Epidemiology Of Adverse Drug Reactions Research Articles

Drug-Induced Anaphylaxis: National Database Analysis.

(1) Background: National health system databases represent an important source of information about the epidemiology of adverse drug reactions including drug-induced allergy and anaphylaxis. Analysis of such databases may enhance the knowledge of healthcare professionals regarding the problem of drug-induced anaphylaxis. (2) Methods: A retrospective descriptive analysis was carried out of spontaneous reports (SRs) with data on drug-induced anaphylaxis (SRsAs) extracted from the Russian National Pharmacovigilance database (analyzed period 2 April 2019-21 June 2023). The percentage of SRsAs among SRs of drug-induced allergy (SRsDIAs) was calculated, as well as of pediatric, elderly, and fatal SrsAs. Drugs involved in anaphylaxis were assessed among total SRsAs, pediatric, and elderly SRsAs, and among fatal SRsAs. Demographic parameters of patients were assessed. (3) Results: SRsAs were reported in 8.3% of SRsDIAs (2304/27,727), the mean age of patients was 48.2 ± 15.8 years, and females accounted for 53.2% of cases. The main causative groups of drugs were antibacterials (ABs) for systemic use (44.6%), local anesthetics (20.0%), and cyclooxygenase (COX) inhibitors (10.1%). Fatal SRsAs were reported in 9.5% (218/2304) of cases, the mean age of patients was 48.0 ± 16.7 years, and females accounted for 56.4% of cases. Pediatric SRsAs accounted for 3.9% of pediatric SRsDIAs and 5.8% of all SRsAs, with a mean age of 11.8 ± 4.5 years, and females acccounted for 51.9% of cases. Elderly SRsAs accounted for 2% of elderly SRsDIAs and 2.8% of all SRsAs, and the mean age was 73.0 ± 5.3 years, and females accounted for 43.5% of cases. ABs caused 40% of SRsAs in the elderly, 42.9% in children, and 50% of fatal SRsAs. (4) Conclusions: Our study revealed a relatively high proportion of anaphylaxis among SRs of drug-induced allergy. ABs were the most prevalent causative agents, especially in fatal SRsAs.

Epidemiology of adverse drug reactions to antihypertensive, antithrombotic and antidiabetic medications among adult inpatients at a National Referral Hospital, Uganda

ABSTRACT Introduction Treatment for hypertension, thrombosis and type 2 diabetes mellitus is long term and usually requires a combination of drugs which increases the risk of adverse drug reactions (ADRs). This study aimed to establish the prevalence at admission, incidence during hospitalization and characteristics of ADRs linked to antihypertensive, antithrombotic and antidiabetic drugs among adult inpatients in Uganda. Methods We conducted a secondary analysis of data from a previously assembled prospective cohort study in Uganda’s Mulago National Referral Hospital. We reviewed the files of inpatients who received antihypertensive, antithrombotic and/or antidiabetic medications prior to and/or during hospitalization. The modified Schumock and Thornton Preventability Scale, the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events and the World Health Organization – Uppsala Monitoring Centre seriousness criteria were used to characterize the ADRs. Results More than a quarter (27%, 42/155) of the inpatients experienced an ADR at admission or during hospitalization. The point prevalence of ADRs at admission was 8% (13/155) and the incidence of ADRs during hospitalization was 23% (36/155). Forty-one percent (35/86) of the ADRs were serious and the majority (59%, 51/86) were preventable. Conclusion One in 13 inpatients experienced an ADR on admission and one in four experienced an ADR that developed during hospitalization. Clinicians ought to prescribe medicines with lower ADR risk profile for cardiovascular and/or diabetic patients whenever possible.

Epidemiology and evaluation of adverse drug reactions in a Korean hospital database for spontaneous reports in the period 2009 to 2018.

