Package labeling, medical information

Medical Information supporting products released to market can exist in many different formats. The medical information produced for the finished product, whether in label format or as a package insert, should correspond with the actual ingredients that the product is formulated to contain and the method and dosage that corresponds with its license. 

The primary responsibility of any medical information department is the provision of product-specific information to healthcare professionals and/or consumers in response to specific inquiries. If a response to a question involves information outside the Food and Drug Administration (FDA)-approved package insert/labeling, the information is considered to be off label, and several factors limit the way in which information is communicated to the customer. 

In general, a medical information staff member can answer an off-label question if the request is of a spontaneous and unsolicited nature, if the response contains both scientific and fair balance, and if an appropriate disclaimer is included. Each company must interpret the FDA guidances and develop policies with respect to the details of how information is disseminated to healthcare professionals. The FDA does not provide any guidelines that delineate how to address consumer inquiries. Each company must again develop policies regarding the dissemination of information to consumers. The majority of companies in the United States limit discussions with consumers, if any occur, to data contained in the product s package insert (PI) or the patient package insert, if available. 

Around 80% of pre-packaged foods carry some nutritional information and failure to do so is likely to lose sales. There will be those customers who have medical advice about diet coupled to those who are trying to lose weight. Both classes of customers are likely to ignore products that do not have a nutritional label. Indeed, some may view the omission as an attempt to cover up an unfavourable situation. 

Certain medications including penicillins and other antibiotics are unstable when stored in solution form and are therefore packaged in powder form. The dry powders must be reconstituted with a sterile diluent such as sterile water for injection or sterile sodium chloride (normal saline) solution. Instructions supplied with the vial state the volume of diluent which should be added. The resulting volume of the reconstituted drug and the approximate average concentration per milliliter are provided in the label or the package information sheet (package insert). 

The Swedish Classification Scheme initiated in 2005 by the Swedish Association of Pharmacy Industries (LIF), the Swedish Medical Products Agency, Apoteket (National Corporation of Swedish Pharmacies), the Swedish Association of Local Authorities and Regions and the Stockholm County Council, take in account Persistence, Bioaccumulation and Toxicity (PBT) characteristics of pharmaceutical products. This voluntary scheme looks at the environmental hazard and the associated risk of pharmaceutical products. The environmental risk is calculated based on the ratio PEC/PNEC according to the EMEA guideline [17,124, 127]. The obtained information is only available on the website www.fss.se, since due to European restrictions it is not possible to include warning labels on the packaging of medications [17]. 

Because of differences in pharmacokinetics in infants and children, simple proportionate reduction in the adult dose may not be adequate to determine a safe and effective pediatric dose. The most reliable pediatric dose information is usually that provided by the manufacturer in the package insert. However, such information is not available for the majority of products, even when studies have been published in the medical literature, reflecting the reluctance of manufacturers to label their products for children. Recently, the FDA has moved toward more explicit expectations that manufacturers test their new products in infants and children. Still, most drugs in the common formularies, eg, Physicians Desk Reference, are not specifically approved for children, in part because manufacturers often lack the economic incentive to evaluate drugs for use in the pediatric market. 

Patient-directed labeling for prescription drugs (patient package inserts and Medication Guides) Summary of essential information needed for safe and effective use of the drug Patients... 

Nitto Denko Corporation primarily manufactures industrial adhesive tapes for the electronics, automotive, health care, packaging and construction industries. The company produces industrial, electronic and functional products. Industrial products include double-coated adhesive tapes, masking tapes surface protective materials, sealing materials and label printing systems. Electronics products include LCD-related items general and advanced device resins printed circuit boards and semiconductor package adhesive sheets. Functional products include medical items such as transdermal therapeutic patches polymer separation membranes used for water purification and treatment and plastic engineering products such as information equipment and porous film materials used in cars, electronics, and home appliances. Nitto Denko America, Inc., an optoelectronics subsidiary, manufactures semiconductor... 

Daily, physicians, nurses, and pharmacists base medical decisions on the information provided by a drug product s labeling and packaging. Unfortunately, poor... 

Directions for using the medication. That most patients use all medication properly is a dangerous assumption. Understanding prescription labels and any instructional how-to-use information contained in the package may be difficult or such data may be subject to multiple interpretations. Furthermore, the various precautions and warnings that exist for all drugs must be observed if therapy is to be optimal. 

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