Analysis of Identified risks in the release of over-the-counter medicines to Teenagers

 

Anastasia Sinitsyna1*, Maria Denisova2, Tatyana Litvinova1, Irina Glazkova1,

Olga Savinova1, Dmitrii Babaskin1

1I. M. Sechenov First Moscow State Medical University (Sechenov University),

8-2 Trubetskaya st., Moscow, 119991, Russian Federation.

2Federal Scientific State Budgetary Institution “N.A. Semashko National Research Institute of Public Health”, 12-1 Vorontsovo Pole st., Moscow, 105064, Russian Federation.

*Corresponding Author E-mail: sinitsyna_a_a@staff.sechenov.ru

 

ABSTRACT:

Despite the absence of prohibiting legal norms in Russia, pharmaceutical workers often refuse to sell over-the-counter medicines to teenagers, guided by the unspoken rules of the pharmacy or the internal moral and ethical code. The purpose of this study was to identify and assess the main types of risks faced by pharmaceutical workers when dispensing medicines to teenagers. The assessment and identification of risks were carried out using the Delphi methods and a questionnaire in which 186 respondents took part (the representativeness of the sample was calculated using the statistical method). The probability of occurrence of risks and the degree of criticality of the consequences of the risk was assessed. The experts stated that the most likely event would be a teenager buying the wrong medicine (a medicine other than the one that the teenager or the persons who asked them to buy it were planning to obtain), with a different trade name, dosage, or formulation, followed by a possible conflict with the child's representatives with a request to return or exchange the medicine. Besides, highly probable events include the use of information obtained from unverified sources, including peer advice and information obtained from social networks, by the teenager. The experts named the purchase of medicines by teenagers for self-poisoning the most critical risk factor. The experts considered the risk of using psychoactive substances an event with a high degree of consequences. The experts considered the improper use of medicines by teenagers to be the least risky event. The risks were ranked using a risk matrix by the following categories: negligible, acceptable, moderate, significant, and unacceptable.

 

KEYWORDS: Risks, Risk identification, Risk register, Risk matrix, Over-the-counter medicines.

 

 

INTRODUCTION: 

In the absence of prohibiting legal norms1-3, pharmacists often refuse to sell medicines to teenagers, guided by internal beliefs or unspoken pharmacy rules.

 

The prevalence of self-medication among teenagers in different countries varies from 2 to 92%4. A survey conducted among high school students in Moscow, Russia showed that 72% of respondents bought over-the-counter medicines on their own, unaccompanied by adults5, while 65% bought them without doctor's recommendations or prescriptions. The lack of experience and basic knowledge in teenagers increases the likelihood of risks during self-medication. A study conducted in 2019 showed that respondents with primary or secondary education were at higher risk of self-medication than those with higher education6.

 

Low medical literacy is the main risk factor in the concept of responsible self-treatment of teenagers7. Teenagers often do not understand the information indicated on the label and in the instructions for use supplied with the medicine or obtained during pharmaceutical counseling8.

 

Another risk factor is the use of medicines for drug abuse. The use of psychoactive substances by teenagers is a new public health problem that can be aggravated by self-medication9. Studies have shown that in the teenage population, there is a correlation between the use of alcohol and tobacco and the frequency of self-medication10.

 

In addition, an urgent social problem of modern society is the use of medicines for deliberate poisoning or suicide among teenagers11. According to the World Health Organization (WHO) data, suicide is the second most common cause of death among young people aged 15 to 29 years12. In Russia, every year 16 teenagers for every 100 thousand commit suicide13. Starting from the age of 14-15, suicidal activity increases, reaching its maximum at the age of 16-19; teenagers are also prone to repeat suicidal attempts: self-poisoning with medicines is the most frequent way of suicide among girls13. Studies have shown that in recent years, the number of intentional medicine poisoning in teenagers has increased by more than 2.5 times11.

 

The purpose of the study is to identify and assess the main types of risks faced by pharmacists when dispensing medicines to teenagers.

 

MATERIALS AND METHODS:

Based on the set goal, a mixed type of research design was chosen, based on a combination of requirements regarding data collection and analysis necessary to achieve the goals of the study. In particular, we considered the peculiarities of the combinatorics of qualitative and quantitative approach elements within the framework of one study. In the process of work, a survey was chosen as the main method.

 

In the first stage of the study, risk identification was carried out by analyzing the results of the survey, in which 186 respondents had participated. Data collection was carried out using a questionnaire. The representativeness of the sample was calculated using the statistical method.

                     Z2 * p * (1-p)

SS = ------------------------------- = 125

                            C2

where Z is the Z factor (1.96 for a 95% confidence interval);

p is the percentage of respondents of interest or answers in decimal form (0.5 by default);

C is the confidence interval in decimal form (±5%).

