The International Conference “Obsolete Pharmaceuticals: Impact On The Environment”

Organizers of conference: Center for Environmental Solutions (CES), Ministry of Natural Resources and Environmental Protection of the Republic of Belarus

The conference was supported by GEF Small Grants Programme, European Union, Coalition Clean Baltic.

PROBLEM DESCRIPTION

There is a growing concern about the damage that can be caused by the pharmaceuticals getting into the environment. Residues of drugs and their metabolites are released into the environment during the production and disposal of unused pharmaceuticals, as well as because of human consumption and treatment of animals.

The topic “Environmentally Persistent Pharmaceutical Pollutants” (EPPP) was named as an emerging issue under the Strategic Approach on International Chemicals Management (SAICM).

Annually in Belarus more than 300 million packages of various drugs are sold, some of which go to the landfills, are washed into sewage system polluting the water and environment.

In 2015-2016 Center for Environmental Solutions has been implementing project “Obsolete pharmaceuticals in the environment: developing a sustainable approach” in Belarus with support of GEF Small Grants Programme. The project aims to assess the current situation and to include the issue of obsolete pharmaceuticals into the spectrum of environmental and health problems in Belarus, as well as to offer a solution for obsolete pharmaceuticals collection from the public and further treatment.

THE PROBLEM FIELD

  • Detection of pharmaceuticals in the environment.
  • Experience in organizing collection and recycling of pharmaceuticals from the public.
  • Methods of obsolete pharmaceuticals treatment.
  • Raising public awareness on obsolete pharmaceutical impact on health and environment and correct treatment methods.
  • International and Belarusian legislation in the sphere of expired pharmaceuticals management.

CONFERENCE PARTICIPANTS

  • Representatives of state authorities that implement policy on pharmaceuticals management, environmental protection and public health;
  • Representatives of research institutions;
  • Representatives of pharmaceuticals manufacturers and distributors;
  • Representatives of non-governmental environmental organizations.

THE OUTCOMES OF THE CONFERENCE

 All conference presentations were structured into the following three sections.

The first section focused on environmental pollution by the pharmaceuticals, in particular the level and sources of pollution, and the transformation of the pharmaceuticals within the environment.

The second section was dedicated to the methods of collection and disposal of the pharmaceuticals waste, highlighting the ones safest for the environment.

The third section gave an overview of the legislative regulation of pharmaceuticals waste management, including analysis of the existing European legislation and assessment of the Belarusian legislation for its subsequent optimization.

1. Environmental pollution by the pharmaceuticals

The general situation on the entry of pharmaceuticals waste into the water sources in Belarus was presented by Natalia Blyschik, Project Coordinator at the Center  for Environmental Solutions (CES), Belarus.

The main sources of pollution in Belarus include: production, consumption of pharmaceuticals and use of veterinary pharmaceuticals in cattle breeding and aquaculture.

In terms of consumption the leadership in Belarus belongs to the analgetics followed by anti-bacterial drugs.

The results of a sociological survey conducted within the project have demonstrated that the principal method of pharmaceuticals waste disposal by the population is throwing in the trash bin without opening the packaging.

Ignacio Sanchez Diaz, Greening Health Systems Specialist, UNDP (Istanbul) gave a presentation on Environmental Safeguarding and Healthcare Waste Management in the Context of UNDP Work.

UNDP has developed an assessment on the medical waste management in the Global Fund projects implemented in Belarus, and gave a number of recommendations for the system optimization.

The UNDP focus is on enhancing the global partnership for sustainable development by promoting public procurement practices that are sustainable.

Adela Maghear, Pharmaceuticals Policy Officer, HCWH-Europe (Belgium) reported on the current state of obsolete pharmaceuticals problem in the European Union.

Mrs. Maghear described the pollution sources by the pharmaceuticals waste giving special attention to the fact that a total of about 3,000 active pharmaceutical ingredients is available at the European market.

