1.1 Background of the Study
An adverse drug reaction (ADR) is a significantly deleterious or undesirable reaction that occurs as a result of an intervention linked to the usage of a medicinal product; adverse effects usually predict potential danger from future administration and necessitate prevention, or treatment plan, or a change in the dosage regimen, or product withdrawal (Coleman and Pontefract, 2016).
According to the World Health Organization (2023), an adverse reaction is described as noxious, unwanted reactions to medicines that appear at normal treatment doses. ADRs are prevalent in clinical practice and are frequently the cause of unprecedented hospitalizations (Coleman and Pontefract, 2016).
Adverse drug reactions have varied and frequently complicated causes (Khalil and Huang, 2020). ADRs can be classified using a number of methods. The initial classification of ADR into Type A and Type B reactions was proposed by Rawlins (1981). Drugs administered at therapeutic doses can cause type A reactions, which are a consequence of an abnormal therapeutical impact of a particular drug that would otherwise have a normal therapeutic effects. Despite being prevalent, they are not likely to be connected to a fatal incident. Contrarily, Type B reactions, which are frequently fatal, have nothing to do with the drug's pharmacological impact or dosage. Four additional kinds of reactions have been added, though, further updating this classification: Type C reactions are those associated with the total dose of a long-term pharmacological treatment, Type D reactions are those associated with the timing of a treatment, Type E reactions are those associated with the discontinuation of a specific medication, and Type F reactions are those associated with ineffective therapies (Edwards and Aronson, 2000).
Antiplatelets, anticoagulants, cytotoxics, immunosuppressants, diuretics, antidiabetics, and antibiotics have been specifically linked to ADR-related hospitalizations. Fatal ADRs are frequently caused by haemorrhage, with an antithrombotic/anticoagulant co-administered with a nonsteroidal anti-inflammatory drug (NSAID) being the most commonly hypothesized cause (Coleman and Pontefract, 2016).
Given the large number of medications accessible today, it shouldn't come as a surprise that these reactions occur frequently (Calonje et al., 2018).
Landmark studies conducted in the United States and the United Kingdom in the late 20th and early 21st centuries show that ADR is a common clinical condition, including unscheduled hospital admissions and post-discharge symptoms. Despite various precautions, studies show that 5% to 10% of patients may suffer from ADR when they are admitted, during hospitalization, or when they are discharged from the hospital. This hasn't changed much over time. The prevalence of events is closely related to the techniques used to detect them, and the majority of ADRs do not cause significant systemic symptoms. The frequency of this possible harm should be carefully considered because of the associated morbidity and mortality and potential economic costs (Coleman and Pontefract, 2016).
ADR represents a significant drain on healthcare resources worldwide and is recognized as a leading cause of morbidity and mortality (Alayed et al., 2019). In the United States, epidemiological studies have shown that ADR significantly affects hospitalization rates. In addition, ADR is presumed to be the cause of many patient hospitalizations in the United States. In Brazil, a study conducted by researchers at the State University of Campinas reported, with limited data, that ADR is responsible for admitting patients to tertiary care school hospitals. Meanwhile, the Arab world has seen a significant increase in her ADR-related hospitalizations for chronically ill patients. In Egypt, children aged 1 month to adolescents admitted to wards and intensive care units (ICU) with drug-related problems (DRP) were at increased risk and had at least one drug-related problem (Alayed et al., 2019; Sabry et al., 2016).
Only important regions like Riyadh, Abha, Jeddah, and Almadinah are the subject of local records and studies evaluating ADR in Saudi Arabia. Researchers in Riyadh estimated that DRP reduced hospital admissions while ADR contributed to patient hospitalization (Al-Olah and Al Thiab, 2008). Additionally, a study of pediatric patients admitted to the Saudi University Hospital in Jeddah that was both retrospective and prospective revealed that the incidence of ADR was greater in the latter. (Alshammari et al., 2017). Central Saudi Arabia, one of the most populous parts of the nation, is where Qasim is situated. Government and private hospitals have been built in the area to meet the needs of the local populace (Alayed et al., 2019).
