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http://www.drugintel.com/pharma/adverse_drug_reactions.htm#A%20Broad%20Sampling%\

20of%20Opinion%20on%20Safety%20and%20Efficacy%20of%20Medications%20Today

 

180,000 people die each year partly as a result of Iatrogenic Injury. The

equivalent of three jumbo jet crashes every 2 days. 20% of all patients admitted

to a university hospital suffered iatrogenic injury. 36 % of those admitted to a

teaching hospital suffered an iatrogenic event, of which 25% were serious or

life threatening. 64 % of cardiac arrests at a teaching hospital were

preventable. Most were due to use of medications.

Leape LL, Error in Medicine. JAMA Dec. 21, 1994; 272(23): 1851-7

 

Medical Malpractice is the 3rd leading cause of Preventable Death in the United

States. Malpractice is responsible for the deaths of 80,000 people annually, one

every 7 minutes. This does not include iatrogenic injury.

Public Citizen Magazine (A Ralph Nader Publication) 1994; May/June

 

Of 1,047 patients during the study. Adverse Events were identified by healthcare

personnel in 480 patients, of which 185 resulted in Serious Complications

ranging from Temporary Disability to Death.

Andrews LB; Stocking C; Krizek T; Gottlieb L; Krizek C; Vargish T; Siegler M; An

alternative strategy for studying Adverse Events in medical care. Lancet

1997;349:309-313.

 

" Only about 15% of all medical interventions are supported by scientific

evidence. This is partly because only 1% of the articles written in medical

journals are scientifically sound. " D. Eddy, M.D., Ph.D.

Smith R, Where is the wisdom?. BMJ 1991; 303(6806):798-9

 

Therapeutic drug use (not illicit drug use) each year; Kills as many as 198,815

people, puts 8.8 million people in hospitals, accounts for 28% of all hospital

admissions, and costs as much as $182 billion dollars.

American Medical News. Jan 15, 1996, p.11

 

Preventable drug-related morbidity and mortality was estimated to cost $76.6

billion in the ambulatory setting in the United States. The largest component of

this total cost was associated with drug-related hospitalizations. The estimated

cost ranged from a conservative estimate of $30.1 to $136.8 billion in a

worst-case scenario.

Johnson JA, Bootman JL, Drug-related morbidity and mortality. A cost-of-illness

model., Arch Intern Med 1995; 155(18):1949-56

 

 

 

 

 

We estimated that the annual additional costs associated with preventable

[adverse drug events]...were $2.8 million and that the costs associated with all

[adverse drug events] were $5.6 million.

Bates DW; Spell N; Cullen DJ; Burdick E; Laird N; Petersen LA; Small SD;

Sweitzer BJ; Leape LL; The costs of adverse drug events in hospitalized

patients. Adverse Drug Events Prevention Study Group. JAMA1997; 277(4):307-11

 

Drug errors not only increase costs, but also significantly prolong hospital

stays and increase the risk of death almost 2-fold.

Classen DC; Pestotnik SL; Evans RS; Lloyd JF; Burke JP; Adverse drug events in

hospitalized patients. Excess length of stay, extra costs, and attributable

mortality JAMA 1997; 277(4):301-6

 

Several easily identifiable factors are associated with a large proportion of

medical prescribing errors. Factors commonly associated with errors in

prescribing medications were inadequate knowledge or use of knowledge regarding

drug therapy; presence of important patient factors related to drug therapy such

as age, impaired renal function, and drug allergy; the need for calculation of

drug doses; and specialized dosage formulation characteristics and medication

prescribing nomenclature. Adverse drug events in hospitalized patients are

" ...countable, dangerous and evaluable events, not just a collection of unhappy

accidents that strike, like cosmic rays, in ways that we cannot predict or

understand. In an era of constrained resources, it is vital to remember that

[drug errors] in hospitals are common, costly and preventable in many cases. "

