Collection Of Adverse Drug Reactions Research Articles

Measuring Safety and Outcomes for the Use of Compassionate and Off-Label Therapies for Children, Adolescents, and Young Adults With Cancer in the SACHA-France Study

Innovative anticancer therapies for children, adolescents, and young adults are regularly prescribed outside their marketing authorization or through compassionate use programs. However, no clinical data of these prescriptions is systematically collected. To measure the feasibility of the collection of clinical safety and efficacy data of compassionate and off-label innovative anticancer therapies, with adequate pharmacovigilance declaration to inform further use and development of these medicines. This cohort study included patients treated at French pediatric oncology centers from March 2020 to June 2022. Eligible patients were aged 25 years or younger with pediatric malignant neoplasms (solid tumors, brain tumors, or hematological malignant neoplasms) or related conditions who received compassionate use or off-label innovative anticancer therapies. Follow up was conducted through August 10, 2022. All patients treated in a French Society of Pediatric Oncology (SFCE) center. Collection of adverse drug reactions and anticancer activity attributable to the treatment. A total of 366 patients were included, with a median age of 11.1 years (range, 0.2-24.6 years); 203 of 351 patients (58%) in the final analysis were male. Fifty-five different drugs were prescribed, half of patients (179 of 351 [51%]) were prescribed these drugs within a compassionate use program, mainly as single agents (74%) and based on a molecular alteration (65%). Main therapies were MEK/BRAF inhibitors followed by multi-targeted tyrosine kinase inhibitors. In 34% of patients at least a grade 2 clinical and/or grade 3 laboratory adverse drug reaction was reported, leading to delayed therapy and permanent discontinuation of the innovative therapy in 13% and 5% of patients, respectively. Objective responses were reported in 57 of 230 patients (25%) with solid tumors, brain tumors, and lymphomas. Early identification of exceptional responses supported the development of specific clinical trials for this population. This cohort study of the SACHA-France (Secured Access to Innovative Medicines for Children with Cancer) suggested the feasibility of prospective multicenter clinical safety and activity data collection for compassionate and off-label new anticancer medicines. This study allowed adequate pharmacovigilance reporting and early identification of exceptional responses allowing further pediatric drug development within clinical trials; based on this experience, this study will be enlarged to the international level.

Neurodoron® for Stress Impairments: A Prospective, Multicenter Non-Interventional Trial.

Introduction Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms. To confirm this, a non-interventional study (NIS) with pharmacies was conducted. Methods The NIS was planned to enroll female and male patients who suffered from nervous exhaustion with symptoms caused by acute and/or chronic stress. The main outcome measures were characteristic stress symptoms, stress burden, and perceived stress. Further outcome measures included perceived efficacy and tolerability of the product as assessed by the patients and collection of adverse drug reactions (ADRs). A study duration of about 21 days with a recommended daily dose of 3–4 tablets was set. Results 279 patients were enrolled at 74 German pharmacies. The analyzed set (AS) included 272 patients (mean age 44.8 ± 14.4 years, 73.9% female). 175 patients of the AS completed the NIS. During the study, all stress symptoms declined significantly (total score 18.1 vs. 12.1 (of max. 39 points), p < 0.0001). Furthermore, a reduction of stress burden (relative difference in stress burden, VAS = −29.1%, p < 0.0001) was observed. For most patients, perceived stress was reduced at the study end (PSQ total score decreased in 70.9% of the patients). 75.9% of the study population rated the product efficacy as “good” or “very good” and 96.6% rated its tolerability as “good” or “very good.” One uncritical ADR was reported. Discussion/Conclusion. This study adds information on the beneficial effects of Neurodoron® in self-medication. The results from this NIS showed a marked reduction in stress burden and perceived stress, along with an excellent safety profile of the medicinal product (MP) Neurodoron®. Further trials are required to confirm these results.

