Symptoms Of Adverse Drug Reactions Research Articles

Physicians’ and pharmacists’ information provision and patients’ psychological distress

ABSTRACTProviding information related to medication has many benefits for patients. However, patients’ conflicting perceptions about medical information provided by physicians and pharmacists may be associated with their psychological distress regarding treatment and medication. This study investigated associations between patients’ perceptions of agreement between physicians and pharmacists about medical information and improvements in their psychological distress. It also clarified the specific relationships of their perceptions with psychological distress. A cross-sectional survey was conducted in Japanese community pharmacy settings. Pharmacists approached 1,500 patients visiting community pharmacies and provided them with questionnaire packages. Patients completed the questionnaires at home and returned them to the researchers by mail. Multivariate logistic regression analysis and signal detection analysis were conducted to examine associations of patients’ perceptions of information agreement with improvement in psychological distress. Measures of improvement in worry and anxiety about disease, improvement in worry and anxiety about medication, and improvement in depressive mood were used to assess alleviation of psychological distress. A total of 645 patients returned the questionnaires; 628 contributed to the data. Multivariate logistic regression analyses clarified that patients’ perceptions of agreement in information regarding need for medication, methods for adverse drug reaction reduction, adverse drug reaction symptoms, coping with forgetting to take medication, and advice for daily life were significantly associated with improvements in psychological distress. Furthermore, signal detection analysis showed that several combinations of patients’ perceptions of agreement between physicians and pharmacists about specific medical information were also significantly associated with improvement in psychological distress. Consistent information provision by physicians and pharmacists could contribute to decreased psychological distress in patients, and consequently to adherence to treatment and taking medication.

Protocol of intensive hospital monitoring with long follow up and large sample: Diemailing Kudiezi injection as example

This is a protocol of intensive hospital monitoring with long follow up and large sample of Diemailing Kudiezi injection, which aims to identify adverse drug reactions(ADRs) of Diemailing Kudiezi injection, including known incidence of adverse reactions, the incidence of new adverse reactions, the incidence of various ADR symptoms and the incidence of ADR among the sub populations; clarify the clinical features of ADRs of Diemailing Kudiezi injection; explore risk factors for ADRs; and analyze their usage in real world. After all, no existing experience about active surveillance on safety issues for postmarkeing traditional Chinese medicine injections could be used for us to learn. On the basis of references to related domestic policies and regulations as well as the design points for observational studies, we extensively solicited opinions from experts in the industry to develop this implementation protocol on monitoring research.

Patient-reported adverse drug reactions and their influence on adherence and quality of life of chronic myeloid leukemia patients on per oral tyrosine kinase inhibitor treatment.

PurposeTo evaluate adverse drug reactions (ADRs) experienced by chronic myeloid leukemia (CML) patients during per oral tyrosine kinase inhibitor (TKI) treatment and correlation of ADR symptoms with medication adherence and perceived quality of life (QoL).Patients and methodsEighty-six adult, chronic-phase CML patients who had been on TKI treatment (79% on imatinib, 10.5% dasatinib, and 10.5% nilotinib) for at least 6 months participated in the study (mean age: 57.8 years, 52% males). The mean time from diagnosis was 5.1 years. All patients were interviewed, and patient-reported ADRs were obtained using a structured list. Adherence was assessed using Morisky’s 8-item Medication Adherence Scale (MMAS). The symptoms’ interference with patient’s daily QoL was measured by asking patients about the influence of symptom(s) on their mood, general condition, enjoyment of life, walking, relationships, and work.ResultsNinety-seven percent of the patients were suffering from at least one ADR. The mean number of different symptoms was seven (range: 0–15, median 6). The most commonly perceived ADRs were muscle soreness or cramp (69/86, 80%); swelling of hands, legs, feet, or around the eyes (59/86, 69%); and fatigue (43/86, 50%). No correlation was found between adherence and ADRs, because symptoms were equally common in each MMAS adherence class. Half of the patients felt that the ADRs had a negative influence on their daily QoL. A quarter of the patients reported that ADRs affected either their mood, general condition, or enjoyment of life. The incidence of almost all ADRs was much higher among patients reporting negative influence of ADRs on their daily life compared to total study population (P=0.016).ConclusionTKI-related ADRs were common among CML patients irrespective of patient’s adherence level. Patients who reported that ADRs had a negative influence on their daily QoL perceived more ADRs than those who did not experience a negative influence.

