NTA Level 4 • Semester 1 • PST04102

Methods for Disposing Pharmaceutical Wastes

Disease Control and Prevention • Source Session/Topic 41

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Session 41: Methods for Disposing Pharmaceutical Wastes

Total Session Time: 120 minutes + 2 hours Assignment

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define Terminologies Applied in Disposal of Pharmaceutical Wastes

• Describe Categories of Healthcare Wastes

• Describe Principles of Waste Management

• Describe Methods for Disposal of Pharmaceutical Wastes

• Explain Consequences of Improper Disposal of Pharmaceutical Wastes

• Describe Procedure for Safe Disposal of Unfit Medicines as per Tanzania

Foods, Drugs and Cosmetics Act, 2003

Resources Needed

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD

• Handout 41.1: Categories of Health Care Wastes

• Handout 41.2: Category of products and their recommended disposal methods

SESSION OVERVIEW

|7 | 10 |Presentation |Procedure for Safe Disposal of Unfit|

SESSION CONTENTS

STEP1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Terminologies Applied in Disposal of Pharmaceutical Wastes (5

minutes)

• Pharmaceutical waste includes expired, unused, spilt, and contaminated

pharmaceutical products, drugs, vaccines, and sera that are no longer

required and need to be disposed of appropriately.

• The category also includes discarded items used in the handling of

pharmaceuticals, such as bottles or boxes with residues, gloves, masks,

connecting tubing, and drug vials.

• Also medicines and cosmetic products are considered as unfit when they

are:

o Improperly sealed

o Damaged

o Unexpired and improperly stored

o Improperly labelled

o Counterfeit

o Substandard and adulterated

o Prohibited and unauthorized

STEP 3: Categories of Health Care Wastes (20 minutes)

|Activity: Brainstorming (10 minutes) |

| |

|Ask students to brainstorm on the following question: |

| |

|What are the categories of healthcare wastes? |

| |

|ALLOW few students to respond |

| |

|WRITE their responses on the flip chart/ board |

| |

|CLARIFY and SUMMARISE by using the content below |

Classification of HCW

[pic]

Source: WHO. National Health-Care Waste Management Plans in Sub-Saharan

Countries. Guidance Manual (1999).

[pic][pic]Refer students to Handout 41.1: Categories of Health Care

Wastes for further reading

STEP 4: Principles of Waste Management (10 minutes)

Pharmaceutical waste

• Pharmacy department stores in each health care facility should be

rigorously managed to reduce the generation of pharmaceutical waste.

Especially, stocks of pharmaceuticals should be inspected periodically

and checked for their durability (expiration date). Stock positions

should be recorded on a regular basis.

Pharmaceutical waste

• Pharmacy department stores in each health care facility should be

rigorously managed to reduce the generation of pharmaceutical waste.

Especially, stocks of pharmaceuticals should be inspected periodically

and checked for their durability (expiration date). Stock positions

should be recorded on a regular basis.

• These wastes usually arise at central locations, i.e. in pharmacies

and laboratories and they are also often found at places where the

ready-to-use cytotoxic solutions are prepared.

• The precautions taken during the use of cytotoxic pharmaceuticals must

also be applied on their journey outside the respective establishment,

as releases of these products can have adverse environmental impacts.

The management of these wastes, in covered and impermeable containers,

must be strictly controlled. Solid containers must be used for

collection. The use of coded containers is recommended. For reasons

of occupational safety, cytotoxic pharmaceutical wastes must be

collected separately from pharmaceutical waste and disposed in a

hazardous waste incineration plant.

STEP 5: Methods for Disposal of Pharmaceutical Wastes (30 minutes)

|Activity: Buzzing (5 minutes) |

| |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

| |

|What are the methods for disposal of pharmaceutical wastes? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

| |

|WRITE their response on the flip chart/board |

| |

|CLARIFY and SUMMARIZE by using the content below |

Disposal Methods

• Landfill

o Involves placing unfit medicines and cosmetic products directly into a

land disposal site without prior treatment.

o The method is used in disposing off solid waste.

o Small quantities of unfit medicines and cosmetic products produced on

a daily basis may be land filled provided that they are dispersed in

large quantities of general waste.

o Cytotoxic, narcotic drugs and cosmetic products containing heavy

metals such as mercury should not be land filled, even in small

quantities.