Prescribing pattern and adverse drug reactions of cardiovascular drugs in out-patient department of a tertiary care hospital

Background: The main objective of prescription pattern analysis is to assess the rationality of drug use. It has been found that cardiovascular disease is the most frequent cause of morbidity and mortality throughout the world. This study is to estimate the prescribing pattern and adverse drug reactions in patients with cardiovascular diseases.Methods: This prospective observational study was conducted for a period of 2 months in cardiology outpatient department.100 patients who fulfilled the study criteria were observed. The central drug standard control organisation (CDSCO) reporting forms were used for the collection of adverse drug reactions. Causality assessment was done by using the World Health Organization Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (WHO-UMC) scoring system and severity assessment by modified Hartwig and Siegel scale.Results: The study group consists of 79% male and 21% females. Average number of drugs per prescription was 4.65. Most commonly prescribed drugs were antiplatelets (32%) followed by statins (18.27%) and the least common were calcium channel blockers (1.72%) and cardiac glycosides (0.86%). A total of 174 adverse drug reactions were reported out of which 24.7% were myalgia due to statins, 15.5% were cough due to angiotensin converting enzyme inhibitors and 14.3% were gastritis due to antiplatelets.Conclusions: Antiplatelets, statins and angiotensin converting enzyme inhibitors dominated the prescribing pattern. Myalgia, cough, gastritis, insomnia by atorvastatin, enalapril, aspirin, beta blockers respectively were found to be the most commonly reported ADRs among the cardiovascular drugs.

Prescribing pattern and adverse drug reactions monitoring in patients with rheumatoid arthritis in a tertiary care hospital

Background: Rheumatoid arthritis is a chronic inflammatory arthritis which requires lifelong treatment to prevent the damage to joints and to maintain day to day functioning of patients. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is very important that their use require regular monitoring for adverse reactions. The present study is designed to estimate the prescribing pattern and the occurrence of adverse drug reactions in patients with rheumatoid arthritis. Methods: This prospective observational study was conducted from July 2014 to September 2014 in rheumatology outpatient department.75 patients who fulfilled the study criteria were observed for 3 months. Their prescriptions were collected and analysed. The CSDCO reporting forms were used for the collection of adverse drug reactions. Causality assessment was done by using WHO-UMC scoring system and severity assessment by modified Hartwig and Siegel scale. Results: The study group consists of 85.6 % female. Majority of them were in age group 40-49 years. Average number of drugs per prescription was 4.97.Out of 75 patients, 57.33% were on single DMARD, and 33.33% required 2 DMARDs and 9.33% were prescribed 3 DMARDs. A total of 64 adverse drug reactions were reported out of which 29.6% was due to glucocorticoids, 25% was due to the use of NSAIDS and steroids. Chloroquine maculopathy occurred in 2 patients and elevated liver enzymes occurred in 6 patients due to methotrexate which necessitated DMARD withdrawal. Eight percent of the ADRs were severe. Conclusions: Treatment of rheumatoid arthritis is based on DMARDs and glucocorticoids where it is difficult to prevent the occurrence of ADRs. Consistent monitoring of therapy is needed for early recognition of ADRs and prompt action.

Verbesserung der Arzneimitteltherapiesicherheit in Deutschland: Allianz von Staat und Ärzteschaft

According to a multitude of international studies the safety of general drug treatment practice is not up to standard. It has been demonstrated that about 50% of adverse drug reactions are avoidable and that their main cause are medication errors. Such errors have often been related to dosing and non-consideration of contraindications and the individual patient's risk profile. In order to resolve this unacceptable situation pharmacovigilance has to be strengthened. Pharmacovigilance in this context does not only imply the assessment and collection of adverse drug reactions, but also the communication of treatment risks to the medical community as well as to pharmacists and patients, and the development and implementation of intelligent electronic prescribing systems. The Federal Government of Germany in co-operation with the Drug Commission of the German Medical Association has decided on a bunch of about 40 single measures to enhance drug safety in this country. This project was issued in November 2007 by the Federal Ministry of Health. The Drug Commission will be responsible for the co-ordination of any future actions.

