Given the scale of change, the pharmacy
department followed its change control procedures
(the main steps and key messages for the switch are
summarised in Table 1).
Managing the transition
Given the complexity of the switch, change control
procedures were followed to cover the following
elements:
Description and reason for change
Provided staff with a rationale for the change being
undertake, including:
• The value of utilising a licensed infusion as per
guidance from the Medicines and Healthcare
products Regulatory Agency (MHRA) 6
• Reducing the need for aseptic dispensing of
infusions (on site or via an outsourced provider)
to release capacity for other therapies, given
ongoing growing demand for parenteral
chemotherapy
• Longer shelf life of infusions, maximising
potential to re-use if late dose changes/deferrals.
Objectives of the change
• Safe transfer from 38mg/ml vials for in-house
aseptic dispensing and outsourced unlicensed
infusions to licensed infusions and 100mg/ml vials
for in-house aseptic dispensing where licensed doses
are not available
• Align gemcitabine prescribing with a single national
dose standardisation table, which was built into
ChemoCare ® e-prescribing as our default means of
dosing.
Risk assessment (impact of change)
• Managing risk of mis-selection of vial
concentrations (38mg/ml and 100mg/ml) through
product segregation/staff awareness
• Managing stock control systems to prevent
automated ordering of 38mg/ml vials and unlicensed
infusions at point of transition
• Minimising waste at point of transition from
residual 38mg/ml vials and unlicensed infusions.
Action plan
• Documentation
• Training
• Equipment and facilities
• Communication
• Other actions
• Post-change monitoring.
Following this process, the following main steps
became apparent for this switch:
• Removal of automated ordering of 38mg/ml vials
and unlicensed infusions within pharmacy stock
control system
• Addition of licensed infusions and 100mg/ml
injection to pharmacy stock control system
• Initial order of stock (vials and infusions) in
anticipation of change
• Segregation of initial stock until time of change
• Generation and validation of aseptic
worksheets using 100mg/ml vials in anticipation
of change
• Staff education (pharmacy and nursing)
• Electronic prescribing: In addition to
automating dose banding, ChemoCare ® has the
capability to have dose-dependent volumes
when prescribing, which results in the correct
infusion volume and rate appearing on the
prescription generated without any additional
input from any staff group during busy
chemotherapy clinics.
hospitalpharmacyeurope.com | 2018 | Issue 90 | 17