To evaluate the epidemiology of adverse drug reactions (ADRs) in the Korean population and to identify their characteristics and factors affecting their severity. The analysis was based on the ADRs reported to the Seoul National University Hospital between 2009 and 2018. Statistical assessment (SPSS Statistics 25) included frequency analysis and the χ2-test. Risk factors were assessed using logistic regression analysis. Results were considered significant at p< 0.05. A total of 44,122 cases were analyzed of which 24,801 (56.2%) cases concerned females and 19,321 (43.8%) males. A total of 47% of cases involved persons aged between 50and79 years. Antineoplastic agents, immunomodulating agents, and systemically administered anti-infective agents accounted for 57.6% of all drugs reported. Gastro-intestinal system disorders accounted for the largest proportion (25.8%) of adverse drug reactions reported. A total of 3,429 (7.8%) ADRs were reported as being in the category severe. Multivariate analysis showed that the risk of an ADR being reported as severe is higher in males than in females (OR=1.25, 95% CI: 1.16-1.35), and higher in those aged 0-4 years (OR=1.74, 95% CI: 1.46-2.08), in those aged 5-19 years (OR=1.19, 95% CI: 1.07-1.31), and in those aged 65 years and over (OR=1.26, 95% CI: 1.16-1.37), compared to those aged 20-64 years. From a public health perspective, ADRs are important because they are preventable. Important determinants, such as differences in specific age groups and drug classes, for the occurrence of ADRs and the occurrence of severe ADRs in particular, were identified. These determinants need to be carefully monitored in both private medical practices, clinics and hospitals. This monitoring of specific groups will involve close attention factors associated with gender, age group, and drug classes.

Epidemiology of Adverse Drug Reactions According to Health Insurance Type

Hye Su Jeong, MPH, Hyun Kyung Kim, MD, Jae Hoon Chung, MD, Yun Jae Han, MD, Sung Jun Cho, MD and Gunn Hee Kim, MD, PhD. Journal of Pharmacoepidemiology and Risk Management 2022;14:79-85. https://doi.org/10.56142/2022.14.1.79

The role of general practitioner in the study of adverse drug reactions epidemiology in ambulatory care setting

Adverse drug reactions (ADRs) cause considerable mortality and morbidity. Its importance becomes greater in relation to the current increase in the use of drugs and multimorbidity. Premarketing studies do not allow a complete knowledge of the safety of a medicine. Many ADRs occurring in the outpatient setting, but there is a significant lack of information regarding the epidemiology of ADRs in this level of health care. Thus, guidance on how to direct attention to effective targets for improvement of medication safety in ambulatory care settings is missing. In this scenario, the general practitioner (GP) is in a rare, special position in the health system, which allows him to combine the clinical tasks of diagnosis and treatment on individuals with epidemiological and public health tasks on communities, including a important role in the study of ADRs’s epidemiology.

Epidemiology of adverse drug reactions in Europe: a review of recent observational studies.

Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Included studies assessed the number of patients who were admitted to hospital due to an ADR, studies that assessed the number of patients who developed an ADR during hospitalization, and studies that measured ADRs in the outpatient setting. In total, 47 articles were included in the final review. The median percentage of hospital admissions due to an ADR was 3.5 %, based on 22 studies, and the median percentage of patients who experienced an ADR during hospitalization was 10.1 %, based on 13 studies. Only five studies were found that assessed ADRs occurring in the outpatient setting. These results indicate that the occurrence of ADRs in the European hospital setting—both ADRs that result in hospitalization and ADRs that occur during the hospital stay—is significant. Furthermore, the limited number of studies that were performed in the outpatient setting identify a lack of information regarding the epidemiology of ADRs in this setting.

Drug induced diseases (DID): Need for more awareness & research.

Drug induced diseases (DID): Need for more awareness & research.

Pharmacovigilance in Pediatrics

Over the last decade, the striking shortfalls in the provision of safe and effective medicines for children and adolescents have been increasingly recognized. In both theUS and the EU, new legislations were introduced to improve pediatric drug therapy. Frameworks for clinical trials in children were established and significantly improved and, in the EU, pharmaceutical companies are required to prepare a Pediatric Investigation Plan (PIP) for all new drugs and licensing extensions, which has to be precisely followed. Clinical trials in children are now mandatory, as is a systematic approach to pharmacovigilance. According to the WHO, pharmacovigilance is the science of, and activities related to, the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. In adults, pharmacovigilance predominantly refers to postmarketing surveillance. However, in the pediatric population, drugs licensed for this age group are limited; therefore, it has been suggested to extend the definition of pharmacovigilance for this population to ‘‘the process of evaluating and improving the safety of medicines used in pediatric patients of all ages’’. This includes the establishment of the epidemiology of adverse drug reactions (ADRs) and the safety of medicines in a clinical trial, and the detection of new ADRs, including increasing the awareness of ADRs and reducing them by developing appropriate treatment strategies and guidelines. The aim of this editorial is to review these aspects of pediatric pharmacovigilance 4 years after the new pediatric regulation came into force in Europe, and to identify areas where more efforts are needed.

