Medicines and Medical Devices Agency of Serbia

PHARMACEUTICAL AND CHEMICAL WASTE MANAGEMENT

ISWA Beacon Conference, Novi Sad, 08 – 10 December 2010

Ivana Bozic, MScHealth, Safety and Environment

458, Vojvode Stepe StreetBelgrade 11152

Serbia

www.alims.gov.rs

www.alims.gov.rs

OUTLINE

• INTRODUCTION

• EMS, WASTE MANAGEMENT / HAZARDOUS WASTE MANAGEMENT

• LEGAL FRAMEWORK

• CHEMICAL WASTE

• PHARMACEUTICAL WASTE

• CONCLUSION

www.alims.gov.rs

INTRODUCTION

• Waste represents an enormous loss of resources in the form of both materials and energy.

• The amount of waste produced can be seen as an indicator of how efficient we are as a society, particularly in relation to our use of natural resources and waste treatment operations.

• Historically, waste management systems were introduced to protect public health.

• In the 1970s and 1980s, waste management systems focused on controlling outlets to air, water and groundwater. In recent years, the focus has been increasingly on utilising waste as a resource.

• Even though several measures have been introduced to reduce waste quantity, waste volumes still increase.

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• Waste management at the Medicines and Medical Devices Agency of Serbia has commenced by organizing the activities of treatment, primarily hazardous waste, and today it includes all types of waste which is generated.

• Namely, even before Environmental Management System was introduced and certified in July 2007, ALIMS has demonstrated its commitment to protect the environment by disposing of hazardous waste generated in the operation processes in a safety manner.

• The recertification of the Environment Management System has been completed this year. During the recertification visit no non-compliance was found, so that certificate of compliance of management system in accordance with the requirements of ISO 14001:2004 covers the period until July 2013.

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WASTE MANAGEMENT AT ALIMS

• At the same time was surveillance visit for the Quality Management System, which confirmed full compliance of the implemented system with the requirements of ISO 9001:2008.

• The importance of introducing these systems, as well as their continuous improvement is not just a current trend, but also an obligation, if we want to save the planet for future generations.

• Waste management is regulated by the standard procedures and guidelines of environmental management and quality management system.

• All generated waste is collected at the source, then it is classified, properly marked, stored and destroyed or recycled, depending on whether it is hazardous or non-hazardous waste. For all types of waste, the records are kept and competent authorities informed.

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HAZARDOUS WASTE MANAGEMENT AT ALIMS

Hazardous waste

pharmaceutical chemical biohazard computer waste fluorescent tubes

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LEGAL FRAMEWORK

• More than 30% of all the regulations that our country should adopt and implement, in the process of European integrations, concern the field of environmental protection.

• In 2003, Serbia adopted a National Waste Management Strategy, which is the basic document to provide cost-effective and sustainable waste management. In 2009 and 2010 it was reviewed and a new strategy was adopted in April this year.

• Management of medical and pharmaceutical waste in Serbia is the responsibility of two ministries: the Ministry of Health and Ministry of Environment and Spatial Planning.

• The Law on Environment Protection generally regulates certain issues of waste management and addresses the regulation of this area by special act on waste management.

• Law on Waste Management had long been in parlamentary procedure and was adopted in May 2009. Law defines: types of waste, classification, waste management planning, generators duties and responsibilities, management of special waste streams, permits for transboundary shipments, financing, inspection... Although the compliance period has passed (... legal entities will coordinate their operations within a year ...), and the Law defines the huge fines for non-compliance, inspections will in near future still act advisory.

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LEGAL FRAMEWORK

• Some obligations of generators of medical waste in accordance with the Law include:

• the classification of waste

• preparation of waste management plan

• appointing of person in charge of waste management

• keeping records and

• delivery of data to Agency for environmental protection.

• The delivery of data is made in accordance with Regulation on the methodology for making the integral cadastre of polluters (Form 8 -Medical waste) and data are delivered not later than March 31 for the previous year. ALIMS is the first institution in Serbia that entered the integral cadastre of polluters.

www.alims.gov.rs

www.alims.gov.rs

LEGAL FRAMEWORK• Regulation on Medical Waste Management has been applied since

November 2, 2010. These rules regulate the separation, collection, transport, treatment and disposal of medical waste; in line with the new Directive on Waste 2008/98/EC (EU Member States should implement and start applying it by December 1, 2010), 91/689/EEC Directive on Hazardous Waste and 99/31/EC Directive on Landfill Waste.

