Effective Date of This Revision: January 9, 2009
Contact: Medical Director 310-679-9126, Administration
Applies to:
* Officers
* Other agents
* Staff
* Visitors
* Student clinicians
* Contractors
* Volunteers
* Subcontractors / Business Associates
BACKGROUND:
An adverse drug reaction shall be defined as a noxious and unintended response experienced by a patient after a medication has been administered which occurs at doses that are normally used for the prophylaxis, diagnosis, or therapy of disease, or for the intended modification of physiological function. This includes any reactions, which meet any of the following conditions:
• Requires treatment
• Requires stopping the medication or decreasing the dose
• Suggests that future therapy with the drug poses a risk to the patient.
PURPOSE:
The purpose of this document is to outline policy and procedures for the handling of adverse drug reactions to medications administered to patients in the Detoxification Units of BHS’s Chemical Dependency Recovery Hospitals.
POLICY:
Appropriate actions shall be taken whenever a suspected adverse drug reaction is identified, as follows:
• Emergency measures shall be initiated if the reaction is life threatening.
• The physician on duty shall be notified immediately whenever a potentially significant adverse reaction is suspected. In these cases, the medication shall be held until further orders are received from the physician.
• All adverse drug reactions shall be fully documented in the patient’s medical record and reported to the pharmacist and Medical Director.
The significance of the reaction will be determined and recorded on the Adverse Drug Reaction report form, as follows:
• “Significant” reactions include those that could expose the patient to serious adverse health consequences if left undetected.
• “Possibly significant” reactions include those that could expose the patient to serious adverse health consequences if left undetected.
• “Insignificant” reactions include those where the probability of serious consequences is remote.
An Incident Report must be completed whenever a patient has experienced a significant adverse drug reaction.
Unexpected reactions should be reported to the manufacturer and/or to the United States Pharmacopeia Drug Problem Reporting Program.
Completed Individual Drug Reaction Reports or a summary reports shall be submitted to the Pharmacy and Therapeutics Committee for further evaluation.
PROCEDURES:
Adverse Drug Reactions Criteria for Identification
Is there an appropriate sequence of events from the administration of the drug to the onset of the suspected reaction?
Is the event consistent with a known pharmacologic or adverse effect of the drug? Can the event be reasonably explained by the patient’s clinical illness?
If the drug is discontinued, what were the consequences (was adverse symptom alleviated)? If the drug is restarted, do adverse symptoms reappear?
Adverse Drug Reactions – Other Indicators to Watch For
Any allergic reaction (rash, hives, anaphylaxis), which may be drug-related.
• May patients who receive a “STAT” does of Benadryl or Adrenalin are likely to experience a drug reaction.
Any reaction that results in prolonged stay or that requires treatment, discontinuation of the drug or patient discomfort. Examples include patients who:
• Accumulate toxic levels of theophylline or digoxin after receiving “normal” doses. (Watch for patients who have an abrupt decrease in dosage, followed by orders for a “STAT” serum level.)
• Demonstrate low serum potassium as a result of therapy with diuretics.
• Develop diarrhea or other G.I. distress
• Experience a rise in BUN, serum creatinine or other change in lab value, which may be drug-related.
Any drug intolerance or intensified reaction to the normal pharmacologic effects of a drug can also be classified as adverse drug reactions. This includes:
• Tachycardia or bradycardia from cardiac or antihypertensive medications
• Over sedation with antidepressant or antianxiety medications.
Adverse Drug Reactions Procedures
Whenever an adverse drug reaction is suspected, the nurse should promptly complete an adverse drug reaction report. This form has been designed to take less than one minute of your time. To complete the form, perform the following steps:
• Addressograph, sign and date the top portion.
• Check the reaction experienced by the patient in the appropriate area.
• Identify the suspected drug(s) that you think may have been responsible for the reaction. Write any brief comments that you feel are pertinent.
• Indicate if any treatment was received to counteract the reaction.
• Indicate whether the physician was notified and if an Incident Report was completed. Please note that an Incident Report is NOT required unless the pharmacist or physician deems the reaction significant.
• Submit completed Adverse Drug Reaction Forms to the Medical Director for follow-up.
