Risk Factors of Cardiovascular Drugs

Risk Factors of Cardiovascular Drugs Characteristics and risk factors of Cardiovascular Drugs induced Adverse Drug Reactions: Hospital based Active Surveillance Study. Abstract: Background: Adverse Drug Reactions (ADRs) is one of the major drug-related problems in hospitalized patients. Several studies report the incidence various from 10 50% of all hospital admissions due to ADRs and no recent data available on the safety of cardiovascular drug from India. Aim: This study aims 1). To estimate incidence and characteristics of ADRs due to cardiovascular drugs in patients admitted in cardiology unit of a tertiary care teaching hospital. 2) To identify the risk factors for ADRs in hospitalized patients treated with cardiovascular drugs. Methods: A prospective active surveillance study was carried out in the cardiology department of a south Indian tertiary care teaching hospital for eight months. Population averaged Poisson regression [Generalized Estimating Equation (GEE)] models was used to estimate the adjusted relative risk associated with ADR. Results: The overall incidence of cardiovascular drug induced ADRs was 31.8%. A total of 757 patients treated cardiovascular medications. Of which 241 patients (31.8%) including 122 (16.1%) females and 119 (15.7%) males reported at least one ADR. Aspirin produced the highest number of ADRs (150; 38.7%) followed by Heparin (45; 11.6%), Atorvastatin (24; 6.2%) and Ramipril (24; 6.2%). The causality assessment reveals that 85.3% of ADRs were probable in nature. GEE was used to estimate the adjusted relative risk of each covariate associated with ADRs. The predictors of ADRs identified were: female gender, age > 60 years, multiple drug therapy (p= 0.0231) and concurrent diseases like diabetes, drugs like Heparin (RR-2.90, 95% CI 2.22-3.8) and Enalapril (RR-1.95, 95% CI 1.34-2.83). Conclusion: The incidence of cardiovascular ADRs was 31.8%. The most common drugs causing ADRs were the anti- platelet and anticoagulant class of drugs. Female gender, age > 60 years, multiple drug therapy, concurrent illness and certain drugs like heparin were identified as potential predictors for adverse reactions. Keywords: adverse drug reactions, hospitalized patients, cardiovascular drugs, pharmacovigilance, Risk factors Key Messages: This study reports the risk factors for adverse reactions to cardiovascular drugs from an Indian clinical setting. The incidence of cardiovascular drugs induced ADRs was 31.8%, which is higher than many reported studies. Anti-platelet and anticoagulant drugs were commonly associated with ADRs in the study population. Introduction: Adverse Drug Reactions (ADRs) is one of the major drug-related problems in hospitalized patients. ADRs are one of the major drug-related problems, resulting in increased morbidity and mortality and healthcare costs.[1-3]The WHO defines an ADR as a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function.[4] The prevalence of cardiovascular diseases (CVDs) has increased in recent years and it has been estimated that CVDs are the most common cause of death.[5] Reports on drug related problems including adverse drug reactions associated with cardiovascular pharmacotherapy are available.[6-10]Studies report that cardiovascular drugs may account for 10 to 50% of all hospital admissions due to ADRs.[11-13] There are reports of serious adverse drug events with cardiovascular drugs.[14]Continuous monitoring of ADRs are important in patients treated with cardiovascular drugs since, these patients who need multiple drug therapies to treat their comorbid conditions and other related risks[15] Various methods are used to detect ADRs in hospitalized patients.[16] Analyzing the adverse reaction data in relation to the presence of risk factors provide the link between the ADRs and the associated factors. Such analysis might help to identify patients who are at increased risk for the adverse reaction and therefore employing suitable monitoring and the preventive procedure is possible.[17] Reports are available on the risk factors for adverse reactions.[18-20] Studies have shown that the cardiovascular drugs are most common cause of ADRs.[6,21]A university hospital-based studies report 49 % ADRs are due to commonly used cardiovascular drugs (nitrates, digoxin, propranolol, heparin, warfarin, anti-hypertensive and anti-arrhythmic drugs)[22] A number of studies are available on the adverse effects of cardiovascular drugs. In the Indian context data on adverse effects of the cardiovascular drugs is not available. Therefore, the current study was planned to evaluate ADRs due to cardiovascular drugs in hospitalized patients. This study aims 1). To estimate incidence and characteristics of ADRs due to cardiovascular drugs in patients admitted in cardiology unit of a tertiary care teaching hospital. 