Medication Safety
Lobna AL Juffali
Objectives
 To know Medication Safety Terminology.
 To Understand the relationship between medication
errors, adverse drug events & adverse drug reactions
 To Know the Types of Medications Errors.
 To understand Latent Failures & Barriers That
Contribute to Medication Errors.
 Recommendations to Prevent Medication Errors.
 Monitoring & Managing Medication Errors.
 the role of pharmacist in medication safety including
pharmacovigilance & SFDA pharmacists
responsibilities
Medication misadventure
 is a very broad term.
 It refers to any iatrogenic hazard or incident
associated with medications.
 A medication misadventure may or may not cause an
injury to a patient .
Medication misadventure
Adverse Drug Events (ADEs): An ADE is the next
broadest term. It refers to any injury caused by a
medicine. An ADE refers to all ADRs, including
allergic or idiosyncratic reactions, as well as
medication errors that result in harm to a patient.
 Adverse Drug Reactions (ADRs) :refer to any
unexpected, unintended, undesired, or excessive
response to a medicine. Drug-drug interactions can
also fall into the category of ADRs.
 A MEDICATION ERROR is any preventable event that
has the potential to lead to inappropriate medication
use or patient harm.
Medication Misadventure
ADEs
ADRs
Medication errors
Medication Misadventure
Medication Errors
Medication errors cause at least one death every day and injure approximately
1.3 million people annually in the United States.
Medication errors can occur anywhere
Prescribing
Repackaging
Administration
Dispensing
Monitoring
Errors are not the result of an individual failure, but
of a systems failure.
Definition
 “Any preventable event that may cause or lead to
inappropriate medication use or patient harm while
the medication is in the control of the health care
professional, patient, or consumer.
Types of Medication Error
Types of Medication Error Cont’d
Prescribing Error
Incorrect drug selection (based on indications, contraindications,
known allergies, existing medication therapy, and other factors),
dose, dosage form, quantity, route, concentration, rate of
administration, or instructions for use of a medication product
ordered or authorized by Physician
Omission Error
The failure to administer
an ordered dose to a patient
before the next scheduled dose, if any.
Types of Medication Error Cont’d
Wrong Time Error
Administration of medication outside a pre-defined time interval
from its scheduled administration time.
Improper Dose Error
Administration to the patient of a dose that
is greater than or less than the amount
ordered by the prescriber or administration
of duplicate doses to the patient.
Example: one or more dosage units in addition
to those that were ordered.
Types of Medication Error Cont’d
Wrong Medication - Preparation Error
Medication product incorrectly formulated or
manipulated before administration.
Wrong Administration Technique Error
Inappropriate procedure or improper
technique in the administration of a medication.
Example: wrong route/site or rate
of administration
Types of Medication Error Cont’d
Monitoring Error
Failure to review a prescribed regimen for appropriateness and detection of
problems, or failure to use appropriate clinical or laboratory data for
adequate assessment of patient response to prescribed therapy.
Compliance Error
Inappropriate patient behavior regarding
adherence to a prescribed medication regimen.
Other Medication Error
Any medication error that does not fall into
one of the above pre-defined categories.
Factors that contribute to Medication
Errors
• Incomplete information about the patient.
• Unclear communication of medication order:
Example; verbal & telephone order - inherently problematic: Different accents and dialects.
- Background noise, interruptions and distractions.
- Limited short-term memory capacity.
- Unfamiliar terminology and medications.
- Spell out 1- 5 for 15 [confused with 50].
No telephone orders for: Chemotherapeutic Medications, Parenteral
Nutrition, Initiation of Epidural Medications, Initiation of
PCA/Narcotic Drips, Initiation of Parenteral Vasopressor Agents
and Initiation of Parenteral Skeletal Muscle Relaxants.
Factors that contribute to Medication
Errors Cont,d
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Lack of unit dose system.
Lack of independent check before dispensing.
Lack of computer warning about excessive dose.
Ambiguous medication references.
Conflicting requirements for staff competency.
Warning not placed prominently on syringe.
Environmental factors (stress, noises…etc).
Medication storage stock standardization and
distribution.
 Device acquisition and use.
 Lack of patient education.
Barriers:
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Failure to create a culture to report medication errors.
The level of patient education and literacy.
Educational support deficit for the staff.
Lack of interdisciplinary collaboration and
communication.
 The absence of front-line staff in sharing decisionmaking and system design.
 Failure to use an effective system and technology
(poorly designed: order forms, medication packaging,
& storage facility).
Most Frequent Serious Medication
Errors Occur With:
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Insulin
Infusion Devices
Patient Controlled Analgesia (PCA)
Parenteral Narcotics
Anticoagulants (Heparin, Warfarin)
Cancer Chemotherapy
Neuromuscular Blockers
Conscious (Procedural) Sedation
Concentrated Electrolytes (potassium, magnesium
and phosphate)
Recommendations to Prevent
Medication Errors Cont’d
 Accept that errors will occur; slips, lapses and mistakes
will happen.
 Redesign the system.
 Focus on the system, not the people.
 Everyone is involved in safety (individual practitioners
& organizational leadership).
 Make the medication errors visible.
 Minimize the consequence of medication errors.
 Report, analyze and share medication error incidents.
 Promote a Culture– in reporting medication errors.
Recommendations to Prevent
Medication Errors
 Adopt a system-oriented approach to medication error
reduction such as: (time-out, & technology
confirmation).
Use technology effectively such as:
- Implement Computerized Physician Order Entry
(CPOE).
- Use of Automated Dispensing Cabinets.
- Use of Pharmacy Dispensing Robotics.
- Use of Barcoding in medication and patient
identification.
- Use of Smart Infusion Pumps.
Recommendations to Prevent
Medication Errors Cont’d
 Implement a unit dose system.
