chapter 12 medication safety chapter 12 topics medical errors medication errors prescription-filling...

Chapter 12

Medication Safety

Chapter 12 Topics

• Medical Errors

• Medication Errors

• Prescription-Filling Process in Community and Hospital Pharmacy Practice

• Medication Error Prevention

• Medication Error and Adverse Drug Reaction Reporting Systems

Learning Objectives

• Understand the extent and effect of medical errors on patient health and safety

• Describe how and to what degree medication errors contribute to medical errors

• List examples of medication errors commonly seen in practice settings

• Apply a systematic evaluation of opportunities for medication error to a pharmacy practice model

• Identify the common medication error–reporting systems available

Medical Errors

• A 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 setting– hospital data make up only a part of a much larger picture

– most healthcare is administered in the outpatient, office-based, or clinic setting

• Medical errors are difficult to define– possible causative circumstances are infinite

Medical Errors

• Medical-related lawsuits show the scope of medical errors in the United States

• One large government studied only medical errors during hospitalization– 44,000 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 Errors

• Pharmacy technicians should – be constantly on the “lookout” for possible sources of

errors

– adopt patient safety–oriented work practices

– take steps to protect the safety of patients

– become an important barrier against an adverse patient outcome

Discussion

What are some examples of medical errors?

Discussion

What 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 medication

• Like medical errors– medication errors have no specific definition because

the possible causes can be endless

– information 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 exist– an 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 patient– 65% of the medication errors detected had a meaningful

effect on the patient’s health

Medication Errors

• Measuring results of medication errors– lost lives

– disabled patients

– time lost from work or school

• cost to the healthcare system– billions of dollars – physician visits

– additional hospitalizations – emergency room visits

– admissions to long-term care – continuation of disease

Healthcare Professional’s Responsibility

• Working in healthcare means making a commitment to “first do no harm”

• The profession of pharmacy exists to safeguard the health of the public

• Healthcare must focus on treating the patient – to the best possible outcome – by the safest possible means

• No “acceptable” level of medication error exists – effect of a potential medication error on the patient cannot

be predicted– each step in fulfilling medication orders should be reviewed

with a 100% error-free goal


The only acceptable level of medication errors is zero.


• Pharmacists are responsible for the accuracy of the medication-filling process– technicians can assist in ensuring safety

• Pharmacists and pharmacy technicians can work together to create a net of safety

• Proper packaging and instruction on medication use – facilitates correct administration by a patient


• Technicians can identify potential patient sources of medication error – careful listening and observation during a patient or medical

staff interaction

– notifying the pharmacist

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

error

Tips for Reducing Medication Errors

• Always keep the prescription and the label together• Know common look-alike and sound-alike drugs

• Keep dangerous or high-alert medications in a separate storage area

• Always question bad handwriting• Prescriptions/orders should be correctly spelled with

drug name, strength, appropriate dosing, quantity or duration of therapy, dose form, and route

• Use the metric system

Tips for Reducing Medication Errors

• Question uncommon abbreviations • Be aware of insulin mistakes• Keep the work area clean and uncluttered• Verify information • Labels should always be compared with the original

prescription by at least two people


If 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 manner• Initial all checked prescriptions• Visually check the product in the bottle• Cross-reference prescription information with other

validating sources• Encourage documentation of all medication use• Document all clarifications on orders• Maintain open lines of communication with patients,

healthcare providers, and caregivers

Tips for Reducing Medication Errors: Technicians

• Use the triple-check system • Regularly review work habits• Verify information with the patient or caregiver• Observe and listen• Keep your work area free of clutter

Patient Response

• Most patients have the intended therapeutic response expected from the medication

• Unique physical and social circumstances make it impossible to predict which– medication errors may result in no substantial harm

– may result in death

Physiological Causes of Medication Errors

• Each patient has a unique response to medication – genetically unique– speed 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 Errors

• Outpatients can contribute to medication errors through incorrect administration

