The Pharma Marketing Glossary

An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug's risk information in a product claim ad. In print ads, they usually do this in the "brief summary." This brief summary would take many minutes to read or scroll down a TV screen. The law allows broadcast ads to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug's risks. To meet the "adequate provision" requirement, the broadcast ad must provide ways to find the drug's FDA-approved prescribing information. Broadcast ads can meet the "adequate provision" requirement by giving a number of sources for finding a drug's prescribing information. These include:

• A healthcare provider (for example, a doctor)
• A toll-free telephone number
• The current issue of a magazine that contains a print ad
• A Web site address

The exemption does not apply to products with black box warnings in their approved product labeling. Source: FDA, Advertising/Labeling Definitions

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Percent of doses of a drug taken as prescribed for entire period of study (compliance + persistence); to combine the proper self-administration of treatment with a patient's sticking with it. Where to find more information:

• Article: "Effective Pharma Adherence Programs Start With the Patient"
• Article: "Eyes on the Adherence Prize"
• Podcast: Physicians Favor Brands with Compelling Adherence Platform: Highlights of Physician Survey

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• An adverse drug reaction (ADR) is an injury caused by taking a medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as pharmacovigilance. An adverse drug event (ADE) refers to any injury occurring at the time a drug is used, whether or not it is identified as a cause of the injury. An ADR is a special type of ADE in which a causative relationship can be shown.
  • Source: Adverse drug reaction
  An adverse drug reaction is "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product." Such reactions are currently reported by use of WHO's Adverse Reaction Terminology, which will eventually become a subset of the International Classification of Diseases. Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). Timing, the pattern of illness, the results of investigations, and rechallenge can help attribute causality to a suspected adverse drug reaction. Management includes withdrawal of the drug if possible and specific treatment of its effects. Suspected adverse drug reactions should be reported. Surveillance methods can detect reactions and prove associations.
  • Source: Adverse drug reactions: definitions, diagnosis, and management.

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• The definition of "adverse event" for both prescription drugs and dietary supplements is "any health-related event associated with the use of a that is adverse". This could include any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease, and, more seriously, death.

FDA defines an Adverse drug experience as "Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action." FDA's MedWatch Form, which is used by physicians and consumers to report adverse events, includes the following outcomes attributed to adverse events:

• • • Death
    • Life-threatening
    • Hospitalization
    • Disability or permanent damage
    • Congenital abnormality
    • Required intervention to prevent permanent impairment or damage
  The FDA requires pharmaceutical companies to monitor and report all adverse events it learns about relating to its products. The agency expects "entities responsible for reporting will promptly review all adverse event information received or otherwise obtained, which potentially includes information from the Internet and social media tools."

Such events should be reported to FDA if there is knowledge of the four basic elements for submission of an individual case safety report, namely:

• • 1. An identifiable patient
    2. An identifiable reporter
    3. A suspect drug or biological product
    4. An adverse experience or fatal outcome suspected to be due to the suspect drug or biological product
  FDA guidance states that those entities should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that they do not sponsor; however, if they become aware of an adverse experience on an Internet site that they do not sponsor, they should review the adverse experience and determine if it should be reported to FDA.

Where to find more information:

• • Source: FDA Regulatory Procedures Manual March 2010
  • Blog Post: New FDA Data: Adverse Event Reporting Increases Dramatically
  • Article: Social Media Adverse Event Reporting Safe Harbors

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FDA requires manufacturers, packers, and distributors of marketed prescription drug products to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiences associated with the use of their drug products. Pharma companies must also develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA. FDA law requires pharmaceutical companies to periodically report any adevrse events it has knowledge of. Before considering any clinical incident for submission to the FDA in an expedited or periodic safety report, applicants, manufacturers, and licensed manufacturers should have knowledge of the following four dats elements:

• An identifiable patient;
• And identifiable reporter;
• A suspect drug, biological product, or device; and
• An adverse event or fatal outcome.

According to the FDA, "Reporting of adverse events from the point of care is voluntary in the United States. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report these events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations" (see "Adverse Event Reporting System (AERS)"). Where to find more information:

• Source: FDA Regulatory Procedures Manual March 2010
• Blog Post: New FDA Data: Adverse Event Reporting Increases Dramatically
• Article: Social Media Adverse Event Reporting Safe Harbors

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Relating to a stage in a patient's behaviorial progression with regard to a medical condition in which the patient is just finding out about the condition and whether it pertains to him or her.

Addiction recovery programs often refer to three stages of behavior leading to recovery: Awareness, Acceptance, and Action. This progression may be called "The Three A's" and is used as a tool to help people come to terms with their addiction.

The same behaviorial progression is seen with patients coming to terms with a chronic medical condition.

Patients need different information from prospects and marketing messages need to change as prospects go through the behavioral progression starting at Awareness (just finding out about the condition and whether it pertains to them), moving to Acceptance (the potential risk has been personalized and the prospect is considering seeking information and/or evaluation), and finally arriving at Action (ready to talk with physician about treatment or is already on therapy).

Pharmaceutical marketers often use the term "Disease Awareness" and try to increase the market size of a therapeutic area by using DTC advertising and physician marketing to "build" awareness of a particular medical condition. An example would be ads for "overactive bladder," which have been successful in building awareness among consumers of a medical condition (urinary incontinence or urgency) that many thought was only of concern for senior citizens.

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