Healthcare Professional Information & Patient Information Leaflet (PL)

Transcription

1 New concept for the SmPC/ Healthcare Professional Information & Patient Information Leaflet (PL) Fiona Reekie Director Global Regulatory Affairs Johnson & Johnson Pharmaceuticals Group

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which h the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association 2

3 Introduction Summary of Product Characteristics (SmPC) is the definitive statement between the competent authority and the holder of the MA. is used to inform Health Care Professionals (HCP) about the particulars of the medicinal i product. Drug Information Association 3

4 Background and drivers for change Evolution of SmPC guideline introducing additional requirements Proposals for additional SmPC information in pharmacovigilance legislative proposals SmPC and PLd do not appear to meet stakeholders needs Several initiatives to improve communication of medicinal products information ongoing Technological advances Drug Information Association 4

5 Expectations for product information To provide information to HCPs and patients on how to use the medicinal product safely and effectively Patients and their carers/family members are the main users of the PL and their expectations will play an important role when re-developing the PL. Drug Information Association 5

6 Expectations for product information Experience gathered during user testing Information from surveys on expectations and attitudes MHRA 2006, EMA 2008 & Prognos, 2008 Minutes and outputs t from EMA & PCWP & HCP WG meetings /P /PCWPh Drug Information Association 6

7 Principles of new SmPC concept Document core to focus on main population Supplements for special populations Followed by more comprehensive information Drug Information Association 7

8 Structure of new SmPC/PL concept Section 1: Product details Section 2: Therapeutic Indication(s) Section 3: Benefits Section 4: Risks Section 5: Administration and dosage Section 6: Other important information Special Populations Drug Information Association 8

9 Structure of new SmPC/PL concept Section 1: Product details Include the trade name, active substance, pharmaceutical form and strength Section 2: Therapeutic Indication(s) A clear description on the indication and target population should be provided, including the objectives of the treatment, ie, the anticipated benefits, and how the objectives can be met by the treatment Drug Information Association 9

10 Structure of new SmPC/PL concept Section 3: Benefits Pharmacological properties Describe in relation to the disease to be treated and in a concise and understandable way Information on key symptoms of the disease usually present without treatment or which will get worse over time and describe how these are affected by the drug Clinical trial information Include short description of outcomes from completed clinical trials Provide clear and concise information on long-term Drug Information Association 10 data or lack of such data

11 Structure of new SmPC/PL concept Section 4: Risks Include relevant preclinical findings, warnings and precautions, undesirable effects The most important risks should be detailed first Undesirable effects - sort by a hierarchy of importance ( guided by risk minimisation activities for that product); include specific frequencies (eg, 4%); Include less important undesirable effects in a summary table Drug Information Association 11

12 Structure of new SmPC/PL concept Section 5: Administration and dosage Details on dosage regimen and how to take the medicinal product. Specific recommendations should be included when doses have been missed for example. Include details on food and drug-drug interactions Include information on special storage conditions Drug Information Association 12

13 Structure of new SmPC/PL concept Section 6: Other important information Subsections on: Effect on driving Overdose Fertility, pregnancy & lactation Special Populations Additional, different information that has not been covered under the main population Drug Information Association 13

14 Next steps Comments from you? Apply the principles i to an approved product Why? Is it workable? What information does it provide? What information does it not provide? Drug Information Association 14

15 Contributors Petra Baddack Solvay Ian Hawkins Celgene Diane Mackleston Lilly Emma Dufour Abbott Paul Heiden Bayer Healthcare Andrew Marr GlaxoSmithKline Elisabeth Fournier Qezari sanofi aventis Angelika Joos Merck Sharp & Dohme (Europe) Inc. Trevor Mil Pfizer Ali Harrison AstraZeneca Patricia Lefebvre sanofi aventis Nilmini Murrell GlaxoSmithKline Esther Nougier Silvia Petak Olivier Poirieux Fiona Reekie Pfizer Merck Sharp & Bristol Myers Johnson & Johnson Dohme (Europe) Inc. Squibb Pharmaceuticals Michael Richardson Katrin Rupalla Eva Stetter Liz Swain Bristol Myers Celgene Merck Sharp & GlaxoSmithKline Squibb Dohme (Europe) Inc. Lisette Vromans Merck Sharp & Dohme (Europe) Inc. Paul Woods AstraZeneca Drug Information Association 15

16 Abbreviations EMA: European Medicines Agency HCP WG: Healthcare Professionals Organisations Working Group MHRA: Medicines and Healthcare products Regulatory Agency PCWP: Patients and Consumers Organisations Working Party Drug Information Association 16