Labelling prescriptions

Some authors have questioned whether there is sufficient efficacy and safety data to support widespread use of the a2-adrenergic agonists (Cantwell et al., 1997), a position which intensified following the report of several sudden deaths of children who were medicated with clonidine and methylphenidate in combination (Popper, 1995). Although the FDA could not establish a causal link between the medications and these catastrophic outcomes, clearly more research is needed. At the same time, interest at the national level in establishing a more extensive scientific database to support the use of previously off-label prescription patterns, and interest on the part of industry to obtain FDA approval for new indications, suggests that larger... 

Even worse, GSK made sure that Study 329 was eventually published in a whitewashed form in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry (Keller et ah, 2001). The title left no doubt about the scientific nature of the study Efficacy of Paroxetine in the Treatment of Adolescent Major Depression A Randomized, Controlled Trial. The conclusion to the lengthy analysis, a mere one sentence long, left no doubt about what the reader was supposed to learn Paroxetine is generally well tolerated and effective for major depression in adolescents. That one sentence, so prominently displayed as the last line of the abstract, was a drug company public relations triumph, one bound to vastly increase the off-label prescription to children of their ineffective, dangerous drug. 

People with low health literacy may not understand the health risks associated with errors in medication management. Shame or embarrassment about their low literacy may deter them from seeking help with medication instructions. Pharmacists can assess health literacy using nonobtrusive screening tests such as the Test of Functional Health Literacy in Adults (TOFHLA), which is available in English and Spanish versions. This test includes items that assess the patient s ability to understand labeled prescription vials, blood glucose test results, clinic appointment slips, and financial information forms. 

Use tail-man lettering to distinguish look-alike/sound-alike drug names on manufacturer s bulk bottle labelling, prescription labels, medication administration records and in hospital and community pharmacy computer systems. 

A good example of a prescriptive approach to quality assessment is the protocol outlined in Figure 15.2, published by the Environmental Protection Agency (EPA) for laboratories involved in monitoring studies of water and wastewater. Independent samples A and B are collected simultaneously at the sample site. Sample A is split into two equal-volume samples, and labeled Ai and A2. Sample B is also split into two equal-volume samples, one of which, Bsf, is spiked with a known amount of analyte. A field blank. Dp, also is spiked with the same amount of analyte. All five samples (Ai, A2, B, Bsf, and Dp) are preserved if necessary and transported to the laboratory for analysis. 

In 1966 the PDA utilized the services of the National Academy of Sciences—National Research Council (NAS—NRC) to estabhsh the relative therapeutic efficacies of prescription dmgs marketed between 1938 and 1962. Those products that were found to meet safety and efficacy requirements were allowed to stay on the market. Suitable changes were required for other products for compliance, ie, formulation or label changes, additional data... 

Labeling. Labeling, controUed by FDA regulations, includes not only the affixed labels, but also the package inserts that provide mote detailed information. Trade, generic, or common name, dose, number of dose units present, and name and address of manufacturer and distributor ate requited. For nonptescription products, adequate directions for use ate requited. Prescription products must beat the phrase, "Caution Federal law prohibits use without a prescription" on theit labels. 

The entire label of the prescription or nonprescription drug container must be read, including the recommended dosage and warning. 

Ipecac is available without a prescription for use in the home. The instructions for use and the recommended dose are printed on the label. 

Reports are most useful when relevant materials such as pioduct label, copy of prescription/order. etc. can be reviewed. Can these materials be provided D No Vfes if yes. please specify. ... 

Yellow 5 and 6 are widely used in candies and drug coatings. Orange B is used in hot dog and sausage casings. Some people are sensitive to Yellow 5 reactions to it can be severe enough that specific labeling is required for prescription medicines that contain it. None of the other certified dyes have this special requirement. 

Over-the-Counter Drug Review begun to enhance the safety, effectiveness and appropriate labelling of drugs sold without prescription. 

The DRA in Venezuela allows prescription drugs to be advertised in the press on a onetime basis as an announcement that the dmg is now registered in Venezuela. Information presented in the promotion and advertising materials must be based on the product information, as specified in the summary of product characteristics (SPC), approved at the time of registration. In all countries except Australia, patient information leaflets and labels are also subject to approval. In Australia, although approval is not needed, the information must not conflict with the approved product information. 

Recent data suggest that COX-2 inhibitors, including rofe-coxib, valdecoxib, and celecoxib, may increase the risk for MI and stroke.47 There is also some evidence that the non-selective NSAIDs may increase the risk for cardiovascular events.47,48 Rofecoxib was withdrawn from the market in late 2004 because of safety concerns. The FDA requested the withdrawal of valdecoxib from the market in 2005. The FDA also asked the manufacturers of celecoxib and non-selective NSAIDs (prescription and over-the-counter) to include information about the potential adverse cardiovascular effects of these drugs in their product labeling. The cardiovascular risk with COX-2 inhibitors and NSAIDs may be greatest in patients with a history of, or with risk factors for, cardiovascular disease. The American Heart Association recommends that the use of COX-2 inhibitors be limited to low-dose, short-term therapy in patients for whom there is no appropriate alternative.48 Patients with cardiovascular disease should consult a clinician before using over-the-counter NSAIDs. 

Dyes. Dose does not appear to be a factor in patient reaction to dyes. The mandatory labeling of the azo dye tartrazine (FD C yellow No. 5) in OTC and prescription medications [58] has focused the attention of pharmaceutical manufacturers and the consumer on the potential danger of dyes in susceptible individuals. 

Product labels may be incorrect, accidentally or intentionally. Herbs may be mislabeled accidentally because of misidentification or the wrong part of the plant was picked. Other products may be mislabeled intentionally—a ginseng label may not disclose that the product contains mandrake (scopolamine) or snakeroot (reserpine) because of the high cost of pure ginseng [34]. Some herbal products may not declare the addition of prescription medications such as corticosteroids. 

In a particularly dramatic case of placebo-induced side effects, doctors at a hospital in Jackson, Mississippi, treated a young man who came into the emergency room, said to the receptionist, Help me, I took all my pills and then collapsed to the floor, dropping an empty prescription container. His blood pressure was abnormally low, and he was treated with intravenous fluids, which brought it back to within a normal range. The prescription bottle bore a label indicating that the medication was part of a clinical trial of antidepressants. Further investigation revealed that he had... 

Pork is the product of a very complex process. All the various characteristics of pork quality cannot be assessed directly in each carcass because these measurements and assessments would be too expensive. Therefore, previous scientific quality assessment of meat is primarily an indirect approach based on a few easily detectable quantitative traits and on the prescription of minimal standards in relation to the product in terms of size or composition and in relation to the production process. The prescriptions and the exclusion criteria vary between countries or between labelling programmes. The most encompassing prescriptions are enshrined in the EC regulation on organic livestock production (EEC No. 2092/91). Owing to this approach, extreme deviations in quality traits and deleterious effects are prevented. However, there is still space left within these framework conditions for huge variability in pork quality. 

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