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Научни трудове на Съюза на учените в България-Пловдив. Серия Г. Медицина, фармация и дентална медицина т. XXII. ISSN 1311-9427 (Print), ISSN 2534-9392 (On-line). 2017. Scientific works of the Union of Scientists in Bulgaria-Plovdiv, series G. Medicine, Pharmacy and Dental medicine, VoLXXII. ISSN 13119427 (Print), ISSN 2534-9392 (On-line). 2018.
ДОКЛАДВАНЕ НА НЕЖЕЛАНИ ЛЕКАРСТВЕНИ РЕАКЦИИ ОТ ПАЦИЕНТИТЕ В ПЛОВДИВСКИЯ РЕГИОН Емил Христов1, Сава Огнянов1, Цветомир Делийски1, Калина Андреевска2 , Христо БургазлиевЗ, Златка Димитрова1
1СУ„Св.Кл. Охридски", Факултет по химия и фармация 2МУ-Пловдив, Фармацевтичен Факултет 3 Университет „Проф. др Аен Златаров"- Бургас, Медицински колеж
ADVERSE DRUG REACTION REPORTING BY PATIENTS IN REGION OF PLOVDIV Emil Hristovl, Sava Ognianovl, Tzvetomir Deliiskil, Kalina Andreevska2, Xristo Burgazliev3, Zlatka Dimitroval
lSofiaUniversity "St. Kl. Ohridski ",Faculty of Chemistry and Pharmacy 2Medical University of Plovdiv, Faculty of Pharmacy 3University "Prof. Asen Zlatarov",College ofPharmacy
Abstract
Introduction: This review discusses the involvement of patients in the reporting of adverse drug reactions (ADRs). Patients benefit from drugs but also experience their adverse effects. Since concerns about the safety of drugs are also patients' concerns, the patient could also play a part in decreasing the risks of drug therapy. The acceptance of patient reporting of adverse drug reactions (ADRs) to spontaneous reporting systems and their contribution to pharmacovigilance is still a subject of discussion. Although in several countries patients have the possibility of reporting ADRs, few publications exist about the contribution that patients' reports have in daily. Aim: The aim of the study is to assess the adverse drug reaction reporting by patients in Bulgaria. Methodology: Documentary and statistical analysis of the completed questionnaires has been used. The study was conducted in Plovdiv region. Results: Under the latest amendments to the Law on Drugs in Human Medicine, patients may report adverse drug reactions at any time to healthcare professionals or the National Drug Agency(NDA). Simultaneously with the previously recommended method of reporting by a medical specialist (physician, pharmacist, midwife, nurse), there is an opportunity to make a direct alert for a suspected ADR to NDA. However, we have found that a larger percentage of patients would report the ADR mainly to physicians and other healthcare professionals and are not aware of the existence of the yellow card. Conclusion: The results of the survey reveal the need for closer links with patient organizations. When conducting
direct contact with the patients themselves in the pharmacies, it is advisable to train them about ADRs and their reporting. Patient education and awareness can also involve media.
Key words: Adverse drug reactions, report, patients
Introduction
Monitoring adverse drug reactions (ADRs) through pharmacovigilance are vital to patient safety. Spontaneous ADR reporting is one method of pharmacovigilance.
Adverse drug reactions (ADRs) are a worldwide problem that affects all drugs and their users. They cause significant disability and mortality, and are expected to be associated with an economic drain on the healthcare system (Bates et al. 1995; Oshikoya and Awobusuyi 2009). ADRs are monitored in many countries and by the World Health Organization (WHO) since the 1960s using spontaneous reporting systems, also called 'early warning' systems (Stricker 2004). Pharmacovigilance is the science and activities relating to monitoring, detection, assessment, understanding, and prevention of ADRs (Aagaard et al. 2009). Monitoring product safety has been traditionally done by passive surveillance (voluntary reports) or the collection of spontaneously reported adverse events from healthcare providers and consumers following the administration of a medicinal product. (Sharrar and Dieck 2013), ( Dweik et al. 2016. )
In the beginning of ADR monitoring, only doctors and dentists were allowed to submit ADR reports to these databases (Aagaard et al. 2009). But, because the health agencies started focusing more on patients' safety, in 1995 all drug manufacturers, world widely, were mandated to report ADRs (WHO 2002). Later, other healthcare professionals (HCPs), pharmacists, and patients were allowed to report ADRs in hope that this would increase the volume and quality of ADR reports (Aagaard et al. 2009).
