Introduction
Healthcare practice is incomplete without drug administration. Although drugs are usually thought to be beneficial but the outcome depends on a number of factors, the most important of which is dose. Any drug, if administered in the wrong way, can cause harmful or unwanted effects. These noxious, unwanted or unintended effects that follow a drug administration are termed Adverse Drug Reaction Effects (ADRs) (Coleman & Pontefract, 2016). With the development of healthcare and pharmaceutical practices, the number of drugs that are being used in healthcare practice is becoming very large. Although the drugs mostly effectively treat a condition, the adverse effects of drugs are extremely common and can range in severity from mild to life-threatening. The adverse drug reactions are a rising cause of morbidity and mortality throughout the world (Khalil & Huang, 2020). The urgency and gravity of the issue are the reasons why this topic was chosen for this report. The report gives an outline of the issue, its causes, prevention and control and recommendations for the future.
Implications of ARDs
ADRs is an emerging problem in healthcare that is leading to mortality or morbidity of patients. According to epidemiological studies, 10 – 15% of hospitalised patients may develop ADRs, for which the mortality can range from 0.14% – 0.32% (Adverse Drug Reactions, 2016). With evolving pharmaceutical research and practice, the number of ADRs is becoming more common and frequent. The problem is also on the rise in the UAE and the Arab region. The cases of ADRs in the UAE have increased from 59 in 2013 to 825 in 2016 (Zain, 2017). According to the WHO, pharmacovigilance programs should be present worldwide with proper reporting of adverse drug reactions in healthcare facilities, in order to prevent and minimize the situation. However, in the UAE, most of the cases of ADRs are not being reported, which is leading to a rise in the cases (Said & Hussain, 2017).
Causes:
There are three common causes or etiologies of ARDs, i.e., dose-related, allergic or idiosyncratic. The most common and mostly predictable causes are dose-related, where an increased dose administration or altered blood levels of a drug due to other causes can lead to an adverse reaction (Coleman & Pontefract, 2016). For example, a person with impaired renal or hepatic function may have a decreased drug clearance rate, which would lead to an increased circulating amount of the drug (Marsh, 2021). Allergic causes of adverse drug reactions can be unpredictable if the drug is being administered for the first time. In this case, the drug triggers an allergic or anaphylactic reaction in the body, which leads to the adverse effects (Marsh, 2021). Idiosyncratic ARDs are those that do not have any known cause and are not associated with dose or route of administration (Coleman & Pontefract, 2016). The reaction can be triggered by pharmacogenetic causes, but the exact mechanisms of these reactions are unknown and may differ from patient to patient (Marsh, 2021).
There are several other factors related to prescription and patient adherence that may lead to adverse drug effects. These factors may be patient-related, including age, gender, genetics, lack of adherence or overdosing. Other factors may be related to prescription errors, including over- or under-prescription, drug-drug interaction, drug-disease interaction, polypharmacy, selection of inappropriate drug or dose, inappropriate treatment or lack of monitoring (Ruscin & Linnebur, 2021).
Prevention and Control
Although most of the adverse drug reactions are unpredictable, a thorough knowledge of drugs and prescription protocols may prevent these effects. It is necessary to know the case and any patient-related factors like age, gender, allergies or previous co-morbid conditions that may lead to any adverse effects (Marsh, 2021). ADRs can be avoided or caught early by carefully managing the initial dose and route of administration of a drug. Factors like drug-disease interaction, drug-drug interactions and polypharmacy should be kept in mind before prescribing a drug. Choosing an inappropriate drug or inappropriate dose can lead to adverse reactions (Ruscin & Linnebur, 2021). Older patients with multiple conditions usually take a number of drugs, which makes them the most susceptible to adverse drug reactions. Choosing an appropriate drug in older patients while keeping the drug-drug and drug-disease interactions in mind may prevent the ADRs (Ruscin & Linnebur, 2021). Appropriate patient monitoring should be done after prescribing a drug. Any unintended or harmful symptoms should be identified early, and the drug should be discontinued or adjusted accordingly. Any non-specific symptoms, after a new drug is administered, should be considered as ADRs and should be managed accordingly. Moreover, factors like lack of adherence should be addressed properly and accordingly through communication and counselling (Ruscin & Linnebur, 2021).
