How Safe Is Our Health Care System?

Patient Safety Initiatives

Presenters: Jerry Phillips, R.Ph., Associate Director for Medication Error Prevention, Food and Drug Administration, U.S. Department of Health and Human Services, Rockville, MD. Ellison Pierce, Jr., M.D., Associate Clinical Professor of Anesthesia, Harvard Medical School, and Executive Director, Anesthesia Patient Safety Foundation, Boston, MA. Michael R. Cohen, M.S., R.Ph., Co-Founder and President, Institute for Safer Medication Practices, Huntington Valley, PA.

Jerry Phillips described factors contributing to medication errors. Dispensing of medications is conducted through complex systems with numerous human interactions that have the potential for harm. Errors can occur at the point of prescribing, repackaging, dispensing, administration, and monitoring. Frequent causes of error include:

• Poor communication.
• Ambiguities in product names.
• Directions for use.
• Abbreviations.
• Poor techniques.
• Knowledge deficit.

It is estimated that 150 deaths per day and 1.3 million injuries per year occur due to medication errors. An example of one such error typifies the opportunity for failure. On July 8, 1993, patients in the same hospital received the drug Mivacron® instead of metronidazole. One death and three serious injuries resulted from this incident. Investigation by the Food and Drug Administration (FDA) identified contributing factors to the error:

• Packaging similarities with foil overwrap.
• Lack of adequate labeling.
• Eleven different products being packaged by the same manufacturer and looking alike.

The manufacturer responded quickly through the issuance of a "Stat-Gram," which is a letter sent to alert physicians and pharmacists about drug safety issues, and replacement stickers for existing stock. The manufacturer also agreed to re-label Mivacron®. Hospital employees were found to place Mivacron® in the storage bins for metronidazole. No stickers had been applied to the existing stock and both nursing and pharmacy staff failed to check that they were picking up the proper drug. In the end, the manufacturer completely re-labeled all 11 products with drug name and strength on both the front and back of the foil overwrap. The manufacturer also issued an alert to all hospital pharmacy directors.

Lessons learned from this experience:

• Many system failures.
• Errors not the result of just one individual.
• Need for hospital system improvements.
• Need for FDA and industry system improvements.

FDA assumes responsibility for reducing medication errors in several important ways:

• Minimizing error potential prior to approval.
• Correcting problems quickly after approval.
• Communicating and managing risk.
• Conducting research.

Hospital responsibilities include:

• Creating a safe and non-punitive reporting environment.
• Analyzing systems.
• Reporting to confidential national reporting systems.

Practitioner's responsibilities include:

• Providing clear and well-understood prescriptions.
• Involving the patient and clearly communicating.
• Reporting errors to local and national reporting systems.

Patient responsibilities include:

• Inquiring and knowing about the risks with treatment.
• Expecting and asking for medication counseling.
• Reporting errors to MedWatch (1-800-FDA-1028).

Dr. Ellison Pierce traced the history of anesthesia and efforts made by the profession to manage and reduce errors. Ether was first introduced in 1846 and chloroform in 1847. The first anesthetic death from chloroform occurred in 1848. Between 1860 and1890, chloroform deaths were found to be 100 times more frequent than ether deaths due to its very rapid action in the body and the ease of overdose, causing ventricular fibrillation.

Between 1950 and 1970, many anesthesia mortality studies were conducted; the death rate in most was 1 per 10,000 anesthetics. In 1978, the Cooper Landmark Study was conducted examining critical anesthesia incidents.

Primary errors included:

• Breathing circuit loss.
• Syringe swap.
• Drug overdose.

Secondary errors were found in:

• No check-out of equipment.
• Inadequate experience in using instrumentation.
• Poor communication among surgeon, anesthesiologist, and nursing personnel.

Between 1975 and 1985, there was a medical liability insurance crisis. Premiums for anesthesia were six times the base rate for all practitioners. During this time, anesthesia accounted for 3 percent of claims but 12 percent of pay-outs. This prompted:

• A new media recognition in the early 1980s of the high anesthesia death rate.
• Appointment of a Committee on Patient Safety by the American Society of Anaesthesiologists (ASA).
• A Boston Symposium on Preventable Anesthesia Mortality.
• Foundation of the Anesthesia Patient Safety Foundation.
• Introduction of safer anesthesia machines and drugs.
• Better anesthesia education and training.