Spontaneous direct patient reporting may prove to be essential for continuous improvement and successful pharmacovigilance. However, the literature is deficient regarding the role of direct patient reporting, and its effects, on pharmacovigilance activities (Herxheimer et al. 2010). Much controversy remains among experts concerning the utility and efficacy of incorporating patient ADR reports into pharmacovigilance guidelines and protocols (Mitchell et al. 1988; Hazell et al. 2013a, b). Some researchers believe that patient ADR reporting is detrimental to pharmacovigilance activities while others fully support it and agreed that direct patient reporting is necessary to add that extra layer for good pharmacovigilance since patients as users of medications have first-hand knowledge of their experiences with ADRs (Aagaard et al. 2009; van Grootheest and de, Graaf L, de, 2003; Blenkinsopp et al. 2007). ( Dweik et al. 2016). In Denmark from June 2003 a new law allowed patients or relatives to report ADRs. Denmark was the first EU Member State to introduce direct patient reporting. ADRs can be reported to the Danish Medicines Agency [DMA] by telephone, post or through their website. Patients' reports are handled together with reports from professionals, by the same staff; patients' stories take longer to analyse. The DMA tries to get medical confirmation of patients' reports; the website asks for permission to contact the reporter when necessary. The DMA receives several hundred reports a year from patients. (Herxheimer, et al. 2010)
In Nitherlands patients began to report possible ADRs to Lareb in April 2003. Lareb is unusual in that it is a foundation ['Stichting'] separate from the Dutch national drug regulatory authority [College voor Beoordeling van Geneesmiddelen, MEB]; it collects and analyses all reports of suspected ADRs for the MEB, and regularly forwards them to the MEB. Within two weeks the MEB copies the reports to the marketing authorisation holders. Lareb does not routinely publish the results of its analyses. Since April 2004 Lareb accepts reports from patients/consumers and from health professionals as having equal value, but reports from patients are marked in its database as 'not medically confirmed'. When necessary, Lareb asks a patient or consumer for permission to contact the person's doctor. Unlike health professionals, patients can submit reports only electronically via the Lareb website; reports on paper or by telephone are not accepted. This
ensures that all reports include the details required for an adequate analysis. The website has separate sections for patients and health professionals.
The aim of this work is to review the current patient Adverse Drug Reaction (ADR) reporting system in Bulgaria.
Methodology
A combined methodology is applied including documentary analysis for reviewing the normative basis for patient ADR report, sociological and mathematic-statistic methods. The study is accomplished with 50 patients from town Plovdiv, the second big town in Bulgaria for the period July 2017 - September 2017. The patients filled in questionnaires including 7 questions.
Results and discussion
According to the latest amendments of the Law on Medicinal Products for Human Medicine patients in Bulgaria may report adverse drug reactions at any time to medical professionals or the National Drug Agency (NDA). According to the requirements of the new European legislation, the NDA provides a form for online filling (yellow card) and free Internet messages for suspected ADRs. In our study participate 50 patients as 68 are women and 32 men. The mean age is 56. At the first question: "Do you know what channels exist in our country for patients to report suspected adverse drug reactions?", all patients responded unanimously that they only knew the first 3 channels - doctors, via pharmacists and through dental practitioners. They do not think they can report through other medical specialists (nurses, midwives, medical technicians and assistant pharmacists), through patient organizations and through the NDA web site At Question 2:" Is there a standard form for reporting ADRs?", all patients responded that they did not and did not know. Bulgaria is a member of the international center in UPSALA-Sweden for the reporting of ADRs from 1973. Since becoming a regular EU member in 2007, NDA has forwarded the information about ADR to EMA. Bulgarian citizens are not informed by their pharmacists about these two possibilities nor about the importance and necessity of collecting ADR information in order to determine the absolute and relative risks. From the absolute risk are interested in the prescribing physicians, and from the relative - the health authorities. In cases where ADRs are common, but mild or infrequent but life-threatening, Ministry of Health (MH) may need to decide and limit the prescription of these drugs by doctors, or introduce a restricted regimen for their use (only under hospital conditions under the supervision of the physician / At Question 3: "Do you know how to get and fill out the yellow card? , patients responded logically negatively.
At question 4: "Have you been informed whether and how patient organizations are involved in the process of implementing EU rules according the safety of medicines?", they have responded with no. This response indirectly indicates that patients' organizations who are interested in the good therapeutic outcomes of treating patients with the disease also have underestimated the problem of informing their members about the risks of ADR and drug-related illness that leads to increased drug costs.
At Question 5: "How many times have you shared with your doctor or pharmacist information about ADRs, or have you reported these ADRs to the NDA or you have informed the manufacturers during the last 5 years?" , 17 patients responded that they did while 31 never have reported ADRs. This response clearly shows that patients experience ADRs, and a third of them have shared with healthcare professionals the presence of a similar problem. At Question 6: "What do you think are the main factors that prevent you from actively participation in a program for drug safety?", 42 of the patients responded that they do not know how and to whom should report the suspected ADRs while according 4 of them, the reason is lack of sufficient information on the problem. The majority of respondents with the answer to this question once again support our thesis that they are unaware of whom and how they should report
the suspected ADRs. All this requires the active inclusion of pharmacists in pharmacy care practice, as ADRs are one of the eight drug-related problems for whose solution pharmacists are responsible. The negative answer of this question can also be referred to the Union of Pharmacists in Bulgaria who, although has adopted rules for the introduction of pharmaceutical care in Bulgaria, approved by the Minister of Health, pharmacists in most pharmacies because of different reasons (lack of knowledge, lack of necessary staff, etc.) have not implemented this new pharmacy practice.
Conclusion
In fact, the patient is the source of information about the true benefit and the relative harm of the medication. The physician delivers the patient's original message together with the objective measures taken. There is a widespread view that direct patient involvement in communicating drug-related problems will increase the effectiveness of pharmacovigilance systems and compensate for inadequate activity of medical professionals. The results of the survey reveal the need for closer links with patient organizations. When conducting direct contact with the patients themselves in the pharmacies, it is advisable to train them about ADRs and their reporting. Patient education and awareness can also involve media.
References
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