2) To identify the risk factors for ADRs in hospitalized patients treated with cardiovascular drugs. Subjects and Methods: A prospective active surveillance study was carried out in the department of cardiology of a tertiary care teaching hospital for eight months (Feb to Sep 2009). The study protocol was reviewed and approved by the institutional ethical committee. All patients admitted to the cardiovascular units were monitored and evaluated for cardiovascular drugs induced adverse reactions. Patients who were previously treated or newly prescribed with cardiovascular drugs were monitored and followed for detecting and recording of ADRs. Adverse drug reactions were identified by conducting a daily patient charts review, patient interview, and consultations with treating physicians. In the suspected cases, past medical/medication history of patients were collected. In addition to patients medication history, information on co-morbidities was also collected. We used the WHO criteria for defining ADRs.[4] For every identified patient with ADR, two patients without ADRs were enrolled as matched controls. The information pertaining to the suspected ADRs was collected and documented in a specially designed ADR computerized documentation database for further assessment.[23] An ADR alert card was distributed to those patients who experienced severe adverse reactions to prevent further re-exposure of the suspected drug. All ADRs were reviewed and assessed by the research team. The documented ADRs were evaluated and characterized respect to patient demographics, nature of the reactions, drugs and organ system involved and outcome of the reactions. Using standard approach, the Causality, severity, preventability and the presences of predisposing factors of the reactions were assessed and reported. Patients age and sex were considered for the analysis. ADRs were classified as either Type A or Type B according to the system introduced by Rawlins and Thompson.[24] The suspected drugs were classified according to Anatomical Therapeutic Chemical (ATC) classification based on WHO-ATC Index 2009.[25]Using WHO Adverse Reaction Terminology documented ADRs were further classified into various organ system classes.[26] Management strategies employed for the ADRs were categorized as drug withdrawal, dose reduction, additional treatment for ADR and no change in a regimen without any additional treatment. Patient outcomes were reported as fatal, fully recovered, recovering and unknown. The causality of suspected ADRs was assessed using Naranjos ADR probability scale and classified into certain, probable, possible and unlikely to be drug induced depending upon the level of association.[27] The preventability of ADRs was analyzed and categorized into definitely preventable, probably preventable and not preventable using the modified criteria of Schumock and Thornton by Lau et al.[28]Using the criterion developed by Hartwig et al., for severity assessment, we assessed the suspected ADRs and classified into mild, moderate and severe reactions.[29] The onset of ADRs was assessed and classified into sub-acute, latent and acute groups.[4] Predisposing/risk factors Many patient-related factors predispose the occurrence of ADRs. The patient related factors like age, gender, multiple and inter-current disease states, and polypharmacy are considered as significant risk factor for developing ADR.[30] Patients age was categorized into 6 groups (less than 20 years, 21-30 years, 31-40 years, 41-50 years, 51-60 years, more than 60 years). Polypharmacy was categorized as minor (2-3 drugs), moderate (4-5 drugs) or major (5 drugs) based on the classification by Veehof et al.[31] Gender of the patient was also considered as a one of the predispose factor for the development of ADRs. Multiple disease state ( > 2 coded diseases) of the patient at the time of reaction also include in the analysis. The overall incidence of ADRs was calculated using the total number of in-patient episodes which resulted in ADRs in relation to the total number of in-patients followed during the study period. The length of hospital stay for each patient was collected from Hospital Patient Administrative System (HPAS) and used to compare the Length of Stay (LOS) between patients with and without ADRs. Additional hospital stay due to ADRs was assessed using the nature and clinical features of ADRs, discussion with treating medical staffs and assessment of patients medical records. Statistical analysis Descriptive statistics was used summarize the patient demographic and clinical characteristics like gender, diagnosis, a number of drug dispensed, the frequency of ADR, drugs involved, organ system involved and severity of ADRs. Mean with 95% confidence interval was used to summarize age and LOS. Chi-square test was used to find the association between age group, gender, the LOS with and without ADRs. Relative risk was used to measure the strength of association. The data were hierarchically arranged, to count the multiple ADR episodes which can occur with multiple admissions. Population averaged Poisson regression (GEE) was used to estimate the adjusted relative risk of each covariate associated with ADR.