Medication errors Medication errors Adverse drug events (ADEs)Adverse drug events (ADEs)

Adverse drug reactions Adverse drug reactions (ADRs)(ADRs)

Medication misadventures Medication misadventures

Pharmacists play a pivotal role in the Pharmacists play a pivotal role in the medication use process. Throughout this medication use process. Throughout this process there is potential for unexpected process there is potential for unexpected adverse events, including errors in adverse events, including errors in prescribingprescribing, , dispensingdispensing, and , and administeringadministering medications, medications, idiosyncratic idiosyncratic reactions, and reactions, and other other adverse effectsadverse effects. These events can all . These events can all be described as be described as medication medication misadventuresmisadventures. .

Pharmacists need to understand the Pharmacists need to understand the potential for various medication potential for various medication misadventures and be prepared to misadventures and be prepared to recognize and prevent such occurrences recognize and prevent such occurrences and minimize adverse outcomes.and minimize adverse outcomes.

All adverse drug events (ADEs), adverse All adverse drug events (ADEs), adverse drug reactions (ADRs), and medication drug reactions (ADRs), and medication errors fall under the umbrella of errors fall under the umbrella of medication misadventures.medication misadventures.

An ADE is the next broadest term. It An ADE is the next broadest term. It refers to any injury caused by a medicine.refers to any injury caused by a medicine.

An ADE refers to all ADRs, including An ADE refers to all ADRs, including allergic or idiosyncratic reactions, as well allergic or idiosyncratic reactions, as well as medication errors that result in harm as medication errors that result in harm to a patient. to a patient.

ADRs Medication errors

Medication Misadventure

ADEs

Medication Misadventure

ADRs refer to any unexpected, ADRs refer to any unexpected, unintended, undesired, or excessive unintended, undesired, or excessive response to a medicine.response to a medicine.

Drug-drug interactions can also fall into Drug-drug interactions can also fall into the category of ADRs.the category of ADRs.

A medication error is any preventable A medication error is any preventable event that has the potential to lead to event that has the potential to lead to inappropriate medication use or patient inappropriate medication use or patient harm. harm.

A landmark study in 1995 estimated that A landmark study in 1995 estimated that ADE-related costs were $76.6 billion ADE-related costs were $76.6 billion annually in ambulatory patients alone.annually in ambulatory patients alone.

Drug expenditures in ambulatory patients Drug expenditures in ambulatory patients at that time were $80 billion per year. This at that time were $80 billion per year. This means that for every $1 spent for a drug, means that for every $1 spent for a drug, almost $1 was also being spent due to a almost $1 was also being spent due to a drug-related problem. drug-related problem.

A 2000 update to these figures indicates A 2000 update to these figures indicates that the problem is not improving. that the problem is not improving.

About a third of these events are thought to be About a third of these events are thought to be preventable preventable

Efforts to minimize medication misadventures Efforts to minimize medication misadventures depend heavily on individual health care depend heavily on individual health care practitioners, including pharmacists, physicians, practitioners, including pharmacists, physicians, and nurses.and nurses.

Multiple studies have highlighted the impact Multiple studies have highlighted the impact individual pharmacists can have on minimizing individual pharmacists can have on minimizing medication misadventures and improving medication misadventures and improving outcomes.outcomes.

In one of the most significant studies, published in In one of the most significant studies, published in the the Journal of the American Medical AssociationJournal of the American Medical Association, , pharmacists participating in hospital rounds in an pharmacists participating in hospital rounds in an intensive care unit decreased prescribing errors by intensive care unit decreased prescribing errors by 66% and saved an estimated $270,000 per year. 66% and saved an estimated $270,000 per year.

Adverse Drug ReactionsAdverse Drug Reactions

All medications, including the excipients of All medications, including the excipients of a product, are capable of producing adverse a product, are capable of producing adverse effects. effects.

The WHO defines an ADR as "any noxious or The WHO defines an ADR as "any noxious or unintended response to a drug that occurs unintended response to a drug that occurs at doses usually used for prophylaxis, at doses usually used for prophylaxis, diagnosis, or therapy of disease or for the diagnosis, or therapy of disease or for the modification of psychological function." modification of psychological function."

