Unused medications, whether over-the-counter or prescription, as well as medical devices, are classified as waste or hazardous waste and must be disposed of in a specific manner prescribed by applicable laws and regulations. Medications contain hazardous chemicals whose components, if disposed of improperly, can be released or interact with various other chemicals, thereby contaminating soil, groundwater, or air, which can have a negative impact not only on human health but especially on the environment. The purpose of this article is to inform the public about how to properly dispose of medicines, primarily from a legal perspective, so as to eliminate risks to human health and the environment that could arise if the obligations of the relevant entities were not complied with, and also to highlight the fact that these obligations have a legal basis in the extensive legislation governing this area.
The primary legal regulations governing the disposal of medicines are:
- Act No. 362/2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts (hereinafter also referred to as the “Medicines Act”)
- Act No. 79/2015 Coll. on Waste and on Amendments to Certain Acts (hereinafter also referred to as the “Waste Act”)
- Act No. 139/1998 Coll. on Narcotic Drugs, Psychotropic Substances, and Preparations
- Act No. 331/2005 Coll. on State Administration Bodies in Matters of Drug Precursors and on Amendments to Certain Acts
- Decree of the Ministry of the Environment of the Slovak Republic No. 371/2015 Coll., implementing certain provisions of the Waste Act
- Decree of the Ministry of the Environment of the Slovak Republic No. 365/2015 Coll., establishing the Waste Catalogue
- Decree of the Ministry of Health of the Slovak Republic No. 129/2012 Coll. on requirements for good pharmacy practice
- Guidelines of the Ministry of the Environment of the Slovak Republic on the classification of waste medicines according to the Waste Catalogue
- EU Commission Regulation No. 1357/2014 of December 18, 2014, replacing Annex III to Directive 2008/98/EC of the European Parliament and of the Council on waste and repealing certain Directives
Section 2(1) of the Waste Act defines waste as any movable object or substance of which the holder disposes, intends to dispose, or is required to dispose in accordance with this Act or specific regulations, while the Waste Act also directly refers to the Medicines Act.
Pursuant to Section 74(1) of the Medicines Act, human medicines are disposed of in accordance with a special regulation, namely the Waste Act. Pursuant to Section 103(8) of the Medicines Act, veterinary medicines are disposed of in accordance with a special regulation, namely the Waste Act. Pursuant to Section 117(9) of the Medicines Act, medical devices are disposed of in accordance with a special regulation, namely the Waste Act.
Pursuant to Section 74(2) of the Medicines Act, the holder of a license issued in accordance with the Medicines Act is considered the waste generator and has a legal obligation to ensure its disposal, at their own expense and under the conditions set forth in the Waste Act, except in the case of human medicines not consumed by natural persons.
Pursuant to Section 74(3) of the Medicines Act, a public pharmacy is required to collect human medicines not consumed by natural persons and to hand them over to the State Institute for Drug Control (ŠÚKL), which is considered the generator of this waste and is obligated to ensure its disposal at its own expense and under the conditions set forth in the Waste Act. Similarly, pursuant to Section 103(12) of the Medicines Act, a public pharmacy is required to collect veterinary medicines not consumed by individuals and hand them over to the State Institute for Drug Control (ŠÚKL), which is considered the generator of this waste and is obligated to ensure its disposal at its own expense and under the conditions set forth in the Waste Act.
Pursuant to the ŠÚKL Methodological Guideline - MP 105/2020, effective as of June 1, 2020 - DISPOSAL OF MEDICINES NOT CONSUMED BY INDIVIDUALS (the purpose of which is to determine the proper handling and collection of hazardous waste—medicines not consumed by individuals—in public pharmacy premises) issued by the State Institute for Drug Control (hereinafter also referred to as “ŠÚKL”), the classification of medicine waste according to the waste catalog is as follows:
Waste from medicines not consumed by individuals is classified under:
- Cat. No. 200131 cytotoxic and cytostatic medicines – hazardous waste,
- Cat. No. 200132 medicines other than those listed in item 200131 – other waste
According to the Ministry of the Environment of the Slovak Republic’s guidelines on the classification of pharmaceutical waste according to the waste catalog, the following are classified as such waste:
- Hazardous waste with cat. no. 200131 arises from all medicines listed in the list of medicines, including medicines containing OPL and precursors, and medicines with cytostatic and cytotoxic effects.
- Hazardous waste with cat. no. 200131 also includes drug delivery systems if the medical device and the drug form a single product intended exclusively for use in that combination and not intended for reuse, e.g., medicated patches (transdermal delivery systems), intrauterine devices containing progestin, pre-filled syringes, aerosols containing drugs, etc.
- Hazardous waste with category number 200131 does not include waste from dietary supplements (vitamins and other dietary supplements), cosmetic products, and medical devices.
