ACMS in­creases PPI ac­cess

Pharmacy Daily - - NEWS -

WIDELY used pro­ton pump in­hibitor (PPI) es­omepra­zole has been rec­om­mended for re­laxed sched­ul­ing by the Ad­vi­sory Com­mit­tee on Medicines Sched­ul­ing (ACMS), to en­hance ac­cess un­der cer­tain con­di­tions.

The Com­mit­tee de­cided that the prod­uct be sched­uled S2 in oral prepa­ra­tions con­tain­ing 20 mg or less of es­omepra­zole for the re­lief of heart­burn and other symp­toms of gas­tro-oe­sophageal re­flux dis­ease, in packs con­tain­ing not more than 14 days’ sup­ply.

The ba­sis of the de­ci­sion rested on over­seas data (UK and US) demon­strat­ing the safety and ef­fec­tive­ness of 14 days’ ther­apy com­pared with just seven days to­gether with the fact that the less ef­fec­tive H2RA al­ter­na­tive ran­i­ti­dine which is al­ready un­sched­uled (seven days’ sup­ply) or S2 (14 days) can be sub­ject to pa­tient tol­er­ance is­sues and is in­fe­rior in in­hi­bi­tion of food-stim­u­lated acid se­cre­tion.

The use of 14 days’ ther­apy with es­omepra­zole has also been demon­strated to pro­vide im­proved sleep qual­ity, work pro­duc­tiv­ity and func­tion­al­ity re­sult­ing from the ef­fec­tive re­lief of the symp­toms of heart­burn and acid re­flux.

Ac­cess to a 14-day pack was also deemed to be more cost-ef­fec­tive than two seven day packs.

In other de­ci­sions, PDE5-in­hibitors silde­nafil and var­danafil for erec­tile dys­func­tion are to re­main S4 for safety rea­sons, given that “phar­ma­cies do not have ad­e­quate screen­ing fa­cil­i­ties to man­age the risks as­so­ci­ated with the use of th­ese prod­ucts”.

Sim­i­larly, the ACMS said the cur­rent sched­ul­ing of ibupro­fen com­bined with parac­eta­mol “re­mains ap­pro­pri­ate”.

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