David B. Brushwood, R.Ph., J.D.Professor of Pharmaceutical Outcomes and Policy
The University of Florida College of Pharmacy
PharmCon is accredited by the accreditation counsel for Pharmacy Education as a provider of continuing pharmacy education
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Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.
PharmCon is accredited by the accreditation counsel for Pharmacy Education as a provider of continuing pharmacy education
Speaker: An innovative classroom teacher, Professor Brushwood has created a series of internet-based lectures on pharmacy law and ethics, using PowerPoint slide shows. These computer applications enable students to learn basic concepts at their own pace. Professor Brushwood frequently conducts continuing education courses for pharmacists and physicians to teach them how to use a process known as "VIGIL" to assure that legitimate pain patients receive necessary medications, while drug abusers and diverters are denied access to medications.
Speaker Disclosure: Professor Brushwood has no actual or potential conflicts of interest in relation to this program
This program has been brought to you by PharmCon
Accreditation:Pharmacists-798-00-08-027-L03-PTechnicians- 798-00-08-027-L03-T
Target Audience: Pharmacists and Pharmacy Technicians
CE Credits:
1.0 Credit hour of Continuing Education or 0.1 CEU for pharmacists/technicians
Expiration Date: 3/27/2011
Program Overview: This presentation is approved for two credits of Medical Errors by Florida Board of Pharmacy, and is acceptable for two credits of ACPE designated law program by New Jersey and New York Boards of Pharmacy. Program attendance is reported to CE Broker for Florida pharmacists.
Objectives:1.Describe threats to quality that are present in pharmacy practice2.Outline techniques and procedures that can be used to reduce pharmacy errors3.Devise practices that will facilitate pharmacy error detection and prevention
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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 mediaState regulatorsThe courtsThe IOM ReportBut…
No pharmacist wants to make a mistakeNo pharmacy manager wants pharmacists to make a mistake
Maybe the system just needs to be organized better.
James Reason, Human ErrorPrinciplesPoliciesProceduresPractices
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.
AdvantagesPractical Appeal.Political Appeal.Emotional Appeal.
DisadvantagesIneffective
Too littleToo much
UnreliableUnfair
Centralized Data Reporting and FeedbackCentralized QA Program Error Prevention ClinicMandatory Error Prevention CEMandatory 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?
The computer must accurately reflect information in the original prescription.At the end of each day, a technician checks the accuracy of computer information from the previous shift.Resolve discrepancies, document what is found.
StandardizationPolicies and ProceduresEvery pharmacist is a risk managerMonitoring and handling complaints and errorsSelf Audit
Focus on the Systems and Processes, and not on Individual Performance.Considers Special Causes in Clinical Processes as Well as Common Causes in Organizational Processes.Repeatedly Answers Question: Why did this happen?Identifies Changes That Can Be Made.
What would happen if….?A patient’s allergies are not recordedTwo drugs are obtained in virtually identical packagingThe names of two drugs are virtually the sameA patient becomes angry about the wait timeA prescriber cannot be contacted to resolve a problemTwo patients have similar names
A.
Receiving the PrescriptionB.
New Prescription Computer EntryC.
New Prescription Drug ReviewD.
Patient CounselingE.
Prescription AssemblyF.
Pharmacist Final Check--G.
The “red line”
goes hereH.
Delivery to the PatientI.
Special Care
(2) "Quality-Related Event" means the inappropriate dispensing of a prescribed medication including:(a) a variation from the prescriber's prescription order, including, but not limited to:1. dispensing an incorrect drug;2. dispensing an incorrect drug strength;3. dispensing an incorrect dosage form;4. dispensing the drug to the wrong patient; or5. providing inadequate or incorrect packaging, labeling, or directions.
(b) a failure to identify and manage:1. over-utilization or under-utilization;2. therapeutic duplication;3. drug-disease contraindications;4. drug-drug interactions;5. incorrect drug dosage or duration of drug treatment;6. drug-allergy interactions; or7. clinical abuse/misuse.
64B16-27.300 Standards of Practice -- Continuous Quality Improvement Program.(1) "Continuous Quality Improvement Program" means a system of standards and procedures to identify and evaluate quality-related events and improve patient care.
P&P ManualCQI CommitteeRecord QREsReview Record at least once every 3 months
staffing levelsworkflowtechnological support
Summarization DocumentProtection from Discovery
Total Quality Management (CQI).Taking a systems view.Shift from a focus on individual responsibility to a focus on collective responsibility.Empowering individuals to find their own solutions within existing policies.
Define the process through which prescriptions are filled.Make a record of quality related events.Discuss how systems can be improved to prevent similar events in the future.Audit as necessary.Monitor after changes.
Telephoned incident reports, summarized and returned.Pharmacist final check.Partner check results.Self-audit results.Recollection of near-misses.Literature Survey
Means of Rx Transmission
Written presented in person
Hand writtenMachine written
FaxElectronicVerbal by live phoneVerbal by recording device
Time of DayOpening to NoonNoon to 5pm5pm to Closing
Day of WeekCharacteristics of the Day
Prescriptions Filled# Pharmacists# Techs
Name of drugDosage formDirections for use
StandardNon-standard
Abbreviations in RxStandardNon-Standard
New or Refill
Age of Patient<66-66>66
Patient AcquisitionWaitingReturn LaterDeliveryMail
Receiving RxIncomplete InfoIncorrect Info
Data EntryWrong DrugWrong PatientWrong StrengthWrong DirectionsIncorrect or Omitted Refill InfoNo Patient InfoIgnored DUR Alert
Rx AssemblyWrong DrugWrong StrengthWrong LabelIncorrect QuantitySwapped LabelsSafety ContainerAuxiliary Label
Final CheckTechnical ErrorJudgmental Error
Will CallCounselingWrong Patient
Everyone must participate: Pharmacists, techs, clerks.There are no stupid questions or suggestions.Blaming others is forbidden.
Evaluation of Staffing IssuesEvaluation of Workflow IssuesEvaluation of Technology IssuesEvaluation of Guideline AdherenceEvaluation of Communication IssuesWays to Recommit to Existing PoliciesNew Policies to Implement
FormsPharmacist Final Check
Partner CheckQRE Causal Followup
ChecklistsResponding to Complaints
Ambiguous Rx'sQuality Process
GuidelinesQuality Consult
Explaining ProblemsDocumenting Errors
P&P Manual
Past experience in institutional settings has been encouraging.Retail businesses have also used CQI with success.A mutual commitment to quality from practitioners and managers can’t fail.