Wastewater treatment plants are unable to completely filter the improperly disposed pharmaceuticals. Residues can reenter the water supply and spread to other environmental compartments (e.g., surface waters, agricultural lands). Up to 25 different pharmaceuticals have been detected in drinking water around the world.

Field and laboratory studies were conducted to define the list of pharmaceuticals with highest priority for monitoring. These were included into so-called “Watch List”. Diclofenac and two synthetic oestrogens are included on the Watch List of substances subject to EU-wide monitoring under the Water Framework Directive (Directive 2013/39 / EU).

In autumn 2016, the Commission will propose a Roadmap on PiEs (pharmaceuticals in the environment). It will concentrate on collection schemes, guidelines in order to create a harmonized system within EC.

Pollution by pharmaceuticals in the Baltic Sea region was presented by Mikhail Durkin, Coalition Clean Baltic Secretariat (Sweden).

About 2200 t of active pharmaceutical ingredients enter the Baltic sea region annually through the waste water treatment plants. The main loads are caused by: cardiovascular, central nervous system and anti-inflammatories and analgesics (diclofenac, ibuprofen and paracetamol being most frequent). The major sources of pharmaceuticals in the environment are excretion by humans and animals as well as incorrect disposal.

Vast observations have been undertaken recently collecting data from 7 out of 9 coastal states (45000 source/ path and 4600 sea/ coastal samples). Those have proved lack of wide-spread advanced waste water treatment plants technology applied across the region – only few pilot plants (e.g. 2 in Sweden). Decreasing the total consumption of pharmaceuticals is important, for that the population needs to be educated to buy less. Eco-labelling of pharmaceutical products can help doctors, pharmacists and consumers to consider environmental perspectives when choosing medication.

Results of research on Pharmaceuticals in wastewater conducted in Belarus were summarized by Natallia Shepeleva, Belarussian State Technological University.

Based on the analysis of medicines consumption in Belarus a list of the most demanded medicines was created. These are most likely to be found in municipal wastewaters: lisinopril, diclofenac, 17-beta-estradiol, 17-alpha-ethinyl estradiol, ampicillin, cefotaxime, ciprofloxacin, ketoprofen, drotaverine levofloxacin. High performance liquid chromatography method was used to investigate the content of pharmaceuticals in the samples. Solid phase extraction method was implemented for the sample purification.

There are two routes the treated wastewaters impact the environment.

The first route: the biological treatment waste consisting of a mixture of raw sludge and excess activated sludge with accumulated pharmaceuticals is sent to a long-term storage into the detention ponds. These ponds in most cases are not equipped with a waterproof base, which leads to medicines infiltering into the ground waters.

The second and the main route: discharge of treated wastewater into the receiving facilities where the medicines effect on aquatic organisms and aquatic ecosystems.

2. Methods of collection and disposal of the pharmaceuticals waste

The second section of the conference was opened by a presentation on the Centralized system of medical waste treatment at the medical institutions and collection of hazardous waste from the population of Saint Petersburg by Dmitry Krutoy, Committee for Nature Use, Environmental Protection and Ecological Safety (Saint Petersburg).

In 2013-2014 a project on the collection of medical waste Class B has been implemented in SPb with the participation of 11 major city health institutions. There are 4.5 thousand tons of medical waste Class B generated annually in Saint Petersburg (SPb).

About 2,000 tons of medical waste Class B were collected and disposed of during the pilot project. Waste was collected by a specialized state organization SPb GUPP “Ekostroy”. Waste treatment was executed at a thermal neutralization installation “Pennram ESS”.

As a result, the project worked out a system of interaction at all stages of the system: collection, transportation, treatment, depositing.

Since 2010 regular collection of hazardous waste (including mercury thermometers, expired medicines) became available for SPb inhabitants via a mobile receiving station “Ecomobile” that regularly attended all parts of the city. Schedule of “Ecomobile” parking is compiled annually based on proposals from administrations of districts and municipalities. Stationary collection points for hazardous waste were opened in 2012 in three city districts.

