C & N Y D o H

, N Y D E C H eadqu ar ter s, Albany

, N Y M a y 15, 2008.



## April 2, 2008: AMC Nursing educ at ion rounds for nursing unit s and radiology for SCC. 55 S t af f trained. 20 posters and 65 handout s distributed. April 24 & 25, 2008: Present ations by AMC & S t ericycle st af f to Envir onment al Service & Clinical S t af f . 4 present ations, 24 attendees. June 1 1 , 2008. Announcement and summary of program by HANYS and av ailability of tours sent to all CEO ’ s a nd Complia n ce Of ficers of HANY S Member Hospit a l s. July 14, 2008. S t ericycle resends the HANYS announc em ent to al l S t ericycle Healthcare customers. July 25, 2008 Resent HANYS announcem ent to pharmwaste list s erv at pharmwaste@list s .dep.st a te.fl.us July 25, August 1, August 22, September 26 and Oct ober 24. T ours of the So uth Clin ical Campus and education s e ssions on pharmaceutical waste co llections scheduled. July 25 – 8 (maximum) attendees. Dr R. Mankes - NEWMOA present ation. US EP A

Region 2 Headquarters, NY ,NY May 7,2008. Dr R. Mankes – Round t able p a rticip ant, Commissi oners’ Round t a ble on Pharmaceutical W a ste, NY DEC & NY DoH, NY DEC Headquarters, Albany , NY May 15, 2008.

34

## Slide 47

Educ ation ass e ss ment tours - Pharmac eutic al w a ste pilot program

- SCC

• M ethods: C l i n i c al staf f w e r e i n ter v i e w ed r e l a ti v e to know l edg e of the prog ram, l o cati on & ty pe of contai ner, cal l numbers for contai ner chang e out and needs of the cl i n i c al staff

. C o mments w e r e sol i c i t ed as to educati on eff e ct i v eness and sug g esti ons f o r i m pr ov ement. Presence of educati onal posters w a s v e ri fi ed a nd addi ti onal i n formati on w a s made av ai l abl e for di str i buti on.

• R esul ts: 19 of 19 staf f surv ey ed corr ectl y responded ( 100%)

. 14 of 14 ( 100%) cl i n i c al areas had phar maceuti c al w a ste contai ners i n use w i th po ster s & educati on materi al s. Staf f q uesti ons i n v o l v ed contr o l l ed substance di sposal and bari u m contrast ag ent.



## Methods: Clin ical st af f were interviewed relative to knowledge of the program, location & type of cont ainer , call number s for cont ai ner change out and needs of the clinical st af f. Comment s were solic ited as to education ef fectiveness and suggesti ons for improvement. Pr esence of educational posters was verified and additional informati on was made available for distribution. Result s: 19 of 19 st af f surveyed correctly re sponded (100%). 14 of 14 (100% ) clinical areas had pharmaceutical waste cont ainers in use with posters & education materials. S t af f questions involve d controlled s ubst ance dispos al and barium contrast agent.

Slide 48



# Waste Accum u lation

• C ontainers ? √ Si z e ? √ N u mber ? √ Locati on ? √ T y pe ? √ Li ners ? √ Li q u i d s ? √ Label i n g & cl osures ? √ Mounti n g ? 4 gal lon com pat i b le Was t e container 2 gal lon i n compatibl e Was t e container



## 35

## Examples of pharmaceutical was t e cont ainers. Blue 4 gallon cont ainer with flap closed top such that cont ainer is closed unless materi al is being added to cont ainer . Smaller 2 gallon incomp atible cont ainer (one only located in Pha rmacy for such waste as silver ni trate applicators). Issues to be determined:Size ? Number ? Location ? T

y pe ? Liners ? Liquids ? Labeling & closures ? Mounting? Slide 49



# PH ARM A C E U T ICAL W A STE PROGRAM LOCATIONS

LOC A TION ROOM # C O NT AI NE R C O LOR RADI OLOG Y ( C T SC A N ) ( S C C 125Q) BL UE M. R

. I

. ( S CC 1 4 8 D ) B L U E O. R. ROOM # 1 ( S C C 295) BL UE O. R. ROOM # 2 ( S C C 293) BL UE O. R. ROOM # 3 ( S C C 292) BL UE O. R. ROOM # 4 ( S C C 289) BL UE O. R. ROOM # 5 ( S C C 287) BL UE O. R. ROOM # 6 ( S C C 286) BL UE O. R. ROOM # 7 ( S C C 285) BL UE O. R. ROOM # 8 ( S C C 283) BL UE PAC U / REC O VERY (SC C 290) B L U E PRE OP ( S C C 294) B L U E POST OP (SC C 242) B L U E PHARM A C Y DISPE N C I NG ROOM (SC C 243) B L A C K** EC M U ( W EST HA LL ) M E D ROOM (SC C 273) B L U E

** O n ly l o c a ti on for di s pos al of non-c o m pat ibl e RCRA pharmac eut ic al s (6 NDC’ s of 2,700 NDC’ s i n formul ary)



## Location of pharmaceutical wast e cont ainer s. No te AMC South Clinical Campus has no Emergency Room so no cont ainer s placed for ER. Slide 50



# Waste Segregation

• No Shar ps!

• No RM W !