The European Commission estimates that approximately 5% of all hospital admissions are due to ADR, and 5% of hospitalized patients experience ADR during hospitalization. In 2008, 197,000 deaths per year were attributed to ADR in Europe (Zazzara et al., 2021). A recent exploratory review by Bouvy et al. (2015) evaluated 32 studies from 12 different countries with different settings. This review included prospective and retrospective observations assessing the incidence of ADR by measuring the number of ADR-related hospitalizations, his ADR number during hospitalization, and his ADR number in an outpatient setting over a period of time. research was included. An analysis of the studies included in the review revealed an overall ADR rate of 3.6% at admission and 10.1% during hospitalization. Only five studies assessed the incidence of ADR in community-dwelling older adults, and estimates varied widely. The overall rate of fatal ADRs was approximately 0.5%, with type A reactions being the most common type of his ADR.
In the United States (US), Budnitz et al. (2006) calculated that 3,487 hospitalizations and more than 700,000 admissions for adverse drug events occurred among all emergency room visits in 2004 and 2005. The seriousness of the incident was gauged by the number of hospitalizations. In this instance, older patients (65 years) accounted for 25.3% of emergency room visits linked to ADEs and 48.9% of hospitalization-related events. According to estimates, patients 65 and elderly are twice as likely as younger patients to experience ADEs (rate ratio (RR), 2.4; 95% confidence interval (CI), 1.8-3.0), and they are also seven times more likely to be hospitalized (RR, 6.8; 95% CI, 4.3-9.2) (Budnitz et al., 2006).
The medications that cause ADRs most frequently were investigated in a systematic review (Field et al., 2001). This research discovered that only four drug groups were responsible for 51% of avoidable drug-related hospital admissions. The majority of the events were specifically related to antiplatelet agents (16%), diuretics (16%), non-steroidal anti-inflammatory drugs (NSAIDs) (11%), and anticoagulants (8%), supporting the notion that ADRs are strongly linked to commonly taken medications. Furthermore, it was discovered that preventable ADRs were frequently linked to medication prescribing issues, poor treatment adherence, and inadequate medication monitoring, highlighting how many ADRs could have been prevented by improving care planning and management.
One of the greatest mimics in healthcare, ADRs frequently mimic "traditional diseases" and appear in all bodily systems. Hospitalized patients may experience a variety of drug-related adverb effects, including weakness or drowsiness, biochemical or haematological abnormalities (such as acute kidney injury, electrolyte imbalance, or anemia), bleeding, gastrointestinal disorders, hypoglycemia, or infections linked to healthcare settings, like Clostridium difficile. Drug-induced lupus, fixed drug eruptions, drug-induced eosinophilia, or drug-induced angioedema are rare manifestations that call for a higher degree of caution and suspicion (Coleman and Pontefract, 2016).
Patient safety depends on pharmacovigilance because uncommon, delayed, severe, or unexpected adverse events frequently only manifest after a medication has been used extensively (Claire and Herxheimer, 2013). A crucial technique for identifying patients who are at high risk of developing ADRs and for understanding the nature and prevalence of ADRs in a given population is to monitor ADRs in a hospital setting. This activity aids in the development of effective interventional strategies to regulate, prevent, and lower the chance of developing ADRs as well as to lower the cost of medical care (Ejeta et al., 2021).
Although there are numerous countries with spontaneous patient reporting systems that support pharmacovigilance, only 46 of them accept these reports and use different methods. Patients are essential to the spontaneous reporting method because only they can truly experience a drug's adverse effects. Any spontaneous reporting system's success or failure relies on the active participation of reporters. Direct patient involvement in ADR reporting will therefore improve the effectiveness of the pharmacovigilance system and close the reporting gap caused by healthcare workers' underreporting (Adisa and Omitogun, 2019).
Patients who report directly can bring benefits such as the promotion of consumer rights and equality, the recognition that consumers have, and the benefit of consumer participation for healthcare organizations. This applies to the UK as well, where patients are now able to immediately report suspected adverse drug reactions (ADRs). Despite worries that patient reports could introduce noise and be disregarded in surveillance systems, a systematic review found that the advantages of direct reporting outweighed the costs. Additionally, three sizable studies in the Netherlands and the UK compared patient reporting with professional reporting and came to the conclusion that patient-reported ADRs can be crucial in pharmacovigilance (Claire and Herxheimer, 2013).
