current scenario of pharmaceutical waste management in bangladesh

Pharmaceutical waste management

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Pharmaceutical

Waste

Management

by

Md. Monirul Islam

Pharmacy Discipline

Khulna University

Bangladesh


1. Introduction

Pharmaceutical products are used in human and veterinary medicine and are a class of

emerging environmental contaminants. These are natural or synthetic chemicals designed to

have a specific mode of action. Worldwide detection of waste pharmaceuticals in the

environment causes risks associated with their introduction into wildlife habitats and is

becoming a serious issue for both regulators and the pharmaceutical industry (Kumari Shalini

et al., 2010)

The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around

the country is raising concerns about the potentially adverse environmental consequences of

these contaminants. The consistent increase in the use of potent pharmaceuticals, driven by

both drug development and our aging population, is creating a corresponding increase in the

amount of pharmaceutical waste generated.

Water pollution creates serious health hazard for Bangladesh. The dumping of municipal

wastes, hospital wastes and toxic environmental discharges from mostly industries pollute

both surface and ground water sources. The mostly contributing industries for water pollution

are pulp and paper, pharmaceuticals, metal processing, food industry, fertilizer, pesticides,

dyeing and painting, textile, tannery etc. More than 200 rivers of Bangladesh directly or

indirectly receive a large quantity of untreated industrial wastes and effluent. Pharmaceuticals

industry causes water pollution 15.9% per year (Islam Faisal, 2002).

In developed countries people are much more aware about pharmaceutical waste

management. They have adopted many techniques to manage this waste for reducing the

detrimental effect on environment and on human health. In Bangladesh some work has been

done on hospital waste disposal system. But the waste generated by the pharmaceutical

industries the most developed sector in Bangladesh is not in bigger concern.

2. Pharmaceutical Waste

Pharmaceutical waste is a form of medical waste that includes unused medications, over-the-

counter personal care products, and sometimes accessories such as sharps, used test strips,

and other supplies. It is a cause for concern because it poses a threat to human and

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environmental health. Because of the dangers, pharmaceutical waste cannot be disposed of

like conventional waste and requires special handling, whether it comes from a hospital,

clinic, pharmacy, or private household. Other types of medical waste include biohazardous

waste and radiation waste.

Fig: Pharmaceutical wastes

Commercial Pharmaceutical Waste includes pharmaceutical waste from facilities such as

hospitals, pharmacies, convalescent homes, and other institutions. Some pharmaceutical

waste is regulated as hazardous waste. It is the responsibility of the generator to properly

classify their waste as either hazardous waste or non-regulated solid waste

3. Pharmaceutical Waste Classifications

Wastes should be categorized as follows and it is recommended to collect (Charlotte A. 2002)

General waste (e.g. paper, obsolete documents, wrapper, cards, boxes, cartons etc.)

General waste is any waste not classified as being within any of the categories of the clinical

and related waste streams. General waste represents the significant majority of all health

industry wastes. As it is much more economical to dispose of general wastes than of clinical

and related wastes, appropriate segregation practices should be maintained.

Sharps (e.g. e.g. broken glass, needle, blade etc.)

Sharps are discarded objects or devices capable of cutting or penetrating the skin, eg

hypodermic needles, intravenous sets (‘spikes’), Pasteur pipettes, broken glass, and scalpel

blades. Various hard plastic items, such as intact amniotic membrane perforators and broken

plastic pipettes, also contribute to sharps.

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Plastic waste (e.g. infusion bag, polybags, container/drum etc.)

Pharmaceutical waste (Miscellaneous Pharmaceutical products and substances e.g.,

disposed raw materials, intermediate & finished products etc.)

There are many chemical and/or pharmaceutical compounds used in research or in the

treatment of diseases that are also considered to be hazardous wastes when disposed of.

Pharmaceutical waste include-

● Rejected/expired raw & packaging materials

● Spills of raw materials

● Waste generate during manufacturing /processing

● Rejected/ expired/ damaged intermediate and finished drug product etc.

● Hazardous waste ( e.g. solid, liquid, acid- base waste, HPLC waste, organic & inorganic

waste, Karl Fisher waste etc.)

● Biological waste (e.g. Live bacteria/ fungus, culture media, contaminated materials etc.)

4. Nature of Pharmaceutical Waste

The properties that make pharmaceuticals useful are the same properties that make them

hazardous. Pharmaceutical companies invest billions of dollars every year to develop

substances able to affect human metabolism at very low concentrations. This potency does

not change when a material enters the waste stream.

Some pharmaceuticals must be extremely toxic in order to function. Antineoplastic agents

(the type of drug most often used in chemotherapy), for example, are designed to kill dividing

cells. Some radioactive compounds are used for the same purpose.

