This is an article about RMPs- Risk Management Plans in PVG and important concepts to understand.

I have divided it into two parts, the first has concepts that need to be understood and are described in detail.

Whereas the second half of the article has 27 key definitions relevant to RMPs.

Let’s dive in :-)

1- Risk minimization measures:

  • Risk minimization measures are interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur.

Two types of RMMs:

1- Routine RMMs

2- Additional RMMs

2- Routine risk minimization measures:

  • Applicable to all products

3- Additional risk minimization measures:

  • In exceptional cases however, routine risk minimization measures will not be sufficient for some risks and additional risk minimization measures will be necessary to manage the risk and/or improve the risk-benefit balance of a medicinal product.

Each safety concern needs to be individually considered and the selection of the most suitable risk minimization measure should take into account:

  1. The seriousness of the potential adverse reaction
  • A safety concern may be addressed using more than one risk minimization measure, and a risk minimization measure may address more than one safety concern.

4- Routine pharmacovigilance:

  • Set of activities required by applicable regulations as a minimum standard of pharmacovigilance to be conducted for all medicinal products.

Routine RMAs include PPL:

  • Product labelling (L)

5- Additional risk minimization activity:

An intervention intended to prevent or reduce the probability of an undesirable outcome, or reduce its severity should it occur, which is in addition to the routine risk minimization activities defined as requirements applied to all medicinal products in the regulations of a particular territory.

Two key components:

  1. Prevention/reduction of probability of occurrence
  • This in addition to common minimum std of PVG applicable for all products

Why are additional risk minimization activities required?

  • Additional risk minimization activities apply to some new medicines, or for older products where a safety issue has been identified, to improve the benefit/risk profile.

Examples of additional risk minimization activities include:

  • Educational programs for HCPs, patients and care givers

6- Burden of Risk minimization activity:

Burden is defined as the additional load that a risk minimization activity imposes on:

(1) Patients

(2) Carers

(3) The healthcare system including health care professionals

(4) Other stakeholders such as regulatory authorities, pharmaceutical companies, the supply chain and those involved in access and supervision of the use of medicines.

The burden may impact, for example:

  • Patients by adversely affecting their access to prescribed medicines and/or needed healthcare services, daily activities or routines.

7- Effectiveness threshold:

Minimum acceptable level of risk minimization to be achieved in order for the intervention to be rated a success.

The effectiveness threshold is determined subjectively taking into account:

β€’ The impact of risk

β€’ The vulnerability of the target population

β€’ The drug’s benefit in a given indication

β€’ Aspects of practicality and feasibility

8- Identified risk:

An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.

Examples of identified risks include:

  • An adverse reaction adequately demonstrated in non-clinical studies and confirmed by clinical data

9- Potential risk

An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this association has not been confirmed.

Examples of potential risks include:

β€’ Toxicological findings seen in non-clinical safety studies which have not been observed or resolved in clinical studies.

β€’ Adverse events observed in clinical trials or epidemiological studies for which the magnitude of the difference, compared with the comparator group (placebo or active substance, or unexposed group), on a parameter of interest raises a suspicion of, but is not large enough to suggest a causal relationship.

β€’ A signal arising from a spontaneous adverse reaction reporting system

β€’ An event known to be associated with other active substances within the same class or which could be expected to occur based on the properties of the medicinal product.

10- Important identified risk and important potential risk-

  • An identified risk or potential risk that could impact on the benefit-risk profile of the product or have implications for public health. What constitutes an important risk will depend upon several factors, including the impact on the individual, the seriousness of the risk, and the impact on public health.

11- REMS-Risk evaluation and mitigation strategy (REMS):

  • Drug safety program that the U.S. FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

If you want to read more about REMS, you can read my article on that below:

12- Risk assessment:

  • Risk assessment consists of identifying and characterizing the nature, frequency, and severity of the risk associated with the use of a product.

13- Risk communication:

  • Any exchange of information concerning the existence, nature, form, severity or acceptability of health or environmental risks.

Effective risk communication involves:

  • Determining the types of information that interested and affected parties need and want.

14- Dominant risk:

  • The risk that is considered to be the major contributor to the overall risk profile.

RMP-related definitions to remember and understand:

  • Alert: An identified risk associated with the use of medicinal products which requires urgent measures to protect patients.

That would do for now.

Let me know what you think in comments and direct msgs!

Thank you for your time :)

Liked what you read?

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You can read the same article on my Linkedin here:

Suggested further readings:

1- A very brief article on medication errors in aggregate reports | LinkedIn

2- Medication misadventures, medication errors and related concepts in PVG | LinkedIn

3- Definitions and difference in PVG terms: Designated medical event (DME), Important medical events (IMEs), WHO critical terms and AESIs | LinkedIn

4- Definitions and differences between drugabuse/misuse/addiction/dependence in less than 5 minutes | LinkedIn

5- All the things you should know about Safety communications in pharmacovigilance (GVP module XV) in 15 minutes | LinkedIn

6- CIOMS glossary of key concepts in drug safety (Signal detection, RMP and aggregate reports) | LinkedIn

7- Summary of Product Characteristics (SPC/SmPC): Introduction, Overview and relevance in aggregate reports | LinkedIn

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πŸ³οΈβ€πŸŒˆ Aditi Sheth πŸ³οΈβ€πŸŒˆ

πŸ³οΈβ€πŸŒˆπŸ“š Bookworm fueled by curiosity | 750+ Certificates | PBRER | Aggregate reports | Artificial Intelligence | Trained Psychologist | Introvert | ISFJ |MBBS