Chapter 12Medication Safety

Chapter 12 TopicsMedical Errors Medication ErrorsPrescription-Filling Process in Community and Hospital Pharmacy PracticeMedication Error PreventionMedication Error and Adverse Drug Reaction Reporting Systems

Learning ObjectivesUnderstand the extent and effect of medical errors on patient health and safetyDescribe how and to what degree medication errors contribute to medical errorsList examples of medication errors commonly seen in practice settings Apply a systematic evaluation of opportunities for medication error to a pharmacy practice modelIdentify the common medication errorreporting systems available

Medical ErrorsA medical error is any circumstance, action, inaction, or decision related to healthcare that contributes to an unintended health result Most of what is known about medical errors comes from information collected in the hospital settinghospital data make up only a part of a much larger picturemost healthcare is administered in the outpatient, office-based, or clinic settingMedical errors are difficult to definepossible causative circumstances are infinite

Medical ErrorsMedical-related lawsuits show the scope of medical errors in the United States One large government studied only medical errors during hospitalization44,000 to 98,000 people in the U.S. die each year as a result of medical errors (greater than the risk of death from accident, diabetes, homicide, or human HIV and AIDS)multiple sources for potential medical errors exist

Medical ErrorsPharmacy technicians should be constantly on the lookout for possible sources of errorsadopt patient safetyoriented work practices take steps to protect the safety of patientsbecome an important barrier against an adverse patient outcome

DiscussionWhat are some examples of medical errors?

DiscussionWhat are some examples of medical errors?

Answer: Lab tests drawn at the wrong time (inaccurate results), major surgical errors ending in injury or death

Terms to Remember

medical error

Medication Errors A medication error is a medical error in which the source of error or harm includes a medicationLike medical errorsmedication errors have no specific definition because the possible causes can be endlessinformation on the effect of medication errors comes mostly from studies done in the hospital setting Medication-related deaths are estimated at about 7,000 each year

Medication Errors Fewer studies of medication errors in community practice existan estimated 1.7% of all prescriptions dispensed in a community practice setting contain a medication error (4 of every 250 prescriptions)

Not all medication errors result in harm to a patient65% of the medication errors detected had a meaningful effect on the patients health

Medication Errors Measuring results of medication errorslost livesdisabled patients time lost from work or school

cost to the healthcare system

Healthcare Professionals ResponsibilityWorking in healthcare means making a commitment to first do no harm The profession of pharmacy exists to safeguard the health of the publicHealthcare must focus on treating the patient to the best possible outcome by the safest possible meansNo acceptable level of medication error exists effect of a potential medication error on the patient cannot be predictedeach step in fulfilling medication orders should be reviewed with a 100% error-free goal

Healthcare Professionals ResponsibilityThe only acceptable level of medication errors is zero.

Healthcare Professionals ResponsibilityPharmacists are responsible for the accuracy of the medication-filling processtechnicians can assist in ensuring safetyPharmacists and pharmacy technicians can work together to create a net of safetyProper packaging and instruction on medication use facilitates correct administration by a patient

Healthcare Professionals ResponsibilityTechnicians can identify potential patient sources of medication error careful listening and observation during a patient or medical staff interactionnotifying the pharmacist

Technicians make a significant contribution to patient safety constant surveillance for potential sources of medication error

Tips for Reducing Medication ErrorsAlways keep the prescription and the label togetherKnow common look-alike and sound-alike drugsKeep dangerous or high-alert medications in a separate storage area Always question bad handwritingPrescriptions/orders should be correctly spelled with drug name, strength, appropriate dosing, quantity or duration of therapy, dose form, and routeUse the metric system

Tips for Reducing Medication ErrorsQuestion uncommon abbreviations Be aware of insulin mistakesKeep the work area clean and unclutteredVerify information Labels should always be compared with the original prescription by at least two people

Healthcare Professionals ResponsibilityIf information is missing from a medication order, never assume. Obtain the missing information from the prescriber.

