Additional Update Lecture

Question 1

What are the additional regulations (2019) that supplement the Falsified Medicines Directive?

Answer 1

• new security features on individual packs

- new electronic scanning authentication process, to be undertaken at the point of dispensing

Question 2

What are the new security featured of the additional regulations of FMD?

Answer 2

• Unique Identifier (2D barcodes)

- Anti Tampering Device - to verify if a pack has been tampered with

Question 3

What is the scanning authentication process?

Answer 3

• manufacturers upload the unique identifier onto a central European hub
• the information is then accessed by a National Medicines Verifications System

Question 4

What types of medicinal products does the Falsified Medicines Directive apply to?

Answer 4

• POMs for human use
• NHS and Private Supplies

NOT for

• OTC medicines
• Medical Devices
• Specials
• Vet Medicines

Question 5

Who is responsible for the Falsified Medicines Directive?

Answer 5

• pharmacy owners/superintendent pharmacist

- GPhC inspectors

Question 6

What schedule is Gabapentin and Pregabalin as of 2019?

Answer 6

Schedule 3

Question 7

Gabapentin and Pregabalin now have to fulfil the same prescription requirements as a Schedule 2 - true or false?

Answer 7

TRUE, prescription requirements for Schedule 2 and 3 are the same

strong requirement that a prescription shouldn’t exceed 30 days

Question 8

Gabapentin and Pregabalin now have to be kept under safe custody - true or false?

Answer 8

FALSE

only Schedule 2 have to be kept under safe custody