Presentation is loading. Please wait.

Presentation is loading. Please wait.

Pharmaceutical Waste Management Leslie Durrant, R.Ph., BCPS, and Nancy Dietz, R.Ph., Ph.D. Harry S. Truman Memorial Veterans Hospital Columbia, Missouri.

Similar presentations


Presentation on theme: "Pharmaceutical Waste Management Leslie Durrant, R.Ph., BCPS, and Nancy Dietz, R.Ph., Ph.D. Harry S. Truman Memorial Veterans Hospital Columbia, Missouri."— Presentation transcript:

1 Pharmaceutical Waste Management Leslie Durrant, R.Ph., BCPS, and Nancy Dietz, R.Ph., Ph.D. Harry S. Truman Memorial Veterans Hospital Columbia, Missouri

2 Harry S Truman Memorial VA Hospital Columbia, Mo. 100 Inpatient beds, 30,000 veterans 100 Inpatient beds, 30,000 veterans

3 What is a hazardous drug? ASHP 2004 TAB criteria for considering a drug hazardous (adopted by OSHA): ASHP 2004 TAB criteria for considering a drug hazardous (adopted by OSHA): 1. Carcinogenicity 2. Teratogenicity 3. Fertility impairment 4. Serious organ toxicity at low doses 5. Genotoxicity NIOSH criteria: 2004: ASHPs criteria plus Structure and toxicity profile of new drugs that mimic existing drugs determined hazardous by above criteria.

4 NIOSH Now updating their list of hazardous drugs. 59 proposed additions. Now updating their list of hazardous drugs. 59 proposed additions. Update is controversial: some proposed drugs are toxic only after prolonged oral usage such as divalproex, aripiprazole, amiodarone. Update is controversial: some proposed drugs are toxic only after prolonged oral usage such as divalproex, aripiprazole, amiodarone. ASHP proposes further study on 40% of the proposed drugs before recommending handling as hazardous drugs. ASHP proposes further study on 40% of the proposed drugs before recommending handling as hazardous drugs.

5 Hazardous Drugs: Each facility should create its own list of hazardous drugs based upon criteria. NIOSH list may be useful in establishing a hospital list. MSDS, literature very helpful. Each facility should create its own list of hazardous drugs based upon criteria. NIOSH list may be useful in establishing a hospital list. MSDS, literature very helpful.

6 Hazardous pharmaceutical Waste Hazardous pharmaceutical waste is NOT synonymous with hazardous pharmaceuticals. Hazardous pharmaceutical waste is NOT synonymous with hazardous pharmaceuticals. Some drugs not considered hazardous drugs by NIOSH,OSHA and NIH are still regulated as hazardous waste by EPA- RCRA. Some drugs not considered hazardous drugs by NIOSH,OSHA and NIH are still regulated as hazardous waste by EPA- RCRA. Some drugs not considered hazardous waste under RCRA are probable environmental hazards (some chemo). Some drugs not considered hazardous waste under RCRA are probable environmental hazards (some chemo).

7 Pharmaceutical Waste: Two main types of pharmaceutical waste: hazardous and non- hazardous. Two main types of pharmaceutical waste: hazardous and non- hazardous. Hazardous waste as defined by EPA RCRA is waste with properties making it dangerous or potentially harmful to human health or the environment, and includes chemicals and drugs. Hazardous waste as defined by EPA RCRA is waste with properties making it dangerous or potentially harmful to human health or the environment, and includes chemicals and drugs.

8 Hazardous Pharmaceutical Waste under RCRA: Two primary ways drug waste is hazardous waste under RCRA: It contains a P or U listed waste as the sole active ingredient It contains a P or U listed waste as the sole active ingredient OR OR It exhibits at least one Characteristic of a hazardous waste. It exhibits at least one Characteristic of a hazardous waste.

9 Hazardous Pharmaceutical Waste under RCRA: In addition to exhibiting a characteristic or Listing as a P, or U, listed waste, three more requirements: It has not been excluded by federal or state law, and It has not been excluded by federal or state law, and It has not been used for its intended purpose, and It has not been used for its intended purpose, and The decision has been made to discard it. The decision has been made to discard it.

10 EPA - RCRA Listings RCRA, P, U, lists originally developed for discarded commercial chemical products. RCRA, P, U, lists originally developed for discarded commercial chemical products. Listings only apply to pharmaceuticals that contain the listed drug as the sole active ingredient. E.g. – pharmaceuticals flavored by saccharin with other ingredients added would NOT be considered hazardous waste under RCRA. Listings only apply to pharmaceuticals that contain the listed drug as the sole active ingredient. E.g. – pharmaceuticals flavored by saccharin with other ingredients added would NOT be considered hazardous waste under RCRA.