• Social causes of error include:– failure to follow medication therapy instructions because

of cost

– noncompliance

– failure to receive therapy

– misunderstanding instructions (language barriers)


• Patients can contribute to medication errors by – forgetting to take a dose or doses

– taking too many doses

– dosing at the wrong time

– not getting a prescription filled or refilled in a timely manner

– not following directions on dose administration

– terminating the drug regimen too soon


• Social 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 Errors

• Possible 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


• omission error: a prescribed dose is not given• wrong 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 physician• wrong 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


• Errors can be classified by what causes the failure of the desired result

• Errors can be categorized within three basic definitions of failure:– human failure

– technical failure

– organizational failure


• Human failure is a failure that occurs at an individual level– pulling 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 therapy

• Technical 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


• Organizational failure is a failure because of organizational rules, policies, or procedures– a policy or rule requiring preparing drugs in an

inappropriate setting

Visit the Veterans Administration (VA) National Center for Patient Safety Web site for a glossary of patient safety terms

http://www.patientsafety.gov/glossary.html

Root Cause Analysis of Medication Errors

• Root 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 error

– determine what type of failure the potential error may be

– create a list of specific potential causes


• Identifying specific potential causes allows a person to take specific actions to prevent the potential error

• Actions taken improve the quality of work being done• Common causes of medication error by handlers and

preparers include:– assumption error

– selection error

– capture error


• assumption error: an essential piece of information cannot be verified and is guessed or presumed– misreading an abbreviation on a prescription

• selection error: two or more options exist, and the wrong option is chosen – using a look-alike or sound-alike drug instead of prescribed

drug

• capture error: focus on a task is diverted elsewhere and an error goes undetected– something captures the person’s attention, preventing the

person from detecting the error or causing an error to be made


• To 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


Maintaining focused attention when filling prescriptions is important to avoid errors.

Discussion

What are some ways to reduce each category of error?

Discussion

What 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 Remember

• medication error• omission error• wrong dose error• extra dose error• wrong dose form error• wrong time error• human failure

• technical failure• organizational failure• root cause analysis• assumption error• selection error• capture error

Prescription-Filling Process in Community and Hospital Pharmacy Practice

• Review for potential causes of medication error begins with outlining work tasks in a step-by-step manner

• Each step in this process can be a– source of medication error

– place where pharmacy personnel can correct a medication error

• In the hospital setting medications pass through an extra set of hands—the nurse’s—before reaching the patient – an extra opportunity to prevent medication errors

– an additional source of potential medication errors

• Each 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



Each 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


Step 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 process

• Legibility: Can you read and understand it? – any unclear information should be clarified before any

further action is taken


Careful review of the prescription or order is very important.

Prescription-Filling Process Step 1

• Validity: Is the prescription valid?– requirements may vary from state to state

• every 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


Outdated prescriptions should not be filled.

Prescription-Filling ProcessStep 1

• Patient 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 included

• Physician information: Is it sufficient to determine that a licensed prescriber wrote the prescription? – contact information should be included

– no prescription or medication order is valid without the signature of the prescriber


A prescriber’s signature is required for a prescription to be considered valid.


• Medication information should include:

– drug name – route of administration

– strength – refills or length of therapy

– dose – directions for use

– dose form – dosing schedule


• Prescribing errors include: – poor handwriting

– using nonstandard abbreviations

– confusing look-alike and sound-alike drug names

– wrong drug

– using “as directed” instructions


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.


• Opportunities for medication errors increase with the number of medications a patient takes– common 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


Check the patient profile for existing allergies or possible drug interactions.


