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Guidelines for the safe disposal of expired drugs

People involved in drug supply management are familiar with the problem of drugs reaching

expiry dates before the stocks are used. Expired drug stocks present problems with serious

implications.

Expired drugs imply financial losses because they should no longer be distributed

and must be discarded.

Expired drugs must be disposed off safely, without harming people and the

environment. Pharmaceutical products may lose their potency in the degradation process.

Physical changes may also lead to reduced absorption, rendering the products less effective.

The manufacturer of a pharmaceutical product can only be held responsible for any harmful

effects of the product within its shelf life and only if the product was transported and stored

under the conditions recommended by the manufacturer.

It is recommended

NOT

to use expired drugs at all

It is important to have a good drug management system:

Estimation of drugs based on health service utilization data and standard treatment

regimens,

A well functioning stock inventory control system,

Practicing ‘First Expiry First Out’ (FEFO) and ‘First In First Out’ (FIFO) for drugs

stocked,

Coordination with health institutions, and

Negotiation with suppliers for the possible return of drugs that are about to expire.

Due to constraints in funding for disposal of waste pharmaceuticals, cost-effective

management and methods are needed.

The following are the recommended guidelines for the safe disposal of expired drugs:

1. Return to donor or manufacturer

Wherever practical the possibility of returning unusable drugs for safe disposal by the

manufacturer should be explored; particularly drugs which present disposal problems,

such as antineoplastics. For unwanted, unrequested donations, especially those that

arrive past or unreasonably near their expiry date it may be possible to return them to the

donor for disposal.

2. Landfill

To landfill means to place waste directly into a land disposal site without prior treatment

or preparation. Landfill is the oldest and the most widely practiced method of disposing of

solid waste. The following types are recognized:

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17 May 2006

a. Open uncontrolled non-engineered dump

Untreated waste discharged into an uncontrolled, non-engineered open dump does

not protect the local environment and should not be used. They should preferably be

discharged after immobilization by encapsulation or inertization.

b. Engineered landfill

An appropriate landfill consists of an evacuated pit isolated from watercourses and

above the water table. Each day’s solid waste is compacted and covered with soil to

maintain sanitary conditions. The term ‘safe sanitary landfill’ refers to such a site that

is adequately situated, constructed and managed.

3. Waste immobilization: encapsulation

Encapsulation involves immobilizing the pharmaceuticals in a solid block within a plastic

or steel drum. They are filled to 75% capacity with solid and semi-solid pharmaceuticals,

and the remaining space is filled by pouring in a medium such as cement or cement/lime

mixture, plastic foam or bituminous sand. For ease and speed of filling, the drum lids

should be cut open and bent back. 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. Steel drum lids should then be bent back and sealed, ideally by seam or

spot welding. The sealed drums should be placed at the base of a landfill and covered

with fresh municipal solid waste. For ease of movement, the drums may be placed on

pallets which can then be put on a pallet transporter.

Encapsulation of antineoplastic drugs requires a slightly different technique. The

drugs must be destroyed in a two-chamber incinerator, which operates at a high

temperature of at least 1200°C in the secondary chamber, and is fitted with gas cleaning

equipment. An after-burner (i.e. the secondary chamber) is important for the destruction

of cytotoxic waste, as it is possible that antineoplastic solutions could become

aerosolized following the initial combustion in the primary chamber. As a result, without a

higher temperature secondary chamber, degraded antineoplastic material may be

emitted from the chimney. The secondary combustion chamber consequently ensures

that such antineoplastic substances are fully incinerated.

4. Waste immobilization: inertization

Inertization is a variant of encapsulation and involves removing the packaging materials,

paper, cardboard and plastic, from the pharmaceuticals. Pills need to be removed from

their blister packs. The pharmaceuticals are then ground and a mix of water, cement and

lime added to form a homogenous paste. Worker protection in the form of protective

clothing and masks is required as there may be a dust hazard.

The paste is then transported in the liquid state by concrete mixer truck to a landfill and

decanted into the normal urban waste. The paste then sets as a solid mass dispersed

within the municipal solid waste. The main requirements are a grinder or road roller to

crush the pharmaceuticals, a concrete mixer, and supplies of cement, lime and water.

The approximate ratios by weight used are as follows:

Pharmaceutical waste: 65%

Lime: 15%

Cement: 15%

Water: 5% or more to form a proper liquid consistency.