• No Cont r o l l e d Su bstances!

• Che m o i n

s e p a ra te ch emo cont ai ne r s !

• N o free li q u ids (Zip Lock ba gg i e s) !



## 36

## W a ste segregation flow chart for use by pharmacy / environment al health and safety st af f members to
sep a rate RCRA from Non-RCRA wastes. For this p ilot project we had 3 sep a rate waste profiles: 2 were RCRA (antineoplastics – U, P and D wastes; phar maceuticals – D, U and P listed wastes) and 1 was non-RCRA phar maceuticals. These were sep a rated by HAZ W OPER trained st af f and p a ckaged for pick up. Because New Y o rk S t ate ret a ined epine phrine salt s as a P listed waste until late 2009, Hazardous waste pick up s for the South Clinical Campus were scheduled every 90 days so that we did not accumulate 2.0 pounds of P listed waste at any time. This allowed us to ret a in our Conditionally Exempt Small Quan tity Generator (CESQG) st atus.

Slide 51



# Waste Segregation

• T ime co nsum ing & La bo r inten s iv e

– 2 sta f f

me mb er s x 1 5 mi n u t e s / c o nt ai n e r

.

• H ig h le v e l of train i ng re qu ire d to id en tify d r u g s.

• H ig h le v e l of se cu rity & re gu latory a p p r ov al for

sta f f b y N e w Y o rk State re qu ire d as contro lled

su bs ta nc es ar e co mmon ly f o u n d in th e p h a r m a ceu t ical w a ste b i ns (d espite th e lab e l no con t rolle d su bsta nces).

• S harps m a ldis posals int o pharmac e utic al w a s t e m a ke w a s t e s o rting hazardous and PPE is required



## Issues revealed during pilot study: For waste segregation it was time consuming and labor intensive r equiring 2 highly trained st af f members at 15 minutes for each cont ainer

. A high leve l of training was requir e d to identify drugs. D r R. Mankes, a pharmacologist and toxicologist wit h over 30 years of experience supervised or performed each sort. Dr Mankes was assisted by 2 bachelor level technicians with special training in pharmacy and chemic al hazards. A high level of secu rity and regulat ory approval for st af f by New Y

o rk S t ate was requir ed as controlled subst ances are commonly found in the pharmaceutical wast e bins (despit e the label no controlled subst a nces). This included swipe and PI N access to the waste storage area, unique locks for ea ch pharmaceutical cont ainer , and prior regulatory approval (by the New Y o rk S t ate Bureau of Narcotic Enforcement) of personnel involved in h andling of drugs. Sharp s maldispos als into pharmaceutical waste make waste sorting hazardous and PPE is required.

37

## Slide 52



# Pharmaceut ical Wast e Compli ance Servi c e Ov erv i ew

• O bjectiv e : dev elop and im plem ent a hos pital-w i de, regulatory

- compl i a n t

, phar m a ceut i c al w a ste m anagement progr am i n or der t o mi nim i z e env i r onm ent al i m pact f r om i m proper handli ng and disposal of phar m a ceut i c al w a ste.

• C omponents:

• R X f

o rmul ar y w a st e char acter i z a tion analy s is

• R X f o rmul ar y D O T w a st e str eam anal y s i s

• H ospital pharmaceutica l w a ste accum u lation tr acki ng

• S our ce and v o lum e analy s is of hospi t a l phar m a ceut i c al w a st e generat i o n

• W as te sor t on code f unctional ity

.

• Logistics model ing

• O n- si t e R X w a st e segregat i o n

• P har m a cy ret u rns.

• M ani f e sted w a st e pi ck- up, tr ansport and di sposal of haz a r dous and nonhaz ardous phar m a ceut i c al w a st e



## In our proposal we had designat ed that an out side contractor woul d provide pharmaceutical waste complianc e services. These would include cont ainer s, supplement al training, waste pick up and disposal and formulary characterization. Facilitie s wishing to use an out s ide contractor should develop a “needs” list to use to determine the services required. A model plan used in the pilot project is presented above and includes: Objective: develop and implement a hospit a l-wid e, regulatory-compliant, pharmaceutical waste management program in order to minimize environment al imp a ct from improper handling and disposal of pharmaceutical waste. Component s : RX formulary waste characterization analys is RX formulary DOT waste stream analys is Hospit al pharmaceutical waste accumulation tracking Source and volume analysis of hospit a l phar maceutical waste generation W a ste sort on code functionality

. Logistics modeling On-site RX waste segregation Pharmacy returns. Manifested waste pick-up, transport and disposal of hazardous and non-hazardous pharmaceutical waste

38

## Slide 53



# Problem Areas

• S ec urity

• W aste pick ups from rooms

• D iagnostic Radiology

– B arium W a ste

• M ixed Was t es

• C ontrolled s ubstance dis posal, e.g., Chloral Hy drate & Paraldehy de RCRA & DEA Regulated, “w asting” of narcotic s into toi l e t, si nk

.



