Reporting of Adverse Drug Reactions by Dentists and Dental Patients in Albania

Abstract

Background

Procedures on reporting adverse drug reactions (ADRs) in Albania are not yet standardised with the European Union despite continuous legislative changes. The aim of this study was to assess for the first time in Albania the reporting of ADRs by dentists and dental patients and to evaluate the frequency and timing of ADRs.

Methods

We conducted a questionnaire-based survey for dentists and dental patients in Albania on their knowledge on ADR signalling. Dentists and their patients were randomly reached in private dental clinics. Ninety-five dentists and 640 dental patients from 5 different cities in Albania agreed to participate in the study. Only dentists who were actively working on their dental clinics and who volunteered to participate in the study were considered eligible.

Results

The response rates were 95.0% and 91.4% for dentists and dental patients, respectively. In addition, 7.36% of dentists reported to have been informed on the national ADR signalling through conferences, but when asked about the procedures only 28.6% of them reported to have knowledge on the concrete process. None of the dental patients knew how to report ADRs.

Conclusions

The findings demonstrate the complete lack of information on ADR signalling in a randomly selected group of 640 dental patients and 95 dentists surveyed. The results of the study are concerning and show that knowledge on ADR signalling should massively increase through public and social media.

Introduction

Adverse drug reactions (ADRs) are defined by World Health Organization (WHO) as “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function”.¹

The early detection of suspected ADRs is important in reducing the problems related to therapy and the societal costs. Many studies have demonstrated several ADRs reported by dentists.^2,3,4

Procedures on reporting ADRs in Albania are not yet standardised with the European Union despite continuous legislative changes. Recent changes have been implemented for ADR reporting forms for both patients and health care professionals. Article 57, point 1 of the pharmaceutical legislation 105/2014, “For medicinal products and pharmaceutical service,”⁵ changed in December 2022, reports that the pharmacovigilance sector is a structure of the Albanian National Agency of Drug Control and Medical Devices (AKBPM). Only in December 2022 it was introduced into the law the time frame of ADR reporting; specifically, unexpected adverse effects must be reported within 24 hours from day 0, serious ADRs within 15 days from day 0, and adverse effects within 90 days from day 0. The person qualified for pharmacovigilance must be a resident of the Republic of Albania; must have completed its studies in the field of medicine, pharmacy, or dentistry; and be specialised or have completed certified training for pharmacovigilance.⁶ Dentists, other health care professionals, and patients can report their suspected ADRs to the AKBPM either electronically or in person through their respective ADR reporting forms. Patients are generally informed about the concept of ADRs through public media, mainly through the advertisement of over-the-counter (OTC) medicine or medical devices, and also by health care professionals (eg, doctors, dentists, pharmacists). The aim of this study was to explore and report ADR signalling by dentists and dental patients in Albania and assess the frequency and timing of ADRs.

Methods

Study design

This was a questionnaire-based survey conducted at multiple dental clinics in Albania. We adopted a mixed-method approach to explore the knowledge and attitude of dentists and dental patients about ADR signalling. The design consents to either receive quantitative data or to explore the respondents’ attitudes on reporting suspected ADRs through a mixed qualitative and quantitative questionnaire. In addition, the qualitative design helps to explore the viewpoint differences between 2 target groups (dentists and dental patients), to analyse experiences, and to generate opinions on how to improve ADR signalling and share the information.

Study setting

The study was conducted in 5 different cities in Albania, including the capital of Albania, Tirana, which is also the most populous city in Albania. Dentists were randomly reached in their private clinics (95 dental clinics), 36 of which were in Tirana and 59 in other Albanian cities (eg, Vlorë, Lushnje, Sarandë, Elbasan).

Study population (inclusion and exclusion)

Only dentists who were actively working on their dental clinics and who volunteered to participate in the study were considered eligible. Patients who did not understand the Albanian language were considered ineligible. Technicians and other dental staff such as nurses (with a non-dental degree) were excluded from the study. Dentists or patients who did not fully complete the questionnaire were excluded.