The Dawn of Pharmacovigilance

This paper provides an anecdotal view from a Dutch perspective on some historical aspects of both the awareness and the systematic attention regarding adverse drug reactions in a period before the term ‘pharmacovigilance’ even existed. What we can learn from history is illustrated by the 1971 study by Lely, who discovered that 19 people died from digitalis intoxication, caused by a production error of the digitalis tablets. Observations of the symptoms of digitalis intoxication had been previously described in the 18th century by Whitering in his study on the foxglove. The Professor of Medicines, Van Doeveren provided another early example of awareness of adverse drug effects when he gave the academic lecture called Remedio Morbi in 1789 on diseases caused by treatment. This academic lecture was given attention by Meyler, who wrote his famous book on adverse drug reactions in 1951. His book Side Effects of Drugs is currently in its 14th edition and is still a standard work in this field. An early example of a systemic collection of adverse drug reactions occurred in the beginning of the 19th century when reactions were reported during a smallpox vaccination campaign in the Netherlands. Systematic attention to adverse drug reactions, including the collection of adverse drug reaction reports, was boosted by the so-called thalidomide disaster in the early 1960s. Since then, governments have started to organise national pharmacovigilance centres to prevent such a disaster happening again. The World Health Organization (WHO) has played an important role in developing this reporting of adverse drug reactions with its WHO International Drug Monitoring Program and the WHO Uppsala Monitoring Centre, which maintains the international database of adverse drug reactions. A comprehensive review of the history of pharmacovigilance is still to be written.

The Dawn of Pharmacovigilance

This paper provides an anecdotal view from a Dutch perspective on some historical aspects of both the awareness and the systematic attention regarding adverse drug reactions in a period before the term 'pharmacovigilance' even existed. What we can learn from history is illustrated by the 1971 study by Lely, who discovered that 19 people died from digitalis intoxication, caused by a production error of the digitalis tablets. Observations of the symptoms of digitalis intoxication had been previously described in the 18th century by Whitering in his study on the foxglove. The Professor of Medicines, Van Doeveren provided another early example of awareness of adverse drug effects when he gave the academic lecture called Remedio Morbi in 1789 on diseases caused by treatment. This academic lecture was given attention by Meyler, who wrote his famous book on adverse drug reactions in 1951. His book Side Effects of Drugs is currently in its 14th edition and is still a standard work in this field. An early example of a systemic collection of adverse drug reactions occurred in the beginning of the 19th century when reactions were reported during a smallpox vaccination campaign in the Netherlands. Systematic attention to adverse drug reactions, including the collection of adverse drug reaction reports, was boosted by the so-called thalidomide disaster in the early 1960s. Since then, governments have started to organise national pharmacovigilance centres to prevent such a disaster happening again. The World Health Organization (WHO) has played an important role in developing this reporting of adverse drug reactions with its WHO International Drug Monitoring Program and the WHO Uppsala Monitoring Centre, which maintains the international database of adverse drug reactions. A comprehensive review of the history of pharmacovigilance is still to be written.

Educational interest of systematic collection of adverse drug reactions (with regard to an experience of nearly 20 years).

In 1978, a systematic collection of adverse drug reactions (ADRs) was set up in a hospital including several departments and continued for more than 18 years. Quarterly meetings were organized gathering clinicians, students, nurses and pharmacologists to discuss the clinical cases collected each quarter. Approximately 100 cases were analysed each year (1823 over the 18-year period). Educational interest resulted from (1) discussion about some ADRs frequently leading to hospitalization or consultation; (2) information about recent drugs and new and/or not well known ADRs; (3) education of physicians for a good prescription of drugs and increasing awareness of pharmacovigilance.

Educational interest of systematic collection of adverse drug reactions (with regard to an experience of nearly 20 years)

Educational interest of systematic collection of adverse drug reactions (with regard to an experience of nearly 20 years)

Teratogenicity of drugs.

Abstract Extract The thalidomide disaster shook the pharmaceutical world. to its foundations. It clearly required that action be taken to prevent by all means possible a recurrence of any similar catastrophe. At the same time, attention was drawn to the occurrence of adverse reactions to drugs of other kinds which had already been the subject of restricted and somewhat sporadic scrutiny, particularly in the United States. There the haematologist, Maxwell Wintrope, had initiated a scheme for collecting reports of haematological reactions to drugs, the importance of which had been brought to the attention of the profession through the cases of aplastic anaemia resulting from the antibiotic chloramphenicol. In Britain, the Committee on Safety of Drugs was formed, of which Sir Derrick Dunlop was the first Chairman, and a subcommittee was set up to deal with the collection of adverse drug reactions. Committees were also set up in Canada, Australia, and a number of other countries including New Zealand, where the Committee is under the joint auspices of the Royal Australasian College of Physicians, the Royal College of General Practitioners, the Pharmacology Department of the University of Otago, and the Health Department. Because the National Poisons Information Centre appeared to offer an appropriate situation for administering such a scheme, I was asked to undertake the task of Medical Assessor and it is reallv in that capacity that I have prepared this paper, rather than as Director of the National Poisons Information Centre.