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16PHARMACEUTICAL SCIENCES
STUDY OF PHARMACISTS' ATTITUDES TO REPORTING ADVERSE DRUG REACTIONS IN
UKRAINE
Horilyk A.,
Pharmaceutical Education And Research Center (nonprofit organization),
Lviv, Ukraine Dorykevych K.,
Danylo Halytsky Lviv National Medical University Department of Organization and Economics of Pharmacy, Lviv, Ukraine
Horilyk D.
Pharmaceutical Education And Research Center (nonprofit organization),
Lviv, Ukraine
Abstract
Collecting the information on adverse drug reactions is a very important component of safe pharmacotherapy. Full and timely reporting the side effects of medicines is the responsibility of medical professionals, including pharmacists.
The research aimed to analyze the attitude of Ukrainian pharmacists to the reporting of adverse drug reactions and to identify the main obstacles to this activity.
An online survey of pharmacists (199 professionals from all 24 regions of Ukraine) was conducted during two-weeks period (27 of April to 10 of May 2020). The study revealed lack of knowledge on ADRs reporting among most pharmacists (72.3%); 79.9% feel the ADR reporting is their duty; only 28.1% of pharmacists had previously reported ADRs. Regarding barriers to reporting ADRs, 31.7% of respondents don't know how to do it, 24.6% aren't even aware that this type of information is collected, and 14.6% complain about the lack of motivational support from management.
Initiatives in the thematic education and training of pharmacists in reporting on ADRs, as well as in simplifying the reporting process, may significantly increase pharmacists' participation in pharmacovigilance, reduce the risks of pharmacotherapy, and enhance patient safety.
Keywords: adverse drug reactions, pharmacovigilance, pharmacists, ADRs reporting.
Introduction
Adverse drug reactions (ADRs) are a significant source of risk for the efficacy and safety of pharma-cotherapy and patient compliance with the prescribed treatment. Among the main risk factors for the ADR occurence are old age, comorbidities, polypharmacy, self-medication, predisposition to allergic reactions, etc. Almost half of ADRs can be prevented, so it is essential to inform doctors, pharmacists, and patients about the risk factors of pharmacotherapy complications, diagnosis, and timely informing about ADRs (1, 2).
According to published data, the overall prevalence of ADRs among inpatients in the UK is 3.22%, in Germany - 4.78%, and in the USA - 5.64%(3) As a result of a three-month follow-up study of 4,970 hospital patients in Sweden, ADRs were detected in 12.0% (4).
Epidemiological studies on the prevalence of ADRs in Ukraine have not been conducted. Totally, in 2019, the State Expert Center (SEC) of the Ministry of Health of Ukraine registered more than 27,424 cases of ADRs in Ukraine, 26,370 of which were recognized as valid (5, 6). However, it should be understood that these statistics do not reflect the actual number of ADRs.
The problem of insufficient reporting on ADRs is inherent in many countries worldwide, and several publications are devoted to this issue (7-18). The effectiveness of reporting in different countries obviously depends not only on the regulation and adjustment of the
reporting process, but also on the involvement of its subjects, especially medical professionals. Pharmacists can be an important part of ADRs reporting process (and pharmacovigilance in general), as they often are the first person to come in contact with the patient and have many opportunities to detect ADRs or other unfavourable effects. However, in Ukraine only a small number of ADRs reports come from pharmacists (19). Although according to the order of the Ministry of Health of Ukraine (20). ADRs reporting is not just a right for pharmacists but an obligation. As a similar situation with non-involvement of pharmacists is observed in other countries (7-12, 14-18), this issue needs to be studied in details.
The aim of the study was to examine the awareness and attitude of pharmacists in Ukraine regarding the reporting of ADRs as well as to identify the main obstacles to this process and to develop solutions.
Materials and methods. Scientific publications on pharmacovigilance and reporting on ADRs were researched. The survey of pharmaceutical specialists with specially designed questionnaires was done. The analysis of the results of the questionnaire survey was performed by methods of descriptive statistics using Microsoft Excel.
Results and discussion. The World Health Organization (WHO) defines pharmacovigilance as the science and set of measures to detect, assess, understand and prevent the development of side effects or any other adverse events associated with the use of
drugs (21). According to the WHO, pharmacovigilance has four main objectives: 1) to improve medical care and safety of drugs and medical technologies for patients; 2) to improve the functioning of the public health system and the safety of treatment in general; 3) to promote the assessment of benefits, effectiveness and risks in the use of drugs, encouraging their safe, rational and more effective use; 4) to promote training in pharmacovigilance and the effectiveness of communication on these issues between health professionals and the public (22). Reporting ADRs is a significant part of phar-macovigilance as this process constantly updates the safety data of drugs and allows to identify new risks as well as reevaluate the risk / benefiting ratio of the medical use of drugs.
