Medical Information and Pharmacovigilance through

acquisition

Lisa Hughes

Medical Affairs Manager

Actavis UK Ltd

Disclaimer

The views and opinions expressed in the following presentation are those of the

individual presenter and should not be taken as an official statement of the company the

presenter is employed by.

Agenda

• Medical Information and Pharmacovigilance requirements and activities

• Difficulties merging different systems

• Option – in-house/outsource

• Pros and cons

• Benefit of merging v’s risk of not

Medical Information UK requirements

4

PIPA Medical Information Guidelines

MHRA Blue Guide Codes of Practice

Medical Information

• ABPI Code of Practice

– Clause 3.2 – promotion of off-label indications is prohibited

– Clause 22.1 – companies must have a scientific service that is responsible for information about medicines which they market

– Clause 23 – details how MI responds to requests from the public

Medical Information

• MHRA Blue Guide – Advertising and promotion of medicines in the UK states:

“Companies responding to enquiries from the public about Prescription Only Medicines should ensure that responses are factual, non-promotional and limited to the subject matter of the enquiry. … Information provided must be appropriate to the enquiry, must be balanced and must not promote a POM. In all cases, companies should take care that they do not inappropriately impact the relationship between the patient and HCP.

• PIPA guidelines on standards for MI, competencies and managers checklists

Local medical information activities • Medical information queries- in-house and

external

• Adverse Event reporting, follow up and extended follow up

• Product Quality Complaints

• Reconciliation with 3rd parties

• eMC maintenance

• Promotional material or Prescribing Information support

• Education material preparation including

Risk Minimisation Measures

Pharmacovigilance

• Regulation (EU) No 1235/2010

• Directive 2010/84/EU

• Human Medicines Regulations 2012 Part 11

• GVP modules I and VI

• PIPA guidelines

Local Pharmacovigilance activities

• Pharmacovigilance training

• Pharmacovigilance intelligence report

• Digital/social media monitoring

• Risk Management

• Safety Data Exchange Agreements

• Compliance metrics

• Legislation compliance

• Inspection readiness

Merging systems

Considerations

• Staff – overlap of roles may lead to redundancies

• Premises – if you have more than one site, which do you choose

• Systems – how many and how different are they, global dictating local systems

• Direction of merged company – do the companies have different focus, where do MI and PV fit

• Division of activities – multitasking or focussed role

• Portfolio – any new skills required

Merging systems – MI difficulties

• Product/specialist knowledge • Portfolio differences

– Brands, generics, OTC, devices, cosmetics, food, biologics

• Database differences – Commercial, in-house, none

• Reporting differences – PV requirements, product quality complaints, marketing

teams

• New customer base • Different types of questions

– Complex clinical, clinical trial, preclinical

Merging systems - PV difficulties

• Different ADR databases – does one size fit all (transfer of data)

• Different PV systems – contacts for each company

• New local activities – larger portfolio, more social media sites

• SDEAs and contract differences

• Training of employees on merged system whilst old systems still in operation

Immediate actions required

• Introduce new or update current SOPs • Prepare procedures for

— call handling — query escalation — reconciliation — maintenance of reference information — Out Of Hours — links to Drug Safety — links to Quality — medical information database

• Group training to introduce MI team to new products • MI database training where required • Contacts to ensure continued processing of information

To out source or not!

Available options

There are three options when considering providing a medical information and pharmacovigilance service, both can be fully or partially implemented.

• In-house

• Outsourced

• Mixed

Pros of opting for in-house

• Quality of service

• Cost-effectiveness

• Reducing dependency on consultants

• More control on local pharmacovigilance activities

• Opportunity to gain organisational learning

• Staff development and learning opportunities

• Able to add value as non-transactional in nature

Cons of opting for in-house

• High set up cost

• Qualified staff required

• Company may view service as a spend with no return

• Difficult to scale up service as new companies are merged

Pros of opting for outsource

• Less overheads

• Expertise in activities outsourced

• Various models to choose from, can be tweaked to suit company needs

• Ability to scale up or down without impact on company staffing levels

Cons of opting for outsource

• Cost

• Lack of oversight and control of service

• Regular auditing needed

• Reliance on contractors and consultants

• Transactional in nature

• Some in-house involvement needed

• Differences in company ethos/culture

Mixed model

This option allows companies to choose which activities it deals with and which it will outsource.

The company size, product portfolio, available staff and business requirements will determine which activity is outsourced.

Benefit vs risk of merging

Benefit

• One company = one culture = one public face

• Remove risk of duplication of work

• Opportunity to restructure team

– Allows for scalability

– Can create a service that is fit for purpose

• Bring in new skills and new blood

Benefit vs risk of merging

Risk

• Time and cost of merging

• Lose focus on task in hand

• Reporting errors

• Unrealistic deadlines and synergies

• Reorganisation casualties