11 P list – Acutely Hazardous NAME EPA HAZ WASTE # Arsenic trioxide P012 Epinephrine*P042 NicotineP075 Nitroglycerin * P081 PhentermineP046 PhysostigmineP204 Physostigmine salicylate P188 Warfarin >0.3% * P001

12 P Listed waste generation: Large qty generator: produces more than 1 Kg (2.2 lbs) per calendar month. Large qty generator: produces more than 1 Kg (2.2 lbs) per calendar month. Small qty generator: < 1 Kg/month. Small qty generator: < 1 Kg/month. Conditionally exempt small quantity. Conditionally exempt small quantity. Most hospitals fall into small or large quantity generator category. Most hospitals fall into small or large quantity generator category.

13 To reduce P waste generation: Practice waste minimization: Minimize inventory, just in time ordering. Practice waste minimization: Minimize inventory, just in time ordering. Purchase unit dose whenever possible on P listed items. Purchase unit dose whenever possible on P listed items. Repackage minimal amounts at a time. Repackage minimal amounts at a time. Encourage patient to take home appropriately Rx labeled partial bulk containers. Encourage patient to take home appropriately Rx labeled partial bulk containers.

14 Nitroglycerin:

15 Nitroglycerin Nitroglycerin in finished dosage forms is exempt by EPA/RCRA (2001). Nitroglycerin in finished dosage forms is exempt by EPA/RCRA (2001). Some states have adopted this exemption, including Missouri, Iowa, and Alaska. Some states have adopted this exemption, including Missouri, Iowa, and Alaska. Some states, such as Michigan, have chosen not to adopt. Check with your state. Some states, such as Michigan, have chosen not to adopt. Check with your state.

16 Epinephrine

17 Epinephrine in syringes: Missouri DNR Hazardous Waste Program: epinephrine in a discarded syringe is not a P listed waste. Missouri DNR Hazardous Waste Program: epinephrine in a discarded syringe is not a P listed waste. Rationale: once the syringe has been used for patient care, it has been used for its intended purpose. Rationale: once the syringe has been used for patient care, it has been used for its intended purpose. Applies to partially used epinephrine IV admixtures, also per Mo DNR. Applies to partially used epinephrine IV admixtures, also per Mo DNR. RCRA: applies to any P or U listed drug in a syringe as waste, after patient use. RCRA: applies to any P or U listed drug in a syringe as waste, after patient use.

18 Epinephrine in syringes: Epinephine syringes after emergency use (e.g. Code Blue): discard in sharps container. Epinephine syringes after emergency use (e.g. Code Blue): discard in sharps container. EXPIRED unused epinephrine STILL considered P listed waste. EXPIRED unused epinephrine STILL considered P listed waste.

19 Warfarin:

20 Warfarin: If present in dosage forms over 0.3%, the whole preparation is a P listed pharmaceutical waste when decision is made to waste. If present in dosage forms over 0.3%, the whole preparation is a P listed pharmaceutical waste when decision is made to waste. Tablet weighings demonstrated that all of the common tablet strengths are >0.3% warfarin, and therefore P waste when discarded. Tablet weighings demonstrated that all of the common tablet strengths are >0.3% warfarin, and therefore P waste when discarded. 5mg/210mg (tablet weight) = 2.4% 5mg/210mg (tablet weight) = 2.4%

21 Nicotine:

22 Nicotine: Patch dosage forms: after patient use, consider used? Or unused? Patch dosage forms: after patient use, consider used? Or unused? Expired unused may be returned to reverse distributor for credit. Expired unused may be returned to reverse distributor for credit. Patient home disposal not regulated by RCRA. Patient home disposal not regulated by RCRA.

23 U List – Toxic Wastes NAME#NAME# ChlorambucilU035HexachloropheneU132 CyclophosphamideU058PhenacetinU187 DaunomycinU059ReserpineU200 MelphalanU150ResorcinolU201 Mitomycin C U010SaccharinU202 StreptozocinU206 Selenium sulfide U205 Uracil Mustard U237 Warfarin <0.3% U248 DiethylstilbestrolU089

24 D list: Characteristic waste Waste exhibits one of 4 characteristics of hazardous wastes: Waste exhibits one of 4 characteristics of hazardous wastes: 1. ignitability – 2. corrosivity – 3. reactivity - 4. toxicity – if concentration of chemical above regulatory level in mg/L.

25 Characteristic Waste: The generator (the hospital) is responsible for deciding if a drug product that is being discarded exhibits a characteristic. The generator (the hospital) is responsible for deciding if a drug product that is being discarded exhibits a characteristic. Decision is based upon testing or knowledge of the drug product properties. Decision is based upon testing or knowledge of the drug product properties. MSDS, pharmacy references and literature can help determine this. MSDS, pharmacy references and literature can help determine this.

26 Characteristic waste: Toxicity NAME EPA # REG.LEVEL ArsenicD004 5 mg/L BariumD mg/L CadmiumD006 1 mg/L ChloroformD022 6 mg/L M-CresolD mg/L LindaneD mg/L MercuryD mg/L SilverD011 5 mg/L

27 Toxicity characteristic Mercury: most vaccines reformulated and now preservative free. Mercury: most vaccines reformulated and now preservative free. Silver: present in silver sulfadiazine cream, silver nitrate sticks. Silver: present in silver sulfadiazine cream, silver nitrate sticks. Barium: in contrast media. Radiology is a satellite accumulation point. Barium: in contrast media. Radiology is a satellite accumulation point.

