[Congressional Record Volume 141, Number 103 (Thursday, June 22, 1995)]
[Extensions of Remarks]
[Pages E1321-E1322]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                      SAFE MEDICATIONS ACT OF 1995

                                 ______


                         HON. WILLIAM J. COYNE

                            of pennsylvania

                    in the house of representatives

                        Thursday, June 22, 1995
  Mr. COYNE. Mr. Speaker, I rise today on behalf of myself and my 
colleagues Representatives Pete Stark and John Lewis to reintroduce the 
Safe Medications Act. This bill improves public health and safety by 
creating a clear and uniform reporting system for deaths that occur 
while prescribing, administering, or dispensing drugs. Needless 
tragedies would be avoided by its enactment.
  Billions of prescriptions are written, dispensed, or administered in 
hospitals, pharmacies, and other health care facilities across the 
United States every year. Yet, if something goes wrong during drug 
therapy there is no requirement for facilities to report adverse 
incidents. As a result, the public could be vulnerable to recurring 
drug-related mishaps and fatalities that are preventable.
  Occasionally, a health care professional misreads a prescription, 
administers the wrong dosage of a drug, or dispenses medication 
incorrectly. These errors will sometimes have little or no consequence. 
Other times, they may produce fatal results. When an individual dies in 
these cases, there is no place for the practitioner to report the 
death. Ultimately, the same mistake can be made a number of times. 
Repeated errors lead to unacceptable risks to patient safety and public 
health.
  Let me sketch how patients and consumers are susceptible to multiple 
errors. A young boy in New York died when he was administered the wrong 
dosage of a sedative. A similar incident happened with the same drug to 
a 4-year-old girl in Texas. In another instance, a community pharmacist 
confused the names of morphine and meperidine which resulted in the 
death of a child. A parallel event proved fatal when a physician 
confused the names of painkillers. Finally, confusion over like drug 
names led to a mistaken and ultimately fatal dosage of a medication for 
a bone-marrow-transplant patient. This drug was involved in a 
comparable case when, again the name of the drug was confused and the 
patient was overmedicated. These events show a pattern of drug therapy 
deaths that could have been avoided and prevented had they been 
monitored and had medical workers been made more aware of the potential 
for mistakes.
  In October, 1993, the Pittsburgh Post-Gazette published a series of 
articles that detailed medication errors. Reporter Steve Tweedt's 
series contained some disturbing statistics in this area. He reported 
that a Pittsburgh-Post Gazette study of 250 hospital pharmacists across 
the country estimated that there were 16,000 medication errors in their 
institutions in 1992; 106 of them caused patient deaths.
  Presently, there are a variety of reporting systems. Only two States 
require reporting; New York has a mandatory program for hospitals and 
North Carolina has a required reporting system for
 pharmacies. However, nothing obliges these States to share the 
information they collect with other States.

  Nationally, there are two primary voluntary reporting systems that 
track errors and deaths that result from drug therapy. The U.S. 
Pharmacopeia [USP], working with the Institute for Safe Medication 
Practices, has received over 1,100 reports since it was established in 
1991. And, it is estimated that the voluntary system operated by the 
Food and Drug Administration [FDA], MedWatch, collects information on 
only 1 percent of the errors that occur. Since these reports are 
voluntary, however, it is unclear what the actual error and death rate 
is what their tracking represents.
  At the Ways and Means Health Subcommittee hearing on this issue last 
September, David Work, the executive director of the North Carolina 
Board of Pharmacy, testified that ``about 10,000 deaths occur 
nationwide from pharmaceuticals each year.'' Joshua Perper, M.D., chief 
medical examiner, Browder County, FL, cited in his testimony a study 
published in the New England Journal of Medicine in 1991 that charted 
an annual mortality rate of 503 per 100,000 hospital discharges due to 
drug errors.
  These trends can and must be changed. We must have a greater 
understanding of these incidents and take precautions to see that they 
are not repeated. The Safe Medications Act of 1995, which I am 
introducing today, provides a solution to this problem and would 
significantly improve the public health.
  The Safe Medications Act creates a national data bank for information 
on deaths that result from the prescribing, dispensing, or 
administering of drugs. This data bank would be maintained by the USP 
for the Secretary of Health and Human Services.
  Within 10 working days after the discovery of a death due to the 
prescribing, dispensing, and administering of drugs, the health care 
facility in which the error occurred would be required to report the 
incident to the U.S. Pharmacopeia.
  The Secretary will analyze these reports and work with USP and the 
appropriate health care provider associations so that they can [[Page E 
1322]] notify and alert their constituencies of potential problems.
  The identity of the facilities that report deaths would remain 
confidential.
  Finally, this bill would not supersede any voluntary reporting 
systems or State systems in place.
  It is clear that a central reporting system is long overdue and 
needed. The medical community must develop a greater awareness and 
understanding of fatal drug reactions and must ensure that they are not 
repeated. The fundamental goals and benefits of the Safe Medications 
Act are indisputable. I urge my colleagues to support this important 
health care measure.


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