## During the pilot we identified some problem areas Security – as mentioned earlier

, a secure, lim ited access storage area was deemed essential,
p a rticularly when maldisposed controlled subs t ances were segregated from the pharmaceutical wast e cont ainers. In our case, a swipe and PIN acce ss controlled by AM C Security was added to the Hazardous W a ste S t orage Buildin g on the South Clin ical Campus (Refer to video of tours and sorting). W a ste pickup s from room s were conducted on an as needed basis by the p a tient care st af f calling a central number when the bins becam e 3⁄4 full. This howev er was supplemented by Biosystems st af f who, during thei r rounds to change out reusable sharp s cont ainers, also changed out full pharmaceutical waste bins. Diagnostic Radiolog y – Barium W a ste was initially thought to be a problem do to potential volumes of liquid was t e generated. However

, it wa s found that barium waste was not significantly g enerated at AMC’ s So uth Clin ical Campus due to the unit dosing o f barium which is us ed in very limited cases at SCC (as comp ared to AMC’ s main hospit a l). Mixe d W a stes Controlle d subst ance disposa l , e.g., Chloral Hydrate & Paralde h yd e RCRA & DEA Re gulated, “wasting” of narcotics i n to toilet, sink.

39

## Slide 54



# Problem Areas (cont’d)

• S tate RCRA

• N itrogly c erin

• E pinephrine

• A lc ohol s w abs

• C ontainer c l osure, Labeling and trac king?

• W hen do pharmaceutical w a s t e c ontainers have to be labeled haz ardous w a s t e? 90% of w a ste is non-regulated?



## RCRA laws of ten vary by st ate and may signific antly dif f er from US EP A

regulations making complianc e for healthcare dif f icult. Drugs which ar e regulated in one st ate may be unregulated by either the US EP A

or another st ate. For exa m ple, up to July 15, epinephrine salt s were RCRA Regu lated in New Y o rk S t ate but not RCRA regul ated by the US EP A, leadin g to the uniqu e dichotomy that epinephrine discarded by p a tient care st af f at the Albany V e terans Administration Hospit al (a federal facility located directly acro ss the street from the Albany Medical Cent er) was not an acutely toxic P liste d RCRA re gulated wa ste. The same epinep hrine, disca rded by a st af f member at Albany Medical Center would be treated as an acutely toxic P- listed RCRA regulated waste. Nitroglycerin is specifically listed as a RCRA wast e but few healthc a re workers are aware that unless the nitroglycerin is in a form which is reactive (D 003) it is exempted from regulation. Alcohol swabs are considered ignit a ble (D001) wastes if they cont ain over 20% alcohol. How does a healthcare worker decide that a used alcohol skin swab cont ains 20% alcohol? Cont ainers used for pharmaceutical wastes present addition al is sues. If they are not self closing, it is likely the cont ainer will remain open even when materials are not being add ed to it in violation of RCRA regulations. Many pharmaceutical cont ainers are single use and dis posed with the waste. This adds weight and expense to the program as well as increasing plastic burning in th e incinerators from the p a ckaging. Obviously , a reusable cont ainer syst em with an inner plasti c bag liner is prefe r able to the single use cont ainer system. If a facility uses a single cont ainer system, each cont ainer should be c onsidered a satellite ac cumulation area and be label ed and managed accordingly

. If a multiple cont ainer system is used wher ein the p a tient care st af f are charged with an initial waste sorti ng, only the cont ainer design a ted for RCRA pharmaceu t icals need be conside r ed a satellite accumulation area and be labeled and managed accordingly

.

40

## Slide 55



## Pharmaceutical Waste Complianc e Program

– G radua ted Roll Out to Ma in Hospita l InPa tient Nursing Units

J une, 2009 Controlled Subs tanc es

August – S eptember, 2009 noncontrolled drug w a s t e



## Slide 56

Main Campus Pilot Program.

• I nit i ated J une, 2009.

• G oal to dev elop a pr oc es s f o r dr ug dis pos al that w ould pr ev ent dr ugs f r om being int r oduc ed int o the w a ter s y s t e m or dis pos ed of in s har ps c ont ainer s on the m a in A l ban y Me dic a l Center Hos p ital Cam pus

.

• F our pat ient c a r e ar eas inv o lve d : gener al m edic a l- s u r g ic al ( D 2N) ; pediat r i c s ( C 7) ; or t hopedic s ( C 6) and apher es is ( M 3)

• B eds ide w a s t ing of liquid f o r m ulat ions c o m m on.

• O ver 1⁄2 of dr ugs s u c h as levof l ox ac in ( ant ibiotic ) or ac etam inophen w i t h c odeine elix ir ( nar c o t i c ) ar e w a s t ed into toilet s and s i nk s

.

• P ilot im plem ented on 4 unit s , w a s t ing of c ont r o lled

s ubs tanc es int o 3 gallon s t ep c ans w i th abs or bent. Good

c o m p lianc e.

• E ight y f our per c ent of dr ugs dis pens ed at AMC ( m ain

c a m pus ) have a 0% w a s t ing and ar e pr edom inant ly s o lid dos age f o r m s dis pens ed as unit dos es

.



