CSHP has heard from CSHP members that their requests to obtain nonmarketed drugs through the Special Access Programme (SAP) have met with an increased rate of rejection within the last year and that decisions are delayed longer than usual relative to the target processing time of 24 hours, in some cases compromising patient safety.
Background
At its meeting on October 21, 2016, the CSHP Board has asked its Executive Officers to advocate a more reliable request process with the SAP.
In January 2017, CSHP sought specific examples of difficulties and positive experiences with SAP from select groups of CSHP members.
On January 30, 2017, CSHP met with the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) and the Director General of the Therapeutic Products Directorate (TPD) at Health Canada. The TPD Director General informed CSHP of recent changes in the process used by the SAP to allow access to unauthorized drugs. Before sending a letter of denial, an SAP pharmacist is now contacting the prescriber by telephone to discuss the reasons for the decision. CSHP then illustrated concerns raised by its members about the process to obtain nonmarketed drugs from SAP with a few examples of problematic requests. The summary of the 171 de-identified examples of positive experiences with SAP and suggested areas for improvement was shared with the HPFB Assistant Deputy Minister and the TPD Director General.
On Monday, April 10, 2017, CSHP met once more with the TPD Director General and representatives from the SAP to continue the conversation about possible further improvements to the SAP.
Key Messages from CSHP