Tips for Reducing Medication Errors: Pharmacists Check prescriptions in a timely mannerInitial all checked prescriptionsVisually check the product in the bottleCross-reference prescription information with other validating sourcesEncourage documentation of all medication useDocument all clarifications on ordersMaintain open lines of communication with patients, healthcare providers, and caregivers

Tips for Reducing Medication Errors: Technicians

Use the triple-check system Regularly review work habitsVerify information with the patient or caregiverObserve and listenKeep your work area free of clutter

Patient ResponseMost patients have the intended therapeutic response expected from the medication

Unique physical and social circumstances make it impossible to predict whichmedication errors may result in no substantial harmmay result in death

Physiological Causes of Medication ErrorsEach patient has a unique response to medication genetically uniquespeed at which medications are removed from body varies

Even a problem caught and corrected before harm occurs is still considered a medication error

Social Causes of Medication ErrorsOutpatients can contribute to medication errors through incorrect administration

Social causes of error include:failure to follow medication therapy instructions because of costnoncompliance failure to receive therapymisunderstanding instructions (language barriers)

Social Causes of Medication ErrorsPatients can contribute to medication errors by forgetting to take a dose or dosestaking too many doses dosing at the wrong timenot getting a prescription filled or refilled in a timely mannernot following directions on dose administrationterminating the drug regimen too soon

Social Causes of Medication ErrorsSocial causes may result in an adverse drug reaction, or a toxic dose

Over 50% of patients on necessary long-term medication are no longer taking their medication after 1 year

All of these social circumstances would be considered medication errors

Categories of Medication ErrorsPossible causes of a medication error are numerous

Categorizing errors into types aids in identification and prevention of possible causes

Categories focus on grouping errors under a set of common definitions

Categories of Medication Errorsomission error: a prescribed dose is not givenwrong dose error: a dose is either above or below the correct dose by more than 5%extra dose error: a patient receives more doses than were prescribed by the physicianwrong dose form error: dose form or formulation that is not the accepted interpretation of the physician order wrong time error: drug is given 30 minutes or more before or after it was prescribed

Categories of Medication ErrorsErrors can be classified by what causes the failure of the desired result

Errors can be categorized within three basic definitions of failure:human failuretechnical failureorganizational failure

Categories of Medication ErrorsHuman failure is a failure that occurs at an individual levelpulling a medication bottle from the shelf based on memory, without cross-referencing the bottle label with the medication order/prescription errors made by the patient such as non-compliance to prescribed drug therapyTechnical failure is a failure resulting from location or equipment incorrect reconstitution of a medication because of a malfunction of a sterile-water dispenser failure to properly operate automated equipment

Categories of Medication ErrorsOrganizational failure is a failure because of organizational rules, policies, or proceduresa policy or rule requiring preparing drugs in an inappropriate settingVisit the Veterans Administration (VA) National Center for Patient Safety Web site for a glossary of patient safety terms

Root Cause Analysis of Medication ErrorsRoot cause analysis is a logical and systematic process used to help identify what, how, and why something happened to prevent reoccurrence

With basic principles of root cause analysis, any person can examine his or her own work flow to determine the opportunities for potential errordetermine what type of failure the potential error may becreate a list of specific potential causes

Root Cause Analysis of Medication ErrorsIdentifying specific potential causes allows a person to take specific actions to prevent the potential error Actions taken improve the quality of work being doneCommon causes of medication error by handlers and preparers include:assumption errorselection errorcapture error

Root Cause Analysis of Medication Errorsassumption error: an essential piece of information cannot be verified and is guessed or presumedmisreading an abbreviation on a prescriptionselection error: two or more options exist, and the wrong option is chosen using a look-alike or sound-alike drug instead of prescribed drugcapture error: focus on a task is diverted elsewhere and an error goes undetectedsomething captures the persons attention, preventing the person from detecting the error or causing an error to be made

Root Cause Analysis of Medication ErrorsTo prevent capture errors determine when and where in the prescription-filling process it is safe to allow focus on a task to be diverted

Knowing when and when not to allow interruptions is important in individual safety practices

Root Cause Analysis of Medication ErrorsMaintaining focused attention when filling prescriptions is important to avoid errors.