285 The psychological impact of adverse drug reactions amongst adults with cystic fibrosis

Objectives Despite the increased incidence of adverse drug reactions amongst patients with cystic fibrosis (CF) receiving intravenous (IV) antibiotic treatment, there is little research regarding their experience of such reactions and subsequent psychological impact. A study was conducted to: 1.Examine the prevalence of self-reported adverse drug reaction symptoms and 2.Investigate subsequent levels of anxiety/trauma symptoms and feelings regarding future treatment. Methods Participants consented to complete a brief anonymous questionnaire, comprising of questions about symptoms of adverse drug reactions to IV antibiotics; levels of anxiety and trauma (The Impact of Event Scale-Revised – IES-R) and their feelings regarding future IV antibiotic treatment. Results 100 participants completed the questionnaire, with 64 reporting they had experienced an adverse drug reaction. Of those who reported an adverse reaction, 89% felt ‘worried or anxious' as a result, with 13% demonstrating PTSD symptoms (i.e. IES-R score ≥33). 39% reported they would feel anxious about future IV treatment, 27% reported they would delay treatment and 22% indicated they would require additional support. Conclusion The experience of an adverse drug reaction can be an anxiety provoking and potentially traumatic experience for CF patients. Appropriate medical and emotional support are essential in order to minimise psychological distress and reduce the impact on future treatment options.

Self-reported adverse reactions associated with topical ophthalmic medication use: a cross-sectional survey

The aim of this study was to investigate self-reported adverse reactions associated with the use of topical ophthalmic medications. A cross-sectional survey, involving 500 ophthalmic patients recruited from three eye care facilities in the Central Region of Ghana was conducted. A structured questionnaire was administered to participants to collect data on demographics, name of drug, dosage form, and dosing frequency of ophthalmic medications used, as well as adverse reactions experienced. The pHs of frequently prescribed ophthalmic medications to the patients were measured. The prevalence of reported adverse drug reaction [predominantly burning sensation (55%), blurry vision (22%) and itching (13%)] was 44.8%. More Females reported adverse drug reactions than males (χ2=26.24, P<0.001). The aged reported more adverse reaction than others (P<0.01). Patients using cream ophthalmic medications reported more adverse drug reactions than those using other dosage forms (χ2=8.80, P=0.024). The pHs of the commonly prescribed ophthalmic medications measured ranged between 4.44-7.37 (desired: 6.6-7.8). There is a high prevalence of reported symptoms of adverse drug reactions among this clinical population attributable to the acid/base status of the drug agent.

Quantitative Evaluation Method of Information Value of Initial Symptoms Based on Bayesian Theory

In accordance with Article 25-2 of the Pharmacists Act, pharmacists provide patients with information about the initial symptoms of adverse drug reactions for detecting and preventing those reactions. Thus far, however, there have been no reports quantitatively evaluating the usefulness of such information. We present a theory of information evaluation using posterior probability (PP), positive likelihood ratio (LR(+)) and incidence of nonspecific initial symptoms (NIS)-a measure of general symptoms without anything come to mind. First, we calculated using the data from the clinical trials. For liver damage caused by loxoprofen sodium hydrate, the LR(+) was as high as 27.9 in the presence of rash, but the PP was 0.002067, which means there were only 2 liver damage cases among 1000 rash cases. Calculated in the same way for voriconazole, the LR(+) was 5 and the PP was 0.2 (1 liver damage case among 5 rash cases). This suggests that information about rash as an initial symptom of liver damage is useful for patients taking voriconazole. However, the PP was greatly reduced when it was calculated by considering NIS. Since patients cannot distinguish initial symptom of side effect from mere change in body condition, the calculation considering NIS is realistic. Therefore, it is necessary to study in order to raise the value of the information service of the pharmacist. Our study demonstrates how PP and NIS, our new effective measure, allow a quantitative evaluation of the usefulness of information about initial symptoms.

