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There are several clinical areas or types of drugs that make prescribing branded drugs preferable, because of potential therapeutic inequivalence or confusion. Bioequivalence criteria may be fine for most drugs, but some conditions may require drug levels with modified variations, like in the case of narrow therapeutic index and critical dose drugs, highly variable drugs and modified-release formulations. Moreover, substitution with generics can be problematic in some patient subpopulations, such as elderly frail people, immunocompromised and transplant patients and patients with epilepsy. We include a list of branded drugs that are considered safer, more effective or with a lower risk of error. The therapeutic substitution is markedly different from therapeutic interchange. The replacement of a brand product with an equivalent has to occur under the control of the physician. At some point in their interaction with individual patients, physicians should let them know that generics are available as substitutes for the more expensive brand-name medications and are equivalent in terms of efficacy and safety. Finally, we hope that a tool like the American Orange book will be also implemented in Italy: it would serve as an accurate reference, that can be useful both to physicians for prescription appropriateness and to patients for their own informed consent. [ABSTRACT FROM AUTHOR]

A lot of issues have been raised to argue that equivalent drugs may not work as well or at least the same as what the drug industry likes to call innovator products. Many doubts and biases are also reported in connection with the use of generic drugs. Doctors are mostly concerned about their efficacy, their tolerability, the quality and amount of active ingredients, their formulation or excipients, their packaging, their pharmaceutical form and their palatability. We describe the differences between prescribability (equivalence when prescribing a drug to a patient for the first time) and switchability (interchangeability of drugs for a patient already in treatment) considering the notions of average bioequivalence, population bioequivalence and individual bioequivalence as well as the usefulness of the U.S. Orange Book in the assessment of bioequivalence. Other key issues deserve attention, such as: duplicate applications for medicinal products, different salt forms, formulations used in the development of each medicinal product and excipients, product quality. Clinicians in collaboration with pharmacists and research pharmacologists have to find solutions for unanswered questions and unsolved doubts, by developing targeted studies, communication tools and shared guidelines. [ABSTRACT FROM AUTHOR]

The article reports the results of an observational study conducted in 53 internal medicine departments of the Emilia Romagna region based on the answers to 54 questions administered in a questionnaire, submitted electronically, based on the type of center (large >250 beds, small <250 beds), laboratory equipment, management aspects, pharmacological and clinical/economic aspects and use of antibiotics in the empirical treatment of severe infections. The result is a snapshot of the existing situation which shows a substantial availability of resources and a good level of expertise in the field of infectious disease management, despite some areas still need improvement. It also highlights some differences in terms of procedures amongst large hospitals, where infectious diseases are treated by an ad hoc specialized staff, and the small ones, where the internist is generally involved, being responsible for both direct management of severe infections and giving advice to other departments (emergency or surgery). It emerged that, both in small and large hospitals, more discussion and continuous assessment are needed to apply the appropriate protocols based on reference checklists. [ABSTRACT FROM AUTHOR]