Russell F. Mankes, Ph.D. 

Associate Professor, 

Center for Neuropharmacology & Neuroscience, 

and Center for Immunology & Microbial Disease

Chemical Hygiene Officer & Responsible Facility Official 

DEPARTMENT OF ENVIRONMENTAL HEALTH AND SAFETY

HUN MEMORIAL BUILDING MC-96 

(518) 262-5490/ (518) 262-8638 (FAX)/(518) 422-0593 (PAGER) 

MANKESR@MAIL.AMC.EDU

29 October, 2009 

Progress Report 

Project Title: “Source Reduction 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 strategies for source reduction of pharmaceutical 

waste from a hospital into the environment, primarily though waterborne disposal (flushing) of drugs, 

reduction in use and wastage of hazardous medications (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 significantly 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 for 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% positive) and sixty-one percent indicated 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 expansion to the main (631 bed) hospital campus. As 

noted in the attached final report, we have begun the roll out at the main hospital, with interesting 

results. This roll out would not have been possible without the knowledge gained from the present 

pilot project. 
 

Measurable Results Reporting Form for EPA Pollution Prevention Grants

EPA reports on measurable results for pollution prevention. Please input your results in the first 

table and provide an explanation of how you arrived at these results in the box below.

Grant Number: X9-97256506-0 

Applicant: Albany Medical Center

Grant Title: Source Reduction Demonstration Project 

Sector: 

Media: 

Primary Measurable Results Initial Estimate Interim Results Final Results 

Hazardous Materials Reduced (lbs) * 100,000 10,000 100,000

Energy Conserved (BTU) ------------- ---------- ----------

Water Conserved (gal) ------------- 8,801 20,000

Dollars Saved $620,000 $62,000 $620,000

Other Results 

Non-hazardous waste reduced (lbs) 

Greenhouse Gases Reduced (carbon 

equivalent) 

For each measure, please provide methods, assumptions, and calculations: 

(Attach extra page(s) if more space is needed)

Hazardous material including pharmaceuticals of concern (refer to final report, slide 23): Our 

initial estimate was based upon a diversion of 105 of the 500 tons annually purchased 

pharmaceuticals at AMC. Our interim results of 10,000 pounds were reported earlier in our 

interim report. Our final amount is based on the amount of pharmaceuticals diverted into our 

pharmaceutical waste containers and reduced dispensing patterns, particularly of surgical 

drugs such as propofol. The final amount also reflects estimated product reduction through 

diversion for 13 Region 2 hospitals who attended tours and proposed adopting P2 principles 

of the present grant. This also includes a reduction in the number of RCRA regulated listed 

drugs (e.g. epinephrine salts)to only a minimal number of characteristic (D-listed) 

pharmaceuticals. 

Energy conserved and water conserved were not proposed as part of this application however, 

we found significant water conservation from avoidance of toilet flushing of controlled 

substances and pharmaceuticals. Up to now, toilet wasting has been the common practice for 

drug wasting by patient care staff (encouraged by regulatory agencies such as the Drug 

Enforcement Administration - DEA and the Bureau of Narcotics of the New York State 

Department of Health-BNE). As each flush represents a minimum waste of 1 gallon of 

potable water, we find 677 units (South Clinical Campus) or 45,604 units (Main Campus) of 

controlled substances/year would be flushed (refer to final report, slides 32 and 60). By 

developing and disseminating a no flush policy of controlled substance disposal as well as 

providing a BNE approved alternative method (refer to final report, slide 68) we eliminate a 
 

minimum of 677 flushes/hospital/year. 

Dollars saved: Disposal of hazardous waste costs average $6.20/pound. The waste reduction in 

pounds are calculated at 100,000 pounds thus savings are estimated at at least $620,000. 

* “hazardous” materials include regulated pollutants, including Clean Air Act criteria pollutants, Clean Water 

Act water quality criteria pollutants, and CWA conventional pollutants. This also includes pollutants regulated 

under EPA-delegated state programs.

 For assistance with conversion, see link: http://www.eia.doe.gov/kids/energyfacts/science/energy_calculator.html 

 
 

Other Activities (workshops, inter-organization cooperation, Environmental Management 

Systems, pamphlets, etc.)

On site tours, Pamphlet development, Workshop presentations

Please provide a brief description of the activity(s) and their effect(s) on Hazardous Waste 

Reduced, Energy Conserved, Water Conserved, and/or Dollars Saved: 

Pamphlets and educational materials: Posters and handouts were prepared by the Department 

of Education and Development (refer to final report, slides 43 – 45). They are attached as 

PDF files. 

Dissemination of Knowledge: Seven two-hour tours of SCC were held with 51 participants 

(refer to final report, slides 39 41). Original dates fully subscribed, 2 additional tours added. 

36 participants registered. 19 Hospital, Government, Waste Management and Consulting 

Organizations represented from Puerto Rico to Canada. 

Partial listing includes: NY DEC, NY DoH, NY Education Department (Board of Pharmacy), 

Bassett Healthcare, Cooperstown, NY, Brookhaven Memorial Hospital Medical Center, 

Patchogue, NY, Crouse Hospital, Syracuse, NY, Glens Falls Hospital, Glens Falls, NY, Mary 

Rutan Hospital, Bellefontaine, OH, Oneida Healthcare Center, Oneida, NY, Saratoga 

Hospital, Saratoga, NY, St Francis Hospital & Health Care Center, Poughkeepsie, NY, St 

Luke's Roosevelt Hospital, Manhattan, NY, St Mary's Healthcare System for Children, 

Bayside, NY, St Peter's Hospital, Albany, NY, SUNY Stony Brook Health Sciences Center, 

Stony Brook, NY, VA Caribbean Healthcare System, PR, Biomedical Waste Services, 

Baltimore, MD, Health Care Without Harm, Jacques Whitford Co, Ontario, CA. Tour 

Handouts attached as PDF files. 

Workshops and presentations: 

April 2, 2008: AMC Nursing education rounds for nursing units and radiology for SCC. 55 

Staff trained. 20 posters and 65 handouts distributed. 

April 24 & 25, 2008: Presentations by AMC & Stericycle staff to Environmental Service & 

Clinical Staff. 4 presentations, 24 attendees. PDF copies of the presentations are attached. 

June 11, 2008. Announcement and summary of program by HANYS and availability of tours 

sent to all CEO’s and Compliance Officers of HANYS Member Hospitals. 

July 14, 2008. Stericycle resends the HANYS announcement to all Stericycle Healthcare 

customers. 

July 25, 2008 Resent HANYS announcement to pharmwaste listserv at 

pharmwaste@lists.dep.state.fl.us 

July 25, August 1, August 22, September 12, September 26, October 10 and October 24. Tours 

of the South Clinical Campus and education sessions on pharmaceutical waste collections 

scheduled. 

Dr R. Mankes - NEWMOA presentation. USEPA Region 2 Headquarters, NY, NY May 7, 

2008. 

Dr R. Mankes – Roundtable participant, Commissioners’ Roundtable on Pharmaceutical 
 

Waste, NY DEC & NY DoH, NY DEC Headquarters, Albany, NY May 15, 2008. 
Slide 1 

10/13/2009

Albany Medical Center

Pharmaceutical waste management:

A 2 year pilot project

Russell F. Mankes, PhD

Associate Professor, Center for

Neuropharmacology and Neuroscience and

Center for Immunology and Microbial Disease

Albany Medical Center 

Pharmaceutical waste management: A 2 year pilot project 

Funded by US EPA grant X9-97256506-0 

In collaboration with HANYS (Healthcare Association of New York State) and the New York State 

Department of Environmental Conservation 

Russell F. Mankes, PhD 

Associate Professor, Center for 

Neuropharmacology and Neuroscience and 

Center for Immunology and Microbial Disease 

Slide 2 

Participants • Albany Medical Center – Albany Medical College

• Russell F. Mankes, PhD Associate Professor, PI

• Timothy Duffey, Hospital Director Albany Medical Center South 

Clinical Campus

• Michael Murphy, RN Director of Patient Care South Clinical Campus

• Elena Cioppa, RPH Director of Pharmacy South Clinical Campus

• Brenda Streeter, CIH Director Environmental Health & Safety

• Laurie DeWeerdt, Chemical Hygiene Officer AMC

• Peter Gorman, Asst Chemical Hygiene Officer AMC

• Healthcare Association of New York State

• Karen Roach, Director governmental Affairs

• New York State Department of Environmental

Conservation

• Alan Woodard, PhD

• Dennis Lucia

2
Participants: Albany Medical Center – Albany Medical College - Russell F. Mankes, PhD Associate 

Professor, PI, Timothy Duffey, Hospital Director Albany Medical Center South Clinical Campus. 

Michael Murphy, RN Director of Patient Care South Clinical Campus, Elena Cioppa, RPH Director of 

Pharmacy South Clinical Campus, Brenda Streeter, CIH Director Environmental Health & Safety, 

Laurie DeWeerdt, Chemical Hygiene Officer AMC, Peter Gorman, Asst Chemical Hygiene Officer 

AMC 

Healthcare Association of New York State - Karen Roach, Director governmental Affairs 

New York State Department of Environmental Conservation - Alan Woodard, PhD, Dennis Lucia, 

Resa Dimino 

New York State Department of Health, Bureau of Narcotic Enforcement – Paula Grogan; Victoria 

Hanson, RPH 

New York State Department of Education 

Stericycle Inc (Contractor) – Maureen Guice Major Account Executive, Dan Fadgen Rx Formulary 

Slide 3 

Planning

• Maldisposals of Pharmaceuticals from OR

– “Houston we have a problem”

Pharmaceutical maldisposals became a significant issue for AMC in 2005. As shown above, 

controlled drugs and regulated substances were haphazardly disposed in cardboard boxes and 

regulated medical waste (white buckets) making drug diversion likely. Additionally, many of the 

regulated drugs were no handled in accord with State or federal regulations (RCRA). 

No consistent guidance for pharmacists or medical practitioners was available and staff were pretty 

much “left on their own”. Regulatory control and guidance from the US EPA and NY DEC was focused 

upon the professional waste managers for healthcare facilities (Environmental Health & Safety) and 

statewide enforcement inspections of hospitals by both EPA and DEC in 2003 had resulted in 

significant penalties. This had not translated into guidance or process improvements to handling of 

pharmaceutical waste by the ultimate caregivers (pharmacy / patient care staff). 

3
Slide 4 

Pharmaceutical Waste

• Goals

– Compliance

–Avoid water wasting and discharge.

– Reduce drug diversion

– Improve medication management 

practices

– New regulations on pharmaceutical 

waste (universal wastes).

Goals: Improve compliance with Joint Commission, State, Federal and Local restrictions on 

discharge of pharmaceutical waste to water supplies. 

Improve compliance with Controlled Substance (Narcotics) regulations and avoidance of 

diversion. 

Improve medication management practices in collaboration with HANYS (AMC - National 

Model). 

Position AMC for compliance with new State and federal regulations on limiting waste water 

discharge of pharmaceutical waste (Universal wastes). 

Slide 5 

What’s Changed?

• New Joint Commission standards.

• Increased compliance 274 currently

regulated drugs.

• Anticipated new regulations on 

discharge of pharmaceuticals to waste 

waters affecting 2,426 not currently

regulated drugs.

• Publication of CCL3 (Third drinking 

water Contaminant Candidate List).