- Other waste with category number 200132 arises from homeopathic medicines and medicinal plants.
In connection with the disposal of unused human medicines by individuals, we may further mention, in addition to the obligations of the State Institute for Drug Control (ŠÚKL) and public pharmacies, the obligations of municipalities in this area.
Pursuant to Section 81(8)(e), fourth point, of the Waste Act, it is the municipality’s obligation to regulate, in a generally binding ordinance and in accordance with the waste management hierarchy, the details regarding the method and conditions for the separate collection of municipal waste, in particular the collection of, among other things, veterinary medicines and human medicines not consumed by individuals, and medical devices.
The State Institute for Drug Control (ŠÚKL) has entrusted the company MODRÁ PLANÉTA, spol. s. r. o., with the organizational arrangements and execution of the disposal of collected medicines not consumed by individuals, in accordance with the results of a public procurement procedure. Waste from pharmacies is collected at regular intervals by employees of this company. Waste collection takes place twice a year, i.e., during the spring collection (March–April) and the fall collection (October–November). In addition to regular collection, irregular collection is also carried out in the event of an emergency or the closure of a pharmacy, as well as summer collection at selected pharmacies with larger amounts of waste.
In accordance with Decree No. 129/2012 Coll. of the Ministry of Health of the Slovak Republic on requirements for good pharmacy practice, the basic equipment of a public pharmacy includes a container designated for the collection of medicines not consumed by individuals, located outside the dispensing area and rooms for storing medicines, medical devices, and dietary foods. Human medicines not consumed by individuals do not include, for example, waste from dietary supplements (such as vitamins or other dietary supplements), cosmetic products, homeopathic medicines, or medical devices. In practice, it is therefore very important to distinguish whether the item is a medicine, a dietary supplement, or a medical device.
Based on the legal definitions in the Medicines Act, a medicine is a drug or a mixture of drugs and excipients that have been processed into a medicinal form and are intended for the prevention of diseases, the diagnosis of diseases, the treatment of diseases, or the modification of physiological functions.
A medical device is an instrument, apparatus, equipment, substance, or other product used alone or in combination, including a computer program necessary for its proper functioning, intended by the manufacturer for diagnostic, preventive, monitoring, or therapeutic purposes, to alleviate a disease or to compensate for an injury or disability, to examine, replace, or modify an anatomical part of the body or a physiological process, or to regulate conception, the principal effect of which is not achieved by pharmacological, immunological, or metabolic means, but whose action may be supported by such means; Accessories for a medical device that are specifically intended by the manufacturer for use with the medical device are also considered medical devices.
If a medical device and a medicinal product form a single product intended exclusively for use in that combination and not intended for repeated use, the product is registered as a medicinal product and may be dispensed by a pharmacist in a public pharmacy. Examples include medicated patches, dressings whose primary function is to “deliver” the drug, and single-use syringes for people with diabetes or for blood clotting disorders.
Unused or unconsumed medicines are returned to a public pharmacy only in their inner packaging, i.e., in a blister pack, glass or plastic container, or aluminum tube. The outer paper packaging and package insert belong in regular household waste. In public pharmacies, unused human medications are placed in a thick, transparent polyethylene bag, while used syringes, which form a single unit with the needle, are collected separately in plastic bottles. A public pharmacy must not place medicines that have expired or have otherwise been rendered unusable during their storage and retention in the public pharmacy into the bag for medicines not used by individuals.
Procedure for the disposal of human medicines not used by individuals:
1) The individual hands over the unused human medication at a public pharmacy
2) At the public pharmacy, the collected hazardous waste is weighed on calibrated scales
3) MODRÁ PLANÉTA, spol. s. r. o. will transport the waste, and an employee of this company:
- issues a confirmation of the quantity of waste collected, which is confirmed by the signature and stamp of both the responsible employee of the public pharmacy and the employee of MODRÁ PLANÉTA, spol. s. r. o.
- hand over empty transparent bags to the responsible employee of the public pharmacy
- label the bags containing waste with the name and address of the public pharmacy and transport them to the hazardous waste incinerator
4) An employee of the hazardous waste incinerator will confirm the hazardous waste consignment note and record the amount of waste delivered
5) The hazardous waste consignment note shall be checked by an authorized employee of the State Institute for Drug Control (ŠÚKL)
6) The public pharmacy shall submit confirmation of the quantity of waste collected from the public and its own waste to the ŠÚKL inspection authorities during an inspection conducted at the public pharmacy
Source:
- Relevant legislation
- ŠÚKL Methodological Guideline - MP 105/2020 effective as of June 1, 2020 - DISPOSAL OF MEDICINES NOT CONSUMED BY INDIVIDUALS