Types of landfill methods

• There are three types recognized as outlined below:

o Landfill for untreated unfit medicines and cosmetic products

o The method is applicable to small quantities of unfit medicine and

cosmetic products. It involves placing untreated waste medicine and

cosmetic into an uncontrolled, non-engineered open dump. The unfit

medicine and cosmetic products should be covered immediately with

large quantities of other type of waste or soil/sand to prevent

scavenging by unscrupulous people.

▪ Discarding of untreated unfit medicine and cosmetics into such a

site is not recommended except as a last resort. They should

preferably be discharged after immobilization by encapsulation or

inertization.

o Discarding in open uncontrolled dump with insufficient isolation from

the aquifer or other watercourses can lead to pollution, with the risk

of drinking water contamination in the worst cases.

o The disposal exercise should be done amid tight security by Police and

be supervised by technical personnel. This method is applicable to

solids, semi-solids, powders, medicines, waste dosage forms and

cosmetics.

• Engineered landfill

Such landfill has some features to protect from loss of chemicals into the

aquifer. Direct deposit of medicines and cosmetics is second best to

discharging immobilized unfit medicines and cosmetic products into such a

landfill.

• Highly engineered sanitary landfill

Properly constructed and operated landfill sites offer relative safe

disposal route for unfit medicines and cosmetic products. An appropriate

landfill consists of an evacuated pit isolated from watercourses and which

is above water table. Once unfit medicine and cosmetic products are thrown

into the pit, they are compacted and covered with soil to maintain sanitary

environment.

• Landfill for treated unfit medicines and cosmetics (medicines and

cosmetics waste immobilization)

Immobilization of unfit medicine and cosmetics can be done in the following

ways:

2. Encapsulation

In this process waste medicines and cosmetics are immobilized in a solid

block within a plastic or steel drum. The drum should be cleaned before

using them and they should not have contained explosive or hazardous

materials previously.

The exercise starts by filling the drum to 75% of their capacity with solid

and semi-solid waste medicines and cosmetics. 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 drum

filled to capacity.

Steel drum lids should then be bent back and sealed by seam or spot

welding. The sealed drum lids should be placed at the base of a landfill

site and covered with fresh municipal solid waste. The method is

applicable to solids waste, semi-solids, powders, and liquids

3. Inertization

The method involves removing the packaging materials (inner and outer

container). The unfit medicines and cosmetics are then ground and a mix of

water, cement and lime added to form a homogenous paste. The paste is then

transported in liquid state by concrete mixer truck to a landfill site and

decanted into a normal municipal waste. The paste then sets as a solid mass

dispersed within the municipal solid waste.

The main tools required for the operation are a grinder or road roller to

crush the medicines/cosmetics, concrete mixer, cement, lime and water.

Medicines or cosmetics waste, lime, cement and water are mixed in the

following ratios by weight 65%, 15%, 15% and 5% respectively. Water can be

added more than the required amount when need arises to have satisfactory

liquid consistency.

The method is applicable to solids, semi-solids, powders, antineoplastics

controlled drugs of that nature and cosmetics containing heavy metals (e.g.

mercury).

4. Sewer

This is a method used whereby waste medicines and cosmetic products in

liquid form e.g. syrups, lotions and intravenous fluids are diluted with

water and flushed into a proper functioning sewerage system/sewers in small

quantities over a period of time without causing serious public health or

environmental effect. Fast flowing watercourses may likewise be used to

flush small quantities of well-diluted liquid medicines/cosmetics or

antiseptics.

5. Medium temperature incineration

This method involves the use of medium temperature incinerators. Unwanted

solid pharmaceuticals may be destructed by using a two-chamber incinerator

that operates at the minimum temperature of 8500C, with a combustion

retention time of at least two seconds in the second chamber. It is

recommended that prior to destruction; pharmaceutical waste should be

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

Medium temperature furnaces may be used in absence of medium temperature

incinerators. This type of incinerator is not suitable for incineration of

halogenated compounds, as they need a more high temperature incinerator.

