by Dr. Aleksandar Knezevic and Dr. Miroslav Sober

Presented by Dr. A. Knezevic

In Bosnia and Herzegovina war has left deep consequences not only on people but on the environment too. Destruction of industrial facilities and spilling of chemicals have the worst effect for the environment, but bizarre situations like usage of transformer oil as a diesel fuel and antilace shampoo containing lindane against pests in the gardens could not bee bypassed. It is very hard to realize the severity of consequences for the environment since there are no data from the field, but effects on human health could be judged to some extent indirectly, on the basis of morbidity in the last two years. According to the information obtained at the Institute for Pathology, Faculty of Medicine in Sarajevo, dramatic increase in the digestive system carcinoma, particularly large intestine carcinoma has been observed last two years. Before the war, in this country cases of Hashimoto thyroiditis haven’t been observed, but nowadays they acquire epidemic dimensions and readily convert to malignant diseases of thyroid gland. Significant number of skin diseases including malignant is also evident. Although there is no reliable evidence, one can assume that such situation could be partly due to the pollution of the food, water and whole environment.

Beside sources of contamination mentioned above, in Bosnia and Herzegovina specific problem is so-called pharmaceutical waste. During the war, huge amount of drugs has arrived as humanitarian aid. Part of these drugs has arrived with expired date, while others haven’t been used due to various reasons, so the whole amount of waste drugs according to the WHO is estimated to reaches 800 tones. There are different reasons why pharmaceutical waste has occurred:

• Donated drugs were often not relevant for the emergency situation, for the disease pattern or for the level of care available. There were sometimes unknown by local health professionals and patients, and did not comply with locally agreed drug policies and standard treatment guidelines.
• Many donated drugs arrived unsorted and labeled in a language that is not easily understood. Some donated drugs were under trade names which were not registered for the use in this country and sometimes without generic name on the label.
• The quality of the drugs did not always comply with standards in this country. For example, some donated drugs had expired before they reached the patient or they were drugs or free samples returned to pharmacies by patients or health professionals.
• Some drugs were donated in the wrong quantities and some stocks couldn’t be used before expiration.

The final consequence is that today in Federation of Bosnia and Herzegovina exist about 800 tones of pharmaceutical waste, mainly stocked in Sarajevo and Mostar.

Problem of unused pharmaceuticals in BH is solved only partially. Theoretical approach and some experience are give here.

The guideline for drug disposal in BH is prepared World Health Organization - Regional office for Europe - Office for Bosnia and Herzegovina. All process are given into two steps.

1. FIRST STEP - SORTING

The first stage of sorting is to separate out the pharmaceuticals which are classed as controlled substances, toxic or hazardous products (Fig. 1).

The appropriate safe disposal method recommended will depend upon the pharmaceutical form of the drugs; therefore the second stage is to sort the materials by form, i.e. type, e.g. tablets, syrups, etc. A trained pharmacist should supervise all sorting activities. The sorting process will dramatically reduce the amount of material to be disposed of in a special way since many of the donations have been found to be a mixture of non- pharmaceutical materials and large quantities of packaging.

1.1.1. CONTROLLED SUBSTANCES, TOXIC 0R HAZARDOUS PRODUCTS

A Ministry of Health Pharmacist should, according to a published list by the Ministry of Health, determine which drugs are classed as cytotoxic, narcotic and which products are hazardous and ensure that materials in these categories are stored separately from the other items.

Flammable and/or water reactive chemicals must only be destroyed in a chemical waste disposal facility.

1.1.2. IN-DATE DRUGS AND USEFUL MATERIALS

• Non-pharmaceutical useful materials, e.g. medical equipment, beds, wheelchairs, dressings, clothing, laboratory glassware, etc. which can either be utilized by the Institution or reallocated to other facilities, recycled, cannibalized for spare parts or disposed to a landfill.
• Pharmaceuticals which are in common use should be separated out and immediately used by the Institution or reallocated according to the needs and instructions of the Regional health authorities. A list can be prepared giving details of the items available, quantities and expire dates and circulated to others who can use the materials.
• Chemicals such as acids, alkalis, reagents, phenol based chemicals used for cleaning floors, disinfectants, etc. If large quantities of these items are found a list can be prepared and offered to other potential users such as galenic laboratories, universities, schools, etc.

