Pharmaceutical surveillance

F.W. Rosa, Computerized on-line Medicaid pharmaceutical surveillance system (COMPASS) human teratology, Teratology, 33(3) (1986) 54C. 

To share such knowledge and discuss these important trends in a timely manner, we have established a pharmaceutical competence network - an attempt to provide a global pharmaceutical surveillance the... 

Getting to gups with manual handling pharmaceutical a abort guide for employers Health surveillance in the pharmaceutical industry (COSHHj Emergency action for burns Eive steps to risk assessment... 

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. 

FIGURE 20.1. The pharmaceutical development process, viewed as four stages (discovery, preclinical development, clinical development, and NDA review) as well as the important post-market surveillance phase. 

It is indeed humbling to compose this introductory chapter as there is already a vast array of introductory literature on process analysis. " It is worthwhile, however, to expand upon these works as the field continues to advance. This chapter is written from a PA experience base spanning three disparate sectors (chemical, pharmaceutical and surveillance) and various real-time analytical problems. The experience includes disparate products (fine chemical, polymer, pharmaceutical materials during product manufacture, etc.) and material physical states as well as PA solutions. 

Group of Health Surveillance, Center of Pharmaceutical Studies, Faculty of Pharmacy, University of Coimbra, Polo III, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal e-mail apena ff.uc.pt... 

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

There has never been any incentive for the pharmaceutical industry to pursue research along these lines even though, as in the case of Vioxx, the end results of neglecting adverse effects may be very costly. The aim of the industry has usually been to extend the market size irrespective of potential risk and attempts to implement effective post-marketing surveillance has received little enthusiasm. It is to be hoped that company medical departments and pharmaceutical physicians will continue to support the need for a broad range of safety evaluation studies to be conducted on new medicinal products. 

Strom BL, Carson JL, Morse ML, et al. The Computerised On-line Medicaid Pharmaceutical Analysis and Surveillance System a new resource for postmarketing drug surveillance. Clin Pharmacol Ther 1985 38 359. 

Jones JK, Idanpaan-HeikkUa, JE. Adverse Reactions, Postmarketing Surveillance and Pharmacoepidemiology. In Burley DM, Qarke JM, Lasagna L, Edward Arnold, eds. Pharmaceutical Medicine. A Division of Hodder Stoughton Publishers, 1993 145-80. 

Recent initiatives by global organizations such as ISO (International Organization for Standardization, www.iso.org) and ICH (International Conference on Harmonization, www.ich.org) are attempting to bring consistency in concept and standardization in definition to the QMS. In 2004, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S, www.picscheme.org) issued its recommendation on Quality System Requirements for Pharmaceutical Inspectorates. The U.S. Food and Drug Administration (FDA) initiated inspection surveillance approaches based upon QMS organization and is another source of definition and interpretation. 

This chapter will review the way in which veterinary pharmaceutical drugs are used and the controls placed on their use. It will also explain how information from veterinary drug residues surveillance programmes coupled with knowledge of the potential risk they pose can be used to assess the hazards they may present if allowed to enter the human food chain. 

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