## Main campus pilot program. Initiated June, 2009. Goal to develop a proc ess for dr ug disposal that would prevent drugs from being introduced into the water system or disposed of in sharp s cont ainers. Four p a tient care areas involv ed: general medical-surgical (D2N); pediat rics (C7); orthopedics (C6) and apheresis (M3). The pilot st arted in June and was limited to bedside wast ing of controlled subst a nces. Each unit was provided with a 3 gallon step-on wast e can and absorbent. The healthcare st af f was instructed to waste controlled subst ances into the can, wher e the material would be absorbed and rendered nonrecoverable. The st af f was trained by pharmacy and nursing st af f. Over 1⁄2 of drugs such as levofloxac in (antibiotic ) or acet aminophen wit h c odeine elixir (narcotic) are w a sted into toilet s and

41

## sinks. Pilot implement ed on 4 unit s , wasting into 3 gallon step cans with absorbent. Non-controlled Subst ance Dispos al T he unit s were provided with re cept acles for disposal of drug waste in late August to early September

. The st af f was trained by pharmacy and nursing st af f. The unit s are using the cont ainers and are cont acting the appr opriate st af f w hen pickup s are needed. Eighty four percent of drugs dispensed at AMC (main campus) have a 0% wasting and are predominantly solid dosage forms dispensed as uni t doses. Liquids squirted into drug cont ainers making “Drug soup” Need for reeducation. Slide 57

HOW DO I KNOW WHA T TO PUT WHERE?

I s i t or di d i t c o n t ai n an AN TI NEOPLAST I C ag ent ?

YE S NO I s i t e m pt y or d oes i t c ont ai n onl y a t r ac e a m ount ? I s i t S H ARP

. BROK E N or pot e n t i al l y shar p ( i

. e GLA S S )?

Y ES NO YE S NO Di s c ar d i n Recor d amt and Di sc ar d i n SH A R PS

d in IN F E C T I O U S (re d H a s i t bec o m e g r oss l y CH

EMO w a s t e di s c ar d i n bul k cont ai ner c ont ami nat ed w i t h bl o od or CH

EMO w a s t e body f l ui ds or i n f e c t i o u s mat e r i al s ?

YE S NO D i s c a r Is it e m p t y?

w a s t e ba g )

. YES N O

D i sc a r d in T R A S H Is it a con t rol l ed

c ont ai ner

. sub s t a nc e ? EMPTY V I A L S A R E CLE A R BA G W A S T E Y E S N O W a s t e * * D i s c a rd in la b e le d * W i tn e s s w a st e c ont ai ne r. D i sc a r d in l abel e d *

w a st e c ont ai ner

. EMPT Y VI A L S A R E CLEA R BA G W A STE

* * See bo x o n l e f t f o r w a st i n g i n st ru ct i o ns * * W

ast

i n g :

( B eds i de wasti n g o f e xces s dr ug)

• Do NOT f l us h

• Do NOT sq ui r t i n t o Sh ar ps Cont ai ne r

• Do NOT di spos e i n r e d bag or cl ear bag t r as h.

• Do sq ui r t ex ces s l i q u i d or p l ac e s o l i d dosag e f o r m s i n t o z i pp er bag c ont ai ni ng han d l o t i o n

.

• Do seal bag a nd pl ace i n t o l abel e d

phar mace ut i c al w a s t e cont ai ner

.

• Do pl ace e m p t y cont ai ner i n t r as h.

• Do wi t ness w a s t i n g ( 2 pers ons neede d)

v i a aut omat ed di s pens i n g c abi net or g i v e f u ll s i g nat ur es ( N O I N I T IA L S )

. * N B : l a bel e d w a st e c ont ai n e r = w h i t e buc ket l abel ed as phar mac eut i c al w a s t e or bl ue phar m a c eut i c al w a st e cont ai ne r. Cal l x 2

- 8700

o p t i o n #3 f o r l a bel s an d c o n t ai ner s. 

## Slightly modified flow char t for th e Main AMC campus Slide 58



# Satellite Accumulation

• Colored Rx w aste containers w i ll be placed in the Patient-care areas

• Clinicians (nurses, phy s icians) w i ll put pharmaceutical w aste in the colored containers

• Clinicians w i ll call the CA LL Center

(x2-4444) w h en a container is 3/4 full



## Satellite Accumulation areas on the main campus Colored Rx waste cont ainers will be placed in the Patient-care areas Clinicians (nurses, physicians) will put pharma ceutical waste in the colored cont ainers Clinicians will call the Call Center (x2-4444) when a cont ainer is 3/4 full

42

## Slide 59

D r ug s D i s p e n s e d (to p 80 % ) at A l ba ny M e dica l Ce nt er Hospit al A p r i l 20 09



## Graphical represent ation of the most dispens ed drugs from PYXIS® automated dispens ing machin es on the AMC Main campus during Ap ril,2009. Comp are this graph to the analogous dat a from South Clinica l Ca mpus (slide 30). Slide 60

C u m u lat i v e 80% Phar maceu ticals D i spen sed at A l b a n y M e dical C e n t er H o sp ital A p ril, 2009



## The top 80% of drugs dispens ed from PYXIS® automated dispens i ng machin es on the main AMC campus. Comp are to slide 31 from the South Clin ical Campus. The main 630 bed AMC campus dispens es far more controlled subst ances and p a in relievers than the Acute Care (23 hour st ay) 20 bed South Clinical Campus. The t op 6 drugs dispensed on AMC’ s main campus (accounting for 37% of drugs dispensed) are controlled subst ances as comp ared to one controlled subst ance (midazolam) in the top 6 at the Sout h Clin ical Campus. Propofol, the most commonly disp ensed (and wasted) drug at the South Clin ical c a mpus, contributes but 1. 3% of all drugs dispensed o n the main campus.