Lesar TS; Briceland L; Stein DS; Factors related to errors in medication

prescribing JAMA 1997; 277(4):312-7

Adverse Drug Reactions: 17% of ALL Hospital Admissions are caused by the Side

Effects of Drugs administered by an MD8 million people are hospitalized annually

for diseases brought on by prescription drugsAdverse Drug Reactions are

responsible for 100,000 deaths yearlyPrescription Drug-Related Diseases and

Death cost the US $77 BILLION dollars Annually

Archives of Internal Medicine; Oct 9, 1995

 

Hospital Reactions

Nosocomial infections (aka " hospital generated " ) strike 1 out of 10 hospitalized

patients, or 2.5 MILLION people per year :

The average nosocomial infection costs $1,800 to clear up, or $4 BILLION dollars

yearlyNosocomial infections cause 20,000 deaths annually and are a contributing

factor in another 60,000 deaths per year

" Total Wellness " by Dr. Joseph Pizzorno

 

Cost Of Drug-Related Illness Is Immense

TUCSON, ARIZONA. The sale of Prescription Medicines in the United States

exceeded $73 billion in 1994. Two researchers from the University of Arizona

conclude that preventable illness and death from the misuse of these medicines

cost the American economy over $75 billion a year; if lost productivity is

included the cost rises to between $138 billion and $182 billion annually. The

researchers point out that the purpose of prescribing pharmaceutical drugs is to

treat disease successfully - not to cause more problems. They estimate that this

purpose is achieved in less than 40 per cent of all cases. More than 60 per cent

of all people prescribed pharmaceutical drugs end up with a drug-related problem

which results in almost nine million hospital admissions a year at an estimated

cost of $47.4 billion. As a matter of fact, it is estimated that more than 28

per cent of all hospital admissions in 1992 were due to drug-related illness and

that somewhere between 80,000 and 200,000 people

died from complications involving prescription medicines. In comparison, it is

estimated that the direct cost of diabetes to the American economy was $45

billion in 1992 and that of heart disease was $117 billion. The researchers

conclude that drug-related illness and death should be considered one of the

leading diseases in the United States.

 

Johnson, Jeffrey A. and Bootman, J. Lyle. Drug-related morbidity and mortality.

Archives of Internal Medicine, Vol. 155, October 9, 1995, pp. 1949-56

 

 

Medication For Elderly People Often Inappropriate

SALFORD, ENGLAND. Doctors at the teaching hospital affiliated with the

University of Manchester have found that many elderly patients have the wrong

drugs prescribed and many are suffering from adverse drug reactions. During a

10-week period the medications of 416 elderly (median age of 76 years) patients

admitted to the hospital were evaluated in detail. Only 8% of the patients were

taking no drugs at all; the remaining 381 patients took a total of 1,348 drugs

between them. 48 of the patients had been prescribed drugs which were clearly

contra-indicated, 155 of the patients were on medication which was unnecessary,

and 103 patients experienced adverse reactions to the drugs they were on. The

authors of the study conclude that appropriate prescribing of drugs by doctors

could go a long way towards improving the quality of life of elderly people.

Age and Aging, July 1992, pp. 294-300

 

 

Drug Information Not Always Accurate

SAN DIEGO, CALIFORNIA. Pharmaceutical companies now spend $10 billion every year

on promoting their drugs. About 25 per cent of this amount goes to pay an army

of drug salesmen who regularly visit doctors to push the latest products. It is

estimated that there is one drug salesman for every 10 to 30 medical doctors in

the United States. A common practice is to provide doctors with a free lunch

while they listen to the salesman's presentation. Now two medical doctors at the

San Diego School of Medicine report that the statements made by the salesmen at

these " lunch conferences " are not always accurate. The researchers taped and

later analyzed all statements made during 13 lunches attended by an average

audience of 33 resident physicians and medical students. They found that 11 per

cent of the statements made about the drugs being promoted were inaccurate. All

the false statements cast the drugs in a more favourable light than warranted.

Two of the false statements could actually lead

to serious complications if accepted at face value. A survey of the attending

doctors showed that 85 per cent of them thought that the drug salesmen provided

useful information and 37 per cent of them said that the information they

provided influenced which drugs they prescribed to their patients.