The method is applicable to solids, semi-solids, powders and controlled

drugs of that nature.

6. High temperature incineration

This involves the use high temperature incinerator, which operates at a

temperature well in excess of 8500C. Our country does not possess such

expensive and sophisticated incinerators so the uses of industrial plant

such as cement kilns serve the purpose. Cement kilns can reach temperatures

of 14500C – 20000C that is suitable for total destruction of organic waste

component. These have long combustion retention times and disperse exhaust

gases via tall chimneys, often to high altitudes thus reducing the risk of

environmental effect.

It may be necessary prior to incineration to remove packaging materials to

avoid clogging and blockage of incinerator or kiln.

7. Burning in open containers

Paper and cardboard packaging materials, if they are not to be recycled,

may be burnt. Polyvinyl Chloride (PVC) plastic however must not be burnt.

Unfit medicines and cosmetics should not be destroyed by burning at low

temperatures in open containers, as toxic pollutants may be released into

the air. It is strongly recommended that only very small quantities of

unfit medicines and cosmetics be disposed of in this way.

8. Return to donor or manufacturer

Wherever practical the possibility of returning unfit medicines and

cosmetic products for safe disposal by the manufacturer should be explored;

particularly medicines and cosmetics which present problems, such as

antineoplastics and heavy metals. For unwanted, unrequested donations,

especially that arrive with past or unreasonably expiry dates, it may be

possible to return them to the donor for disposal.

[pic] Refer students to Handout 41.2: Category of products and their

recommended disposal methods for further reading.

STEP 6: Consequences of Improper Disposal of Pharmaceutical Wastes (15

minutes)

|Activity: Buzzing (10 minutes) |

| |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

| |

|What are the consequences of improper disposal of pharmaceutical |

|wastes? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

| |

|WRITE their response on the flip chart/board |

| |

|CLARIFY and SUMMARIZE by using the content below |

In general, improper disposal of pharmaceutical wastes and unfit

medicines and cosmetics presents a serious threat to public health. Some

of the health risks are;

• Contamination of drinking water.

• Non-biodegradable antibiotics, antineoplastics and disinfectants may

kill bacteria necessary for the treatment of sewage.

• Burning medicines and cosmetics at low temperatures or in open

containers results in release of toxic pollutants into the air which

should ideally be avoided.

• Inefficient and insecure sorting and disposal may allow medicines and

cosmetics beyond their expiry dates to be diverted for resale to the

general public.

• In the absence of suitable disposal sites, if stored in their original

packing there is a risk of diversion.

STEP 7: Procedure for Safe Disposal of Unfit Medicines as per Tanzania

Foods, Drugs and Cosmetics Act, 2003 (10 minutes)

Disposal of unfit medicines and cosmetic products shall involve the

following procedures:

1. A Drug Inspector, Health Officer, Environmental Officer and Policeman

shall supervise the transport of consignment from the owner’s premises to

the disposal site for destruction exercise.

2. The destruction exercise shall be supervised by Health Officer,

Environmental Officer, Policeman and Drug Inspector.

3. Unfit medicines and cosmetic products shall be transported in a closed

motor vehicle to avoid pilferage.

4. Supervisors shall wear protective gears such as overalls, gloves, masks,

caps and boots during the exercise.

5. Upon completion of the exercise, a Drug Disposal Form shall be duly

filled in and signed by the supervisors and owner/owner’s representative.

6. Drug Disposal Form shall be sent to TFDA headquarter offices.

7. Once TFDA has received the form, a certificate of destruction of unfit

medicines and cosmetic products shall be prepared and sent to the

consignee.

8. Particular care shall be taken while handling anti- cancer drugs,

narcotic drugs and penicillins to avoid associated hazards.

STEP 8: Key Points (5 minutes)

• Pharmaceutical waste includes expired, unused, spilt, and contaminated

pharmaceutical products and drugs that are no longer required and need to

be disposed of appropriately

• Stocks of pharmaceuticals should be inspected periodically and checked

for their durability (expiration date) in order to minimize amount of

wastes.

• Improper disposal of pharmaceutical wastes and unfit medicines and

cosmetics presents a serious threat to public health.