1.1.3. EXPIRED DRUGS

• Solids (Tablets, capsules, granules, powders, antibiotics in vials, etc.)
• Semi-solids (Creams, lotions, gels, suppositories, etc.)
• Liquids (Solutions, suspensions, symps, ampoules, etc.)
• Aerosol Canisters (Including propellant driven sprays and inhalers, antihistamine sprays)
• Damaged pressurized cylinders.

Sorting should ideally be done in the open or in a well ventilated and heated covered structure designated by the Regional Health Authority. Sorting should be done as close as possible to the stockpile and should be done in a orderly way. Staff supplied with protective equipment (gloves, boots, overalls, dust masks, etc.) should work under the direct supervision of the Pharmacist and should receive training on the sorting criteria and health and safety risks associated with handling the materials before work commences.

Once sorted the pharmaceuticals should be carefully packed directly into steel drums or into containers such as sturdy cardboard boxes and the contents clearly indicated on the outside of the containers. The materials should be kept in a dry and secure room, preferably in a separate room to avoid being confused with in-date pharmaceuticals, until disposal is performed.

2. SECOND STEP - DISPOSAL METHODS

Landfill is the oldest and the most widely practiced method of disposing of solid waste. Properly constructed and operated landfill sites offer a safe disposal route for municipal solid wastes. An appropriate landfill will consist of an excavated pit away from water courses and above the water table. Each day's rubbish will be covered by soil to maintain sanitary conditions Uncontrolled dumping of waste, which does not protect the local environment, should not be used. Upgrading of an uncontrolled tip to a reasonable standard should be considered and advice is available from the WHO on this.

Any solid pharmaceuticals disposed of to a landfill should be covered immediately by fresh municipal waste at the base of the working face of the landfill. It may be deemed necessary to transport the pharmaceuticals some distance to the nearest landfill.

If a recycling Programme exists for the reuse of materials such as glass, aluminum or paper then packing materials and glass can be separated from the pharmaceuticals.

Encapsulation involves placing the pharmaceuticals in a plastic or steel drum. When the drum is 90% full, fill the remaining space by pouring a media such as cement/lime mortar, plastic foam or bituminous sand. Seal the drums and then place at the base of the working face of a landfill.

For cytostatics use a ratio of 40% cement, 30% water and 30% waste by weight well mixed and allow to set for between 7 and 28 days prior to landfill. This will form a firm immobile solid block in which the wastes are relatively securely isolated. The most economical ratios to achieve a minimum permeability of the blocks should be determined by experiment.

The inertization disposal method used in Catalonia, Spain involves firstly the removal of all packaging materials, (paper, cardboard, plastic), from the pharmaceuticals then grinding the pharmaceuticals and adding a mix of water, cement and lime to form an homogenous paste which 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 into a hard harmless substance dispersed amongst the urban waste.

The process is relatively inexpensive and can be done in a relatively unsophisticated manner. The main requirements are a grinder or road roller to crush the pharmaceuticals, a concrete mixer, a labor force 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%).

Some liquid pharmaceuticals (e.g. syrups and IVfluids) can be diluted with water and flushed into the sewers in small quantities over a period of time without any serious public health or environmental effect. If there are no sewers or there is no functioning sewage treatment plant, liquid pharmaceuticals, (excluding antibiotics, narcotics and cytostatics) can be first diluted with large volumes of water and poured into large water courses, providing they are immediately dispersed and diluted by the flowing river water.

In many countries there are no incinerators which meet emission control standards such as though published by the EC however it is suggested that it is acceptable to destroy expired solid-form pharmaceuticals using a two-chamber incinerator that operates at the minimum temperature of 850^oC with a combustion retention time of at least 2 seconds in the second chamber.

