Abstract

Abstract: 

Hospital pharmacies play a vital role in healthcare systems worldwide, compounding drug products (DPs) to meet demand, address specific clinical needs, and ensure continuity of treatment—particularly in cases of market shortages or withdrawals, unavailable active pharmaceutical ingredients (APIs), or individualized therapies such as weight-based dosing for infants. Compounding occurs in two main forms: nominal preparations, short-term formulations tailored to individual prescriptions, and batch compounding, larger-scale preparations stored for extended periods to streamline intravenous services and ensure timely access to commonly needed formulations.

A critical yet overlooked challenge lies in batch compounding: the widespread off-label use of plastic primary packaging. Driven by limited awareness, cost pressures, and regulatory gaps, packaging designed and validated for acute, short-term use is frequently repurposed for long-term storage. Safety data generated by medical device manufacturers apply strictly to intended use and cannot be extrapolated to extended applications. This practice creates conditions under which potentially harmful leachable compounds are completely unmonitored and may migrate into drug formulations, with direct implications for patient safety.

The risks are global and disproportionately affect vulnerable populations. Neonates, infants requiring frequent parenteral or ophthalmic administration, and oncology patients undergoing long-term therapy face heightened exposure to unassessed leachables. Furthermore, batch compounding can sometimes be of semi-complex to complex galenical formulations, which may exacerbate extraction of plastic-related substances, amplifying the risk.

Urgent action is needed. Raising awareness among healthcare professionals, regulators, and industry leaders, conducting analytical and toxicological evaluations of batch compounding, and enforcing evidence-based regulation of plastic packaging are essential steps. Addressing this overlooked issue is critical to safeguarding vulnerable patients and protecting public health worldwide.