A few drugs have other properties, unrelated to their intended action that makes them

hazardous. Nitroglycerin, for example, which causes blood vessels to dilate and can be used

to treat chest pain, is also well known for its explosive properties.

A relevant property of pharmaceuticals unrelated to their function is their water solubility. In

order to administer drugs in liquid form, those that are not sufficiently soluble in water must

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be dissolved in some kind of solvent, generally an alcohol-water mixture. This can pose a

flammability hazard.

Pharmaceutical waste is a small fraction of urban municipal waste. There should be a greater

consensus on how much of the waste generated is actually infectious or hazardous. Infectious

or hazardous pharmaceutical waste represents only a small part of total pharmaceutical waste;

yet, because of ethical questions and potential health risks, it is a focal point of public

interest. Most hazardous and toxic waste is coming from clinical and hospital. Only a small

amount is from domestic or industrial sources. According to World Health Organization

(WHO) (BAN & HCWH, 1999) approximately 85% or hospital wastes are actually non-

hazardous, 10% are infectious, and around 5% are non-infectious but hazardous.

5. Potential impacts (risks) associated with Pharmaceutical Waste

Pharmaceuticals in the waste stream can pose several different types of risk. The most

straightforward is that the active ingredients in a discarded drug could act on an unintended

target. But other ingredients in pharmaceutical formulations can present hazards:

Preservatives and other ingredients can pose a toxicity hazard over and above the

effect of the main active ingredient

Some common solvents can pose a fire hazard (ignitability)

A few compounding agents are corrosive, including strong acids with pH less than 2

(such as glacial acetic and carbolic acids) and strong bases with pH greater than 12.5

(such as sodium hydroxide)

Some compounds are radioactive, including certain chemotherapy drugs, and certain

agents that are used as tracers or markers.

Risks from pharmaceuticals in healthcare facilities generally cannot be eliminated by finding

substitute materials, since the risk is often inherent in the function. But the risks can be

minimized and managed.

6. Type of waste material found from different pharmaceutical industries

From Production floor and Quality Control Lab:

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Inorganic solvent

Organic solvent

Halogenated organic solvent

Non halogenated organic solvent

Solid waste/tested sample:

Unused and rejected / expired reagent test samples (e.g. ampoules, vials,

LVP bags, tablets,, capsules, dry suspensions, oral liquids, cream, ointments, gel,

mouthwash, nasal preparation, eye / ear drops Shampoo, and powder for raw / blend

/intermediate / finished stage.)

Packaging wastes: carton, leaflet, label, papers, spoon, cup, rubber, stopper, dropper,

aluminum tube aluminum foil PVC /PVDC etc.

Liquid waste: general washing discharge, used inorganic and organic solvents, HPLC

waste e.g. mobile phase, Karl fisher waste.

Type of waste from Microbiology Lab:

solid waste / tested samples:

Unused and rejected / expired reagents and test sample (e.g. ampoules, vials,

LVP bags, tablets,, capsules, dry suspensions, oral liquids, cream, ointments, gel,

mouthwash, nasal preparation, eye / ear drops Shampoo, and powder for raw / blend

/intermediate / finished stage)etc. used culture media, gloves, centrifuge tubes, culture

bottles, pipette tip, cotton, swabs, Sharps, (needles, syringe, slide broken glass etc.)

biological / Microbiological laboratory waste.

7. Pharmaceutical waste management

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The flow chart of waste management in pharmaceutical industry is given bel

Figure : Flow chart of waste management

7.1 Treatment and Disposal Methods of Solid Pharmaceutical Waste

There is not much treatment of solid pharmaceutical waste. Most of the time solid waste is

disposed of. Separation and reprocessing of some of the solid waste are also done for

recycling purpose. Incineration and land filling of pharmaceutical solid waste is most

common.

The safe and reliable long-term disposal of solid pharmaceutical waste residues is an

important component of integrated waste management. Solid waste residues generated by

pharmaceutical industry:

components that are not recycled,

Residues that remain after processing at a material recovery facility, or

that remain after the recovery of conversion products and/or energy

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7.1.1 Autoclaving

Autoclaving involves the heating of infectious waste by steam under pressure. The

effectiveness of autoclaving depends on the temperature, pressure, exposure time and the

ability of steam to penetrate the container. Confirmation that the required temperature has

been reached is imperative (Clark, 1989).

Autoclaving are used for the bulk of clinical and related wastes. Care must be taken to

exclude body parts, pharmaceuticals, including cytotoxics, and radioactive wastes.

