Committed to Your Safety

Pfizer employs medicine safety specialists around the world, including research scientists, physicians, nurses, pharmacists, epidemiologists, and others. These colleagues work with regulatory authorities to understand, as precisely as possible, the risks and benefits of our medicines both before and after they are approved for doctors to prescribe for patients. We do this through observational studies and other activities, including independent safety studies we fund but are conducted by third party investigators on our behalf, and through the collection of adverse event reports. An adverse event is any undesired, health-related occurrence experienced by a patient who has taken or who is currently taking a medication.

The goal of safety reporting activities is to ensure that patients, health care professionals, and regulators have all the relevant information about the benefits and risks of medicines to help them make informed decisions about their use. Explore this section to view the science-based processes we follow when we receive a report of an adverse event.

Step 1: Receiving a safety report

Adverse event reports come to a pharmaceutical company from many different sources, such as clinical studies and spontaneous reports from a variety of sources, including health care professionals, patients and caregivers.

Regardless of the source of the report, the regulatory timelines for submitting reports to Health Canada begins the moment the first person anywhere in the company learns of the event. So anyone who works for, or on the behalf of, the company must be trained to recognize reports of adverse events and forward them to the company's medicine safety department.

Step 2: Capturing and reviewing information

After an adverse event report is received by a pharmaceutical company, all information about the case is entered into the company's safety database. From here, the case will be reviewed by medical professionals and reported out to regulatory agencies, such as Health Canada.

Step 3: Analyzing the facts

The pharmaceutical industry professionals who review and assess case data and follow-up information—physicians, other health care professionals, and scientists—are all highly trained in medicine safety. These professionals use their expertise to assess how the adverse events reported for a medicine affect the benefit-risk profile of the product. Once the information for a report is considered complete and has been entered into the safety database, it is permanently available for future analyses of safety trends for a medicine.

Step 4: Reporting and communicating risk

Individual case reports are submitted to regulatory agencies, such as Health Canada, when they meet certain specific reporting criteria. In addition, all cases in the safety database will be incorporated into periodic reports-designed to report safety information about a medicine that accumulates over time. These reports are sent to Health Canada at regular time intervals determined by the length of time for which the medicine has been approved. Pharmaceutical companies also communicate changes in risk information, when warranted, to investigators, physicians, and patients through vehicles such as investigator letters or "Dear Health Care Professional" letters, labeling changes, and other targeted medical communications.

Additional Useful Resources on Medication Safety:

Pfizer Canada was approached by the Institute for Safe Medication Practices Canada (ISMP Canada) in March 2009 to participate on a cross-functional project related to bar coding on pharmaceutical products. The initiative is guided by a national Implementation Committee and it is being developed with the assistance of a 34 member technical Task Force, representing several health care sectors.

The project mandate is to increase patient safety by implementing standardized bar codes on all pharmaceutical labeling. Currently, the exterior packaging of most medication in Canada includes a bar code. However, the application of bar codes to inner labels of ampoules, vials and blister packs is very limited and lacks standardization. There is a potential risk to patient safety when non-automated, e.g., human identification methods, are used to verify product identity and potency. In order to reduce this risk, an industry standard would be developed and implemented.

Patient safety is key to our activities at Pfizer Canada. Therefore, Pfizer Canada fully supports this imitative.

• Medication safety for children: A guide for parents and caregivers
• Medication safety for the elderly: A guide for patients and caregivers
• www.pfizer.com/medicinesafety

To report an adverse drug event experienced with a Pfizer medication, Canadians may contact Pfizer's Drug Safety Unit at the following toll-free number: 1-866-723-7111.

Helpful Links

The websites below may help you learn more about medicine safety. These Web sites are neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of these sites.

• ClinicalTrials.gov
• www.clinicalstudyresults.org
• Health Canada
• Canadian Medical Association
• www.SafeMedication.com