Pharmaceuticals should not be destroyed by open burning at low temperatures as this will cause aerosol forms or the drugs to be released into the open air.

2.6. High Temperature Incineration

Industries such as cement kilns, thermal power stations or foundries usually have furnaces which operate at temperatures exceeding 850^oC and which have long combustion retention times and disperse exhaust gases via tall chimneys to a high altitude. Many countries do not posses and cannot justify economically expensive and sophisticated chemical disposal facilities 50 the use of industrial plant provides a viable and cheap alternative.

Cement kilns are particularly suitable for the disposal of expired pharmaceuticals, chemical waste, used oil, tires, etc. There are several features of a cement kiln which renders it suitable for the disposal of pharmaceuticals During burning the cement raw materials reach temperatures of 1450^oC while the combustion gases reach temperatures up to 2000^oC The gas residence time at these high temperatures is several seconds In these conditions all organic waste components are effectively destroyed. Some dangerous or toxic combustion products become adsorbed into the cement or are removed in the heat

exchange equipment.

Cement producers in many countries, such as in Europe (Belgium, France, Germany, Greece, Italy, Spain, Sweden, and Switzerland), the USA, Canada, South America and Japan are keen to use alternative fuels as their use reduces the fuel bill for cement production without affecting the quality of the cement. With appropriate environmental impact control mechanisms in place there will be minimal impact on the surrounding area. It is recommended that discussions be held with cement companies and the appropriate environmental control agencies to arrange for the waste to be disposed of using a cement kiln.

Pharmaceuticals should be introduced into the furnace as a reasonably small proportion of the total fuel feed It is suggested that as a sensible "rule of thumb" figure, no more than 5% of the fuel fed into the furnace at any one time is pharmaceutical material. Cement kilns typically produce 1,500 to 8,000 tones of cement per day and therefore quite large quantities of pharmaceutical material can be disposed of in a short period It may be necessary to remove packaging and or to grind the pharmaceuticals to avoid clogging and blockage of the fuel feed mechanisms.

2.7. Disposal For Special Classes Of Pharmaceuticals

• Chemical Decomposition

If an appropriate incinerator is not available, chemical decomposition can be carried out in accordance with the manufacturer's recommendation, followed by landfill. However, chemical inactivation is tedious and time consuming, and stocks of treatment chemicals must be made available at all times F or disposal of a small quantity of cytotoxic drugs/waste, this method is viable However for large quantities, e g larger than 50 kg, of cytostatics, chemical decomposition is not practical, and these consignments need to be treated through repeated application of this method.

Small quantities of pharmaceuticals, typically less than 500 kg, requiring safe disposal and excluding cytotoxic and narcotic drugs can be disposed of with large volumes of general wastes to landfill.

Pharmaceuticals which can be classed as readily biodegradable organic materials e.g. vitamins, in the solid or semi-solid form can also be disposed of to a landfill in the solid forms or if in the liquid forms diluted and flushed into a sewer.

• Solids and Semi-Solids

• Liquids

• Intravenous fluids : These are harmless solutions of different concentrations of salts, amino acids, lipids, glucose etc. which can be disposed of to the sewers.

• Disinfectants: These normally do not have an expiry date and so can be stored and gradually used over time. Large quantities of disinfectants must not be flushed into the sewer as they will kill off the bacteria in a sewage works and 50 stop the biological treatment of the sewage. Similarly large quantities should not be put into any watercourse since the disinfectant will kill off aquatic life. Small quantities of disinfectants may be disposed of by discharge to sewer providing the operation is supervised by a Pharmacist and the quantities are strictly controlled to set limits. The guideline control proposed is 50 litters total per day, with the disposal spread over the whole working day. Some disinfectant such as a strong bactericide/viralcide, e.g. Lysol (5O% Cresylic Acid) may have an expiry date which has past in which case the material can either be used for general disinfection purposes at an appropriate dilution decided by the Pharmacist or disposed of in a chemical waste disposal unit or a cement kiln. In many countries a chemical waste disposal unit does not exist and 50 the materials may have to be shipped out of the country. However this is an expensive and complicated operation and should only be contemplated if there is truly no viable alternative.