28 Chemotherapy Only seven chemotherapy drugs on the U list. However, RCRA was enacted in 1976 and the list has not been updated since then. Only seven chemotherapy drugs on the U list. However, RCRA was enacted in 1976 and the list has not been updated since then. Most hospital consider all cytotoxic chemotherapy to be hazardous waste, including our VA hospital. Most hospital consider all cytotoxic chemotherapy to be hazardous waste, including our VA hospital.

29 Putting it all together: Receipt into pharmacy: As the medication order received is sorted, medications that could become hazardous wastes are placed into specially labeled bins: Receipt into pharmacy: As the medication order received is sorted, medications that could become hazardous wastes are placed into specially labeled bins:

30 Repackaging: As drugs that could become hazardous waste are repackaged, a code is included on the label for Nursing notification: HW-P list As drugs that could become hazardous waste are repackaged, a code is included on the label for Nursing notification: HW-P list

31 Re-packaged drug: HW-P List: text chosen to alert Nurse, but not alarm Veteran: HW-P List: text chosen to alert Nurse, but not alarm Veteran:

32 Dispensing: Before dispensing, a drug that could become hazardous waste Has the code included on the barcode label:

33 Patient discharge: Partial bulk medication that could become hazardous waste, if prescribed at discharge, is re-labeled and given to the patient during discharge counseling by the Pharmacist. Partial bulk medication that could become hazardous waste, if prescribed at discharge, is re-labeled and given to the patient during discharge counseling by the Pharmacist.

34 Reverse Distributors Receive outdated drugs (products) from pharmacies and ship to manufacturer for credit. Receive outdated drugs (products) from pharmacies and ship to manufacturer for credit. Outdates not meeting manufacturers policy become waste once the RD makes the decision to discard. Outdates not meeting manufacturers policy become waste once the RD makes the decision to discard. EPA supports this practice as long as it is not the sole waste management practice. EPA supports this practice as long as it is not the sole waste management practice.

35 Disposal: P,U, or D listed items Drug with P,U Or D Listed ingredient Bulk: at discharge If ordered, Give to pt. Expired unused: Reverse Distributor for credit Not suitable For R.D.: P,U, Or D bucket

36 P Bucket: Satellite accumulation

37 P,U, and D buckets: Satellite accumulation Point Pharmacy satellite accumulation point: Pharmacy satellite accumulation point:

38 Satellite accumulation: List of all contents with dates required:

39 Satellite Accumulation: Satellite storage up to 1 year before sending to facility hazardous waste storage area, unless > 1 quart of P listed or 55 gallons of hazardous waste. Satellite storage up to 1 year before sending to facility hazardous waste storage area, unless > 1 quart of P listed or 55 gallons of hazardous waste. Industrial Hygienist utilizes licensed hazardous waste contractor to pick up from facility hazardous waste area. Industrial Hygienist utilizes licensed hazardous waste contractor to pick up from facility hazardous waste area.

40 Disposal: Chemotherapy Chemo U listed OR cytotoxic chemo: Bulk: (>3%), hazardous Waste BULK yellow Chemo bucket Trace:(<3%): Empty vials, Syringes, gowns, Yellow chemo bucket Chemo sharps: Needles: Yellow chemo bucket

41 Trace Chemo:

42 Bulk Chemo: Contains: expired and partially used vials, IV bags. Contains: expired and partially used vials, IV bags. Grossly contaminated items Grossly contaminated items Spill clean up material Spill clean up material Must label bucket as Chemotherapy AND Hazardous waste. Must include names of EACH drug within, and date 1 st waste placed. Keep closed! Must label bucket as Chemotherapy AND Hazardous waste. Must include names of EACH drug within, and date 1 st waste placed. Keep closed!

43 Disposal: non hazardous pharmaceuticals: Non-chemo Non-cytotoxic non-RCRA: Expired: Reverse distributor plain IVS: (NS,D5W,LR) Sink disposal Controlled Substances: RD licensed For controlled substances

44 Take home points: Know P, U, and D toxicity lists. Know P, U, and D toxicity lists. Know State law. Know State law. Label all P, U, and D drugs as HW all through chain from receipt to final dispensing or segregation for pickup. Label all P, U, and D drugs as HW all through chain from receipt to final dispensing or segregation for pickup. Implement safe handling practices and policies for hazardous drugs. Implement safe handling practices and policies for hazardous drugs. Questions? Questions?


Download ppt "Pharmaceutical Waste Management Leslie Durrant, R.Ph., BCPS, and Nancy Dietz, R.Ph., Ph.D. Harry S. Truman Memorial Veterans Hospital Columbia, Missouri."

Similar presentations


Ads by Google