43

## Slide 61

S a tellite A ccu mulatio n Contai ner s

Compatible Rx W aste (Blue container w ith a blue label)

Non-compatible Rx W aste (Black container w ith a black label)
Not found on nursing units. May use in pharmacy

.



## Cont ainers Reusable: 2 types Comp atib le Rx W a ste (Blue cont ainer with a blue label) Non-comp atible Rx W a ste (Black cont ainer with a black label) Not found on nursing unit s . May use in phar macy

. Slide 62



# Rx Waste Container & Label

CO M P A

T I B LE PHA R M A CE U T I C A L W A ST E

(H a z a r dous Wa s t e
– S a t e llite A c c u mu la tio n C o n t a i n e r )
KE EP L I D CL OSE D

DO NO T RE M O VE O R DISP E N SE ITEM S F R OM THIS CONT A I NE R

NO SHA R PS ( U se app r o p r i ate sh a r p s con t ain e r )

NO INF E CT IO US /BIO HA ZA R D O U S ( N o b l oo d or b o d y fl u i ds )

NO CONT ROL L ED SUBS T A NCES (Witn ess waste per p o licy )

N O FR E E LI Q U I D S ( U se z i p lock bag t o co n t ain liqu i d

bef o r e placin g in co n t ain e r )



## Photo of reusable com p atible was t e cont ainer (4 gallon) and label. Note labe l st ates “Hazardous W a ste” , “Satellite Accumulation Cont a i ner” Det a iled warnings on label no sharp s , no dispens ing, no biohazar ds, no controlled subst ances, no free liquids

44

## Slide 63

Phar m a c eut ic al W a s t e as a Per c entage of Dr ug Dis pens ed A l ba ny Medic a l Cent er Hos p it al A p r il, 2009



## Graphical represent ation of pharma ceutical wasting as a percent of drug dispensed from PYXIS® automated dispens ing machines on the AMC main ca mpus in April, 2009, comp are to slide 32.

Slide 64

Medicat ion s R eco rd ed as Wasted f r o m PY XIS®

R ecor d s A l b a n y M e dical C e n t er H o sp ital A p ril, 2009

O n ly an av erage of 2% of 256 dr ugs dispensed at t he Al bany M edical C enter H o spi t al w e re recor ded as w a sted in the PY X I S® di spensing sy stem records. Fort y of the medi cat i ons di spensed av er aged 14% w a sting w i th a range fr om 52% to 1%. Liqui d m edications w e re by far t he m o st f r equent l y w a sted and w e r e predominant l y cont rol l ed subst ances, ant ibi o ti cs, and anti h ist a m i nic s / a n t i

- i n f l amm a t o ry dr ugs. O f

the non- contr o l l ed dr ugs: 3⁄4 50% of lev o f l ox acin l i qui d di spensed w a s w a st ed. 3⁄4 38% of pr om et haz ine l i qui d di spensed w a s w a sted 3⁄4 29% of nalbuphi ne li quid dispensed w a s w a sted 3⁄4 16% of v e curonium l i qui d dispensed w a s w a st ed. 3⁄4 14% of diphenhy dr am ine li quid dispensed w a s w a st ed. 3⁄4 13% of dex amethasone li quid dispensed w a s w a st ed. 3⁄4 6% of hal oper i dol li quid dispensed w a s w a st ed. 3⁄4 4% of benz t r opine di spensed w a s w a sted. 3⁄4 Fi v e drugs (3 soli d and 2 li quids) w e re 2% w a st ed. 3⁄4 T h irt een dr ugs ( 6 soli d and 7 l i qui d) w e re 1% w a sted. 3⁄4 O f 22, 061.8 m L of pr opofol dispensed, only 98. 2 m L w e r e r ecorded as

w asted. 3⁄4 T w o hundred six t een (84%) medi cat i ons dispensed had 0% w a sted

.



## Medication s Recorded as W a sted from PYXIS® Reco rd s Albany Medica l Cent er Hospit al April, 2009 Only an average of 2% of 256 drugs dispensed at the Albany Medical Center Hospit al were recorded as wasted in the PYXIS® dispensing system records. Forty of the medications dispensed averaged 14% wasting with a range from 52% to 1%. Liquid medications were by far the most frequently wasted and were predominantly controlled s ubst ances, antibiotics, and antihist a minics / antiinflammatory drugs. Of the non-controlled drugs:

45

## 50% of levofloxacin liquid dis pensed was wasted. 38% of promethazine liquid dispensed was wasted 29% of nalbuphine liquid dispens ed was wasted 16% of vecuronium liqui d dispens ed was wasted. 14% of diphenhydram ine liquid dispensed was wasted. 13% of dexamethasone liqui d dis pensed was wasted. 6% of haloperidol liquid dispensed was wasted. 4% of benztropine dis pensed was wasted. Five drugs (3 solid and 2 liquids) were 2% wasted. Thirteen drugs (6 solid and 7 liquid) were 1% wasted. Of 22,061.8 mL of propofol dispensed, only 98.2 mL w e re recorded as wasted. T

w o hundr ed sixteen (84%) medicati ons dis pensed had 0% wasted.