DiscussionWhat are some ways to reduce each category of error?

DiscussionWhat are some ways to reduce each category of error?

Answer: Assumption errors may be avoided by verifying all information instead of guessing; capture errors may be avoided by reviewing work habits and determining when interruptions are or are not appropriate; selection errors may be avoided by cross-referencing products chosen with the order/prescription and the shelf label.

Terms to Remembermedication erroromission errorwrong dose errorextra dose errorwrong dose form errorwrong time errorhuman failuretechnical failureorganizational failureroot cause analysisassumption errorselection errorcapture error

Prescription-Filling Process in Community and Hospital Pharmacy PracticeReview for potential causes of medication error begins with outlining work tasks in a step-by-step manner

Each step in this process can be asource of medication errorplace where pharmacy personnel can correct a medication error

In the hospital setting medications pass through an extra set of handsthe nursesbefore reaching the patient an extra opportunity to prevent medication errorsan additional source of potential medication errorsEach step should be reviewed to determine what information is necessary to complete the step what resources can be used to verify the information what errors might result if information is missed or verification is not performed

Prescription-Filling Process in Community and Hospital Pharmacy Practice

Prescription-Filling Process in Community and Hospital Pharmacy PracticeEach person who participates in the filling process has the opportunity to catch and correct a medication error.

Prescription-Filling Process Think of each step in three parts: information that must be obtained or checked

resources that can be used to verify information

potential medication errors that would result from a failure to obtain or check the necessary information using the appropriate resources

Prescription-Filling ProcessStep 1: Receive Prescription and Review Patient Profile

Initial check of all key pieces of information is vital thoughtful and thorough initial review reduces the chances that an unidentified error will continue through the filling processLegibility: Can you read and understand it? any unclear information should be clarified before any further action is taken

Prescription-Filling Process Careful review of the prescription or order is very important.

Prescription-Filling Process Step 1Validity: Is the prescription valid?requirements may vary from state to stateevery technician should be familiar with the definition of valid prescription for the state in which he or she practice

does it contain all the required information to be valid? a prescription is valid for up to 1 year (less in some cases) from the date of its writing

if not valid, the prescription should not be filled

Prescription-Filling Process Outdated prescriptions should not be filled.

Prescription-Filling ProcessStep 1Patient information: Is there enough detail to ensure that unique individuals can be pinpointed? full names, addresses, dates of birth, and phone numbers give multiple points to cross-reference and separates patients date of birth and allergies should always be includedPhysician information: Is it sufficient to determine that a licensed prescriber wrote the prescription? contact information should be includedno prescription or medication order is valid without the signature of the prescriber

Prescription-Filling Process A prescribers signature is required for a prescription to be considered valid.

Prescription-Filling ProcessStep 1Medication information should include:

Prescription-Filling ProcessStep 1Prescribing errors include: poor handwritingusing nonstandard abbreviationsconfusing look-alike and sound-alike drug nameswrong drugusing as directed instructions

Prescription-Filling Process A leading zero should precede values less than one, but a zero should not follow a decimal if the value is a whole number. A tenfold error occurs if the decimal point is not detected.

Prescription-Filling ProcessStep 1Opportunities for medication errors increase with the number of medications a patient takescommon with many older patients

Profile review for every prescription should include: check for existing allergies and multiple drug therapy check for drug interactions or duplication of therapy

Prescription-Filling Process Check the patient profile for existing allergies or possible drug interactions.

Prescription-Filling ProcessStep 2: Enter Prescription into Computer

Accuracy in this function can make the difference between a patient receiving a correct and appropriate medication or a prescription that could cause the patient serious harm or death

Prescription-Filling ProcessStep 2Concentration and focus are very importantprescription information should be compared with choices from the computer menuDoes the form or formulation match the route of administration? Compare each data element of the completed entry with the same data elements on the original prescriptionCheck the Institute for Safe Medication Practices Web site for dangerous abbreviations or dose designations

Prescription-Filling Process Prescriptions that contain unapproved error-causing abbreviations should be confirmed with the prescriber.

