When deciding on the name of a medicinal product, regulatory requirements play an important role at an early stage for pharmaceutical manufacturers.
Serious safety concerns arise when confusion exists regarding the naming of a medicinal product and it is advisable for manufacturers to exercise a high level of care to avoid confusion between similarly named or sounding brand and generic medicine names.
A principal consideration of pharmaceutical manufacturers is to ensure that medicines are taken safely and correctly, that a proposed name will not give rise to safety or efficacy concerns and that the name complies with legislative requirements.
The Medicines and Healthcare products Regulatory Agency (MHRA) has previously highlighted the dangers associated with medicines with look-alike or sound-alike names – including cases with fatal outcomes, in which patients received the wrong medicine due to confusion between similar names.
For example, drugs pairs with known links to errors include:
MHRA guidance explains that an umbrella segment (also known as root name) of an invented name is a section of invented name that is used in more than one medicinal name to create a brand or range of products.
Umbrella brands are generally associated with particular actives, a therapeutic area or set of indications and or a particular sponsor or retailer. For example, ‘Sample Cold & Flu Blackcurrant Powder for Oral Solution’, where ‘Sample’ is the umbrella segment repeated across a related product range.
Most authorised umbrella branded ranges do not pose safety or efficacy concerns although regulators do encourage applicants to develop new product names without umbrella segments for each new product.
The reason for such discouragement is that there are situations when the proposed extension to the umbrella brand range poses significant risks of confusing consumers regarding the differences between the proposed medicine and the current medicines within that umbrella brand.
Therefore, when proposing an umbrella segment for more than one product, its use should not result in safety or efficacy concerns resulting from confusion related to products sharing the same umbrella segment.
Such concerns may arise, for example:
In order to allow a risk-based assessment of proposed product names including umbrella segments, MHRA, in its assessment of an application, considers several factors as appropriate in order to determine whether a product name that includes an umbrella segment is acceptable.
These factors include for example:
The MHRA assesses each proposal for a name using an umbrella segment on a case-by-case basis, considering the above concerns, with safety being the paramount consideration. Therefore when deciding on the name of a medicinal product, regulatory requirements play an important role at an early stage.
Our team can assist you with the legislative requirements for naming medicines. Please get in touch.
Reference:
1. MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label 2019.
2. HPRA Guide to Invented Names of Human Medicines 2015
Serious safety concerns arise when confusion exists regarding the naming of a medicinal product and it is advisable for manufacturers to exercise a high level of care to avoid confusion between similarly named or sounding brand and generic medicine names.
A principal consideration of pharmaceutical manufacturers is to ensure that medicines are taken safely and correctly, that a proposed name will not give rise to safety or efficacy concerns and that the name complies with legislative requirements.
The Medicines and Healthcare products Regulatory Agency (MHRA) has previously highlighted the dangers associated with medicines with look-alike or sound-alike names – including cases with fatal outcomes, in which patients received the wrong medicine due to confusion between similar names.
For example, drugs pairs with known links to errors include:
- Clobazam / Clonazepam
- Propranolol / Prednisolone
Use of an umbrella segment
The MHRA is an executive agency of the Department of Health and Social Care in the United Kingdom that is responsible for ensuring that medicines and medical devices work and are acceptably safe.MHRA guidance explains that an umbrella segment (also known as root name) of an invented name is a section of invented name that is used in more than one medicinal name to create a brand or range of products.
Umbrella brands are generally associated with particular actives, a therapeutic area or set of indications and or a particular sponsor or retailer. For example, ‘Sample Cold & Flu Blackcurrant Powder for Oral Solution’, where ‘Sample’ is the umbrella segment repeated across a related product range.
Most authorised umbrella branded ranges do not pose safety or efficacy concerns although regulators do encourage applicants to develop new product names without umbrella segments for each new product.
The reason for such discouragement is that there are situations when the proposed extension to the umbrella brand range poses significant risks of confusing consumers regarding the differences between the proposed medicine and the current medicines within that umbrella brand.
Therefore, when proposing an umbrella segment for more than one product, its use should not result in safety or efficacy concerns resulting from confusion related to products sharing the same umbrella segment.
Such concerns may arise, for example:
- if the products contain different active ingredients;
- if the products can be used in different populations;
- if their safety profile is different in different populations (e.g. one can be used in pregnancy or in patients with renal impairment or in elderly people, and the other cannot); and
- if their interactions and speeds of onset are different.
In order to allow a risk-based assessment of proposed product names including umbrella segments, MHRA, in its assessment of an application, considers several factors as appropriate in order to determine whether a product name that includes an umbrella segment is acceptable.
These factors include for example:
- the legal status of the product (i.e. whether ‘POM’, ‘P’, or ‘GSL’);
- the description of other products within the company’s own range or from another company with the same or similar (either in spelling or phonetic terms) umbrella segment;
- indications for each relevant product;
- discussion of any safety issues that may arise from use of the umbrella segment for the new product, should it be confused with other products with the same or similar umbrella segments, based on consideration of the safety profile of the active ingredients;
- specific populations of patients/consumers where differences exist between products with the same umbrella segment e.g. children, pregnant women, elderly people, those with renal or hepatic impairment;
The MHRA assesses each proposal for a name using an umbrella segment on a case-by-case basis, considering the above concerns, with safety being the paramount consideration. Therefore when deciding on the name of a medicinal product, regulatory requirements play an important role at an early stage.
Our team can assist you with the legislative requirements for naming medicines. Please get in touch.
Reference:
1. MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label 2019.
2. HPRA Guide to Invented Names of Human Medicines 2015