Roles of Intravenous Iron Therapy in Various Patient Settings

Objective: To provide clinical information on intravenous iron products and their role in chronic kidney disease (CKD), dialysis, oncology, critical illness, and heart failure. Data Sources: Intravenous iron products information, national clinical practice guidelines, and the latest primary literature available were reviewed. PubMed and MEDLINE databases were searched from January 2000-December 2009. Study Selection and Data Extraction: All FDA-approved intravenous iron products information, available national clinical practice guidelines, and primary literature were included. Data Synthesis: Iron deficiency is common in patients with CKD, dialysis, oncology, critical illness, and heart failure. Routine supplementation with intravenous iron therapy is indicated in patients with CKD, including those receiving dialysis; however, its role in oncology, critical illness, and heart failure is not clearly defined. Assessing patients for iron deficiency, evaluating their status, and knowing the risks of adverse events are important in determining the roles of intravenous iron therapy in each setting. If patients are initiated on intravenous iron, they must be closely monitored for signs and symptoms of adverse drug reactions, as well as clinical worsening. Additionally, intravenous iron must be discontinued upon resolution of iron deficiency. Conclusions: The importance of intravenous iron therapy is well established in patients with CKD, including those receiving dialysis, who have iron deficiency. Its roles in oncology, critical illness, and heart failure should be assessed on a case-by-case basis.

Adverse events to Houttuynia injection: A systematic review

To systematically assess the main clinical features of Houttuynia injection-associated adverse drug reactions (ADRs), as described in published reports, and to contribute to the post-marketing re-evaluation and clinical practices of Houttuynia injection. We searched the electronic databases- PubMed, EMBASE, the Chinese National Knowledge Infrastructure (CNKI), the Chinese Science and Technology Journal Full-text Database (VIP) and the Chinese Biomedical Disc (CBMdisc), for articles published through June 2010. We then extracted and analyzed the data. A total of 645 articles were included, with a total of 1232 ADR cases reported. Respiratory diseases accounted for 52.44% of all cases of Houttuynia injection ADRs, followed by reproductive system diseases (4.30%) and urinary system diseases (3.73%). Multiple systems or organs were involved in the ADRs, the top five were: respiratory system (37.42%), skin (34.66%), digestive system (25.49%), circulatory system (25.41%), and nervous system (23.96%). Serious systemic adverse reactions accounted for 22.56% of total ADRs. Of the reported 1,232 ADR cases, 286 ADR cases reported previous allergies in detail; allergy to penicillin accounted for 15.03% of the total cases with the allergic history, followed by unknown drugs (8.05%), and sulfonamides (3.15%). Among the ADR cases, Houttuynia injection was commonly used together with cephalosporins, penicillins, and macrolides. Macrolides combined with Houttuynia injection showed higher ADR risk than Houttuynia injection used alone (RR = 8.80, 95% CI 6.12 to 12.65, P < 0.0001). The ADR risk for intravenous injection of Houttuynia injection was higher than that of intramuscular injection (OR = 6.86, 95% CI 1.88 to 56.95, P= 0.0016). We used the WHO ADR Classification Criteria to divide the ADR cases into four grades. There were 22.56%, 36.28%, 16.48%, and 24.68% cases of Grade I, II, III, and IV, respectively. Anaphylactic shock accounted for 58.99% of the most serious ADRs (Grade I). All cases of death were caused by allergic shock, except one, who died of multiple organ failure caused by anaphylactic purpura. The fastest-onset three ADR cases occurred in one minute after injection. The respiratory system was the most common system treated in Houttuynia injection ADR cases. It was also the most common site of ADR symptoms. The ADRs of Houttuynia injection were serious. The precautions should be taken to prevent the anaphylactic shock. Intravenous injection and the combination with with cephalosporins, penicillins, and macrolides increased the ADR risk of Houttuynia injection.

