Medication Safety

DEFINITIONS:

Drug-related problems (DRPs) – events associated with

drug therapies that can hamper optimal patient health

outcome.

Medication misadventures – incidents associated with

indicated drug therapy resulting in patient harm.

Types of Drug-related problems

Drug-related problems

Medication

Errors

Adverse

Drug

Reactions

Side

Effects

MEDICATION ERRORS - mistakes in the medication use process that may result in

negative outcomes.

Categories:

A. According to their impact on patients

NO ERROR ERROR, NO HARM ERROR, HARM ERROR, DEATH

CATEGORY A:

Capacity to cause error

CATEGORY B:

Error occur, Didn’t reach the

patient

CATEGORY C:

Error occur, Reached the patient

but didn’t cause harm to patient

CATEGORY D:

Error occur, Reached the patient

but cause harm to patient

CATEGORY E:

Error occur, temporary harm to

patient & require intervention

CATEGORY F:

Error occur, temporary harm to

patient & require hospitalization

CATEGORY G:

Error occur, permanent harm

CATEGORY H:

Error occur, Require intervention

necessary to sustain life

CATEGORY I:

Error occur, result to patient’s

death

B. According to where they exist in the medication use system

Administration errors – patients are administered something other

than that prescribe for the patient.

Dispensing errors – mistakes made during the dispensing process.

Prescribing errors – prescriptions have an incorrect drug selection,

dosage form, quantity, route, concentration, rate and instruction for

use of a drug product.

Monitoring errors – failure to review a prescribed regimen for

appropriateness or the failure to use appropriate clinical or

laboratory data for adequate assessment of patient response to

prescribed therapy.

Transcription errors – misinterpretation of prescriptions

Prescribing

Wrong drug

Correct drug, Wrong patient

Wrong dose

Wrong form or route of administration

Error in preparation or calculation

Dispensing & Preparation

Transcribing & Interpretation

Misinterpretation

Omission

Wrong drug, dose, route, time, rate

Administration & Monitoring

Illegible

Wrong patient or drug

Error in drug utilization review

Incorrect handling or storage

Missed dose

Failure to review a prescribed regimen

Consequences

C. According to errors that cause drug-related problems

Error of Commission - patients receives either a correct drug or an

incorrect drug.

Error of Omission - patient failing to receive drugs that can be

beneficial.

Error of Commission

Correct Drug

Sub-therapeutic dosage

Over dosage

Adverse drug reaction

Drug interaction

Improper Drug selected

Drug use without

indication

Untreated indication

Failure to receive

prescribed drug

Incorrect Drug No Drug

Error of Omission

D. According to errors associated with outcome

Negative Outcome

Drug-related morbidity - failure of a drug to achieve its intended health

outcome due to unresolved DRPS.

Sentinel Events – unexpected incidents resulting in death or the

potential for serious physical or psychological injury.

No Negative Outcome

Latent Injury - propensity or predisposition for harm during the process

of care that actually does not result in patient injury.

Potential Injury – mistakes in prescribing, dispensing, or medication

administration that have the potential to cause injury but did

not.

Drug Related Problems

ERROR

Negative Outcome

NO ERROR

No Negative Outcome

Latent Injury

Potential Injury

Drug related morbidity

ADVERSE DRUG REACTIONS (ADRs) – DRPs that are unexpected, unintended,

undesired, or excessive responses to a drug that require some type of

medical response or resulting in a negative outcome.

Allergic reactions – immunologic hypersensitivity to drugs

Idiosyncratic reactions – abnormal responses drugs that are

peculiar to individual.

Adverse drug events (ADEs) – ADRs that result in an injury due to the

use or lack of intended use of a drug.

SIDE EFFECTS – well-known reactions that require little or no change in

patient management. They are no ADRs

PREVENTING MEDICATION ERRORS

INSTITUTE OF MEDICINE

Involve patient in medication use process

Consumer-oriented medication

Access to patient information

Improved medication labeling

Improved Health information technology

Increased congressional funding

Active health care payers

PREVENTING MEDICATION ERRORS

RECOMMENDATION TO PHARMACIST

Keep up with medication literature

Verify accuracy of prescription

Verify patient’s identity

Engage patient in managing their own medication

Educate patient in preventing medication errors

Electronic prescribing should be used.

Trivial warnings should be avoided

Improved prescription filling technology

Monitor patients for high risk of side effects

Review patient medication

CULTURE OF SAFETY

Culture of Safety - exist where safety is the key element of everyone’s job.

MODELS OF QUALITY IMPROVEMENT

Status quo is unacceptable

Safety can be enhanced by improving the core process of medication use

process.

Safety efforts must be patient centered

Quality must be measured

Solutions to safety problems should address the system, not individuals

MODELS OF QUALITY IMPROVEMENT

PDSA Cycle of Safety Improvement

PLAN – Clarify the purpose of the quality improvement effort.

DO – Implementation is done in a small scale to allow adjustment to the plan as

experienced with the problem gained .

STUDY – “check”; studies the effect of the change on safety measure.

ACT – a new goal is established that further improves the safety of patient within

the medication use process.

MODELS OF QUALITY IMPROVEMENT

Measures of Health Care Quality - Donabedian sated that quality measures can

be divided into the following categories:

STURCTURES – These are measures of the presence of something that is

reasonably associated with quality.

PROCESSES – These are actions reasonably associated with quality such

as the checking of patient medication profiles prior to dispensing, double

checking technician work and electronic prescribing.

OUTCOME – the quality of safety systems needs to be assessed by their

impact on patient health outcomes.

MONITORING, REPORTING & COMMUNICATING

ADR- Monitoring and Reporting Programs

Based on reports of suspected ADRs by health professionals.

Monitor for alerting orders (prescription which alert pharmacists that an

ADR may have occurs and that an investigation needs to be

conducted)

a. Traces drugs use to treat ADRs

b. Discontinuation or decrease in dosage of drug

c. Stat orders for laboratory assessment of therapeutic drug levels

MONITORING, REPORTING & COMMUNICATING

Medication Reconcillation – is a process of resolving discrepancies with what a

patient has been taking in the past with what the patient should be taking at

the moment.

STEPS:

1. Verification – most up-to-date medication

2. Clarification – medication and dosage are checked for

appropriateness.

3. Reconciliation – Clinical decisions are then made based upon a

comparison of newly prescribed medication.

4. Transmission – Therapy changes are communicated to those

people who need to know about the changes.

NATIONAL QUALITY ORGANIZATION

The Institute of Medicine (IOM)

Institute for healthcare Improvement (IHI)

National Quality Forum (NQF)

The Leapfrog Group

The Joint Commission

Centers for Medicare and Medicaid Services (CMS)

Agency for Healthcare Research and Quality (AHRQ)

National Committee for Quality Assurance (NCQA)

American Society of Health-System Pharmacy (ASHP)

Pharmacy Quality Alliance (PQA)