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A USP Council of Experts Statement of Scientific Policy

Appropriate drug use encompasses drug selection, professional monitoring, and patient compliance. It includes efforts toward recognition/diagnosis, prevention and treatment of illness, including achievement of intended outcomes. Appropriate drug use also includes steps to assure that: (1) drug selection is optimally adjusted to the needs of individual patients; (2) patients are appropriately monitored for the result of therapeutic intervention and adverse events; (3) patients are adequately educated and the treatment program is communicated to all concerned; (4) steps are taken to assure, for individual patients and for the whole population or population group under consideration, that both over and under utilization are adequately scrutinized and addressed; and (5) necessary interventions occur when drug use is shown not to be appropriate.

Recognizing that appropriate drug use is essential to good health and beneficial to both individuals and society the following principles should guide drug selection and use from the individual patient and population perspective.

1. Drug selection for individual patients is based on the proper assessment of diagnosis, stage, severity, and duration of the disease, disorder, or condition and patient characteristics. The best available scientific evidence should be the basis for drug selection at both the individual and population levels.
2. Successful therapy for individual patients is based on consideration of non-drug therapies, all relevant approved drugs, and medically accepted uses not included in FDA approved labeling when supported by scientific evidence, and established medical practice. At the population level, all relevant therapeutic options should be considered.
3. Optimal therapy for the individual patient takes into account the variation anticipated in drug response due to individual variations in pharmacodynamics, pharmacokinetics, co-morbid condition(s), allergies and/or the presence of concurrent therapies. At the population level, drug selection must take into account anticipated drug response variation by assuring access to an adequate range of well designed therapeutic alternatives.
4. Drug selection for individual patients takes into account the anticipated side effects of a specific drug. At the population level, scientific studies have demonstrated that the use of certain drugs in particular patient groups may increase the likelihood of undesirable outcomes in those patients. If the risk of adverse drug reactions exceeds the expected benefits, use of such drugs in these patients should be discouraged.
5. Dose, regimen, drug formulation, and route of administration may affect the achievement of therapeutic goals for individual patients. Accordingly, at the population level, access to an adequate range of formulations or guidelines for preparing needed formulations (e.g., compounded preparations) is necessary for prescribers to consider patient variability.
6. Communication of the treatment program to the patient, his or her representative, and involved health professionals, as well as its inclusion in the patient record, is essential to achieving therapeutic goals for the individual patient. Communication must be two-way, with health professionals providing information about the use of medicines and patients informing health professionals about their use of herbals, over-the-counter medicines and other matters. Communication tools should include providing patient-specific written and oral information. At the population level, evaluation of effectiveness of educational information and compliance with the treatment program is necessary. Information about individuals in population level data is also privileged and confidential as specified in applicable standards and statutes.
7. Individual patient therapy should undergo continuous monitoring by health care providers to assure adjustments (alternate dosage regimen, drug formulation, and route of administration, alternate drug) or discontinuance of drug use can be made, as necessary, to achieve specific therapeutic objectives for the patient. At the population level, treatment monitoring should aggregate and evaluate data to improve the quality of care and to determine whether satisfactory outcomes are achieved for the use of drugs in specific health conditions particularly those involving significant public health consequences (e.g., AIDS, Tuberculosis, and antimicrobial resistance).
8. When alternative drugs or therapies have similar expected risks and benefits, costs may be an appropriate determining factor in choosing drugs for an individual patient. At the population level, access and coverage decisions for pharmaceutical products should be based on analysis of overall health care costs and outcomes, rather than impact on the pharmaceutical budget alone.