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Medication errors Adverse drug events (ADEs) Adverse drug reactions (ADRs)
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  1. Medication errors Adverse drug events (ADEs)Adverse drug reactions (ADRs) Medication misadventures

  2. Pharmacists play a pivotal role in the medication use process. Throughout this process there is potential for unexpected adverse events, including errors in prescribing, dispensing, and administering medications, idiosyncratic reactions, and other adverse effects. These events can all be described as medication misadventures. • Pharmacists need to understand the potential for various medication misadventures and be prepared to recognize and prevent such occurrences and minimize adverse outcomes.

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

  4. Medication Misadventure ADRs Medication errors ADEs Medication Misadventure

  5. 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.

  6. A landmark study in 1995 estimated that ADE-related costs were $76.6 billion annually in ambulatory patients alone. • Drug expenditures in ambulatory patients at that time were $80 billion per year. This means that for every $1 spent for a drug, almost $1 was also being spent due to a drug-related problem. • A 2000 update to these figures indicates that the problem is not improving.

  7. About a third of these events are thought to be preventable • Efforts to minimize medication misadventures depend heavily on individual health care practitioners, including pharmacists, physicians, and nurses. • Multiple studies have highlighted the impact individual pharmacists can have on minimizing medication misadventures and improving outcomes. • In one of the most significant studies, published in the Journal of the American Medical Association, pharmacists participating in hospital rounds in an intensive care unit decreased prescribing errors by 66% and saved an estimated $270,000 per year.

  8. Adverse Drug Reactions • All medications, including the excipients of a product, are capable of producing adverse effects. • The WHO defines an ADR as "any noxious or unintended response to a drug that occurs at doses usually used for prophylaxis, diagnosis, or therapy of disease or for the modification of psychological function."

  9. Classification of ADRs • Minor: No antidote, therapy, or prolongation of hospitalization is required. • Moderate: Requires a change in drug therapy, specific treatment, or an increase in hospitalization by at least 1 day. • Severe: Potentially life-threatening, causing permanent damage, or requiring intensive medical care. • Lethal: Directly or indirectly contributes to the death of the patient.

  10. Mechanism of Adverse Drug Reactions • Hypersensitivity: A reaction, not explained by the pharmacologic effects of the drug, caused by altered reactivity of the patient and generally considered to be an allergic manifestation. • Intolerance: A characteristic pharmacologic effect of a drug produced by an unusually small dose, so that the usual dose tends to induce a massive overaction. • Drug interaction: An unusual pharmacologic response that could not be explained by the action of a single drug, but was caused by two or more drugs. • Pharmacologic: A known, inherent pharmacologic effect of a drug, directly related to dose. • Idiosyncrasy: An uncharacteristic response of a patient to a drug,

  11. Reporting • Well-designed programs that monitor ADRs, as well as network information to the medical community, are essential. • Surveillance of ADRs makes it possible to detect early signals of a developing problem. This is why postmarketing surveillance of ADRs is so important. • Postmarketing ADR reporting can cause changes in prescribing drugs as well as result in the withdrawal of various drugs from the market.

  12. Adverse reactions that occur only rarely (e.g., 1 out of a million) often will not be detected until after a drug is approved and used in millions of people. Therefore, the FDA relies on postmarketing information to establish a better understanding of adverse events • Pharmaceutical companies are required by the FDA to submit quarterly reports of all ADRs for the first 3 years that a drug is on the market as part of the postmarketing surveillance system.

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

  14. In the early 1980s, an average of one medication error per patient per day was reported. • A review of medication error-related deaths from 1983 to 1993 has shown an increase from 2876 deaths in 1983 to 7391 deaths in 1993, a 2.57-fold overall increase. • Medication error-related deaths in outpatients had an 8.48-fold increase and in inpatients there was a 2.37-fold increase during the same period.

