Adverse Drug Reactions, Drug Interactions and Pharmacovigilance
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Adverse Drug Reactions, Drug Interactions and Pharmacovigilance
Date May 07-11, 2018
Place Oxford, United Kingdom

The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course[1] is a one-week module of the MSc in Experimental Therapeutics. Offered by the Department of Oncology and the Department for Continuing Education’s CPD Centre, the teaching will be led by Dr Michael Theodorakis, Radcliffe Department of Medicine, University of Oxford, and will feature face-to-face lectures and tutorials from some of the country's leading clinicians and scientists. The module can be taken as a stand-alone short course. It includes group work, discussions, guest lectures, and interaction and feedback with tutors and lecturers. To quantify the importance of drug-drug interactions (DDIs) in the occurrence of adverse drug reactions (ADRs) reported with serotoninergic reuptake inhibitors in a pharmacovigilance database. All spontaneous reports of ADRs registered in 2008 by the Midi-Pyrénées PharmacoVigilance Centre that contained mention of one of the serotoninergic reuptake inhibitor (SRI) antidepressants marketed in France were reviewed.Around 40% of ADRs reported with SRIs were related to DDIs. Most of these occurred after association with psychotropics, antithrombotics, or diuretics, especially in the elderly. (Ref///www.researchgate.net/publication/51829775 "The importance of drug-drug interactions as a cause of adverse drug reactions .A pharmacovigilance study of serotoninergic reuptake inhibitors" in France//Ref)

Drug-Drug Interactions : In addition to adverse events caused by use of a single drug, adverse events can be caused by drug interactions. Drug-drug interactions (DDIs) can make a medication less effective, cause unexpected side effects, or increase the action of a particular drug (FDA, 2003). They have the potential to cause significant harm to patients. Workshop participants discussed databases for recording and evaluating DDIs and ways to effectively communicate information about DDIs to practitioners and the public. Sidney Kahn of Pharmacovigilance and Risk Management, Inc., noted that all drugs have actions that we do not fully understand. Robert Califf, Forum member, added that it is hard to define exactly what characterizes an interaction. He asserted that more research is needed to help healthcare providers make more informed decisions about how interactions occur and which ones are clinically significant. DDIs can be neutral, synergistic, or additive.[2]

.Preventing medication errors and making appropriate decisions about prescribing drugs for patients who are taking multiple medications will reduce adverse drug events (ADEs). In one study, 6.5 percent of pharmacist-screened admissions to a unit of a hospital’s medical service were drug related, and 67 percent of those cases were considered to be preventable (Howard et al., 2003). In a systematic review of 15 investigations, an earlier study found that a median of 7.1 percent of hospital admissions were drug related and 59 percent of those cases were preventable (Winterstein et al., 2002). The drugs most commonly associated with Suggested Citation:"5 Drug-Drug Interactions." Institute of Medicine. 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11897.Add a note to your bookmark preventable drug-related admissions are nonsteroidal anti-inflammatory drugs (NSAIDs), low-dose aspirin, beta-blockers, antiepileptics, diuretics, sulfonylureas, digoxin, inhaled corticosteroids, nitrates, and insulin (Howard et al., 2003).From a purely financial perspective, improving databases that monitor drug interactions is advantageous. Zynx Health representative Scott Weingarten asserted that a perfect drug information database could potentially save the U.S. health-care system $4.5 billion per year (Hillestad et al.2005). [3] Summary: We define an adverse drug reaction as “an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.” Such reactions are currently reported by use of WHO's Adverse Reaction Terminology, which will eventually become a subset of the International Classification of Diseases. Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). Timing, the pattern of illness, the results of investigations, and rechallenge can help attribute causality to a suspected adverse drug reaction. Management includes withdrawal of the drug if possible and specific treatment of its effects. Suspected adverse drug reactions should be reported. Surveillance methods can detect reactions and prove associations.

DRUG LABELING AND DRUG-DRUG INTERACTIONS Labels are not being utilized effectively to communicate a drug’s potential side effects or interactions with other substances. “We need to think about putting information in formats that are more clinically directed and useful, although a way of testing such formats … has yet to be established,” said Jeffrey Drazen. Dr. Kahn added that it is extremely necessary to devise a categorization or standard terminology to uniformly evaluate interactions for their clinical importance. He noted that the FDA and industry are restricted by the liability concerns surrounding labeling. As discussed earlier, parties have incentives to cite every possible safety hazard associated with drug use, resulting in too much information on the label for it to be useful. All reported safety information must be included on the label because there is no framework for excluding it. “Correct and accurate is good and is not good enough. Information has to be actionable,” stated Dr. Kahn in reference to information included on drug labels. [4]

