When I use a word . . . The languages of medicines—umbrella terms

Guidance in naming proprietary medicinal products

In the world of medicines, proprietary names are the brand names or trade names that pharmaceutical manufacturers give to their medicinal products. They are distinct from the generic names of the active ingredients they contain.

In previous articles12 I have described various aspects of two sets of regulatory guidelines on the desiderata governing a manufacturer’s choice of a proprietary name for a medicinal product: those published by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK in 20193 and by the US Food and Drug Administration (FDA) in 2020.4 However, one major aspect remains to be discussed.

Umbrella terms

The word “umbrella” is the diminutive form of the Latin noun “umbra,” with various meanings related to shade. English words that come from it include adumbrate, penumbra, sombre, sombrero, and umbrage. And, from the diminutive of umbra, an umbrella gives you a little shade. Originally, the shade you got was from the sun. The word entered English surprisingly late, if the earliest published citation, from 1611, as listed in the Oxford English Dictionary (OED), is indeed the earliest written occurrence of the word. The text in which the word appears is to be found in a book commonly called Coryat’s Crudities; the spelling here is as in the original:

“Also many of them [sc. Italians] doe carry other fine things of a far greater price [than fannes], that will cost at least a duckat, which they commonly call in the Italian tongue umbrellaes, that is things that minister shadow unto them for shelter against the scorching heate of the Sunne. These are made of leather something answerable to the forme of a little cannopy & hooped in the inside with divers little wooden hoopes that extend the umbrella in a pretty large compasse.”

The author of the Crudities was Thomas Coryat or Coryate (1577–1617), from Odcombe in Somerset, and the book was an account of his travels in Europe during 1608.5 He dedicated it to “The High and Mighty Prince Henry, Prince of Wales,” the son of James I, signing the dedication “Your Highnesse poore Observer, Thomas Coryate, Peregrine [i.e. Traveller] of Odcombe.”

Later the umbrella started to be used as a protection from the rain, which was reportedly the case in Persia at the time, as a citation from Thomas Herbert’s Relation of Some Yeares Trauaile of 1634 attests: “The better sort sleepe upon Cots, or Beds two foot high, matted or done with girth-web: on which a Shagg or Yopangee which riding serves as an Umbrella against raine, and sleeping for a bed and coverture.” 6

The French had a word for each of the two different functions: “parasol,” a device for shading you from the sun, and “parapluie,” a device for sheltering you from the rain. “Parasol” entered English at the start of the 17th century, at about the same time as “umbrella,” but “parapluie” lagged behind by a bit more than 100 years, by which time its place had been usurped by “umbrella.” According to the OED’s usage data, “umbrella” is used, hardly surprisingly, about 10 times more often in English than “parasol” and about 500 times more often than “parapluie.”

The extended metaphorical use of “umbrella,” as both a noun and adjective, to indicate a class that encompasses a range of entities, dates from the 20th century. For example, the earliest example that I have found of the term “umbrella term,” the technical term for which is a hypernym, comes from 1924: “Merely spraying a community with a large number of disconnected studies that can be broadly covered by the umbrella term ‘personnel research’ will not lead to a community program.”7

Umbrella segments in proprietary name nomenclature

The MHRA’s guidance introduces the term “umbrella segment” to describe an aspect of an invented (i.e. proprietary) name of a medicinal product, which it defines as “a section of [an] invented name that is used in more than one medicinal name to create a brand or range of products.”

The guidance applies to all types of medicines, both prescription-only medicines (POM) and over-the-counter medicines, whether pharmacy-only (P) or those available more widely via the General Sales List (GSL).

The guidance recommends that when an umbrella segment is proposed to be used for more than one product, “the umbrella segment should not be used if its use is likely to result in safety or efficacy concerns resulting from confusion between the products sharing the same umbrella segment.” Listed examples of such concerns include marketing different products under names that contain an umbrella segment: if they have different active ingredients; if they can be used in different populations; if they have different adverse effects profiles in different populations; if they are subject to different drug-drug interactions; if overdose causes different clinical features and requires different treatments; or if they have different speeds of onset.

