Pharma jargon

I started my career off working on technology clients who were bad for having their own language but pharma jargon takes things to a new level of complexity. I thought I would write a bluffers guide to make other peoples lives easier.

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Here’s some of the examples of pharma jargon that came to mind that aren’t immediately apparent to marketers coming in from other disciplines.

ABPI – Association of the British Pharmaceutical Industry is the trade association for companies in the UK producing prescription medicines. It has a code that members should adhere to. See also PhRMA.

Adherence – takes treatment as directed.

Aggregated – usually in terms of electronic medical records (see EMR below), the most in-depth record of information about a patient’s historical set of conditions, treatments and tests for those conditions and much more.

AE – Adverse event. When you get a reaction from a medicine that is negative. It could be soreness from an injection, or an upset stomach right the way through to death. Pharma companies have time-bounded compliance issues related to AEs. This was one of the reasons why they had been slow to use social media in the past.

Behaviour change – a lot of pharma marketing hinges on behavioural science to drive behavioural change. In a lot of sectors behavioural science usually elicits small changes that might not be worth the effort. In healthcare, it could mean saving lives, so it is leaned on much more.

Biologics – treatments made from actual live organisms rather than synthetic chemicals (which would be called drugs).

BLA – biologics licence application. Paperwork submitted to the FDA. Similar to NDA below.

Building the plane as we’re flying it – building the business to scale up. Usually indicates that the company is growing the amount of people it employs and marketing function to help prepare for product launch. This can be teams in a large pharma company attached to a new drug, or a smaller research company who is looking to take a discovery to launch.

CBER – center for biologics evaluation and research (part of FDA) does the same role for biologics as CDER does for drugs.

CDER – center for drug evaluation and research (part of the FDA)

Clinical endpoint – Used in trials. In the trial design there will be a measurable outcome that determines clinical success… if achieved. All trials have a primary endpoint, they may have additional secondary endpoints. Think of endpoints as medical trial objectives.

Clinical studies – research conducted to understand a treatment’s safety and efficacy,

CME – continual medical education – used interchangeably with CPD – continual professional development. Online modules or events that allow HCPs to keep up to date with the latest developments. Useful from a marketing point-of-view to reduce barriers to prescribe through upskilling, or reframing the way a condition is used to favour one product over another.

Co-insurance – the amount the patient has to pay on private healthcare.

Co-morbidity – having more than one medical condition or disease at the same time. For instance, one of the reasons why obesity has become such a public health issue is down to the higher incidence of co-morbidity that can occur including cancer, diabetes, heart disease, fatty liver disease to name but a few.

Co-pay – see co-insurance.

CRO – contract research organisation – a company that helps move a drug to commercialisation a new drug or device from its conception to legal marketing approval. It would be analogous in a lot of other industries to IT outsourcing in terms of its role in a business value chain.

CVA – see eDetail

DTC – direct to consumer. With certain product categories there has been a trend to prescribe via telemedicine consultation with a qualified HCP and then the product can be sent direct to the patient.

eDetail – an interactive presentation usually delivered using a tablet that sales reps use to discuss their client’s product (or increasingly product with a digital service attached) with healthcare professions

EMA – European Union’s regulatory body, see FDA.

EHR – electronic health record. Aggregated and shared across different HCPs from different organisations

EMR – electronic medical record. Used within one medical system / one set of healthcare providers.

EOB – explanation of benefits – the positive effects a given pharma product has for the patient. This will be expressed not only in biological terms but also impact on quality of life or improvements in standard of care enjoyed.

Ethical pharma – branded as opposed to generic prescription products.

FDA – Food and Drug Administration – the body that certifies whether a product is allowed to be used in the US.

Formulary – a list of pharma products that are approved for prescribing from a finance perspective.

GP – general practitioner – family doctor.

Generic – a pharmaceutical product this is no longer protected by patent rights. It can be manufactured by any company. Patents protecting pharma product intellectual property rights surrounding a product run out after 14 years in the UK, but can vary in other markets.

HCP – usually a prescriber or a gatekeeper. This can be a hospital specialist of some sort, a prescribing nurse or a prescribing pharmacist. The gatekeeper category might be wider such as specialist nurses, surgery nurses, hospital pharmacists – the rationale for reaching these people is to reduce the friction in using a product once it has been prescribed. A less common gatekeeper role is about referring a patient to a prescriber – particularly where the treatment can only be prescribed by a specialist.

Ideopathic – as in ideopathic X disease means that the medical profession don’t know the cause.

In-label: a use of a drug that is within its approved ‘label’ see also off-label, USPI and SmPC.

iVA – see eDetail

KOL – key opinion leader. Can be someone who has specialist expertise, is a prolific researcher often cited in medical journals, someone who has an active profile speaking at professional events or on social media. They may be an academic, doctor, a nurse or a pharmacist depending on the market sector, country and product.