• The rules specify the manner and content of medical waste management plan, management of medical and pharmaceutical waste, and the obligation of pharmacies to take over the expired medicines from the citizens.

• The novelty is the clearly defined uniformity in packaging and labeling the waste, for example, all cytotoxic waste shall be in purple containers, pharmaceuticals in red bags and containers ... The labels shall have the symbol for indicating the waste, the date of waste generation, the index number and name of the type of waste, quantity of waste and the name of the person who filled in the label.

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LEGAL FRAMEWORK• The regulation defines medical waste

as the waste generated in the provision of health care services to people, which comprise the non-hazardous and hazardous waste as defined in the Waste Catalogue.

• non-hazardous medical waste (not contaminated with hazardous or other substances, and which by its composition is similar to municipal waste)

• hazardous medical waste (patho-anatomical, sharp objects, pharmaceutical, cytotoxic, waste contaminated with blood and body fluids, infectious and highly contagious, other hazardous medical waste-chemicals, waste with high content of heavy metals, waste containers under pressure)

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CHEMICAL WASTE – WAYS OF DISPOSAL

• There is no way to dispose both safely and cheaply of significant quantities of hazardous chemical waste. The appropriate means of disposal is dictated by the nature of the hazard presented by the waste. One is certain, hazardous chemical waste should not be discharged into sewerage system.

• Some combustible wastes, including many solvents, may be incinerated (large quantities of halogenated solvents should not be undertaken unless facilities have adequate gas-cleaning equipment).

• Other possibilities include return to the original supplier, who should be equipped to deal with them safely (appropriate provisions should be included in the original purchase contract for the chemicals).

• The waste could also be exported to a country with the expertise and facilities to safely dispose of hazardous waste. Shipment for this purpose should comply with international agreements, such as Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal.

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• Chemical waste is, depending on the physical state and character of waste / chemicals, classified into: solutions of acids and bases, HPLC waste, organic solvents, solutions of cytostatics and chemicals in the solid state.

• Chemical waste in liquid state, which occurs during the implementation of tests in laboratories, is collected at the source in glass bottles of 1l or 2.5l, located in digesters or near the place of application. When the bottles are full, their contents are stored in canisters of waste material (10L volume) that are marked as follows:

• Container No. 1 - HPLC waste

• Container No. 2 - TLC wastes (organic solvents)

• Container No. 3 –ACIDS AND BASES

• Container No. 5 - CYTOSTATICS.

CHEMICAL WASTE MANAGEMENT AT ALIMS

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CHEMICAL WASTE MANAGEMENT

AT ALIMS

• Canisters are placed in temporary storage, and each employee who pours waste also completes the form "List of chemical waste“, which is located in a suitable place near canister. A special folder with the records is kept for each type of waste. Filled canisters are emptied into noncorrosive, plastic barrels, capacity of 25l, with waste labels as indicated above. Plastic barrels are stored in the ″Hazardous Waste Storage" until their transport.

• Solid chemical waste (solid chemicals, standard substance), which is generated during the tests, is deposited in a glass bottles, while the chemicals with expired date or of inadequate quality are disposed in the original packing in a container no. 4 - CHEMICALS. The records of disposed chemical are kept on the form "List of chemical waste".

www.alims.gov.rs

www.alims.gov.rs

www.alims.gov.rs

• Incineration is the best way to dispose of pharmaceutical waste.

• Low-temperature incineration (<800°C), however, provides only limited treatment for this type of waste; it is not recommended unless it is followed by combustion in a second chamber, operating at temperatures about 1000°C, to burn off potentially toxic exhaust gases that may be produced.

• Ideally large amounts of pharmaceuticals should be treated in incinerators designed for industrial waste (rotary kilns for example) which can operate at high temperatures (>1200°C). Cement kilns are also particularly suited to the treatment of pharmaceuticals; in many countries cement producers accept pharmaceutical waste as an alternative fuel, thus reducing fuel cost.

• However, it is suggested that no more than 1% of the fuel fed into the furnace at any time is pharmaceutical material.

PHARMACEUTICAL WASTE –WAYS OF DISPOSAL

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CYTOTOXIC WASTE

• Full destruction of all cytotoxic substances may require temperatures up to 1200°C.Incineration at lower temperatures may result in the release of hazardous cytotoxic vapours into the atmosphere. Double chamber pyrolitic incinerators are suitable, provided that a temperature of 1200°C with minimum gas residence time of 2 seconds or 1000°C with minimum gas residence time of 5 seconds can be achived in the second chamber. The incinerator should be fitted with gas-cleaning equipment. Incineration is also possible in rotary kilns designed for thermal decomposition of chemical wastes, in foundries, or in cement kilns, which usually have furnace operating well in excess of 850°C.

