Exhibits, safety problems with

Naturally, the industry as a prime inventor has the opportunity to carry out seminal work with entirely unique concepts, even if many of them do not become therapies for humans. Human is a unique animal which can, and does, exhibit unique responses to a new chemical entity. No pre-clinical work can be entirely predictive of a successful response in the clinic, and there can, in the end, be no substitute for human testing. Some products fail because of safety problems specific to humans, and some because the early promise of efficacy in model systems is not realized in humans. 

The pharmacist or physician can report any problems experienced with dmg products and medical devices. In cases where the PDA and/or manufacturer finds that a marketed product constitutes an actual or potential threat to the safety and welfare of the pubhc, that product must be withdrawn from the marketplace, ie, recalled. Several classes of recalls exist, depending on the relative danger that the product exhibits. C/ass I dmgs pose a serious health threat and may require withdrawal at the consumer level C/ass II dmgs pose a possible or potential health problem that usually means withdrawal at the pharmacy or wholesaler levels and C/ass III dmgs may present a remote hazard to health and safety. 

The traditional scheme is complicated by the fact that some antidepressants exhibit characteristics of more than one class. For example, clomipramine, a tricyclic antidepressant (TCA) with side effects and toxicity similar to other TCAs, works more like the selective serotonin reuptake inhibitors (SSRls). Similarly, venlafaxine and duloxetine, which are usually grouped with the atypical antidepressants, have a side effect and safety profile comparable to the SSRls. Although a classihcation system based on mechanism of action offers some advantage (see Table 3.7), even this scheme is limited by the fact that antidepressants that work in the same way may have widely divergent side effect and safety profiles. In the following discussion, the traditional classification system is adopted. Although fraught with problems and inconsistencies. 

Often one of the leader s biggest challenges is to get the team members to accept that serious accidents can happen. This acceptance can be a particular problem in those facilities which have a good safety record. Indeed, the most difficult analyses for a leader can be those where standards are high and the team members consistently exhibit a high level of professionalism. In such cases, the leader can have a hard time persuading the team members that risk never is zero, and serious accidents can happen anywhere and in any place. These team members can have trouble thinking the unthinkable. They will make statements such as I ve been here 14 years, and never seen that —with the unspoken follow-on, therefore it can t happen. ... 

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