MHRA – Medicines and Healthcare products Regulatory Agency – a UK regulatory body that is equivalent to the EU’s EMA and the FDA in the US.

MLR – medical, legal and regulatory. Equivalent of legal and compliance in other industries such as financial services.

MOA – mode of action, also called mechanism of action. How a pharmaceutical product works (if known).

MOD – mode of disease, also called mechanism of disease. What a condition does to the body, what cells it attacks or biochemical processes it interferes with.

MSL – medical science liaison. A non-promotional specialist expert in a pharma company. The equivalent in the enterprise technology space would be a pre-sales engineering role.

NDA – new drug application. Pharma companies like this because it extends the protected life for a drug. A classic example would be semaglutide. Initially it was marketed to treat people with diabetes. But during those trials it was found to correlate with weight loss. It then became a weight loss and management focused product as well. Each application has a patent protected time period.

Off-label: where a doctor prescribes a medicine or treatment do do something that isn’t on its SmPC or USPI (depending which country you are in). A classic example of this at the moment is the use of Ozempic to help with weight loss and weight management. Ozempic was licensed to help with the treatment of diabetes. It is the same active ingredient, but at a different dose rate in Wegovy. Wegovy is licensed for weight loss / weight management.

On-label: exactly the same as ‘in-label’.

OTC – over the counter. In the UK examples would be Gaviscon or Panadol for upset stomachs and pain respectively. Both are available without a prescription.

PAAB – Pharmaceutical Advertising Advisory Board – an American body that would be similar to the ABPI in the UK. It looks specifically at advertising practices.

Patent cliff – intellectual property rights on drugs are protected for a period of time (which varies by market). Generally it’s between 8 – 14 years. Once this period is over, the drug can be made by anybody. When a company has a series of drugs falling out of this protected period, the company is considered to have ‘fallen’ off a patent cliff if it doesn’t have new drugs to replace the old versions.

PAG – patient advocacy group. They advise patients, help fund research, advocate for patient standard of care.

Patient – person with a medical condition. The end consumer of a pharma product.

Patient advocate – a patient advocate plays multiple roles. They act as the voice of the patient with pharma companies providing insight into the patient experience. This is important in order to drive a more patient-centric approach. They may appear in the media as a spokesperson and may testify in front of regulators and legislators.

Patient-centric – a move in marketing over the past two decades from pharma companies just thinking about getting the HCP to prescribe, to thinking about the end consumer experience. Probably one of the first things they could do is stopping using patient and try people with X instead.

PCP – primary care provider. A family doctor or GP.

PDUFA date – (prescription drug user fee act). Part of the FDA approval process once the application has been assessed by CBER / CDER. It’s the date that the FDA must respond to the drug approval application. There are four tracks with varying speeds to the process depending on product need etc.

PHR – personal health record. A patient-facing record accessed through patient portals etc.

PhRMA – Pharmaceutical Research & Manufacturers of America. Industry body that lobbies on behalf of its members. Its role and code is similar to the ABPI and its code in the UK.

PI – prescribing information, although I have heard product information used. What dose is a product given? How often? Any adverse effects that can happen? Any groups of patients who can’t have the medicine? Any medicines or foods that the products can’t be used in combination with – like antibiotics and alcohol?

Placebo – in this case not the moderately successful band. An inactive treatment, used in control tests for new drugs. If your new medicine doesn’t perform better than the placebo control; it’s not going to get approved for use.

Primary care – family doctor, general practitioner or community clinic.

Rx – prescription (which drives pharma sales).

SmPC – summary of product characteristics, a European equivalent of the USPI. A sheet in medicine packaging covering properties, side effects, officially approved ways of using a medicine. The USPI and SmPC can be different for various reasons: a drug can be approved for different uses in different territories, or may have a different brand name. Also USPIs generally have more information.

Submitted charges – American healthcare system speak for amount billed.

Titrate – process of measuring and finding out the concentration of one substance is in a solution (of something else).

Tx – treatment

USPI – US prescribing information is a sheet that goes into every medicine box properties, side-effects and the officially approved ways of using the medicine. The US version includes details of clinical studies.

Veeva – in the same way that Adobe has become the operating system for creative agencies, Veeva is the same thing for pharma companies. Veeva Vault PromoMats will haunt your dreams.

Vx – vaccination

Warning letter – as bad a news as you probably think it would be. Usually sent to pharmaceutical companies by the likes of the FDA of specific regulatory or legal violations that have happened. They have a request for action to correct the violations. This could be down to company practices, procedures or products – or a combination there-of. The company need to go back with a plan and is likely to under increased surveillance from the authorities.