Analysis of the adverse reactions induced by natural product‐derived drugs

Compared with the therapeutic effects of established medicinal drugs, it is often considered that natural product-derived drugs are of a more benign nature in side-effects, which has made natural medicines become a popular form of therapy. Traditional Chinese medicine (TCM) is generally considered as being natural and harmless. TCM has been paid much more attention than before and widely used for the treatment nowadays. However, with the increasing cases of adverse drug reactions (ADRs), the ADRs induced by TCM are becoming more widely recognized. Some ADRs are sometimes even life-threatening. This article reviews literatures on ADRs induced by TCM which was published in the past 10 years. A total of 3122 cases including complete data are selected for the present analysis. From the data of the 3122 cases, statistics is carried out to the distribution of administration routes and time of the occurrence of ADRs, the prognosis of ADRs, sex and age factors, types and clinical symptoms of ADRs, and drugs involved in ADRs. In addition, occurrence and influencing factors of TCM-induced diseases are also analysed, which includes spices confusion, processing drugs improperly, toxic components, long-term medication, improper concerted application, interaction of TCM and Western medicine. It is concluded that the efficacy and toxicity of TCM, often using the compound prescription involving various plants and animals, resulted from a variety of chemical constituents, which lead to a comprehensive response in the human body. The 'toxicity' of TCM should be correctly recognized and reasonably utilized.

Tolerability and safety of the intravenous immunoglobulin Octagam®: a 10‐year prospective observational study

Following the approval of Octagam in 1995, an open prospective observational cohort study has been initiated to observe the tolerability of the intravenous immunoglobulin Octagam. This study aimed to evaluate the long-term safety profile of Octagam in daily use in the treatment of various primary (PID) and secondary (SID) immunodeficiencies and autoimmune diseases (AID). Within a time period of 10 years, data were collected in 310 study sites. The treating physicians documented patient characteristics, treatment parameters and the occurrence of an adverse drug reaction (ADR) by using detailed case record forms (CRF). A total of 6357 patients of all ages received 92 958 infusions of Octagam. ADR occurred in 4.2% of the patients and in 0.35% of all infusions. Most of them (94.8%) were classified as nonserious, the majority (90.2%) were of mild or moderate intensity. The ADR frequency differed slightly between the indication groups, for example in PID patients ADR occurred in 8.3% of patients and 0.5% of infusions, in SID patients in 5.0% of patients and 0.62% of infusions. Rigors were reported most frequently, followed by fever, headache, nausea and flush. The ADR symptoms differed between the indication groups, rigors were predominantly described in SID patients, headache in PID and AID patients including idiopathic thrombocytopenic purpura (ITP). A relation between the ADR frequency and elevated infusion rates or high dosages was not detected. This unique 10-year observational study demonstrates that Octagam is well tolerated in routine clinical use with an overall ADR frequency of 0.35%.

Development of the Database of Early Symptoms of Adverse Drug Reactions

Development of the Database of Early Symptoms of Adverse Drug Reactions

Adverse Reactions to Anticoagulants and to Antiplatelet Drugs Recorded by the German Spontaneous Reporting System

According to their code of professional conduct, German physicians are obliged to report suspected cases of adverse drug reactions (ADRs) to the Drug Commission of the German Medical Association (AkdA). On the basis of an agreement between the German Medical Association and the Federal Institute for Drugs and Medical Devices (BfArM) a common pharmacovigilance database within the German spontaneous reporting system was created. A user-friendly application program developed in-house enables the user to conduct searches about reported ADRs covering a wide variety of questions within a short period of time. ADRs caused by anticoagulants and by antiplatelet drugs still belong to the most reported adverse events. The most frequently reported suspected drugs are heparins, followed by ticlopidine, phenprocoumon, acetylsalicylic acid, and clopidogrel. Bleeding complications are the most often described ADR symptoms of any anticoagulation therapy, especially of phenprocoumon and acetylsalicylic acid. Another serious ADR is heparin-induced thrombocytopenia or changes in blood counts (CBC) due to ticlopidine and clopidogrel. During the past few years a reduction in severe reactions, such as cerebral hemorrhage, especially with fatal outcome was detectable because of better clinical management of oral anticoagulant therapy and of adverse events concerning heparin.

