OBJECTIVES:

Drug shortages are a worldwide problem and affect all stakeholders in the pharmaceutical supply chain. The worst impact that a drug shortage can cause is afflicting patients. This study investigates the estimated clinical impact of two oncologic drug shortages: fluorouracil (5-FU) and trastuzumab.

METHODS:

Two Delphi-studies were set up: (i) 5-FU in the treatment of colon cancer and (ii) trastuzumab in the treatment of HER2-positive breast cancer. Questions regarding the alternative treatment, the remaining stock, effects of a shortage on the overall survival (OS) and progression free survival (PFS) and side effects were surveyed. For 5-FU, 20 gastroenterologists specialized in oncology were enrolled and for trastuzumab 18 gynecologists specialized in oncology.

RESULTS:

When 5-FU and its generic medicines would encounter supply problems, experts agree that capecitabine would be a valid alternative. OS and PFS will remain about the same. The perception by patients of most side effects, such as anemia, infections, diarrhea, etc. will be the same. However, when patients are treated with capecitabine instead of 5-FU, it is more likely that they will suffer from the hand-foot syndrome.

When trastuzumab and its expected biosimilars would experience supply problems, no valid alternative is available. Some experts would continue the treatment without trastuzumab, others would switch to lapatinib or trastuzumab emtansine (T-DM1). It is expected that OS and PFS will decrease enormously. Patients will experience some side effects, such as diarrhea, nausea, vomiting etc CONCLUSIONS: For most drug shortages (e.g.