The rise in the field of pharmacogenetics is proving useful in the prediction, identification and prevention of adverse drug effects. Several tests have been designed and are being used to predict genetic factors that may lead to adverse drug effects. These tests are useful, but only a limited number of these tests are currently being used in clinical practice (Marsh, 2021).
In the UAE, the Ministry of Health and Prevention published guidelines in 2017 for Pharmaceutical Manufacturers. These guidelines introduce pharmacovigilance practices for these companies and aim to reduce adverse drug reactions by ensuring adherence to pharmacovigilant practices. The guidelines describe the role and duties of the marketing authorization holder and provide a proper pharmacovigilance plan with proper training and documentation. A risk management system has been made with interventions for reducing and preventing ADRs (UAE MOH Guidelines in Good Vigilance Practice (GVP), 2017).
Recommendations
The following are a few recommendations that can prevent and control the cases of adverse drug reactions (Guidelines for Detecting and Reporting Adverse Drug Reactions, 2014):
Post-marketing detection of ADRs can lead to the detection of any harmful drug in the market.
Developing a system of proper reporting of ADRs may help in post-marketing detection.
Proper monitoring systems for any potential harmful effects of drugs may reduce morbidity and mortality.
Development of social programs helping older patients with drug intake and adherence.
Development of proper systems to detect any malpractice related to drug prescription.
Education of healthcare professionals, including doctors, nurses, pharmacists and patients regarding adverse drug reactions, early detection and remedies.
Training of medical personnel to deal with any drug reaction emergencies that may lead to morbidity or mortality.
Incorporation of pharmacovigilance practices in healthcare settings with proper involvement of doctors, nurses, pharmacists and patients.
References
Adverse Drug Reactions. (2016). Washington Manual of Medical Therapeutics. Retrieved from: https://www.unboundmedicine.com/washingtonmanual/view/Washington-Manual-of-Medical-Therapeutics/602207/all/Adverse_Drug_Reactions
Coleman, J. J., & Pontefract, S. K. (2016). Adverse Drug Reactions. Clinical Medicine, 16(5), 481–485. https://doi.org/10.7861/clinmedicine.16-5-481
Guidelines for Detecting and Reporting Adverse Drug Reactions. (2014). Rational Drug Use and Pharmacovigilance Department, Jordan Food and Drug Administration. Retrieved from: https://who-umc.org/media/1079/jordan.pdf
Khalil, H., & Huang, C. (2020). Adverse Drug Reactions in Primary Care: A Scoping Review. BMC Health Services Research. https://doi.org/10.1186/s12913-019-4651-7
Marsh, D. E. (2021). Adverse Drug Reactions. MSD Manual. Retrieved from: https://www.msdmanuals.com/professional/clinical-pharmacology/adverse-drug-reactions/adverse-drug-reactions
Ruscin, J. M., & Linnebur, S. A. (2021). Drug-Related Problems in Older Adults. MSD Manual. Retrieved from: https://www.msdmanuals.com/professional/geriatrics/drug-therapy-in-older-adults/drug-related-problems-in-older-adults#v1133525
Said, A. S., & Hussain, N. (2017). Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers. Hospital Pharmacy, 52(5), 361–366. https://doi.org/10.1177/0018578717715364
UAE MOH Guidelines in Good Vigilance Practice (GVP). (2017). Dubai Health Authority. Retrieved from: https://www.dha.gov.ae/Documents/HRD/UAE%20MOH%20GVP%20Guidlines%202017.pdf
Zain, A. A. (2017). Cases of Adverse Drug Reactions on the Rise in the UAE. Khaleej Times. Retrieved from: https://www.khaleejtimes.com/health/cases-of-adverse-drug-reactions-on-the-rise-in-the-uae