• Incineration in most municipal incinerators, in single chamber incinerators or by open-air burning is inappropriate.

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• Pharmaceutical waste consists of samples of expired medicines which are stored in the warehouse of samples and samples of medicines that remained in the laboratory after conducting tests. Pharmaceutical waste is classified into four groups: cytostatics, narcotics, biological products and other medicines.

• The medicines that remained in the laboratory after testing (not cytostatics and narcotics) are disposed in bags marked "for destruction" and they are recorded on a special form "List of samples for destruction." Biological products are autoclaved before disposal. When bags are full, samples of medicines are stored in metal barrels capacity of 200 L, which are labeled with SAMPLES FOR DESTRUCTION.

• Barrels are placed in the "Hazardous Waste Storage", which is located outside the building of ALIMS. The access to storage is limited, and keys to the warehouse have only persons in charge of waste disposal.

PHARMACEUTICAL WASTE

MANAGEMENT AT ALIMS

www.alims.gov.rs

PHARMACEUTICAL WASTE

MANAGEMENT AT ALIMS

• The expired medicines, from the warehouse of control samples (other than cytostatics and narcotics), are removed from the stock by using the corresponding applications of ALIMS’s information system and they are disposed in barrels labeled SAMPLES FOR DESTRUCTION. The list of samples for destruction is printed from information system.

• Treatment of cytostatics and narcotics, because of their nature, is strictly controlled. Specifically, expired cytostatics, are deposited into a barrel labeled SAMPLES FOR DESTRUCTION - CYTOSTATICS, which is stored in the "Hazardous Waste Storage" until transport.

• Narcotics are stored separately in a vault, under lock and key, according to the Law on substances used in prohibited production of narcotic drugs and psychotropic substances, and they are removed from the stock in presence of all members of the internal Commission for destruction of narcotic drugs and psychotropic substances.

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• Incineration has a number of outputs such as the ash and the emission to the atmosphere of flue gas.

• Before the flue gas cleaning system, the flue gases may contain significant amounts of particulate matter, heavy metals, dioxins, furans, sulfur dioxide and hydrochloric acid.

• In a study from 1994, Delaware Solid Waste Authority found that, for same amount of produced energy, incineration plants emitted fewer particles, hydrocarbons and less SO2, HCl, CO and NOx than coal-fired power plants, but more than natural gas fired power plants.

• According to Germany’s Ministry of the Environment, waste incinerators reduce the amount of some atmospheric pollutants by substituting power produced by coal-fired plants with power from waste-fired plants.

INCINERATION – SOME PROS AND CONS

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• As for the hazardous waste in our country there is no adequate treatment, it is exported to EU countries that have incinerators, where it will be destroyed properly. Pharmaceutical waste generated in ALIMS is destroyed in Vienna incinerator, where it is turned into useful waste and used for city heating. Chemical waste has no practical value, but is destroyed in Basel by incineration.

• Before export by an authorized organization, it is necessary to provide a Report on the character of waste. An integral part of the request are details about medicines and chemicals that are destroyed.

• List of samples for the destruction is very detailed and contains the following information:

control number of the sample, name of product, name of manufacturer, series / lot samples, group that active substance belongs to (analgesic, antibiotic, antirheumatic, etc...), pharmaceutical form, active ingredient / generic (INN), chemical formula, expiration date andquantity (kg).

WASTE EXPORT

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WASTE EXPORT

• After sampling, the waste is analyzed. Based on the analysis, one of six authorized organizations for waste sampling (at the moment) will issue report (it defines index numbers of waste and radioactivity).

• The transport of hazardous waste is followed with the Document on the transport of hazardous waste signed by all who take over the waste (Article 46, Law on Waste Management and Regulation on the form of documents on the movement of hazardous waste and instructions for filling out).

• The procedure for obtaining licenses for the export of hazardous waste is very complex and requires notification of Customs, Ministry of Environment and Spatial Planning, as well as all the countries of transit that such cargo is in transit through their country, licenses of the ministries of ecology in those countries...

• Export is carried out in accordance with the principles of Basel Convention whereby ALIMS receives the certification that the waste is received and destroyed by the registered plant in the EU.

www.alims.gov.rs

www.alims.gov.rs