1. Labelling Survey 19991 FIP Working Group on Labelling

2. Labelling Survey 19992 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

3. Labelling Survey 19993 Purpose of survey How is drug labelling done in different parts of the world?

4. Labelling Survey 19994 Distribution Mail: FIP member organisations E-mail: FIP-list E:mail; E-DRUG

5. Labelling Survey 19995 Answers 58 answers from 46 countries fax 2 mail24 e-mail32

6. Labelling Survey 19996 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 Federation147 mill - 5%

7. Labelling Survey 19997 Missing countries >50 mill China Egypt Indonesia Iran Pakistan Ethiopia Viet Nam Ukraine Phillipines

8. Labelling Survey 19998 Distribution channels for prescription medicine

9. Labelling Survey 19999 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

10. Labelling Survey 199910 Is ”prescription medicine” an useful or usable term in discussing drug labelling?

11. Labelling Survey 199911 Packaging Prepack Bulk Extemperanous preparations

12. Labelling Survey 199912 Prepack and bulk 90% or more prepack 22 countries, 584 mill India 75% prepack 90% or more from bulk 5 countries, 191 mill

13. Labelling Survey 199913 Labelling Prescription medicine Dispensed by pharmacy As seen by the patient, not as it leaves the manufacturer Inner package (immediate container)

14. Labelling Survey 199914 Customizing (general question) Always:18 countries750 mill Never:11 countries1.524 mill 7 of these countries, 1.297 mill had pharmacy market share >90%

15. Labelling Survey 199915 Patient’s name Prepack (Table 12) Never21 countries1.931 mill Often 5 countries 130 mill Always17 countries 608 mill

16. Labelling Survey 199916 Patient’s name Bulk (Table 13) Never 7 countries1.083 mill Often 5 countries 401 mill Always13 countries 624 mill

17. Labelling Survey 199917 Patient’s name Bulk versus prepack Bulk slightly better (better in 3 countries, equal in 20)

18. Labelling Survey 199918 Individual Dosage Instructions Prepack (Table 14) Never 8 countries1.236 mill Often10 countries 312 mill Always25 countries1.073 mill

19. Labelling Survey 199919 Individual Dosage Instructions Bulk (Table 15) Never 2 countries983 mill Often 9 countries231 mill Always12 countries896 mill

20. Labelling Survey 199920 Individual Dosage Instructions Bulk versus prepack: Fairly equal. Bulk better in 2 countries equal in 19 not as good in 3.

21. Labelling Survey 199921 Generic name Prepack (Table 17) Never 2 countries 42 mill Often13 countries 686 mill Always29 countries1.958 mill

22. Labelling Survey 199922 Strength (one active ingredient) Prepack (Table 20) Never 2 countries 42 mill Often 8 countries1.357 mill Always34 countries1.287 mill

23. Labelling Survey 199923 Dosage form Prepack (Table 20) Never 1 country 20 mill Often 8 countries1.254 mill Always34 countries1.412 mill

24. Labelling Survey 199924 Amount (Volume, or number of tablets) Prepack (Table 24) Never 2 countries 42 mill Often 9 countries 489 mill Always33 countries2.155 mill

25. Labelling Survey 199925 Batch number Prepack (Table 26) Never 4 countries 41 mill Often 7 countries 538 mill Always33 countries2.107 mill

26. Labelling Survey 199926 Batch number Bulk (Table 27) Never11 countries 350 mill Often 9 countries1.503 mill Always 4 countries 194 mill

27. Labelling Survey 199927 Batch number Bulk versus prepack (Table 28): Prepack definitely better than bulk better in 15 countries equal in 8

28. Labelling Survey 199928 Expiry date Prepack (Table 29) Never 1 country 21 mill Often 8 countries 273 mill Always35 countries2.392 mill

29. Labelling Survey 199929 Expiry date Bulk (Table 30) Never 7 countries 300 mill Often10 countries 131 mill Always 7 countries1.616 mill

30. Labelling Survey 199930 Expiry date Bulk versus prepack (Table 31) Prepack better than bulk: better in 11 countries equal in 13

31. Labelling Survey 199931 GSD Generic name Strength individual Dosage instructions

32. Labelling Survey 199932 Stein Lyftingsmo Hospital Pharmacy of Elverum N-2400 Elverum Norway Tel:+47-6243 8950 Fax+47-6243 8955 e-mailstein@lyftingsmo.no