The concept of obsolete pharmaceuticals collection and treatment in Belarus currently elaborated by Centre for Environmental Solutions was introduced by Natallia Blyshchyk, Project Coordinator, CES (Belarus).

Two different approaches are applied for regulating the production and consumption waste in Belarus.

Production waste is regulated by the waste management legislation. Consumption waste (pharmaceuticals waste generated in the population) is subject to the municipal household waste management requirements.

The methods of pharmaceuticals waste treatment: burning at 1200°C, two-stage pyrolytic incineration (at temperature 800-850°C), chemical decontamination, microwave irradiation dumping at the landfill.

The method applied currently (in accordance with the medical waste treatment rules in Belarus) is burning at 1200°C (applied since 2014). Prior to this, a two-stage pyrolytic incineration (at temperature of 800-850°C) or dumping at the landfill with waste encapsulation were applied in the country.

Chemical decontamination and microwave irradiation are not yet introduced in Belarus. However, a microwave irradiation installation is developed by the Belarusian National Technical University (undergoing testing at the moment).

At this stage the municipal waste management schemes in Belarus do not set up a procedure for the pharmaceuticals waste collection from the population. The medicines labeling does not include information on the method of disposal.

Based on the experience of hazardous waste collection in Europe and in Belarus, waste collection by specialized companies having financial interest in collecting waste appears to be the most efficient.

The pharmacies and medical institutions could provide the space for the special containers installation (without an obligation to organize the collection of pharmaceuticals waste from the population).

Extended Producers Responsibility principle is applied in Belarus to electronic waste, and this scheme could serve as an example for the pharmaceuticals waste management.

Viktor Golubev, PhD at Belarusian National Technical University, examined several environmentally neutral methods of pharmaceuticals treatment, and described the installation for the medical waste treatment using microwave irradiation developed in 2015. This installation will be introduced into service in several health institutions in Belarus as a pilot project.

International experts have underscored the importance of chemical decontamination as the most secure method of pharmaceuticals treatment – as a perspective method to be introduced for Belarus.

Adela Maghear, Pharmaceuticals Policy Officer, HCWH-Europe (Belgium) reported on a study conducted in 2013 in the European Union (EU) on pharmaceutical waste treatment in different countries of the EU.

HCWH conducted a snapshot report in 2013 “Unused Pharmaceuticals – Where Do They End Up?” to assess the obsolete pharmaceuticals collection system from the population in Europe. Survey was carried out in the capitals of six European countries: Belgium, Hungary, Italy, Lithuania, Portugal, the United Kingdom.

At EU level this issue is regulated by directive Directive 2004/27 / EC (relating to medicinal products for human use) that introduces an obligation for Member States to implement appropriate collection schemes for unused pharmaceutical products (without providing any guidelines on implementation of schemes).

Before being placed on the European market, pharmaceuticals have to undergo an authorization process. The application must contain “an indication of any potential risks presented by the medicinal product for the environment”, and “specific arrangements to limit it [the environmental impact] shall be envisaged” (Directives 2001/83/EC and 2004/27/EC)

3. Legislative regulation of pharmaceuticals waste management

Irina Ilyukova, Head of the Laboratory of Preventive and Environmental Toxicology, State Enterprise “Scientific and Practical Centre of Hygiene” elaborated further on legislative regulation (the third section of the conference) with a presentation on problems and prospects of pharmaceuticals management in Belarus.

The quantity of medical waste classified as “production waste” generated in Belarus makes about 30 thousand tons (0.1% of the total production waste).

The expert noted a steady increase in medical waste generation, growth of pharmaceuticals production volumes, lack of hygienic standards and methods for the medicines content determination in the production area air, as well as complexity of the impact control in different components of the environment (water, soil, air).

The cytostatics treatment appears to be a problem as there is no sufficient information on which residues are formed after the combustion; high probability that hazardous dioxins are formed in process of medical waste pyrolytic destruction.

