Figure 1. Distribution of patients with gender wise ADRs.
RESEARCH ARTICLE
Mounika Thogaru *
a Department of Pharmacy Practice, St. Peter's Institute of Pharmaceutical Sciences, Vidya Nagar, Hanamkonda, Warangal, Telangana, India
Received 21 June 2020; Revised 07 August 2020; Accepted 27 August 2020.
DOI: https://doi.org/10.53411/jpadr.2020.1.1.4
Introduction: Antiplatelet agents prevent platelets from dumping and prevent clots from forming and growing. Anticoagulants slow down clotting thereby reducing fibrin formation and preventing clots. Drug-related problems are a major concern in the view of physical, psychological, and economic burden to patients.
Objectives: The aim of the research work is to access, evaluate and monitor the drug-related problems on antiplatelet and anticoagulants in stroke patients.
Methods: In this study 300 numbers of patients were screened including both males and females of all age groups in a super specialty hospital.
Results: The number of ADRs was found to be predominantly associated with a male as compared to females as well as most ADRs were reported for patients with cardiac stroke as compared to ischemic stroke and hemorrhagic stroke.
Conclusions: Low molecular weight heparins, aspirin, clopidogrel drugs resulted in various adverse drug reactions. Mostly 114 cases of ADR were due to drug-drug interactions followed by drug-food interactions and drug ethanol interactions as was concluded from the study.
Keywords: Heparin, aspirin, clopidogrel, stroke, drug related problems, drug interactions
A drug related problem is an event or incident involving drug therapy that potentially interferes with required health outcomes. The increasing number combined drug regimens led to more adverse events and complicates follow-up. Drug related problems (DRPs) lead to substantial morbidity and mortality, as well as increased health care expenditure, which in turn affect both patients and society (Alvarez-Sabín et al., 2016). This can lead to prolonged hospital stay and increased health care costs. So the injury or death that may occur as a result of drug related problems has to be evaluated so as to reduce the occurrence of similar events in future. Drug-related problems include medication errors and adverse drug reactions. Drug-related problems are relatively common in hospitalized patients and can result in patient morbidity and mortality, and increased costs (Dahal et al., 2013). The range of reported incidences of adverse drug reactions is even wider. These wide ranges can be largely explained by the different study methods. The introduction of systems for the early detection of adverse drug reactions may help to reduce problems related to drug therapy. Drug-related problems are common in the elderly and include drug ineffectiveness, adverse drug effects, overdosage, underdosage, and drug interactions. Adverse drug effects are effects that are unwanted, uncomfortable, or dangerous. Common examples are over sedation, confusion, hallucinations, falls, and bleeding. Among ambulatory people ≥ 65, adverse drug effects occur at a rate of about 50 events per 1000 person-years (Jauch et al., 2013). Hospitalization rates due to adverse drug effects are 4 times higher in elderly patients (about 17%) than in younger patients (4%) (Sobrino et al., 2010).
Antiplatelets are the group of powerful medications that prevent the formation of blood clots. Antiplatelets may be prescribed for patients with a history of coronary artery disease, heart attack, angina (chest pain), stroke and transient ischemic attacks (TIAs), peripheral artery disease (DeGregorio-Rocasolano et al., 2018). Antiplatelets may have side effects. Nausea, upset stomach, stomach pain, diarrhoea, rash, and itching are the most common side effects. Any signs of unusual bleeding, such as blood in the urine or stool, nose bleeds, any unusual bruising, heavy bleeding from cuts, black tarry stools, coughing up of blood, unusually heavy menstrual bleeding or unexpected vaginal bleeding, vomit that looks like coffee grounds, dizziness, severe headache, difficulty swallowing, shortness of breath, difficulty breathing or wheezing (European Stroke Organisation, 2008).
It was reported from a study that low dose aspirin increases the risk of bleeding 2-folds as compared to placebo (Flesch et al., 2006). Taking anti-platelets during the last two weeks of pregnancy may cause bleeding problems in the baby or mother both before and after delivery. Anti-platelets can be passed to the infant through breast milk. However, their effect on nursing infants is unknown. Anticoagulants are medicines that help prevent blood clots. Warfarin, acenocoumarol and phenindione block the effects of vitamin K and prevents blood clots forming (Saver et al., 2008). A study conducted to find out the effect of anticoagulant agents associated with chronic subdural hematoma in the elderly reveled that both anticoagulant and antiplatelet agents were associated with an increased risk of CSDH for patients receiving oral anticoagulants, ADP-antagonists, or COX-inhibitors, respectively (Pasquale De Bonis, et al., 2013). The study conducted on atrial fibrillation outcome trials of oral anticoagulant and antiplatelet agents reveled that there was an indication of reduced mortality compared with warfarin. This may in turn reap substantial benefits in terms of reducing the clinical and economic burden of stroke. (Jean-Pierre Bassand, et al., 2012)
The proposed study was carried out in indoor wards of neurology and cardiology department of Rohini super specialty hospital. Rohini super specialty hospital, a Territory Care Hospital set up, Hanamkonda. It is a 300 bedded hospital with departments like general medicine, cardiology, neurology, urology, gastroenterology, orthopedics, pediatrics, general surgery and gynecology. It provides all the facilities along with adequate laboratory needs. A prospective observational study was designed for a study period of 6 months. Patients diagnosed with antiplatelets and anticoagulants in ischemic, hemorrhagic strokes and cardiac stroke were enrolled in the study. The in patients who are diagnosed with the antiplatelets and anticoagulants in the department of neurology and cardiology were enrolled into the study by considering following inclusion and exclusion criteria.