 

The sampling was carried out using the probabilistic stratified method. The study (questionnaire) was conducted to collect the opinions of pharmacists on cases when they refused to sell medicines to teenage customers due to personal doubts.

 

To obtain an agreed opinion of the expert group on the probability of occurrence of risks identified at the first stage, the Delphi method was used14. A series of questionnaires (two rounds) was used, during which the positions of experts regarding probabilistic forecasts were analyzed. The experts were specialists with higher pharmaceutical education, working as pharmacy managers or deputy pharmacy managers and having at least 10 years of professional experience. The selection of expert respondents for the survey was carried out using the deterministic method to obtain a sample of specialists with pharmaceutical education working in various positions, with various work experience and ages participating in the survey. A total of 10 people took part in the survey. The respondents expressed their opinion by assessing the probability of occurrence of each of the listed risks and expressing it as a percentage, guided solely by their opinion and experience. A scale was used to assess the consequences of the risk (Table 1). Before the repeated survey, information containing collective conclusions was prepared and presented to the experts for possible correction of their answers.

 

Table 1: Risk probability assessment scale

Probability interval, %

Verbal formulation

Numerical evaluation

1-33

Low

1

34-67

Average

2

68-100

High

3

 

The structured interview method was used to assess the consequences of the risk. The group of experts interviewed earlier assessed the consequences of the occurrence of each identified risk with a four-point rating system (Table 2).

 

Table 2. Scale of assessment of the consequences of the occurrence of risk

Verbal formulation

Numerical evaluation

low

1

average

2

high

3

critical

4

 

A risk matrix model was used to assess the magnitude of the risk (Figure 1).

 

Figure 1: Risk matrix model

 

Data analysis:

The calculation of the number of risk points was carried out according to the formula:

The number of points = Average numerical estimate of the probability of occurrence x Average numerical estimate of the occurrence of probability.

 

RESULTS:

As a result of the survey of respondents, seven main risks were identified:

1)    Buying the wrong medicine;

2)    Use of information obtained from unverified sources;

3)    Improper use;

4)    Low medical literacy;

5)    Improper storage;

6)    Poisoning;

7)    Use of psychoactive substances.

 

The experts assessed the probability of occurrence of each of the identified risks (Table 3), according to the background information on probability intervals and numerical evaluation.

 

Table 3: Numerical assessment of the probability of occurrence of identified risks

Risk

No. of the expert

Buying the wrong medicine

Use of information obtained from unverified sources

Use of psychoactive substances.

improper use

Low medical literacy

Improper storage

Poisoning

1

2

2

2

3

2

1

1

2

3

4

2

2

3

2

1

3

3

3

1

2

2

1

1

4

4

3

2

1

2

2

1

5

3

2

2

2

3

1

1

6

2

3

1

1

1

1

2

7

3

1

2

2

2

1

1

8

4

4

3

3

2

2

2

9

3

4

1

1

2

1

1

10

4

3

2

1

2

2

1

An average numerical estimate of the probability of occurrence

3

3

2

2

2

2

1

Verbal formulation

High

High

Average

Average

Average

Average

Low

 

All ratings were set during the first round of the survey. When demonstrating the average numerical estimate of the probability of an attack during the second round, none of the experts changed their opinion.

 

The experts stated that the most likely event would be a teenager buying the wrong medicine (a medicine other than the one that the teenager or the persons who asked them to buy it were planning to obtain), with a different trade name, dosage, or formulation, followed by a possible conflict with the child's representatives with a request to return or exchange the medicine. Besides, highly probable events include the use of information obtained from unverified sources, including peer advice and information obtained from social networks, by the teenager.

 

The experts stated that the following events would have an average probability of occurrence:

·      Use of psychoactive substances;

·      Improper use of medicine by the teenager, as a result of a misunderstanding of terms used by a pharmacist;

·      Low medical literacy (the ability to receive and understand information related to health issues and follow treatment instructions);

·      The teenager's misunderstanding of the rules and requirements for the place of storage of the purchased medicine.

 

The experts considered the acquisition of medicine by the teenager for poisoning to be the least likely event.

The experts also assessed the consequences of the occurrence of each of the risks (Table. 4) using reference materials.

 

The experts named the purchase of medicines by teenagers for self-poisoning the most critical risk factor. The experts considered the risk of using psychoactive substances an event with a high degree of consequences. The experts considered the improper use of medicines by teenagers to be the least risky event.

