J. Med. Internet Res. - Packaging and labeling of pharmaceutical products obtained from the internet.


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CKGROUND: For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging.OBJECTIVE: The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging.METHODS: During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States.RESULTS: Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms.CONCLUSIONS: Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.

Resumo Limpo

ckground patient prescript contain label may sourc instruct take medicin unit state legal requir prescript label set feder law state statut contain compar manufactur use packag drug product preserv product ident strength qualiti puriti prevent contamin safeti featur childresist closur provid pharmaceut product purchas intern onlin pharmaci approv food drug administr fda may meet us guidelin label packagingobject studi object determin whether common purchas pharmaceut product obtain intern onlin pharmaci compar product dispens unit state regard label packagingmethod march januari pharmaceut oral dosag form sampl obtain intern internet pharmaci websit evalu generic simvastatin sampl generic amlodipin sampl generic sildenafil sampl content packag observ record comparison prescript label packag product made prescript label packag requir unit statesresult drug product obtain onlin pharmaci differ countri product canada meet label packag guidelin product dispens unit state meet requir dispens paper envelop label affix either handwritten type contain miss inform name address dispens name prescrib name patient direct use anoth product label affix drug product inform print paper document enclos ship packag product label affix drug product drug product packag meet us guidelin asid canadian product product mexico dispens contain meet guidelin establish unit state total product dispens plastic vial dispens unit dose packag paper envelop loos dosag form blister pack drug held togeth rubber band combin packag formsconclus result suggest label packag standard intern generic drug product equival label packag standard unit state suggest dissimilar substandard distribut process compar unit state turn present challeng patient comprehens health literaci may affect patient adher drug treatment regimen find strong implic drug product qualiti patient outcom therapeut effect safeti

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