Lessons learned on the review of the labelling of pandemic vaccines

Transcription

1 Lessons learned on the review of the labelling of pandemic vaccines Presented on April 2015 by Thomas Girard Regulatory Affairs Officer Regulatory Affairs Office An agency of the European Union

2 Problems identified during the review of pandemic vaccines labelling in 2009 outbreak Timing for the printing of final labelling material Use of common labelling English only labelling Prominence of key information on the outer labelling Readability of the information displayed on small immediate labelling Use of multi-dose vials Labelling impact for a posology change from full dose to half dose Outdate of the Package leaflet 1 Providing critical information for the safe and effective use (risk of medication errors) of the vaccine in a mass vaccination setting vs. logistical constraints (delay in the supply of vaccines)

3 Timing for the printing of final labelling material Problem statement: Due to logistical constraints, Marketing Authorisation Holders (MAH) printed final labelling material prior to the submission of scientific data (i.e. prior to the start of the approval process). The Agency performs an extensive checking of the mock-ups and specimen of the labelling material (outer and immediate labelling). Requested changes to the mock-ups labelling could, in most cases, not be addressed. Recommendation: Mock-ups labelling should be submitted for review prior to the printing of final labelling material. The Agency will offer earlier slots for the submission of mock-ups labelling, as well as accelerated review 2

4 Use of common labelling Problem statement: Some MAHs opted for common labelling: invented name of the vaccine (Pandemrix, Focetria, etc ) only displayed on the outer carton Type of vaccine, such as <pre-pandemic> <pandemic> Influenza vaccine displayed on vial/pre-filled syringe labels. Adopted interim measures: to include in the cartons sheets of peel-off stickers displaying the invented name and the batch number. In some cases, vaccines cartons were not big enough, peel-off stickers were provided in separate cartons. Additional source of error, especially in mass vaccination centre where large amount of vials are stored from different batches/vaccines. The use of such labelling raised issues for the identification of the vaccine, ensuring traceability and may lead to medication errors if different compositions between the pre-pandemic and pandemic vaccines. Recommendation: Critical information such as the invented name or the type of vaccines should be specifically indicated on the labelling. 3

5 English only labelling Problem statement Some MAHs wished to opt for an English only vial label. Legal basis: The new pharmacovigilance legislation has expanded the scope of Article 63(3) of Directive 2001/83/EC to allow Member States to grant full or partial exemption for the labelling to be in the official language: when the medicinal product is to be delivered by healthcare professionals when there are problems in respect of the availability of the medicinal product Recommendation Possibility to request for a translation exemption at national level. 4

6 Prominence of key information on the outer labelling Problem statement MAHs used their own design/layout to prepare the labelling. Labelling layout: key information was not prominently displayed Considering the particular setting of mass vaccination centres, it is important that key information to help healthcare professionals to correctly administer the vaccines is prominently displayed to minimise medication errors. Recommendation In addition to the critical information (invented name, common name, pharmaceutical form) the following key information should also appear prominently displayed on the main panel: Route of administration Total volume Statement on multi-dose vial (if appropriate) Shelf-life after mixing/reconstitution Mixing/reconstitution instructions (e.g. suspension to be mixed with X before use ) 5

7 6 Examples of reviewed outer cartons

8 Readability of the information displayed on small immediate labelling Problem statement The readability/prominence of the information on small immediate labelling was affected by the lack of line spacing, use of a small font size, number of languages and amount of information displayed. (EN only) (Bilingual) Recommendation It is acknowledged that containers used for vaccines are generally very small. However, the biggest size label suitable for the concerned containers should always be used. Other types of labels should be investigated e.g. concertina type of labels. Some simplification to the text used to display the minimum requirements (Art.55(33) of Directive 2001/83/EC) have been performed by the EMA and could be used provided the information appears on the outer labelling. Possibility to request exemption of some particulars (article 63(1) of Directive /83/EC) to be addressed to the Agency