New Joint Commission standards. 

4
(EC.02.20.01; MM.02.01.01; MM.03.01.01; MM.05.01.11; MM.05.01.19) 

Increased compliance action on 274 currently regulated pharmaceuticals by OSHA; US EPA; 

NYS DoH; NYS DEC and Albany County Sewer District e.g.., Chemotherapy drugs, 

epinephrine, fentanyl, aerosol containers. 

Anticipated new federal and state regulations on discharge of pharmaceuticals to waste waters 

affecting 2,426 not currently regulated drugs. Mood altering drugs – prozac, antiviral drug, 

endocrine drugs, heart medications digoxin and antiinflammatory drugs – ibuprofen and 

cholesterol lowering drugs – lipitor. 

Publication (September, 2009) Third Drinking Water Contaminant Candidate List (CCL3) 

including estrogens, formaldehyde, ethylene glycol and nitroglycerine. 

Slide 6 

2009 Joint Commission Standards

Environment of Care Standard (EC.02.02.01): manage 

risks 

Elements of Performance: 

• Minimize risk disposing of hazardous medications.

• Minimize risk managing hazardous medications. 

Medication Management Standard (MM.02.01.01): select, 

procure medications.

Elements of Performance

• Maintain formulary (strength and dosage). 

• Formulary readily available.

• Reviewed at least annually.

Joint Commission Standards 2009 Applicable to Pharmaceuticals Waste Management 

Environment of Care Standard (EC.02.02.01) 

The [organization] manages risks related to hazardous materials and waste. 

Elements of Performance for EC.02.02.01 

The hospital minimizes risks associated with disposing hazardous medications. (See also 

MM.01.01.03, EP 4). 

MM.01.01.03 (4): A, 3 The hospital minimizes risks associated with managing hazardous medications. 

(See also EC.02.02.01, EP 8) 

5
Slide 7 

Medication Management Standard

(MM.03.01.01): safe storage

• Maintain integrity

• Promote availability

• Reduce diversion and dispensing errors.

• A written policy to control medications from

receipt to administration.

• Label all medications and components with 

contents, expiration date, and warnings.

• Expired, damaged, and/or contaminated

medications are removed and stored separately.

• Periodically inspect medication storage areas.

Medication Management Standard (MM.03.01.01) 

The [organization] safely stores medications. 

Rationale for MM.03.01.01 

Medication storage is designed to assist in maintaining medication integrity, promote the availability of 

medications when needed, minimize the risk of medication diversion, and reduce potential dispensing 

errors. 

Law and regulation and manufacturers' guidelines further define the [organization]’s approach to 

medication storage. 

Elements of Performance for MM.03.01.01 

The hospital stores controlled (scheduled) medications to prevent diversion, in accordance with law 

and regulation. 

The hospital has a written policy addressing the control of medication between receipt by an 

individual health care provider and administration of the medication, including safe storage, handling, 

security, disposition, and return to storage. 

All stored medications and the components used in their preparation are labeled with the contents, 

expiration date, and any applicable warnings. 

The hospital removes all expired, damaged, and/or contaminated medications and stores them 

separately from medications available for administration. 

The hospital periodically inspects all medication storage areas. 

6
Slide 8 

Medication Management Standard

(MM.05.01.11): dispense medication

• Practices and recordkeeping include antidiversion

strategies.

• Medications dispensed in ready-to-administer or unit 

doses.

Medication Management Standard (MM.05.01.19): 

manage returns.

• Medications are returned when allowed.

• Returns are accounted, controlled, and disposed to keep 

patients safe and prevent diversion.

– The hospital determines if and when outside sources are used 

for destruction of medications.

– The hospital implements its process for managing unused, 

expired, or returned medications

Medication Management Standard (MM.05.01.11) 

The [organization] safely dispenses medications. 

Elements of Performance for MM.05.01.11

The hospital dispenses medications and maintains records in accordance with law and regulation, 

licensure, and professional standards of practice. 

Note: Dispensing practices and recordkeeping include antidiversion strategies. 

Medications are dispensed in the most ready-to-administer forms commercially available, and, if 

feasible, in unit doses that have been repackaged by the pharmacy or licensed repackager.

Medication Management Standard (MM.05.01.19) manages returned medications. 

Rationale for MM.05.01.19 

Medications may be returned to the [organization] when allowed by law or regulation and organization 

policy. 

Previously dispensed but unused, expired, or returned medications in the [organization] must be 

accounted for, controlled, and disposed of in order to keep patients safe and prevent diversion. 

The hospital determines under what circumstances unused, expired, or returned medications will be 

managed by the pharmacy or the hospital. 

When the hospital accepts unused, expired, or returned medications, it has a process for returning 

medications to the pharmacy’s control, that includes procedures for preventing diversion. 

The hospital determines if and when outside sources are used for destruction of medications. 

The hospital implements its process for managing unused, expired, or returned medications 

7
Slide 9 

Implement

Grant Awarded

• Stage 1: Months 1-6; Baseline Data 

Collection, Education & Roll Out.

• Stage 2: Months 7 – 18: Program 

Implementation, Refinement and Data 

Collection

• Stage 3: Post Mortem Analysis & Decision 

Making for Full Scale Roll Out

Grant Awarded 

Stage 1: Months 1-6; Baseline Data Collection, Education & Roll Out. 

Stage 2: Months 7 – 18: Program Implementation, Refinement and Data Collection 

Stage 3: Post Mortem Analysis & Decision Making for Full Scale Roll Out 

Slide 10 

Stage 1

• Baseline Metrics (see attached graphs)

• Award Contract for Pharmaceutical Waste 

Services

9Stericycle

• Triumvirate

• PharmEcology

• Design Education Program

Stage 1: baseline data on weight and cost of pharmaceutical waste disposal was collected from 

AMC’s Main campus and South Clinical Campus. Additional data from the AMC Pharmacies returns 

program was collected. 

The AMC Formulary (some 2,700 items) was assembled by NDC in preparation for formulary 

characterization by an outside contractor. 

8
Three outside contractors were solicited to provide bids for a subcontract under the EPA Grant. The 

sub contractor would provide formulary characterization and support, supplementary training, 

reusable waste containers and labels, and disposal of Non-RCRA Regulated pharmaceuticals. 

PharmEcology Inc requested not to be considered as a subcontractor for business reasons. 

Stericycle Inc., was awarded the sub contract by AMC. 

The AMC Department of Education and Development designed an educational program focused 

upon the AMC caregiver. During this time, popular press reports of drinking water contamination by 

pharmaceuticals were appearing daily, so advantage was made of this confluence of events and 

flyers & Posters touting “What’s in Your Water” were distributed to the AMCH South Clinical patient 

care staff well in advance of the program’s kick off. 

In addition to AMC’s education program, Stericycle provided a number of handouts and flyers 

targeting Environmental Services Staff and Nursing Staff based on other operating programs. AMC 

modified these for use at the South Clinical Campus. Stericycle also provided a 4 day train the trainer 

program just prior to placement of the pharmaceutical containers. AMC Facilities Maintenance had 

mounted the distinctive carriers and posters but had not placed any continers until the training was 

completed. 

Slide 11 

Overview of Pharmaceutical Waste 

Management at AMC

• Management fragmentary and driven by

competing regulations and practices

• Controlled substances (CS)

• Vaccines, biologicals and mixed wastes

(regulated medical waste – RMW)

• Antineoplastic and cytotoxic drug wastes

• Radiopharmaceuticals

• Dyes and contrast agents (Barium)

• Shielding for radiotherapy

Controlled substances (CS) 

Bedside wasting vs drug destruction 

Most common toilet or sink wasting 

Fentanyl patches must be put in sharps containers 

Some CS are RCRA regulated (Chloral Hydrate / Paraldehyde) 

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 vaccines, biologicals, human insulin.are hazardous wastes 

Antineoplastic and cytotoxic drug wastes 

9
Special handling and identification due to risk to employees (OSHA / NIOSH) during 

administration and clean up 

Trace vs Residual waste 

Radiopharmaceuticals 

 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?

• When drawn up?

• When partially administered?

• When returned to pharmacy?

• Floor stocks vs unit dosing?

• PYXIS® automated dispensing – return 

drawer

• Research, Investigational and patient’s

own medications

When drawn up? 

When partially administered? 

When returned to pharmacy? 

Floor stocks vs unit dosing? 

PYXIS® automated dispensing – return drawer 

All transactions for all drugs recorded or just some? 

Controlled substance wasting, returned to stock, etc. 

Outdated stock 

Research, Investigational and patient’s own medications 

10
Slide 13 

Metrics

Pharmaceutical Waste Generation – “Trace” vs “Residual”

Stage 1: baseline data on weight and cost of pharmaceutical waste disposal was collected from 

AMC’s Main campus and South Clinical Campus. Additional data from the AMC Pharmacies returns 

program was collected. 

“Trace” pharmaceutical waste refers to materials characteristic of regulated medical waste that have 

come into contact with regulated pharmaceuticals during administration. The most common example 

is trace contaminated materials from the administration of antimetabolite – antineoplastic drugs 

“Chemo”. These are labeled “CHEMO INCINERATE ONLY” 

“Residual” pharmaceutical waste refers to both RCRA and Non-RCRA pharmaceutical wastes 

shipped for disposal by a commercial hazardous waste hauler. 

Despite the increased focus on pharmaceutical waste management and disposal, AMC experienced 

very modest increases in weight and cost of disposal of pharmaceutical wastes from January 2007 to 

the present. AMC’s pharmacy returns program also maintained a stable return for credit weight and 

cost. This program accounted for the bulk of returned medications. 

11
Slide 14 

“Trace” vs “Residual” Pharmaceutical Waste 

Generated at Albany Medical Center (lbs) 

2007 - 2009

532 

census

536 

census

532 

census

533 

census

Average 

weight per 

patient-year = 

23.7 pounds

Graphical display of baseline data for “trace” and “residual” pharmaceutical waste generated at the 

Albany Medical Center’s Main Campus and South Clinical Campus from 2007 through 2009. The 

above amounts do not include pharmaceuticals returned for credit under AMC’s guaranteed returns 

program. During the project period, residual pharmaceutical waste (e.g., recognizable drug waste, 

partial vials, tablets, etc) doubled from about 500 pounds / year to over 1,000 pounds, yet overall 

waste generation was not significantly changed. Hospital occupancy levels remained relatively 

constant at 532, 536 and 532 patients per day. These data also provide some expectations for other 

facilities which wish to embark on pharmaceutical waste collection programs, allowing for rough 

projection of 23.7 pounds (21.6 pounds “trace” and 1.9 pounds “residual”) of drug waste generated 

per patient-year. 

Slide 15 

“Trace” vs “Residual” Pharmaceutical Waste 

Generated at Albany Medical Center ($)

2007 - 2009

532 

census

536 

census 532 

census

533 

census

Average cost 

per patient -

year= $11.61

12
As noted earlier, the cost per pound of disposal of “residual” (RCRA) pharmaceutical waste is 

markedly higher than for “trace” (RMW) contaminated drug waste for incineration only. Current RMW 

rates average between $0.26 - $0.45 per pound, depending on contractor. RCRA (“residual”) 

disposal rates may range as high as $156 per pound for acutely toxic (P –listed) drug wastes. The 

above graph clearly indicates the necessity for careful waste segregation into appropriate streams as 

a small increase in RCRA waste can translate into a large increase in cost with no significant 

environmental benefit. Per patient-year costs for drug waste disposal over the baseline period 2007 – 

2009 were $11.61 ($5.67 “trace” and $5.94 “residual” – RCRA). 

