Quality of medicines in Portugal: a retrospective review of medicine recalls (2005-2015) Ana Teresa Reis Bruna Berardo Rui Loureiro
Introduction Human medicines Cosmetics Veterinary medicines Medical devices Herbal and homeopathic medicines Other health products
Introduction Human medicines Cosmetics Veterinary medicines Medical devices Herbal and homeopathic medicines Other health products
Introduction INFARMED Alerts Quality Alerts Safety Alerts Medicinal Products Other Health Products Human Medicine Recall Alerts
Materials/Methods o INFARMED website Quality Alerts 2005-2015 o Excel database File number Issuing date Drug name and Dosage Generic Comercially available MA Status MAH No. batches affected Expiry Date Shelf Life Time on the Market Pharmaceutical Dosage Form Quality Defect Issuing Agency Voluntary/Mandatory recall Notes
Materials/Methods o Item Time on the Market Expiry Date Shelf Life = Production Date Alert Issuing Date Production Date = Time on the market 0-6 months 7-12 months 13-18 months 19-24 months 25-30 months 31-36 months > 36 months
Materials/Methods o Item Pharmaceutical Dosage Form Oral Solids Tablets Capsules Lozenges Powders and/or granules for oral suspension/oral solution Liquids and Semi-solids Injectables Creams Ointments Gels Cutaneous solutions Transdermal systems Eye drops, eye ointments Powders for inhalation Pressurized inhalation solutions Oral suspensions and solutions Syrups Oral gels Oral drops Mouth solutions Solutions for gargling Ovules Vaginal ointments Rectal suppositories Rectal ointments
Total Alerts Issued (2005-2015) n = 1115 60 Total Alerts other Health Products Total Medicine Alerts Medicine Recall Alerts Other Medicine Alerts 617 498 338 160 Total Alerts other Health Products Total Medicine Alerts Medicine Recall Alerts Other Medicine Alerts
Frequency Total Medicine Quality Alerts / Total Medicine Recalls 80 70 70 68 60 57 50 40 30 20 34 26 24 19 49 31 27 36 32 40 34 45 46 47 29 33 30 35 24 10 0 YEAR MEDICINES QUALITY ALERTS MEDICINE RECALLS
Frequency Total Medicine Quality Alerts (2005-2015) 80 70 60 70 68 57 50 40 30 47 46 45 40 36 34 31 24 20 10 0 YEAR
Frequency Total Medicine Quality Alerts (2005-2015) 80 70 60 70 68 57 50 40 30 47 46 45 40 36 34 31 24 20 10 0 YEAR
Frequency Total Medicine Quality Alerts / Total Medicine Recalls 80 70 70 68 60 57 50 40 30 20 34 26 24 19 49 31 27 36 32 40 34 45 46 47 29 33 30 35 24 10 0 YEAR MEDICINES QUALITY ALERTS MEDICINE RECALLS
Alerts Issued 1115 quality alerts were issued between 2005 and 2015 Production No. Medicine Quality Alerts issued Regulatory agencies awareness Pharmaceutical Industries awareness
No. of Recalls per Marketing Authorisation Holder MAH No. Recalls Sandoz 15 Generis 13 B. Braun Labesfal GlaxoSmithKline Janssen 12 Baxter 10 Sanofi Teva Pharma 9 Laboratórios Basi Mylan Ratiopharm Roche Schering Plough Farma 8 MAH Grünenthal Jaba Pfizer Novartis Wynn Actavis Alter Bristol-Myers Hospira Octapharma Pierre Fabre ToLife UCB Pharma No. Recalls 7 6 5 MAH Bayer Laboratórios Azevedos Pentafarma Ranbaxy Portugal Alexion Europe SAS Almirall Angelini Bluefish Farmacoquímica Baldacci Ferring Portuguesa Gilead Sciences Laboratório Medinfar Lundbeck Portugal Mallinckrodt Medical BV Tecnimede No. Recalls 4 3
No. Alerts issued Alerts Issued 300 294 200 100 0 Infarmed 6 UK 6 Spain 6 France 5 Germany 4 EMA 4 Italy 4 Denmark 9 Other
No. of defects Quality Defect Origin 237 200 100 45 46 0 Pharmaceutical Form Primary Packaging Secondary Packaging 1 4 3 2 Packaging Regulatory Affairs Other N/A
Affected Medicinal Products by Pharmaceutical Form 36% 45% Oral Solids Liquids and Semi-solids Injectables 19%
Recall Causes / Type o Product recall causes: 1. Pharmaceutical Dosage Form 2. Packaging problems o Pharmaceutical Dosage Form 36 % Injectables 45 % Oral Solids Pharmaceutical Industry concern with product s quality 87% (338) Voluntary recalls Efficient detection of quality issues
Number of Batches 29 1 batch 2 batches 3 batches 4 batches All product batches 78 158 26 47
Time on the Market 31-36 months 7% > 36 months 7% 0-6 months 17% 25-30 months 8% 19-24 months 18% 7-12 months 21% 13-18 months 22%
AUTHORS Ana Teresa Reis Bruna Berardo Rui Loureiro o QUESTIONS?
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