Organizational aspects of the disposal of unusable medicines: a focus on consumers

Background

Against the backdrop of the existing problem of household waste disposal, for which no effective systemic solutions have yet been developed in our country, a specific task of collecting and safely disposing of unusable medicinal products (MPs) deserves particular attention. This issue requires special focus due to the potential hazard of such waste to the population and the environment [1].

Unusable medicinal products are a subset of medical waste and belong to the category of other waste generated in the course of pharmaceutical activities and the production of medicinal products [2].

Despite the existence and efficient functioning of the medicinal product manufacturing and distribution system in the Russian Federation, a system for the collection and disposal of unusable medicinal products stored in home medicine cabinets has not yet been established [3]. Consumers may possess medicinal products that have expired or have become unfit for use due to improper storage in household conditions, as well as leftovers of unused medicinal products. Unused medicinal products enter the environment together with household waste, affect nature and humans, or become objects of secondary use [1, 4].

Owing to the significant risks of harm to the environment and public health, ensuring proper disposal of unusable medicinal products by the population constitutes an important and pressing task.

Objective

The objective of this study is to conduct a situational analysis of the organisation of disposal of unusable medicinal products by the population.

Materials and Methods

The study materials included questionnaires from 238 consumers of medicinal products; regulatory and legal documents governing the destruction of medicinal products in the Russian Federation and the activities of pharmaceutical workers; and websites of organisations engaged in the collection and processing of medical waste.

For the purpose of assessing the current state of the organisation of disposal of unusable medicinal products, the Yaroslavl Region was selected.

The study comprised the following stages:

• Analysis of the regulatory and legal framework governing the destruction of unusable medicinal products;

• Assessment of the level of public awareness regarding the problems of medicinal product disposal;

• Identification of the role of pharmaceutical workers and pharmacy organisations in the system of destroying unusable medicinal products;

• Analysis of the activities of organisations involved in medical waste processing.

The research methods employed included content analysis, questionnaires, observation, synthesis, structural analysis, comparative analysis, and mathematical-statistical analysis.

Results

The destruction of medicinal products is the final stage in the medicinal product circulation system [5]. Federal Law No. 61‑FZ of 12 April 2010 [5] and Decree of the Government of the Russian Federation No. 1447 of 15 September 2020 [6] regulate the general principles, grounds, and procedures for the destruction of medicinal products, as well as the responsibility of their owners. However, the requirements of these regulatory legal documents apply exclusively to organisations engaged in pharmaceutical, medical, or manufacturing activities involving medicinal products. The issues of disposal of unusable medicinal products by the population currently remain outside the legal framework and are not subject to control.

The results of the questionnaire survey of medicinal product consumers made it possible to determine the population's approaches to disposing of unusable medicinal products, identify their main information needs, and reveal organisational problems in this area.

As the survey showed, the majority of respondents (64.7%) discard unusable medicinal products together with household waste. A substantial proportion of consumers (35.3%) dispose of these medicinal products into the sewerage system.

At the same time, most respondents (72.7%) are aware of the environmental problem caused by improper disposal of medicinal products. Of these, 23.5% consider this issue very important. Unfortunately, 18.1% of survey participants do not regard disposal as significant from an environmental perspective, which indicates insufficient public awareness of this problem.

The main obstacle to proper disposal is the population's lack of knowledge about collection sites for unusable medicinal products, as reported by 64.7% of respondents. Other reasons include lack of time (17.2%) and lack of willingness to engage in this activity (18.1%).

Nevertheless, the majority of respondents (81.9%) expressed their readiness to return unusable medicinal products to dedicated collection points. As possible locations for such points, respondents indicated pharmacy organisations (56.3%), medical organisations (35.3%), and shopping centres (8.4%).

An assessment of the population's information needs regarding the proper disposal of unusable medicinal products revealed the most preferred information channels: placement of informational materials in pharmacy organisations (54.6%), in mass media (31.9%), and in medical organisations (13.5%).