Slide 16 

Metrics

AMC-SCC Formulary characterization

*Nine drugs removed from RCRA Hazardous by

US EPA & NY DEC:

1. Cyclophosphamide injection -U058; 

10019095701

2. Cytoxan ® injection - U058, 00015050641

3. Epinpehrine injection - 1mg/mL - P042, 

66860002001

4. Epinpehrine HCL - 1mg/mL - P042, 

00548331600

5. Epinephrine HCL- 1mg/mL - P042, 

00409724101

6. Mitomycin injection 40mg - U010 -

55390045301

7. Mitomycin injection 5mg- U010 -

55390045101

8. Physostigmine salicyclate injection 1 mg/mL 

- P188, 11098051002

9. Trisenox - P012, 1459060010

The formulary for AMC is representative of most hospitals which have between two and three 

thousand individual items. If a drug is not on the formulary, it is normally not available unless by 

special order. Characterization of the hospital formulary is the first step in RCRA and Joint 

Commission compliance. A facility without a formulary (or “drug list”) will not know what medications 

are either available for administration or what solid wastes are generated, thus failing the first test in 

“cradle to grave” RCRA compliance. Furthermore, the facility is unable to determine its generator 

status under RCRA, any manifesting, notification or training requirements which may apply. AMC’s 

South Clinical Campus maintained its status as a Conditionally Exempt Small Quantity Generator 

(CESQG) despite generating small amounts of the P listed waste - epinephrine. In April, 2009, The 

New York State Department of Environmental Conservation concurred with an earlier determination 

by the US EPA to delist epinephrine salts (epinephrine is insoluble in water so medical epinephrine for 

drug use is converted to the hydrochloride salt for administration). This ruling also affected other P

and U (but not characteristic – D) listed wastes in syringes and needles. Because of this recent 

clarification and the rather standardized formularies in use, most healthcare facilities should now find 

themselves as CESQG status. 

13
Slide 17 

AMC Formulary

• Albany Medical Center’s

Formulary is 2,700 items

• Ninety (90%) percent not 

regulated

• Five (5%) percent 

controlled substances.

• Four (4%) percent 

hazardous chemicals

• Three (3%) percent 

cancer drugs.

• Three (3%) percent 

medical waste and

• Three tenths (0.3%)

percent aerosols .

Of the 2,700 pharmaceuticals (unique NDC’s) which comprise the Albany Medical Center’s

Formulary, ninety percent are not currently regulated (e.g., endocrine disruptors, steroids, antibiotics, 

mood altering drugs, heart & blood pressure medications, anti-inflammatory and cholesterol lowering 

drugs). 

Five percent are controlled substances, regulated by the US DEA or New York State. 

Four percent (April, 2009) were regulated as hazardous chemical wastes (N.B. the US EPA and New 

York State have since deregulated epinephrine salts and syringes with listed wastes). 

Three percent are OSHA / NIOSH regulated cytotoxic drugs. 

Three percent are medical waste (biohazardous); and 

three tenths of a percent are aerosols regulated by the US Department of Transportation. 

Slide 18 

RCRA Pharmaceutical Wastes

D’s

• 72 Characteristic wastes of 2,700 NDC’s

• Ignitable, corrosive, reactive or toxic

• Ignitable (alcohol) – D001 (38/72)

• Corrosives – D002 (2/72)

• Toxics (TCLP)

– Cresol (preservative) – D024, D026 (12/72)

– Mercurials (preservative) – D009 (11/72)

– Selenium – D010 (5/72)

– Silver – D011 (4/72)

– Chromium – D007 (2/72)

“Characteristic” wastes not affected by NY DEC 

April, 2009 letter.

14
Examples of characteristic drug wastes: 

Ignitable – Aromatic ammonia, argatroban, benzoin tincture, clindamycin, collodion, dexamethasone, 

etoposide, iodine tincture, kaletra, mastisol, nitroglycerine injection, norvir, paclitaxel, trileptal; 

Corrosive – Trichlor liquid; 

Reactive – none; and 

Toxicity (D004 – D043) – Multitrace-4 injectable concentrate, Tab-a-vite, Thera vitamin (D007); Bio 

Glo, flurbiprofen, Genesal solution, nasal decongestant, neomycin/polymyxin/gramacidin ophthalmic

solution, Neo-synephrine spray, oxymetazoline solution, trifluridine ophthalmic solution (D009), 

Adqadeks liquid, selenious acid injection, selenium sulfide lotion/shampoo (D010), silver nitrate 

applicator, SSD cream, thermazine cream (D011); Apidra injectable, Humalin®, lantus, Novolin N 

injectable (D024), and clobetasol cream, Humalog, Novolin 70/30, Novolog (D026). 

TCLP – Toxic constituent leaching potential as expressed as mg/L (40 CFR 261.24) 

Slide 19 

RCRA Pharmaceutical Wastes

P’s (Acutely Toxic)

• 31 of 2,700 NDC’s

• Generator status – 1 kg, includes container weight

• Included:

– Warfarin / Coumadin – P001- solid (tablet) dosage 

form only.

– Nicotine – P075 (gum, patches)

• Excluded:

– Epinephrine (salts) – July 15, 2009

– Physostigmine Salicylate –injection residual

– Trisenox ® arsenic trioxide – injection residual

Examples of non-excluded P listed pharmaceutical wastes: 

Coumadin tablets 2-10 mg, Jantoven tablets 2-10 mg, Warfarin tablet 2-10 mg (P001); and Nicorelief, 

nicotine transdermal (P075) 

Affects generator status – 1 kg (2.2 pounds) generated 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!!!!!!! 

Excluded: 

Epinephrine (salts) – Delisted by New York, July 15, 2009 for salts of epinephrine and injection 

residuals (syringes, vials, sharps, etc). 

Physostigmine Salicylate – P188 injection residuals (syringes, vials, sharps, etc). 

Trisenox ® arsenic trioxide – P012 injection residual (syringes, vials, sharps, etc). 

15
Slide 20 

RCRA Pharmaceutical Wastes

U’s

• 10 of 2,700 NDC’s

• Discarded virgin product not in syringe / needle

• Sole active ingredient

• Chemo / Cytotoxic

3⁄4 Mitomycin C – U010

3⁄4Cyclophosphamide – U058

• Shampoo – Selenium Sulfide U205

• Throat Spray – Phenol U188

• Warfarin / Coumadin – U248 (1 mg tablet)

Examples of non-excluded U listed pharmaceutical wastes (virgin discarded product, sole active 

ingredient only, not in sharps or syringe - injectable): Sore throat spray cherry (U205), selenium 

sulfide lotion and shampoo (U205); coumadin 1 mg tablet, Jantoven tablet 1 mg, Warfarin tablet 1 mg 

(U248) 

Slide 21 

Antineoplastic / Cytotoxic Drugs

• 5 fluoro Uracil 

• Arsenic trioxide

• Azaserine

• Azathioprim

• Bleomycin

• Busulfan

• Carmustine

• Chlorambucil 

• Cyclophosphamide

• Chlornaphazin

• Cisplatin 

• Cytarabine 

• Dicarbazine

• Dactinomycin

• Danorubcin

• Daunomycin

• Doxorubicin

• Lomustine

• Mechlorethamine

• Melphalan

• Mercaptopurine

• Methotrexate

• Mithramycin

• Mitomycin

• Mitomycin C

• Procarbazine

• Uracil Mustard

In 1987, an EPA policy letter clarified that waste contaminated with trace residues of chemotherapy 

agents would be considered non-hazardous waste if it meets the “ empty container” criteria. OSWER 

Directive 9441.1987(45) (policy directive from J. Sales, Chief, Regulation Development Section, 

EPA), U.S. Environmental Protection Agency, June 16, 1987; cited in W. L. Turnberg, loc. cit. “ Empty 

containers” are containers from which chemotherapy agents have been removed and no more than 1 

16
inch of residue or no more than 3% by weight of residue remains in the container. The EPA

recommends that materials such as vials, syringes, gloves, etc. contaminated with these chemicals 

not be handled after use to minimize exposure. 

Slide 22 

Not Currently Regulated Drugs

(2,426)

• Antibiotic/antiviral drugs – 250 (10.3%)

– Examples: amoxicillin, ketoconazole, miconazole, 

levofloxacin

• Antipsychotic/antidepressant drugs – 109 (4.5%)

– Examples: haloperidol, clozapine. imipramine

• Endocrine disruptors/hormones – 100 (4.1%)

– Examples: bromocriptine, estradiol, megestrol, tamoxifen

• Heart/blood pressure drugs – 71 (2.9%)

– Examples: amiodarone, propranolol

• Antiarthritic / antinflammatory drugs – 55 (2.9%)

– Examples: allopurinol, aspirin, ketoprofen

Non-regulated does not mean not harmful. In December 2008, The US EPA proposed to extend the 

universal waste rule to hazardous (RCRA regulated) pharmaceuticals “Amendment to the Universal 

Waste Rule: Addition of Pharmaceuticals” 73 FR 73519-73544 Dec 2, 2008. The EPA specifically 

encouraged (but did not mandate) healthcare facilities to manage all pharmaceutical wastes 

(hazardous and non-hazardous) as universal wastes under this new proposed rule. An area left

unresolved was the handling of RCRA regulated controlled substances. Neither RCRA nor the 

proposed rulemaking supersede the requirements of the Controlled Substances Act and DEA

regulations for the disposal of controlled substances. Thus, any entity generating, collecting, handling 

or managing a RCRA hazardous pharmaceutical waste that is also a controlled substance in 

Schedule II-V \43\ must abide by RCRA as well as the requirements of the Controlled Substances Act 

and DEA regulations. Three examples of listed hazardous wastes that are also controlled substances 

are phentermine (alpha, alpha-dimethyl- benzenethanamine, P046), chloral hydrate (U034), and 

paraldehyde (U182). 

Additional pharmaceuticals were listed by the US EPA to the Contaminant Candidate List 3 (CCL3) on 

September 22, 2009. These included 9 endocrine disruptors/hormones: 17 alpha estradiol, 17 beta

estradiol; 17 alpha ethynyl estradiol, estriol, estrone, mestranol, equilenin, equilin, 19 norethisterone, 

and 1 antibiotic: erythromycin. 