• Procedure for safe disposal of unfit medicines as per Tanzania Foods,

Drugs and Cosmetics Act, 2003 should be adhered in order to get away from

consequences involved.

STEP 9: Evaluation (10 minutes)

• What is the pharmaceutical wastes?

• What are the categories of healthcare wastes?

• What are the principles of waste management?

• What are the methods for disposal of pharmaceutical wastes?

• What are the consequences of improper disposal of pharmaceutical wastes?

• What is the procedure for safe disposal of unfit medicines as per

Tanzania Foods, Drugs and Cosmetics Act, 2003?

STEP 10: Assignment (10 minutes)

|Activity: Take Home Assignment (10 minutes) |

| |

|DIVIDE students in groups or individuals |

| |

|ASK the students to work on the following Assignment |

|Basing on Handout 41.1, prepare a presentation on pharmaceutical |

|wastes, giving specific examples of wastes on each category that is |

|found in their pharmaceutical setting. |

| |

|ALLOCATE time for students to do the assignments and submit |

| |

|REFER students to recommended references |

References

TFDA. (2009). Guidelines for safe disposal of unfit medicines and cosmetic

products(1sted). Dar-es- salaam: MoHSW

WHO (1999).National Health-Care Waste Management Plans in Sub-Saharan

Countries

Guidance Manual. Geneva.WHO

World Health Organization (1999), Guidelines for safe disposal of unwanted

pharmaceuticals in and after emergencies. Geneva: WHO

|[pic] |Handout 41.1: Categories of Health Care Wastes |

A. Non-risk HCW: includes all the waste that has not been infected like

general office waste, packaging or left over food. They are similar to

normal household or municipal waste and can be managed by the

municipal waste services. Three groups can be established:

A1. Recyclable waste: It includes paper, cardboard, non-

contaminated plastic or metal, cans or glass that can be recycled if any

recycling industry exists in the country.

A2. Biodegradable waste: This category comprises for instance,

left over food or garden waste that can be composted.

A3. Other non-risk waste: all the non-risk waste that do not

belong to categories A1 and A2.

B. Biomedical and health-care waste requiring special attention:

B1. Human anatomical waste: This category comprises non-infectious

human body parts, organs and tissues and blood bags. Examples of such

wastes: tissue waste, removed organs, amputated body parts and

placentas

B2. Waste sharps: Sharps are all objects and materials that are

closely linked with health-care activities and pose a potential risk

of injury and infection due to their puncture or cut property. For

this reason, sharps are considered as one of the most hazardous waste

generated and they must be managed with the utmost care. Examples of

such wastes: all types of needles, broken glassware, ampoules, scalpel

blades, lancets, vials without content

B3. Pharmaceutical waste: This category comprises expired

pharmaceuticals or pharmaceuticals that are unusable for other

reasons. They are divided into three classes:

B3.1 Non-hazardous pharmaceutical waste: This class includes

pharmaceuticals such as chamomile tea or cough syrup that pose no

hazard during collection, intermediate storage and waste management.

They are not considered hazardous wastes and should be managed jointly

with municipal waste.

B3.2 Potentially hazardous pharmaceutical waste: This class

embraces pharmaceuticals that pose a potential hazard when used

improperly by unauthorized persons. They are considered as hazardous

wastes and their management must take place in an appropriate waste

disposal facility.

B3.3 Hazardous pharmaceutical waste: This comprises heavy metal

containing and unidentifiable pharmaceuticals as well as heavy metal

containing disinfectants, which owing to their composition require

special management. They must be considered as hazardous wastes and

their management must take place in an appropriate waste disposal

facility.

B4. Cytotoxic pharmaceutical waste: these can arise by use

(administration to patients), manufacture and preparation of

pharmaceuticals with a cytotoxic (antineoplastic) effect. These

chemical substances can be subdivided into six main groups: alkylated

substances, antimetabolites, antibiotics, plant alkaloids, hormones,

and others. A potential health risk to persons who handle cytotoxic

pharmaceuticals results above all from the mutagenic, carcinogenic and

teratogenic properties of these substances. Consequently, these wastes

pose a hazard, and the measures to be taken must also include those

required by occupational health and safety provisions. Examples of

such wastes: Discernible liquid residues of cytotoxic concentrates,

post-expiration-date cytotoxic pharmaceuticals and materials proven to

be visibly contaminated by cytotoxic pharmaceuticals must be disposed

of as cytotoxic pharmaceutical waste.