Autoclaved wastes are disposed of by landfill.

7.1.2 Incineration

Incineration is a term used commonly to describe all systems of burning, although only one

standard is considered to be effective. Combustible waste are incinerated provided that an

appropriate incinerator is used. Incinerator residues are generally disposed of in landfills.

Incineration is one of the best techniques for treating hazardous waste because:

It can be used to recover heat energy

Use as volume reduction method

Use for preheating combustion air

Detoxification of toxic material can be done by destroying the organic

molecular structure through oxidation or thermal degradation

Long-term cost of land disposal is likely to be greater than the short-term cost

of incineration.

7.1.3 Landfill

Landfills are physical facilities used for the disposal of residual solid wastes in the surface

soils of the earth.. Solid pharmaceutical waste usually incinerated but in some places most of

the solid Pharmaceutical waste is landfilled. Where pharmaceutical and related wastes are

disposed of by landfill, the sites are confirmed as suitable.

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7.2 Treatment of waste water

Wastewater pollution is the main issue of pharmaceutical sector. In pharmaceutical industries

wastewater is mainly generated through the washing activities of the equipment. Though the

wastewater discharged is small in volume, is highly polluted because of presence of

substantial amounts of organic pollutants (Overcash, 1986).

Hence Effluent Treatment Plants or ETPs are used by leading companies in the

pharmaceutical and chemical industry to purify water and remove any toxic and noneffluent-

treatment-plant toxic materials or chemicals from it. These plants are used by all companies

for environment protection.

Figure : Process flow diagram for Effluent Treatment Plant

The effluent treatment plant consists of primary(Chemical treatment), secondary(Biological

treatment) & tertiary(Filtration) treatments which comprises of screening chambers, oil and

grease trap, equalization tank-1, flush mixer, primary settling tank, equalization tank-2

secondary settling tank neutralization tank primary clarifier (PC), MBBR-1, secondary

clarifier, MBBR-2, secondary clarifier-2, pressured sand filter, and activated carbon filter.

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7.3 Testing Method

Waste water sample collected from the ETP are tested according to standard testing

procedure. The testing procedure of physicochemical parameters which are tested are

described here.

7.3.1 Testing procedure for pH:

Principle:

pH is the usual means of expressing the hydrogen-ion concentration of water. It is defined as

the negative logarithm of the hydrogen ion concentration.

pH = - log 10 [H+]

Procedure:

1. Calibrate the pH meter with the buffer solutions of 10, 7 & 4 as per the Guidelines of

pH meter.

2. Dip the pH electrode in the sample.

3. Note the pH reading.

7.3.2 Testing procedure for Total Dissolved Solid (TDS)

Principle:

Total dissolve solids are determined as the residue left after evaporation of the filtered sample.

Procedure:

Weigh 100 ml silica dish (D) Filter the sample through filter paper and take 50 ml in silica dish. Evaporate The sample at 80 – 100 deg C. Take the final weight after cooling in a desiccator. (E)

Calculation:

TDS(mg / l)=(E−D) x10 6ml of sample

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7.3.3 Testing procedure for Chemical Oxygen Demand (COD)

Principle:

The Chemical Oxygen Demand (COD) provides a measure of the oxygen to that portion of the organic matter in a sample that is susceptible to oxidation by a strong chemical oxidant. Most types of organic matter are destroyed by boiling with a mixture of dichromate and sulfuric acid. A sample is refluxed with known amount of potassium dichromate and sulphuric acid and the excess dichromate is titrated with ferrous ammonium sulphate. The amount of oxidisable organic matter, measured as oxygen equivalent is proportional to the dichromate consumed.

Procedure:

1. Place 0.4 gms of HgSO4 in refluxing flask. Dissolve it in 5 ml H2SO4 reagent. To

that add 20ml of sample or suitable portion diluted to 20 ml by addition of D/W.

2. Add 10ml std.K2Cr2O7 solution in flask.

3. Slowly add 25ml acid reagent in the flask & add some glass beads.

4. Connect flask to condenser & reflux for 2 hours at above 1000 C temp.

Disconnect condenser and dilute mixture to about 150 ml with distilled water.

5. Cool to room temperature and titrate with FAS using 3-4 drops of Ferroi as

indicator. Take end point the sharp colour change from blue green to reddish brown.

6. Reflux in the same manner a blank consisting of 20ml distilled water together

with reagents.

Calculation:

COD mg / l=(a−b) x N x8000ml sample taken

a = ml of Fe (NH4)2 (SO4)2 used for blank

b = ml of Fe (NH4)2 (SO4)2 for sample

N = Normality of FAS.