A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms

The study addressed issues surrounding the patient's recognition of whether a symptom is drug- or disease-related. Studies have demonstrated that the information the lay population has about illness can be organized into five categories: identity (symptoms and label), cause, time course, consequences, and cure. These elements, termed illness representations or prototypes, facilitate patient interpretation and response to symptoms as they occur. Theoretically, patients may have such a framework for interpretation of symptoms that they considered adverse drug reactions. The purpose of this study was to explore whether an adverse drug reaction (ADR) prototype exists. A self-administered questionnaire was used to elicit the subject's perceptions and awareness of adverse drug reactions. Subjects were also asked to make judgments about severity of ADRs and frequency of particular symptoms as drug-related effects. The study population was a sample of 338 adults visiting a family practice clinic over a four-week ...

DIAGNOSTIC TESTING FOR DRUG HYPERSENSITIVITY

Adverse drug reactions are important and frequent complications of medication therapy. Estimates are that 5% to 15% of patients develop adverse reactions to medication during treatment. 19,32 As many as 30% of hospitalized patients experience at least one adverse drug reaction. 10,32 Approximately 3% of all acute care medical admissions and 0.3% of all hospital admissions are attributed to adverse medication reactions. 19 Fatal drug reactions occur in 0.1% of medical in-patients and 0.01% of surgical in-patients. 19 Drug sensitivity has been implicated in 4.3% of deaths and 5.6% of cerebral damage in cases of anesthetic mishaps reported in the United Kingdom. 25 The first step in properly diagnosing adverse drug reactions is to understand the different types that can occur. There are certain adverse drug reactions that may occur in all individuals. 20 These reactions include overdoses, which are toxic reactions caused by excessive doses or impaired excretion or metabolism of a medication. Side effects are undesirable but are potentially unavoidable because of the pharmacologic action of the particular medication, such as tremors with use of beta agonists. Secondary effects are undesirable effects that are unrelated to the primary pharmacologic action of the medication, such as oral candidiasis secondary to the use of inhaled steroids. Drug interactions involve the interaction of two or more drugs causing toxicity that otherwise would not be present, such as that seen with the terfenadine–erythromycin interaction. Other adverse drug reactions occur only in susceptible patients in an unpredictable manner. These include drug intolerance, which is caused by a lower threshold to the normal pharmacologic action of a particular medication, such as tinnitus seen at low doses of salicylates in selected patients; idiosyncratic reactions, which usually result from a genetically determined metabolic or enzyme deficiency that is not expressed under normal situations, such as hemolytic anemia occurring in patients with glucose-6-phosphate dehydrogenase deficiency after receiving an oxidant drug; drug allergies that by definition involve immunologic mechanisms such as IgE penicillin anaphylaxis; and pseudo-allergies, which are reactions that have similar clinical manifestations as allergic reactions but the mechanism has been proven not to involve effector immune cells (antibodies or sensitized T lymphocytes). Allergic drug reactions (involving immunologic mechanisms) account for approximately 5% to 10% of adverse drug reactions. 5 Properly diagnosing an offending medication as a cause of an adverse drug reaction is often difficult. Multiple medications are sometimes in use at the same time, and the clinical symptoms of adverse drug reactions may overlap with symptoms of the underlying disease. A common example is a patient who develops an exanthem. It is often unclear if the cutaneous reaction is related to the antibiotic prescribed or to the underlying infectious process. Our general lack of knowledge of the immunochemistry of drug metabolism and immunoreactive metabolites also greatly hampers our ability to accurately use diagnostic tests to evaluate allergic drug reactions. Except for penicillin and to a lesser degree anticonvulsant medications and sulfonamides, our understanding of the immunoreactive metabolites and immunochemistry of medications is quite limited. At times we employ tests for drug-specific immune responses, but we lack knowledge of the positive and negative predictive value of these as diagnostic tests. This lack of knowledge is understandable because there are only a few studies in which large numbers of patients with negative and positive diagnostic tests have been rechallenged with the suspected medication. Despite these difficulties, it is worth attempting to diagnose immunologic drug reactions. It is important to define the causal agent to help guide the selection and use of future medications for a given patient and to properly manage the present adverse drug reaction. Labeling a patient inaccurately allergic to a medication may cause the future use of less effective or more toxic medications as substitutes for the preferred medication.