  15. Because the medication use process is complex and involves multiple individuals representing several health professions and some nonprofessionals, communication and teamwork among the various professions are a necessity. • Because society perceives pharmacists to be responsible for the safe and effective use of drugs, however, the pharmacy profession needs to take a prominent role in the maximization of safe medicine use as a core responsibility of pharmaceutical care.

  16. Error Type • 1. Prescribing error: • inappropriate drug selection • dose • dosage form • route of administration. • Examples may include ordering duplicate therapies for a single indication, prescribing a dose that is too high or too low for a particular patient, writing a prescription illegibly, prescribing an inappropriate dosage interval, or ordering a drug to which the patient is allergic.

  17. In one study, the most common type of prescribing error (56.1%) was related to an inappropriate dose (either too high or too low). • The second most common prescribing error was related to prescribing an agent to which the patient was allergic (14.4%). • Prescribing inappropriate dosage forms was the third most common error (11.2%). • Other relatively common prescribing errors have included failing to monitor for side effects and serum drug levels, prescribing an inappropriate medication for a particular indication, and inappropriate duration of therapy.

  18. 2. Omission error: • An omission error occurs when a patient does not receive a scheduled dose of medication. • This is considered to be the second most common error in the medication use process, behind wrong time errors.

  19. 3. Wrong time error: • this type of error occurs when a dose is not administered in accordance with a predetermined administration interval. • Most institutions realize that it is often impossible to be totally accurate with the administration interval and typically 15 to 30 minutes outside that interval is acceptable.

  20. 4. Unauthorized drug error: • This type of error occurs when patients receive a drug that was not authorized by an appropriate prescriber. • This might include giving the wrong patient a medication.

  21. 5. Improper dose error: • This type of error is different from that which occurs when a prescriber orders an inappropriate dose of a medication. • This error occurs when the dose administered is different than what was prescribed, assuming that the prescribed dose was appropriate.

  22. 6. Wrong dosage form error: • This error is also different from the type described in the prescribing error section. • This error occurs when a patient receives a dosage form different from that prescribed, assuming the appropriate dosage form was originally ordered.

  23. 7. Wrong drug preparation error: • When medications require some type of preparation, such as reconstitution, this type of error may occur. • These kinds of errors may also occur in the compounding of various intravenous admixtures and other products.

  24. 8. Wrong administration technique: • These errors occur when a drug is given to a patient inappropriately. • An example is when an intravenously administered agent is given at an excessive rate or when an agent meant for intramuscular administration is given intravenously.

  25. 9. Deteriorated drug error: • This error occurs when drugs are administered that have expired or have deteriorated prematurely due to improper storage conditions.

  26. 10. Monitoring error: • These errors occur when patients are not monitored appropriately either after they have received a drug or before they received a drug. • For example, if a patient is placed on warfarin therapy and adequate blood tests are not performed to assess the patient's response, resulting in a life-threatening hemorrhage, a monitoring error has occurred. • Further, in a community pharmacy, if a pharmacist fails to review a patient's medication history prior to dispensing a medication, resulting in a significant drug-drug interaction, a monitoring error has occurred.

  27. 11. Compliance error: • This type of error occurs when patients use medications inappropriately. • Although it may seem that health care professionals have little responsibility here, proper patient education and follow-up may play a significant role in minimizing this type of error. • This type of error may be a direct result of insufficient patient counseling from a dispensing pharmacist, a prescribing physician, or both.

  28. Outcome or Severity • 1. No error • Category A: Circumstances or events that have the capacity to cause error. • 2. Error, no harm • Category B: An error occurred, but the medication did not reach the patient. • Category C: An error occurred that reached the patient, but did not cause the patient harm. • Category D: An error occurred that resulted in the need for increased patient monitoring, but caused no patient harm. • 3. Error, harm • Category E: An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm. • Category F: An error occurred that resulted in initial or prolonged hospitalization and caused temporary 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., anaphylaxis and cardiac arrest). • 4. Error, death • Category I: An error occurred resulting in patient death.

