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Acknowledgements

The PIPA Committee would like to thank John Barber,  Plain Pharma Consulting Ltd, for writing this course.

The PIPA Committee would also like to thank the following members of the Training Working Party who contributed to the development of this course:

  • Sarah Hall, Mipsol Ltd.
  • Sharon Braithwaite, PIPA Membership & Events Coordinator
  • Anne Turnbull, PIPA Operations Manager

Example 4

A pharmacist rang to check if the use of drug-z is allowed in pregnant women.

He has a patient, who is 6 months pregnant, in the pharmacy with a repeat prescription for drug-z.

Is this a side effect?

What should you do?

ANSWER

It is not a side effect but this is pregnancy exposure to drug-z.

You have the four minimum criteria:

  • Event: pregnancy
  • Patient: female
  • Reporter: pharmacist
  • Suspected drug: drug-z

YOU MUST REPORT TO YOUR COMPANY PHARMACOVIGILANCE SERVICE

Example 3

A pharmacist rang to comment on the colour of your company’s drug and another company’s drug packaging. The pharmacist said that due to similarity in product name, the wrong medicine was given to a patient.

This resulted in a female patient taking your company’s drug instead of the other company’s drug.

The patient felt fine.

Is this a side effect?

What should you do?

ANSWER

This is not a side effect as the patient felt fine.

BUT, you have the four minimum criteria:

  • Event: medication error
  • Patient: female, 23
  • Reporter: pharmacist
  • Suspected drug: your company’s drug

YOU MUST REPORT TO YOUR COMPANY PHARMACOVIGILANCE SERVICE

Example 2

A GP reported that a male patient reported feeling dizzy after taking your company’s brand of drug-y 5mg tablets. He stated that the patient has been taking drug-y for “years” (brand unknown), and asked whether dizziness has been reported before for this batch of drug-y.

Caller is retaining the box and blister strip at the pharmacy until contacted.

Is this a side effect?

What should you do?

ANSWER

It may be a side effect.

You have the four minimum criteria:

  • Event: dizziness
  • Patient: male
  • Reporter: GP
  • Suspected drug: drug-y 5mg tablets

BUT this may also be a defective product / product complaint.

YOU MUST REPORT TO YOUR COMPANY PHARMACOVIGILANCE SERVICE

Example 1

Your neighbour tells you that since she started taking drug-x, she has experienced “bad periods of shortness of breath” and was in hospital 3 times. She was told in the hospital that drug-x is not causing “shortness of breath” but she saw that the Patient Information Leaflet lists breathing…

She saw that drug-x was made by your company and thought to ask you…

Could this be a side effect?

What should you do?

ANSWER

It may be a side effect, even though the hospital said it was not.

You have the four minimum crietira:

  • Event: bad periods of shortness of breath
  • Reporter: your neighbour
  • Drug: drug-x
  • Patient: your neighbour

YOU MUST REPORT TO YOUR COMPANY PHARMACOVIGILANCE SERVICE

Introduction

The following pages contain four examples of potential Pharmacovigilance scenarios for you to consider….

  • Are they reports of side effects (assume any drugs mentioned are your company’s drugs)?
  • What should you do?

Audits and inspections

Audits and inspections

To ensure that pharmaceutical companies meet their obligations relating to pharmacovigilance regulations, pharmacovigilance departments may be audited and inspected.

Audit

May be done by the company’s Quality Department or by a partner company (e.g. if there is a co-marketing or other licensing agreement for one or more drugs).

Inspection

Done by a regulatory authority (e.g. MHRA in the UK).

What happens during an audit or inspection?

Members of the company’s Pharmacovigilance Department will be interviewed by the auditor or inspector. They will be asked to provide evidence that they are following the company’s pharmacovigilance processes and procedures and to show that these are in line with the pharmacovigilance…

In addition, other company employees may be interviewed. It is possible that you may be interviewed to show that you know how to pass on to Pharmacovigilance information relating to a suspected adverse event.

What do you do?

Once you become aware of an AE, product complaint or other safety information, you must:

  • Forward the caller, email, fax, newspaper article, website information, scientific literature article, details of TV programme or letter to your company Pharmacovigilance service
  • Note all available information, especially:
    • Type of reporter and reporter’s contact details
    • Patient
    • Drug(s)
    • Event(s)
    • Date first known to you
  • As soon as possible
    • Ideally within 1 working day

Anything you write information about an adverse event on counts as a source document. You must send source documents to your company PV service after you have reported the the event to them.

If you do not know what to do, get in touch with your company Pharmacovigilance service.

Who does it?

YOU

You may become aware of an adverse event relating to a drug made by your company in a number of ways. For example:

  • Whilst at work, you may receive a phone call from a patient reporting a side effect
  • You may be told about a side effect outside of work
  • You may read a newspaper article or see a TV programme with information about a side effect

YOUR COMPANY

Your company will have a process for receiving and handling reports of side effects.

It is important that you know:

  • Who you pass adverse event reports to in your company
  • Who you pass product complaint reports to in your company
  • Who provides answers to questions on the use of your drugs (Medical Information) by patients and healthcare professionals

For all of the above, do you know their contact details, e.g. phone number(s) and email address(es)?

QUALIFIED PERSON FOR PHARMACOVIGILANCE

Under European Pharmacovigilance regulations, every company must have a Qualified Person for Pharmacovigilance (QPPV).

The QPPV is responsible for the safety of the company’s drugs and for ensuring that the company has a system in place for monitoring and reporting of any safety issue related to the company’s drugs.

As well as a European QPPV, some countries in the EU also require a local QPPV. At the present, the UK does not require a UK QPPV. However, post-Brexit, a UK QPPV will be required for each UK pharmaceutical company.