Application of Safety Principles to Labeling, Packaging and Nomenclature Decisions Michael R. Cohen, RPh, MS, ScD, FASHP Institute for Safe Medication Practices Huntingdon Valley, PA 19006

Medication Errors Reporting Program Operated by the United States Pharmacopeia in cooperation with the Institute for Safe Medication Practices Report medication errors in confidence: ERROR (USP and ISMP are FDA MED W ATCH partners)

Failure analysis n A systematic assessment of how and where pharmaceutical trademarks may be vulnerable to confusion n Set up process flow diagram n Determine failure modes n Rank likelihood of occurrence, severity of outcome n Where effects of errors are judged unacceptable, action may be taken to minimize potential for errors

Consider the Process Flow: n Who purchases? n Where stored? n Who prescribes? n Ordering process? –handwritten, verbal, telephone, computer n Where used? How does it get to site? How does it get to site? n Who administers? n Who/how monitored? n Who adjusts therapy? n Recording of administration? n Reordering?

Factors to consider - trademark and nonproprietary name n n Looks similar when handwritten? n n Sounds similar when spoken? n n Are suffixes confused with medical terminology? n n Product strengths similar? n n Typical dosing schedule similar? (e.g., frequency of use) n n Product dose (or dose range) similar? n n Dosage units similar? n n Route of administration similar?

Factors to consider - trademark and nonproprietary name n n Dosage form similar (e.g., tab, cap, etc.)? n n Clinical indications similar between new and established products? n n Product instructions similar (e.g., take on empty stomach, etc.)? n n Products likely to be stored near one another (e.g., both refrigerated, next to each other on a shelf, etc.)? n n Packaging similar or from the same company? n n Bad outcome if error happens?

Package/Label n Is the drug packaging similar to a current formulary product? –Manufacturer “trade dress” –Size/shape of package –Expression of drug concentration/strength »(per total volume vs. per mL)

Package/Label n Presence of problem elements –Inadequate type size, spacing, placement –Confusing or ambiguous terminology –Distracting logo, symbols, icons –Color scheme problem –Potential for storage confusion –Potential for dosing confusion

Package/Label n Readability –Brand name (trademark) –Generic name –Storage information –Expiration date –Lot number –Bar codes –Other information

High risk patient populations n Patients with renal/liver impairment n Pregnant/breast feeding patients n Neonates n Elderly/chronically ill n Patients on multiple medications n Oncology patients n etc.

Other issues n Bar coding n Computeriztion n Unit dose n Unit of use n Patient education materials

Other issues n Bar coding n Computeriztion n Unit dose n Unit of use n Patient education materials

Final Recommendations n Practitioner input - testing n Work with group purchasing organizations, and safety agencies n Follow medication error prevention literature n Address issues raised by practitioners and respond appropriately