Pharmaceutical Legal Glossary
Glossary of Pharmaceutical Terms
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z #
Click on the first letter of the word from the list above to go to the appropriate section of the glossary.
- P -
PPA: A chemical used in over the counter and prescription medications. PPA was very common in diet drugs, nasal decongestants and cough medications. PPA might cause between 200 and 500 hemorrhagic strokes per year in patients age 18 to 49. U.S. consumers bought about 6 billion doses of PPA last year. Popular PPA Products containing PPA include:
- Dexatrim Weight Control Candy and Tablets
- Acutrim Weight Control Candy and Tablets
- Permathene Mega 16 Weight Control Tablets
- Robitussin CF Cough Syrup
- Triaminic DM Cough Syrup
- Tavist D Cold, allergy and sinus tablet
On November 6, 2000, while regulators moved to take it off the
market, U.S. health officials urged consumers to stop taking
decongestants and diet drugs containing a key ingredient linked to cases
of strokes. The ingredient, phenylpropanolamine (PPA), is found in
hundreds of over-the-counter and prescription products, including the
cold medicine Dimetapp and such weight-loss drugs as Dexatrim and
Acutrim. It works as a decongestant in cough and cold remedies and as an
appetite suppressant in diet drugs. The Food and Drug Administration
(FDA) said it has asked all drug companies to voluntarily stop marketing
products containing PPA. Makers would have the option to reformulate the
products with other ingredients. The agency also is writing a proposal
that will make the sale of PPA products, both prescription and
over-the-counter, illegal. That process is likely to take several
months. Regulators determined that PPA is linked to cases of bleeding
strokes in adults under age 50. Research pointed to a higher risk of
hemorrhagic strokes, or bleeding into the brain, for women, but the FDA
cautioned that men were also at risk. The strokes occurred within three
days after people took the products. Other popular products that contain
PPA include some versions of Alka-Seltzer Plus, Comtrex, Coricidin,
Tavist-D and Triaminic.
Paxil: An antidepressant drug belonging to a class of medications
known as selective serotonin reuptake inhibitors (SSRIs). Paxil is
believed to be very addictive, and many users report severe withdrawal
symptoms after discontinuing use. Some experts even link Paxil to an
increased suicide risk. The manufacturer has been accused of misleading
the public and medical profession by downplaying side effects.
Peremptory Challenge: A challenge to a particular juror that
requires no reason. Normally an attorney has a limited number of these
challenges.
Percocet: A prescription pain reliever containing Oxycodone and
acetaminophen. Classified in the same category as Oxycontin, Percocet
contains no more than 5mg of Oxycodone.
Percodan: A prescription pain reliever containing Oycodone and
aspirin. Classified in the same category as Oxycontin, Percodan-Demi
only contains 2.25mg of Oxycodone.
Petition: A formal request that the court take some action; a
complaint.
Personal Property: Defined by the law as “things movable.” This
is distinguished from the term “real property,” which includes things
such as trees, buildings and land.
Pharmacology: The scientific discipline that studies the action
of drugs on living systems (animals or human beings).
PHASE 1, 2, 3, 4 DRUG TRIALS: Different stages of testing drugs
in humans, from first application in humans (Phase 1) through limited
and broad clinical tests (Phase 3), to post-marketing studies (Phase 4).
- PHASE 1 DRUG TRIAL Phase 1 trials include the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers; sometimes, where the drug is intended for use in patients with a particular disease, however, such patients may participate as subjects. Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness; they are typically closely monitored. The ultimate goal of Phase 1 trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies.
- PHASE 2 DRUG TRIAL Phase 2 trials include controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well-controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects.
- PHASE 3 DRUG TRIAL Phase 3 trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide and adequate basis for physician labeling. In Phase 3 studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to the FDA for approval to market the drug.
- PHASE 4 DRUG TRIAL Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain post-marketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time.
Physical Dependence: A physiological need for a substance, the
absence of which leads to withdrawal. Physical dependence is
distinguishable from addiction in that addiction also involves mental
fixation.
Placebo: A chemically inert substance given in the guise of
medicine for its psychologically suggestive effect; used in controlled
clinical trials to determine whether improvement and side effects may
reflect imagination or anticipation rather than actual power of a drug.
Plaintiff: The party bringing the case against another.
Pleading: The process of making formal, written statements by
litigants during a lawsuit. All papers filed with the court are
collectively referred to as “pleadings.”
Prempro: A hormone replacement therapy (HRT) drug prescribed to
treat menopause symptoms, Prempro® was recently a subject of a drug
recall. It was pulled from shelves in 2002 after the Women's Health
Initiative Study found that it increased women' s risk of stroke by 41
percent, cardiovascular disease by 29 percent, and breast cancer by 26
percent. Warnings from the American Heart Association and the Journal of
the American Medical Association also prompted the recall.
Precedent: The value that a completed case has on deciding future
cases.
Process Serving: The method by which a defendant in a lawsuit is
notified that a plaintiff has filed a suit against him.
Product liability: A manufacturer of a product may be held liable
for damage caused by that product if it was somehow defective, to the
point that it was unreasonably dangerous to the consumer. A product can
be defective in 3 ways: Manufacturing Defect (When one particular
product out of many like products has a flaw that makes it unreasonably
dangerous, it is said to have a manufacturing defect); Design Defect (If
the actual design makes it unreasonably dangerous); Information Defect
or Failure to Warn (A defendant may be liable for not adequately warning
of a product’s risk that were known in light of scientific knowledge at
the time of manufacturing).
Pro Se: On one’s own behalf; not using an attorney.
Propulsid: Propulsid (Cisapride) may cause irregular heartbeats
and even sudden death. At least 341 reports of heart-rhythm
abnormalities, including 80 reports of deaths, have been associated with
Propulsid. Report of deaths and hospitalizations have mounted since the
FDA first warned that Propulsid can cause serious heart problems in June
1998. Some 30 million U.S. residents, including President Clinton, have
taken the medication since it hit the market in 1993 for
Gastroesophageal Reflux Disease (GERD). Propulsid can cause serious side
effects such as:
- Sudden cardiac death
- Heart attack
- Irregular heartbeat
- QT interval prolongation
After the drug's approval in 1993, there were several revisions to
the Propulsid label, informing health care professionals and patients
about various side effects and risks, the most serious of which involved
cardiac irregularities. Although Propulsid was only associated with mild
adverse effects upon approval, the drug was soon linked to
life-threatening heart rhythm abnormalities (arrhythmias) and cardiac
arrest in people with no prior heart disease. After years of escalating
fatalities and pressure from the FDA, Janssen Pharmaceutical Inc., a
division of Johnson & Johnson, announced that it would voluntarily stop
marketing Propulsid in the United States beginning July 14, 2000.
Purity: The relative absence of extraneous matter in a drug or
vaccine that may or may not be harmful to the recipient or deleterious
to the product.
Punitive Damages: Damages given for the purpose of punishing the
defendant.