[32,33] Further compound symmetry was used to account for the within-subject correlation. All analysis was performed using SPSS for window 15 (SPSS Inc., South Asia, Bangalore). The significance level was set at P Results: A total of 757 patients (431 men and 326 women) using cardiovascular medications were intensively monitored. The mean age of the study population was 57.21  ± 14.22 years (18 -92 years). The average length of hospital stay was 10.6  ± 5.8 days. Overall, the incidence of ADRs was 31.84%. Two hundred and fourteen patients including 122 females and 119 males reported at least one ADR. Maximum of six ADRs were reported from one patient. Compared to males, females developed more of ADRs was observed more in females when (p 0.0001). The length of stay was increased due to ADR for a minimum of 3 days and a maximum of 28 days. The frequency of different age groups in patients with and without ADRs is presented in table-1. The main diagnosis of the study population is listed in table-1. Age group of less than 20 years is excluded because of lower sample size. Age group of more than 60 years had more ADRs compared to other age groups. Cardiovascular risk factors of a patient with and without ADR are shown in table-2. The most frequent system-organ class affected by ADRs was Platelet, bleeding clotting disorders (188, 48.89%), followed by metabolic and nutritional disorders (53, 13.66%) and gastrointestinal system disorders (50, 12.89%) (Table-3). The most common strategy for management of ADRs was drug withdrawal (94.3%) and dose alteration (5.4%) (Table-4). The mean length of hospital stay was 13.3 and 6.5 days for patients with and without ADR respectively. The length of stay was found to be longer in patients with ADR. Aspirin produced the highest number of reactions (150; 38.7%) followed by heparin (45; 11.6%), Atorvastatin (24; 6.2%) and Ramipril (24; 6.2%) (Table -3) with Platelet, bleeding clotting disorders (188, 48.89%). The most frequently reported reaction was bleeding (186; 47.9%) followed by gastric ulcer (52, 13.4%) (Table-3). The causality assessment of ADRs revealed that 85.31% of ADRs were classified as probable, followed by 7.99% as definite and 6.7% as possible. 64.4 % patients recovered from the ADRs and 35.6 % were recovering at the time of discharge (Table-4). The GEE analysis shows that the female, alcoholics, smokers and patients those taking more than 7 drugs had a higher risk for developing an ADR. (Table-2). Statistical analyses also revealed that patient taking Heparin (RR 2.90, 95% CI 2.22-3.80, Enalapril (RR 1.95, 95% CI 1.34-2.83), warfarin (RR 1.69, 95% CI 1.33-2.54) had a significantly increased probability of developing of ADRs (Table-5). Discussion: ADRs can significantly increase patients mortality or morbidity and consequently higher healthcare expenditure.[34] The study findings reveal that developing an ADRs in hospitalized patients substantially contribute to patients morbidity, further increasing the disease burden and cost of managing ADRs. The incidence of ADRs (31.8%) found in this study was twice higher than a previously reported systematic review of international studies (15.1%).[2] The present study showed that females experienced a higher incidence of ADRs (9.87%) when compared to males (7.23%) which are similar to the findings of previously published studies.[1,35-37]Several reasons have been put forth for this observed difference. Men and women have a different pharmacodynamic response to various drugs; which may consider as one of the factors for women to develop more number of ADRs. But in a study reported by Jose., on comparable Indian population male patients were found to have more ADRs than female population .[38] The incidence of ADRs was higher in the elderly patients (31.19%; age > 60 Years) compare to other age groups. (à Ã¢â‚¬ ¡2= 23.03, df-5, p 0.0001); this finding is similar to the results of Mohebbi et al.[19] Studies have shown that the incidence of ADRs may increase with increasing age. Again, due to multiple comorbid conditions and receive multiple drug therapy the elderly patients tend to have a higher risk for developing an ADR. In addition, older individuals undergo changes in drug responsiveness and disposition.[39] It appears that elderly patients need more attention to prevent the occurrence of ADRs. In this study, the incidence of Aspirin-induced ADRs was 38.7% (n=150); which was the highest rate compared to other cardiovascular drugs in this study. However, High rates of ADRs with streptokinase have been reported previously.[40]Studies reported a rate of amiodarone-induced ADRs as 16%, whereas in the current study it was too low at 0.5%.[41] This might be due to the lower use of amiodarone in the current study subjects. In a study conducted by Wiffen et al., investigating ADRs induced by all groups of drugs, warfarin was among the top three drugs causing ADRs.[42] In our study, the rate of ADRs attributed to warfarin was just 3.6%, whereas heparin-induced bleeding was the second highest ADR in this study population (45, 11.6%). In this study, we found central nervous and gastrointestinal systems are the most frequently affected organ system classes by ADRs. These findings were similar to the findings of a study conducted in Iran.[13]The incidence of preventable ADRs in this study (6.9%) is comparably lower than those detected in other studies.[34]This might be probably due to intensive monitoring of CCU patients in our study. The rate of serious ADRs (22.2%) detected in this study tend to be higher than other studies.