 

Ziegler, Michael G., et al. The accuracy of drug information from pharmaceutical

sales representatives. Journal of the American Medical Association, Vol. 273,

No. 16, April 26, 1995, pp. 1296-98

 

 

Adverse Drug Reactions are Frequent and Costly

SALT LAKE CITY, UTAH. It is estimated that adverse drug reactions kill about

140,000 people in the United States every year and that from 3 per cent to 28

per cent of all hospital admissions are related to adverse drug reactions. Now

researchers at the LDS Hospital (affiliated with the Utah School of Medicine)

report that adverse drug events within hospitals are frequent, costly, and often

deadly. Their three-year study involved 1580 patients who had suffered an

adverse drug event (ADE) while hospitalized and 20,197 matched controls. The

researchers found that ADE victims had a three times higher crude death rate

than did controls; the length of their hospital stay was 70 per cent longer and

the average cost of their stay was $10,010 versus $5,355 for controls. Among the

drugs most commonly involved in adverse events were morphine, digoxin,

meperidine, acetaminophen (Tylenol, Paracetamol), warfarin, and vancomycin. The

patients who experienced an ADE were given an average of 12

different drugs prior to the adverse event. Cardiac arrhythmias were common

results of ADEs and were associated with an excess hospitalization cost of over

$4,000 and excess length of stay of almost four days. The LDS Hospital study

showed that about 2.4 per cent of all hospital patients develop an ADE. Other

studies have shown a rate of 6.5 per cent. Extrapolating the 2.4 per cent rate

to the 32 million yearly hospital admissions in the United States results in an

estimate that over 770,000 patients in American hospitals experience an adverse

drug reaction. Direct hospital costs to treat these ADEs are estimated at $1.56

billion annually. If it is assumed that the national average rate of ADEs is

closer to 6.5 per cent, then it can be estimated that the total cost of treating

adverse drug events is about $79 billion every year. The LDS Hospital study

concludes that 50 per cent of all adverse drug events occurring in American

hospitals are preventable. A major cause of the events is

the failure to properly calculate the drug dosage based on the patient's weight

and calculated renal (kidney) function.

Classen, David C., et al. Adverse drug events in hospitalized patients. Journal

of the American Medical Association, Vol. 277, No. 4, January 22/29, 1997, pp.

301-06

 

 

Another Study Finds Hospital Errors Injure Patients

BACKGROUND: Data about the frequency of adverse events related to inappropriate

care in hospitals come from studies of medical records as if they represented a

true record of adverse events. In a prospective, observational design we

analysed discussion of adverse events during the care of all patients admitted

to three units of a large, urban teaching hospital affiliated to a university

medical school. Discussion took place during routine clinical meetings. We

undertook the study to enhance understanding of the incidence and scope of

adverse events as a basis for preventing them.

 

METHODS: Ethnographers trained in qualitative observational research attended

day-shift, weekday, regularly scheduled attending rounds, residents' work

rounds, nursing shift changes, case conferences, and other scheduled meetings in

three study units as well as various departmental and section meetings. They

recorded all adverse events during patient care discussed at these meetings and

developed a classification scheme to code the data. Data were collected about

health-care providers' own assessments about the appropriateness of the care

that patients received to assess the nature and impact of adverse events and how

health-care providers and patients responded to the adverse events.

 

FINDINGS: Of the 1047 patients in the study, 185 (17.7%) were said to have had

at least one serious adverse event; having an initial event was linked to the

seriousness of the patient's underlying illness. Patients with long stays in

hospital had more adverse events than those with short stays. The likelihood of

experiencing an adverse event increased about 6% for each day of hospital stay,

37.8% of adverse events were caused by an individual, 15.6% had interactive

causes, and 9.8% were due to administrative decisions. Although 17.7% of

patients experienced serious events that led to longer hospital stays and

increased costs to the patients, only 1.2% (13) of the 1047 patients made claims

for compensation.