Prescription-Filling Process Confirm that information entered into the computer matches the original prescription.

Prescription-Filling ProcessStep 3: Generate Prescription Label

Check for the accuracy of any technology in the prescription filling processCross-check the label output from the computer with the original prescription make sure that a typing error or inherent program malfunction did not alter the informationIs the correct patient name on the label? Are the drug, dose, concentration, and route information identical to the original prescription?

Prescription-Filling ProcessStep 4: Retrieve Medication

Products can contribute to errors with look-alike labelssimilarities in brand or generic namessimilar pill shapes or colorsUse NDC numbers, drug names, and other information to verify selection of the correct productuse both the original prescription and the generated label when selecting a manufacturers drug product from the storage shelfuse NDC numbers as a cross-check

Prescription-Filling ProcessStep 4Accidental substitution of one drug or ingredient for another is one of the most serious events that can occur in pharmacy practiceMost pharmacy practices possess a computer-based pill identification program and use a shelf labeling system to organize inventoryvisual comparison of the medication dispensed with a picture of the medication

Prescription-Filling ProcessStep 5: Fill or Compound Prescription

Calculation and substitution errors are sources of medication errorswrite out the calculation and have a second person check the answer

Take care when reading labels and preparing compounded products

Prescription-Filling ProcessStep 5Medication errors may occur whenusing more than one container of productpreparing more than one product at a timedistractions and interruptions intrudeAll equipment should be maintained, cleaned, and calibrated on a regular basispotential for serious harm to a patient if the residue or dust from an allergy-causing medication contaminates the patients prescriptioncleaning the counting tray with alcohol after each drug is dispensed is recommended

Prescription-Filling Process When compounding, do not allow interruptions and prepare products one at a time.

Prescription-Filling ProcessStep 5Caution and warning labels on a prescription container serve as reminders to patients about drug handling or administration

Computerized systems generate caution and warning labels with the prescription labelcoordinate with patient information handoutsshould be included with prescription labeling

Prescription-Filling ProcessStep 6: Review and Approve Prescription

The pharmacist must be the one to review and approve the prescriptionverifies the quality and integrity of the end product

Providing the pharmacist with all resources that are useful to ensure accurate verification is vital to patient safety

Prescription-Filling ProcessStep 6Determine what information and resources are important ask whether the information provided with the medication filled allows the pharmacist to retrace the technicians steps in filling the prescriptionCan the pharmacist determine whether prescription is valid, patient information is accurate, and medication correctly prepared from information provided with the finished product?

Prescription-Filling Process The pharmacist must always check the technicians work.

Prescription-Filling ProcessStep 7: Store Completed PrescriptionEnsuring the integrity of medication is an important part of medication safetyMany medications are sensitive to light, humidity, or temperaturefailure to properly store medications may result in loss of drug potency or effectimproper storage of a drug may result in a degraded product that causes serious harmWell-organized and clearly labeled storage systems help to keep a patients medications together and separate from other patients

Prescription-Filling ProcessStep 8: Deliver Medication to Patient

In community pharmacies, medication is directly received by the patient In hospitals, medications are administered and monitored by someone other than the patientVerify prescription information against knowledge and expectations of patient or caregiverComparing completed prescription against information provided by patient allows a final opportunity to capture potential errors

Prescription-Filling Process Pharmacy technicians cannot instruct patients. If a technician suspects that a patient requires instruction, then the technician should alert the pharmacist.

Prescription-Filling ProcessStep 8In hospitals, medication is ultimately received by the nursean additional person to confirm accuracy and appropriateness creates opportunity for a medication error

Notify the nurse that a newly prescribed medication has been delivered to the floor

Prescription-Filling ProcessStep 8Ask whether the nurse knows about the medicationmedications delivered were all they were expecting

If a drug is missing from the drug therapy combination, treatment is incompleteincomplete therapy is also a medication error

DiscussionWhat information should be checked at each step of the prescription fill process?