[14] Population averaged Poisson regression (GEE) model showed that factors like gender and age of more than 60 years, multiple drug therapy and the presence of co-morbidity were risk factors for experiencing ADRs. The average duration of drug usage was found to be longer in patients without ADR. It appears that most of the ADRs have been noted shortly after initiating cardiovascular drugs and the incidence of ADRs in this study population was not related to the duration of usage. Similar to findings of many other studies, increasing the number of drugs led to increased frequency of ADRs. Conclusion The finding of this study indicates that cardiovascular drugs cause serious and frequent adverse reactions. The incidence of cardiovascular ADRs was 31.84%. The most common drugs causing ADRs were the anti-platelet and anticoagulant class of drugs. Female gender, age more than 60 years and use of more than 7 drugs was found to be the risk factors for developing ADRs. The identified incidence was higher than many reported studies. The current study identified the common ADRs and their predictors. Patients with identified predictors for adverse drug reactions can be intensively monitored and necessary preventive measures can be initiated if signs of reactions are observed.

Chilean Copper Mine Collapse Essay

This paper will discuss in how important it’s to know your audience. When having to communicate a disaster like the Chilean copper mine that occur in South America it’s one example of where knowing your audience was a very important issue. This disaster in the Chilean copper mine, a disastrous downfall in one of the shafts of the mine has left 33 miners trapped 310 meters below the ground. The outcomes of the company and their reaction to the disaster would eventually define how the world, their audience, would see them. It turns out to be very crucial that the spokesperson of the company who issues updates and information to the public is careful and sensitive to the families. The audience the company would be reporting to would be made up of the news correspondence, the victim’s families, and the media. Not only would the company spokesperson have to keep the reputation and point of view of the mining company in one piece, they would have to issue specific and straightforward information that would not always be in the greatest interest of the company’s position. All though in the beginning the company may not have a great extent of information, it’s necessary for them to inform the families with as much information as soon as possible. This would consist of any information as to what is taking place in the mine while the miners are still trapped. When communicating we need to have some emotion and sympathy than just  the facts of what is going on inside the mine. With all the families wanting to be inform that everything is okay and everyone is doing his or her best to get the situation under control. When speaking to any type of media they are concerned only about the facts. They do not care about emotions or sympathy of the friends or families. If there are no facts to give to the media than nothing should be assumed to those until there are facts to share. The collapse would not only have emotional impact on the 33 miners trapped underground, the family members of those miners would be distressed as well. The family members of those 33 men would have to wait in suffering before they would receive word of their family member’s fate. When a disaster of this extent occurs, the company has the obligation to keep the family members well-informed every step of the rescue progression, above the news bulletin and media. Furthermore informing the families right away in regards to what’s being done to rescue the miners is very important. For instance the families should be inform that while the miners remain in the trapped mines the government is taking steps from getting doses of anti-depressants for the men. Also they’re sending down fresh clothes and games to help keep them physically and mentally fit. In addition the families need to know that the government and rescue team is guiding the miners to a secure area. The secure area is where they can establish various places one for resting and sleeping. The families of the miners need to be informed that the rescue team is doing everything possible to keep the miners in good spirits. Also asking the families to get involve by writing positive encouraging letters for their love ones it’s encouraged. When communicating to the families that the government has contacted NASA to help with the rescue it will give them a little piece of mind. Let them know the rescue team will be able to utilize all the new technology of NASA‘s and their resources to rescue the miners. NASA who has sent people to the moon and outer space has many tools and resources for a situation like this. Therefore the most appropriate channel to communicate with the media, families in a situation like this one of the trapped miners is face to face. The reason to announce the incident face to face is because it shows your compassion, truthfulness and braveness. I would say for the employees of the company I would use email and face to face. The email would be sent out first to the employees followed up with a face to face is case they had any questions or concerns. In conclusion it’s important to remember that timeliness is of the utmost importance when dealing with situations of this magnitude. When taking families into consideration, the company must deliver the information of the mine collapse with an extreme level of discretion, clarity, and encouragement and compassion. References http://web.ebscohost.com.ezproxy.apollolibray.com http://www.msnbc.com.world_news-americas/t/trapped-chilean-mines

