Pharmacoeconomics and Safe Medication Use

the description and analysis of the costs of drugs and pharmaceutical services as well as their effects on individuals, health care systems, and/or society.

charges are actually costs (also termed expenses) plus profit

Costs associated with prevention, detection, or treatment of a disease or illness

Costs as a result of disease or illness that do not involve the purchase of medical services

Costs associated with morbidity or mortality, related to change in productivity as a result of disease or illness

Costs associated with nonfinancial outcomes of disease

Additional costs to purchase additional benefit or effect of medical care

costs that remain constant and are not dependent on volume of use

costs depend on volume of use

Compares only cost (i.e., no effectiveness) of two or more treatments or services

Both costs and outcomes are measured in monetary units

Costs are measured in monetary terms, whereas outcomes are measured in units of effectiveness.

the additional cost to the next most effective intervention producing another unit of output.

the outcomes are virtually identical (e.g., effectiveness) except for costs

Should not be used if no evidence supports the therapeutic equivalence of the treatment alternative

outcome is expressed with respect to patient preferences, quality of life, or quality-adjusted life-years (QALYs)

Direct approaches include rating scales, time trade-off (acute and chronic conditions), and standard gamble (acute and chronic conditions).

Indirect approaches include multi-attribute health state scores (e.g., quality-of-life assessment tools).

the life-years gained is determined and then multiplied by the utility of that life-year.

Cost analysis (partial evaluation)

Formulary management to determine whether newly marketed or approved medications should be included/excluded with/without use criteria that may affect prescribing patterns

a higher chance of being administered a high-risk medication and the potential for altered response to medications because of altered pharmacokinetics and organ failure.

Mishaps that occur during the medication use process (e.g., reconciling, prescribing/ordering, transcribing, dispensing, administering, monitoring)

Medication errors that are intercepted and stopped before they occur

No error – Scenarios that can cause error

An error occurred but did not reach the patient

An error occurred and reached the patient but did not cause harm

An error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient or required intervention to prevent harm

An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention

An error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization

An error occurred that may have contributed to or resulted in permanent patient harm

An error occurred that required intervention necessary to sustain life

An error occurred that may have contributed to or resulted in the patient’s death

Injuries resulting from use of a drug

ADE is the broader term used to describe any harmful event associated with a medication, including inappropriate use such as an overdose, whereas ADR is used when an adverse response, including harm, occurs with normal use of the medication.

A preventable ADE occurs when a breach of standard professional behavior, practice, or technique was identified or when necessary precautions were not taken

About 30%–50% of all ADEs are preventable.

ADEs not associated with a medication error and are unintended reactions without known mitigation strategies resulting in patient harm

any response to a drug which is noxious and unintended, and which occurs at doses normally used for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.

according to the WHO definition, therapeutic failures are an unintended effect and an ADR, whereas according to the definition by Karch and Lasagna, they are not.

the patient outcome is death, life threatening (real risk of dying), hospitalization (initial or prolonged), disability (significant, persistent, or permanent), congenital anomaly, or required intervention to prevent permanent impairment or damage.

a postmarking surveillance tool for medications and biologics.

identifying potential signals for adverse events associated with vaccines licensed for use within the United States.

A comprehensive ADE program should have a policy and procedure, with guidelines for ADE detection, reporting, management, surveillance, and education.

a proactive, structured method to identify potential failure points within a system that may lead to an ADE.

a structured method to determine why an ADE occurred (i.e., retroactive)

the specific medication that caused the allergy, the type of reaction, and when the allergy occurred

recorded in the electronic medical record and maintained in the record indefinitely.

increasing the number of alerts may result in decreased attention to interacting with the alerts.

events are grossly underreported.

drugs that are routinely prescribed to treat ADEs, such as antidotes, or physiologic antagonists or agents for gastric decontamination.

Naranjo criteria for causality determination

temporal sequence, dechallenge (removal of the suspect drug), rechallenge (reintroduction of the suspect drug), evaluation of other causes, objective evidence that is available or obtained, and history of a reaction to a similar drug.

capturing medication administration errors that are not typically identified with other detection methods.

if an individual is aware of being observed, the individual may change behavior to be “optimal” (i.e., the “Hawthorne effect”).

quality of evidence: A = high to D = very low; strength of recommendation: 0 = no recommendation, 1 = strong, 2 = weak

Guidelines suggest implementing computerized provider order entry to decrease medication errors and preventable ADEs (2B).

Guidelines suggest using CDS systems to decrease the number of medication errors and ADEs (2C).

Guidelines suggest using protocols\/bundles to reduce medication errors/ADEs (2B).

Guidelines recommend compliance with safe medication concentration practices (e.g., premade mixes, standardized medication concentrations within institution) to reduce the number of medication errors and potential ADEs (1B).

Guidelines suggest use of medication labeling practices (e.g., tall man lettering) for sound-alike look-alike drugs to reduce medication errors (2B).

Guidelines suggest use of bar code medication administration (BCMA) to reduce medication errors and/or ADEs in the ICU (2C).

Guidelines suggest smart intravenous infusion pumps be used to reduce the rate of medication errors and ADEs (2C).

Guidelines recommend use of direct observation as an active medication surveillance system to identify the medication errors (1A).

Guidelines suggest targeted chart review to increase ability to detect ADEs compared with voluntary reporting (2B).

When the effects of one drug can be changed by the presence of another substance

A documented drug interaction with known outcomes can be considered a medication error, a preventable ADE, or an ADR, depending on clinical context.

Drug-drug interaction alert fatigue can be managed by reducing the alert number, using severity or tiering of the interaction as a criterion for alert selection.

a temporal relationship, consideration of the pharmacologic properties of the object and precipitant drug, patient factors and disease states, the possible contribution of other drugs, and, when possible, a positive dechallenge.

ADE nomograms such as the Naranjo nomogram are designed to evaluate ADEs, not drug-drug interactions

The drug interaction probability scale may be used to determine drug-drug interaction causation

develop and approve the criteria for selecting medications into the drug formulary.

medications with known significant safety concerns (e.g., birth defects, hepatotoxicity)

Cost acquisition and total cost of care: This is a good application of the budget impact analysis.

The P&T committee is responsible for maintaining the drug formulary and ensuring that new medications that can improve patient care are reviewed for formulary inclusion.

Prospective double-blind randomized controlled trials should have greater weight than retrospective cohort and case-control studies

Case reports should be used only when no other evidence is available.

appropriate CDS such as dosing and recommended monitoring, as well as information on formulary restrictions.

preferably within 3–6 months and again in 1 year.

Effectiveness is the use of a drug in the real-world setting outside a randomized controlled trial

All drugs on the formulary within a class should be assessed annually or more often when there is an important change in prescribing information, when a landmark trial or publication affects the drug’s use, or when new FDA label-approved agents are available within the drug class.