Prescription guidelines

Clinical Prescription Guidelines Same as Clinical Practice Guidelines above but with a focus on prescriptions. 

In 1998, Pierson summarized earlier data on HMV from Great Britain, France, and the United States (10). At that time, the U.S. government estimated there to be 4000 ventilator-assisted individuals (VAIs) for a prevalence of 1.5/100,000 population. However, this figure likely underestimates the actual number by as much as 25%. In France, LTMV at home is received by 1500 to 2000 patients. In countries such as Denmark, Spain (Catalonia), Belgium, and Switzerland, only partial information is available. Germany has prescription guidelines, but Switzerland and France have closer control of the HMV population and France has a national registry of VAIs. 

The relevant regulations governing the conduct of clinical trials in the U S are shown in Table 5.4. As they also reflect the principles of GCP, they are quite similar in requirements to those of the E U. However, because they apply to a single jurisdiction, they are framed to provide more prescriptive detail than can be found in the equivalent EU directives. Similarly, they are supported by the ICH- and FDA-specific guidelines. As most of the practices are the same as discussed in the previous section, the chapter will now just examine some of the aspects that are unique to the US regulations. 

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. 

Three volumes of information on the format and content of applications for marketing authorization and relevant regulatory guidelines have been prepared by the Commission (Enterprise Directorate General) and published as the Notice to Applicants. These volumes do not have legal force, but applications that fail to follow their prescriptions can be returned to applicants as invalid. 

The sterilization processes described in the Ph Eur are preferred, especially terminal sterilization in the final container alternative processes have to be justified. All sterilization processes will need to be described and appropriate in-process controls and limits included. Where Ph Eur prescriptions are followed, there should be a statement to this effect in the application. Most of this information should be discussed in the development pharmaceutics section. Reference is made to the specific guidelines on ethylene oxide sterilization and irradiation sterilization, which are discussed further below. The possibility of parametric release for terminal processes such as saturated steam and irradiation is mentioned (see below). For all sterile products there should be a sterility requirement included in the finished product specification regardless of the outcome of validation studies. 

In Chapter 9, lecturers V. Ortun Rubio of Pompeu Fabra University and L. Cabiedes Miragaya of the University of Oviedo address the subject of measures intended as a way of influencing prescriber decisions. The authors place special emphasis on analysing prescriber incentive policies, distinguishing between incentives of a financial nature (both coercive and non-coercive) and non-financial incentives (information, training, treatment protocols, monitoring of prescription practices, cost-effectiveness guidelines, interaction with other professionals, pressure from patients and so on). The authors advocate incentive policies based on a combination of financial and non-financial incentives. 

Although no prescriptions on sampling odours are included in the Dutch guideline, some recommendations will be included in the Air Pollution Control Manual. 

Based on the Prescription Drug User Fee Act (PDUFA), the FDA collects fees from applicants to expedite the review and approval processes under strict guidelines. Tlie PDUFA fees for fiscal year 2007 (October 1,2006 to September 30,2007) are shown in Table 8.2. 

There is also an EU guideline (dated 29 September 1998 and in operation since January 1999) on changing the classification for the supply of a medicinal product for human use. Article 3 predetermines the POM products. Therefore, the criteria in Article 3 have been used as a basis for this guideline. This guideline does not address the different restrictions that may be available for medicinal products not subject to a medical prescription, such as available in pharmacies only following initial medical diagnosis, or available on general sale, as the case may be. 

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

The guidelines are interpreted in a very prescriptive manner, and have been the subject of ongoing discussion. Improved health outcomes that are difficult to quantify, such as indirect benefits, are accorded a low weighting. Also large head-to-head comparative studies with adequate power to yield significant differences may be required before superior outcomes are regarded as proven. 

Gafni A., and S. Birch. 1993. Guidelines for the Adoption of New Technologies A Prescription for Uncontrolled Growth in Expenditures and How to Avoid the Problem. Canadian Medical Association Journal 148(6) 913-917. 

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