Despite the significance of spontaneous reporting, patients frequently underreport negative drug responses. Low awareness of the reporting system, a lack of education, dependence on other health care workers for reporting, and not being able to identify ADRs are a few noteworthy causes of underreporting of ADRs. Evidence shows that patients use information about medications from various sources, including healthcare providers, internet sources, and patient information leaflets (PILs), to help identify potential adverse drug reactions (ADRs). How well patients are informed about the medications and their safety is unknown (Gordon and Padayachee, 2020).
In the majority of earlier studies conducted in Nigeria and many other developing nations, attention was given less to patients and more to health-care professionals, pharmacists, and medical students' knowledge and perception of ADR. Therefore, this research looks into how well-informed and aware patients are of adverse drug reactions.
1.2 Aim of the Study
The study aims to evaluate patient knowledge and awareness of adverse drug reactions.
1.3 Objectives of the Study
The study had the following specific objectives:
- 1. To examine the impact of knowledge and awareness of adverse drug reaction on patient
- To identify the need for patient knowledge and awareness of adverse drug reaction
- 3. To identify the techniques of providing knowledge and creating awareness of adverse drug reaction to patient
1.4 Statement of the Problem
Pharmacovigilance's importance in ensuring patient safety is highlighted by pragmatic changes in the healthcare sector, which are defined by a shift from curative to preventive approaches. Pharmacovigilance is the study and practice concerned with the detection, assessment, understanding, and mitigation of reactions to drugs or other drug-related issues (WHO, 2023). It is imperative to practice pharmacovigilance because it is only when drugs are used frequently that rare, late, serious, or unexpected side effects can appear (Claire and Herxheimer, 2013).
Delays in reporting ADRs can have disastrous effects; for instance, nearly seven million patients used Fenfluramine before its connection to valvular heart disease (VHD) was discovered and the medication was pulled off the market (Avong et al. 2018). Similar to this, Thalidomide was discovered and removed from clinical use after over 10,000 infants in Germany in the early 1960s developed Phocomelia (Dove, 2011).
Many nations have pharmacovigilance systems that allow for spontaneous reporting, but only a small number of them currently do. For instance, the Netherlands, Australia, Brazil, Canada, and Thailand currently accept such reports from consumers, which are classified as non-healthcare professionals (non-HP) (patients, patients' family members, or caregivers) (Avery et al., 2011).
In ancient times, spontaneous reporting (SR) of ADRs was done only by healthcare professionals; however, patient involvement is the most recent move toward more effective pharmacovigilance (PhV). Patient reporting of adverse drug reactions (ADRs), which has been described in the literature, is a noteworthy way of obtaining new information regarding the safe use of medications (Kassem et al., 2021).
An essential step in improving medication safety is timely and efficient reporting of ADRs to drug regulatory organizations (Avong et al., 2018). In spite of its importance, under reporting (UR) of adverse drug reactions (ADRs) is pervasive and a difficult challenge in pharmacovigilance (PV), and it has been reported to be as high as 94% even in developed nations with sufficient resources (both human and material) to address the issue (Tandon et al., 2015).
Under-reporting of ADRs is influenced by a variety of factors; patient-related reasons for UR are unawareness of ADR or inability to attribute ADRs to a medication (Alomar, 2014). Joshi et al. (2015) in a study conducted in a tertiary hospital found out that none of the patients knew that there was an ADR notification center in the institute and thus, no ADR cases were reported.
According to Joshi et al., one factor contributing to the underreporting of ADR is patient ignorance. This clarifies how it is possible that patients may not be completely informed about the side effects of the medications they are prescribed. In a similar vein, a UK research found that very few knew that adverse effects could occur when taking a prescription drug. (Hughes and Whittlesea, 2002).
1.5 Justification of the Study
In the majority of earlier studies conducted in Nigeria and many other developing nations, healthcare workers, pharmacists, and medical students were examined and their knowledge and attitudes toward ADR were reported; with less attention paid to patients. Therefore, the purpose of this research is to ascertain how much information patients know and understand about adverse drug reactions.
The results of this study will be helpful for students, teachers, healthcare workers, policy makers in government, and other relevant parties to develop policies to support providing adequate and sufficient information about the adverse effects of drugs and to inform the patient about reporting any unexpected symptoms to their doctor or pharmacist. It is essential to encourage the secure use of medications. Last but not least, the analysis provided in this study will provide crucial data for later research.
1.6 Scope of the Study
The study's focus is on patients' knowledge and awareness of adverse drug reactions.