Sampling and sample size calculation

Dentists were randomly reached in their private dental clinics. Patients who agreed to participate were chosen randomly and asked to complete the entire questionnaire at one time, preferably on their dental visit date. Participation in the study was completely voluntary and the identification of participants were kept confidential. In all, 95 dentists from 5 different cities in Albania agreed to participate in the study, and 640 dental patients completed the questionnaire.

Study instrument

Two different questionnaires were developed for dentists and dental patients to evaluate their knowledge on ADR signalling. The validity of the questionnaire was assessed by 3 experts. The questionnaires consisted of 12 questions and 13 questions for dentists and for dental patients, respectively. We used either open or multiple-choice questions. The questions were designed by 3 experts to assess the respondents knowledge on the pharmacovigilance system in Albania, on ADR reporting forms, on the most frequent ADRs, and on the procedures and time frame of reporting ADRs. We report the English version of the questionnaires distributed to dental patients and dentists respectively (Appendix).

Study process

The survey was questionnaire-based and was distributed in the private dental clinics within normal opening hours to dentists and dental patients from January 2023 to May 2023. The questionnaires were conducted in Albanian. The completion of questionnaire lasted 15 minutes. The principal researcher took additional notes.

Statistical analysis

Raw data were obtained from the respective questionnaires and exported into Excel files. R software was used to estimate sample means, frequency distributions, and other descriptive statistics. Content analysis was used for qualitative data.

Ethical considerations

The study was performed following the Declaration of Helsinki.

Results

Results from dentists questionnaire

One hundred questionnaires were distributed to the dentists in their private dental clinics in Albania. The response rate was 95.0%.We observed a high response, almost for every question, whether they were correct or not.

The baseline characteristics of the cohort are shown in Table 1. It was observed that 37.9% of the dentists worked in Tirana and 62.1% worked in different Albanian cities. The mean age of the participants was 40.05 years, with 55.8% being female and 44.2% being male. Dentists’ years of experience are also reported in Table 1.

Table 1.

Baseline characteristics of dentists

	No.	%
Sex
Male	42	44.2
Female	53	55.8
Residence
Tirana (capital city)	36	37.9
Other cities	59	62.1
Years of experience
0–5	12	12.6
6–10	20	21.0
11–15	60	63.2
>16	3	3.2

Respondents were asked to define ADRs. All participants responded correctly to the question. All dentists confirmed to have experienced ADRs with either local anaesthetics, analgesics, and sedatives, and 12.6% confirmed to encounter them often in patients. Seven dentists reported to have heard of the national ADR reporting forms through conferences; however, when asked about the concrete procedures, only 28.6% of them reported to have knowledge on the process.

All participants reported that the last update on the topic was before the pandemic. Of those who had knowledge on ADR reporting forms, no one had ever reported at least 1 ADR. None of the dentists had received information on ADR reporting forms through public media or other sources, and none had information on the time frame of ADR signalling.

Results from dental patient questionnaire

A total of 700 questionnaires were distributed to the dental patients reached in different dental clinics in Albania during their treatment visit; 640 questionnaires were completed, for a response rate of 91.4%.

Of the 640 participants surveyed, 362 were female (56.6%) and 278 were male (43.4%). The mean age of the participants was 47.6 years (Table 2).

Table 2.

Baseline characteristics of dental patients

	No.	%
Sex
Male	278	43.4
Female	362	56.6
Residence
Tirana (capital city)	316	49.4
Other cities	324	50.6
Highest level of education
Elementary school	2	0.3
Middle school	12	1.9
High school	226	35.3
University	364	56.9
PhD	36	5.6
None of the above	0	0

