s awareness and education with respect to the safe and appropriate use of medicines with special attention to OTC medicines Regulatory view EDQM Expert workshop: OTC medicines: The role of good classification practices promoting medication safety and accessibility in Europe Zagreb 20 21 November 2014 Presented by: Zaide Frias Head of Human Medicines Research & Development Support Division (ad interim) An agency of the European Union
Network of European patients / consumers organisations 36 eligible organisations by Q2/2014 2014... 1996 Building the foundation of the interaction between EMA and patients 2006 Framework of interaction with patient and consumer organisations Real life experience of patients is now routinely embedded in regulatory output Clinical practice is becoming an important element of the regulatory process 1
involvement in EMA activities involvement in SAGs Public Consultation Orphan Designation representation in COMP = 2 2 Scientific Advice protocol Assistance Involvement Paediatric Investigation Plan Evaluation CHMP representation in PDCO = 3 representation in PRAC = 1 representation in CAT = 2 MA and Product Information involvement in review Market and patient access PA
involvement in EMA activities 551 interactions with patients in 2013 s systematically review package leaflets and EPAR summaries 3
Risk/Benefit of Non-prescription Additional benefits: rapid access, reduced absences efficient use of doctor s time healthcare budgets Well known safety profile 4
Risk/Benefit of Non-prescription A different perspective R/B known in Rx setting only Masking underlying conditions Self-assessment Understanding CI/warnings/ Role of pharmacist Perception that is safer Incorrect use 5
EMA - Centrally authorised switches orlistat Suma- triptan Esomeprazol Pantoprazol IBU/ DiPH sildena fil alli Nexium control Controloc Control 6
Nexium Control 20 mg (OTC) Short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. Section 4.2: treatment: up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor Nexium 10mg granules, 20mg, 40mg tablets, 40 mg iv (Rx) Gastroesophageal Reflux Disease (GERD); Treatment of erosive reflux esophagitis; Prolonged treatment after i.v. induced; Prevention of rebleeding of peptic ulcers Treatment of Zollinger Ellison Syndrome Pack sizes: up to 140 tablets Pack sizes 7, 14 tablets 7
alli 60mg (OTC) Weight loss in adults who are overweight (body mass index, BMI, 28 kg/m 2 ) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet. CIs: under 18s, pregnant / breastfeeding, concomitant medication Take special care with alli: diabetes, renal impairment Interactions : ciclosporine, oral anticoagulants, oral contraceptives, Levothyroxine, fat soluble vitamins, amiodarone, etc. Xenical 120mg (Rx) Indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors. 8
Pantozol Control 20mg (OTC) 1) Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. Section 4.2: The treatment should not exceed 4 weeks without consulting a doctor. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Pack sizes: 7,14 Pantozol 20 mg (Rx) 1) For the treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). 2) For long-term management and prevention of relapse in reflux oesophagitis. 3) Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4). Pack sizes:14,15, 28, 30, 56, 60, 98, 98 100 9
Challenges ahead Identify when regulators should get views from individual versus patient community Develop means to identify and manage differences of view between patients and between patients and other stakeholders Ensure that patients and healthcare professionals views come from independent sources Research how to collect and use the wealth of information available from patients and healthcare professionals in post-marketing phase 10