 Have the Pharmacy supply High-Alert intravenous
medications and Do Not store concentrated
electrolytes solutions (potassium, magnesium, and
phosphate) on patient care units.
 Use special procedures and written protocols for the
use of High-Alert Medications.
 Ensure the availability of Pharmacist during patient
care rounds.
Recommendations to Prevent
Medication Errors
 Make relevant patient information available at the
point of care.
 Improve patient knowledge about treatment.
 separate storage areas, color differentiation, and
change products.
A New Way of Thinking in Medication
Safety:
Hierarchy of Effectiveness to Prevent Medication
Errors:
Monitoring Medication Errors:
 Ongoing quality improvement programs for
monitoring medication errors are needed. Medication
errors should be identified and documented and their
causes studied in order to develop systems that
minimize recurrence.
 Several error monitoring techniques exist: (e.g.
anonymous self-reports, incident reports, critical
incident technique and disguised observation audits).
High Alert Medications
Definition:
Medication that have a higher likelihood of causing
injury if they are misused. Errors with these
medications are not necessarily more frequent – just
that their consequences may be more devastating.
High Alert Medications Classes/
Categories List:
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Adrenergenic agonists (e.g., Epinephrine, Phenylephrine,
Norepinephrine)
 Adrenergenic antagonists (e.g., Propranolol, Metoprolol,
Labetalol)
 Anesthetic agents, general, inhaled, and IV (e.g., Propofol,
Ketamine)
 Antiarrhythmic, IV (e.g., Lidocaine, Amiodarone)
High Alert Medications Classes/
Categories List:
 Cardioplegic solutions
 Chemotherapeutic agents, parenteral and oral
 Dextrose hypertonic, 20% or greater
 Dialysis solutions, peritoneal and hemodialysis
 Epidural or Intrathecal medications
 Hypoglycemics, oral
 Inotropic medications (e.g., Digoxin, Milrinone)
 Liposomal forms of drugs (e.g., Liposomal Amphotericin B)
High Alert Medications Classes/
Categories List:
 Moderate sedation agents, IV (e.g., Midazolam)
 Moderate sedation agents, oral, for children (e.g., Chloral
Hydrate)
 Narcotics / Opiates, IV, transdermal, and oral (including liquid
concentrates, immediate and sustained-release formulations)
 Neuromuscular blocking agents (e.g., Succinylcholine,
Rocuronium, Vecuronium)
High Alert Medications Classes/
Categories List:
 Antithrombotic agents (anticoagulants), including Warfarin,
Low- Molecular-Weight Heparin, IV Unfractionated Heparin,
Factor Xa Inhibitors (Fondaparinux), Direct thrombin inhibitors
(e.g., Argatroban, Lepirudin, Bivalirudin), Thrombolytics (e.g.,
Alteplase, Reteplase, Tenecteplase) and Glycoprotein IIb / IIIa
Inhibitors (e.g., Eptifibatide)
 Radiocontrast agents, IV
 Total parenteral nutrition solutions
Look-Alike Medications:
 These refer to names of medications, which due to
their spelling, may look similar to other
medications’ names, and the
distribution/administration of these medications may
be prone to errors. Also refer to product
labeling/packaging.
Example
Prozac ® and Proscar®
Sound-Alike Medications:
 These refer to names of medications, which due to
their pronunciation, may sound similar to other
medications’ names, and the
distribution/administration of these medications may
be prone to errors.
Example
Dianben ® and Diovan®
The Impact of the problem:
 Many medication names can look or sound like other
medication names, which may lead to potentially
harmful medication errors.
 Health care providers and organizations need to be
aware of the role medication names play in medication
safety.
 Sound-alike, look-alike medications account for an
estimated 25- 30% of medication errors.
 With tens of thousands of medications currently on
the market, the potential for error due to confusing
medication names is significant.
Causes of the problem:
 ILLEGIBLE handwriting.
 Incomplete knowledge of medication names, newly available
products.
 Similar clinical use.
 Similar packaging, labeling or dosage forms.
 Similar strengths and frequency of administration.
 The failure of manufacturers and regulatory authorities to
recognize the potential for error, both for nonproprietary and
brand names, prior to approving new product names. (e.g.,
LOSEC vs. LASIX).
General Recommendations for Preventing
Medication Name Mix-ups:
 Maintain awareness (e.g. FDA).
 Insure update of IT Systems (e.g, Computer systems,
Smart Pumps, Automated Distribution Cabinets, etc.)
to incorporate safety measures.
 Annual review of anything related to medication
process.
 Consider the possibility at time of Formulary addition.
General Recommendations for Preventing
Medication Name Mix-ups:
 Several preventative strategies exist to help reduce the
chance of these errors, one of which is Tall Man
Lettering.
- Examples of Tall Man Lettering:
Chlorpromazine …ChlorproMAZINE
Chlorpropamide ... ChlorproPAMIDE
 Store in different locations in pharmacies and patient
care units.
 Involve patients and their caregivers.
General Recommendations for Preventing
Medication Name Mix-ups:
 Develop strategies to overcome illegible prescribing:
- Printing (NOT writing) of medication names and dosages.
- Computerize prescribing.
- Preprinted orders or prescriptions as appropriate.
- Indication for use to be included on the prescription.
 Encourage reporting of errors.
 Implement Policies which:
 Minimize verbal and telephone orders.
 Continue to employ independent double checks in the dispensing
and administration processes.
 Barcoding, Automated Distribution Cabinets and Robotics.
Important Reminder!!
 Medication Names Should be Written In Full
 Abbreviations Are Not Permitted
 The listed recommendations are applied to all orders and all
medication related documentation (e.g., handwritten or on preprinted forms).
 They should never be used in medical documentation.
 Place adequate space between the full medication name, dose
and unit of measure.