Avoidable Adverse Events Research Articles

Wasted medicines and avoidable adverse events: a multibillion pound problem

SummaryFew studies assess the economic burden that potentially avoidable adverse drug reactions (ADRs) impose on the National Health Service. Therefore, we performed a first-order, hypothesis-generating heuristic estimate that suggested 392,000 acute admissions were due to ADRs during 2003/4, which accounted for about 0.7% of the Department of Health budget. We assumed that 59% of the ADRs were potentially preventable, equivalent to a potential saving of almost £369 million. Furthermore, we estimated that the community consultation costs reached £1 billion. Of these, 59% could have been prevented, equivalent to a potential saving of £600 million.We used liquid formulations as an example of how savings can offset the costs of initiatives to improve compliance, even using some very conservative assumptions about the downstream benefits. For example, preventing a single day's admission to a psychiatric hospital would fund liquid chlorpromazine instead of solid formulation for a year for three patients.More research is needed into the economics of noncompliance, competing formulations and the association between clinical outcomes and adherence. Furthermore, the analysis contains numerous assumptions and inferences. Nevertheless, we provisionally suggest that the total cost of potentially avoidable ADRs in the community and secondary care is approximately £1 billion a year.

Building a Safer NHS for Patient. Improving Medication Safety

Medication errors occur in all health care systems and in all health care settings. If the errors are identified through an active management and effective reporting system they can be removed before they can cause harm to patients. In order to reduce the risk it is important to understand the causes of medication errors. The NHS Report aims to provide a guide to current knowledge of the frequency, nature and causes of errors, the risk factors inherent in current medication processes and helping the NHS organizations and health professionals in achieving a reduction in serious medication errors. In July 2001 the UK Government established the National Patient Safety Agency (NPSA, http:// www.npsa.nhs.uk) which, in 2004, implemented a national reporting and learning system to enable the NHS to report all type of adverse incidents including those involving medicines. The NPSA core purpose is to improve patient safety and to accomplish this task; it looks at the identification of patterns and trends in avoidable adverse events so that the NHS can entrust practice and management to reduce the risk of recurrence. Before the establishment of the NPSA, there had been no attempt to establish a unified mechanism for reporting and analyzing medication errors. Despite the many published studies there is no clear definition for medication errors and thus they do not distinguish between errors and adverse drug reactions. The Report defines and highlights the differences between medical errors and drug reactions.

From the FDA

DRUG labeling is of vital importance in guiding the safe and effective use of approved drugs. Drug labels represent the most visible expression of months or years of scientific review by physicians and scientists at the U.S. Food and Drug Administration (FDA), and they are also fundamental to the purpose and mission of the FDA. Creation of the FDA dates to the 1906 passage of the Food and Drugs Act, which prohibited the manufacture and interstate shipment of adulterated and misbranded foods and drugs.† A 1937 disaster, in which more than 100 people died after ingestion of Elixir Sulfanilamide, precipitated the Federal Food, Drug, and Cosmetic Act of 1938, which, for the first time in U.S. history, required demonstration of safety before marketing new drugs. Elixir Sulfanilamide contained diethylene glycol and had never been tested for safety. In 1960, a marketing application for the drug thalidomide was submitted to the FDA. Withstanding enormous pressure from the applicant, FDA reviewers, including Frances Kelsey, M.D., Ph.D., a medical officer at the Center for Drug Evaluation and Research at the FDA (Washington D.C.),‡ determined that inadequate data were available to support the safety of the drug product despite its already widespread use throughout the rest of the world. The application was not approved. After thousands of children in 46 countries were born with deformities as a consequence of thalidomide use, leaving the United States relatively unscathed, a political movement for tighter drug controls in the United States gained popular support. The Drug Amendments of 1962 were the first to require demonstration of effectiveness before marketing, recognizing that the assessment of safety must also consider benefit. Since 1962, more than a thousand prescription drugs have had their labeling changed or have been taken off the market to reflect the scientific evidence (or lack thereof) documenting their safety and/or effectiveness.§ Section 505 of the Federal Food, Drug, and Cosmetic Act (21 USC 355) currently specifies that approved drugs must be safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Current regulations stipulate the following labeling requirements:

Evolution of trends in risk management

In the past, the detection and response to adverse clinical events were viewed as an inherent part of professionalism; and, if perceived problems were not sorted out at that level, the ultimate expression of dissatisfaction was litigation. There are now demands for the adoption of more transparent and effective processes for risk management. Reviews of surgical practice have highlighted the presence of unacceptable levels of avoidable adverse events. This is being resolved in two ways. First, attention is being directed to the extent that training and experience have on outcomes after surgery, and both appear to be important. Second, a greater appreciation of human factors engineering has promoted a greater involvement of surgeons in processes involving teamwork and non-technical skills. The community wants surgeons who are competent and health-care systems that minimize risk. In recent times attention has been focused on the turmoil associated with change; but, when events are viewed over a period of several decades, there has been considerable progress towards these ideals. Further advancement would be aided by removing the adversarial nature of malpractice systems that have failed to maintain standards.

