Quality of medicines in Portugal: a retrospective review ... · Farmacoquímica Baldacci Ferring...
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Quality of medicines in Portugal: a retrospective review of medicine recalls (2005-2015) • Ana Teresa Reis • Bruna Berardo • Rui Loureiro
Transcript of Quality of medicines in Portugal: a retrospective review ... · Farmacoquímica Baldacci Ferring...
Quality of medicines in Portugal: a retrospectivereview of medicine recalls (2005-2015)
• Ana Teresa Reis
• Bruna Berardo
• Rui Loureiro
Introduction
Human medicines
Veterinary medicines
Herbal and homeopathic
medicines
Other health products
Medical devices
Cosmetics
Introduction
Human medicines
Veterinary medicines
Herbal and homeopathic
medicines
Other health products
Medical devices
Cosmetics
Human medicines
Introduction
INFARMED Alerts
QualityAlerts
Medicinal Products
Other Health Products
SafetyAlerts
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
Liquids and Semi-solids
Injectables
• Tablets• Capsules• Lozenges
• Powders and/or granules for oral suspension/oral solution
• …
• 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)
160
Total Alerts other Health Products
Total Medicine Alerts
Medicine Recall Alerts
Other Medicine Alerts
617
338
160
498
Total Alerts other Health Products
Total Medicine Alerts
Medicine Recall Alerts
Other Medicine Alerts
n = 1115
Total Medicine Quality Alerts / Total Medicine Recalls
34
24
57
31
3640
45 46 47
7068
26
19
49
27
3234
2933
30
35
24
0
10
20
30
40
50
60
70
80
Freq
uen
cy
YEAR
MEDICINES QUALITY ALERTS MEDICINE RECALLS
Total Medicine Quality Alerts (2005-2015)
70 68
57
47 46 4540
36 3431
24
0
10
20
30
40
50
60
70
80
Fre
qu
ency
YEAR
Total Medicine Quality Alerts (2005-2015)
70 68
57
47 46 4540
36 3431
24
0
10
20
30
40
50
60
70
80
Fre
qu
ency
YEAR
34
24
57
31
3640
45 46 47
7068
26
19
49
2732
34
2933
30
35
24
0
10
20
30
40
50
60
70
80
Freq
uen
cy
YEAR
MEDICINES QUALITY ALERTS MEDICINE RECALLS
Total Medicine Quality Alerts / Total Medicine Recalls
Alerts Issued
1115 quality alerts were issued between 2005 and 2015
No. Medicine Quality Alerts
issued
Production
Regulatoryagencies
awareness
PharmaceuticalIndustries awareness
No. of Recalls per Marketing Authorisation Holder
MAH No. Recalls
Sandoz 15
Generis 13
B. BraunLabesfal
GlaxoSmithKlineJanssen
12
Baxter 10
SanofiTeva Pharma
9
Laboratórios BasiMylan
RatiopharmRoche
Schering Plough Farma
8
MAH No. RecallsGrünenthal
JabaPfizer
7
NovartisWynn
6
ActavisAlter
Bristol-MyersHospira
OctapharmaPierre Fabre
ToLifeUCB Pharma
5
MAH No. Recalls
BayerLaboratórios Azevedos
PentafarmaRanbaxy Portugal
4
Alexion Europe SASAlmirallAngeliniBluefish
Farmacoquímica BaldacciFerring Portuguesa
Gilead SciencesLaboratório Medinfar
Lundbeck PortugalMallinckrodt Medical BV
Tecnimede
3
Alerts Issued
94445666
294
0
100
200
300
OtherDenmarkItalyEMAGermanyFranceSpainUKInfarmed
No
. Ale
rts
issu
ed
Quality Defect Origin
237
45 46
1 4 3 20
100
200
PharmaceuticalForm
PrimaryPackaging
SecondaryPackaging
Packaging RegulatoryAffairs
Other N/A
No
. of
def
ects
Affected Medicinal Products by Pharmaceutical Form
45%
19%
36%
Oral Solids
Liquids and Semi-solids
Injectables
Recall Causes / Type
87% (338) Voluntary recalls
Pharmaceutical Industry concern
with product’s quality
Efficient detection of
quality issues
o Product recall causes:
1. Pharmaceutical Dosage Form
2. Packaging problems
o Pharmaceutical Dosage Form
36 % Injectables
45 % Oral Solids
Number of Batches
158
47
26
78
29
1 batch2 batches3 batches≥ 4 batchesAll product batches
Time on the Market
0-6 months17%
7-12 months21%
13-18 months22%
19-24 months18%
25-30 months8%
31-36 months7%
> 36 months7%
AUTHORS
o QUESTIONS?
Rui LoureiroAna Teresa
ReisBruna Berardo
THANK YOU!