17
Slide 23 

Examples of Environmentally Harmful but Non-Regulated 

Drugs of Concern* Pharmaceutical PBT Risk of Pharmaceutical PBT Risk of 

(persistence, bioaccumulation, toxicity) Bioaccumulation (persistence, bioaccumulation, toxicity) Bioaccumulation

acitretin 9 N/A diazepam** 6 N/A

allopurinol 6 moderate docetaxel 9 cannot be excluded

amiodarone 9 N/A drospirenone 8 cannot be excluded

amoxicillin** 6 moderate dutasteride 8 cannot be excluded

atovaquone 9 N/A efavirenz 9 insignificant

beclomethasone 9 cannot be excluded escitalopram 9 insignificant

bromocriptine 9 N/A estradiol 9 high

budesonide 8 insignificant ethinyl estradiol 9 high

carvedilol 9 insignificant etonogestrel 8 insignificant

citalopram 9 insignificant felodipine 9 low

clemastine 9 N/A fentanyl** 7 N/A

clozapine 9 insignificant haloperidol 8 insignificant

cyproterone 8 cannot be excluded imipramine 9 N/A

dasatinib 9 insignificant isradipine 9 insignificant

desogestrel 8 insignificant ketoconazole 9 moderate

dextropropoxiphene 8 cannot be excluded ketotifen 9 N/A

dydrogesterone 8 cannot be excluded leflunomide 8 N/A

levofloxacin 8 insignificant megestrol 9 N/A

miconazole 9 N/A ofloxacin 9 insignificant

propofol 9 N/A propranolol 3 moderate

tamoxifen 9 N/A telithromycin 9 insignificant

*Those with a PBT (persistence, bioaccumulation and toxicity) score of 8/9 or 9/9 and/or a moderate or high risk (high 

production/use or high environmental measurement) as reported by “Environmental Classification of Pharmaceuticals

in www.fass.se”. **Included in list due to high production, usage and environmental release.

The table was abstracted from “Environmental Classification of Pharmaceuticals in www.fass.se”. 

Additional pharmaceuticals with lower PBT scores were included because of high production, usage 

and environmental release (e.g., amoxicillin, 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 Bioaccumulation was assessed as the drug concentration 

in the environment compared to the expected drug concentration based on drug production / usage 

(e.g. a drug with a moderate score would have a greater than expected environmental concentration 

as compared to a drug with an insignificant score which would have a lower than expected 

concentration in the environment). 

Antibiotic/antiviral drugs – 250 (10.3%): amoxicillin - PBT 6, moderate bioaccumulation; atovaquone – 

PBT 9, no data available for bioaccumulation; efavirenz - PBT 9, insignificant bioaccumulation; 

levofloxacin - PBT 8, insignificant bioaccumulation; miconazole – PBT 9, no data available for 

bioaccumulation; ketoconazole – PBT 9, moderate bioaccumulation; ofloxacin – PBT 9, insignificant

bioaccumulation; telithromycin – PBT 9, insignificant bioaccumulation. 

Antipsychotic/antidepressant drugs – 109 (4.5%): citalopram - PBT 9, insignificant bioaccumulation; 

clozapine - PBT 9, insignificant bioaccumulation; escitalopram - PBT 9, insignificant bioaccumulation;

haloperidol – PBT 8, insignificant bioaccumulation; imipramine – PBT 9, , no data available for 

bioaccumulation; 

Endocrine disruptors/hormones – 100 (4.1%): cyproterone - PBT 8, cannot be excluded from 

bioaccumulation; desogestrel - PBT 8, insignificant bioaccumulation; dydrogesterone - PBT 8, cannot 

be excluded from bioaccumulation; tamoxifen - PBT 9, no data available for bioaccumulation; 

drospirenone - PBT 8, cannot be excluded from bioaccumulation; dutasteride - PBT 8, cannot be 

excluded from bioaccumulation; estradiol – PBT 9, high bioaccumulation (CCL3 listed); ethinyl 

estradiol – PBT 9, high bioaccumulation (CCL3 listed); etonogestrel – PBT 8, insignificant 

bioaccumulation; megestrol – PBT 9, no data available for bioaccumulation; 

Heart/blood pressure drugs – 71 (2.9%): amiodarone - PBT 9, no data available for bioaccumulation; 

carvedilol- PBT 9, insignificant bioaccumulation; felodipine – PBT 9, low bioaccumulation; isradipine – 

PBT 9, insignificant bioaccumulation; propranolol – PBT 3, moderate bioaccumulation; 

18
Antiarthritic/antinflammatory drugs – 55 (2.9%): allopurinol – PBT 6, moderate bioaccumulation; 

leflunomide - PBT 8, no data available for bioaccumulation; beclomethasone – PBT 9, cannot be 

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

Slide 24 

AMC Pharmacy Reverse Distribution

• Vendor: Guaranteed Returns, Holbrook, NY

• Quarterly pickups.

• 539 items were returned (March 10, 2009) for a credit of 

$89,375.19

• 487 items were sent to vendor and not credited due to 

various reasons – charged $35,105.34

• 50 “Hazardous Materials” were returned for a credit of

$1,868.92

• 8 Controlled substances were returned for a credit of

$283.99

• Net credit to AMC $56,422.76 - March 10, 2009.

AMC Pharmacy Reverse Distribution 

Vendor: Guaranteed Returns, Holbrook, NY; Quarterly pickups. Representative data 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 frequently returned were flumazenil ( 9 items - $3,924); 

Abilify® - 8 items – $95.12; Coreg® tablets – 8 items - $1,293.89; Ceftin 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 returned for a credit of $1,868.92. These included insulin (21 returns – 

Humulin®, Novolin® - $1,583.79) ; epinephrine (8 returns - $50.10); influenza vaccine (2 returns - 

Fluarix® - $86.13) and one each physostigmine ($36.45), alcohol (98% - $81.25), nicotine 

transdermal ($25.99) and amyl nitrate ($5.21). 

8 Controlled substances were returned for a net credit of $283.99 

19
Slide 25 

What Have We Done?

• Received 2 year grant from US EPA for pharmaceutical waste 

pilot program at South Clinical Campus.

• Program implemented at SCC & extended to all offsite 

and practice sites.

• Collection of ALL pharmaceutical waste and on site 

sorting.

• AMC Pharmacy uses reverse distributor and take back of

unopened or outdated drugs.

• Participated in formation of a State program “Do Not Flush Your

Drugs”

• State Program expands to drug take back days in each region.

• Main campus pilot program implemented. 

• Authorized for 4 patient care areas. 

• Focused on controlled substances (narcotics) wasting.

• Culture change from bedside wasting into toilets and 

sinks by patient care staff.

What Have We Done? 

Received 2 year grant from US EPA for pharmaceutical waste pilot program at South Clinical 

Campus. 

Program implemented at SCC & extended to all offsite and practice sites. 

Collection of ALL pharmaceutical waste and on site sorting. 

AMC Pharmacy uses reverse distributor and take back of unopened or outdated drugs (NO WASTES 

ACCEPTED). 

Participated in formation (http://www.dec.ny.gov/press/45813.html) of a State program “Do Not Flush 

Your Drugs” http://www.dec.ny.gov/docs/administration_pdf/0409dontflush.pdf 

State Program expands to drug take back days in each region Statewide Household Pharmaceutical 

Collections -- October 19 -24, 2009 http://www.dec.ny.gov/chemical/45083.html 

AMC’s pilot project provided model for protection of New York City Watershed – Office of the NYC 

Watershed Inspector General. 

Main campus pilot program implemented. 

Authorized for 4 patient care areas. 

Focused on controlled substances (narcotics) wasting. 

Culture change from bedside wasting into toilets and sinks by patient care staff. 

20
Slide 26 

Results - AMC South Clinical Campus

• Project period runs May 9, 2008 – August 27, 2009 (475 days)

• 226 containers from 8 OR’s Post-Op; Pre-Op, MRI, Patient care floor and a Surgical practice site 

• 0.008 lbs/container/day

• Total weight 851.7 pounds

• 17.2 pounds (2.0%) RCRA

• 717.2 pounds (84%) Non-RCRA

• 191.4 pounds of propofol, the most common (27% - by weight 

includes container weight) non-RCRA medication.

• 662 sharps

• 760 antibiotics (30.1 pounds – 4.2%)

• 178 controlled substances (2.2 pounds – 0.3% )

• Costs per pound (RCRA contractor): 

– RCRA pharmaceutical waste $156 - $3.52; 

– RCRA chemotherapeutic waste $6.07; 

– Non-RCRA pharmaceutical waste for incineration only $4.37 – $2.23.

• Stericycle = $0.36/lb (Incinerate only).

• 113 hr for labor in waste sorting (2 persons )

Results – AMC South Clinical Campus 

From May 9, 2008 – August 27, 2009 (475 days) 226 containers were collected from 8 operating 

rooms (8,00 surgical cases per year), Post-Op; Pre-Op, Post Anesthesia Care Unit (PACU), Magnetic 

Resonance Imaging and Radiology, one patient care floor (20 beds – 23 hour stay) and a Surgical 

practice site. This averaged 0.008 lbs/container/day from a total weight collected of 851.7 pounds, 

only 17.2 pounds (2.0%) was RCRA regulated pharmaceutical waste. Non-RCRA pharmaceutical 

waste constituted 84% of the collected material or 717.2 pounds. Propofol, a non-narcotic lipid 

soluble anesthetic was the most common (27% - by weight includes container weight) non-RCRA

medication accounting for 191.4 pounds of drug waste. During the course of the pilot program 

propofol waste management was targeted for a process improvement and propofol waste declined 

from 43% of initial waste collections from the operating rooms to less than 20% by weight. Other nonRCRA drug wastes included 760 antibiotics (30.1 pounds – 4.2%) and 178 controlled substances (2.2 

pounds – 0.3% ). 

662 sharps including broken glass vials, uncapped needles with or without syringes and ampoules 

were removed during sorting and resulted in maldisposal reports to the Director of Patient Care 

Services. 

Costs per pound (RCRA contractor): RCRA pharmaceutical waste $156 - $3.52; RCRA

chemotherapeutic waste $6.07; Non-RCRA pharmaceutical waste for incineration only $4.37 – $2.23. 

Stericycle® provided disposal under contract for Non-RCRA pharmaceutical waste by incineration 

only at a cost of $19.00 for a 4.0 Cu.Ft. cardboard box (55 pounds Maximum weight). Labor for 

sorting required 113 hr for 2 persons. Refer to the sorting video for a more detailed review of the 

process of drug waste sorting. 

21
Slide 27 

Cumulative Top 80 Percent of Pharmaceutical Wastes

Albany Medical Center - South Clinical Campus

Graphical representation of cumulative “80/20” data from pharmaceutical wastes 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 the drug wastage. Forty-five percent of the drug waste collected was 

one drug - Propofol (Diprivan®) waste. This wastage 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 wastes were 

non-RCRA, non-controlled drugs used primarily in surgical procedures (anesthetics – lidocaine, 

bupivacaine, lidocaine/epinephrine; pressors – ephedrine; a neuromuscular blocker – succinylcholine; 

and a topical antimicrobial – benzoin swab sticks, 77% alcohol) 

Slide 28 

Typical drugs collected:

1. propofol

2. lidocaine

3. succinylcholine

4. bupivacaine

5. lidocaine/epinephrine

6. benzoin swabsticks 

(77% alcohol)-g

7. ephedrine

8. epinephrine

9. bupivacaine/epinephri

ne

10. atracurium

11. proparacaine

12. atropine

13. omnipaque

14. lidocaine/marcaine 

15. bacitracin-g

16. phenylephrine

17. dye

18. vancomycin-g

19. heparin

20. neostigmine

21. gadodiamide

22. lidocaine jelly

23. cefazolin 

24. diatrizoate meglumine

25. oxymetazoline

81%

95%

22
Listing of the top 25 (of 2,700 formulary drugs) wasted drugs from the South Clinical Campus from 

May, 2008 through August, 2009. Note that RCRA regulated drugs were a very minor component of 

the drug waste (epinephrine, dye, oxymetazoline – RCRA) and no controlled substances were among 

the top 25 (95% cumulative percent). 