Monitoring of pollutants in the water bodies in Belarus was presented by Marina Eresko, Head of Environmental Monitoring Department of the State Entreprise “BelRSC “Ecology”.

The national environmental monitoring system was established in 1993 and comprises of 12 self-organizational types of environmental monitoring.

Ministry of Natural Resources and Environmental Protection defined a list of items (location, status), the frequency and parameters of observations for each item:

  • hydrological indicators (resources of river flow, water flow)
  • hydrobiological indicators: taxonomic diversity of communities.
  • hydro-chemical indicators:
    • elements of the basic salt composition
    • exponents of the physical properties and gas composition;
    • organic substances;
    • nutrients;
    • metals;
    • pestitcides (only on cross-border sections of water flows);
    • chlororganic hydrocarbons and polychlorinated biphenyls (only on cross-border sections of water flows).

In order to introduce a pollutant into the monitoring system, it is necessary to have: the rationale (purpose, objectives, achievable effect, source of financing), the availability of measurement techniques and an accredited laboratory.

FURTHER DEVELOPMENT OF THE TOPIC IN BELARUS

First of all, a concept of pharmaceuticals waste management for the waste generated by the population is needed in Belarus. The concept draft is under preparation by the Centre for Environmental Solutions and is due in August 2016 when it will be submitted to the Ministry of Health. The second step would concentrate on creation of a pilot project for the testing of the proposed concept.

Participants of the Conference proposed the following actions as a “road map” – a list of the primary steps to be taken in the field of obsolete pharmaceuticals management:

  1. Analyze the legal framework for medical waste management, to introduce changes into the legislation to ensure proper problem-solving process.

2. Evaluate the methods used for medical waste treatment and develop recommendations for the process optimization.

  • Consider separately the question of medical waste treatment (including the pharmaceutical industry waste) using international experience.
  • -Pay attention to the safe treatment of cytotoxic waste.
  • -Encourage the development of centralized systems for medical waste treatment.
  • -Reduce the consumption of disinfectants and promote the use of autoclaving.
  • -Implement risk assessment criteria for the safe waste management.

3. Conduct analysis and classification of medicines depending on the hazard level for a human and the environment, create a database and develop recommendations on safe methods of disposal depending on the class of hazard.

  • Create the Belarusian Watch list – an analogue of a European Watch list (the list of medicines to the EU Framework Directive). This list needs to be created on the basis of a study of the medicines consumption at Belarusian market, as well as on the basis of analytical research of pharmaceuticals waste content in Belarus water bodies.
  • Develop recommendations on methods of environmental pollution control.
  • Conduct additional research and monitoring, to analyze the entry, traffic and environmental impact of the pharmaceuticals waste. The studies conducted currently will give primary data. For a complete situation analysis an extensive research is necessary. Such research will give the reasons for the inclusion of persistent and hazardous pharmaceuticals into the list of constantly monitored indicators.

Note: Funding for the monitoring activities can be procured within a framework of an international project with Finnish partners as well as partners from St. Petersburg.

4. Determine the role of industry, importers.

Based on the principle of the extended producer’s responsibility described in the Decree 313 and currently implemented when handling electronic waste, to develop an analogue to the pharmaceuticals waste. It is important to use positive European experience in extended producer’s responsibility for pharmaceuticals waste. By the time when a medicine gets to the market the manufacturer should have a clear understanding how it will be treated.

5. Develop the concept of medical waste collection from the population, taking into account the experience of other countries.

  • Work with the authorities on the development of a holistic concept that includes collection system, transportation, treatment and depositing.
  • Implement a pilot project for the installation of containers in public places/ pharmacies and launch “Ecomobile” – mobile waste collection point.
  • Organize an informational campaign in mass media highlighting the impact of drugs on the environment and human health.

6. Share information and experience with international organizations within the framework of the network Health Care Without Harm (of which Center for Environmental Solutions is a member).

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