Topics

  • Safety of medicines for human use – principles and framework
  • Adverse drug reactions – mechanisms, analysis, reporting, vulnerable populations
  • Drug interactions – epidemiology, mechanisms, detection and prevention
  • Principles of optimal pharmacotherapy
  • Pharmacovigilance – principles, methodologies, risk management & pharmacoepidemiology
  • Clinical trials – bioethics of drug safety, pharmacovigilance in trial design, applications for marketing authorisation
  • Regulatory framework and legislation

Clinical trials allow the drug to be tested for safety by different ethnic population. Due to the higher medical needs and increasing disease prevalence, developing countries are becoming a hub for clinical trial execution. The clinical trials market has been estimated to reach USD 14.2 billion in 2016 and is projected to reach around USD 22 billion by the year 2021, and the annual growth rate of (7.5%). There are additionally numerous clinical trials started by scholarly clinical scientists. Whether started by industry or by scholastic clinical examiners and research is frequently performed in national, European and overall consortia, which can be expansive ones. Clinical research brings up moral and security issues. Clinical research is exceedingly controlled. To encourage and coordinated efforts crosswise over fringes. [5]

Overview The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course is a one-week module of the MSc in Experimental Therapeutics. Offered by the Department of Oncology and the Department for Continuing Education’s CPD Centre, the teaching will be led by Dr Michael Theodorakis, Radcliffe Department of Medicine, University of Oxford, and will feature face-to-face lectures and tutorials from some of the country's leading clinicians and scientists. The module can be taken as a stand-alone short course. It includes group work, discussions, guest lectures, and interaction and feedback with tutors and lecturers.

Please send me an email about future Adverse Drug Reactions, Drug Interactions, and Pharmacovigilance courses.

The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course will provide students with the opportunity to learn more about and discuss the following topics:

Safety of medicines for human use – principles and framework Adverse drug reactions – mechanisms, analysis, reporting, vulnerable populations Drug interactions – epidemiology, mechanisms, detection and prevention Principles of optimal pharmacotherapy Pharmacovigilance – principles, methodologies, risk management & pharmacoepidemiology Clinical trials – bioethics of drug safety, pharmacovigilance in trial design, applications for marketing authorisation Regulatory framework and legislation

The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course is a one-week module of the MSc in Experimental Therapeutics. Offered by the Department of Oncology and the Department for Continuing Education’s CPD Centre, the teaching will be led by Dr Michael Theodorakis, Radcliffe Department of Medicine, University of Oxford, and will feature face-to-face lectures and tutorials from some of the country's leading clinicians and scientists. 

The module can be taken as a stand-alone short course. It includes group work, discussions, guest lectures, and interaction and feedback with tutors and lecturers.

The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course will provide students with the opportunity to learn more about and discuss the following topics: •Safety of medicines for human use – principles and framework

•Adverse drug reactions – mechanisms, analysis, reporting, vulnerable populations •Drug interactions – epidemiology, mechanisms, detection and prevention •Principles of optimal pharmacotherapy •Pharmacovigilance – principles, methodologies, risk management & pharmacoepidemiology •Clinical trials – bioethics of drug safety, pharmacovigilance in trial design, applications for marketing authorization •Regulatory framework and legislation

The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course will provide students with the opportunity to learn more about and discuss the following topics: Safety of medicines for human use – principles and framework Adverse drug reactions – mechanisms, analysis, reporting, vulnerable populations Drug interactions – epidemiology, mechanisms, detection and prevention Principles of optimal pharmacotherapy Pharmacovigilance – principles, methodologies, risk management & pharmacoepidemiology Clinical trials – bioethics of drug safety, pharmacovigilance in trial design, applications for marketing authorisation Regulatory framework and legislation There are several terms commonly used to describe adverse effects of drug therapy:

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and is suspected to be related to the drug. An ADR will usually require the drug to be discontinued or the dose reduced. An adverse event is harm that occurs while a patient is taking a drug, irrespective of whether the drug is suspected to be the cause. A side-effect is any effect caused by a drug other than the intended therapeutic effect, whether beneficial, neutral or harmful. The term ‘side-effect’ is often used interchangeably with ‘ADR’ although the former usually implies an effect that is less harmful, predictable and may not even require discontinuation of therapy (e.g. ankle oedema with vasodilators). Drug toxicity describes adverse effects of a drug that occur because the dose or plasma concentration has risen above the therapeutic range, either unintentionally or intentionally (drug overdose). Drug abuse is the misuse of recreational or therapeutic drugs that may lead to addiction or dependence, serious physiological injury (such as damage to kidneys, liver, heart), psychological harm (abnormal behavior patterns, hallucinations, memory loss), or death.