Today, anesthesia mortality has been reduced by ten- to twentyfold for healthy patients in hospital and surgicenters. Why?

• Leadership.
• Active involvement by ASA in Committee on Patient Safety, claims study, protocols, and safety sessions.
• Better personnel and devices.
• Use of patient simulators.

Despite gains, errors still occur: systems fail, hypoxic deaths occur, standards are ignored, fatigue sets in, equipment fails, and there is pressure to produce.

Michael Cohen reported on the Medications Errors Reporting Program operated by the U.S. Pharmacopeia in cooperation with the Institute for Safe Medication Practices. The program focuses on the need to create nonpunitive environments to address medication errors as the property of the system as a whole rather than results of the acts or omissions of individuals. Many factors, latent and active, must be present and in proper alignment for error to occur. Although errors are inevitable, the system should be redesigned to make it more difficult to err.

Healthcare has many hierarchical levels that impede communication and cooperation, further compounding errors. Although front-line staff are often the source of investigations, many errors originate where organizational policies, procedures, and resource-allocation decisions are made.

High-alert medications represent a small number of medications that have a high risk of causing injury if misused and where the consequences of errors may be devastating. The number one high-alert medication is insulin. Some of the key concepts in safeguarding high-alert medications include:

• Differentiate items (appearance, location, touch, color, smell, etc).
• Standardize communication and dosing methods.
• Create redundancy in check systems, back-up.
• Use constraints that limit access or use.
• Analyze failure for new products and procedures.

Certain types of situations involving medications are more prone to error than others. These include:

• Patient-controlled analgesia and epidural analgesia.
• Medications using automated dispensing equipment.
• Preparation of complex products with automated compounders.
• Administration of enteral feedings in patients with IV (intravenous) catheters in place.

Ideas for changes that are needed to improve medication use processes were discussed:

• Need for focused problem review and elimination of "error rates" as a measurement tool.
• Nonpunitive approach.
• Computerization of medication-use process.
• Use of machine-readable codes for most administered medications.
• More consumer involvement in medication safety.
• Improved access to confidential patient information.

Mr. Cohen strongly advocated oversight by State agencies and accrediting organizations to ensure that safety practices derived from reporting programs are well publicized and addressed locally by hospitals and other healthcare facilities.

Given that the Medications Errors Reporting Program receives a great deal of information about errors and their prevention, there needs to be someone within each State agency who reviews this information and then provides oversight needed to ensure that this information is being put to use. Otherwise, errors that cause patient harm or death will continue to be repeated over and over.

References

Anesthesia Patient Safety Foundation. Comparison standards applicable to ambulatory surgery. Pittsburgh (PA): The Safety Foundation;2000 Jan.

Gaba DM. Strategies for data collection and analysis to protect patient safety in office-based anesthesia and surgical settings. Pittsburgh (PA): Anesthesia Patient Safety Foundation;2000 Feb.

Good ML. Simulation: can it contribute to safer OBA? Pittsburgh (PA): Anesthesia Patient Safety Foundation;2000 Feb.

Grazer FM, DeJong RH. Fatal outcomes from liposuction: census of cosmetic surgeons. J Plast Reconstruct Surg 2000;105(1):443.

Moss E. OBA Regulations. Pittsburgh (PA): Anesthesia Patient Safety Foundation;2000 Feb.

National Coordinating Council for Medication Error Reporting and Prevention. Medication Error Evaluation Forum. Rockville (MD): The National Council;1999 Jul.

Peirce EC. The 34th Rovenstine Lecture: 40 years behind the mask: Safety Revised. Anesthiology 1996:84(4):965-75.

Siker R. OBA Workshop. Pittsburgh (PA): Anesthesia Patient Safety Foundation;1999 Nov.

Stoelting RK. Introduction to office-based anesthesia safety. Pittsburgh (PA): Anesthesia Patient Safety Foundation;2000 Feb.

Trombly ST. Office-based anaesthesia and potential liability. Pittsburgh (PA): Anesthesia Patient Safety Foundation;2000 Feb.

Twersky RS. Update on office-based anesthesia: standards, regulations, guidelines and accreditation. Pittsburgh (PA): Anesthesia Patient Safety Foundation;2000.

Woodcock J, editor. Medication errors: a CDER perspective. Proceedings of the FDA's workshop on Minimizing Medical Product Errors: A Systems Approach;1998 Jan 8; Bethesda (MD). Bethesda: Food and Drug Administration;1998.

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