Preventable adverse event

Are all adverse events preventable The answer depends on the definition of "adverse event." Some patients will die in the natural course of events, irrespective of the quality of treatment provided. But this by itself does not mean that some number of medical errors are inevitable. 

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

Centers for Disease Control and Prevention Gamma hydroxy butyrate use—New York and Texas, 1995-96. JAMA 277 1511, 1997 Centers for Disease Control and Prevention Adverse events associated with ingestion of gamma-butyrolactone—Minnesota, New Mexico, and Texas, 1998-1999. MMRW Morb Mortal Wkly Rep 48 137-140, 1999 Chatlos JC Recent trends and a developmental approach to substance abuse in adolescents. Child Adolesc Psychiatr Clin N Am 5 1-27, 1996... 

There are a variety of process safety risks one needs to assess with chemical processes. In general, these risks will lead to an evaluation of the potential for the process to have precipitous changes in temperature and or pressure that lead to secondary events such as detonations, explosions, over pressurizations, fires, and so forth. The most cost-effective way of avoiding these sorts of risks is through the adoption of inherent safety principles. Inherent safety principles are very similar to and complementary to pollution prevention principles, where one attempts to use a hierarchy of approaches to avoid and/or reduce the risk of an adverse event. The reader is referred elsewhere to a more complete treatment of this important area of process design. ... 

Refer to Chapter 14 on gastroesophageal reflux disease for more information on the PPIs. The PPI omeprazole is superior to both ranitidine and misoprostol for preventing recurrence of NSAID-associated PUD. In one study, omeprazole 20 mg daily was compared to misoprostol 200 meg twice daily for NSAID-associated PUD prevention. At 6 months, the omeprazole-treated group had significantly fewer ulcers than those taking misoprostol. Furthermore, more patients discontinued ulcer prophylaxis in the misoprostol group due to adverse events.26... 

The goals of maintenance immunosuppression are to further aid in preventing acute rejection episodes and to optimize patient and graft survival Anti-rejection medications require careful selection and dosage titration to balance the risks of rejection with the risks of adverse events. Common maintenance immunosuppressive agents can be divided into four basic medication classes ... 

Knowing how to prevent and treat adverse events from chemotherapy is an important aspect of patient care. Unmanaged events may result in excess morbidity and cause delays in chemotherapy administration and reduced chemotherapy doses and contribute to treatment failure. 

In any case, injection site responses (erythemia, edema, pain, and tenderness) and systemic responses are both evaluated in subjects (Mathieu, 1997). USFDA also has specific guidance on the tracking and reporting of adverse clinical responses to vaccines. Any adverse events or product problems with vaccines should not be sent to MedWatch but to the Vaccine Adverse Event Reporting System (VAERA), operated jointly by FDA and the national Centers for Disease Control and Prevention. For a copy of the VAERS form, call 1-800-822-7967, or download the form (in PDF format) from www.fda.gov/cber/vaers/vaersl.pdf on FDA s Website. 

From 1978 through 1990, the Centers for Disease Control and Prevention (CDC) and the Food and Drag Administration divided the responsibility for postmarketing surveillance of vaccines in the United States. FDA received reports of adverse events after vaccines were administered in the private sector events occurring after the administration of vaccines purchased with public funds were reported to the Monitoring System for Adverse Events Following Immunization. 

A recent report by the Inshtute of Medicine (lOM), To Err is Human, Building a Safer Health System, claims that an3rwhere from 44,000 to 98,000 people die each year as a result of preventable medical errors. Many of these adverse events are associated with the use of pharmaceuhcals and are potenhally preventable. The lOM estimates that in the United States more than 7000 deaths occur annually as a result of preventable medication errors. In addihon, preventable medicahon errors are estimated to increase hospital costs by about 2 billion nationwide. ... 

The lOM report concludes that most of these errors are the result of systemic problems rather than poor performance by individual providers. Pharmacists play a key role in helping prevent and eliminate medication errors by providing information on the proper use of medications. Pharmacists provide the link between prescribers and patients, as shown in Figure 27.1, and can monitor for medication errors and adverse events. 

The first extensively tested RES-specific contrast agent on the basis of iodinated lipids was EOE-13 with its precursors, AG 52-315 and AG 60-99. EOE-13 is an aqueous emulsion of the iodinated ester of poppy seed oil and is able to selectively enhance the normal liver and spleen parenchyma [10-12]. However, severe adverse events such as headache, fever and chills prevented further use of these contrast agents [13-15], although their extent could be decreased by hydrocortisone given prior to contrast injection. 

Lactation It is not known whether ganciclovir or valganciclovir is excreted in human milk. Because of potential for serious adverse events in nursing infants, mothers should be instructed not to breastfeed if they are receiving valganciclovir tablets. In addition, the Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. 

Drug adverse events will always remain part of modern medicine and the potential for another thalidomide disaster cannot be totally dismissed. The prevention of a future disaster lies, not in simply increasing the number of regulatory hurdles but in the ability to communicate and control unexpected events and where necessary make rapid withdrawal from the market. 

Extensive databases [see Table 24-1) have now shown that paroxetine and sertraline can reduce panic attacks to zero and prevent relapse. Paroxetine studies constitute the largest data set more than 700 patients have been treated for periods ranging from 10 to 36 weeks. In the placebo-controlled comparisons with clomipramine, paroxetine had an earlier onset of action and was better tolerated than clomipramine. Paroxetine was significantly better than placebo from week 4 onward, whereas no separation was seen between clomipramine and placebo until the end of the study. Fewer withdrawals occurred as a result of adverse events with paroxetine (7.3%) than with either clomipramine (14.9%) or placebo (11.4%). The minimum dose shown to be superior to placebo was 40 mg/day. 

If a botanical is shown to reverse an abnormal test result, modify another drug s adverse event, or act synergistically with another modality, it will usually be best developed as a drug. This is especially true if the botanical provides a distinct benefit for a patient population, but would pose safety concerns if used by the general public. In contrast to prevention, risk-reduction, or health-maintenance trials, therapeutic studies are often able to demonstrate clinical benefit with smaller numbers of subjects and with more tangible measures of outcome. 

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