Course aims

  • Introduce students to concepts of adverse drug reactions in terms of epidemiology and classification, mechanisms and monitoring and prevention
  • Enable students to undertake systematic reviews of adverse drug reactions
  • Enable students to understand and analyse drug interactions in terms of epidemiology, mechanisms and prevention
  • Enable students to appreciate beneficial drug interactions using combinations of drugs
  • Enable students to understand and use pharmacovigilance methodologies.


The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course is a one-week module of the MSc in Experimental Therapeutics. Offered by the Department of Oncology and the Department for Continuing Education’s CPD Centre, the teaching will be led by Dr Michael Theodorakis, Radcliffe Department of Medicine, University of Oxford, and will feature face-to-face lectures and tutorials from some of the country's leading clinicians and scientists.

The module can be taken as a stand-alone short course. It includes group work, discussions, guest lectures, and interaction and feedback with tutors and lecturers.

Please send me an email about future Adverse Drug Reactions, Drug Interactions, and Pharmacovigilance courses.

The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course will provide students with the opportunity to learn more about and discuss the following topics:

Safety of medicines for human use – principles and framework Adverse drug reactions – mechanisms, analysis, reporting, vulnerable populations Drug interactions – epidemiology, mechanisms, detection and prevention Principles of optimal pharmacotherapy Pharmacovigilance – principles, methodologies, risk management & pharmacoepidemiology Clinical trials – bioethics of drug safety, pharmacovigilance in trial design, applications for marketing authorisation Regulatory framework and legislation

Programme details This course can be taken:

as a 5 day short course (for credit or not for credit) as part of the MSc in Experimental and Translational Therapeutics as part of the Postgraduate Diploma in Health Research as part of the Postgraduate Certificate in Health Research

References

Knowles, S.R., Wong, G.A., Rahim, S.A., Binkley, K., Phillips, E.J., Shear, N.H. Hydrochlorothiazide-induced non cardiogenic pulmonary edema: an underrecognized yet serious adverse drug reaction. Pharmacotherapy. 2005;25:1258–1265. Naranjo, C.A., Busto, U., Sellars, E.M. et al, A method for stimulating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–245. Crossref | PubMed | Scopus (6059) | Google Scholar Goetschalckx, K., Ceuppens, J., Van Mieghem, W. Hydrochlorothiazide-associated noncardiogenic pulmonary oedema and shock: a case report and review of the literature. Acta Cardiol. 2007;62:215–220. Crossref | PubMed | Scopus (9) | Google Scholar Lee, P.Y., Salinas, M., Lora, P., Reynolds, E., Enciso, G. Hydrochlorothiazide-induced acute pulmonary edema: a rare adverse reaction. Rev Chil Enferm Respir. 2015;31:105–108. Crossref | Scopus (1) | Google Scholar Darwish, O.S., Criley, J. Hydrochlorothiazide-induced noncardiogenic pulmonary edema: BAL fluid analysis. Chest. 2011;139:193–194. Crossref | Scopus (4) | Google Scholar Biron, P., Dessureault, J., Napke, E. Acute allergic interstitial pneumonitis induced by hydrochlorothiazide. Can Med Assoc J. 1991;145:28–34. Google Scholar Manso, L., Heili, S., Fernandez-Nieto, M., Sastre, B., Sastre, J. Basophil activation in two cases of hydrochlorothiazide-induced noncardiogenic pulmonary edema. Allergy. 2009;65:135–136. Crossref | Scopus (8) | Google Scholar Gamboa, P.M., Achotegui, V., Irigoyen, J., Pérez-Asenjo, J., Merino, J., Sanz, M.L. Hydrochlorothiazide-induced acute non-cardiogenic pulmonary edema. J Invest Allergol Clin Immunol. 2005;15:299–301. PubMed | Google Scholar Vereda, A., Cárdaba, B., Quirce, S., de las Heras, M., Cuesta, J., Sastre, J. Immunological studies in a case of hydrochlorothiazide-induced pulmonary edema. J Invest Allergol Clin Immunol. 2005;15:297–298. Google Scholar

  1. ↑ https://www.conted.ox.ac.uk/courses/adverse-drug-reactions-drug-interactions-and-pharmacovigilance
  2. ↑ https://www.nap.edu/read/11897/chapter/7#38
  3. ↑ https://www.nap.edu/read/11897/chapter/7
  4. ↑ https://www.nap.edu/read/11897/chapter/8#44
  5. ↑ https://pharmacovigilance.pharmaceuticalconferences.com/

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