Training Hospital Waste Officer

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Correspondence – course III:

Training Hospital Waste Officer

Pharmaceutical Waste

Changsha, P.R. China

Autumn 2002

With compliments:

ETLog EnviroTech & Logistics GmbH

Brunnenstraße 164

10119 Berlin, Germany

Tel.: +49 / 30 / 443187-30

Fax: +49 / 30 / 443187-49

E-mail:

Info@etlog.com

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Internet: www.etlog.com

Table of contents

1

Introduction ...3

2

General information pharmaceutical waste...3

2.1

What means “pharmaceutical waste”... 3

2.2

Amounts of generated “pharmaceutical waste”... 4

2.3

Characterization of “pharmaceutical waste”... 4

2.3.1 Non-hazardous pharmaceutical waste:... 4

2.3.2 Hazardous pharmaceutical waste:... 5

2.3.3 Controlled drug waste:... 5

3

Management of pharmaceutical waste ...6

3.1

Internal Disposal Logistics ... 6

3.1.1 Collection and transport:... 6

3.1.2 Central segregation:... 6

3.1.3 Transportation and storage:... 7

3.2

Observing the precaution during the segregation: ... 7

4

Disposal of pharmaceutical waste ...8

4.1

Disposal of non-hazardous, liquid waste... 8

4.2

Disposal of non-hazardous, solid waste... 8

4.3

Disposal of hazardous, solid and liquid waste ... 8

4.4

Description of disposal methods ... 9

4.4.1 Encapsulation (according to WHO standards):... 9

4.4.2 Inertization (according to WHO standards):... 9

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1 Introduction

As the other sectors of a hospital, also the pharmacy is generating healthcare waste. Next to the domestic (household like) waste, the pharmacy is generating naturally the sub-group “pharmaceutical waste” and is the main generator of this kind of waste. In general, most pharmaceutical waste is not hazardous and does not represent a serious threat to the public health or the environment. As example, according to the European Waste Catalogue, this kind of waste is not classified as “hazardous substance”. However, pharmaceutical waste may contain hazardous substances like non-biodegradable antibiotics, antineoplastics, disinfectants, etc. which are harmful for the environment or the public health. Also certain risks of the misuse of disposed of drugs by scavengers and kids are existent, especially if pharmaceutical waste is disposed of in unprotected insecure landfills. To prevent this kind of risk, pharmaceutical waste must be sorted and disposed in an efficient and secured way. As the so called “cytotoxic” waste (antineoplastics drugs) due to their special risks often form an own waste group in several regulations and definitions, this sub-group of pharmaceutical waste shall be excluded. In a separate hand-out, detailed information about this kind of waste will be supplied.

2 General information pharmaceutical waste

2.1 What is “pharmaceutical waste”

pharmaceutical waste is the group of waste, produced during the production, distribution and application of pharmaceuticals. It includes the necessary transportation packaging as well as expired products. Typical samples of pharmaceutical waste are:

• Expired, damaged or unused drugs

• Vaccines and sera not kept cold and by this unusable

• Chemical products and solutions used to make preparations or to analyse them

• Packaging like blisters, boxes, etc. • Alcohols, disinfectants and other liquids • Spilled contaminated pharmaceutical products

• Discarded items used in handling pharmaceuticals such as bottles, tubes , syringes, boxes, vials, gloves, compresses, masks, clothes

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2.2 Amounts of generated “pharmaceutical waste”

The amount of produced pharmaceutical waste is difficult to calculate and will depend, next to the size of the hospital, on the kind of service provided in the healthcare institution and mainly on the management of pharmaceutical products as well as on the established waste management for pharmaceutical waste. To make it even more complicated, largest part of pharmaceutical waste is not generated by hospitals but by pharmacies and the manufacturers of pharmaceutical. However, this course will concentrate on pharmaceutical waste, generated by hospitals.

As example, a research in the University Hospital Freiburg (about 1.700 beds) in Germany showed, that per year 0,5 tons of to be disposed of pharmaceuticals (without packaging, spillages, etc.) are produced (worth of the pharmaceuticals: about 400.000 US$).

Especially care must be taken during times of vaccination campaigns, natural disasters or times of conflict. As example, after the war in Bosnia and Herzegovina (former Yugoslavia), large amounts of pharmaceuticals had been donated. Due to mismanagement (expired, unusable, wrong donation, etc.), about 2,000 metric tons of pharmaceutical waste had been generated. Several reports are telling stories about huge amounts of pharmaceutical waste produced during vaccination campaigns.