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17 May 2006

5. Sewer

Some liquid pharmaceuticals, e.g. syrups and intravenous (IV) fluids, can be diluted with

water and flushed into the sewers in small quantities over a period of time without serious

public health or environmental affect. Fast flowing watercourses may likewise be used to

flush small quantities of well-diluted liquid pharmaceuticals or antiseptics. The assistance

of a hydrogeologist or sanitary engineer may be required in situations where sewers are

in disrepair or have been war damaged.

6. Burning in open containers

Pharmaceuticals should not be destroyed by burning at low temperature in open

containers, as toxic pollutants may be released into the air. Paper and cardboard

packaging, if they are not to be recycled, may be burnt. Polyvinyl chloride (PVC) plastic

however must not be burnt.

7. Medium temperature incineration

In emergency situations the responsible authorities may consider it acceptable to treat

expired solid form pharmaceuticals using a two-chamber incinerator that operates at the

minimum temperature of 850°C, with a combustion retention time of at least two seconds

in the second chamber. It is recommended that the pharmaceutical waste be diluted with

large quantities of municipal waste (approximately 1:1000).

8. Novel high temperature incineration

Industries which use high temperature technology, such as cement kilns, coal fired

thermal power stations or foundries, usually have furnaces that operate at temperatures

well in excess of 850°C, have long combustion retention times, and disperse exhaust

gases via tall chimneys, often to high altitudes.

During burning the cement raw materials reach temperatures of 1450°C while the

combustion gases reach temperatures up to 2000°C. The gas residence time at these

high temperatures is several seconds. In these conditions all organic waste components

are effectively disintegrated. Incinerators conforming to these regulations may be used

for the disposal of halogenated compounds, X-ray contrast media and povidone iodine;

lower temperature incinerators should not be used.

9. Chemical decomposition

If an appropriate incinerator is not available, the option of chemical decomposition can be

used in accordance with the manufacturer's recommendations, followed by landfill. This

method is not recommended unless chemical expertise is readily available. Chemical

inactivation is tedious and time consuming, and stocks of the chemicals used in treatment

must be made available at all times. For disposal of a small quantity of antineoplastic

drugs this method may be practical. However, for large quantities, for example, more

than 50 kg of antineoplastics, chemical decomposition is not practical, as even small

consignments need to be treated through repeated application of this method.

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17 May 2006

Summary of disposal methods in and after emergencies

Disposal methods

Types of p

harmaceutical

Comments

Return to donor or

manufacturer

(Transfrontier transfer for

disposal)

All bulk waste

pharmaceuticals, particularly

antineoplastics

Usually not practical

–

transfrontier procedures

may be time consuming.

Landfill

a. Highly engineered

sanitary landfill.

Limited quantities of untreated

solids, semi-solids and

powders. PVC plastics.

Disposal of waste

pharmaceuticals

preferable after

immobilization

b. Engineered landfill Waste solids, semi-solids and

powders, preferably after

immobilization. PVC plastics.

Immobilization of solids,

semi-solids, powders is

preferable.

c. Open uncontrolled non

engineered dump

Untreated solids, semisolids,

powders

As last resort. Not for

untreated controlled

substances. Must be

covered immediately with

municipal waste.

Waste Immobilization:

encapsulation

Solids, semi-solids, powders,

liquids, antineoplastics,

controlled substances

Waste Immobilization:

inertization

Solids, semi-solids, powders,

antineoplastics, controlled

substances.

Sewer

(Fast-flowing

watercourse)

Diluted liquids, syrups,

intravenous fluids, small

quantities of diluted

disinfectants (supervised).

Not recommended for

antineoplastics, and

undiluted disinfectants

and antiseptics.

Burning in open

containers

Packaging, paper, cardboard. As last resort. Not

acceptable for PVC

plastics or

pharmaceuticals.

Medium temperature

incineration with two-

chamber incinerator with

minimum temperature of

850°C. Cement kiln

incineration in the absence

of high temperature

incinerators

Solids, semi-solids, powders,

controlled substances.

Antineoplastics best

incinerated at high

temperature.

High temperature

incineration with

temperatures greatly in

excess of 1200°C

Solids, semisolids, powders,

antineoplastics, controlled

substances

Expensive.

Chemical deco

mposition

Not recommended unless

special chemical

expertise and materials

available. Not practical

for quantities over 50 kg.

Guidelines for the safe disposal of expired drugs 5

17 May 2006

Summary of pharmaceutical categories and disposal methods in and after

emergencies