Clinical surveillance

Close clinical surveillance of all women taking OCs is essential they should be reexamined at least once a year. In all cases of undiagnosed persistent or recurrent abnormal vaginal bleeding, rule out malignancy. Monitor women with a strong family history of breast cancer or who have breast nodules, fibrocystic disease of the breast, cervical dysplasia, or abnormal mammograms. 

The absorption of oral dantrolene can be significantly increased by metoclopramide (15). As the risk of hepatotoxicity has been related to the dosage of dantrolene, increased clinical surveillance is necessary to avoid toxicity of dantrolene during concurrent treatment with metoclopramide. 

Problems in access function should be detected by clinical surveillance and promptly referred for further evaluation and treatment. 

Clinical Surveillance of UHMWPE Using Radiographic Methods... 

Einahy, all data, including the results of the clinical investigation, ate collected in a New Dmg Apphcation (NDA) and sent to the EDA. Once approved, the new dmg goes into production. After manufacturing begins, the new dmg products must be monitored in clinical use in the marketplace for reports of untoward reactions. This amounts to post-approval surveillance known as Phase IV. All such reports must be submitted to the EDA in a timely manner. 

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

Resistance to commonly prescribed antimicrobials such as the penicillins and macrolides/azalides increased dramatically in the late 1980s through the middle to late 1990s. Table 68-2 provides resistance information collected nationally from 1999 to 2004 using the Tracking Resistance in the US Today (TRUST) surveillance database.26 In 2004, the average national rate of resistance to penicillin and macrolides was approximately 18% and 25%, respectively. Susceptibility results alone do not account for clinical success or failures when treating pneumonia. 

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

The excellent safety profile observed in clinical trials has been confirmed by the postmarketing surveillance program [117]. More than 8.5 million patients have been treated in Italy and abroad with rifaximin since its introduction to the market. During the overall postmarketing... 

---