Clinicians preparing compounds for patients is as old as humanity. Today, compounding is a pharmacy practice that enables medicine customization for patients who need ingredient, dosage, or delivery modifications. Compounding also enables health care organizations to respond to critical drug shortages. This theme issue canvasses prospective benefits and harms of prescribing and dispensing compounded medicines and suggests practice and policy changes that can support organizations, prescribing clinicians, and pharmacists execute their duties to keep patients and members of the public safe.
When clinicians prescribe customized, compounded medicines for their patients, they usually do so with an expectation that the prescribed compound will safely prepared and administered, but this is not always the case. Injuries, illnesses, and deaths since around the year 2000 have generated lawsuits, which have generated regulatory changes from the Food & Drug Administration (FDA) and practice guidelines from US Pharmacopeia. An upshot is that alternatives to conventionally manufactured drug products—even those that contain FDA-approved products as ingredients—can pose substantial and numerous risks of which many patients and prescribing clinicians are not aware. When prescribing clinicians drive patients to compounding pharmacies to fill their prescriptions, what should those clinicians know about those ingredients’ sources and preparation practices? Should the scope of prescribing clinicians’ duties now include verifying that their patients’ compounded medicines contain what they prescribed and expected?
We welcome wide-ranging manuscripts investigating regulatory gaps and describing how sterility, purity, or potency of what is sourced, prepared, and dispensed to patients in some compounding pharmacies can be compromised. This issue also looks to pose key ethical, clinical, legal, and policy-level questions about national and international active ingredient and excipient supply chains used by some pharmacies; consider which values should guide compounding practices; and canvass strategies for how all clinicians—especially prescribing clinicians and practicing pharmacists—might collaborate to promote the prescription, preparation, and dispensing of quality medicines.
Manuscripts submitted for peer review consideration and inclusion in this issue must follow Instructions for Authors and be submitted by 30 June 2025.
The AMA Journal of Ethics® invites original, English-language contributions for peer review consideration on the upcoming themes.