Globally, the role of the pharmacist in the system of pharmacovigilance differs in countries. It is generally accepted that ADRs reporting is part of pharmaceutical care. However, even in countries where pharmacists are involved in this process, there are a significant number of gaps. Thus, there are two groups of barriers regarding the reporting of ADRs by pharmacists. First group include obstacles that are caused by the health care system, lack of access to patient records, and ADRs database, unclear requirements/recommendations for reporting, lack of financial or other motivation, as well as the threat of legal liability). Second group of barriers is related to the pharmacist personality (insufficient professional competencies in drug safety activities: detecting ADR, establishing a causal relationship, skills of filling out the reporting form on ADR and reporting it to the Health Authority, lack of understanding of responsibility for reporting / not reporting on the side effects of drugs etc.) (9).
The involvement of pharmacists in the ADRs reporting process has been studied in different countries. A study of the level of knowledge and prospects for reporting of ADRs by pharmacists in Australia (232 specialists were interviewed) showed that their medium level of knowledge about pharmacovigilance and reporting (5 points on a 10-point scale); 31% of respondents consider their level of knowledge and training on reporting side effects of drugs to be sufficient; 35.3% of pharmacists in the last 12 months reported at least one ADR. Specialists who did not report any ADR in the previous yearmore commonly named lack of time as a reason for that. In addition, they indicated that they would be willing to report ADRs if this practice had been rewarded (14).
According to an online cross-poll of pharmacists in Saudi Arabia (1,717 pharmacists and 153 hospital pharmacists participated), it was found that only 10.2% and 26.8%, respectively, reported ADR at least once. The most influential factors that would positively impact the pharmacists' participation in pharmacovigi-lance are the constant improvement of knowledge about the side effects of drugs, attending educational courses in this area, experience of serious ADRs among patients and the access to information about patients. The examples of colleagues as well as suspected ADRs of plant medicines and traditional medicines were the least important factors for ADRs reporting (7).
An analysis of pharmacovigilance processes in India found that the main barriers to ADR reporting are the lack of awareness of health professionals, especially their perception of the need for this work, problems with the reporting process, and insufficient training to identify side effects. Wider involvement of various specialists: pharmacists, nurses, as well as patients in the system of ADRs reporting may improve the situation. It is also necessary to simplify and speed up the safety communication process using modern digital technologies and implement specific educational programs for healthcare providers and patients (15).
A survey of pharmacists (1857 participants) on their knowledge, attitude, and participation in drug safety was conducted in Lebanon in 2016. It showed that most respondents had a good understanding of pharmacovigilance scope and purpose, as well as drug safety activities (such approaches to ADRs reporting, the importance of detecting and reporting of ADRs etc). Surveyed specialists treat pharmacovigilance primarily positively and define drug safety activities as their "core" responsibilities. The survey revealed a lack of practical training in this area: pharmacists are positive and ready to work, but there is no state system for ADRs reporting on a country level (10).
A study of pharmacists' involvment in assistance of ADRs reporting by patients was conducted in Italy. Most patients reported side effects of commonly used and over-the-counter drugs, unlike reports from healthcare professionals (13).
A survey of pharmacists of pharmacists in Quebec, Canada (179 people interviewed in 2014) showed that 90% considered themselves capable and sufficiently prepared to work in pharmacovigilance area. The majority (98%) observed at least one serious or unexpected ADR during the last year; 77% reported at least one ADR to the pharmacovigilance center. Factors that encourage ADR reporting are the ADR severity, unexpectedness, or detected ADR to a recently dispensed drug. More than 69% of respondents consider fatigue at work as a fundamental obstacle to ADR reporting. In general, hospital pharmacists showed a positive attitude and willingness to actively take participation in drug safety activities. Also, they helped identify areas for its optimization, particularly the implementation of pharmacovigilance coordinator position in healthcare institutions (8).
Analysis of the state of ADRs reporting by pharmacists in Poland showed that 41% of pharmacists and 12% of pharmaceutical technicians have adequate knowledge. In most cases (72%), pharmacists know that a patient can report side effects independently, but most patients do not. Patients indicated that when ADR occurs, they say it to their doctor (76.6%) or pharmacist (14.6%). Only one-fifth of patients (20.3%) identify the pharmacy as a subject of pharmacovigilance: institutions that collect and report information on ADRs. The authors identify the need for more thorough training of pharmacists and extensive information campaigns about drug safety (18).