Classification of ADRsClassification of ADRs

Minor:Minor: No antidote, therapy, or prolongation of No antidote, therapy, or prolongation of hospitalization is required. hospitalization is required.

Moderate:Moderate: Requires a change in drug therapy, Requires a change in drug therapy, specific treatment, or an increase in specific treatment, or an increase in hospitalization by at least 1 day. hospitalization by at least 1 day.

Severe:Severe: Potentially life-threatening, causing Potentially life-threatening, causing permanent damage, or requiring intensive permanent damage, or requiring intensive medical care. medical care.

Lethal:Lethal: Directly or indirectly contributes to the Directly or indirectly contributes to the death of the patient.death of the patient.

Mechanism of Adverse Drug Mechanism of Adverse Drug ReactionsReactions

Hypersensitivity:Hypersensitivity: A reaction, not explained by the A reaction, not explained by the pharmacologic effects of the drug, caused by altered reactivity pharmacologic effects of the drug, caused by altered reactivity of the patient and generally considered to be an allergic of the patient and generally considered to be an allergic manifestation. manifestation.

Intolerance:Intolerance: A characteristic pharmacologic effect of a drug A characteristic pharmacologic effect of a drug produced by an unusually small dose, so that the usual dose produced by an unusually small dose, so that the usual dose tends to induce a massive overaction. tends to induce a massive overaction.

Drug interaction:Drug interaction: An unusual pharmacologic response that An unusual pharmacologic response that could not be explained by the action of a single drug, but was could not be explained by the action of a single drug, but was caused by two or more drugs. caused by two or more drugs.

Pharmacologic:Pharmacologic: A known, inherent pharmacologic effect of a A known, inherent pharmacologic effect of a drug, directly related to dose.drug, directly related to dose.

Idiosyncrasy:Idiosyncrasy: An uncharacteristic response of a patient to a An uncharacteristic response of a patient to a drug, drug,

Reporting Reporting Well-designed programs that monitor ADRs, as Well-designed programs that monitor ADRs, as

well as network information to the medical well as network information to the medical community, are essential. community, are essential.

Surveillance of ADRs makes it possible to detect Surveillance of ADRs makes it possible to detect early signals of a developing problem. This is why early signals of a developing problem. This is why postmarketing surveillance of ADRs is so postmarketing surveillance of ADRs is so important.important.

Postmarketing ADR reporting can cause changes Postmarketing ADR reporting can cause changes in prescribing drugs as well as result in the in prescribing drugs as well as result in the withdrawal of various drugs from the market.withdrawal of various drugs from the market.

Adverse reactions that occur only rarely (e.g., Adverse reactions that occur only rarely (e.g., 1 out of a million) often will not be detected 1 out of a million) often will not be detected until after a drug is approved and used in until after a drug is approved and used in millions of people. Therefore, the FDA relies millions of people. Therefore, the FDA relies on postmarketing information to establish a on postmarketing information to establish a better understanding of adverse eventsbetter understanding of adverse events

Pharmaceutical companies are required by Pharmaceutical companies are required by the FDA to submit quarterly reports of all the FDA to submit quarterly reports of all ADRs for the first 3 years that a drug is on ADRs for the first 3 years that a drug is on the market as part of the postmarketing the market as part of the postmarketing surveillance system. surveillance system.

Medication ErrorsMedication Errors

Errors in the medication use process, Errors in the medication use process, including errors in medication including errors in medication prescribing, dispensing, prescribing, dispensing, administering, and monitoring, are administering, and monitoring, are responsible for 14% of drug-related responsible for 14% of drug-related deaths. deaths.

In the early 1980s, an average of one medication In the early 1980s, an average of one medication error per patient per day was reported.error per patient per day was reported.

A review of medication error-related deaths from A review of medication error-related deaths from 1983 to 1993 has shown an increase from 2876 1983 to 1993 has shown an increase from 2876 deaths in 1983 to 7391 deaths in 1993, a 2.57-fold deaths in 1983 to 7391 deaths in 1993, a 2.57-fold overall increase.overall increase.

