Principles of Medication Administration

Healthcare providers should also make sure they use the proper system of measurement when calculating a dose (see Chapter 4 Principles of Medication Administration). 

Once a decision has been made to develop a compound further following the extensive pre-clinical pharmacological and toxicological studies, approval for the first clinical studies must be sought from the regulatory authority (Medicines Board in Europe or the Food and Drug Administration in the USA). A clinical trial of a new drug is, in the words of Bradford Hill (in his Principles of Medical Statistics) ... 

The methodology to predict the time course of drug concentration in plasma after administration is well described and well accepted as a pharmacokinetic principle. Today, pharmacokinetic principles are used routinely to estimate and manage dosing of medications for their safe and effective use. Such knowledge is useful not only in designing clinical trials for a new molecular entity, but also in day-to-day clinical practice (Box 5.1). 

Because these patients may be exquisitely sensitive to the effects of medication, the general principle is always to start with the lowest dose and increase medication only if necessary and very slowly. The route of administration may also be problematic, because some patients have very poor absorption, and thus medications may not be adequately assimilated. Parenteral administration is also often complicated by decreased muscle mass, thrombocytopenia, and difficulty in finding veins. 

The structure of a P T committee varies depending on the organizational type. The committee typically has representatives from fhe principle users of medications, including physicians, nurses, and pharmacists, and peripheral users, such as laboratory personnel and nutritionists. Hospital administration may also be represented, because it has a vested interest in the cost of medications. 

Despite their favourable properties, peptide-based drugs are under-represented in the pharmaceutical market. This discrimination is usually due to their poor bioavailability, which sometimes necessitates non-oral administration or even special medical devices such as inhalers. Another related major disadvantage of peptides is their low metabolic stability due to proteolytic degradation, hi addition, costs of goods for the drug substance are sometimes tremendous. Therefore, there is considerable interest to transform the active principle of biologically active peptides into small molecules with improved pharmacokinetic properties, hi this chapter, we present an overview of... 

The bases for all expedited, but also cumulative or periodic reports are individual case reports. The accepted reporting format for individual case reports is the Council of International Organizations of Medical Sciences (CIOMS) form. However, all other forms are acceptable in principle, as long as they contain the necessary information. Cases must fulfill minimum requirements to qualify for reporting a reporter, an event, a drug and a patient must be identifiable. In the EU, the reporter can only be a healthcare professional, unlike in the United States, where the Food and Drug Administration (FDA) accepts reports from consumers. 

The principles of care for a casualty with nerve agent intoxication include termination of exposure, maintenance of ventilation, administration of antidotes, and supportive therapy. For successful medical management, early and intense therapy after severe exposure to nerve agents is necessary to prevent death. The condition of the patient will dictate the need for specific treatment procedures and the order of administration. It is of utmost importance that medical care providers are protected from contamination by use of appropriate protective clothing, otherwise they may become additional casualties. ... 

Classical pharmacokinetic models of systemicaUy administered drugs (see Chapter 1) do not fuUy apply to many ophthalmic drugs. Most ophthalmic medications are formulated to be apphed topically or may be injected by subconjunctival, sub-Tenon s, and retrobulbar routes (Figure 63-1 and Table 63-1). Although similar principles of absorption, distribution, metabolism, and excretion determine drug disposition in the eye, these alternative routes of drug administration introduce other variables in compartmental analysis. 

FDA (2002) General principles of software validation. US Food and Drug Administration EC (2009) EC/TR 80002. Guidance on the application of ISO 14971 to medical device software... 

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