Labelling Survey 1999 1

Labelling Survey 1999

FIP Working Group on Labelling

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 5

Answers

• 58 answers from 46 countries

• fax 2

• mail 24

• e-mail 32

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 11

Packaging

• Prepack

• Bulk

• Extemperanous preparations

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 31

GSD

• Generic name

• Strength

• individual Dosage instructions

Labelling Survey 1999 32

Stein LyftingsmoHospital Pharmacy of ElverumN-2400 ElverumNorway

Tel: +47-6243 8950Fax +47-6243 8955e-mail stein@lyftingsmo.no