Step 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

• Concentration and focus are very important– prescription information should be compared with choices

from the computer menu

• Does 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 prescription


Check the Institute for Safe Medication Practices Web site for dangerous abbreviations or dose designations


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


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 process

• Cross-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 information

– Is 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 labels

– similarities in brand or generic names

– similar pill shapes or colors

• Use NDC numbers, drug names, and other information to verify selection of the correct product– use both the original prescription and the generated label

when selecting a manufacturer’s drug product from the storage shelf

– use NDC numbers as a cross-check


• Accidental substitution of one drug or ingredient for another is one of the most serious events that can occur in pharmacy practice

• Most pharmacy practices possess a computer-based “pill identification” program and use a shelf labeling system to organize inventory– visual 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 errors– write out the calculation and have a second person check

the answer

• Take care when reading labels and preparing compounded products


• Medication errors may occur when– using more than one container of product

– preparing more than one product at a time

– distractions and interruptions intrude

• All equipment should be maintained, cleaned, and calibrated on a regular basis– potential for serious harm to a patient if the residue or dust

from an allergy-causing medication contaminates the patient’s prescription

– cleaning the counting tray with alcohol after each drug is dispensed is recommended


When compounding, do not allow interruptions and prepare products one at a time.


• Caution 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 label– coordinate with patient information handouts

– should be included with prescription labeling

Prescription-Filling ProcessStep 6: Review and Approve Prescription

• The pharmacist must be the one to review and approve the prescription– verifies 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


• Determine what information and resources are important – ask whether the information provided with the medication

filled allows the pharmacist to retrace the technician’s steps in filling the prescription

– Can the pharmacist determine whether prescription is valid, patient information is accurate, and medication correctly prepared from information provided with the finished product?


The pharmacist must always check the technician’s work.

Prescription-Filling ProcessStep 7: Store Completed Prescription

• Ensuring the integrity of medication is an important part of medication safety

• Many medications are sensitive to light, humidity, or temperature– failure to properly store medications may result in loss of

drug potency or effect

– improper storage of a drug may result in a degraded product that causes serious harm

• Well-organized and clearly labeled storage systems help to keep a patient’s 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 patient

• Verify prescription information against knowledge and expectations of patient or caregiver

• Comparing completed prescription against information provided by patient allows a final opportunity to capture potential errors


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


• In hospitals, medication is ultimately received by the nurse– an 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


• Ask whether – the nurse knows about the medication

– medications delivered were all they were expecting

• If a drug is missing from the drug therapy combination, treatment is incomplete– incomplete therapy is also a medication error

Discussion

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

Discussion

What 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 failure

– using available resources to verify information given or decisions made

• Drug identification is the most common error in dispensing and administration


• Pharmacy technicians “own” a substantial portion of the prescription-filling process– first to examine a prescription submitted for filling

– last to handle medication before it reaches the patient

• Pharmacy technicians have the most opportunities to prevent medication errors – can identify potential sources of error beyond prescription

dispensing

– interact with a patient or nurse when a prescription comes in or goes out of the pharmacy


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


• Many medication errors occur during prescribing and administration

• Prescribers are responsible for ensuring the “five Rs” or five rights– the right drug – for the right patient – at the right strength – given by the right route – administered at the right time


• 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 medications– other associated medications are correct – correct drug is dispensed– correct dose is prepared– correct route of administration is indicated– appropriate dose form is prepared – correct administration times– correct conditions for administration are met

Patient Education

• Patients and caregivers must have necessary knowledge to administer, handle, and support safe medication use

• Pharmacy technicians can encourage patients to – ask questions

– relay complete medical and allergy history

– check medications for information on administration

• Pharmacy technicians should be actively involved in monitoring for potential errors

Patient Education

• Pharmacy technicians cannot instruct patients but can– encourage patients to become informed about their

conditions

– encourage patients to ask the pharmacist questions about prescribed medications

– assist patients in becoming more informed

– empower them to be advocates for their own safety and health

Patient Education

Patients should understand ten key pieces of information about every medication:

1) what the brand and generic names are

2) what the medication looks like

3) why they are taking the medication, and how long they will have to take it

4) how much to take, how often, and the best time or circumstances to take a medication

5) what to do if they miss a dose

Patient Education

6) medications or foods which interact with what they are taking

7) whether new medication is in addition to or replaces medication currently taken

