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Labelling Survey 1999 2
FIP Working Group on Labelling
• Stein Lyftingsmo, Hospital Pharmacy, Norway
• Oscar Bruce, Pharmacy Information, Ghana
• Leander Fontaine, Industrial Pharmacy, USA
• Avi Moshenson, Community Pharmacy, Israel
• Jerome A Reinstein, World Self-medication Industry, Great Britain
Labelling Survey 1999 3
Purpose of survey
• How is drug labelling done in different parts of the world?
Labelling Survey 1999 4
Distribution
• Mail: FIP member organisations
• E-mail: FIP-list
• E:mail; E-DRUG
Labelling Survey 1999 6
Countries & population
• Survey population 2.751 mill
• 46,7% of world population 5.901 mill
• India 982 mill - 36% of survey total
• USA 274 mill - 10%
• Brazil 166 mill - 6%
• Russian Federation 147 mill - 5%
Labelling Survey 1999 7
Missing countries >50 mill
• China Egypt
• Indonesia Iran
• Pakistan Ethiopia
• Viet Nam Ukraine
• Phillipines
Labelling Survey 1999 8
Distribution channels for prescription medicine
0
10
20
30
40
50
60
70
80
90
pharmacies
doctors'clinics
others
Labelling Survey 1999 9
Prescription medicine without prescription
• Easy in 14 countries with 60% of survey population.
• 7 of these countries with 45% of survey population had market share for pharmacies 90% or higher
Labelling Survey 1999 10
Is ”prescription medicine” an useful
or usable termin discussing drug labelling?
Labelling Survey 1999 12
Prepack and bulk
• 90% or more prepack 22 countries, 584 mill
• India 75% prepack
• 90% or more from bulk 5 countries, 191 mill
Labelling Survey 1999 13
Labelling
• Prescription medicine
• Dispensed by pharmacy
• As seen by the patient,not as it leaves the manufacturer
• Inner package (immediate container)
Labelling Survey 1999 14
Customizing(general question)
• Always: 18 countries 750 mill
• Never: 11 countries 1.524 mill
• 7 of these countries, 1.297 mill had pharmacy market share >90%
Labelling Survey 1999 15
Patient’s name
• Prepack (Table 12)
• Never 21 countries 1.931 mill
• Often 5 countries 130 mill
• Always 17 countries 608 mill
Labelling Survey 1999 16
Patient’s name
• Bulk (Table 13)
• Never 7 countries 1.083 mill
• Often 5 countries 401 mill
• Always 13 countries 624 mill
Labelling Survey 1999 17
Patient’s nameBulk versus prepack
• Bulk slightly better
• (better in 3 countries, equal in 20)
Labelling Survey 1999 18
Individual Dosage Instructions
• Prepack (Table 14)
• Never 8 countries 1.236 mill
• Often 10 countries 312 mill
• Always 25 countries 1.073 mill
Labelling Survey 1999 19
Individual Dosage Instructions
• Bulk (Table 15)
• Never 2 countries 983 mill
• Often 9 countries 231 mill
• Always 12 countries 896 mill
Labelling Survey 1999 20
Individual Dosage Instructions
• Bulk versus prepack:
• Fairly equal.
• Bulk better in 2 countriesequal in 19
not as good in 3.
Labelling Survey 1999 21
Generic name
• Prepack (Table 17)
• Never 2 countries 42 mill
• Often 13 countries 686 mill
• Always 29 countries 1.958 mill
Labelling Survey 1999 22
Strength(one active ingredient)
• Prepack (Table 20)
• Never 2 countries 42 mill
• Often 8 countries 1.357 mill
• Always 34 countries 1.287 mill
Labelling Survey 1999 23
Dosage form
• Prepack (Table 20)
• Never 1 country 20 mill
• Often 8 countries 1.254 mill
• Always 34 countries 1.412 mill
Labelling Survey 1999 24
Amount(Volume, or number of tablets)
• Prepack (Table 24)
• Never 2 countries 42 mill
• Often 9 countries 489 mill
• Always 33 countries 2.155 mill
Labelling Survey 1999 25
Batch number
• Prepack (Table 26)
• Never 4 countries 41 mill
• Often 7 countries 538 mill
• Always 33 countries 2.107 mill
Labelling Survey 1999 26
Batch number
• Bulk (Table 27)
• Never 11 countries 350 mill
• Often 9 countries 1.503 mill
• Always 4 countries 194 mill
Labelling Survey 1999 27
Batch number
• Bulk versus prepack (Table 28):
• Prepack definitely better than bulk better in 15 countries
equal in 8
Labelling Survey 1999 28
Expiry date
• Prepack (Table 29)
• Never 1 country 21 mill
• Often 8 countries 273 mill
• Always 35 countries 2.392 mill
Labelling Survey 1999 29
Expiry date
• Bulk (Table 30)
• Never 7 countries 300 mill
• Often 10 countries 131 mill
• Always 7 countries 1.616 mill
Labelling Survey 1999 30
Expiry date
• Bulk versus prepack (Table 31)
• Prepack better than bulk:better in 11 countries
equal in 13
Labelling Survey 1999 32
Stein LyftingsmoHospital Pharmacy of ElverumN-2400 ElverumNorway
Tel: +47-6243 8950Fax +47-6243 8955e-mail [email protected]