David B. Brushwood, R.Ph., J.D. Professor of Pharmaceutical Outcomes and Policy The University of Florida College of Pharmacy

 List the challenges and opportunities for improved patient safety in pharmacy practice.  Describe the operation of root cause analysis and failure mode and effects analysis.  Discuss strategies for error reduction and prevention in pharmacy.  List techniques that pharmacists can use to prevent medication errors.  Describe the organization of pharmacy systems to manage the risk of medication errors.

 The media  Television programs  Magazines  Newspapers  State regulators  The courts  The IOM Report  But…  No pharmacist wants to make a mistake  No pharmacy manager wants pharmacists to make a mistake  Maybe the system just needs to be organized better.

 James Reason, Human Error  Principles  Policies  Procedures  Practices  Fallibility is a part of the human condition.  We can’t change the human condition.  We can change the conditions under which people work.

 Safety is everybody’s business.  We must accept setbacks and anticipate errors.  Safety issues should be reviewed regularly.  Past events should be reviewed and changes implemented.  After a mishap, concentrate on fixing the system, not on blaming individuals.  Effective error reduction depends on the collection, analysis and dissemination of data.  Error reduction must be proactive.

 Safety information has direct access to the top.  Everyone helps everyone else.  Meetings on safety are attended by staff at every level.  Messengers are rewarded, not shot.  The culture of safety must be just.  Reporting must include qualified indemnity, separation of discipline from data collection.  Discipline should involve peers and agree as to the difference between acceptable and unacceptable behavior.

 Training in the recognition and recording of errors.  Feedback on recurrent error patterns.  Awareness that procedures cannot cover all circumstances; on the spot training.  Protocols written with those doing the job.  Procedures must be workable, available, and supported.

 Rapid, useful, and intelligible feedback on lessons learned and actions needed.  Bottom up information listened to and acted on.  When mishaps occur  Listen carefully.  Apologize.  Objectively explain what happened, if known.  Assure patient lessons will be learned.

 The Issue: Whether a pharmacist has committed malpractice based simply on the evidence that the pharmacist has made a mistake.

 “Because of a risk of neonatal infection, the attending physicians ordered that the infant receive a specified dosage of an intravenous antibiotic every twelve hours.”  “Because the hospital pharmacy made an error in preparing the medication, the infant received approximately five times the prescribed dosage.”

 “Defendants at trial and on appeal have argued that, because it can be predicted that a certain percentage of errors will occur in filling pharmacy orders, and because not all errors are negligent, the jury could have reasonably inferred that the mistake made by the University’s pharmacy was the type of calculation error that was due not to negligence, but rather to a statistical error rate that cannot be eliminated.”

 “Some negligence in the course of human endeavors is predictable. The mere fact that a certain percentage of errors will predictably occur provides no basis to infer that an error on a particular occasion was free of negligence. To err is human. To forgive divine. To be responsible for injuries caused by undisputed negligence is the law of this state.”

 It is usually impossible to discover the cause of pharmacy errors.  Negligence and the making of mistakes are usually viewed as being different, but in pharmacy they are the same.  Pharmacy is a “no mistakes” profession.

 “Forgive and Remember”  Charles Bosk  “That humans make 0.1 percent errors on prescriptions may be forgivable; that hospitals don’t take obvious actions to protect themselves and patients, well within state-of-the-art, is not.”  Michael Millenson  “Almost all accidents result from human error, it is now recognized that these errors are usually induced by faulty systems that ‘set people up’ to fail. The great majority of effort in improving safety should focus on safe systems, and the health care organization itself should be held responsible for safety.”  The IOM Report

 Do Nothing.  Punishment.  Advantages  Practical Appeal.  Political Appeal.  Emotional Appeal.  Disadvantages  Ineffective  Too little  Too much  Unreliable  Unfair  Centralized Data Reporting and Feedback  Centralized QA Program  Error Prevention Clinic  Mandatory Error Prevention CE  Mandatory CQI

“The prescription was illegible. The pharmacist gave the plaintiff Tambocor, an antiarrhythmic drug used by cardiologists. It is undisputed that the prescription actually called for Tamoxifen. The pharmacist did not attempt to call the physician to verify the accuracy of her reading of the prescription and did not even try to question Ms. Holloway about why her oncologist was supposedly prescribing a heart medication for her.”

“We note that the jury was also informed of 233 incident reports that had been prepared by Harco employees during the three years preceding the incident. This evidence, in addition to evidence of complaints filed with the State Board of Pharmacy and the evidence of lawsuits filed alleging misfilled prescriptions, was relevant to show Harco’s knowledge of problems, and Harco’s having failed to initiate sufficient institutional controls over the manner in which prescriptions were filled.”

 Individual pharmacists must be competent and caring within a practice system.  Pharmacies must provide the best possible system so that pharmacists will succeed.  A good system of institutional controls organizes the system as interlinked processes with defined steps, it records success/failure, and it empowers everyone to reflect on the past and improve in the future.

RPh. & P.T. dispense according to established Procedures Quality related event occurs Quality Supervisor Reviews Incident Reports and near-miss documentation Quality Supervisor Reviews Quality Inservice Developed Management Kept Informed of Progress Management Reviews Policies and Adjusts PRN Quality Consult held

 Select and use techniques that put theory into practice.  Use the techniques to catch or absorb errors.  Recommit to existing policies.  Develop new techniques with consensus of all stakeholders.

 Identify those prescription items causing "problems"  Place colored tape on that part of the shelf-or put on different shelf  To cause "a second thought"

 Reduces likelihood of prescriptions for one patient being confused with those for another patient.  All items for a patient’s prescription are placed in a basket.  “Two-Second Rule”  No vial is left with a label and without medication for any longer than two seconds.  Same for any vial with medication and without a label.

 Check medication label with name on sack.  Check name and phone number on sack with person requesting medication.

 Why does my medication look different this time?  Why are the directions different from those my doctor told me?  Are you sure you spelled my doctor’s name correctly?  If I’m allergic to aspirin can I take this?