Questionnaire‐based survey of lifetime‐prevalence and character of allergic drug reactions in German children

Data on the epidemiology of adverse drug reactions (ADR), especially allergic drug reactions, in children are rare. The reported prevalence of ADR in pediatric populations varies a lot, depending on type of the study and the country where the data were collected. In order to assess the prevalence of ADR and allergic drug reactions in a population of German children, we conducted a study in a German pediatric university hospital. A questionnaire concerning occurrence and character of ADR was distributed to all parents presenting their children in the hospital for planned admissions or in the emergency department from May 2004 to November 2004. Additional telephone interviews were conducted to specify the reported symptoms in ambiguous cases. One thousand four hundred forty-seven questionnaires were collected. The reported life-time prevalence of ADR according to the information given by the parents was 7.5% (108/1447). Six of the reactions were severe, three children had experienced anaphylactic reactions. In 4.2% (61/1447), the history was suspicious for a potential allergic mechanism because of an immediate or late phase cutaneous drug reaction. In this group, the suspected drugs were antibiotics in 85% (32.7% aminopenicillins, 29.5% other penicillins, 11.5% cefaclor, 8.2% macrolides and 18% others), antiphlogistic and respiratory drugs in 4.9% each and vaccines and contrast media in 3.3% each. There was a higher percentage of children under the age of four suffering from ADR. This trend was not significant when analyzing only the allergic reactions. Forty-four percent of the parents stated, their children suffer from drug allergy, although a clear non-allergic reaction was described. Both, ADR and allergic drug reactions are frequent phenomena in children. It is important to monitor drug therapy for any adverse reaction in order to inform the parents about the character of the adverse reaction, the necessary consequences and to initiate further diagnostic procedures.

Epidemiology of Adverse Drug Reactions

Adverse drug reactions constitute a major health concern for the individual patient and the community. However, most reports on adverse drug reactions in Europe depend heavily on extrapolations based on incidence estimates from US studies. In order to explore the epidemiology of adverse drug reactions in Switzerland, we set up a pharmacoepidemiologic database on medical inpatients at the University Hospital Zurich and the Kantonsspital St. Gallen and monitored so far over 10000 hospitalisations for drug utilisation and adverse drug events. 4.1% of all admissions were caused by adverse drug events. About 1/3 of them were caused by medication errors, whereas the remaining represented non-preventable adverse drug reactions. 7.5% of the patients experienced an incident adverse drug event during hospitalisation and 1 among 20 of these were caused by medication errors. So far, we also have explored the epidemiology and characteristics of selected adverse drug reactions, such as for example drug-induced liver injury, NSAID-associated gastrointestinal bleeding and a potential drug interaction between paracetamol and phenprocoumon. These findings and the strength and limitations of such databases will be discussed.

Epidemiology of adverse drug reactions in the elderly by drug class.

As the growth of the elderly population continues, the burden on the health care system and society will also increase. Since chronic diseases such as hypertension, coronary artery disease, arthritis, stroke, cancer and diabetes mellitus are more prevalent with age, the number of people with multiple chronic diseases will also increase. These patients are likely to be treated for some or all of their conditions with drug therapies. When used appropriately, drugs may be the single most important intervention in the care of an older patient, but when used inappropriately they no longer provide therapeutic benefit, and they may even endanger the health of an older patient by causing an adverse drug reaction (ADR). Factors believed to be responsible for increased adverse reactions in elderly patients are polypharmacy (including prescription and over-the-counter medications), increased drug-drug interaction, pharmacokinetic changes, pharmacodynamic changes, the pathology of aging and compliance. The exact role that age plays in ADRs is not clear. This is in part because few older patients are included in the large randomised trials, and so much of the information used to ascertain the age-associated risks of drugs comes from observational studies. Although the interactions of aging, concurrent comorbidities and polypharmacy are known, older patients do appear to be at increased risk. Improvements in the management of drug therapies of older patients can lead to improvements in their overall health, functioning and safety, as well as providing potential benefits to society by ameliorating some of the burden of their health care.