Slide 29 

Drugs Disposed in Pharmaceutical Waste 

Containers (top 85%):

Cumulative data table for cumulative drug waste from May, 2008 through August, 2009. Cumulative 

totals based upon units (mL unless otherwise specified – e.g., benzoin swabsticks –grams not mL). 

Note of 50,150 units total waste collected only 854 mL of epinephrine was collected as waste. 

Slide 30 

Program Highlights

• SCC program operating 2 years.

– Good compliance 

– low maldisposal rate. 

– Developed educational materials. 

– Reduced opportunity for diversion

• Process Improvements & Cost Savings –

SCC

– Propofol wasting from surgery reduced.

– Est $100,000 in annual savings (8,000 surgical

case/yr)

• Offsite & Practices.

– Excellent compliance. 

– Minimal maldisposals. 

– Increased compliance

Highlights.

SCC program operating 2 years. 

23
Good compliance low maldisposal rate. Developed educational materials. Significantly 

reduced opportunity for diversion of controlled substances (narcotics – morphine, 

fentanyl, midazolam) 

Process Improvements & Cost Savings – SCC 

Propofol wasting from surgery reduced by changing sizes dispensed to 20cc only. 

Translates to $100,000 in annual savings based on 8,000 surgical case load. 

Offsite & Practices. 

Excellent compliance. Minimal maldisposals. Increased compliance with hazardous 

waste laws and regulations. 

Main campus pilot program. 

Bedside wasting of liquid formulations common. Over 1⁄2 of drugs such as levofloxacin 

(antibiotic) or acetaminophen with codeine elixer (narcotic) are wasted into toilets and 

sinks. Eighty four percent of drugs dispensed at AMC (main campus) have a 0% 

wasting and are predominantly solid dosage forms dispensed as unit doses. 

Slide 31 

Top 80% Pharmaceuticals Dispensed at AMC South 

Clinical Campus

August, 2008 – February, 2009

Graphical representation of cumulative dispensing data from PYXIS® automated dispensing 

machines at the AMC South Clinical Campus. Propofol, the most common waste, was also the most 

frequently dispensed medication. It however accounted for but 10.5% of the drugs dispensed as 

compared to 45% of the waste collected. Midazolam, a controlled drug, was next most frequently 

dispensed. Four controlled substances were among the 80% most dispensed drugs. Epinephrine 

and oxymetazoline were the only RCRA regulated (at that time) drugs which contributed to the top 

80%. 

24
Slide 32 

Cumulative 80% Pharmaceuticals Dispensed at AMC South 

Clinical Campus

August, 2008 – February, 2009

Cumulative dispensing data from PYXIS® automated dispensing machines at AMC South Clinical 

Campus collected from August, 2008 – February, 2009. All data were downloaded weekly, stripped of 

patient identifiers and summarized by drug using Microsoft Excel and Microsoft Access. Out refers to 

number of drug units dispensed from the PYXIS®. Ret refers to the number of drug units recorded as

returned to the PYXIS® machine. Wst refers to the number of drug units recorded as wasted in the 

PYXIS® records. Net refers to net drug units (out less returned and wasted). All units are the same 

for comparison and may be thought of as individual prescriptions. Of the 2,700 drugs in the AMC 

Formulary, 26 accounted for 80% of the drugs dispensed at the South Clinical Campus. As noted 

above, propofol was the most commonly dispensed medication. Five controlled substances ( 

midazolam, hydrocodone/apap, apap/codeine, fentanyl and morphine); four local anesthetics 

(lidocaine, bupivacaine, lidocaine/epinephrine, tetracaine), three anti-inflammatory drugs 

(dexamethasone, ondansetron, ketorolac); vasopressors; muscle relaxants; and antibiotics rounded

out the 26 dispensed medications 

25
Slide 33 

Pharmaceutical Waste as a Percentage of Drug Dispensed

Albany Medical Center - South Clinical Campus

May, 2008 - May, 2009

Graphical representation of drug wasting as a percentage of drug dispensed from PYXIS® automated 

dispensing machines. Great variability was noted in the percentage of wasting which averaged 

18.05%. Ninety four percent of all dyes (RCRA regulated) dispensed were collected in the 

pharmaceutical waste. Neostigmine (90.3%), edetate (69.9%), bupivacaine/epinephrine (68.1%) 

exceeded 60% wasting. Eleven drugs exceeded 50% wasting. Refer to next slide for details on 

individual drug wasting. 

Slide 34 

Collection of Dispensed Medications as Pharmaceutical Waste at 

South Clinical Campus We are collecting an average of 18% (range 0-1126%*) of the medications dispensed and not returned as pharmaceutical waste (not counting packaging) or bedside wasted.

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/bupivacaine, lidocaine/bupivacaine/hydase/, lidocaine/epinephrine/hydase, lidocaine/marcaine, and lidocaine/marcaine/hydase dispensed is thrown out

3⁄4 49.9% of acetaminophen/codeine dispensed is thrown out

3⁄4 40% of pilocarpine dispensed is thrown out

3⁄4 39% of phenylephrine dispensed is thrown out

3⁄4 36% of testosterone dispensed is thrown out

3⁄4 30% of neomycin/polymixin/bacitracin dispensed is thrown out

3⁄4 23% of proparacaine dispensed 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 dispensed 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 agents or drug combinations were found during waste sorting but not dispensed from PYXIS® machines.

*NB: because of

dilution and 

mixing, totals

recovered may 

exceed

amounts

dispensed

Drug wasting as a percentage of drug dispensed from PYXIS® automated dispensing machines. We

are collecting an average of 18% (range 0-1126%*) of the medications dispensed and not returned as 

pharmaceutical waste (not counting packaging) or bedside wasted.

26
3⁄491% of neostigmine dispensed is thrown out 

3⁄469% of bupivacaine/epinephrine dispensed is thrown out 

3⁄459% each of kanamycin, lidocaine/bupivacaine, lidocaine/bupivacaine/hydase/, 

lidocaine/epinephrine/hydase, lidocaine/marcaine, and lidocaine/marcaine/hydase dispensed is 

thrown out 

3⁄449.9% of acetaminophen/codeine dispensed is thrown out 

3⁄440% of pilocarpine dispensed is thrown out 

3⁄439% of phenylephrine dispensed is thrown out 

3⁄436% of testosterone dispensed is thrown out 

3⁄430% of neomycin/polymixin/bacitracin dispensed is thrown out 

3⁄423% of proparacaine dispensed is thrown out 

3⁄421% of succinylcholine dispensed is thrown out 

3⁄420% each of atropine and epinephrine dispensed is thrown out 

3⁄419% of atracurium dispensed is thrown out 

3⁄418% of etomadate dispensed is thrown out 

3⁄417% of propofol dispensed is thrown out 

3⁄416% of naloxone dispensed is thrown out 

3⁄415% of lidocaine dispensed is thrown out 

3⁄414% of albuterol dispensed is thrown out 

3⁄4From 1% to 10% of 35 drugs dispensed are thrown out 

3⁄4Less than 1% of 95 drugs dispensed are thrown out 

3⁄4Forty two drugs, radio-contrast agents or drug combinations were found during waste sorting but 

not dispensed from PYXIS® machines 

Slide 35 

Bedside "Wasting" of Controlled Substances as a Percentage of Drug 

Dispensed at Albany Medical Center - South Clinical Campus

May, 2008 - April, 2009

Graphical representation of controlled substance wasting as a percentage of drug dispensed from 

PYXIS® automated dispensing machines. Wasting averaged 7.8% and was primarily due to 

acetaminophen/codeine liquid. This drug is normally dispensed in 12.5 mL bottles and is seldom fully 

dispensed. Of the controlled substances dispensed from the AMC South Clinical Campus Formulary, 

only 7 drugs had any significant wasting. These were almost exclusively liquid formulations, few solid 

dosage forms (tablet, capsule) were found as waste or recorded as wasted in the PYXIS® records. 

Please refer to the following slide for more detailed description of controlled substance wasting. 

27
Slide 36 

Bedside Wasting vs Discarding of Controlled

Substances AMC-SCC data

An average of 7.8% (range 0 to 50%) of controlled substances dispensed from automated dispensing machines (PYXIS®) are bedside wasted. 

3⁄4 Acetaminophen and codeine dispensed as a liquid is most

frequently bedside wasted (50%).

3⁄4 34% of midazolam dispensed is bedside wasted.

3⁄4 31% of hydrocodone/acetaminophen tablets dispensed are bedside wasted.

3⁄4 18% of hydromorphone liquid dispensed is bedside wasted.

3⁄4 12% of acetaminophen and codeine tablets are bedside wasted.

3⁄4 2% of morphine is bedside wasted.

3⁄4 1% of hydrocodone/acetaminophen liquid dispensed is

bedside wasted.

3⁄4 12 controlled substances dispensed are not reported as bedside wasted.

An average of 7.8% (range 0 to 50%) of controlled substances dispensed from automated dispensing 

machines (PYXIS®) are bedside wasted. 

Acetaminophen and codeine dispensed as a liquid is most frequently bedside wasted (50%). 

34% of midazolam dispensed is bedside wasted. 

31% of hydrocodone/acetaminophen tablets dispensed are bedside wasted. 

18% of hydromorphone liquid dispensed is bedside wasted. 

12% of acetaminophen and codeine tablets are bedside wasted. 

2% of morphine is bedside wasted. 

1% of hydrocodone/acetaminophen liquid dispensed is bedside wasted. 

12 controlled substances dispensed are not reported as bedside wasted. 

Slide 37 

Process Improvement –

Propofol (Diprivan®)

Propofol is an injectable anesthetic agent used for outpatient 

or inpatient 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, 

bioaccumulation and toxicity (Environmentally classified

pharmaceuticals, http://ww.janusinfo.se). During waste

segregation, propofol was found to comprise 41% of the 

total waste generated from the operating rooms as each 

case required a new vial of propofol to be opened and all

propofol from the preceding case to be discarded. 

Solution: 50 and 100 mL vials of propofol were removed 

from AMC Pharmacy inventory. Propofol would only be 

available in the smallest size manufactured to reduce 

wastage.

28
Propofol is an injectable anesthetic agent used for outpatient or inpatient 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, bioaccumulation and toxicity (Environmentally classified 

pharmaceuticals, http://ww.janusinfo.se). During waste segregation, propofol was found to comprise 

41% of the total waste generated from the operating rooms as each case required a new vial of 

propofol to be opened and all propofol from the preceding case to be discarded. 

Solution: 50 and 100 mL vials of propofol were removed from AMC Pharmacy inventory. Propofol 

would only be available in the smallest size manufactured to reduce wastage. 

Slide 38 

Opportunity for Improvement

These data on wasting and disposed drugs as a proportion 

of pharmaceuticals dispensed at a small surgical hospital

are in line with publications from the literature. 

3⁄4 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 costs due to wasted drugs based on 2001 

drug costs. 

3⁄4 We have already seen a marked decrease in propofol

wastage caused by our removal of the larger (50 and 

100 cc) propofol vials. 

3⁄4 Processes to reduce lidocaine, succinylcholine and 

bupivacaine wastage will be designed and implemented.

These data on wasting and disposed drugs as a proportion of pharmaceuticals dispensed at a small 

surgical hospital are in line with publications 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 costs due to wasted drugs based on 

2001 drug costs. 