B5. Blood and body fluids waste: these are wastes that are not

categorized as infectious waste but are contaminated with human or

animal blood, secretions and excretions. It is warranted to assume

that these wastes might be contaminated with pathogens. Examples of

such wastes: Dressing material, swabs, syringes without needle,

infusion equipment without spike, bandages

C. Infectious and highly infectious waste: Special requirements

regarding the management of infectious wastes must be imposed whenever

waste is known or – based on medical experience – expected to be

contaminated by causative agents of diseases and when this

contamination gives cause for concern that the disease might spread.

In this category two groups can be considered depending on the degree

of infectiousness that is expected.

C. 1 Infectious waste: This class comprises all biomedical and health-

care waste known or clinically assessed by a medical practitioner or

veterinary surgeon to have the potential of transmitting infectious

agents to humans or animals. Waste of this kind is typically generated

in the following places: isolation wards of hospitals; dialysis wards

or centers caring for patients infected with hepatitis viruses (yellow

dialysis); pathology departments; operating theatres; medical

practices and laboratories which mainly treat patients suffering from

the diseases specified above. It includes: Discarded materials or

equipment contaminated with blood and its derivatives, other body

fluids or excreta from clinically confirmed infected patients or

animals with hazardous communicable diseases. Contaminated waste from

patients known to have blood-borne infections undergoing haemodialysis

(e.g. dialysis equipment such as tubing and filters, disposable

sheets, linen, aprons, gloves or laboratory coats contaminated with

blood); Carcasses as well as litter and animal faeces from animal

test laboratories, if transmission of the above-mentioned diseases is

to be expected. Examples of such wastes: Blood from patients

contaminated with HIV, viral hepatitis, brucellosis, Q fever. Faeces

from patients infected with typhoid fever, enteritis and cholera.

C2. Highly infectious waste: It includes all microbiological cultures

in which a multiplication of pathogens of any kind has occurred. They

are generated in institutes working in the fields of hygiene,

microbiology and virology as well as in medical laboratories, medical

practices and similar establishments; laboratories. Examples of such

wastes: Sputum cultures of TB laboratories, contaminated blood clots

and glassware material generated in the medical analysis laboratories,

high concentrated microbiological cultures carried out in medical

analysis laboratories.

D. Other hazardous waste: This category of waste is not exclusive to the

health-care sector. They include: gaseous, liquid and solid chemicals,

waste with high contents of heavy metals such as batteries and

pressurized containers. Chemical waste consists of discarded chemicals

that are generated during disinfecting procedures or cleaning

processes. Not all of them are hazardous but some have toxic,

corrosive, flammable, reactive, explosive, shock sensitive, cyto- or

genotoxic properties. Examples of such wastes: thermometers, blood-

pressure gauges, photographic fixing and developing solutions in X-ray

departments, halogenated or non-halogenated solvents, organic and in-

organic chemicals.

E. Radioactive health-care waste: this includes liquids, gases and

solids contaminated with radionuclides whose ionizing radiations have

genotoxic effects. The ionizing radiations of interest in medicine

include X and γ-rays as well as α- and β- particles

[pic] Handout 41.2: Category of products and their recommended disposal

methods

|S/N |Category |Disposal methods |

|1. |Solids, semi-solids and powders|Landfill, incineration and waste|

| | |immobilization |

|2. |Liquids |Sewer, high temperature |

| | |incineration and treated waste |

|3. |Antineoplastics |Treated waste and landfill, high|

| | |temperature incineration and |

| | |return to manufacturer |

|4. |Controlled Drugs |Treated waste and landfill, high|

| | |temperature incineration |

|5. |Aerosols and inhalers |Landfill without waste |

| | |inertization |

|6. |Disinfectants |Sewer or fast-flowing |

| | |watercourse |

|7. |PVC plastics, glass (ampoules, |Landfill and re-cycling |

| |bottles and vials) | |

|8. |Paper, cardboard |Recycle, burn, landfill |

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