Another study on pharmacists' low ADRs reporting rate issue was conducted in 2016-2018 in Poland. Thus, only 16% of respondents (84 specialists) at least
once participated in pharmacovigilance training. 81% (422 pharmacists) believe that not all synthetic drugs registered on the market are safe; 28% (146 pharmacists) were sure about the safety of drugs of natural origin, and 16% thought that there was no need to report the ADRs of such medications. The authors identify an increased need to optimize the practice of pharma-covigilance, in particular, in part concerning herbal remedies (12).
Researchers from Pakistan surveyed a focus group of hospital pharmacists on their ADRs reporting practice. It was found that, although the theoretical foundations of pharmacovigilance are studied during the bachelor's degree, there is no actual application of this knowledge in practice. Several barriers to ADRs reporting were identified, such as lack of knowledge, skills, time, peer support, communication between health care professionals, and a lack of reporting mechanisms. Respondents are generally optimistic about changes in the functioning of this system so that pharmacists have a clear place in it (23).
In the Russian Federation, a study of pharmacists' awareness (187 specialists were interviewed) on drug safety was conducted. 28% of pharmacy employees encounter ADRs in their practice, but only 5% of them report spontaneous reports. The main reasons for the low activity of pharmacists are lack of time to report and low level of knowledge on the safe use of drugs. The majority (89%) of pharmacists need educational programs on pharmacovigilance (24).
Pilot projects for the implementation of pharma-covigilance systems led by pharmacists have been carried out in different countries. So in one of China's hospitals in 2015-2017 clinical pharmacists were the main ADRs reporters and the main specialists in their processing and management. The scope of their work included all the workload of clinical pharmacy, conducting consultations of patients on the manifestations of ADRs, centralized monitoring of such cases, analysis of warning signals on the manifestations of ADRs, and the evaluation of drugs in terms of safety. In total, 533 reports on ADRs were received from this hospital in 2017, while in 2012, it was only 177 reports (11). A similar model was tested in hospitals in South Africa (province Gauteng): a pharmacovigilance system managed by pharmacists was developed, tested in a hospital and evaluated. As a result, the number of ADR reports tripled. The level of knowledge of medical professionals about the reporting of drug side effects, in general, has significantly improved (17). Studies by Spanish scientists (2014) in the same direction confirm the view that the system of pharmacovigilance with the active involvement of pharmacists generally improves the detection of ADRs and helps to prevent them (16).
It can be concluded from the above research that the issue of active involvement of pharmacists in the process of ADRs reporting is relevant and is being studied in different countries. In order to perform a situa-tional analysis of this process in Ukraine, we conducted our research.
We organized an online survey of persons with pharmaceutical education. It lasted for two weeks, from
27.04.2020 to 10.05.2020. The questionnaire was created through the Google Forms service and distributed through Viber groups and professional Facebook communities, the most numerous of which are "Phar-mdvizhenie" (19,800 participants,
https://www.facebook.com/groups/farmdvizhenie/), "Practical Pharmacy" (9,400 participants, https://www.facebook.com/groups/303252657278677/ ), "Pharmacy workers" (7,000 participants, https://www.facebook.com/groups/spilka.pharmacevti v), and "Pharmaceutical Ukraine" (5,200 participants, https://www.facebook.com/groups/171248333366137/ ).
So during two weeks of open access to the questionnaire and its active distribution on social networks, we received 199 questionnaires from pharmacists from all 24 regions of Ukraine. Most respondents worked in Lviv and Lviv region (33.7%) or Kyiv and Kyiv region (17.6%). The vast majority of respondents in our study are women (92.5%). Half of the respondents (50.8%) are pharmacists aged 26 to 35, another quarter (26.6%) are young people under 25. Only 6% of respondents were aged 51 and older. Regarding the characteristics of the educational levels of the respondents, half of the respondents (49.8%) have the educational level of a specialist, and a quarter (25.1%) has a master's degree. Some respondents covered by our survey have degrees of candidate (6.0%) and doctor of pharmaceutical sciences (0.5%).
The majority (69.9%) of respondents work as managers and pharmacists. Other respondents study or are engaged in teaching activities in pharmaceutical education institutions, work in pharmaceutical companies as medical representatives, authorized persons, analysts, etc.
All questions in the questionnaire were divided into three blocks. The first block - information about the respondent, includes five questions about educational level, age, gender, region, and type of activity. The next block contains five questions about awareness of the ADRs reporting process. And in the final step, respondents were asked to describe their own experience in ADRs reporting and identify problems in this process by answering the last six questions. Thus, the entire questionnaire consisted of 16 questions.
We have found that a significant number of pharmacists are self-critical about their knowledge of ADRs reporting process: 66.3% answered that they do not know enough, and 6.0% know nothing about it at all.