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7.3.4 Testing procedure for Total Suspended Solid (TSS)

Principle:

TSS of a water sample is determined by pouring a carefully measured volume of water

through a pre-weighed filter of a specified pore size, then weighing the filter again after

drying to remove all water. The gain in weight is a dry weight measure of the particulates

present in the water sample expressed in units derived or calculated from the volume of water

filtered (typically milligrams per litre or mg/l or ppm)

Procedure:

1. Initially weigh the filter paper after drying it for some time.

2. Take 50 ml of the effluent sample whose suspended solids are to be determined in a measuring cylinder.

3. Filter the effluent sample through the man Filter Paper; allow the water to drain through the filter paper. Once the sample is filtered, dry the filter paper in oven at around 105 – 108 deg C till drying.

4. After drying, cool the filter paper in dessicator and take the final weight.

Calculation:

TSS in mg/l ¿ ( A – B)x 1000000ml sample taken

A = Final weight of the filter paper in gms.

B = Initial weight of the filter paper in gms.

.7.3.5 Testing procedure for Dissolved Oxygen (DO)

Principle:

The Dissolved Oxygen can be defined as the Oxygen which is dissolved in water, it is required to the aquatic life for their survival.

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Methods of determination of Dissolved Oxygen

1. Collect treated water sample in 300 ml BOD bottle.

2. Add 1 ml each of Manganous Sulfate and Azide –Iodide

3. Stopper and mix by inverting the bottle.

4. When the precipitate settle down, repeat the shaking.

5. after complete settling remove stopper and add 1 ml H2SO4

6. Re-stopper and mix well.

7. The precipitate will get dissolved & colour will change to yellow –orange.

8. Titrate 200 ml of above solution against Na 2S2O3 (0.025N) using starch as

indicator.

9. Note the burette reading End point is blue to colorless

Calculation:

DO , mg/l = Burette Reading of Na2S2O3

8. Waste management strategy

All generators of pharmaceuticals and related wastes are responsible for the safe transport

and disposal of these wastes in an environmentally sound manner that minimizes risk to the

community and staff involved in its management.

An organization’s strategy and implementation plan will depend on its location, size,

specialty and access to disposal services. Even within one organization different procedures

may be necessary to cope with the varying volume of waste generated in particular areas.

Nevertheless, procedures should be uniform, wherever possible, within and between

organizations. This will reduce the possibility of confusion and possible accidents when staff

moves between services.

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The strategy should:

Clearly outline management commitment to the principles of responsible waste

management;

Clearly outline management commitment in terms of resource allocation;

Highlight the accountabilities and responsibilities of management, staff and contractors;

Clearly define the various categories of the waste stream;

Clearly articulate appropriate disposal procedures; and

Provide adequate and on-going education.

9. Conclusion

Environmental degradation is an escalating problem owing to the continual expansion of

industrial production and high-levels of consumption. A renewed dedication to a proven

strategy to resolve this problem is needed. Green Productivity (GP) is one such strategy for

enhancing productivity and environmental performance for overall socio-economic

development. It is the application of appropriate productivity and environmental management

tools, techniques, technologies to reduce the environmental impact of organization’s

activities, goods and services. However, further study is required to reveal the overall real

condition of how much this sector polluting our environment and how we can get rid of from

this worst situation.

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10. References

1. Brunner C. Looking at incineration Waste Management and Environment. 1993; 31–34.

2. Bertino JS. Waste generation of drug product sample versus prescriptions obtained through pharmacy dispensing. Pharmacotherapy. 2000; 20(5):593–598.

3. Clark R. ‘Infectious waste: a survey of handling practices in Lincoln, Nebraska’, Journal of Environmental Health, 1989; 51(4); 206–208.

4. Clark County (Washington). Clark County and Partners Launch New Program for Safe Disposal of unwanted or Outdated Medicine, 2003; 34-39.

5. Daughton, C. G., "Cradle-to-cradle stewardship of drugs for minimizing their environmental disposition while promoting human health. I. Rationale for and avenues toward a green pharmacy." Environmental Health Perspectives, 2003; 754-774.

6. Daughton. “Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?” Environmental Health Perspectives , 1999; 107(5):907-938.

7. Green S. Sewer disposal of pharmaceutical waste. Tri-Tac, 2003; 03–07.

8. Heberer T. Occurrence, fate, and removal of pharmaceutical residues in the aquatic environment:a review of recent research data. Toxicol Lett, 2002;131(1–2):05–17.

9. Kuspis DA. What happens to expired medications? A survey of community medication disposal.Vet Hum Toxicol, 1996;38(1):48–49.

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current scenario of pharmaceutical waste management in bangladesh

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