OTC Proton Pump Inhibitors and the Quality Use of Medicines
The Australian Self Medication Industry (ASMI) has stated that consumers can have confidence in the safety profile and effectiveness of over-the counter (OTC) Proton Pump Inhibitors (PPIs) when they are used as recommended.
OTC PPIs are used for the relief of frequent heartburn and are taken only for a shorter duration (up to 14 days) and usually at a lower dose than prescription PPIs.
However, a study published in BMJ on the possible association between PPI use and a heightened risk of death only examined the effect of prescription PPIs, not OTC products. Prescription PPIs are typically used at higher doses and for longer durations.
As noted in BMJ, this is an observational study, so no firm conclusions can be drawn about cause and effect. Also, researchers were unable to obtain information on the causes of death and study participants who were treated with prescription PPIs were older and therefore more likely to have other serious health conditions.
Steve Scarff, ASMI Regulatory and Legal Director, said:
"OTC PPIs are effective for the short-term management of gastro-oesophageal reflux disease, which is characterised by frequent heartburn. They should be used in accordance with the label directions and if consumers have any concerns they should discuss them with their healthcare professional.
"ASMI commends the study for assessing risk in older adults whose conditions require the use of stronger PPIs under medical supervision.
"This study emphasises the value of a quality use of medicines approach - the use of the appropriate medicine for the condition, in the appropriate dose and for the correct duration," Scarff said.
The study authors wrote:
"Although our results should not deter prescription and use of PPIs where medically indicated, they may be used to encourage and promote pharmacovigilance [monitoring the side-effects of licensed drugs] and [they] emphasise the need to exercise judicious use of PPIs and limit use and duration of therapy to instances where there is a clear medical indication and where benefit outweighs potential risk."
Mr Scarff says, "In Australia there is already a robust pharmacovigilance system in place for both OTC and prescription products.
"Consumers whose symptoms persist after short-term use of OTC PPIs at the recommended dosage are advised to consult their healthcare professional."