Study was conducted in neurology and cardiology department. Those patients admitted to have been reviewed on daily basis and the patients who met the criteria were enrolled into the study. For the identification of drug related problems on anti-platelets and anticoagulants, a data collection form was developed consisting of a check list of commonly occurring DRPs and a semi structured patient interview to support the performance of a medication review. All the cases were reviewed and those who met the study criteria were followed after getting the drug therapy. Details were recorded in the suitable designed data collection form including the drug history, treatment chart, adverse effects and drug interactions as per the need of the study. The patient drug therapy was monitored for the drug related problems of antiplatelets and anticoagulants and interviewed the patients or their care givers when necessary. The identified DRP's were identified (Steinberg et al., 2015; Viktil et al., 2008). All the relevant and necessary data was collected from the following source data such as patient case records – demographics, medication history, treatment chart, direct patient or their care givers interview. Truven Health Analytics-Micromedex solutions for identifying Drug-Drug interactions. Drug interaction checker also for identifying Drug-Drug interactions.
The results were presented in following tables. The distribution of patients based on gender were presented in Table 1.
Table 1. Distribution of patients based on gender.
| Gender | No. of Patients (n) | Percentage % |
|---|---|---|
| Male | 181 | 69.3 |
| Female | 119 | 39.66 |
| Total | 300 | 100 |
Printed percentages do not reconcile with the counts shown (181/300 = 60.3%, not 69.3%) and are also inconsistent with Table 3's total of 182 males. Transcribed literally; verify against the original typeset PDF.
The distribution of patients with gender wise ADRs were presented in Figure 1.
Figure 1. Distribution of patients with gender wise ADRs.
The distribution of patients with different types of strokes were presented in Table 2.
Table 2. Distribution of patients with different types of stroke.
| Type of Stroke | No. of Patients (n) | Percentage % |
|---|---|---|
| Ischemic stroke | 114 | 38 |
| Hemorrhagic stroke | 11 | 3.66 |
| Cardiac stroke | 175 | 58.3 |
| Total | 300 | 100 |
The distribution of patients according to gender in different strokes were presented in Table 3.
Table 3. Distribution of patients according to gender in different strokes.
| Type of Stroke | Males | Females |
|---|---|---|
| Ischemic stroke | 62 (54.38%) | 52 (45.61%) |
| Hemorrhagic stroke | 6 (54.54%) | 5 (45.45%) |
| Cardiac stroke | 114 (65.14%) | 61 (34.85%) |
| Total | 182 | 118 |
Distribution of patients according to their age were presented in Table 4.
Table 4. Distribution of Patients according to Age.
Age-distribution data (Table 4) was severely fragmented in the source document -- only 3 partial data rows were recoverable, with no reliable column headers. Recoverable fragments: '82-88': 1 (8.77%), 0, 8 (4.57%); '89-95': 1 (0.87%), 0, 0; '13-19': 1 (0.87%), 0, 0. Full reconstruction NOT attempted -- please re-enter this table from the original typeset PDF.
The distribution of types of ADRs in different Strokes were presented in Figure 2.
Figure 2. Distribution of types of ADRs in different Strokes.
The distribution of the drug Interaction based on severity were presented in Table 5.
Table 5. Distribution of the drug Interaction based on severity.
Table 5 (Distribution of drug interaction based on severity) data was NOT recoverable from the source document -- only the table heading survived extraction; no data rows were present anywhere in the file. Please re-enter this table from the original typeset PDF before publishing.
The distribution of identified drug related problems were presented in Table 6.
Table 6. Distribution of identified drug related problems.
| Type of Drug Related Problem | No. of Patients (n) | Percentage % |
|---|---|---|
| Adverse drug reactions | 62 | 13.7 |
| Indication without drug | 1 | 0.2 |
| Drug without indication | 0 | 0 |
| Incorrect drug of choice | 0 | 0 |
| Double medication | 122 | 27.05 |
| Unnecessary long duration | 24 | 5.32 |
| Missed dose | 43 | 9.53 |
| Too high dose | 5 | 1.1 |
| Too low dose | 4 | 0.88 |
| Contraindications | 0 | 0 |
| Drug interactions | 188 | 41.68 |
| Total | 451 | 100 |
Printed Total (451) is 2 higher than the sum of the individual counts shown (449) -- a minor arithmetic inconsistency present in the original manuscript, transcribed as-is.
Figure 3. Distribution of ADRs based on Drugs.
NOTE: this chart's actual data matches Table 6 (Distribution of identified drug related problems), not a drug-based ADR breakdown as the caption states. Likely a caption/label mismatch in the original manuscript -- flagged for editorial verification.
In this study, about in 300 prescriptions were analyzed including both male female of all ages in super specialty hospital. In the study population the demographic data and ADR's are found that male dominate over female and cardiac stroke over ischemic and hemorrhagic stroke. Out of 300 patients, patients enrolled with cardiac stroke, ischemic stroke, hemorrhagic stroke. Among 300 patients, drug-drug interactions were 114, drug-food interactions were 68, drug-ethanol interactions were 6. Among all the drugs low molecular weight heparins, aspirin, clopidogrel has shown more ADRs compared with other antiplatelet and anticoagulants.
[Conflict of interest statement not present in extracted source text -- verify with author/editorial record before publishing.]
© 2020 The Author(s). This article is distributed under the terms of the Creative Commons CC BY-NC-ND 4.0 License. | DOI: https://doi.org/10.53411/jpadr.2020.1.1.4