How can real‐world evidence aid decision making during the life cycle of nonprescription medicines?

Abstract

is an employee of Bayer Consumer Healthcare o Christelle Anquez-Traxler is an employee of AESGP, the Association of the European Self-Care Industry, which represents the manufacturers of nonprescription medicinal products, self-care medical devices and food supplements in Europe. The association is funded by member companies and national member associations' fees. o Matthew J Francis is an employee of The Procter & Gamble Company o Larry Ma is an employee of Johnson & Johnson o Denise Teotico Pohlhaus is an employee of GSK Consumer Healthcare o Sabine Landes is an employee of Sanofi-Aventis Germany Medical writing support was provided by Dr James Walmsley (Snakestick Ltd).

Self-Medication for the Treatment of Abdominal Cramps and Pain—A Real-Life Comparison of Three Frequently Used Preparations

“…HBB [ 7 , 9 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ], PLUS [ 9 ] and PO [ 8 , 25 ] have proven effectiveness in controlled trials, compared with a placebo for each of them. However, based on the trial setting and on the inclusion and exclusion criteria such randomized, controlled trials are not helpful to reflect real-world conditions in OTC settings where they are inherently dispensed without the involvement of a prescribing physician [ 26 ]. On the other hand, PBPS are established tools in the evaluation of OTC products and were used in real-world trials in various indications including functional bowel disorders [ 10 ], headache and migraine [ 11 , 14 , 27 ], or cough and cold [ 12 , 13 ].…”

Safety of fexofenadine and other second-generation oral antihistamines before and after the removal of the prescription requirement in Italy and other European countries: A real-world evidence study and systematic review

“…Opportunities for real-world studies include the validation of OTC drug safety and efficacy, monitoring real world outcomes, and examination of when/why consumers purchase and use these products; consequently, such studies may have a powerful impact on decision-making surrounding non-prescription medicines. 53 …”

Self-Medication for the Treatment of Abdominal Cramps and Pain – a Real-Life Comparison of Three Frequently Used Preparations

“…HBB (7,9,(18)(19)(20)(21)(22)(23)(24), PLUS (9) and PO (8,25) have proven effectiveness in controlled trials as compared to placebo for each of them. However, based on the trial setting and on the inclusion and exclusion criteria such randomized, controlled trials are not helpful to reflect the real-world in OTC settings where they are inherently dispensed without involvement of a prescribing physician (26). On the other hand, PBPS are established tools in the evaluation of OTC products and were used in real-world trials in various indications including functional bowel disorders (10), headache and migraine (11,14,27) or cough & cold (12,13).…”