  29. Why Do Errors Occur? • Being human, health care professionals of all types have a propensity to commit errors • :

  30. 1. Lack of communication: • This factor may also fall under interpersonal factors listed above. • Failure to communicate among fellow employees or among health care professionals has frequently been named as contributing to medication error. • For example, an error may be more likely to occur if a pharmacist chooses not to clarify unclear physician orders. • Poor physician handwriting and verbal orders are also significant factors.

  31. 2. Failure to comply with policy: • This is a common factor in dispensing and administering drugs. • In one survey, 42 to 46% of pharmacists said that failing to check drugs before dispensing was a significant factor in dispensing errors.

  32. 3. Lack of knowledge: • This is a frequently cited factor in the committal of medication errors. • Mistakes, rather than slips, are typically committed as a result of inadequate knowledge. • Placing inexperienced recent graduates in positions where they cannot interact with more experienced practitioners may increase medication errors. • Nonspecialists covering a service that is normally staffed by a specialist may also lead to errors. • Nurses untrained in pharmacology may be more unlikely to recognize potential inconsistencies in disease state and medication usage and doses, resulting in the possibility of increased medication errors reaching the patient.

  33. 4. Lack of patient counseling: • It has been said that the last safety check prior to dispensing medication should be counseling the patient. • Talking to the patient allows the pharmacist to correlate the medication and dose with the patient's condition and helps the pharmacist to detect any errors that may have occurred in the medication use process. • In one study, 89% of errors committed in a community pharmacy were detected during patient counseling. • However, errors may occur not only from lack of counseling, but also from providing incorrect information during patient counseling. • Providing incorrect information may also fall in the lack of knowledge category.

  34. 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.

  35. 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)

  36. 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)

  37. (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)

  38. Medication Error Reporting • Reporting medication errors, particularly severe or life-threatening errors, may have adverse consequences for both the individuals and the organization involved • Health care professionals have lost their jobs and been sued as a result of medication errors. As a result, health care professionals and health systems are reluctant to open themselves up to adverse outcomes associated with reporting medication errors.

  39. As an example, in one hospital there were only 36 incident reports regarding medication errors over a yearlong reporting period. • At the same institution, an observational study revealed that as many as 51,200 errors were likely to have actually occurred during that same reporting period. • In New York, a pharmacist had his license suspended after committing a single dispensing error that resulted in brain damage in a patient. • 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 infant. • In Colorado, three nurses were indicted on charges of criminal negligence after a medication administration error killed an infant. In the current environment, the disincentives for error reporting seem to outweigh the incentives.

  40. Despite the negative actions taken against individuals and organizations that commit medication errors, reporting errors is an absolute necessity for at least three reasons. • First, to improve current medication use systems, the circumstances under which errors occur must be understood. Without adequate reporting, institutional and national self-evaluation would be impossible. • Second, taking a proactive role in identifying errors and using that information to improve medication use systems may actually protect organizations from negligence claims. When errors are not reported, it may be interpreted as concealment. • Finally, voluntary error reporting is necessary to avoid being placed on accreditation watch by the JCAHO. If the JCAHO discovers that a serious error occurred at an accredited organization that was not previously reported, the JCAHO will perform an immediate on-site survey and place the organization on accreditation watch. The JCAHO has recently made voluntary reporting appear less risky for organizations and

  41. Conclusion • Medication misadventures are a serious problem in the health care system • Recognition of the problem is an important first step in developing strategies to minimize their occurrence. • Reporting of medication misadventures is an absolute necessity to gauge our progress and direct our efforts.

  42. Pharmacists have the responsibility of ensuring the safe and effective use of medications. • Although other health care providers and health care systems must significantly contribute to this effort, pharmacists, as champions of the medication use process, must take a leading role. • Several studies have already demonstrated the tremendous benefit pharmacists can provide to patients through reduction of medication misadventures. • As a mandate of pharmaceutical care, pharmacists need to continue to contribute to improving patient care by actively pursuing improvements in the medication use process.