Independent anaphylaxis to cefazolin without allergy to other β-lactam antibiotics

Independent anaphylaxis to cefazolin without allergy to other β-lactam antibiotics

Drug therapy in the elderly

The elderly are known to be more susceptible to adverse drug reactions. Age differences in pharmacokinetics (i.e., absorption, distribution, metabolism, and elimination) may contribute to an increased susceptibility of the elderly to both the therapeutic and toxic effects of some drugs. For many drugs studied, such pharmacokinetic differences are generally consistent with age differences in body composition, renal function, and protein binding. Ageing is associated with a decrease in lean body mass and total body water, and a decline in glomerular and tubular function in the kidney, and diminished cardiac output and liver blood flow. In addition to considering the epidemiology of adverse drug reactions and the altered physiology and pharmacokinetics in the elderly, this review attempts to provide an overview of what is known about the relationship between advanced age and the pharmacokinetics of some drugs mainly eliminated via the kidney. Thus, several methods are presented to permit rational dosage regimen modifications for elderly patients with diminished renal function. Based on a review of the accumulated literature related to clinical geriatric pharmacology, it is concluded that dosage regimen adjustments based on therapeutic drug monitoring are essential to make drug therapy in the elderly safer and more effective.

Epidemiology of Adverse Drug Reactions in Intensive Care Units. A Multicenter Prospective Survey

Epidemiology of Adverse Drug Reactions in Intensive Care Units. A Multicenter Prospective Survey

Using the Adverse Reactions Register to study the effects of age and sex on adverse drug reactions.

Many countries maintain a register of reports of adverse reactions to drugs. Although reports are made voluntarily by doctors and dentists these registers contain much information that may be useful in pharmaco-epidemiological studies. We show how the epidemiology of adverse drug reactions (ADRs) can be studied using data from such a register, together with estimates of the numbers of prescriptions of the drug, categorized by age and sex of the patient. Reporting rates of ADRs are compared for different ages and sexes by logistic analysis, using extrapyramidal reactions to metoclopramide as an example. Highly significant effects of sex and age on reporting rates are found, with young women being most at risk. We consider possible alternative explanations of this finding, and show that relative overdosage does not account for the differences between the age and sex groups. Other possible errors in the data are also considered unlikely to alter these conclusions; these include differential bias in reporting ADRs for various age-sex groups, and errors in the prescription data. Studies based on the adverse reactions registers are useful for formulating hypotheses which can be tested in a prospective study.

Epidemiology of adverse drug reactions in intensive care units. A multicentre prospective survey

Clinically relevant events possibly attributable to drug exposure have been monitored prospectively over a period of six months in 27 general intensive care units. Fifty-four events attributed to drugs were reported in 51 patients during their stay in hospital, corresponding to an overall incidence of 1.35%. The behaviour of the physicians following attribution of the events to a prescribed drug is analyzed and discussed in detail with respect to its relationship to the quality and severity of the reaction, and the classes of drugs. Twenty-four of the 4537 monitored admissions during the six months were due to life-threatening emergencies linked to the administration of drugs (14) and radio-contrast media (10) (overall incidence 0.5%). While the clinical burden attributable to adverse drug reactions in Intensive Care Units appears to be relatively small, the analysis shows that there is ample room for a greater reduction in their incidence.