• The World Health Organization publishes Chemical Safety Sheets for common disinfectants (and also pesticides). The sheets provide data on the chemical composition of the substance and indicate suitable methods of disposal The sheets may be obtained from the WHO Head Quarters in Geneva.

• Ampoules: These can be crushed on a hard impermeable surface (e.g. concrete) or in a metal drum or bucket using a stout block of wood or hammer Workers doing this should wear protective equipment (eye protection, boots, clothing, gloves, etc. ) The crushed glass should be swept up, placed in a container suitable for sharp objects, sealed and disposed of to a landfill The liquids released from the ampoules should be diluted and disposed of to a sewer Ampoules should not be burnt or incinerated as high temperatures will cause them to explode causing injury to operators and/or damage to the furnace or incinerator. Melted glass will also clog up the grate of a furnace or incinerator if the operating temperature is above the melting point of glass.

• Small quantities of other liquid pharmaceuticals which are not narcotic or cytostatic can be flushed into the sewers. Larger quantities however should be treated using the encapsulation or inertization disposal methods described above or dammed for eventual high temperature incineration.

• Volatile liquids in small quantities can be allowed to evaporate in the open air

Aerosol Canisters

Disposable aerosol canisters and inhalers should not be burnt or incinerated as high temperatures will cause them to explode causing injury to operators and/or damage to the furnace or incinerator. Providing they do not contain poisonous substances they should be disposed of to the landfill dispersed amongst normal wastes.

Special Classes Of Drugs

Certain classes of drugs require particular consideration. These include:

Cytostatics

These drugs, also known as antineoplastic drugs, have the ability to kill or stop the growth of living cells. They are mainly used in the chemotherapy of cancer which is normally only done in specialized treatment centers. They are very expensive and therefore do not normally fall into the public domain. It is extremely unlikely that they would form part of an aid donation. If discharged into the environment they can have very serious affects such as interfering with reproductive processes in various life forms. Their disposal must therefore be handled with great care.

Cytostatics should be segregated from other pharmaceuticals and kept separately in clearly marked closed containers with rigid walls. They should be safely packed and returned to the supplier for disposal.

If this option is not possible they must be destroyed in a two chamber incinerator which operates at a high temperature, i e 1 100^o C in the secondary chamber and which is fitted with gas cleaning equipment. An after-burner (i.e. the secondary chamber) is important for the destruction of cytotoxic waste, as there is a possibility of a cytotoxic solution being aerosolized, following the combustion in the primary chamber As a result, without a higher temperature secondary chamber degraded cytotoxic material may be emitted from the chimney. The secondary combustion chamber ensures that such cytotoxic substances are destroyed.

The temperatures attained by most modern purpose-built incinerators are sufficient to meet the current recommendations of the manufacturers of each of the 25 licensed cytotoxic drugs widely in use.

Cytotoxic drugs/waste should never be disposed to landfill or be discharged to a sewerage system unless treated to be non-hazardous by inertization or chemical decomposition prior to the disposal. They must not be discharged into surface water drains or natural water courses.

Narcotics must be destroyed under police supervision. Narcotics must not be allowed into the public domain as narcotics can be abused. They should be either be rendered unusable and dispersed amongst domestic waste in a landfill or incinerated at high temperature.

Damaged pressurized cylinders

An explosion-proof dismantling facility which could be used for the treatment of pressurized cylinders may be available. It is recommended that the cylinders are stored securely and periodically taken to a military site where they can be destroyed in a controlled explosion and the scrap metal recycled or disposed in a landfill.

Regarding the subject matter treated in the workshop, the analysis of the incineration of expired drugs and other pharmaceutical materials is of particular importance. The issue of regulation of the pollution of air by the incineration products is of primary importance.