Medication error-related deaths in outpatients Medication error-related deaths in outpatients had an 8.48-fold increase and in inpatients there had an 8.48-fold increase and in inpatients there was a 2.37-fold increase during the same period. was a 2.37-fold increase during the same period.

Because the medication use process is Because the medication use process is complex and involves multiple individuals complex and involves multiple individuals representing several health professions representing several health professions and some nonprofessionals, and some nonprofessionals, communication and teamwork among the communication and teamwork among the various professions are a necessity.various professions are a necessity.

Because society perceives Because society perceives pharmacists pharmacists to be responsibleto be responsible for the safe and for the safe and effective use of drugs, however, the effective use of drugs, however, the pharmacy profession needs to take a pharmacy profession needs to take a prominent role in the maximization of prominent role in the maximization of safe medicine use as a core responsibility safe medicine use as a core responsibility of pharmaceutical care. of pharmaceutical care.

Error Type Error Type

1. 1. Prescribing error:Prescribing error: inappropriate drug selectioninappropriate drug selection dosedose dosage form dosage form route of administration.route of administration.

Examples may include ordering duplicate Examples may include ordering duplicate therapies for a single indication, prescribing a therapies for a single indication, prescribing a dose that is too high or too low for a particular dose that is too high or too low for a particular patient, writing a prescription illegibly, patient, writing a prescription illegibly, prescribing an inappropriate dosage interval, or prescribing an inappropriate dosage interval, or ordering a drug to which the patient is allergic. ordering a drug to which the patient is allergic.

In one study, the most common type of prescribing In one study, the most common type of prescribing error (56.1%) was related to an inappropriate dose error (56.1%) was related to an inappropriate dose (either too high or too low).(either too high or too low).

The second most common prescribing error was The second most common prescribing error was related to prescribing an agent to which the patient was related to prescribing an agent to which the patient was allergic (14.4%). allergic (14.4%).

Prescribing inappropriate dosage forms was the third Prescribing inappropriate dosage forms was the third most common error (11.2%). most common error (11.2%).

Other relatively common prescribing errors have Other relatively common prescribing errors have included included failing to monitor for side effects and serum failing to monitor for side effects and serum drug levelsdrug levels, prescribing an , prescribing an inappropriate medicationinappropriate medication for for a particular indication, and inappropriate duration of a particular indication, and inappropriate duration of therapy. therapy.

2. 2. Omission error:Omission error:

An omission error occurs when a An omission error occurs when a patient does not receive a scheduled patient does not receive a scheduled dose of medication.dose of medication.

This is considered to be the second This is considered to be the second most common error in the most common error in the medication use process, behind medication use process, behind wrong time errors. wrong time errors.

3. 3. Wrong time error:Wrong time error: this type of error occurs when a dose is this type of error occurs when a dose is

not administered in accordance with a not administered in accordance with a predetermined administration interval. predetermined administration interval.

Most institutions realize that it is often Most institutions realize that it is often impossible to be totally accurate with impossible to be totally accurate with the administration interval and typically the administration interval and typically 15 to 30 minutes outside that interval is 15 to 30 minutes outside that interval is acceptable. acceptable.

4. 4. Unauthorized drug error:Unauthorized drug error:

This type of error occurs when This type of error occurs when patients receive a drug that was not patients receive a drug that was not authorized by an appropriate authorized by an appropriate prescriber. prescriber.

This might include giving the wrong This might include giving the wrong patient a medication. patient a medication.

5. 5. Improper dose error:Improper dose error:

This type of error is different from This type of error is different from that which occurs when a prescriber that which occurs when a prescriber orders an inappropriate dose of a orders an inappropriate dose of a medication.medication.

This error occurs when the dose This error occurs when the dose administered is different than what administered is different than what was prescribed, assuming that the was prescribed, assuming that the prescribed dose was appropriate. prescribed dose was appropriate.

6. 6. Wrong dosage form error:Wrong dosage form error:

This error is also different from the type This error is also different from the type described in the prescribing error described in the prescribing error section. section.