Improving Patient Safety through Computerized Drug Management: The Devil Is in the Details

Electronic prescribing and computerized drug management can improve the safety, quality and cost-effectiveness of prescribing. However, if the problems that lead to avoidable adverse events are not addressed by information technology, there is a risk of making considerable investment without the expected return of error reduction and improved patient safety. Improving the safety of prescribing is particularly important in ambulatory care, where most drugs are prescribed. To improve patient safety, IT solutions should be developed that provide: (1) access to the list of all currently active drugs, (2) alerts for relevant prescribing problems (therapeutic duplication, excess dose, dose adjustment for weight (children, elderly) and renal impairment, drug-disease, drug-drug, drug-age and drug-allergy contraindications), (3) the capacity to electronically submit medication stop orders to the dispensing pharmacy and (4) integration of electronic prescriptions (e-rx) into pharmacy software to avoid transcription errors. To improve quality of prescribing, IT solutions should be capable of providing physicians with reminders and alerts for evidence-based preventive care and disease management based on patient-specific drug, disease, therapeutic intent and other relevant clinical information. To improve the cost-effectiveness of prescribing, IT solutions should be developed to provide the cost of medication at the time the prescription is written, and evidence-based alerts for drugs of choice recommendations when appropriate.

Elective resection and anastomosis for colorectal cancer: a prospective audit of mortality and morbidity 1976-1998.

The purpose of this paper is to audit the morbidity and mortality for colorectal cancer after open elective resection and anastomosis by a single colorectal surgeon (MK), with reference to any differences between intraperitoneal (IPA) and extra-peritoneal anastomoses (EPA). The prospective documentation of postoperative complications was compiled by the surgeon, charge nurses and a research assistant (PB). The operations were performed in three hospitals between 1976 and 1998. Some 1392 consecutive patients were treated electively by 1418 resections with anastomosis. There were 23 postoperative deaths (1.6%). Significant adverse events, which were potentially avoidable, occurred in 10 (43.5%) of the patients who died. The morbidity rate was 41.6%. Clinical anastomotic leaks occurred more frequently in EPA (27/581, 4.7%) than in IPA (2/827, 0.2%; P < 0.0001). Anastomotic leak caused the death of two patients (0.14%).Routine prophylactic anticoagulation did not decrease the incidence of pulmonary embolism. Significant thrombophlebitis at the intravenous cannula site occurred in 54 patients (3.8%), wound infection in 29 (2.1%), and postural peripheral nerve injury in the upper limbs occurred in 11 patients (0.8%). Thirty-eight patients (2.7%) were returned to the operating theatre for 42 unscheduled operations. Mortality associated with elective resection of colorectal cancer with anastomosis is principally related to age, cardio-vascular disease and avoidable adverse events. A wide range of complications may follow this type of surgery, especially after extra peritoneal operations. A classification of anastomotic leaks is suggested to assist in comparisons of this complication which remains a significant concern following extra peritoneal anastomoses.

Is the sildenafil product information adequate to facilitate informed therapeutic decisions?

Optimal therapeutics and the prevention of adverse drug effects begin with complete information. When new drugs are released, the manufacturer's product information is the main and often only readily available source of drug information and, therefore, greatly influences treatment strategies. Thus, it is vital that the information in the package insert is not only complete, but also as relevant as possible for the great diversity of patients that physicians encounter. To review the product information for sildenafil for comprehensiveness and accuracy, with respect to whether the information is sufficient to facilitate optimal therapeutics and to prevent avoidable adverse events in the wide diversity of patients with erectile dysfunction seen in clinical practice. Sildenafil package inserts, unpublished information provided by the manufacturer, Food and Drug Administration reports, and articles retrieved through MEDLINE through March 2000. Deficiencies or inaccuracies persist in the sildenafil product information regarding sildenafil's effects on blood pressure; potential drug interactions with cimetidine, protease inhibitors, some antihypertensive drugs, alcohol, and drugs that may competitively inhibit cytochrome P450 pathways; and recommended sildenafil doses for older patients. For physicians to practice optimal therapeutics, adequate, clinically relevant drug information is required. Several brief changes and additions in the sildenafil product information would assist physicians in making therapeutic decisions regarding the use of sildenafil in a very diverse patient population and in avoiding preventable adverse events.

The measurement and monitoring of surgical adverse events.

The measurement and monitoring of surgical adverse events.

Quality control of end results: identifying avoidable adverse events in dentistry

Avoidable adverse events in dental practice, identified in a survey of malpractice cases, are used in the construction of a quality assurance program. On the basis of causes of malpractice suits, avoidable adverse events in dental practice were identified and used in the construction of a quality assurance program. A new approach to quality control in dentistry is examined with emphasis on treatment outcomes. An expert panel of clinicians and lawyers studied cases of dental malpractice. A system that places increased responsibility for quality assurance on the individual dentist and dental society is proposed.

Identifying avoidable adverse events in medicine.

The 350 malpractice cases involving orthopedic surgery that reached the Appellate Court and occurred between 1910 and 1972 were examined for determining medical events that could be considered by the profession as highly avoidable. When these cases were reviewed, they were sorted to eliminate those that were not by their very character evident of relatively highly avoidable adverse events. The remaining cases, which numbered approximately 117, were placed into categories of causes of adverse events with illustrative cases for each category. A committee of orthopedic specialists and legal scholars was convened to reflect on this listing of untoward outcomes in order to evaluate the considerations of making such determinations and to arrive at a final list of broad avoidable events for which the orthopedic profession should be held accountable. Although this was viewed as a pilot endeavor, it was felt that avoidable adverse events may be identifiable and could serve as the basic structure for an effective mechanism of quality control and patient compensation. The next step should be a more quantitative assessment of the degree of avoidability of the events selected by the committee.