We have already seen a marked decrease in propofol wastage caused by our removal of the larger 

(50 and 100 cc) propofol vials. 

Processes to reduce lidocaine, succinylcholine and bupivacaine wastage will be designed and 

implemented. 

29
Slide 39 

Tours and Dissemination of

Knowledge Gained

• Seven, two-hour tours announced by

HANYS.

• Fifty-one participants registered. 

• Twenty-nine hospital, government, 

waste management and consulting 

organizations from Puerto Rico to

Canada.

• Survey forms collected from each tour 

group.

Seven, two-hour tours of SCC pharmaceutical waste operations announced by HANYS. 

Fifty-one participants registered: 26% safety or environmental services; 20% compliance; 19% 

administration; 13% clinician; 11% RPh; 4% scientist; and 7% other. 

Twenty-nine hospital, government, waste management and consulting Organizations from Puerto 

Rico to Canada: 62% hospitals; 21% government; 6% pharmacy and 12% other (waste management, 

services, journalism). 

Survey forms collected from each tour group. 

Slide 40 

Survey Results 

• Program highly rated - eighty-five percent

• Would recommend to peers - eighty-five percent

• Presentations were of a lot or a great deal of

help - eighty-three percent

• Educational materials useful - seventy-two

percent

• Tour an impetus for change at their institution - sixty-one percent

• Tours a lot or a great deal of assistance to

understanding the program - sixty percent

• Only 9% felt the tours were of some or no help in 

understanding the program.

Eighty-five percent of respondents rated the program highly overall.. 

30
Eighty-five percent of respondents would recommend the program to their peers. 

Eighty-three percent of respondents felt the presentations were of a lot or a great deal of help. 

Seventy-two percent of respondents felt the educational materials were very useful. 

Sixty-one percent of the respondents felt the tour was an impetus for change at their institution. 

Sixty percent of respondents felt the tours were of a lot or a great deal of assistance to understanding 

the program. 

Only 9% felt the tours were of some or no help in understanding the program 

Slide 41 

Model Education Plan

• Purpose: Find optimal education plan to support 

pharmaceutical waste management program

• Goal: Staff compliance with JCAHO and State and 

Federal pollution prevention standards

• Plan:

1. Audience: Nursing, PA’s, The Anesthesia Group, PC

2. Staff Meeting Presentations one month prior to Stage 2.

3. Poster development for medication rooms

4. Flyer development for mailbox distribution

5. Manager follow up to determine staff knowledge

6. Trainee feedback to refine training

7. Develop & Test training DVD

Purpose: Find optimal education plan to support pharmaceutical waste management program 

Goal: Staff compliance with JCAHO and State and Federal pollution prevention standards 

Plan: 

Audience: Nursing, PA’s, The Anesthesia Group, PC 

Staff Meeting Presentations one month prior to Stage 2. 

Poster development for medication rooms 

Flyer development for mailbox distribution 

Manager follow up to determine staff knowledge 

Trainee feedback to refine training 

Develop & Test training DVD 

31
Slide 42 

Model Education Plan (cont’d)

• Outcome: Managers and Directors hold 

staff accountable for incorporating change 

into practice.

• Metrics:

1. Post test – 80% minimum passing. 

Completion rates for each job title, 99%

target rate. New hires must receive training at

hire.

2. Random trainee follow-ups. Correct response

rates below 80% trigger retraining.

Outcome: Managers and Directors hold staff accountable for incorporating change into practice. 

Metrics: 

Post test – 80% minimum passing. Completion rates for each job title, 99% target rate. New hires 

must receive training at hire. 

Random trainee follow-ups. Correct response rates below 80% trigger retraining. 

Slide 43 

Education

Model education flyer developed by AMC Department of Nursing Education and Development for use 

in “Train the Trainer” sessions held before pilot project roll out. 

32
Slide 44 

Clinical Staff Handout (Cont’d)

Opportune timing due to widespread news reports of drinking water contamination by 

pharmaceuticals appearing in local news outlets. Flyer was distributed to all nursing and patient care 

staff on the South Clinical Campus prior to roll out of the pilot project. A laminated 11” x 14” color 

poster of the flyer was produced and placed near each pharmaceutical waste container and copies 

given to each nurse manager. 

Slide 45 

Flow chart laminated and placed near each blue pharmaceutical waste container. Other copies 

distributed to nursing staff and placed at PYXIS® machines. 

33
Slide 46 

Education Activities: • April 2, 2008: AMC Nursing education rounds for nursing units and radiology for SCC. 55 Staff trained. 20 posters and 65 handouts distributed.

• April 24 & 25, 2008: Presentations by AMC & Stericycle staff to 

Environmental Service & Clinical Staff . 4 presentations, 24 attendees.

• June 11, 2008. Announcement and summary of program by HANYS and availability of tours sent to all CEO’s and Compliance Officers of HANYS 

Member Hospitals.

• July 14, 2008. Stericycle resends the HANYS announcement to all 

Stericycle Healthcare customers.

• July 25, 2008 Resent HANYS announcement to pharmwaste listserv at

pharmwaste@lists.dep.state.fl.us

• July 25, August 1, August 22, September 26 and October 24. Tours of the 

South Clinical Campus and education sessions on pharmaceutical waste collections scheduled. July 25 – 8 (maximum) attendees. 

• Dr R. Mankes - NEWMOA presentation. USEPA Region 2 Headquarters, 

NY,NY May 7,2008.

• Dr R. Mankes – Roundtable participant, Commissioners’ Roundtable on Pharmaceutical Waste, NY DEC & NY DoH, NY DEC Headquarters, 

Albany, NY May 15, 2008.

April 2, 2008: AMC Nursing education rounds for nursing units and radiology for SCC. 55 Staff 

trained. 20 posters and 65 handouts distributed. 

April 24 & 25, 2008: Presentations by AMC & Stericycle staff to Environmental Service & Clinical Staff 

. 4 presentations, 24 attendees. 

June 11, 2008. Announcement and summary of program by HANYS and availability of tours sent to 

all CEO’s and Compliance Officers of HANYS Member Hospitals. 

July 14, 2008. Stericycle resends the HANYS announcement to all Stericycle Healthcare customers. 

July 25, 2008 Resent HANYS announcement to pharmwaste listserv at 

pharmwaste@lists.dep.state.fl.us 

July 25, August 1, August 22, September 26 and October 24. Tours of the South Clinical Campus and 

education sessions on pharmaceutical waste collections scheduled. July 25 – 8 (maximum) 

attendees. 

Dr R. Mankes - NEWMOA presentation. USEPA Region 2 Headquarters, NY,NY May 7,2008. 

Dr R. Mankes – Roundtable participant, Commissioners’ Roundtable on Pharmaceutical Waste, NY

DEC & NY DoH, NY DEC Headquarters, Albany, NY May 15, 2008. 

34
Slide 47 

Education assessment tours -

Pharmaceutical waste pilot program - SCC

• Methods: Clinical staff were interviewed relative to 

knowledge of the program, location & type of container, 

call numbers for container change out and needs of the 

clinical staff. Comments were solicited as to education 

effectiveness and suggestions for improvement. 

Presence of educational posters was verified and 

additional information was made available for 

distribution.

• Results: 19 of 19 staff surveyed correctly responded 

(100%). 14 of 14 (100%) clinical areas had 

pharmaceutical waste containers in use with posters & 

education materials. Staff questions involved controlled 

substance disposal and barium contrast agent.

Methods: Clinical staff were interviewed relative to knowledge of the program, location & type of 

container, call numbers for container change out and needs of the clinical staff. Comments were 

solicited as to education effectiveness and suggestions for improvement. Presence of educational 

posters was verified and additional information was made available for distribution. 

Results: 19 of 19 staff surveyed correctly responded (100%). 14 of 14 (100%) clinical areas had 

pharmaceutical waste containers in use with posters & education materials. Staff questions involved

controlled substance disposal and barium contrast agent. 

Slide 48 

Waste Accumulation

• Containers?

√ Size ?

√ Number ?

√ Location ?

√ Type ?

√ Liners ?

√ Liquids ?

√ Labeling & closures ?

√ Mounting? 4 gallon compatible

Waste container

2 gallon incompatible

Waste container

35
Examples of pharmaceutical waste containers. Blue 4 gallon container with flap closed top such that 

container is closed unless material is being added to container. Smaller 2 gallon incompatible 

container (one only located in Pharmacy for such waste as silver nitrate applicators). Issues to be 

determined:Size ? 

Number ? 

Location ? 

Type ? 

Liners ? 

Liquids ? 

Labeling & closures ? 

Mounting? 

Slide 49 

PHARMACEUTICAL WASTE 

PROGRAM LOCATIONS

LOCATION ROOM # CONTAINER COLOR

RADIOLOGY (CT SCAN) (SCC 125Q) BLUE

M.R.I. (SCC 148D) BLUE

O.R. ROOM # 1 (SCC 295) BLUE

O.R. ROOM # 2 (SCC 293) BLUE

O.R. ROOM # 3 (SCC 292) BLUE

O.R. ROOM # 4 (SCC 289) BLUE

O.R. ROOM # 5 (SCC 287) BLUE

O.R. ROOM # 6 (SCC 286) BLUE

O.R. ROOM # 7 (SCC 285) BLUE

O.R. ROOM # 8 (SCC 283) BLUE

PACU / RECOVERY (SCC 290) BLUE

PRE OP (SCC 294) BLUE

POST OP (SCC 242) BLUE

PHARMACY DISPENCING ROOM (SCC 243) BLACK**

ECMU (WEST HALL) MED ROOM (SCC 273) BLUE

** Only location for disposal of non-compatible RCRA pharmaceuticals (6 NDC’s

of 2,700 NDC’s in formulary)

Location of pharmaceutical waste containers. Note AMC South Clinical Campus has no Emergency 

Room so no containers placed for ER. 

Slide 50 

Waste Segregation

• No Sharps!

• No RMW !

• No Controlled

Substances!

• Chemo in

separate chemo

containers!

• No free liquids 

(Zip Lock 

baggies)!

36
Waste segregation flow chart for use by pharmacy / environmental health and safety staff members to 

separate RCRA from Non-RCRA wastes. For this pilot project we had 3 separate waste profiles: 2 

were RCRA (antineoplastics – U, P and D wastes; pharmaceuticals – D, U and P listed wastes) and 1 

was non-RCRA pharmaceuticals. These were separated by HAZWOPER trained staff and packaged 

for pick up. Because New York State retained epinephrine salts as a P listed waste until late 2009, 

Hazardous waste pickups 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 retain our 

Conditionally Exempt Small Quantity Generator (CESQG) status. 

Slide 51 

Waste Segregation

• Time consuming & Labor intensive – 2 staff 

members x 15 minutes / container.

• High level of training required to identify drugs.

• High level of security & regulatory approval for 

staff by New York State required as controlled

substances are commonly found in the 

pharmaceutical waste bins (despite the label no

controlled substances).

