Table 1.
Timeline of Events Regarding IV APAP.
| Date | Events |
|---|---|
| November 2010 | IV APAP (Ofirmev) approved by the Food and Drug Administration |
| January 2011 | IV APAP commercially available in the United States |
| April 2011 | IV APAP added to institutional formulary with restrictions: Patients unable to take oral APAP, or if a pediatric patient, unable to take oral or per rectal administration of APAP. Use is limited to 24-hour use unless approved by Pain Service. The use will be assessed at 3 months to determine if additional restrictions are necessary. |
| July 2011 | PDSA 1: Reviewed institution usage per restriction criteria and cost (planned medication use evaluation) Revised restrictions to: Restricted to patients who cannot take anything by mouth, including medications, food or water (strictly nil per os), unless approved by the hospital pain service or anesthesia. |
| May 2014 | IV APAP price increased from $12/g to $33/g |
| June 2014 | PDSA 2: Performed MUE and reviewed restriction criteria Surveyed other academic medication centers regarding IV APAP formulary status and restrictions Elected to keep IV APAP on formulary but revised restrictions: Each order is restricted to 24 hours. Order must be reentered every 24 hours. |
| September 2016 | PDSA 3 Revised restriction criteria to: Patients unable to take PO/PFT AND neutropenic (ANC <500) OR Patients unable to take PO/PFT AND also unable to receive per rectum (eg, surgical removal of rectum). |
| January 2017 | PDSA 4 Revised restriction criteria to: Patients unable to take PO/PFT AND neutropenic (ANC <500) OR Patients unable to take PO/PFT AND also unable to receive per rectum (eg, significant rectal pathology, psychosocial concerns, <5 kg) |
| April 2017 | PDSA 5 Revised restriction criteria to: Patients unable to take PO/PFT AND neutropenic (ANC <500) OR Patients unable to take PO/PFT AND also unable to receive per rectum (eg, significant rectal pathology, history of sexual abuse, <5 kg) |
Note. IV = intravenous; APAP = acetaminophen; PDSA = Plan-Do-Study-Act; MUE = medication use evaluation; PO/PFT = oral/per-feeding-tube; ANC = absolute neutrophil count.