Adverse drug experiences/events

The number on the outside of the case is required to be numeric or alphanumeric, not the name of the patient. Patient names are not permitted to be publicly disclosed in the context of a MedWatch report according to 21 CFR 21.63(f). The initial report is the first reported information received by the company about an individual s adverse drug experience. There must be a prompt attempt to obtain follow-up information about each initial report. The attempt(s) are made according to the company s written procedures. If the written safety procedures are not followed, the safety reports are not appropriately submitted, or the safety records are not appropriately kept, FDA has the authority under Section 80 of Part 315 to withdraw the market NDA. The follow-up report is the format for submitting additional information about an experience. Each case regards only one individual unless the experience is both temporally and clinically unrelated to a second event experienced by the same person taking the same drug product. 

Synonyms of adverse reactions generally include adverse medical effects, untoward effects, side effects, adverse drug experiences, and adverse drug reactions. Specific distinctions among some of these terms may be defined operationally. For example, the term adverse reaction is used to denote those signs and symptoms at least possibly related to a medicine, whereas the term adverse experience is used to include nonmedicine-related medical problems in a trial such as those emanating from trauma or concurrent illness. Distinctions among side effects, adverse events, and adverse reactions are illustrated in the definitions of the two former terms. 

Adverse drug event (or adverse drug experience) (ADE)... 

In a placebo-controlled study of 1142 hypercholestero-lemic patients treated with pravastatin for 8-16 weeks, the numbers of adverse drug experiences were similar in the treated and untreated individuals (1). Rash was the only adverse clinical event that was different (4.0 versus 1.1%). However, in the same patients withdrawal of therapy during follow-up was thought to be necessary in 3.2% of those given pravastatin alone. Myopathy was observed in one instance only, and increases in creatine kinase activity in those taking pravastatin did not differ significantly from controls. There were marked persistent increases in transaminases in 1.1%, with no cases of symptomatic hepatitis. Pravastatin is believed to have a particularly low potential for nervous system-related adverse effects, as it has not been shown to enter the cerebrospinal fluid, and clinical experience suggests that muscle toxicity occurs less often with pravastatin than with lovastatin (2). 

Experience from hundreds of organisations has shown that poor communication of medical information at transition points is responsible for as many as 50% of all medication errors in the hospital and up to 20% of adverse drug events (IHI MedReconcilliation 2008). In our different settings at a university and county hospitals, we had errors in 40-85% of the elderly patients before starting a new practice. 

A number of terms are used to describe an adverse event, including adverse drug reaction (ADR), adverse experience, adverse effect, and albeit rarely, drug misadventure. In this paper, the term adverse event is used in most cases to avoid confusion. 

As increasing numbers of people experience the ill effects of medication use and realize that this is not an inevitable consequence of our health care system, the public outcry for answers will intensify. Medication safety has been the driving force for many health care advances, such as the 1937 Elixir Sulfanilamide scandal (FD C Act), the European thalidomide tragedy (1962 Kefauver Drug Amendments), and the incidence of adverse drug events in nursing homes (1974 Consultant Pharmacists Law). ... 

The terminology for describing adverse drug events can be confusing (13). An adverse drug event can be defined as any undesirable experience associated... 

Etminan, M., Carleton, B., Rochon, P. A. (2004). Quantifying adverse drug events Are systematic reviews the answer Drug Safety An InternationalJournal of Medical Toxicology and Drug Experience, 27(11), 757-761. 

Adverse experience (or event). A putative adverse drug reaction. Any unwanted medical event obtained during treatment with a drug. 

According to the Institute of Medicine (lOM), 1.5 million patients in the United States experience an adverse drug event per year [21]. 

Is there a possibility that the patient may experience an adverse drug reaction so severe that it is life-threatening And, if so, what is the likelihood of snch an event occurring A likelihood of 1 in 100 will be viewed very differently by both the physician and the patient than a likelihood of 1 in 1,000,000. 

The varying nomenclature used to describe safety data in clinical trials can be confusing. Terms used include adverse events, adverse experiences, adverse drug reactions, side effects, severe adverse events, significant adverse events, tteattnent-emeigent adverse events, adverse events of special interest, and toxidties. We therefore endeavor to bring some consistency to this terminology. 

Susceptibility factors Age Older adults who are on insulin or other oral hypoglycaemic agents, are about fom- to seven times more likely than yoxmger persons to experience adverse drug events (ADEs). The most frequent ADE that causes hospitalisation (>90%) is hypoglycaemia. Insulin causes hypoglycaemia that requires hospitalisation more... 

Advances in clinical therapeutics can result in major improvements in the health of patients. These benefits can become overshadowed by increased risks. An adverse drug event (ADE) is defined as harm experienced by a patient as a result of exposure to a medication, and ADEs account for nearly 700,000 emergency department visits and 100,000 hospitalizations each year. ADEs affect nearly 5 percent of hospitalized patients, making than one of the most common types of inpatient errors ambulatory patients may experience ADEIs at even higher rates. 

---