This error occurs when a patient receives This error occurs when a patient receives a dosage form different from that a dosage form different from that prescribed, assuming the appropriate prescribed, assuming the appropriate dosage form was originally ordered. dosage form was originally ordered.

7. 7. Wrong drug preparation Wrong drug preparation error:error:

When medications require some type When medications require some type of preparation, such as reconstitution, of preparation, such as reconstitution, this type of error may occur.this type of error may occur.

These kinds of errors may also occur These kinds of errors may also occur in the compounding of various in the compounding of various intravenous admixtures and other intravenous admixtures and other products. products.

8. 8. Wrong administration Wrong administration technique:technique:

These errors occur when a drug is These errors occur when a drug is given to a patient inappropriately. given to a patient inappropriately.

An example is when an intravenously An example is when an intravenously administered agent is given at an administered agent is given at an excessive rate or when an agent excessive rate or when an agent meant for intramuscular meant for intramuscular administration is given intravenously. administration is given intravenously.

9. 9. Deteriorated drug error:Deteriorated drug error:

This error occurs when drugs are This error occurs when drugs are administered that have expired or administered that have expired or have deteriorated prematurely due have deteriorated prematurely due to improper storage conditions. to improper storage conditions.

10. 10. Monitoring error:Monitoring error:

These errors occur when patients are not monitored These errors occur when patients are not monitored appropriately either after they have received a drug or appropriately either after they have received a drug or before they received a drug. before they received a drug.

For example, if a patient is placed on warfarin therapy and For example, if a patient is placed on warfarin therapy and adequate blood tests are not performed to assess the adequate blood tests are not performed to assess the patient's response, resulting in a life-threatening patient's response, resulting in a life-threatening hemorrhage, a monitoring error has occurred.hemorrhage, a monitoring error has occurred.

Further, in a community pharmacy, if a pharmacist fails to Further, in a community pharmacy, if a pharmacist fails to review a patient's medication history prior to dispensing a review a patient's medication history prior to dispensing a medication, resulting in a significant drug-drug interaction, medication, resulting in a significant drug-drug interaction, a monitoring error has occurred. a monitoring error has occurred.

11. 11. Compliance error:Compliance error:

This type of error occurs when patients use This type of error occurs when patients use medications inappropriately. medications inappropriately.

Although it may seem that health care Although it may seem that health care professionals have little responsibility here, professionals have little responsibility here, proper patient education and follow-up may play proper patient education and follow-up may play a significant role in minimizing this type of error.a significant role in minimizing this type of error.

This type of error may be a direct result of This type of error may be a direct result of insufficient patient counseling from a dispensing insufficient patient counseling from a dispensing pharmacist, a prescribing physician, or both. pharmacist, a prescribing physician, or both.

Outcome or SeverityOutcome or Severity 1. No error 1. No error

Category A: Circumstances or events that have the capacity to cause Category A: Circumstances or events that have the capacity to cause error.error.

2. Error, no harm 2. Error, no harm Category B: An error occurred, but the medication did not reach the Category B: An error occurred, but the medication did not reach the

patient. patient. Category C: An error occurred that reached the patient, but did not Category C: An error occurred that reached the patient, but did not

cause the patient harm. cause the patient harm. Category D: An error occurred that resulted in the need for increased Category D: An error occurred that resulted in the need for increased

patient monitoring, but caused no patient harm.patient monitoring, but caused no patient harm. 3. Error, harm 3. Error, harm

Category E: An error occurred that resulted in the need for treatment or Category E: An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm. intervention and caused temporary patient harm.

Category F: An error occurred that resulted in initial or prolonged Category F: An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm. hospitalization and caused temporary patient harm.

Category G: An error occurred that resulted in permanent patient harm. Category G: An error occurred that resulted in permanent patient harm. Category H: An error occurred that resulted in a near-death event (e.g., Category H: An error occurred that resulted in a near-death event (e.g.,

anaphylaxis and cardiac arrest).anaphylaxis and cardiac arrest). 4. Error, death 4. Error, death

Category I: An error occurred resulting in patient death.Category I: An error occurred resulting in patient death.