 

 

Table 4: Assessment of the consequences of the occurrence of identified risks

Risk

 

No. of the expert

Buying the wrong medicine

Use of information obtained from unverified sources

Use of psychoactive substances.

improper use

Low medical literacy

Improper storage

Poisoning

1

2

2

3

1

2

4

4

2

4

3

2

2

4

1

3

3

2

2

2

1

2

2

4

4

2

2

4

1

2

4

4

5

2

3

4

3

2

3

4

6

2

1

3

1

1

2

4

7

2

2

2

1

2

1

2

8

2

2

2

2

1

3

4

9

3

1

1

1

3

2

4

10

2

2

4

1

1

2

3

Average numerical assessment of the criticality of consequences

2

2

3

1

2

2

4

Verbal formulation

Average

Average

High

Low

Average

Average

Critical

 

To determine the amount of risk, the previously selected model of the risk determination matrix was used (Figure 1). The purchase of a medicine (Figure 2) with a trade name, dosage, or formulation other than those planned for purchase is the only risk considered with a significant value (9 points). In the case of the sale of medicine to a teenage population group: the age and lack of experience increase the chance of this risk. Following Decree No. 2463 of the Government of the Russian Federation "On approval of the Rules for the sale of goods under a retail purchase and sale agreement, a list of durable goods that are not subject to the consumer's requirement to provide them with goods having the same basic consumer properties for the period of repair or replacement of such goods and a list of non-food goods of the appropriate quality not subject to exchange, as well as amendments to certain acts of the Government of the Russian Federation" dated 31.12.2020 and the rules for working with the IS MMMP (Information System for the Monitoring of Movement of Medical Products), the pharmacist cannot return or exchange a sold medicine of proper quality. In the event of this risk, the pharmacist may find themselves in a conflict situation, unable to help the consumer.

 

Figure 2: Matrix of identified risks

 

The moderate risks were the use of information from unverified sources (6 points), the use of psychoactive substances (6 points), poisoning (4 points), low medical literacy (4 points), and improper storage (4 points). The use of information obtained from unverified sources is the only risk from this group, the probability of which the experts assessed as high. Identification of this particular risk in some cases may be the most difficult for the pharmacist since it does not depend on their experience and skills.

The risks of medicine abuse, low medical literacy, and improper storage, and application have an average probability of occurrence (2 points). The probability of the occurrence of risks associated with the lack of basic knowledge and experience in a teenager can be reduced by detailed pharmaceutical counseling with an explanation of terms incomprehensible to the teenager.

 

Poisoning (4 points) is the only risk with a critical level of consequences of the onset; at the same time, it is the risk with the lowest probability of occurrence of all.

 

DISCUSSION:

In the course of the study, the following risks arising from the release of medicines to teenagers were identified: buying the wrong medicine, the use of information obtained from unverified sources, the use of psychoactive substances, improper use, low medical literacy, improper storage, and poisoning. In a similar study conducted in Finland15, the risks of improper use and low medical literacy were identified.

 

As a result of the analysis, the risks were ranked according to the degree of probability of occurrence. Thus, the risks of buying the wrong medicine and the use of information obtained from unverified sources were assessed by the experts as risks with the highest probability. According to the degree of criticality of the consequences, the most significant were the risks of poisoning (critical) and the use of psychoactive substances (high). However, when using the risk matrix, no risk was considered unacceptable, since, according to the results of expert assessment, the probability of occurrence of risks with the most critical consequences is the lowest.

 

Among the risks under consideration, only one, i.e. buying the wrong medicine (high probability of occurrence, high degree of criticality of the onset of consequences) is significant. All other risks were classified as moderate, except for the risk of improper use of a medicine by the teenager, which was recognized as acceptable.

 

It is advisable to compile a risk register and work out an action plan in case of their occurrence, as well as to reduce the magnitude of risks, primarily with red and orange markers.

 

In the absence of the possibility of completely preventing the occurrence of all risks16-19, it is important to develop methods for managing these risks20-22, such as internal consolidation of regulations for pharmaceutical counseling of teenagers23-25, similar to those already created in the USA, Japan, and the EU26, training of employees and explaining the consequences of the occurrence of risks.

 

CONCLUSION:

As a result of the study, we concluded that young age increases the likelihood of risks when selling over-the-counter medicines, which was confirmed by the survey results. The purpose of the study was achieved, the identified risks were assessed, and the most significant risks were identified.

 

In the future, we plan to analyze the reasons why pharmacists refuse to release medicines to teenagers to create an algorithm for pharmaceutical counseling.

 

CONFLICT OF INTEREST:

The authors have no conflict of interest to declare.

 

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Received on 21.04.2023           Modified on 10.06.2023

Accepted on 17.07.2023          © RJPT All right reserved

Research J. Pharm. and Tech 2024; 17(1):297-302.

DOI: 10.52711/0974-360X.2024.00046