Slide 65



# Co ntrolled Substances

Ac co rd ing to NY S Sec t io n 80 .5 1 o f th e Rule s a n d R e gu lation s of C o n t rolle d Su bsta nces: To d i sc ar d a co nt ro lled s u b s t a n c e me an s t o “r en de r it to ta lly u n r e c o v e r a b l e an d be y o nd re cla m at ion

. ”
Tra d it ion a lly , t h is h a s be en t o f l us h it or po ur it d o w n the sink.
To da y , in th e in te re st of preserv i n g the env iro n m e n t this is no longer ac cept able. Alt e rnativ e m e thods need to be ut ilized.



## Controlled Subst ances According to NYS Sec t ion 80.51 of the Rule s and Regulations of Controlled Subst ances: T

o discard a controlled subst ance means to “render it tot a lly unrec overable and beyond reclamation.” T r aditionally , this has been to flus h it or pour it down the sink. T

oday , in the interest of preservi ng the environment this is no longer accept able. Alternative methods need to be utilize d

.

46

## Slide 66



# Waste vs. Destruction

'W a s ti ng '

- f or si ng l e

- uni t doses or parti al doses r e ma i n i n g af ter the admi n i s tr ati on or attempted admi n i s tr ati on of a por ti on of l i q ui d or sol i d uni t dose of a contr o l l e d substance.

- done i mmedi atel y after the admi n i s trati on or attempted admi n i s trati on;

- destr oy ed on pr emi s e of an i n sti t uti onal di spenser by

a phar maci st or nur se;

- destr ucti on w i tnessed by a second pharmaci st,

nur se or other r e sponsi b l e per son desi g nated b y the admi n i s tr ator; and

- t he control l ed substance i s r endered total l y
unr ecov er abl e and bey ond recl amati on.

N Y S S e cti o n 80.51 o f t h e R u l e s and R e g u l a ti o n s o f C o nt r o l l e d S ubs t a nce s



## 'W asting' - for single-unit doses or p a rtial doses remaining af ter the administration or attempted administration of a portion of liquid or so lid unit dose of a controlled s ubst ance. done immediately af ter the administrat ion or attempted administration; destroyed on premise of an institutional dispenser by a pharmacist or nurse; destruction witnessed by a second pharmacist, nurse or other responsib le person designated by the administrator; and the controlled subst a nce is rendered tot a lly unrecoverable and beyond reclamation.

Slide 67

'De s t r u c t i on ' - f or con t ro ll ed su bstan c es t h at are un de sired

, de t e rio r ated

, ob sol e te or f o r an y rea s on no l o n g e r

ne ed ed

. O p t i o n s f o r de s t r u c t i on i n c l ud e t h e f i ve f o ll ow in g m e c h an i s m s : 1

. R e turn t o t h e li cen s ed m a nu f a cture r/ d i strib utor f r om w h om

c o nt r o l l e d s u bs t a n c e w a s p r oc u r ed ; 2. S u r r e nd er t o a 'R ever s e Di s t r i b u t o r ' l i c e ns e d b y D O H ; 3

. Su rren d e r t o Bure au o f Na rcotic En f o rce m en t (BN E ); 4. S u r r e nd er t o D E A ; or 5. P e r f o r m on

- s it e de s t r u c t i on :

- m ust rece iv e w r itt e n a p p r ov al f r om BNE f i rst;

- c om p l e t e f o rm s DOH 23 40 a n d D O H 16 0 an d subm i t t o BNE;

- t h e c o nt r o l l e d s u b s t a nc e i s r e nd er e d t o t a l l y un r e c o ver a bl e

an d b e y o n d re cla m atio n.

N Y S S e cti o n 80.51 o f t h e R u l e s and R e g u l a ti o n s o f C o nt r o l l e d S ubs t a nce s 

# W aste vs. Destruction

'Destruction' - for controlled subst ances that are undesir ed, deteriorated, obsolete or for any reason no longer needed.

47

## Options for destruction include the five following mechanisms: 1. Return to the licens ed manufacturer/distri butor from whom controlled subst ance was procured; 2. Surrender to a 'Reverse Distributor' licens ed by DOH; 3. Surrender to Bureau of Narcotic Enforcement (BNE); 4. Surrender to DEA; or 5. Perform on-site destruction: - must receive written approval from BNE first; - complete forms DOH 2340 and DOH 160 and submit to BNE; - the controlled subst ance is rendered to t a lly unrecoverable and beyond reclamation.