Four categories of standards can be distinguished in the legislative practice on the environmental protection to the subject they regulates: (1) quality standards of an environmental sector (e.g. air quality), (2) emission standards (e.g. emission limits), (3) process standards (e.g. technical requirements: equipment, treatment etc.) and (4) product standards (e.g. sulfur content in the used fuel. Each facility has indirectly to comply with quality standards of environmental sector, but directly it must comply with one or more of the three last-mentioned standards. For waste incineration plants process and emission standard used to be prescribed but, in comparison with "ordinary" combustion plants, greater intention is paid to the process standards.

During waste incineration improved combustion conditions must be ensured. The results of investigation into hazardous waste incineration showed that the total removal of organic compounds depend more on combustion way then on gas cleaning technologies used. Because of that particular care was taken to the reduction of permitted CO content. It was thus taken into consideration that CO is the most representative indicator of the combustion completeness and can be easily continuously monitored (fig.2).

Under certain operating conditions, especially these of incomplete combustion, waste incineration can emit PCDD, PCDF, PAH, PCB/PCT, that are not primarily fed into the incinerator as a part of waste, but are formed during the incineration process. Such an emission increases with decreasing incineration temperature. It is also possible that the organic substances, previously fed into the incinerator be destroyed during the incineration process, and at the same time the new dangerous compounds are being formed.

According investigation, dioxin and furan emissions have three principal sources: (1) they can be present in the waste feed and pass through the combustion process without being destroyed, (2) they can be formed in the combustion process as product of incomplete combustion, and (3) they can be formed "de nuovo" in cooler areas downstream of the combustion products from elements and compounds that act as precursors.

In the report of German Federal Environmental Agency it was stressed that the operating requirements include furnace temperatures of 800 to 1000^oC and an oxygen content to the flue gas of 8 - 12 %. US EPA investigations showed that the successful combustion concerning the flue gas destruction can be achieved in a relatively broad domain of varying the influencing parameters (820 - 1500^oC, 8-15% O₂, residence time in the combustion chamber 0,2 - 6,5 s.). But increasing of combustion temperature as well as residence time can not lead to complete combustion if the third condition is not satisfied - turbulence (3T rule - Temperature, Time, Turbulence), how turbulent heat transfer could be assured.

The major part of expired pharmaceuticals is still not adequately treated in BH. Using the above described technology, a certain quantity of drugs and other materials has been treated in the city of Mostar. Various solutions, like infusions, were discharged in the sewers, the cardboard and other packaging separated, while the drugs themselves were encapsulated, and the barrels sealed with concrete and thus obtained concrete blocks were disposed at the city landfill. In all this, particular attention was given to the organisation of work i.e. to harmonious action of people from different areas of work - from pharmacists who made a selection of drugs, through experts in treatment, to direct operators - and to introduction of quality assurance system.

The possibility of incineration of drugs was also considered. The attention was focused particularly on the thermal power plant Kakanj (40 km north of Sarajevo). This TPP has wet bottom boilers, with temperature in the firebox reaching between 1500 and 1600^o C. These are 110 and 230 MW blocks with a relatively large retention span, so that it was estimated that all drugs could be incinerated, except the chemotherapeutic and narcotic drugs. This TPP has a stack 300 m high, so that the dilution of incineration products is possible on two grounds - with flue gases produced by burning coal (100 and 200 tons per hour), and in the atmospheric air, after leaving the stack. However, the very news of the possibility of incinerating drugs in TPP Kakanj provoked unfavorable reaction of local population, so that the management of TPP Kakanj declined even to discuss this proposal. Nevertheless, the fact remains that this TPP is very appropriate for incineration of unused drugs and other kinds of special waste.

1. Grayling, Tom: Guidelines for Drug Disposal, World Health Organization, Sarajevo March 1977.

2. Barbalic, N. and Jelavic.V.: Flue Gas Emission Limits and technical prerequisites necessary for waste incineration, Gospodarstvo i okolis J. Zagreb (1) 1996 .

3. Guidelines for Drug Donations, World Health Organization, May 1966.