OBJECTIVES : Cancer drugs shortages have a significant impact on patient access to essential treatment. This study shows the extent of cancer drugs shortages in Romania during 2015 - 2017 and analyses for the first time its causes. The study proposes a framework which can be used for identification of cancer drugs with high risk of shortage.

METHODS : Complains officially notified to the Romanian health authorities were obtained and analyzed. The status of pharmaceuticals reimbursed under the publicly-funded National Oncology Program was analyzed in terms of availability on the market, price and parallel trade. A decision tree to identify the risk of shortages was developed. Main causes of shortages risk were identified. The analysis was performed separately for each pharmaceutical product and generic alternatives were included.

RESULTS : During 2015 - 2017, a number of 2683 complains of shortages were registered, with a peak of 741 during the first half of 2017. Available administrative data shows that from the 113 cancer medicines analyzed, 17 INNs were temporary unavailable on the Romanian market, 8 had their market authorization withdrawn, 39 were at least once parallel traded, 9 were more expensive than in the referenced EU countries thus not complying with the national regulations on external reference pricing, and 1 was registered with manufacturing difficulties. Results at product level are also available. By applying the decision tree developed, 13 cancer drugs were identified as having a high shortage risk. Shortage risk causes were identified, with the biggest preponderance being parallel trade, followed by pricing and regulatory policies, manufacturers' commercial interest and manufacturing difficulties.

CONCLUSIONS : Cancer drugs status should be periodically monitored in order to identify those with a high shortage risk and to enable early mitigation actions of the highly negative shortages impact on patients. Policy tools and frameworks can be developed to implement proactive mechanisms.