Medication Recall process:

1. Any medication (drug) recalls received by the CEO, Medical Staff, Nursing Staff or any Pharmacy staff must be passed on to the Director of Pharmacy (or the most senior pharmacist) as soon as is practicable.

2. If stock affected by the recall is kept at Ballarat Health Services (BHS) the Director of Pharmacy (during normal working hours) or the On-Call Pharmacist (after hours), as the delegate, will assess the recall to determine its urgency and the response required. This will range from an immediate organisational response (via a Code Yellow), in consultation with the Patient Flow Coordinator (PFC), to a lesser response involving pharmacy staff members conducting a review of stock.

• Urgent recalls will require stock to be removed as soon as is practicable. Refer also to section "Urgent and serious recalls" section below.
• Non-urgent recalls will have stock checked and removed by Pharmacy staff within one working day of receipt of the recall.
• Agencies external to BHS, or with a contracted community pharmacy service, will be responsible for conducting their own checks.
• The Director of Pharmacy or delegate will notify affected areas of BHS (and external agencies where appropriate) to alert them of the recall, and include any relevant details or a copy of the recall notice.
• Notification will be by way of phone call / fax, and/or email, depending on the method of recall and the urgency of the recall.
• The notification will include details of potential patient harm from the recalled stock, the action to be taken by the Pharmacy or BHS staff and any ongoing stock issues.
• A copy of the alert is to be kept with the completed Appendix 1- BHS Medication Recall Tool in the pharmacy "Drug Recall" electronic folder, and in hard copy in the Director of Pharmacy office.
• External agencies where the affected product has been supplied are to be telephoned with the details as well as faxing/emailing the alert to ensure they are aware of the recall and that they will return all affected stock to BHS.

3. The Director of Pharmacy (or their delegate) will be responsible for coordinating the checking and removal of affected stock. 

• Support to this process may be provided by the Pharmacy Clerk (Purchasing), the Distribution Technician, Ward Pharmacists and Nursing Staff where applicable.
• The replacement of the stock (when non recalled stock is available) is also to be undertaken.
• See Appendix 1- BHS Medication Recall Tool to record and facilitate this process. Once completed this form is to be filed in the Drug Recall folder in the Pharmacy Office.

4.    The Pharmacy Clerk, or Pharmacy Technician is to print a stock movement report to track stock movements.  iPharmacy imprest lists, distributions and script register (where appropriate) will also need to be checked in order to determine locations where the stock may have been issued. Depending on the type of product being recalled, patient medication drawers may also need to be checked.

5.    If the Recall Notice has instructions to contact patients, to notify them of the recall then this will need to be undertaken.

Patients who have had the product dispensed to them can be identified by using the stock movement report, the iPharmacy Product Details screen or the Script Register search function.

6.    Pharmacy staff are to return affected stock (with quantity and location added to the BHS Medication Recall Tool) to the Storeperson or other staff member as nominated by the Director of Pharmacy.

• The stock will be quarantined in bags or boxes clearly labelled "Medication recall - quarantined. Do not use".
• Areas checked, and not holding any affected stock, must also be indicated on the Tool.
• If the affected products are on ward stock, then the Distribution Technician will be responsible for coordinating the reissuing and recording of replacement stock, and forwarding a copy of the completed Tool to the Director of Pharmacy.

7.    The Recall Notice is then to be published on the Pharmacy page of the BHS Intranet, with a copy to be kept on the pharmacy shelving.

8.    If notification to the Supplier / Sponsor of the product is required, this will be sent by the Pharmacy Clerk. 

• A copy of the fax confirmation will need to be kept with this paperwork. 
• If the recalled stock requires returning to the Supplier, then this will be coordinated by the Pharmacy Clerk with the support of the Pharmacy Storeperson. 
• This also involves completing any paperwork sent by the manufacturer with the medication recall.
• A copy of this paperwork is to be kept with the BHS Medication Recall Tool.
• Record in the comments section of the tool a note of what stock was returned to the manufacturer, and when credit or new stock was received.

1. Director of Pharmacy or delegate briefs pharmacy team on details of withdrawal and where possible  allocates staff to remove affected medication from wards, departments, and pharmacy stock as soon as possible as per recall procedure above.

2. Director of Pharmacy or delegate notifies Ballarat Base Hospital Campus Patient Flow Coordinator (PFC) of the alert, required actions & to determine if a Code Yellow is required.  If a Code Yellow is called – standard processes for notification of the code by the PFC will apply.

• If necessary the Sub-Acute & RACS facilities will be notified
• The Patient Flow Coordinator, or Director of Pharmacy will alert the Manager: Emergency Management to provide support & assistance to the response
• If applicable on duty medical staff can be notified with a group page from switchboard, in additional to a group email from Medical Administration.

3. Director of Pharmacy, or delegate, notifies Executive Director of Medical Services (or Executive on call) and discusses the need to call a urgent briefing of Ward Team Leaders (Nurses in charge)

4. If an organisational briefing session is required, the follow action is to follow;

• Pharmacy instructs switchboard operator to overhead page the following message;

                  i.    “Attention All Ward Staff. Could all Nurses in charge of wards and departments please attend the ERC in 10 minutes for an urgent briefing”

                 ii.    Instruct switchboard operator that emergency chimes are not required