A shortage of protamine, an essential drug to reverse heparin's effects in heart surgeries, has forced private clinics in Chile to suspend elective procedures. The scarcity stems from issues with the sole registered supplier, BPH S.A., which is struggling to release batches of the medication. While the public sector reports no suspensions, private institutions urgently seek state support.
Various surgery units in Chile's private sector have warned of a protamine shortage, a key antidote used to counteract the anticoagulant effects of heparin during open-heart operations and renal dialysis. According to the Public Health Institute's datasheet, protamine is administered via slow intravenous injection to avoid adverse reactions, guided by blood coagulation tests or neutralization assays, and requires post-administration monitoring in cases of excessive bleeding or overdose.
La Tercera confirmed that the supply disruption arose after notification from BPH S.A., the only company with a valid sanitary registration in the country, which reported 'low availability' due to difficulties releasing a batch of the drug. This has led to the postponement of elective surgeries in private clinics, prioritizing only emergency cases. The company, which avoids mentioning a total stock break, states it is importing the product and distributing it on a limited basis, favoring the public network and critical conditions across all institutions, including private ones.
Given the impact on operating rooms, private providers have requested the Subsecretaría de Redes Asistenciales to facilitate stock supply from the Central Nacional de Abastecimiento (Cenabast) and expedite Public Health Institute procedures for rapid imports. In a joint response, the Subsecretaría and Cenabast confirmed that 'no public health facility or Service has informed or alerted us of protamine shortages or issues,' though they acknowledge the private sector problem due to support requests.
They are currently gathering data on national and Cenabast stocks to assess actions. 'Considering that protamine has only one supplier in our country and the time of year, we will likely face a tight stock,' they note, adding that Cenabast is quoting 12,000 doses and evaluating therapeutic alternatives. Notably, BPH S.A. was fined 200 UTM in 2023 by Santiago's 21st Civil Court for marketing contaminated potassium chloride ampoules, a rehydration product showing visible foreign particles, per ISP inspectors.