49.4% of respondents lived in the capital, and 50.6% lived in other Albanian cities. Only 2 respondents had an elementary school education, and 35.3% and 56.9% had a high school and university education, respectively. All patients confirmed to have experienced ADRs with either local anaesthetics, analgesics, or sedatives during or following dental treatment, and 6.4% reported having experienced them often. Some of the ADRs experienced were as follows: paraesthesia, seizures, erythematous skin rashes, dizziness, and hepatotoxicity (Figure). They all confirmed not to be informed by health care professionals or public or social media on ADR reporting forms. Additionally, none of the 640 dental patients who completed the questionnaire and gave the right definition of ADRs had knowledge on national ADR reporting forms, time frame, and procedures. We hypothesise that patients were informed on the definition of ADRs by public media, usually through the advertisement of OTC medicines and medical devices, but they were not informed by health professionals on the ADR signalling form. We believe that the high education levels of the participants surveyed also increase their knowledge on the definition of ADRs.

Fig.

The most common adverse drug reactions reported by dental patients.

Discussion

This study is the first one to identify dentists’ and patients’ knowledge on ADRs, signalling, time frame, and reporting forms in Albania. The results of the study revealed the complete lack of information on ADR signalling mainly in patients, but also in dentists in Albania. Only 2.1% of the dentists responded correctly to ADR signalling form procedures, but none of them knew the time frame for reporting the suspected ADRs. The most frequent source of information for dentists on ADR reporting was scientific conferences; however, none of them was updated recently on the procedures. None of the patients was ever informed by either dentists, doctors, pharmacists, or other health care professionals on ADR reporting procedures and time frames. Of greater concern, 3.45% of the respondents who had experienced ADRs often had never reported them. The cause of undersignalling in this group should be further assessed. The age range, level of education, and residence did not influence knowledge on ADRs for either group of respondents.

These results are very significant and concerning, showing that knowledge on ADRs should massively increase. Submitting ADR reporting forms can help not only in detecting ADRs but also in increasing the safety of medicines, reducing the real time health problems related to therapy, and reducing morbidity.

We believe that the main approach to inform the Albanian population on the procedures of ADR reporting is through national TV channels, as well as through social media platforms (Facebook, Instagram). The AKBPM, and the Ministry of Health should share information on their official websites, on their main home pages, and on their social media accounts. Advertisement campaigns also providing personal experiences will increase awareness on ADRs. Moreover, all health professionals, including dentists, should be constantly informed through scientific accredited events on ADR reporting. Apps for smartphones are another convenient reporting tool that can reduce underreporting. Telephonic support by a pharmacovigilance specialist should be available to facilitate the reporting process. The current findings can be used to persuade government policies to improve patient care quality by choosing the best interventions to motivate people to reduce the underreporting of ADRs.

The main strength of the study is that is innovative and gives information, for the first time in Albania, on a specific group of health care professionals and patients on their knowledge on ADR reporting. The high response rate of the 2 groups of respondents is another strength of the study. However, there are some limitations, such as the small sample size and the misinterpretation of some open-ended questions.

Conclusions

This study is the first questionnaire-based survey to investigate ADR reporting in Albania either by a category of health care professionals, such as dentists, or dental patients. The current findings demonstrate the complete lack of knowledge on ADR reporting forms and procedures in a group of 640 dental patients, and in 95 dentists surveyed. The response rate was very high in both cases (91.4% and 95%, respectively). Further, 7.36% of dentists reported to have been informed on the national ADR signalling procedures through conferences; however, when asked about the concrete procedures only 28.6% of them reported to have knowledge on the process. As most of the respondents were from different cities in Albania, we consider that this study reflects current ADR signalling in the whole country.

In Albania, citizens should be massively informed through public media and social media, and not only through scientific events, on ADR reporting forms, on the importance of ADR reporting, on the time frame of ADR signalling, and on the procedures to follow.

It would be interesting to assess the ADRs reported by other Albanian health care professionals and discern whether this complete lack of information is only related to dentists and dental patients, or whether it is a general phenomenon.

Another limitation of the study is to increase the study sample from other different cities of Albania. The results of this study are an indicator of improving the pharmacovigilance system in Albania, which will contribute to improving public health in the country.

Conflict of Interest

None disclosed.