Why Do Errors Occur? Why Do Errors Occur?

Being human, health care Being human, health care professionals of all types have a professionals of all types have a propensity to commit errors propensity to commit errors

: :

1. 1. Lack of communication:Lack of communication:

This factor may also fall under interpersonal This factor may also fall under interpersonal factors listed above. factors listed above.

Failure to communicate among fellow employees Failure to communicate among fellow employees or among health care professionals has frequently or among health care professionals has frequently been named as contributing to medication error. been named as contributing to medication error.

For example, an error may be more likely to occur For example, an error may be more likely to occur if a pharmacist chooses not to clarify unclear if a pharmacist chooses not to clarify unclear physician orders. physician orders.

Poor physician handwriting and verbal orders are Poor physician handwriting and verbal orders are also significant factors. also significant factors.

2. 2. Failure to comply with Failure to comply with policy:policy:

This is a common factor in This is a common factor in dispensing and administering drugs. dispensing and administering drugs.

In one survey, 42 to 46% of In one survey, 42 to 46% of pharmacists said that failing to check pharmacists said that failing to check drugs before dispensing was a drugs before dispensing was a significant factor in dispensing significant factor in dispensing errors. errors.

3. 3. Lack of knowledge:Lack of knowledge: This is a frequently cited factor in the committal of medication This is a frequently cited factor in the committal of medication

errors. errors.

Mistakes, rather than slips, are typically committed as a result of Mistakes, rather than slips, are typically committed as a result of inadequate knowledge. inadequate knowledge.

Placing inexperienced recent graduates in positions where they Placing inexperienced recent graduates in positions where they cannot interact with more experienced practitioners may increase cannot interact with more experienced practitioners may increase medication errors.medication errors.

Nonspecialists covering a service that is normally staffed by a Nonspecialists covering a service that is normally staffed by a specialist may also lead to errors. specialist may also lead to errors.

Nurses untrained in pharmacology may be more unlikely to Nurses untrained in pharmacology may be more unlikely to recognize potential inconsistencies in disease state and medication recognize potential inconsistencies in disease state and medication usage and doses, resulting in the possibility of increased usage and doses, resulting in the possibility of increased medication errors reaching the patient. medication errors reaching the patient.

4. 4. Lack of patient Lack of patient counseling:counseling: It has been said that the last safety check prior to dispensing It has been said that the last safety check prior to dispensing

medication should be counseling the patient. medication should be counseling the patient.

Talking to the patient allows the pharmacist to correlate the Talking to the patient allows the pharmacist to correlate the medication and dose with the patient's condition and helps the medication and dose with the patient's condition and helps the pharmacist to detect any errors that may have occurred in the pharmacist to detect any errors that may have occurred in the medication use process.medication use process.

In one study, 89% of errors committed in a community pharmacy In one study, 89% of errors committed in a community pharmacy were detected during patient counseling.were detected during patient counseling.

However, errors may occur not only from lack of counseling, but However, errors may occur not only from lack of counseling, but also from providing incorrect information during patient also from providing incorrect information during patient counseling. counseling.

Providing incorrect information may also fall in the lack of Providing incorrect information may also fall in the lack of knowledge category. knowledge category.

High Alert Medications High Alert Medications

Definition: Definition:

Medication that have a higher Medication that have a higher likelihood of causing injury if they are likelihood of causing injury if they are misused. Errors with these misused. Errors with these medications are not necessarily more medications are not necessarily more frequent – just that their frequent – just that their consequences may be more consequences may be more devastating. devastating.

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)

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)

(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)

Medication Error ReportingMedication Error Reporting

Reporting medication errors, particularly Reporting medication errors, particularly severe or life-threatening errors, may have severe or life-threatening errors, may have adverse consequences for both the adverse consequences for both the individuals and the organization involved individuals and the organization involved

Health care professionals have lost their Health care professionals have lost their jobs and been sued as a result of jobs and been sued as a result of medication errors. As a result, health care medication errors. As a result, health care professionals and health systems are professionals and health systems are reluctant to open themselves up to adverse reluctant to open themselves up to adverse outcomes associated with reporting outcomes associated with reporting medication errors. medication errors.