Analysis of responses to the question "Who should be responsible for the disposal of medicinal products?" showed that, in the opinion of 60.5% of respondents, responsibility should lie with pharmacy organisations and manufacturers; 28.9% assigned it to the state, and only 10.6% to consumers themselves.

The results obtained from the questionnaire indicate that the population expects a systemic approach and organisational measures to address the existing medicinal product disposal problem. Moreover, consumers of medicinal products attribute a significant role in this process to pharmacy organisations.

In this regard, the next stage involved an analysis of the existing potential for pharmacy organisations to participate in organising the collection of unusable medicinal products from the public. For this purpose, the requirements of regulatory documents governing the necessary knowledge and job tasks of pharmaceutical workers in the course of their professional activities were examined: the professional standards "Pharmacy Technician" [7], "Pharmacist" [8], and "Specialist in Pharmaceutical Management" [9].

The analysis of the requirements of professional standards for pharmaceutical workers enabling them to participate in the medicinal product destruction stage is presented in the table.

Table. Requirements of professional standards for the knowledge and actions of pharmaceutical workers in the field of destruction of medicinal products

Analysis of the professional standard "Pharmacy Technician" [7] showed that an employee of a pharmacy organisation with secondary pharmaceutical education must know the methods for identifying and sources of information on, as well as the procedure for handling, substandard medicinal products. Their job duties consist of identifying and withdrawing these medicinal products from civil circulation.

The professional standard "Pharmacist" [8] requires a specialist with higher pharmaceutical education to know the rules for destroying falsified and counterfeit medicinal products, without mention of substandard ones. However, it includes in the job duties of pharmacists the withdrawal from circulation of medicinal products that have become unfit for use or have expired.

The job duties of the head of a pharmacy organisation, in accordance with the professional standard "Specialist in Pharmaceutical Management" [9], include receiving information on substandard medicinal products and organising work with them. Knowledge of the procedure for handling such medicinal products is required.

The professional standards for all categories of pharmaceutical workers do not contain specific indications as to whether these actions apply only to medicinal products owned by the pharmacy organisation. Consequently, employees of pharmacy organisations should possess the knowledge and competencies necessary for organising the destruction of unusable medicinal products.

Currently, the collection of unusable medicinal products from the population in pharmacy organisations is not carried out. This is explained by the absence of clear mechanisms regulating the procedure for transferring medicinal products received from the public for destruction, as this aspect is not regulated at the legislative level.

Within the framework of the third stage of the study, the possibility for consumers of medicinal products to independently transfer unusable medicinal products for disposal was analysed. It was found that 65 organisations located in the Yaroslavl Region hold a licence for activities involving the collection, transportation, processing, disposal, neutralisation, and landfilling of hazard classes I–IV waste. Analysis of the information presented on the official websites of these companies revealed that only 39 of them provide medical waste processing services, including the disposal of unusable medicinal products. It was also found that the clients of disposal companies may only be legal entities, meaning that an ordinary consumer of medicinal products cannot avail themselves of the services of these organisations.

Discussion

Based on the results of the conducted study, it has been established that consumers of medicinal products currently have no possibility to hand over unusable medicinal products either to companies engaged in their disposal or to other organisations involved in the circulation of medicinal products. This situation creates barriers for that part of the population which has expressed readiness to adopt responsible handling of medicinal product waste and necessitates the development of solutions to this problem.

The following organisational measures are proposed:

1. Conducting an active information campaign aimed at raising public awareness of the risks associated with improper disposal of medicinal products.

2. Establishing collection points for unusable medicinal products from the public in pharmacy and medical organisations.

At the same time, regulating the subsequent destruction of medicinal products requires the adoption of decisions at the legislative level.

Conclusion

Thus, addressing the problem of disposal of unusable medicinal products by the population requires a comprehensive approach that includes the creation of specialised collection points, active engagement of medicinal product consumers through information campaigns, and the adoption of legislative measures, which will contribute to improving the environmental situation and protecting public health.