9 Readability of the information displayed on small immediate labelling (continued) Text simplification Minimum requirements for the Core labelling antigen vial 1. Name of the medicinal product Antigen for {(INVENTED) NAME OF PRODUCT} {pharmaceutical form} <Pandemic Influenza vaccine {strain}> or <Pre-pandemic Influenza vaccine {strain}> Examples for the display of the strain: {A/California/7/2009 (H1N1)v X-179A} {A/California/07/2009 (H1N1)} {H1N1} {Route of administration} (Full term as per Standard Terms, space permitting, otherwise abbreviation) 2. Method of administration Mix <with><into><adjuvant vial> before use 3. Expiry date EXP 4. Batch number Lot 5. Contents by weight, by volume or by unit x ml <After mixing with <adjuvant vial>: <x dose><x doses of y ml>> 6. Other Storage conditions (space permitting) Shelf-life after reconstitution (space permitting) <After mixing: use within {x}<hours> <days>> MAH name (full name, space permitting, otherwise MAH logo) <Address> (space permitting) Minimum requirements for Adjuvant vial Core labelling 1. Name of the medicinal product Adjuvant for (INVENTED) NAME {Pharmaceutical form} {Route of administration} (Full term as per Standard Terms, space permitting, otherwise abbreviation) 2. Method of administration Mix <with><into><antigen vial> before use 3. Expiry date EXP 4. Batch number Lot 5. Contents by weight, by volume or by unit x ml <After mixing with <antigen vial>: <x dose><x doses of y ml>> 6. Other Storage conditions (space permitting) Shelf-life after reconstitution (space permitting) <After mixing: use within {x}<hours> <days>> 8

10 Use of multi-dose vials Problem statement Due to the large scale immunisation program, vaccines were delivered in multi-dose vials (multi-dose vials are not routinely used in EU for vaccines). Information/instruction provided to healthcare professionals on the handling of multi-dose vials did not adequately address key aspects regarding the correct handling of this type of vials to minimise the risk of medication errors and the risk for contamination of multi-dose vials is much higher. Recommendation Specific key information about the correct handling of multi-dose vial should be included. Early discussions with competent authorities on the adequacy of the information/instruction for the handling of the vaccines, ideally with the participation of healthcare professionals. 9

11 Labelling impact for a posology change from full dose to half dose Problem statement Posology changes from full dose to half dose (for the paediatric population) MAHs proposed not to specify the number/volume of the doses on the vial/prefilled syringe labels. Only the total volume was displayed. For pre-filled syringes the posology change also had an impact on the pre-filled syringe presentations since they were not graduated and could not therefore accommodate the administration of different doses. Recommendation Because of the specific nature of multi-dose vials, the information about the possible use of a half dose would be clearly stated in the SmPC and in the package leaflet while the vial/pre-filled syringe would only display the total volume. For pre-filled syringes, in view of the possibility that a half dose could be administered, the pre-filled syringe barrel should be graduated. 10

12 Outdate of the package leaflet Problem statement Due to the on-going scientific assessment, the package leaflet included in the cartons was quickly outdated and did not contain most up-to-date approved information. To address the availability of the latest information, the Agency recommended to include in the package leaflet a link to the European Medicines Agency website where the most up-to-date information is published Recommendation The above approach to refer to the EMA website in addition to the standard life-cycle of the package leaflet is maintained The QRD standard statement Detailed information on this medicine is available on the European Medicines agency website should be included. 11

13 References Lessons learnt on pandemic 2009 Guideline on the packaging information of medicinal products for human use Guideline on the readability of the label and package leaflet of medicinal products for human use ( provides guidance on the presentation of the content of the labelling and package leaflet Process for checking mock-ups and specimens in the centralised procedure (EMEA/305821/2006) 12

14 Conclusions Flexibility increase in terms of requirements and review process without impairing the objectives of the labelling correct identification / providing critical information for the safe and effective use of the vaccines Pandemic preparedness systems differ between Member States which may lead to different products/labelling/presentations requirements 13

15 Thank you for your attention Acknowledgment Monica Prizzi QRD Officer Further information European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website Follow us