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Glossary

Pharma terms, explained in plain words.

Start with the prescribing information, which people in pharma call the label. It is the official document a regulator approves for each medicine: the FDA in the US, the European Commission or a national agency in Europe, the MHRA in the UK, and most terms below relate to it.Each definition starts with the plain meaning, then the detail. Each term has its own link you can share.

Start here

Prescribing information (the label)

The official document a regulator approves for each medicine. The regulator is the FDA in the US, the EMA or European Commission in Europe, or the MHRA in the UK. It says what the medicine treats, the dose, who should not take it, the warnings and the side effects. People in pharma call it the label, even though it is a document and not the sticker on the box. In the US it is often called the USPI, and in Europe and the UK the SmPC.

Every Juncture check compares material with the current prescribing information. See how it works.

A

AI answer check

Juncture’s check of what AI tools tell doctors about a medicine. It asks ChatGPT, Gemini, Perplexity, Claude and Google AI Overviews the questions doctors ask, compares each answer with the prescribing information, and records which pages each answer cites. It reports what the tools say and does not change their answers. The product is called Answer Monitor.

See the AI answer check.

AI answer monitoring

Checking what AI tools say about a medicine. It means asking AI tools such as ChatGPT, on a schedule, the questions doctors and patients ask about a medicine, and checking each answer against the prescribing information. It shows whether the medicine appears, whether the answer gives the approved uses and dose, and which sources the tool relied on.

Juncture does this across ChatGPT, Gemini, Perplexity, Claude and Google AI Overviews in its AI answer check.

C

CCDS

The drug company’s own master document of core facts about a medicine. Company core data sheet: the document the company that holds a medicine’s licence keeps with its core safety information and other core data, such as uses, dosing and pharmacology. The prescribing information in each country, such as the SmPC and the USPI, is written from it, so a CCDS update is often where a change in each country begins.

Change Check

Juncture’s review of everything that relies on a medicine’s prescribing information after it changes. For one medicine in one country, Juncture lists what changed, finds every key message, source, brochure, slide, email, web page and letter to doctors that relies on it, checks what AI tools say, and gives the team one list with the proof and a suggested action for each item. A Change Check sample does the same from public information only.

See the Change Check.

Claims library

The company’s list of approved key messages about a medicine. It is the approved set of claims a company may make, each with the sources that support it and a record of the materials that use it. Claims libraries are often kept in a content system such as Veeva PromoMats or Aprimo.

Juncture checks the source behind every message in a library with its Source check.

E

Evidence hierarchy

How much weight each kind of source carries. It is the order of weight given to the sources that support a claim. For a claim the prescribing information can support, the prescribing information is the expected source and ranks above a journal publication.

The Juncture Source check weighs the hierarchy for every message.

F

Fair balance

Showing a medicine’s risks as clearly as its benefits. It is the principle in prescription drug promotion that information about a medicine’s risks is presented with prominence comparable to the information about its benefits. In the US it comes from FDA rules on prescription drug advertising, and reviewers check it on every piece of material that makes a benefit claim.

Juncture Pre-check checks that the safety information is there and appears with the benefit claims it has to accompany.

I

Important safety information (ISI)

A short summary of a medicine’s most serious risks. It is drawn from the prescribing information, and US promotional materials and brand websites carry it alongside benefit claims. It usually covers the boxed warning, who should not take the medicine, and the key warnings and precautions.

L

Label change impact assessment

The work of finding everything a change to the prescribing information affects. After an update, the team finds everything that relies on the changed sections and decides for each item whether to update it, withdraw it or confirm that it still stands. It covers claims, references, promotional materials and modules, medical information letters, training and risk materials, public websites and what AI tools say about the changed topics.

Juncture runs it for one medicine in one country as the Change Check.

Label of record

The version of the prescribing information a company checks its materials against. For a given medicine and country it is the current SmPC in the EU and UK, or the current USPI in the US. When the prescribing information changes, the new version replaces it.

Every Juncture check is measured against it, as the platform overview explains.

M

MLR review

The review every piece of material needs before it goes out. Medical, legal and regulatory review is the process in which a company’s medical, legal and regulatory reviewers approve promotional and medical materials before they are used. It usually runs in a review system such as Veeva PromoMats or Aprimo.

Juncture Pre-check checks a draft against the prescribing information before it reaches MLR review.

Modular content

Approved wording kept as small blocks that can be reused. A block, such as a claim with its reference and required safety text, is approved once and then combined into emails, web pages and other materials across channels and countries.

Juncture matches material to approved blocks by meaning, so a reworded copy still points back to its block, in Content Intelligence, your library of approved messages and materials.

O

Off-label

A use the medicine is not approved for. It covers any use outside what the prescribing information allows, such as another condition, patient group, dose or way of taking it. Doctors may prescribe a medicine off-label, but companies may not promote it for those uses.

Juncture Pre-check flags wording that suggests an off-label use, with the part of the prescribing information and the reason.

Off-label drift

When wording slowly comes to describe a use the medicine is not approved for. It happens to AI answers and to approved claims that get reworded over time. Often the qualifier that limits a use, or the warning that goes with a benefit, has been dropped.

The Juncture AI answer check flags it in AI answers.

P

PIL

The leaflet for patients inside the medicine’s pack. Patient information leaflet: the leaflet in the pack of a medicine in the EU and UK, written for patients and based on the SmPC. EU law calls it the package leaflet.

R

Recent major changes

The list of major changes at the top of a US prescribing information. It sits in the Highlights and names each section with a substantive recent change, with the month and year. It covers the boxed warning, indications and usage, dosage and administration, contraindications, and warnings and precautions, and a changed section stays on the list for at least one year.

Source: 21 CFR 201.57(a)(5)

For a US medicine, the Change Check sample starts from this list.

Reference currency

Whether a cited source is still the current version. For a citation of the prescribing information, it asks whether the reference points at the version in force today or at an old one that has been replaced.

Juncture checks it with a live lookup on EMA and emc in Europe and DailyMed and openFDA in the US, in its Source check.

S

Share of Answer (SoA)

How often AI tools mention a medicine when doctors ask about it. It measures how often and how prominently a medicine appears when AI tools answer real doctor-style questions, for each tool and overall.

It is one of the six core measures in the Juncture AI answer check.

SmPC

The prescribing information for a medicine in Europe and the UK. Summary of product characteristics: written for doctors and other healthcare professionals, in numbered sections such as 4.1 Therapeutic indications, 4.2 Posology and method of administration and 4.3 Contraindications. In Europe, all advertising for a medicine must comply with its official information.

Source: Directive 2001/83/EC, Article 87(2)

Juncture holds the SmPC as numbered sections and follows a change in any of them in the Change Check.

Standard response letter

A ready-made letter a company sends when a doctor asks a question. It is a pre-approved reply that a medical information team sends to an unsolicited question from a doctor or other healthcare professional, for example about dosing in a special group of patients. Letters should reflect the current prescribing information, so a change can leave them out of date.

Juncture is shaping a Letter check with medical information teams.

U

USPI

The prescribing information for a medicine in the US. United States prescribing information is the FDA-approved document for a prescription medicine, written for doctors and other healthcare professionals. It opens with Highlights, including Recent major changes, followed by the full prescribing information in numbered sections.

Put the terms to work

See what one change to your medicine touched.

Check one of your medicines using public information only, or talk to us about a full Change Check with your messages, materials and letters to doctors.