2.3 Characterization of “pharmaceutical waste”

pharmaceutical waste can be classified in three main groups non-hazardous, hazardous and to be controlled drugs:

2.3.1 Non-hazardous pharmaceutical waste:

This will be largest group of pharmaceutical waste (70 - 90%) and will contain all kind of unused / expired or unsealed drugs waste, not classified as hazardous or controlled drugs:

• Unsealed syrups or eye drops (expired or unexpired)

• Unsealed tubes of creams , ointments (expired or unexpired)

• Unsealed injection or infusion solutions

• Bulky or loose tablets, capsules, suppositories.

• Loose ampoules

• Cold chain damaged items

o e.g. insulin’s, vaccines, antithrombin etc.

• Materials necessary for making preparations o non-toxic chemicals, salts, sugars, etc.

• Other pharmacy related solid waste

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2.3.2 Hazardous pharmaceutical waste:

Hazardous pharmaceutical waste will be waste that carry a public health or environmental risk. Typical hazardous waste could be:

• Unused / expired cytotoxic drugs – Cytotoxic anti-cancer drugs – antineoplastic agents

• Interferones, – anti viral agents

• Ganciclovir, Ribavirin, • Unused / expired highly toxic other drugs

– immunsuppressiv agents • Azathioprin

• Cyclosporin – Anti-infective

• Chloramphenicol, Ciprofloxacin, Metronidazol – Hormones

• Diethylstilbestrol, Estradiol, Medroyxprogesteron – toxins ( Botulinum and others )

• excess / unused chemicals and diagnostic materials – Benzene

– flammable organic liquids like acetone, ether, Alcohols – Non empty sprays

– Peroxides

• excess / unused / organic solvents and residues – Formaldehyde

– Disinfectants,

– Organic liquids used for analysis

– Heavy metal salts /toxic reagents used for chemical reactions – Mercury containing diagnostic items disinfectants

• Thiomersal, Merbromin, Nitromersol, Diuretika – Godolinium

• Gadodiamid, Gadopentat, Prohance

2.3.3 Controlled drug waste:

Depending on local regulation, certain pharmaceuticals will be classified as to be controlled substances. Typical samples will be:

• Morphine containing substances

• Opiate

• Narcotics, psychotropic substances,

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3 Management of pharmaceutical waste

3.1 Internal Disposal Logistics

If no further segregation is carried out, pharmaceutical waste should be classified as hazardous waste. This will lead to large amounts and high costs of hazardous waste disposal. Generally it can be said that the main part of pharmaceutical waste is not hazardous. Out of this a segregation of the generated pharmaceutical waste should be carried out. In Hospital several hundred of different pharmaceuticals will be used and a nurse will not know if a pharmaceutical will contain hazardous substances or not. As one of the few exemption in medical waste management, the segregation should be carried out not by the generator but only central, in the pharmacy.

3.1.1 Collection and transport:

pharmaceutical waste should be collected in the wards in a safe, central place which is inaccessible to strangers. The pharmaceuticals should be collected in the original packaging, if possible in a special box. After delivery of new pharmaceuticals, the transport service should take the pharmaceutical waste back to the pharmacy.

3.1.2 Central segregation:

The sorting for the segregation should be done in the pharmacy in a well ventilated. Only staff which is trained for the sorting by the pharmacist should carry out this task under observation of occupational safety and the using of protection equipment. The sorting process includes:

• Identifying each item

• Making a decision whether it is usable or unusable

• If it is unusable the packing should be removed

• The hazardous or controlled pharmaceuticals should be put in special drums, flasks or containers, suitable for the item.

• Non hazardous solid, semi-solid and powders pharmaceuticals (e.g. tablest, capsules, granules, powders for injection, mixtures, creams, lotions, gels, suppositories, etc.) should be stored together in one bin

• Non hazardous liquids (solutions, suspensions, syrups, etc.) can be put together in another bin.

Objectives of sorting:

• Sorting into categories that require different disposal methods (e.g. all controlled drugs together, all cytotoxic waste together, etc.)

• Disposal method may depend on the pharmaceutical dosage form of the drug

• Storage areas or color-coded receptacles must be provided for each sorted category!

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3.1.3 Transportation and storage:

After the segregation, the drums, bins, bags etc. must be labeled. The transportation should be done as the transportation for other hazardous waste and should be carried out on demand. The transportation personal must be trained for the transportation of this kind of waste and necessary spillage kits for accidents must be available.