Slide 68

Controlled Subs tance Wasting

Equipm e n t:

Ste p c a n will be la be le d C ONTR O L L ED S U BS T ANCES ONL Y Dawg ® - a bso r bent solid



## Illustration of bedside wasting equi pment to be used during AMC pilot

Slide 69

Controlled Substance Wasting

• M ust be done at poi nt of care

• M ust be w i tnessed

• M ust be di scarded i n appropr i a tel y l abel ed pharmaceuti c al

w a ste contai ner 4 oral l i q ui d medi cati ons may be pour ed di r e ctl y i n to can
4 i n j e ctabl e l i q ui d medi cati ons may be sq ui r t ed d i r e ctl y in to ca n 4 oral sol i d medi cati ons shoul d be crushed, mi x e d w i th

some w a ter and poured i n to can
4 f entany l patches must be di scar ded i n red sharps

contai ner as per N Y S D O H g u i dance l e tter ( 1 0 / 4/01)



## 48

## Controlled Subst ance W a sting Must be done at point of care Must be witnessed Must be discarded in appropriately l abeled pharmaceutical waste cont ainer 1. oral liquid medications ma y be poured direc t ly into can 2. inject able liquid medic a tions may be squirted directly into can 3. oral solid m edications should be c r ushed, mixed with some wate r and poured into can 4. fent anyl p a tches must be discarded in red s harp s cont ainer as per NYS DOH guidance letter (10/4/01)

Slide 70

Beds ide " W as ting" of Cont r o lled Dr ugs as a P e r c ent age of Dr ug Dis pens ed at A l ba ny Medic a l Cent er Hos p it al Apr il, 2009



## Graphical represent ation of bedsi de wasting of controlled subst ances as recorded in PYXIS® automated dispens ing machines from the Albany Medical Center main campus during April, 2009.

Slide 71

49C o nt ro lled Su bst a nces R eco rd ed as Wasted f r o m PY XIS® R eco rd s A l ban y M e dical C e n t er H o sp ital A p ril, 2009

Con t r o lled su bst a nce s in liq u i d f o r m w e r e co mm on ly r e cor d ed a s

w a sted i n the P Y XIS ® r e cords o f the A l ba ny M e di ca l C e n t er Ho s p it a l in Ap r il o f 2 0 0 9

, aver ag in g 7% of 46 c o n t r o lled sub s tan c es d i spe n se d. Of the s e, ov er on e h a l f ( 2 7) h a d 0%

wa s t i n g

.

• 5 2% o f a c et a m in op he n/ c o de ine liq u i d d i s p e n s e d w a s w a s t ed

.

• 4 8 % of ph en ob arbi ta l l i q ui d d i spe n se d w a s w a sted

.

• 3 8 % of l o raz e p a m l i q ui d di sp en sed w a s w a sted

.

• 3 1 % of hy dromorph on e l i q u i d di sp en sed w a s w a ste d

.

• 2 6 % of m e pe r i d i ne l i q ui d d i spe n se d w a s w a sted

.

• 2 3% o f m i da z o lam liq uid dis p en s e d w a s w a s t ed

.

• 1 7 % of f e nta n y l l i q u i d di sp en sed w a s w a ste d

.

• 9 % of m o r p hin e liq uid dis p en s e d w a s w a s t ed

.

• 8 c o nt r o lle d s u b s t a n c es dis p en s e d in t a b l et or dr y f o r m r a n g ed

f r om 1% to 4% w a sti n g

.



## Controlle d Subst ance s Recorded as W a sted from PYXIS® Record s Albany Medica l Cent er Hospit al April, 2009 Controlle d subst ances in liqu i d form were commonl y recorded as wasted in the PYXIS® records of the Albany Medical Center Hospit al in April of 2009, averaging 7% of 46 controlled subst ances dispens ed. Of these, over one half (27) had 0% wasting. 52% of acet aminophen/codeine li quid dis pensed was wasted. 48% of phenobarbit a l liquid dis pensed was wasted. 38% of lorazep a m liquid dispensed was wasted. 31% of hydromorphone liqui d dis pensed was wasted. 26% of meperidine liqui d dispens ed was wasted. 23% of midazolam liquid dispensed was wasted. 17% of fent anyl liquid dispens ed was wasted. 9% of morphine liquid dispens ed was wasted. 8 controlled subst ances dispens ed in t ablet or dry form ranged from 1% to 4% wasting.

Slide 72



# Bullet Points – C ontrolled Substances

• F e n tan y l pa tc he s mu st be w a sted into SHARPS

co ntaine rs

• A ll co nt rol l e d sub s t a n c e m e di ca ti on sh ou ld be rem o v e d

f r om it s ori g i n a l co nt ai ne rs an d d i sca r de d i n la bel e d

con t ro ll ed sub s t a n c e ph a r m a c e u t ica l w a st e cont ai ne rs

• A ll em p t y co nt ai ne rs w h ich p r ev io usly co nt ai ne d

co ntrolle d su bs ta nc e s sh ou ld be d i s p o s e d of in re gu la r t r ash.

• W a s ting do cu men t atio n in PYXIS® re mains u n c h an ge d

an d sh ou ld be d o n e in c o n j u n c t ion w i th th es e p r oced u r e s



## 50

## Slide 73



# Bullet Points

• W he n in do ub t, refer to FL OW C H A R T

• A ll un op en ed

, u n u s e d me dic a t i on s (in c lu d i ng

c o n t r o lle d su bs ta nc es ) sh ou ld b e re tu rn e d t o ph arma cy

• A ll empt y t u b i ng , sy rin g e s , et c sh ou ld be

dispo s e d of in reg u la r trash.

• A ll me dic a t i on v i a l s co nt ain i ng pa rt ial a m ou nt s

o f me dic a t i on (e x c ep t c o n t r o lle d s u b s t a n c es ) sh ou ld be d i scarde d in lab e le d ph arma ceu t ical

w a ste con t a i ne rs (curre ntly BLU E ).