According to the legal requirements, pharmacists, as part of the healthcare system, are obliged not only to report on ADRs in a timely manner but also to actively identify them. This is clearly stated in the abovemen-tioned order of the Ministry of Health of Ukraine № 898. But only less than half of pharmacists (45.2%) know about it. It is optimistic that the majority of pharmacists (79.9%) feel the ADR reporting as their duty, but on the other hand, a fifth of pharmacists do not think so.
To the following question, "Who do you think has the right to report ADRs in Ukraine?" half of the respondents (53.3%) answered correctly: according to the legislation of Ukraine, medical specialists (including
pharmacists), healthcare institutions of all forms of ownership, Marketing Authorization holders on medicinal products, patients and their representatives have the right to report on ADRs. All identified drug safety concerns should be reported, regardless of their severity or predictability.
It should be noted that more than half of the surveyed pharmacists (59.3%) encountered cases of ADRs. At the same time, only a quarter (28.1%) answered that they submited a report on ADRs. For the question "What ways did you use for ADR reporting?", it is expected that the majority answered that none (61.8%). This question provided an opportunity to choose several answers from the list or a respondent's proposal. It is important to note that the majority of re-
spondents (37.7% of those who indicated using any reporting routes) chose the option of "notifying their supervisor." Moreover, a quarter (23.4%) chose this option as the only way to report a safety data. We emphasize that informing the manager about the detected ADR cannot be considered an appropriate method of reporting. Instead, you should fill in the message card in paper form or online (https://aisf.dec.gov.ua) and send it to the State Expert Center. Thus, information about this case will be entered into the Automated Information System for Pharmacovigilance. You can also inform the applicant/manufacturer of medicines or the patient's doctor if the reporter has such contacts. Only 7.5% of respondents indicated that they have filled in the ADRs notification card.
Fig. 1. Ways of ADRs reporting, which respondents of the survey use
The vast majority of respondents (94.0%) reported problems that prevent reporting (Figure 2). A third of respondents (31.7%) don't know how to do it, and a quarter (24.6%) isn't even aware that this type of information about drugs is collected in any way. Some respondents (14.6%) say that they need some motivational support from management. The complexity of
the process (12.6%), lack of time to complete the notification form (9.0%) were among other voiced problems. In addition, 72.9% of respondents indicated that the management of their organizations did not support the process of ADRs reporting.
What problems can keep you from ADR submission?
Don't know how to submit ADR Nobody collects this data Lack of motivation from company management My activity will not impact the drug safety profile The process is too complicated Don't have time for this activity This task is for a physician, not for a pharmacist Too much time and efforts are needed Have no problems Fear publicity and legal consequences
31,7%
24,6%
M 14,6% I 13,1% 12,6%
Fig. 2. Obstacles that deter pharmacists from reporting ADRs
As a result, our study reveals an important problem of insufficient awareness of pharmacists about the importance of ADRs reportings. Given the small number of experts who participated in the survey (199 respondents), the sample cannot be considered fully representative of the pharmaceutical community. Therefore, statistical analysis of the consistency of expert opinions and the probability of error was not performed. However, the results of our study allow us to see a general picture of the situation with reporting on ADRs in practical pharmacy, and it gives important results for decision-making analytics to improve the ADRs reporting by pharmacists. We believe that pharmacists have the necessary level of education, sufficient competencies to implement this process and are in contact with more patients than even doctors.
Considering the results of the study, in our opinion, the ways to improve the ADRs reporting rate by pharmacists are as follows:
- introduction an information campaign on ADRs reporting process, disseminated through personal training services (for example, on the Ukrainian platform of open online courses Prometheus), corporate events of pharmaceutical companies to train their employees, and the system of postgraduate education;
- validation and correction of functional deficiencies of the reporting form on the State Expert Center web-page https://aisf.dec.gov.ua.
- development, improvement, dissemination, and state support of modern telecommunication reporting methods that would simplify and reduce the time of filling in and sending a card-notification about ADR for a pharmacist (for example Telegram-bot @pharma-link_bot) (https://t.me/pharmalink_bot) (25);
- providing motivational support of the management of pharmaceutical organizations for their employees in ADRs reporting process.
Conclusions. The world practice of pharmacovig-ilance indicates a general problem of underreporting on ADRs, in particular, by pharmacists. In this direction, information campaign and special trainings are needed as well as elaboration of motivational program for ADRs reporting. The introduction of pharmacovigi-lance systems managed by pharmacists, in particular, in hospitals is also a possible ways of improving the whole situation. The study itself revealed a severe lack of awareness of pharmacists about the purpose of ADRs reporting and its practical component (necessity, responsibility, importance, direct impact on the safety of pharmacotherapy, etc.).
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