The waste should be stored together with other chemical waste at the hazardous storage place. Non hazardous liquids may be able to be discarded direct via the sewage system. The storage management and documentation can be carried out as for other hazardous waste.

3.2 Observing the precaution during the segregation:

Avoid occupational exposure to cytotoxics

• Centralized cytotoxics preparation area, Safety cabinet

• Always two persons working

• Protective clothing

• Gloves, clothes, overshoes, cap, (mask)

• Separate waste collection in leak-proof containers and labeling for identification

• Safe storage

Ensure high safety standards

• Written procedures

• Safety data sheets

• Procedures for accidents and spillages

• Education and training

Avoid skin and eye contact to hazardous lab. Chemicals

• Exhauster

• Protective clothing

• Gloves, safety goggles Ensure high safety standards

• safety data sheets

• Exercises with fire extinguisher

• Education

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4 Disposal of pharmaceutical waste

4.1 Disposal of non-hazardous, liquid waste

Non-hazardous liquid waste can be disposed of via the sewage system. After the disposal, the sewage system should be spoiled by running water for several minutes.

4.2 Disposal of non-hazardous, solid waste

To guarantee a proper disposal, a misuse of the pharmaceutical waste must be prevented. The best disposal practice will be to return the waste to the manufacturer or supplier. If this will not be possible accepted disposal methods are:

• High temperature incineration (If possible with a temperature >1.200°C)

• Highly engineered sanitary landfills (No access for kids, waste pickers)

• Waste encapsulation

• Waste inertization

4.3 Disposal of hazardous, solid and liquid waste

As for the non-hazardous waste, also for hazardous solid waste the best disposal method is to return the waste to the manufacturer or supplier. If this will not be possible accepted disposal methods for hazardous waste are:

• High temperature incineration with a temperature >1.200°C

• Waste encapsulation

• Waste inertization

Controlled drugs should be immobilized under supervision of the pharmacist, the police or a judicial representative, depending on the local regulations.

Disinfectants do normally not have an expiry date and there is no logical reason to dispose them. However for certain applications special and strong disinfectants are needed (e.g. Lysol) which will have an expiry date. If these kinds of disinfectants are expired, they should be used for other purposes like general disinfection for washing rooms, etc. In the unlikely case that still disposal is necessary it never should be done via the sewage as disinfectants can harm the waste water treatment system but should be incinerated as liquid, hazardous waste.

If a hospital consists on bride chemical expertise, a chemical decomposition of hazardous materials may could be an option. For this, the manufacturer’s recommendations must be followed. Further information on this subject can be found under treatment methods for cytotoxic waste.

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4.4 Description of disposal methods

While information on high temperature incineration and sanitary land filling widely can be found and will be discussed in other lectures, information shall concentrate on three ways of waste treatment methods, suitable for pharmaceutical waste:

4.4.1 Encapsulation (according to WHO standards):

Encapsulation involves immobilizing the pharmaceuticals in a solid block within a plastic or steel drum. These drums are filled to 75% capacity with solid and semi-solid pharmaceuticals and the remaining space is filled by pouring in a medium such a s cement or cement/lime mixture, plastic foam or bituminous sand. Once the drums are filled to 75% capacity, the mixture of lime, cement and water in the proportions 15:15:5 (by weight) is added and the drum filled to capacity. Afterward the drums should be hermetically closed (e.g. spot welding). The sealed drums should be placed at the base of a landfill and covered with fresh municipal solid waste. In case antineoplastic (cytotoxic) waste shall be encapsulated the drum should only be filled to 50 % and it should be land filled only after one month to allow setting.

4.4.2 Inertization (according to WHO standards):

Inertization is a variant of encapsulation. Pharmaceuticals are ground and mix of water, cement and lime is added (e.g. 65 % Pharmaceuticals, 15% Lime, 15% Cement and 5% water) to form a homogenous paste. Important is the worker protection in the form of protective clothing and masks as there may be a dust hazard. The mass than can be decanted into the normal waste.

4.4.3 Pharma-Immobilization:

Pharma-Immobilization is a combination of encapsulation and inertization and is mainly carried out by disposal companies. The waste producer (hospitals, pharmacies, etc.) is separating and sorting hazardous and non-hazardous pharmaceutical waste. The waste is collected in reusable containers provided by the disposal company (non-hazardous waste) or in (used) one-way containers e.g. containers used for disinfection fluids, etc. (hazardous waste). The disposal company will mill the non-hazardous waste, mix it with concrete and will form blocks out of ti which can be disposed. The hazardous waste containers will be filled up with a mixture of lime, cement and water and will be stored for one month.

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