As an example, in one hospital there were only 36 incident reports As an example, in one hospital there were only 36 incident reports regarding medication errors over a yearlong reporting period.regarding medication errors over a yearlong reporting period.

At the same institution, an observational study revealed that as many as At the same institution, an observational study revealed that as many as 51,200 errors were likely to have actually occurred during that same 51,200 errors were likely to have actually occurred during that same reporting period.reporting period.

In New York, a pharmacist had his license suspended after committing a In New York, a pharmacist had his license suspended after committing a single dispensing error that resulted in brain damage in a patient.single dispensing error that resulted in brain damage in a patient.

A medical center in New Jersey was successfully sued for $12 million and A medical center in New Jersey was successfully sued for $12 million and fined by the state board of pharmacy after a medication error killed an fined by the state board of pharmacy after a medication error killed an infant.infant.

In Colorado, three nurses were indicted on charges of criminal negligence In Colorado, three nurses were indicted on charges of criminal negligence after a medication administration error killed an infant. In the current after a medication administration error killed an infant. In the current environment, the disincentives for error reporting seem to outweigh the environment, the disincentives for error reporting seem to outweigh the incentives. incentives.

Despite the negative actions taken against individuals and Despite the negative actions taken against individuals and organizations that commit medication errors, reporting errors is organizations that commit medication errors, reporting errors is an absolute necessity for at least an absolute necessity for at least three reasons.three reasons.

First,First, to improve current medication use systems, the to improve current medication use systems, the circumstances under which errors occur must be understood. circumstances under which errors occur must be understood. Without adequate reporting, institutional and national self-Without adequate reporting, institutional and national self-evaluation would be impossible. evaluation would be impossible.

SecondSecond, taking a proactive role in identifying errors and using , taking a proactive role in identifying errors and using that information to improve medication use systems may that information to improve medication use systems may actually protect organizations from negligence claims. When actually protect organizations from negligence claims. When errors are not reported, it may be interpreted as concealment.errors are not reported, it may be interpreted as concealment.

FinallyFinally, voluntary error reporting is necessary to avoid being , voluntary error reporting is necessary to avoid being placed on accreditation watch by the JCAHO. If the JCAHO placed on accreditation watch by the JCAHO. If the JCAHO discovers that a serious error occurred at an accredited discovers that a serious error occurred at an accredited organization that was not previously reported, the JCAHO will organization that was not previously reported, the JCAHO will perform an immediate on-site survey and place the perform an immediate on-site survey and place the organization on accreditation watch. The JCAHO has recently organization on accreditation watch. The JCAHO has recently made voluntary reporting appear less risky for organizations made voluntary reporting appear less risky for organizations and and

Conclusion Conclusion

Medication misadventures are a serious Medication misadventures are a serious problem in the health care systemproblem in the health care system

Recognition of the problem is an important Recognition of the problem is an important first step in developing strategies to first step in developing strategies to minimize their occurrence. minimize their occurrence.

Reporting of medication misadventures is Reporting of medication misadventures is an absolute necessity to gauge our an absolute necessity to gauge our progress and direct our efforts.progress and direct our efforts.

Pharmacists have the responsibility of ensuring the safe Pharmacists have the responsibility of ensuring the safe and effective use of medications. and effective use of medications.

Although other health care providers and health care Although other health care providers and health care systems must significantly contribute to this effort, systems must significantly contribute to this effort, pharmacists, as champions of the medication use process, pharmacists, as champions of the medication use process, must take a leading role. must take a leading role.

Several studies have already demonstrated the tremendous Several studies have already demonstrated the tremendous benefit pharmacists can provide to patients through benefit pharmacists can provide to patients through reduction of medication misadventures. reduction of medication misadventures.

As a mandate of pharmaceutical care, pharmacists need to As a mandate of pharmaceutical care, pharmacists need to continue to contribute to improving patient care by actively continue to contribute to improving patient care by actively pursuing improvements in the medication use process.pursuing improvements in the medication use process.