Pharmacists therapeutic decision making

Interaction between the pharmacist and the patient must occur to assure that a relationship based upon caring, trust, open communication, cooperation, and mutual decision making is established and maintained. In this relationship, the pharmacist holds the patient s welfare paramount, maintains an appropriate attitude of caring for the patient s welfare, and uses all his/her professional knowledge and skills on the patient s behalf. In exchange, the patient agrees to supply personal information and preferences, and participate in the therapeutic plan. The pharmacist develops mechanisms to assure the patient has access to pharmaceutical care at all times. 

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. 

In a specific situation, the pharmacist first studies the Summary of Product Characteristics (SPC) to check whether a preparation may be modified and if so, how [37]. Normally, this can be found in its Sect. 4.2 Posology and method of administration. When the information on modification is negative or absent, a pharmacotherapeutic alternative is the most obvious choice. Such an alternative may be a different dosage form of the same active substance or a different active substance with a comparable therapeutic effect. Clinical and pharmacokinetic background of the modified-release profile is paramount for making a justified decision. Clinically superfluous modified release can also be concluded with such a literature search. 

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