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In an era of cost pressure, substituting generic drugs represents one of the main cost-containment strategies of healthcare systems. Despite the obvious financial benefits, in a minority of cases, substitution may require caution or even be contraindicated. In most jurisdictions, to obtain approval, the bioequivalence of generic products with the brand-name equivalent needs to be shown via bioavailability studies in healthy subjects. Rare diseases, defined as medical conditions with a low prevalence, are a group of heterogenous diseases that are typically severe, disabling, progressive, degenerative, and life-threatening or chronically debilitating, and disproportionally affect the very young and elderly. Despite these unique features of rare diseases, generic bioequivalence studies are typically carried out with single doses and exclude children or the elderly. Furthermore, the excipients and manufacturing processes for generic/biosimilar products can differ from the brand products which may affect the shelf-life of the product, its appearance, smell, taste, bioavailability, safety and potency. This may result in approval of generics/biosimilars which are not bioequivalent/comparable in their target population or that meet bioequivalence but not therapeutic equivalence criteria. Another concern relates to the interchangeability of generics and biosimilars which cannot be guaranteed due to the phenomenon of biocreep. This review summarizes potential concerns with generic substitution of orphan drugs and discusses potentially problematic cases including narrow therapeutic index drugs or critical conditions where therapeutic failure could lead to serious complications or even death. Finally, we put forward the need for refining regulatory frameworks, with emphasis on Saudi Arabia, for generic substitution and recent efforts toward this direction. [ABSTRACT FROM AUTHOR]

Introduction: The ambulatory care pharmacy practice in the Kingdom of Saudi Arabia (KSA) is a fairly new but evolving specialty that has provided patient‐centered care in various clinics over the past 20 years. It mainly resembles the United States in its structure and provides its services to patients mostly free of charge. The Saudi Vision 2030 and the new transformation in its health care system present many opportunities for ambulatory care clinical pharmacists with some expected challenges. Method: This is a review written by a group of experts under the Saudi Society of Clinical Pharmacy umbrella propose a definition and comprehensively review the history of ambulatory care pharmacy practice in KSA, the currently available services, potential future opportunities, and expected challenges. Results: The expert's insight would support the ambulatory care pharmacy practice in KSA, evaluate the need to expand its services, define its role, and suggest set requirements for pharmacists to be eligible to provide ambulatory care pharmacy services. Conclusion: The position statement recommendations may help legislative bodies provide a more explicit explanation of ambulatory care pharmacy services in KSA to build a more robust base structure for such services. [ABSTRACT FROM AUTHOR]