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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
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Medication Errors Reporting Program Operated by the United States Pharmacopeia in cooperation with the Institute for Safe Medication Practices Report medication errors in confidence: 1 800 23 ERROR www.ismp.org/www.usp.org (USP and ISMP are FDA MED W ATCH partners)
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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
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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?
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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?
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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?
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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)
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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
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Package/Label n Readability –Brand name (trademark) –Generic name –Storage information –Expiration date –Lot number –Bar codes –Other information
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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.
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Other issues n Bar coding n Computeriztion n Unit dose n Unit of use n Patient education materials
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Other issues n Bar coding n Computeriztion n Unit dose n Unit of use n Patient education materials
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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
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