The School s Grading System - 1479 Words

Since 1983, grades have been steadily rising which might seem like a good improvement, but instead, it has been negatively impacting students’ education and the world around them, leaving people to question the school’s grading system. According to Vikram Mansharamani and Peter Jacobs, one of the main reasons for grade inflation was that during the Vietnam War, students were given â€Å"higher grades to ensure that students wouldn’t fail out or be drafted†. Although this may be true, even after the Vietnam War, grades were above average. In the early 2000s, Wellesley College and Princeton both tried to combat the inflation and got two different results. Despite Wellesley’s â€Å"average GPA falling from 3.55 to 2.28, it’s been slowly drifting back†¦show more content†¦One simple error from them and I could be dead or in a coma forever. Or in the instance of a surgeon, if they didn’t put in enough hours in the skill lab, or ve ry minimal, and didn’t even master their techniques, I wouldn’t allow them to perform on me. In this sense, if students graduate without the necessary skills and knowledge that they should have learned, they can ultimately begin to destroy the population. With the inflation of grades, their value drops to the point where some people suggest not even using grades. Mark Oppenheimer suggests in his article, There’s nothing wrong with grade inflation, that instead of grades, the professors essentially write feedback and tell the students what they did correctly and what they need to improve on. If we think of grade inflation as currency, we can easily see how it would lose its value. As grades lose their value, professors lose their credibility. They are hired for the sole purpose of educating their students, not to give them good grades. Although passing their students is one of the main goals as an educator, they should ensure that their students are learning the material and not taking the easy route out. Professor Rebecca Schuman exclaimed that â€Å"as a professor, there is little worse than spending an entire semester attempting to connectShow MoreRelatedGrading System807 Words   |  4 PagesThe grading system of UH is a problem. For sure, students care about the grades. Some of them worried about it if they didn t make A in classes. Some of them afraid of failing the courses. Parents want their kids to make good grades, also. The grading system of UH make the students working hard if they want to get good grades. Grading system is a problem, to solve this problem we should vote for it. Let the student and parents tell the school whether they want to change it or not. At UH, weRead MoreHigh Family s University Grading System975 Words   |  4 Pagesand commitment is insufficient to do well in school. 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The Contribution Of Karl Marx Essay - 1337 Words

This essay considers the contribution of Karl Marx to the study of sociology, throughout this essay I will be discussing what Marxism is, how Marxism has affected today’s society as well as academics that did not agree with Marx’s theories. Marxism is the social and economic system based on the theories of Karl Marx and Freidrich Engels. Karl Marx was born in Trier, Germany in 1818, Marx studied law and Berlin University but later changed to philosophy until finally perusing his interest in journalism. When Marx finished his studies he began writing for a left-winged newspaper, the Rhensig Gazette (Rheinishe Zeitung) where they would publish his articles almost every week. Marx soon became the editor in 1942 however the newspaper closed soon after due to new censorship laws in Germany. In 1983 Marx and his wife Jenny moved to Paris where Marx thought he would be able to express himself more freely without the fear of being judged or censored, like he was back in Germany. 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Marxism was discovered after theShow MoreRelatedThe Contribution to Economics of Each of the Following: †¢ Adam Smith †¢ Thomas Malthus †¢ David Ricardo †¢ Karl Marx †¢ Alfred Marshall †¢ John Maynard Keynes †¢ Milton Friedman2179 Words   |  9 PagesWrite an essay describing the contribution to economics of each of the following: †¢ Adam Smith †¢ Thomas Malthus †¢ David Ricardo †¢ Karl Marx †¢ Alfred Marshall †¢ John Maynard Keynes †¢ Milton Friedman â€Å"Many Economists have tried to establish why the economy performs as it does and want to have a basis for predicting how the economy will perform when circumstances change†. (Nagel, S pg 1 1999) Economists are just people after all, who have lived through different times and experiences in theirRead MoreKarl Marx And Max Weber1324 Words   |  6 PagesKarl Marx and Max Weber were influential sociologists that paved the way for modern sociological school of thought. 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