## Slide 74

HOW DO I KNOW WHA T TO PUT WHERE?

I s i t or di d i t c o n t ai n an AN TI NEOPLAST I C ag ent ?

YE S NO I s i t e m pt y or d oes i t c ont ai n onl y a t r ac e a m ount ? I s i t S H ARP

. BROK E N or pot e n t i al l y shar p ( i

. e GLA S S )?

Y ES NO YE S NO Di s c ar d i n Recor d amt and Di sc ar d i n SH A R PS

d in IN F E C T I O U S (re d H a s i t bec o m e g r oss l y CH

EMO w a s t e di s c ar d i n bul k cont ai ner c ont ami nat ed w i t h bl o od or CH

EMO w a s t e body f l ui ds or i n f e c t i o u s mat e r i al s ?

YE S NO D i s c a r Is it e m p t y?

w a s t e ba g )

. YES N O

D i sc a r d in T R A S H Is it a con t rol l ed

c ont ai ner

. sub s t a nc e ? EMPTY V I A L S A R E CLE A R BA G W A S T E Y E S N O W a s t e * * D i s c a rd in la b e le d * W i tn e s s w a st e c ont ai ne r. D i sc a r d in l abel e d *

w a st e c ont ai ner

. EMPT Y VI A L S A R E CLEA R BA G W A STE

* * See bo x o n l e f t f o r w a st i n g i n st ru ct i o ns * * W

ast

i n g :

( B eds i de wasti n g o f e xces s dr ug)

• Do NOT f l us h

• Do NOT sq ui r t i n t o Sh ar ps Cont ai ne r

• Do NOT di spos e i n r e d bag or cl ear bag t r as h.

• Do sq ui r t ex ces s l i q u i d or p l ac e s o l i d dosag e f o r m s i n t o z i pp er bag c ont ai ni ng han d l o t i o n

.

• Do seal bag a nd pl ace i n t o l abel e d

phar mace ut i c al w a s t e cont ai ner

.

• Do pl ace e m p t y cont ai ner i n t r as h.

• Do wi t ness w a s t i n g ( 2 pers ons neede d)

v i a aut omat ed di s pens i n g c abi net or g i v e f u ll s i g nat ur es ( N O I N I T IA L S )

. * N B : l a bel e d w a st e c ont ai n e r = w h i t e buc ket l abel ed as phar mac eut i c al w a s t e or bl ue phar m a c eut i c al w a st e cont ai ne r. Cal l x 2

- 8700

o p t i o n #3 f o r l a bel s an d c o n t ai ner s.



## 51

## Educational Tour of Albany Medi cal Center’s South Clinical Campus. Pharmaceutical Waste Collec tion in Operating Rooms.

Sharps Container Pharmaceutical Waste Container

Tour conducted for regulators and healthcare administrators through HANYS (Healthcare Association of New York State) and NY DEC



# Dr. Mankes (US EPA PI) describing pharmaceutical waste management process to tour group

# Michael Murphy, RN, Director of Patient Care Services for the South Clinical Campus di scussing patient care aspects of the pharmaceutical waste management system.



# Question from representative of NY DEC commissioner on pharmaceutical waste management process.

# Close up of secure pharmaceutical waste container with wire bracket, lock and labeling “satellite accumulation area.”

Michael Murphy, RN, Director of Patient Care Services for the South Clinical Campus di scussing patient care aspects of the pharmaceutical waste management system.

NB: No sinks or drains in operating rooms, thus no wasting possible

## Close up of a pharmaceutical waste collection bin secured to a medication cart in the post anesthesia care unit (PACU) at the Albany Medical Center’s South Clinical Campus.

Flow charts and reminders located near the pharmaceutical waste collection bin in the post operative care unit (Post-Op) at the Albany Medical Center’s South Clinical Campus.

## Dr. Mankes (US EPA PI) demons trates opening of a full pharmaceutical waste collection bin in the South Clinical

Campus’ central hazardous waste accumulation area.



# Dr. Mankes demonstrates weighing of contents from a full pharmaceutical waste collection bin.

## Dr. Mankes demonstrates use of heavy puncture resistant gloves due to maldisposals of sharps into pharmaceutical waste collection bin.

Syringe with needle attached



# Dr. Mankes demonstrates close up of syringe labeling during sorting of pharmaceutical waste.

# Dr. Mankes demonstrates sorting of pharmaceutical waste using long forceps.

Sorted pharmaceutical waste – p ropofol syringes and vials are the predominant waste discarded from the South Clinical Campus’ Operating Rooms.

## Dr. Mankes demonstrates maldisposal of controlled substance into pharmaceutical waste bin to representatives of NY DEC, NY Board of Pharmacy.



# Dr. Mankes demonstrates sorting of pharmaceutical waste.

# Examples of waste pharmaceuticals recovered from the South Clinical Campus Operating Rooms.

Sharps containers in central hazardous waste accumulation area at the Alba ny Medical Center’s South Clinical Campus.

# Central hazardous waste accumulation area at the Albany Medical Center’s South Clinical Campus.

Conference room and participants for pharmaceutical waste tour at the Albany Medical Center’s South Clinical Campus.