In a section headed “Acceptability of Umbrella Segments” the guidance goes on to state that the MHRA will “consider on its merits” names of this kind that will not give rise to concerns about safety or efficacy and that comply with legislative requirements. This section is followed by a section headed “Specific Circumstances,” which appears to outline those considerations. However, that is not specifically stated, and I find the contents of this section hard to understand. I have therefore refrained from summarising them here. One has to assume that when a company proposes a new name it will already understand what is and is not likely to succeed, either from experience or because the agency will advise accordingly.

The guidance continues with instructions to manufacturers on the type of information that should accompany applications for proprietary names, in order to allow a risk analysis. These include:

● a statement of the rationale for the proposal;

● a description of other products that include the same or a similar umbrella segment;

● the indications for each relevant product;

● discussion of any potential harms that might arise from using the umbrella segment;

● details of specific populations of consumers who might use the products when there are differences between the products (e.g. children, pregnant women, elderly people, those with renal or hepatic impairment);

● differences in drug-drug interactions;

● differences in indications, contraindications, warnings, and dosage regimens;

● differences in the effects of overdose and its management;

● differences in the mode and speed of action.

● various aspects relating to the packaging of the products.

The FDA’s guidance

In its guidance on proprietary names for prescription medicines the FDA uses the term “brand name extension,” similar to the MHRA’s term “umbrella segment” but defined slightly differently, as “a naming strategy that uses a proprietary name that is already associated with one or more marketed drug products, with or without a modifier, for a product that does not share any active ingredient(s) or active moiety(ies) with the marketed product(s).” The FDA gives two examples:

1. The proprietary name “Drugname” is already associated with a marketed product that contains a specific active ingredient or active moiety, and the sponsor uses the same proprietary name to introduce a new product that does not contain that same active ingredient.

2. A sponsor uses a portion of the proprietary name already associated with a marketed drug product, with or without a modifier, to introduce a new product that does not contain the same active ingredient.

The FDA advises against using a brand name extension for a new product. Although it does not cite specific cases, the guidance says that using the same proprietary name that is already associated with another marketed drug product “has led to the use of a product for the wrong indication, in the wrong patient population, at the wrong dose, or in a contraindicated manner” and that some of those errors “have resulted in serious adverse events.”

However, in its draft guidance on proprietary names of non-prescription medicines8 the FDA repeats its advice about brand name extensions and refers to cases, with citations, in which confusion occurred. For example, it reported five cases of errors involving consumers who had used Maalox Total Relief by mistake, when they had intended to use one of the traditional Maalox liquid antacid products, the two products having different indications. It also reported that in some cases such confusion had resulted or might have resulted in serious adverse events,9 many of them documented by the Institute for Safe Medication Practices.1011

A final thought

Umbrella segments, it appears, do not provide much shade from the possibility of medication errors. Many years ago my attention was drawn to problems that could arise through their use.12 A woman took an overdose of a medicinal product called Anadin and was admitted to hospital. Thinking that all formulations of Anadin contain aspirin, the admitting doctor measured the plasma concentration of salicylate and found none. The patient was subsequently found to have taken Anadin Paracetamol, which contained paracetamol and not aspirin. Consequently, I surveyed a range of proprietary names of products available over the counter in the UK as listed in a publication called Chemist and Druggist.13 I found many other examples that could have given rise to similar problems.

The instructions contained in the MHRA’s guidance document are complex. It would be much simpler if the agency stated clearly that umbrella segments will not be condoned and that each new product should have a completely distinct name, even though that that might not find agreement among pharmaceutical companies, who value consumers’ brand familiarity.14

A proviso

My summary of the agencies’ guidance documents contains my own interpretation of the guidance and should not be regarded as a definitive version. For that, and further references, the original documents should be consulted.34