8) common side effects and what to do about them

9) special precautions for each particular drug therapy

10) where and how to store the medication

Innovations to Promote Safety

• The physical pharmacy work setting can have a major contribution to the overall safety of any work environment

• Automate and bar code all fill procedures• Maintain a clean, organized, orderly work area• Provide adequate storage areas• Encourage prescribers to use common

terminology and only safe abbreviations• Provide adequate computer applications and

hardware


• Innovations can minimize possibility of errors• In community pharmacy, redesigned packaging helps

patients take medication safely– Target ClearRx packaging helps patients manage their

medications• colored rings help patients identify medications intended for

each family member

• clear, easy-to-read label for patient administration instructions and cautions

• includes a pullout patient information card or printout

Learn more about the Target label design


• In hospital pharmacy, integrated computerized filling systems allow institutions to– improve efficiency

– redirect resources


• When a pharmacist is actively involved in medication decisions, safety and outcomes for patients are substantially improved– technologic 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 McKesson’s technologies

http://www.mckesson.com/

Discussion

What can a pharmacy technician do to prevent medication errors?

Discussion

What 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 Systems

• The first step in prevention of medication errors is collection of information

• Fear of punishment is a concern with errors– people may decide not to report an error at all

– allows the same error to occur again and again

• Anonymous (no-fault) reporting systems have been established– focus on fixing the problem, not fixing the blame

State Boards of Pharmacy

• More than 20 states have mandatory error-reporting systems– most 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 punishment

– most boards of pharmacy will not punish pharmacists for errors


• Pharmacy 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 place– commonly the task of the pharmacist


• The circumstances leading to the error should be explained completely and honestly

• Patients should understand – the nature of the error

– what if any effects the error will have

– how they can become actively involved in preventing errors in the future

• People are more likely to forgive an honest error

Joint Commission on Accreditation for Healthcare Organizations

• Organizations can create a centralized point through which all members may channel error information safely

• The 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 Organizations

• When 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 cause

– monitor the changes made

– determine whether the cause of the error is eliminated

• Accreditation of hospitals depends on demonstrating an effective active error–reporting system

Learn more about the Joint Commission International Center for Patient Safety

United States Pharmacopeia

• The United States Pharmacopeia (USP) supports two types of reporting systems for the collection of medical errors and adverse drug reactions– Medication Errors Reporting Program– MEDMARX


• The 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


• Both 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

http://www.usp.org/patientSafety/

Food and Drug Administration

• Food 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


• FDA 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 market– often safety risks may be reduced or eliminated by

• improving of prescribing information

• education of healthcare professionals or the public

• name change


The FDA provides an adverse event reporting form

Get an adverse event reporting form

http://www.fda.gov/medwatch/getforms.htm

Institute for Safe Medication Practices

• The Institute for Safe Medication Practices (ISMP)– non-profit healthcare agency

– comprised 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 program– MERP (Medication Errors Reporting Program)

Visit ISMP


• Errors reported through MERP include: – wrong drug, strength, or dose

– confusion over look-alike and sound-alike drugs

– incorrect route of drug administration

– calculation or preparation errors

– misuse of medical equipment

– errors in prescribing, transcribing, dispensing, or monitoring medications

• Reports can be completed on-line


• ISMP has – sponsored national forums on medication errors

– recommended addition of labeling or special hazard warnings on potentially toxic drugs

– encouraged revisions in potentially dangerous pharmaceutical advertising

– promoted the use of a zero prior to a decimal number less than 1 on drug doses


• ISMP is active in disseminating information to healthcare professionals and consumers – email newsletter

– journal articles

– videotape training exercises

• ISMP web site posts– FDA Safety alerts

– ISMP Hazard Alerts

Discussion

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

Discussion

Why 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

chapter 12 medication safety chapter 12 topics medical errors medication errors prescription-filling...

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degree medication errors

effect of medical errors

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scope of medical errors

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