Epidemiology of Adverse Drug Reactions in the Newborn

A prospective study on the epidemiology of adverse drug reactions (ADR) in the 200 neonates consecutively admitted to a newborn intensive care unit had shown that 136 ADR occurred in 60 babies (incidence = 30%). 20 of these ADR (14.7%) were major (life-threatening), 34 (25%) were moderate (prolonged hospital stay) and 82 (60.3%) were minor (resolved spontaneously, no therapy required). Respiratory depression, cardiac arrhythmias, renal failure, metabolic abnormalities (hyperglycemia, electrolyte imbalance) and gastrointestinal bleeding were the most common major and moderate ADR. Hematologic (eosinophilia, thrombocytopenia) and metabolic (lipemia, hyperglycemia) were the most frequent minor ADR. The case fatality rate is 5%. Most commonly suspected drugs associated with the ADR were cardiovascular drugs (tolazoline, digoxin, methoxamine), antibiotics, diuretics and components of intravenous nutrition solutions.

Textbook of Adverse Drug Reactions.

D.M. Davies: History of adverse drug reactions D.H. Lawson: Epidemiology of adverse drug reactions M.D. Rawlins & J.W. Thompson: Mechanisms of adverse drug reactions N.P. Bown & D.F. Roberts: Chromosome disorders R.E. Ferner & J.M. Smith: Disorders of the fetus and neonate J.C. Cowan, M.W. Baig & L-B. Tan: Disorders of the heart D.M. Davies: Disorders of the peripheral vascular system N.P. Keaney: Respiratory disorders J.G. Walton & R.A. Seymour: Dental disorders D.N. Bateman: Gastrointestinal disorders M. Davis & R. Williams: Hepatic disorders D.N.S. Kerr & M.J.D. Cassidy: Renal disorders V.T.F. Yeung & C.S. Cockram: Endocrine disorders I, J.C.N. Chan & C.S. Cockram: Disorders of metabolism R. Swaminathan: Disorders of metabolism H.G.M. Shetty, P.A. Routledge & D.M. Davies: Disorders of muscle, bone, and connective tissue R.H. Felix & A.G. Smith: Skin disorders P.G. Blain & R.J.M. Lane: Neurological disorders S.I. Davidson & M. Hickey-Dwyer: Eye disorders C. Diamond: Ear, nose, and throat disorders K. Davison & F. Hassanyeh: Psychiatric disorders Disorders of blood cells and haemostasis: G.H. Jackson & S.J. Proctor: Part I - Blood cells P.J. Carey & S.J. Proctor: Part II - Haemostasis D.M. Davies: Effect of drugs on infection J.S. Malpas: Neoplastic disorders Drug allergy and tests for its detection: E-S.K. Assem: Part I - Drug allergy E-S.K. Assem: Part II - Tests for detecting drug allergy J.F. Dunne: Systemic toxicity of antiseptics G. Ansell: Toxicity of opaque media used in X-ray diagnosis K.W. Woodhouse: Disorders of temperature regulation Linda Beeley: Drug-induced sexual dysfunction and infertility M.C.L'E. Orme: Drug interactions of clinical importance.

Epidemiology of adverse drug reactions to phenformin and metformin.

Adverse drug reactions (ADRs) to phenformin and metformin reported to the Swedish Adverse Drug Reaction Committee during 1965--77 were analysed in relation to sales and prescription data. The biguanides accounted for 0.6% of all reported adverse drug reactions but for 6% of the fatal cases (all phenformin). Sixty-four ADRs to phenformin and eight to metformin were classified as causal relation "probable" or "not excluded." Fifty-one of these reactions (71%) were lactic acidosis, all but one being reactions to phenformin. After 1973 phenformin was prescribed less in Sweden and metformin became predominant. A nationwide prescription survey during 1975--6 disclosed no differences in age and sex between patients receiving phenformin and metformin. The mean daily doses prescribed in 1976 were 74 mg of phenformin and 1.5 g of metformin. The numbers of ADRs to the two drugs reported during 1975--7 were related to use. The relative incidences of ADRs reported for phenformin and metformin did not differ. Significantly more cases of lactic acidosis and deaths were reported for phenformin.

How study of geographic epidemiology of disease can help in detection of adverse drug reactions.

The geographic epidemiology of adverse drug reactions can often help in their recognition and in pinpointing the responsible drug. Since different countries often introduce new drugs at varying periods of time and they achieve varying degrees of popularity and use, this information may sometimes aid the epidemiologist in the search for the etiology of unwanted drug effects. Some examples where geography helped unravel the story behind certain adverse drug reactions are presented.