• Sharps maldisposals into pharmaceutical waste 

make waste sorting hazardous and PPE is 

required

Issues revealed during pilot study: 

For waste segregation it was time consuming and labor intensive requiring 2 highly trained staff 

members at 15 minutes for each container. A high level of training was required to identify drugs. Dr

R. Mankes, a pharmacologist and toxicologist with 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 chemical hazards. A high level of security and regulatory approval for staff by New 

York State was required as controlled substances are commonly found in the pharmaceutical waste 

bins (despite the label no controlled substances). This included swipe and PIN access to the waste 

storage area, unique locks for each pharmaceutical container, and prior regulatory approval (by the 

New York State Bureau of Narcotic Enforcement) of personnel involved in handling of drugs. Sharps

maldisposals into pharmaceutical waste make waste sorting hazardous and PPE is required. 

37
Slide 52 

Pharmaceutical Waste Compliance 

Service Overview • Objective: develop and implement a hospital-wide, regulatory-compliant, pharmaceutical waste management program in order to minimize environmental impact from improper handling and disposal of

pharmaceutical waste.

• Components:

• RX formulary waste characterization analysis 

• RX formulary DOT waste stream analysis

• Hospital pharmaceutical waste accumulation tracking

• Source and volume analysis of hospital pharmaceutical waste generation

• Waste sort on code functionality.

• Logistics modeling

• On-site RX waste segregation

• Pharmacy returns.

• Manifested waste pick-up, transport and disposal of hazardous and nonhazardous pharmaceutical waste

In our proposal we had designated that an outside contractor would provide pharmaceutical waste 

compliance services. These would include containers, supplemental training, waste pick up and 

disposal and formulary characterization. Facilities wishing to use an outside 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 hospital-wide, regulatory-compliant, pharmaceutical waste 

management program in order to minimize environmental impact from improper handling and 

disposal of pharmaceutical waste. 

Components: 

RX formulary waste characterization analysis 

RX formulary DOT waste stream analysis 

Hospital pharmaceutical waste accumulation tracking 

Source and volume analysis of hospital pharmaceutical waste generation 

Waste 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

• Security

• Waste pick ups from rooms

• Diagnostic Radiology – Barium Waste

• Mixed Wastes

• Controlled substance disposal, e.g., 

Chloral Hydrate & Paraldehyde RCRA & 

DEA Regulated, “wasting” of narcotics into 

toilet, sink. 

During the pilot we identified some problem areas 

Security – as mentioned earlier, a secure, limited access storage area was deemed essential, 

particularly when maldisposed controlled substances were segregated from the pharmaceutical waste 

containers. In our case, a swipe and PIN access controlled by AMC Security was added to the 

Hazardous Waste Storage Building on the South Clinical Campus (Refer to video of tours and 

sorting). Waste pickups from rooms were conducted on an as needed basis by the patient care staff 

calling a central number when the bins became 3⁄4 full. This however was supplemented by 

Biosystems staff who, during their rounds to change out reusable sharps containers, also changed 

out full pharmaceutical waste bins. Diagnostic Radiology – Barium Waste was initially thought to be a 

problem do to potential volumes of liquid waste generated. However, it was found that barium waste 

was not significantly generated at AMC’s South Clinical Campus due to the unit dosing of barium 

which is used in very limited cases at SCC (as compared to AMC’s main hospital). Mixed Wastes 

Controlled substance disposal, e.g., Chloral Hydrate & Paraldehyde RCRA & DEA Regulated, 

“wasting” of narcotics into toilet, sink. 

39
Slide 54 

Problem Areas (cont’d)

• State RCRA

• Nitroglycerin

• Epinephrine

• Alcohol swabs

• Container closure, Labeling and tracking?

• When do pharmaceutical waste containers 

have to be labeled hazardous waste? 90% 

of waste is non-regulated?

RCRA laws often vary by state and may significantly differ from US EPA regulations making 

compliance for healthcare difficult. Drugs which are regulated in one state may be unregulated by 

either the US EPA or another state. For example, up to July 15, epinephrine salts were RCRA

Regulated in New York State but not RCRA regulated by the US EPA, leading to the unique

dichotomy that epinephrine discarded by patient care staff at the Albany Veterans Administration 

Hospital (a federal facility located directly across the street from the Albany Medical Center) was not 

an acutely toxic P listed RCRA regulated waste. The same epinephrine, discarded by a staff member 

at Albany Medical Center would be treated as an acutely toxic P-listed RCRA regulated waste. 

Nitroglycerin is specifically listed as a RCRA waste but few healthcare workers are aware that unless 

the nitroglycerin is in a form which is reactive (D003) it is exempted from regulation. Alcohol swabs 

are considered ignitable (D001) wastes if they contain over 20% alcohol. How does a healthcare 

worker decide that a used alcohol skin swab contains 20% alcohol? Containers used for 

pharmaceutical wastes present additional issues. If they are not self closing, it is likely the container

will remain open even when materials are not being added to it in violation of RCRA regulations. 

Many pharmaceutical containers are single use and disposed with the waste. This adds weight and 

expense to the program as well as increasing plastic burning in the incinerators from the packaging. 

Obviously, a reusable container system with an inner plastic bag liner is preferable to the single use 

container system. If a facility uses a single container system, each container should be considered a 

satellite accumulation area and be labeled and managed accordingly. If a multiple container system is 

used wherein the patient care staff are charged with an initial waste sorting, only the container 

designated for RCRA pharmaceuticals need be considered a satellite accumulation area and be 

labeled and managed accordingly. 

40
Slide 55 

Pharmaceutical Waste 

Compliance Program – Graduated 

Roll Out to Main Hospital InPatient Nursing Units

June, 2009 Controlled Substances

August – September, 2009 noncontrolled drug waste

Slide 56 

Main Campus Pilot Program.

• Initiated June, 2009.

• Goal to develop a process for drug disposal that would 

prevent drugs from being introduced into the water system or disposed of in sharps containers on the main Albany Medical 

Center Hospital Campus.

• Four patient care areas involved: general medical-surgical 

(D2N); pediatrics (C7); orthopedics (C6) and apheresis (M3)

• Bedside wasting of liquid formulations common. 

• Over 1⁄2 of drugs such as levofloxacin (antibiotic) or acetaminophen with codeine elixir (narcotic) are wasted into 

toilets and sinks.

• Pilot implemented on 4 units, wasting of controlled substances into 3 gallon step cans with absorbent. Good compliance.

• Eighty four percent of drugs dispensed at AMC (main campus) have a 0% wasting and are predominantly solid

dosage forms dispensed as unit doses.

Main campus pilot program. 

Initiated June, 2009. Goal to develop a process for drug disposal that would prevent drugs from being 

introduced into the water system or disposed of in sharps containers. Four patient care areas 

involved: general medical-surgical (D2N); pediatrics (C7); orthopedics (C6) and apheresis (M3). The 

pilot started in June and was limited to bedside wasting of controlled substances. Each unit was 

provided with a 3 gallon step-on waste can and absorbent. The healthcare staff was instructed to 

waste controlled substances into the can, where the material would be absorbed and rendered nonrecoverable. The staff was trained by pharmacy and nursing staff. Over 1⁄2 of drugs such as 

levofloxacin (antibiotic) or acetaminophen with codeine elixir (narcotic) are wasted into toilets and 

41
sinks. Pilot implemented on 4 units, wasting into 3 gallon step cans with absorbent. Non-controlled 

Substance Disposal The units were provided with receptacles for disposal of drug waste in late 

August to early September. The staff was trained by pharmacy and nursing staff. The units are using 

the containers and are contacting the appropriate staff when pickups are needed. 

Eighty four percent of drugs dispensed at AMC (main campus) have a 0% wasting and are 

predominantly solid dosage forms dispensed as unit doses. Liquids squirted into drug containers 

making “Drug soup” Need for reeducation. 

Slide 57 

HOW DO I KNOW WHAT TO PUT 

WHERE?

Is it or did it contain an ANTINEOPLASTIC agent? 

 

 YES NO 

Is it empty or does it contain only a trace amount? Is it SHARP or potentially sharp (i.e. BROKEN GLASS)?

YES NO YES NO 

Discard in Record amt and Discard in SHARPS

 

d in INFECTIOUS

(red

 Has it become grossly 

CHEMO waste discard in bulk container contaminated with blood or 

 CHEMO waste body fluids or infectious materials? 

 YES NO 

 Discar Is it empty?

 waste bag). 

 YES NO

 Discard in TRASH Is it a controlled

container. substance? 

 EMPTY VIALS ARE CLEAR 

 BAG WASTE 

 YES NO

 Waste** Discard in labeled*

 Witness waste container.

 Discard in labeled*

 waste container.

EMPTY VIALS ARE CLEAR 

BAG WASTE 

** See box on left for wasting 

instructions 

**Wasting: (Bedside wasting of excess drug)

• Do NOT flush 

• Do NOT squirt into Sharps Container 

• Do NOT dispose in red bag or clear bag

trash.

• Do squirt excess liquid or place solid 

dosage forms into zipper bag containing

hand lotion.

• Do seal bag and place into labeled

pharmaceutical waste container.

• Do place empty container in trash.

• Do witness wasting (2 persons needed)

via automated dispensing cabinet or give

full signatures (NO INITIALS). * NB: labeled waste container = white bucket

labeled as pharmaceutical waste or blue

pharmaceutical waste container. Call x2-8700 

option #3 for labels and containers.

Slightly modified flow chart for the Main AMC campus 

Slide 58 

Satellite 

Accumulation 

• Colored Rx waste containers will be 

placed in the Patient-care areas

• Clinicians (nurses, physicians) will put 

pharmaceutical waste in the colored 

containers

• Clinicians will call the CALL Center 

(x2-4444) when a container is 3/4 full

Satellite Accumulation areas on the main campus 

Colored Rx waste containers will be placed in the Patient-care areas 

Clinicians (nurses, physicians) will put pharmaceutical waste in the colored containers 

Clinicians will call the Call Center (x2-4444) when a container is 3/4 full 

42
Slide 59 

Drugs Dispensed (top 80%) at Albany Medical 

Center Hospital April 2009

Graphical representation of the most dispensed drugs from PYXIS® automated dispensing machines 

on the AMC Main campus during April,2009. Compare this graph to the analogous data from South 

Clinical Campus (slide 30). 

Slide 60 

Cumulative 80% Pharmaceuticals Dispensed at Albany

Medical Center Hospital April, 2009

The top 80% of drugs dispensed from PYXIS® automated dispensing machines on the main AMC 

campus. Compare to slide 31 from the South Clinical Campus. The main 630 bed AMC campus 

dispenses far more controlled substances and pain relievers than the Acute Care (23 hour stay) 20 

bed South Clinical Campus. The top 6 drugs dispensed on AMC’s main campus (accounting for 37% 

of drugs dispensed) are controlled substances as compared to one controlled substance (midazolam) 

in the top 6 at the South Clinical Campus. Propofol, the most commonly dispensed (and wasted) drug 

at the South Clinical campus, contributes but 1.3% of all drugs dispensed on the main campus. 

43
Slide 61 

Satellite Accumulation

Containers

Compatible Rx Waste

(Blue container with a blue label)

Non-compatible Rx Waste

(Black container with a black label)

Not found on nursing units. May use in 

pharmacy.

Containers 

Reusable: 2 types 

Compatible Rx Waste 

(Blue container with a blue label)

Non-compatible Rx Waste 

(Black container with a black label) 

Not found on nursing units. May use in pharmacy. 

