deck_3404317 Flashcards
Appropriate prescribing
means only using medications when they are the best type of treatment, selecting the correct medication, understanding the harms and benefits associated with the medication, prescribing it in the correct dose and for the right period of time, informing patients about the nature of their treatment, and monitoring patients to ensure that the drug is having beneficial effect.
Association
in statistical terms, means there is a relationship between 2 items; however, the presence of an association does not prove a cause and effect.
Basic research
the research phase where the basic discoveries are made about how cells function and about human physiology. This type of research lays groundwork for further work in developing new molecules that affect these functions
Canada’s research based pharmaceutical companies (Rx&D)
association that represents the Canadian subsidiaries of the brand-name multinational companies operating in Canada
Clientele pluralism
term that describes the relationship between an agency of the state and the industry that it is charged with regulating, whereby some of the authority of the state is transferred to the industry.
Clinical drug trials
testing of drugs on humans
FDA
the US equivalent of the Health products and food branch.
Food and Drugs Act
the federal legislation dealing with medicines
Gastrointestinal medications
drugs for stomach/bowel problems
Health Canada
the federal department responsible for helping the people of Canada to maintain and improve their health. Within health Canada he health products and food branch is responsible for drug, food, and consumer safety and in the HPFB there are 4 directorates dealing with medicine. The therapeutic products directorate approves and monitors prescription and nonprescription drugs derived from chemical manufacturing and medical devices. The TPD also is responsible for making the decision to remove drugs for safety reasons. The biologics and genetic therapies directorate is responsible for biological and radiopharmaceuticals drugs, including blood an d blood products, viral and bacterial vaccines, genetic therapeutic products, tissues, organs, and xenografts. The marketed health products directorate deals with the safety of products already approved for marketing, finally, the natural health products directorate approves natural health products.
Human testing
the testing that a drug must go through before it can be approved for marketing in Canada. In the first stage, drugs are tested in a small number of healthy people to determine the mechanism by which the drug works and to look at whether the number of side effects increases with higher doses. In the second stage, the drugs are tested in about 100-3000 people who have the disease in question in order to evaluate how well the drugs work and to determine side effects and risks. Finally, in stage three the drug is used in several hundred to several thousand people to gather the additional information about its efficacy and safety to more accurately determine the drug’s harm-to-benefit ratio.
Market failure
the failure of the free-market system to produce results that are socially desirable due to the absence of a sufficient profit motive
Neglected diseases
diseases that occur in small numbers of people or in people with little to no purchasing power. In these cases the absence of sufficient sales means that drugs for these illnesses will not be developed by profit-seeking companies
Patented Medicine Priced Review Board (PMPRB)
a federal Canadian agency that sets a maximum introductory price for any new patented medicine that is marketed in canada and also limits the rise in the price for patented medicines to the annual rate of inflation. The PMPRB has authority over prices as long as the medication has a valid patent.
Patents
medicines typically have 2 different types of patents- a patent on the process used to make them and a patent on the product itself. While a patent is valid the company owning the product has exclusive right to sell it. Patents are granted for a 20 year term from the date when the patent application is filed. Patent terms are the same worldwide except for a group of very poor countries
Pharmaceutical Advertising Advisory Board (PAAB)
an organization with membership from the medical and pharmacy professions, the generic and brand-name industry associations, consumer groups, and organizations representing both medical advertising agencies and medical publications. PAAB evaluates all print advertising directed to medical professionals before it appears in print
Post-marketing surveillance
refers to all of the activities that are undertaken to monitor the safety and effectiveness of drugs once they have been approved for marketing
Precautionary principle
means not only taking into account known risks of a drug but also potential risks even if the evidence for them is weak. In these circumstances the precautionary principle would say that the product should either not be marketed or should be marketed under significant restrictions
Prescreen
under this system, pharmaceutical companies submit their print advertising to PAAB and only use that advertising when PAAB has given approval.
Principle agent theory
proposes that there is a relationship between a principle, who has a task that needs to be performed, and an agent, who is contracted to do the task in exchange for compensation
Promotional activities
all of the methods undertaken by pharmaceutical companies to increase the sales for their products. These include, but are not limited to, advertisements in medical journals, visits by pharmaceutical sales representatives to doctor’s offices, medication samples left behind in doctor’s offices, and television advertisements about diseases.
Risk management
taking the known risks and benefits of a drug into consideration before allowing in onto the market. Unless the product has serious known risks, the preference is to allow it to be sold.
Self regulation
the process by which an industry is allowed to regulate its own behaviourSmart regulatio
Smart regulation
regulating in a way that enhances the climate for investment and trust in the markets such that the administrative burden is reduced for businesses
Summary basis of detection
a document that is released by health Canada after it has approve a new drug. It outlines the scientific and benefit/risk-based reasons for health Canada’s decision to grant market authorization for a product.
Transparency
in the context of drug regulation, refers to how much input the public health care practitioners have in the decision to approve a new drug and how much public access there is to the clinical information that companies have to submit to health Canada when they apply to get a drug approved.
User fees
a general term applied when an individual, group, company, or organization that benefits from a public service is required to pay part of the cost of that service. With respect to pharmaceuticals, it means that when companies apply to have a new drug approved they must pay a fee to health Canada. Those fees form part of the revenue that is used to operate the part of health Canada that deals with medications
