A pharmacy service wants to use a licensed vaccine outside its marketing-authorisation age range. A locally authorised PGD explicitly describes that

Question

A pharmacy service wants to use a licensed vaccine outside its marketing-authorisation age range. A locally authorised PGD explicitly describes that off-label use and its evidence base. Which statement is correct?

Accepted Answer

Include it only when off-label use is clearly stated and justified by best clinical practice

Answer

Exclude it because every use outside the marketing authorisation requires a PSD

Answer

Include it only after replacing the licensed product with an unlicensed equivalent

Answer

Extend the PGD age range locally whenever the patient gives written consent

Answer

Include it whenever the practitioner records verbal authorisation from the PGD author

PGD supply suitability — GPhC CRA MCQ

A pharmacy service wants to use a licensed vaccine outside its marketing-authorisation age range. A locally authorised PGD explicitly describes that off-label use and its evidence base. Which statement is correct?