drug safety management

• Adverse Drug Reactions (ADRs)

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

  
• There is a causal link between a drug and an ADR

  
• Examples of ADRs


  • rashes, jaundice, anaemia, low WBC count, kidney damage, nerve injury
• Adverse drug event (ADE)

  "an injury resulting from the use of a drug"
• ADEs may or may not be related to the administered drugs
• What ADEs include


  • Harm caused by the drug (ADE & overdoses)
  • Harm from the use of the drug (including dose reduction & discontinuation of drug therapy)
• Most ADEs do not result from medication errors
• Medication misadventures


  • All ADEs, ADRs & medication errors
• Allergy


  An ADR mediated by an immune response (rash, hives)
• Side effect (SE)


  An expected & known effect of a drug that is not the intended therapeutic outcome
• The term "side effect" tends to nominalize the concept of injury from drugs and it has been recommended that this term should generally be avoided in favour of adverse drug reaction
• Examples of ADRs


  • Urticaria - eruption of wheals / hives lasting < 24H
  • Pruritus – itch of the skin without rash
  • Purpura - non-blanching dark red macules or bruises due to bleeding from small blood vessels
  • Angioedema - swelling of the mucous membrane (oral eye/ genitalia). May be associated with laryngeal oedema if severe

  
• Pharmacovigilance (PV)


  "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug- related problem." (WHO)

  
• Goals of PV


  • To bolster patient safety concerning medicine use by providing a system to collect, assess & distribute drug safety data
  • To identify previously unknown AEs
  • To recognize changes in the frequency or severity of known adverse effects
  • To assess a drugs risk/benefit to determine if action is required to improve safety
  • To ensure the accuracy of information communicated to health care professionals & patients, and to ensure information contained in patient information leaflets (PILs) is up to date

  
• PATIENT SAFETY GOAL NO. 7: To Ensure Medication Safety

  
• Medication Error


  Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events maybe related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature
• Medication errors are more common than ADEs, but result in harm <1% of the time
• About 25% of ADEs are due to medication errors
• Medication Error ("Actual")


  An error occurred and reached the patient
• Medication Error ("Near Misses")


  Any medication error that does not reach patient
• Medication errors may occur at various points of care and often go undetected
• Some medication errors may lead to serious morbidity and even mortality
• Types of medication errors

  • Prescribing
  • Omission
  • Wrong time
  • Unauthorized drug
  • Dose
  • Dosage form
  • Drug preparation
  • Route of administration
  • Administration technique
  • Deteriorated drug
  • Monitoring
  • Compliance & others
• Prescribing error


  • Incorrect drug (ordered or authorized by physician or other legitimate prescriber)
  • Incorrect drug product selection (based on indications, contraindications, known allergies, existing drug therapy, other factors)
  • Incorrect dose
  • Incorrect dosage form
  • Incorrect quantity
  • Incorrect route of administration
  • Incorrect concentration
  • Incorrect rate of administration
  • Incorrect instructions for use of a drug product ordered or authorized by physician (or other legitimate prescriber)
  • Illegible prescriptions or medication orders that lead to errors
• Omission error


  • Failure to administer an ordered dose to a patient before the next scheduled dose, or
  • Failure to prescribe a drug product that is indicated for the patient

  
• Time error


  • Administration of medication outside a predefined time interval from its scheduled administration time (this interval should be established by each individual healthcare facility)
  • Administering doses too early or too late may affect the drug serum level and consequently the efficacy of the drug

  
• Right time often governed by the 30 minutes medication rule - "On time" if it is given 30 minutes before until 30 minutes after the scheduled administration time
• A time critical medication is one for which early or late administration 30 minutes before or after scheduled time) might result in harm or negatively affect the patient's treatment
• Unauthorized error


  Dispensing or administration to the patient of medication not authorised by a legitimate prescriber
• Dose error


  • Dispensing or administration to the patient of a dose that is greater or less than the amount ordered by the prescriber, or
  • Administration of multiple doses to the patient, i.e. one or more dosage units in addition to those that were ordered

  
• Dosage form error


  Dispensing or administration to the patient of a drug product in a different dosage form than that ordered by the prescriber
• Depending on the state law & healthcare facility guidelines, dosage forms changes may be acceptable to accommodate specific patient needs
• Drug preparation error


  Drug product in correctly formulated or manipulated before dispensing or administration
• Medications and dosage forms with well known risk for errors include oral liquid formulations requiring reconstitution /dose measurement, oral liquids with multiple volume containers or concentrations available, injectables with more than 1 size volume vials or concentrations available, injectables with multiple formulations, and injectables with complicated or unusual preparation processes
• Route of administration error

  Wrong route of administration of the correct drug
• Administration technique error


  Inappropriate procedure or improper technique in the administration of a drug other than wrong route
• Deteriorated drug error


  Dispensing or administration of a drug that has expired or for which the physical or chemical dosage-form integrity has been compromised
• Some medications need to be refrigerated, and once they are used or reconstituted, stability varies affected by temperature</b>
• Monitoring error


  Failure to review a prescribed regimen for appropriateness & detection of problems, OR use appropriate clinical or laboratory data for adequate assessment of patient response to prescribed therapy
• Compliance error


  Inappropriate patient behaviour regarding adherence to a prescribed medication regimen