60 Seconds with Louise Morshead
In this 60 second interview Quality and Regulatory Affairs Pharmacist, Louise Morshead, talks about the steps UL Medicines takes to ensure the right paperwork reaches the pharmacist and patient.
What is the most common documentation question asked by hospital pharmacists and technicians?
We regularly get asked to clarify the differences between a Certificate of Analysis (CofA) and a Certificate of Conformity (CofC), or a Patient Information Leaflet (PIL) and a Summary of Product Characteristics (SPC).
Other questions commonly asked include, when wouldn’t the pharmacy team receive a CofA with their imported medicine? What is a TSE certificate, and when is it required?
To help pharmacists with their documentation questions, we have covered all these questions in our lead article, Documentation for Unlicensed Medicines: Your Questions Answered.
What steps are taken to ensure non-English PILs are accurately translated?
When we introduce a new product to the over-labelling portfolio, we send the non-English PIL to our approved translation company. Once the translated PIL has been received, we perform a series of checks to verify that it is an accurate translation with no omissions from the original text. We then code it, create a label and an over-labelling specification.
As the product’s marketing authorisation holder in the country of origin may update the PIL at any time, each time we receive one of our over-labelled products through goods-in, it is diverted for a quality check. This enables us to confirm we still have the most recent PIL translation.
If we identify a change in the PIL, we send it for translation again and perform our checks on its return. Once approved, we update the code to a new version. We also revise and update the related labels and specification.
Each non-English PIL translation must undergo version-control and be professionally certified to ensure accuracy. Translated labelling and PILs ensure instructions remain clear for the patient (and carers), and Healthcare Professionals to help ensure the medicine is taken correctly. Without clear instructions, patients could be at risk of taking the medicine incorrectly or overlooking relevant side effects, or contraindications.
How should a hospital go about securing the required documentation from an unlicensed medicines supplier?
It is the responsibility of the pharmacy team to check they have received all the supporting documents from an unlicensed medicines supplier, if not they will need to request it. Supporting documentation provides the evidence of the purchasing specification i.e. the prescriber’s requirements meet appropriate pharmaceutical quality, and suitability for the patient. The Marketing Authorisation (MA) holder may also supply the appropriate paperwork for imported medicines. Documents may include:
* Certificate of Analysis
* Certificate of Conformity
* Summary of Product Characteristics
* Patient Information Leaflet
How does UL Medicines ensure hospital customers get the most up-to-date documentation?
UL Medicines always supply the most up-to-date documentation with every delivery. Registered customers also have 24/7 access to download the latest versions of product documentation direct from our website, including a CofA and a SPC. Register here to gain access.
If you have any further questions about the key documents required for unlicensed medicines, call free on 0800 112 3363 or email firstname.lastname@example.org.