DiscussionWhat information should be checked at each step of the prescription fill process?

Answer: Patient identity, medication dose and form, directions for use

Medication Error Prevention Preventing medication errors means carefully examining potential points of failureusing available resources to verify information given or decisions made

Drug identification is the most common error in dispensing and administration

Medication Error Prevention Pharmacy technicians own a substantial portion of the prescription-filling processfirst to examine a prescription submitted for fillinglast to handle medication before it reaches the patientPharmacy technicians have the most opportunities to prevent medication errors can identify potential sources of error beyond prescription dispensinginteract with a patient or nurse when a prescription comes in or goes out of the pharmacy

Medication Error Prevention Incorrect drug identification is the most common error in dispensing or administration.

Medication Error Prevention Many medication errors occur during prescribing and administrationPrescribers are responsible for ensuring the five Rs or five rightsthe right drug for the right patient at the right strength given by the right route administered at the right time

Medication Error Prevention Pharmacy practice overlays physician responsibility and thereby facilitates patient safety and error prevention by processes to verify the following: the correct patient is being given the medicationsother associated medications are correct correct drug is dispensedcorrect dose is preparedcorrect route of administration is indicatedappropriate dose form is prepared correct administration timescorrect conditions for administration are met

Patient EducationPatients and caregivers must have necessary knowledge to administer, handle, and support safe medication usePharmacy technicians can encourage patients to ask questionsrelay complete medical and allergy historycheck medications for information on administration Pharmacy technicians should be actively involved in monitoring for potential errors

Patient EducationPharmacy technicians cannot instruct patients but canencourage patients to become informed about their conditions encourage patients to ask the pharmacist questions about prescribed medicationsassist patients in becoming more informed empower them to be advocates for their own safety and health

Patient EducationPatients should understand ten key pieces of information about every medication:what the brand and generic names arewhat the medication looks likewhy they are taking the medication, and how long they will have to take ithow much to take, how often, and the best time or circumstances to take a medicationwhat to do if they miss a dose

Patient Education

medications or foods which interact with what they are takingwhether new medication is in addition to or replaces medication currently takencommon side effects and what to do about themspecial precautions for each particular drug therapywhere and how to store the medication

Innovations to Promote SafetyThe physical pharmacy work setting can have a major contribution to the overall safety of any work environmentAutomate and bar code all fill proceduresMaintain a clean, organized, orderly work areaProvide adequate storage areasEncourage prescribers to use common terminology and only safe abbreviationsProvide adequate computer applications and hardware

Innovations to Promote SafetyInnovations can minimize possibility of errorsIn community pharmacy, redesigned packaging helps patients take medication safelyTarget ClearRx packaging helps patients manage their medicationscolored rings help patients identify medications intended for each family memberclear, easy-to-read label for patient administration instructions and cautionsincludes a pullout patient information card or printoutLearn more about the Target label design

Innovations to Promote SafetyIn hospital pharmacy, integrated computerized filling systems allow institutions toimprove efficiency redirect resources

Innovations to Promote SafetyWhen a pharmacist is actively involved in medication decisions, safety and outcomes for patients are substantially improvedtechnologic advances empower the pharmacy technician staff to become more productive, and as a result, pharmacists are freed to become more involved in patient care Learn more about McKessons technologies

DiscussionWhat can a pharmacy technician do to prevent medication errors?

DiscussionWhat can a pharmacy technician do to prevent medication errors?

Answer: A pharmacy technician is in the ideal position to identify potential sources of error, encourage patient education, and monitor for problems.