Slide 62 

Rx Waste 

Container & Label

COMPATIBLE

PHARMACEUTICAL WASTE (Hazardous Waste – Satellite Accumulation Container)

KEEP LID CLOSED

DO NOT REMOVE OR DISPENSE ITEMS 

FROM THIS CONTAINER 

NO SHARPS

(Use appropriate sharps container)

NO INFECTIOUS /BIOHAZARDOUS 

(No blood or body fluids)

NO CONTROLLED SUBSTANCES

(Witness waste per policy)

NO FREE LIQUIDS

(Use zip lock bag to contain liquid

before placing in container)

Photo of reusable compatible waste container (4 gallon) and label. 

Note label states “Hazardous Waste”, “Satellite Accumulation Container” 

Detailed warnings on label no sharps, no dispensing, no biohazards, no controlled substances, no 

free liquids

44
Slide 63 

Pharmaceutical Waste as a Percentage of Drug Dispensed

Albany Medical Center Hospital April, 2009

Graphical representation of pharmaceutical wasting as a percent of drug dispensed from PYXIS® 

automated dispensing machines on the AMC main campus in April, 2009, compare to slide 32. 

Slide 64 

Medications Recorded as Wasted from PYXIS® 

Records Albany Medical Center Hospital April, 2009

Only an average of 2% of 256 drugs dispensed at the Albany Medical Center

Hospital 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 substances, antibiotics, and antihistaminics / anti- inflammatory drugs.

Of the non-controlled drugs:

3⁄4 50% of levofloxacin liquid dispensed was wasted.

3⁄4 38% of promethazine liquid dispensed was wasted

3⁄4 29% of nalbuphine liquid dispensed was wasted

3⁄4 16% of vecuronium liquid dispensed was wasted.

3⁄4 14% of diphenhydramine liquid dispensed was wasted.

3⁄4 13% of dexamethasone liquid dispensed was wasted.

3⁄4 6% of haloperidol liquid dispensed was wasted.

3⁄4 4% of benztropine dispensed was wasted.

3⁄4 Five drugs (3 solid and 2 liquids) were 2% wasted.

3⁄4 Thirteen drugs (6 solid and 7 liquid) were 1% wasted.

3⁄4 Of 22,061.8 mL of propofol dispensed, only 98.2 mL were recorded as wasted.

3⁄4 Two hundred sixteen (84%) medications dispensed had 0% wasted. 

Medications Recorded as Wasted from PYXIS® Records Albany Medical Center Hospital April, 2009

Only an average of 2% of 256 drugs dispensed at the Albany Medical Center Hospital 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 substances, antibiotics, and antihistaminics / antiinflammatory drugs. 

Of the non-controlled drugs: 

45
50% of levofloxacin liquid dispensed was wasted. 

38% of promethazine liquid dispensed was wasted 

29% of nalbuphine liquid dispensed was wasted 

16% of vecuronium liquid dispensed was wasted. 

14% of diphenhydramine liquid dispensed was wasted. 

13% of dexamethasone liquid dispensed was wasted. 

6% of haloperidol liquid dispensed was wasted. 

4% of benztropine dispensed 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 were recorded as wasted. 

Two hundred sixteen (84%) medications dispensed had 0% wasted. 

Slide 65 

Controlled 

Substances

According to NYS Section 80.51 of the Rules and

Regulations of Controlled Substances:

To discard a controlled substance means to “render it 

totally unrecoverable and beyond reclamation.”

Traditionally, this has been to flush it or pour it down

the sink.

Today, in the interest of preserving the environment

this is no longer acceptable. Alternative methods 

need to be utilized.

Controlled Substances 

According to NYS Section 80.51 of the Rules and Regulations of Controlled Substances: 

To discard a controlled substance means to “render it totally unrecoverable and beyond reclamation.” 

Traditionally, this has been to flush it or pour it down the sink. 

Today, in the interest of preserving the environment this is no longer acceptable. Alternative methods 

need to be utilized.

46
Slide 66 

Waste vs. Destruction

'Wasting' - for single-unit doses or partial doses remaining after

the administration or attempted administration of a 

portion of liquid or solid unit dose of a controlled 

substance.

- done immediately after the administration or 

attempted administration;

- destroyed on premise of an institutional dispenser by

a pharmacist or nurse;

- destruction witnessed by a second pharmacist, 

nurse or other responsible person designated by the 

administrator; and

- the controlled substance is rendered totally

unrecoverable and beyond reclamation.

NYS Section 80.51 of the Rules and Regulations of Controlled Substances

'Wasting' - for single-unit doses or partial doses remaining after the administration or attempted 

administration of a portion of liquid or solid unit dose of a controlled substance. 

done immediately after the administration or attempted administration; 

destroyed on premise of an institutional dispenser by a pharmacist or nurse; 

destruction witnessed by a second pharmacist, nurse or other responsible person designated by the 

administrator; and 

the controlled substance is rendered totally unrecoverable and beyond reclamation. 

Slide 67 

'Destruction' - for controlled substances that are undesired,

deteriorated, obsolete or for any reason no longer

needed. 

Options for destruction include the five following mechanisms:

1. Return to the licensed manufacturer/distributor from whom

controlled substance was procured;

2. Surrender to a 'Reverse Distributor' licensed 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 substance is rendered totally unrecoverable 

and beyond reclamation.

NYS Section 80.51 of the Rules and Regulations of Controlled Substances

Waste vs. Destruction

'Destruction' - for controlled substances that are undesired, deteriorated, obsolete or for any reason 

no longer needed. 

47
Options for destruction include the five following mechanisms: 

1. Return to the licensed manufacturer/distributor from whom controlled substance was procured; 

2. Surrender to a 'Reverse Distributor' licensed 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 substance is rendered totally unrecoverable and beyond reclamation. 

Slide 68 

Controlled Substance Wasting

Equipment:

Step can will be labeled

CONTROLLED SUBSTANCES

ONLY

Dawg® - absorbent solid

Illustration of bedside wasting equipment to be used during AMC pilot 

Slide 69 

Controlled Substance Wasting

• Must be done at point of care

• Must be witnessed

• Must be discarded in appropriately labeled pharmaceutical

waste container

4oral liquid medications may be poured directly into can

4injectable liquid medications may be squirted directly

into can

4oral solid medications should be crushed, mixed with 

some water and poured into can

4fentanyl patches must be discarded in red sharps 

container as per NYS DOH guidance letter (10/4/01)

48
Controlled Substance Wasting 

Must be done at point of care 

Must be witnessed 

Must be discarded in appropriately labeled pharmaceutical waste container 

1. oral liquid medications may be poured directly into can 

2. injectable liquid medications may be squirted directly into can 

3. oral solid medications should be crushed, mixed with some water and poured into can 

4. fentanyl patches must be discarded in red sharps container as per NYS DOH guidance letter 

(10/4/01) 

Slide 70 

Bedside "Wasting" of Controlled Drugs as a Percentage of Drug Dispensed at 

Albany Medical Center Hospital April, 2009

Graphical representation of bedside wasting of controlled substances as recorded in PYXIS® 

automated dispensing machines from the Albany Medical Center main campus during April, 2009. 

Slide 71 

49
Controlled Substances Recorded as Wasted from

PYXIS® Records 

Albany Medical Center Hospital April, 2009

Controlled substances in liquid form were commonly recorded as wasted in the PYXIS® records of the Albany Medical Center Hospital in April of 2009, averaging 7% of 46 controlled

substances dispensed. Of these, over one half (27) had 0% wasting.

• 52% of acetaminophen/codeine liquid dispensed was wasted.

• 48% of phenobarbital liquid dispensed was wasted.

• 38% of lorazepam liquid dispensed was wasted.

• 31% of hydromorphone liquid dispensed was wasted.

• 26% of meperidine liquid dispensed was wasted.

• 23% of midazolam liquid dispensed was wasted.

• 17% of fentanyl liquid dispensed was wasted.

• 9% of morphine liquid dispensed was wasted.

• 8 controlled substances dispensed in tablet or dry form ranged

from 1% to 4% wasting.

Controlled Substances Recorded as Wasted from PYXIS® Records Albany Medical Center Hospital 

April, 2009 

Controlled substances in liquid form were commonly recorded as wasted in the PYXIS® records of 

the Albany Medical Center Hospital in April of 2009, averaging 7% of 46 controlled substances 

dispensed. Of these, over one half (27) had 0% wasting. 

52% of acetaminophen/codeine liquid dispensed was wasted. 

48% of phenobarbital liquid dispensed was wasted. 

38% of lorazepam liquid dispensed was wasted. 

31% of hydromorphone liquid dispensed was wasted. 

26% of meperidine liquid dispensed was wasted. 

23% of midazolam liquid dispensed was wasted. 

17% of fentanyl liquid dispensed was wasted. 

9% of morphine liquid dispensed was wasted. 

8 controlled substances dispensed in tablet or dry form ranged from 1% to 4% wasting. 

Slide 72 

Bullet Points – Controlled 

Substances • Fentanyl patches must be wasted into SHARPS 

containers

• All controlled substance medication should be removed 

from its original containers and discarded in labeled

controlled substance pharmaceutical waste containers

• All empty containers which previously contained 

controlled substances should be disposed of in regular 

trash.

• Wasting documentation in PYXIS® remains unchanged

and should be done in conjunction with these 

procedures

50
Slide 73 

Bullet Points

• When in doubt, refer to FLOW CHART

• All unopened, unused medications (including

controlled substances) should be returned to

pharmacy

• All empty tubing, syringes, etc should be

disposed of in regular trash.

• All medication vials containing partial amounts 

of medication (except controlled substances) 

should be discarded in labeled pharmaceutical 

waste containers (currently BLUE).

Slide 74 

HOW DO I KNOW WHAT TO PUT 

WHERE?

Is it or did it contain an ANTINEOPLASTIC agent? 

 

 YES NO 

Is it empty or does it contain only a trace amount? Is it SHARP or potentially sharp (i.e. BROKEN GLASS)?

YES NO YES NO 

Discard in Record amt and Discard in SHARPS

 

d in INFECTIOUS

(red

 Has it become grossly 

CHEMO waste discard in bulk container contaminated with blood or 

 CHEMO waste body fluids or infectious materials? 

 YES NO 

 Discar Is it empty?

 waste bag). 

 YES NO

 Discard in TRASH Is it a controlled

container. substance? 

 EMPTY VIALS ARE CLEAR 

 BAG WASTE 

 YES NO

 Waste** Discard in labeled*

 Witness waste container.

 Discard in labeled*

 waste container.

EMPTY VIALS ARE CLEAR 

BAG WASTE 

** See box on left for wasting 

instructions 

**Wasting: (Bedside wasting of excess drug)

• Do NOT flush 

• Do NOT squirt into Sharps Container 

• Do NOT dispose in red bag or clear bag

trash.

• Do squirt excess liquid or place solid 

dosage forms into zipper bag containing

hand lotion.

• Do seal bag and place into labeled

pharmaceutical waste container.

• Do place empty container in trash.

• Do witness wasting (2 persons needed)

via automated dispensing cabinet or give

full signatures (NO INITIALS). * NB: labeled waste container = white bucket

labeled as pharmaceutical waste or blue

pharmaceutical waste container. Call x2-8700 

option #3 for labels and containers.

51
Educational Tour of Albany Medical Center’s South Clinical 

Campus. 

Pharmaceutical Waste Collection 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 discussing 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 discussing 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) demonstrates 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 – propofol 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 Albany 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.