Pharmaceutical (Technical Reporter) Medical error and clinical mistakes are potential threats to healthcare system around the world. Major considerations are as under,
Product Labeling: Labels may emphasize manufacturer’s name or logo instead of drug name & dose; same labeling scheme, including letter size, print, background color, to associate the product with manufacturer. Makes all labels look alike; Different vial sizes of injections may be similarly labeled with concentration (mg/mL), Potassium chloride (KCl) & normal saline. Potassium chloride injection- black vial caps -overseals with warning “must be diluted”
Other Problems: Color Coding-relying on color of product packaging is not safe practice; Daunorubicin 20 mg & doxorubicin 10 mg are packaged in vials shaped similarly & have dark blue vial caps both are lyophilized powders that turn red upon reconstitution
Advertising Zyrtec oral products contain active ingredient cetirizine: Zyrtec Itchy Eye Drops; contain active ingredient ketotifen; Claritin oral products; contain loratadine as active ingredient; Claritin Eye contains ketotifen; Pepcid; Pepcid contains active ingredient famotidine; Pepcid Complete contains famotidine, calcium, magnesium hydroxide
Drug Preparation Errors; Read product labels carefully; Process one prescription at a time; Label prescriptions properly; Store drugs properly; Maintain safe work environment; Keep up with changes in medical profession
Work Environment Inadequate lighting Poorly designed work spaces: Inefficient workflow; Cluttered work spaces & stock areas; Distractions & interruptions; Improper maintenance of equipment.
Personnel Issues Scheduling of staff members; Frequency of rotating shifts; Staffing levels; Amount of supervision; Untrained, inadequately trained, or inexperienced personnel; Relying on memory instead of checking references; Performing complicated calculations without doublecheck.
Deficiencies in Drug Use Systems: Errors frequently due to defective/inadequate systems; Stocking dangerous drugs in patient care areas; Floor stock mixups; Heparin injection & normal saline flush; Potassium chloride & furosemide injections; Premixed Lidocaine in D5W500mL & D5W500mL plain bags; Automation/technology reduce medication errors
Prevention of Medication Errors: Systems /methods to help prevent medication errors; Failure mode & effects analysis (FEMA); Systems designed to prevent medication errors; Legal requirements; Policies & procedures; Multiple check systems; Standardized order forms; Education & training; Computerization & automation.
Failure Mode & Effects Analysis: Systematic evaluation of process; Predicts opportunity for errors at steps in process; Evaluates “how” & “why” instead of “who”; Each step in process; Opportunities for failure at each stage; Effects of failures on process; Root causes described; Severity, likelihood of occurrence, probability of actually identifying failure are estimated.
Criticality Index: Multiply; Severity; Likelihood of occurrence; Probability of actually identifying failure; Address first those steps with highest criticality index; Greatest potential for reducing risk for error; After making changes to process; Perform FMEA again to determine effectiveness of changes.