 

INTERPRETATION: This study shows that there is a wide range of potential causes

of adverse events that should be considered, and that careful attention must be

paid to errors with interactive or administrative causes. Healthcare providers'

own discussions of adverse events can be a good source of data for proactive

error prevention. 45% of patients suffered inappropriate care resulting in

complications or medical injury caused by an action or inaction of a hospital

staff member17.7% had at least one serious adverse eventPatients with long stays

in hospital had more adverse events than those with short stays. The likelihood

of experiencing an adverse event increased about 6% for each day of hospital

stay37.8% of adverse events were caused by an individual15.6% had interactive

causesand 9.8% were due to administrative decisions17.7% of patients experienced

serious events that led to longer hospital stays and increased costs to the

patients, only 1.2% (13) of the 1047 patients made

claims for compensation.

Andrews LB, Stocking C, Krizek T, Gottlieb L, Krizek C, Vargisn T, Siegler M. An

alternative strategy for studying adverse events in medical care. Lancet 349:

309-313 (1997)

 

 

Cost And Human Toll Of Medical Errors Estimated

WESTPORT, Oct 10 (Reuters) - The number of injuries attributable to medical

errors in the inpatient setting may top 3 million and cost more than $200

billion, according to data presented Thursday in New York during a media

briefing, " Finding Cures for Medical Error, " sponsored by the AMA's National

Patient Safety Foundation. Dr. Lucian Leape, of Harvard School of Public Health,

presented data from a University of Chicago study in which investigators used

" ...an on-site, real-time observational method of collecting data, " an AMA press

release explains. The Chicago study also revealed, according to the press

release, that " ...serious injuries due to errors occur in over 17 percent of

patients admitted to intensive care and surgical units at a teaching hospital. "

Dr. Leape said, " When this figure is extrapolated to the hospital and then the

nation as a while, the increase of injury can reach into the millions with costs

climbing into the billions. " He added that past studies based on

data taken largely from medical records probably underestimated the magnitude

of the problem. Meanwhile, results of a Louis Harris poll presented during the

briefing showed that more than 100 million Americans have been directly

" touched " by a medical error at some point. In the random survey, 42% of

respondees said that they had been " ...involved in a situation where a medical

mistake was made, either personally or through a friend or relative, " according

to an AMA press release. Despite this, most Americans think healthcare is

relatively safe. " Overall, including those affected by a mistake and those who

have not been, the survey reveals a public that considers the healthcare

environment to be 'moderately safe,''' officials with the National Patient

Safety Foundation said in the press statement.

 

 

Incorrect Information In PDR Could Affect Overdose Management

WESTPORT, Feb 07 (Reuters) - Physicians who rely on the Physicians' Desk

Reference (PDR) for overdose management advice may be using deficient

information that could lead to " unnecessary morbidity or mortality, " report

researchers in the February issue of the Annals of Emergency Medicine. The

researchers at the University of California surveyed physicians who called the

San Francisco Bay Area Regional Poison Control Center during 1 month, to

determine their use of the PDR for overdose information. They found that 50% of

the physicians did so in the preceding 12 months. The investigators also

compared PDR overdose treatment recommendations with five current major

toxicology references. They report that " [o]f the 20 PDR entries [studied], 16

(80%) had at least one deficiency, and 5 (25%) had two or more deficiencies.

Thirteen (65%) omitted an indicated specific treatment, three (15%) recommended

contraindicated treatments, and four (20%) advised ineffective treatments with

potential

for harm. " Specifically, the researchers note that the Elavil entry remains

unchanged since 1973, and the Sinequan entry since 1977. " We did find quite

serious discrepancies between toxicologic management and the guidelines given in

the PDR, " one of the authors, Dr. Walter H. Mullen, told Reuters Health. " I

think there are two things that can be done by the FDA. First, they can

eliminate that section [on overdose management in the drug labeling guidelines]

if there's difficulty keeping it up-to-date, or alternatively, they can have

some periodic update of the management guidelines to reflect current standards.

The point of the article is to alert physicians that the information in the PDR

may not be as accurate as we'd like and perhaps it's not, at this time, the best

reference for overdose management. "

Ann Emerg Med 1997;29:255-261.

 

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