Clinical evaluation, drugs pharmacists

There are currently five clinical evaluation units within DSEB, each headed by a senior medical officer and supported by pharmacists. Applications are distributed among the five evaluation units based on the therapeutic area of the drug under evaluation. The DSEB contracts a number of external clinical evaluators who are specialist medical practitioners in the medical condition that the proposed new drug is intended to treat. External evaluators may also be contracted to evaluate the Module 4 data. The head of the clinical evaluation unit coordinates the evaluation and makes the final decision on marketing approval as a delegate under the Therapeutic Goods Act. 

The Drug Information Centre provides a unique learning environment for the education of clinical pharmacologists, other medical doctors, information pharmacists or information technicians, and for any other health care personnel that need training in clinical pharmacology, drug evaluation and the rational use of drugs. 

Programs that are updated frequently, even daily, are available, and they can be put onto a PDA to give pharmacists access to the most up-to-date information. Clinical evaluation of the new PDA drug information programs has begun but is complicated by the constant updating of databases and the lack of a certification board. However, evaluations are useful for the publishers of these programs because they provide valuable... 

The new millenium professional pharmacist with rigorous training in the scientific and clinical properties of drug substances and pharmaceutical formulations should be well able to dispassionately evaluate bioe-quivaleny data and give an objective, professional opinion as to validity of data purported to demonstrate generic bioequivalence. 

For an optimal therapeutic response, the clinical pharmacist must select a suitable drug and determine an appropriate dose with the available strengths and a convenient dosing interval. To meet this responsibility, the serum or plasma drug concentrations have to be analyzed, pharmacokinetic parameters have to be evaluated, the drug dose has to be adjusted, and the dosing interval has to be determined. 

Conventional evaluation of new medical technologies such as pharmaceutical products includes consideration of efficacy, effectiveness, and safety. The methodology for such analyses is well developed, and studies of safety and efficacy often are required prior to drug marketing. Health care researchers from a variety of disciplines have developed new techniques for the evaluation of the economic effects of clinical care and new medical technologies. Clinicians, pharmacists, economists, epidemiologists, operations researchers, and others have contributed to the field of clinical economics , an evolving discipline dedicated to the study of how different approaches to patient care and treatment influence the resources consumed in clinical medicine. 

Many have proposed that evaluation of drug therapy and pharmacists value-added services should include assessments of economic, clinical, and humanistic outcomes. The economic, clinical, and humanistic outcomes (ECHO) model assumes that the outcomes of medical care can be classified along the three dimensions of economic, clinical, and humanistic outcomes (Kozma, Reeder, and Schultz, 1993). Clinical outcomes are defined as medical events that occur as a result of disease or treatment. Economic outcomes are defined as the direct, indirect, and intangible costs compared with the consequences of medical treatment alternatives. Humanistic outcomes are defined as the consequences of disease or treatment on patient functional status or quality of life. All three of these outcomes need to be balanced simultaneously to assess value. 

The generalist and the specialist models have been successful in many hospitals, provided that there has been a systematic approach to the development, implementation, and evaluation of the clinical services provided. There must be a clearly articulated philosophy of practice that describes why a pharmacist provides clinical services and a clear definition of the work to be done. We must remember that the patient is central to any endeavor. If the clinical service is defined in terms of patient need, it becomes easier to define priorities, resource requirements, and optimal outcomes. The primary focus of a clinical service should be the patient and not a medical service or a drug category. Full integration of clinical practice into drug distribution services optimizes the chances for success. 

This diversity in package design mandates that specific functional standards be developed to help guide manufacturers, distributors, and pharmacists as they evaluate packaging systems and dispense drugs in such a way so as to protect their patients. Nowhere is this high level of quality assurance as necessary as it is in clinical health care, and guaranteeing such quality is a non-trivial task. 

Another facet, obviously, is to deal with the patient whose compliance has been substandard and take effective action to make as much improvement as possible in drug intake, and to switch, if necessary, to the agent whose therapeutic actions are least influenced by lapses in dosing. These are, of course, new issues that have previously not been considered in drug evaluation, for the simple reason that reliable measures of patient compliance have not previously been available. The potential roles of pharmacists, nurses and other health professionals remain to be defined as this new information and its implications become available and integrated into clinical thinking. 

Pharmacists are expected to deliver pharmaceutical care, that is, to accept responsibility for patients well-being by ensuring optimum outcomes of drug therapy. Therefore, their performance must be evaluated based on this expectation. The template should be a useful tool for assessing the extent to which clinical pharmacists performance meets predefined practice standards. Its adaptability will allow it to meet site-and pharmacist-specific requirements for performance appraisal. The evaluator and clinical pharmacist should work together to establish a priori percentage standards. 

Other applications include the use of the intervention definition in projects incorporating evaluation of clinical pharmacists activities. SHPA recently completed a prospective multicenter study of pharmacist-initiated changes to drug therapy and patient management in acute care government-funded hospitals in Australia. This was a prospective study performed in eight hospitals to examine resource implications of pharmacists interventions and was assessed by an independent, multidisciplinary clinical panel. Results of the study are to be published soon. 

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