Prescription assessment

Product Customer-related processes Clinical risk assessment Prescription assessment... 

In the previous section we described several internal methods of quality assessment that provide quantitative estimates of the systematic and random errors present in an analytical system. Now we turn our attention to how this numerical information is incorporated into the written directives of a complete quality assurance program. Two approaches to developing quality assurance programs have been described a prescriptive approach, in which an exact method of quality assessment is prescribed and a performance-based approach, in which any form of quality assessment is acceptable, provided that an acceptable level of statistical control can be demonstrated. 

With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

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. 

Once a control chart is in use, new quality assessment data should be added at a rate sufficient to ensure that the system remains in statistical control. As with prescriptive approaches to quality assurance, when a quality assessment sample is found to be out of statistical control, all samples analyzed since the last successful verification of statistical control must be reanalyzed. The advantage of a performance-based approach to quality assurance is that a laboratory may use its experience, guided by control charts, to determine the frequency for collecting quality assessment samples. When the system is stable, quality assessment samples can be acquired less frequently. 

In the United States, through the NDA review process, pharmaceutical companies that seek FDA approval for new dmg products are assessed user fees by FDA to gain faster approval, by virtue of the U.S. Prescription Dmg User Fee Act of 1992. These assessments are used to increase the new dmg review staff of the FDA, which has agreed to reduce the NDA review time to 12 months by 1997 (6). 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

For non-prescription and generic dmgs, the documentation required is simplified and is mostly concerned with chemical and pharmaceutical data. In general, the documentation required for registering products containing new chemical entities is more extensive than that for products in other categories (see Table 8.2). Countries that have the capacity to make an independent assessment of the safety, efficacy and quality of products, such as Australia, Estonia and the Netherlands, do not request the WHO-recommended Certificate of Pharmaceutical Product. Only Cyprus and Tunisia request price information. 

Obtain a thorough history of prescription, nonprescription, and natural drug product use. Determine what treatments for cholesterol the patient has used in the past (if any). Assess if the patient is taking any medications that may contribute to his or her abnormal lipid levels. 

Obtain a thorough history of prescription, non-prescription, and dietary supplement use. Assess inhaler technique and adherence to the medication regimen. Ask the patient about effectiveness of medications at controlling symptoms and adverse effects. 

Assess the patient s medical history for pertinent drug allergies, tobacco use, and current prescription and nonprescription drug therapies. Determine if any of the medications could exacerbate IBD. If applicable, inquire about adherence or recent changes to the patient s current IBD drug regimen. 

Obtain a thorough medication use history, including present and past drugs prescription and nonprescription drugs the patient s self-assessment of response and side-effect problems use of alcohol, tobacco, caffeine, and illicit substances and use of herbal products and dietary supplements, as well as any allergies and adherence difficulties. 

Elicit adverse effects of drug therapy using a non-leading approach and ask the patient/caregiver to judge their severity and what measures, if any, the patient used to ameliorate them. Assess adherence (ask patient about missed doses or do a pill count if the prescription container was brought to the visit). 

Elicit adverse events of therapy in a non-leading manner and ask the patient to judge their severity. Ask the patient or par-ents/guardians what measures if any were used to ameliorate them. Assess adherence (ask patient or parents/guardians about missed doses do pill counts if the prescription vial is available). 

Assess the patient s symptoms to determine if symptoms are consistent with oropharyngeal or esophageal candidiasis. All patients with suspected oropharyngeal or esophageal candidiasis should be referred to a practitioner or physician since no antifungal products appropriate for oral use are available without a prescription. 

After performing a nutrition assessment and estimating nutritional requirements, determine the optimal route to provide specialized nutrition support (e.g., oral, enteral, or parenteral). If PN is deemed necessary, venous access (i.e., peripheral or central see below) for PN infusion must be obtained. Finally, formulate a PN prescription, and administer PN according to proper safety guidelines. 

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. 

A study on racial differences in receipt of analgesics found that nearly three-fourths (74%) of white patients compared with 57% of African American patients received analgesics for lower extremity fractures in emergency departments (Todd et al., 2001). An assessment of racial/ethnic differences in physicians prescriptions of patient-controlled analgesia for postoperative pain found that after adjustment for age, gender, preoperative... 

Noah, L., "Advertising Prescription Drugs to Consumers Assessing the Regulatory and Liability Issues," Ga. L. Rev., 32,141-180 (1997). 

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