New Form Code Committee Annual Report 1998

Dr. J. Niessing, Boehringer Ingelheim GmbH,

Germany (Chairman)

Ms. F. Colin, Hoechst Marion Roussel, France

Ms. A. Ladjedj, Rhône Poulenc Rorer

Ms. T. Ormiston, IMS

Dr. D. Camilleri-Novak, IMS

Ms. H. Harbrow, IMS

Membership

The members of the Committee in 1997 were:

New Form Code Committee Annual Report 1998

Membership

Dr. J. Niessing, Boehringer Ingelheim GmbH,

Germany (Chairman)

Ms. M. Albeau, Synthelabo

Ms. T. Ormiston, IMS

Dr. D. Camilleri-Novak, IMS

Ms. H. Harbrow, IMS

The current members of the Committee are:

New Form Code Committee Annual Report 1998

Meetings

24./25. March 1998 at Boehringer Ingelheim, Germany

22. September 1997 at IMS, London

New Form Code Committee Annual Report 1998

Achievements (1)

Reclassification 1998

• 5.078 packs investigated

• 2.380 pack codes either queried or

changed

• 176 Form 10's (= 438 packs) handled

All changes have been forwarded to the local IMS offices for implementation

New Form Code Committee Annual Report 1998

Achievements (2)

New classes

FNB Parenteral Ordinary Dry Prefilled Syringes

GNB Parenteral Retard Dry Prefilled Syringes

NZY Ophthalmic Other Medical Aids

Deleted classes

GMC Parenteral Retard I V Ampoules

GNC Parenteral Retard I V Pre-Filled Syringes

GPC Parenteral Retard I V Injection Vials

JMA Other Systemic Ampoules

JPA Other Systemic Injection Vials

JPB Other Systemic Dry Injection Vials

New Form Code Committee Annual Report 1998

Achievements (3)

Changed Descriptions

FP Parenteral Ordinary Vials

FPA Parenteral Ordinary Vials

FPB Parenteral Ordinary Dry Vials

FPC Parenteral Ordinary I V Vials

FPD Parenteral Ordinary I M Vials

FPE Parenteral Ordinary S C Vials

FPY Parenteral Ordinary Other Vials

GP Parenteral Retard Vials

GPA Parenteral Retard Vials

GPB Parenteral Retard Dry Vials

GPD Parenteral Retard I M Vials

GPE Parenteral Retard S C Vials

GPY Parenteral Retard Other Vials

NP Ophthalmic Vials

NPA Ophthalmic Vials

NPB Ophthalmic Dry Vials

New Form Code Committee Annual Report 1998

Achievements (4)

Unknown Products (ZYY)

An IMS analysis of packs comparing Q3 97 data and Q3 97 data showed

that the target < 1% by units and by sales has been met.

Non-valid NFC

The number of packs for Q4 97 were 12 packs, which compares well aganist

approx. 1.5 million packs on MIDAS (0.0008 %).

New Form Code Committee Annual Report 1998

Achievements (5)

NFC Poster

The 1998 Version of the Poster has been produced and the EphMRA Logo added.

Database of Decisions

IMS has established a Lotus Notes database to record all decisions

made by the NFC Committee.

New Form Code Committee Annual Report 1998

Classification of Injectables (1)

Proposal (Zeneca):

Split the dry powder forms of injectables (ampoules, vials, prefilled syringes)

to show their route(s) of administration.

New Form Code Committee Annual Report 1998

Classification of Injectables (2)

Current NFC‘s Used for Dry Powder Injectables

NFC New Form Code Description

FMB Parenteral Ordinary Dry Ampoules

GMB Parenteral Retard Dry Ampoules

FPB Parenteral Ordinary Dry Vials

GPB Parenteral Retard Dry Vials

FNY Parenteral Ordinary Other Pre-Filled Syringes

GNY Parenteral Retard Other Pre-Filled Syringes

New Form Code Committee Annual Report 1998

Classification of Injectables (3)

Possible 3rd Levels for Dry Powder Injectables

3rd Level New Form Code Description

B Dry Powder Injectables with

More than One Route of Administration

H For Intravenous Dry Powder

J For Intramuscular Dry Powder

K For Subcutaneous Dry Powder

X For Other Single Routes of Administration

New Form Code Committee Annual Report 1998

Classification of Injectables (4)

• IMS reviews all packs by country to identify products with

administration route indicators in the form description

• Seek approval for the proposed classification concept and support

by member companies

• Investigate and change the NFCs of the remaining packs with

support from member companies

New Form Code Committee Annual Report 1998

Plans for 1998

• Follow up regarding the new classification of dry powder

injectables

• Split the NFC23 = GP (Unit dose liquids) into true unit dose liquids

and metered dose products

• Continue the efforts to attract new members

New Form Code Committee Annual Report 1998