Reporter and Event

An identifiable reporter

Enough information is required to be collected so that the company can contact the reporter in case the company needs further information. For example:

  • Name
  • Phone number
  • Email address

Details of the type of reporter also need to be recorded. E.g.

  • Doctor
  • Nurse
  • Patient
  • Lawyer
  • Carer

An identifiable event

Details of the event (or events) must be recorded e.g.

  • A side effect
  • Overdose without a side effect
  • Medication error
  • Use in a pregnant woman

Patient and Drug

An identifiable patient

It is important that the patient is identifiable. Enough information needs to be collected so that the reporter knows who the patient is in case the company needs further information.

Ideally at the least the following information should be collected:

  • Patient initials
  • Age or age group
  • Gender

An identifable company drug

The drug must be identifiable as the company’s own product.

Adverse event reports are not required on drugs from other companies.

Data privacy

  • Any information that can identify a patient must be recorded in line with your company’s data privacy policies

Minimum information

The minimum information required for a valid adverse event report is:

  • An identifiable patient
  • An identifiable company drug
  • An identifiable reporter
  • An event

This information should be passed to your company pharmacovigilance service within company timelines – these are usually 24 hours.

You should be able to get the minimum information, but if you can’t you must forward to your Pharmacovigilance service anyway.

Serious Adverse Events

An adverse event is considered serious if it:

  • Is fatal
  • Is life-threatening (at the time of the event)
  • Causes / prolongs hospitalisation
  • Is disabling / incapacitating
  • Is a congenital abnormality
  • Is medically significant
    • Reporter or company may make this decision
    • Includes transmission of an infectious agent

AE vs ADR

To summarise:

  • Adverse Event (AE)
    • May or may not be related to the medicine
  • Adverse Drug Reaction (ADR)
    • Probably or definitely related to the medicine

Adverse Drug Reaction (ADR)

What is an Adverse Drug Reaction (ADR)?

  • An ADR is a response to a medicinal product which is noxious and unintended. Reponse in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship can not be ruled out
  • ADRs may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include overdose, misuse, abuse and medication errors
  • An ADR is a report suggesting that a person has received a company product and there is a possible causal relationship between the event and the product

Adverse Event (AE)

What is an Adverse Event (AE)?

  • An AE is any untoward medical occurence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment
  • An AE can be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medical (investigational) product, whether or not considered related to the medicinal product
  • An AE can arise from any use of the drug (e.g. off-label use, use in combination with another drug) and from any route of administration, formulation, or dose, including an overdose
  • An AE includes changes in clinically significant symptoms or laboratory results, physical abnormalities, injuries, drug interactions, overdose (deliberate or unintentional), drug dependency or abuse, drug misuse, drug maladministration, accidental exposure, dispensing errors and lack of efficacy
  • An AE may or may not be related to the medicine

Product complaints and requests for information on the use of a drug

As well as reports of possible side effects with one of your company’s drugs, you may also receive the following types of call:

Product complaints

These can include reports of:

  • Damaged or missing tablets e.g. broken tablet in a blister, empty blister or empty carton.
  • Change in appearance e.g. tablet wrong colour, solution for injection cloudy.
  • Missing Patient Information Leaflet in a carton.
  • Drug not working i.e. lack of effect.

These should be reported to your company’s Quality Department.

You may also have to report to your company’s Pharmacovigilance Department if a patient has taken the drug.

Medical information

Patients, carers and healthcare professionals may call for advice and information on your company’s drugs. You must never give advice or information. These queries to should be forwarded to your company’s Customer Services or Medical Information service.

Collection of safety information

The safety information collected about drugs includes, but is not limited to, the following:

  • Side effects
    • Immediate e.g. severe allergic reaction to an injection
    • Delayed e.g. cancer following several years treatment with a drug
  • Defective products – examples include
    • Broken tablet
    • Wrong tablet in a pack – different drug or wrong strength
    • Wrong leaflet in pack
  • Reports of overdose
    • Even if no side effects are reported
  • Use in special patient groups
    • Pregnancy or breast feeding exposure
    • Children and teenagers
    • Elderly patients
    • Patients with poor livers or kidneys
  • Medication errors
    • Wrong drug dispensed to the patient
    • Wrong drug taken by the patient
  • Off label / unlicensed use
    • Use of a drug outside of its approved (licensed) disease indication
    • Administration by an unapproved route
  • Reports of abuse or misuse
    • e.g. use of a drug to get “high”
  • Occupational exposure
    • e.g. injection leaking on to a nurse’s or carer’s skin
  • Unexpected positive effects 
    • Improvement in signs and symptoms of another illness
  • Suspected transmission of infectious agents
    • e.g. bacteria causing illness
  • Worsening of illness being treated
    • e.g. drug not effective
  • Treatment non-compliance
    • Not taking the drug properly, including missing doses
  • Interaction with other drugs 
    • Including drugs bought without a prescription or herbal remedies

Why collect extra safety data?

So….if you’ve got a licence for a medicine, why do you need more safety data?

The answer is that the safety data from clinical studies are limited: the drug is studied in a small, controlled population.

When marketed, the intended patients may differ from clinical study patients in a number of ways, for example:

  • The patients may have other illnesses
  • They may be taking other drugs
  • Both of the above may affect how the drug works and its side effects

Thus, the full safety profile of a drug may not be known at launch.

Furthermore, some side effects may be rare and may only occur in 1 in every 10,000 patients treated. Other side effects may not occur until after the patient has been taking the drug for several years.

There may also be a side effect due to an interaction with a new class of drug.

When more is learnt about the potential side effects of a medicine, the information provided to healthcare professionals (HCPs) and patients is updated.