Medication Error and Adverse Drug Reaction Reporting SystemsThe first step in prevention of medication errors is collection of informationFear of punishment is a concern with errorspeople may decide not to report an error at allallows the same error to occur again and againAnonymous (no-fault) reporting systems have been establishedfocus on fixing the problem, not fixing the blame

State Boards of PharmacyMore than 20 states have mandatory error-reporting systemsmost state officials admit medical errors are still under-reported mostly because of fear of punishment

Some states have worked to reduce the fear of reporting allow pharmacists to document errors and error-prone systems without worry of punishmentmost boards of pharmacy will not punish pharmacists for errors

State Boards of PharmacyPharmacy technicians are an integral part of the error identification, documentation, and prevention process

The final and most important piece of medication error reporting is informing the patient that a medication error has taken placecommonly the task of the pharmacist

State Boards of PharmacyThe circumstances leading to the error should be explained completely and honestlyPatients should understand the nature of the errorwhat if any effects the error will havehow they can become actively involved in preventing errors in the futurePeople are more likely to forgive an honest error

Joint Commission on Accreditation for Healthcare OrganizationsOrganizations can create a centralized point through which all members may channel error information safelyThe Sentinel Event Policy was created by the Joint Commission on Accreditation for Healthcare Organizations (JCAHO) in 1996 A sentinel event is an unexpected occurrence involving death or serious physical or psychologic injury

Joint Commission on Accreditation for Healthcare OrganizationsWhen a sentinel event is reported, the organization is expected to analyze the cause of the error (perform a root cause analysis)take action to correct the causemonitor the changes madedetermine whether the cause of the error is eliminatedAccreditation of hospitals depends on demonstrating an effective active errorreporting systemLearn more about the Joint Commission International Center for Patient Safety

United States PharmacopeiaThe United States Pharmacopeia (USP) supports two types of reporting systems for the collection of medical errors and adverse drug reactionsMedication Errors Reporting ProgramMEDMARX

United States PharmacopeiaThe Medication Errors Reporting Program is designed to allow healthcare professionals to report medication errors directly MEDMARX is an internet-based program for use by hospitals and healthcare systems for documenting, tracking, and trending medication errors

United States PharmacopeiaBoth USP programs support research into medication-related adverse events use the information to develop medication-specific patient safety initiatives Learn about the Medication Errors Reporting Program and MEDMARX

Food and Drug AdministrationFood and Drug Administration (FDA) is the government body responsible for approving the safety of medications and medical devices

MedWatch is an FDA reporting system for adverse events resulting from medications and medical devices

Food and Drug AdministrationFDA uses MedWatch information to track unrecognized problems or issues not apparent when the medication or medical device was approved

A problem or potential for error does not mean the product will be removed from the marketoften safety risks may be reduced or eliminated byimproving of prescribing informationeducation of healthcare professionals or the publicname change

Food and Drug AdministrationThe FDA provides an adverse event reporting formGet an adverse event reporting form

Institute for Safe Medication PracticesThe Institute for Safe Medication Practices (ISMP)non-profit healthcare agencycomprised of physicians, pharmacists, and nurses The mission statement is to understand the causes of medication errors and to provide time-critical error reduction strategies to the healthcare community, policy makers, and the public ISMP in concert with USP provides a confidential national voluntary programMERP (Medication Errors Reporting Program)

Visit ISMP

Institute for Safe Medication PracticesErrors reported through MERP include: wrong drug, strength, or doseconfusion over look-alike and sound-alike drugsincorrect route of drug administrationcalculation or preparation errorsmisuse of medical equipmenterrors in prescribing, transcribing, dispensing, or monitoring medications

Reports can be completed on-line

Institute for Safe Medication PracticesISMP has sponsored national forums on medication errorsrecommended addition of labeling or special hazard warnings on potentially toxic drugsencouraged revisions in potentially dangerous pharmaceutical advertising promoted the use of a zero prior to a decimal number less than 1 on drug doses

Institute for Safe Medication PracticesISMP is active in disseminating information to healthcare professionals and consumers email newsletterjournal articlesvideotape training exercises

ISMP web site postsFDA Safety alertsISMP Hazard Alerts

DiscussionWhy is the most effective error-reporting systems, anonymous or no-fault?

DiscussionWhy is the most effective error-reporting systems, anonymous or no-fault?

Answer: Fear of punishment may be a deterrent to error-reporting.

Terms to Remember

sentinel event

MEDMARX

MedWatch