副作用文献情報モニタリングに関する検討

In order to grasp the current status of collecting the articles for literature monitoring of adverse drug reactions (ADR) in DI room and to utilize it as a guide for future activities, we investigated the contents and source of the articles which we ourselves selected, collected and reported in monthly drug information journal of our hospital during the period of 1980-1985. We also analysed the contents and source jounals of the articles describing on ADR which had been collected in our DI room during the past 6 years paying our attention to the drugs most frequently reported in the literatures in 1984, and compared with the results of on-line search using MEDLINE to examine the coverage.The selecting standard of the articles describing on ADR has been established in our DI room. The articles describing on the terms manifesting ADR symptoms as well as drug name or drug group name in the titles of the articles in particular case reports of ADR are indispensable.From the analysis of the articles collected according to this selecting standard, it was found that the drug groups most frequently reported in the literatures were 1) central nervous system agents, 2) cardiovascular agents, 3) hormone preparations, 4) antineoplastic agents and 5) antibiotic preparations, and this order showed an almost same tendency through the past 5 years. However, individual drug names most frequently reported in the literatures brought about considerable changes every year. According to the source journals reporting ADR, the four journals, “Lancet”, “Brit. Med. J.”, “J. Am. Med. Assoc.” and “N. Engl. J. Med.” were overwhelming, but Japanese journals reporting ADR were widely distributed without focusing on certain journal.From the study on the coverage, it was found that the number of articles we collected was apparently less than that of MEDLINE, but we had collected the articles describing on important ADR. This study suggests that the literature monitoring of ADR in DI room will play an important role in early collection and early communication of ADR.

Difficulties in assessing the adverse effects of drugs.

1 In recent years the phenomenon of the adverse drug reaction (ADR) has become a focus of increased attention and research, and we have become aware of the clinical complexity of the phenomenon and some of the difficulties inherent in assessing adverse effects. Evidence for such difficulties includes the discrepancies in figures for ADR incidence in epidemiological studies, the non-specificity and suggestibility of ADR symptoms, and the substantial disagreements, even among experts, in the diagnosis of ADRs. 3 An observed clinical manifestation heavily depends on the clinical setting and on the intent of the clinician, and the large number of factors that many confound the link between a given manifestation and an administered drug. A diagnostic algorithm, or branched logic decision format, has recently been developed. It comprises six axes of decision strategy and provides standardized, operational rules for rating the probability of an ADR.

Drug-related hospital admissions

The association between hospital admissions and drug-related problems was studied in 216 patients. All patients admitted to a general 100-bed ward in a large teaching hospital over a two-month period were interviewed by the pharmacist to determine (1) prescription and nonprescription drugs regularly administered by the patient, (2) method of administration, (3) patients' compliance with prescribed therapy, and (4) signs and symptoms of adverse drug reactions. Fifty-nine (27.3%) patients were found to have a drug-related problem associated with their hospital admission. Twenty-four patients (11.1%) had an adverse drug reaction associated with their hospital admission; in only 17 (7.9%) of the patients did the adverse reaction cause the hospital admission. Adverse drug reactions and noncompliance (10.5%) appeared to be the principal factors in hospital admission. To a lesser extent, inadequate therapy, improper or erroneous drug use and drug overdose were found to be associated with hospital admissions. As to mechanism of drug reaction, a drug side effect was involved in most cases. While hospital pharmacists have traditionally concentrated on improving inpatient distribution services, this study indicates a need for the improvement of drug monitoring and education services available to patients in outpatient settings.