Monitoring and evaluating the effectiveness of drug regulation

The ultimate measures of the effectiveness of dmg regulation can be summarized as follows  

The first three objectives relate to pharmaceutical products, and the fourth to pharmaceutical usage although, in most countries, promoting rational use of dmgs is not part of regulatory activities. In order to achieve the four objectives, the various pharmaceutical activities— manufacturing, importation, exportation, distribution 

Each of these key dmg regulatory functions is designed to accomplish the four interrelated objectives outlined above. Some regulatory functions relate directly to dmg regulation objectives, while others play a complementary role in assuring successful implementation of another function. So in evaluating the effectiveness of dmg regulatory policy, two concepts must be clear, namely  

This example shows not only that it is difficult to develop outcome measures, but that measuring outcomes may be rendered more difficult and complicated by other factors. On the one hand, spurious effects may be found, caused by factors other than regulatory functions. On the other hand, even when regulation does work, detection of the desired outcomes and their impact may be difficult. 

Even though outcome measures may fail to detect the intended effects, this does not automatically mean that regulation is ineffective it may be that this particular regulatory mechanism, although necessary, is unable to produce the intended outcomes alone. The challenge is to identify factors that will complement the regulatory mechanism in order to achieve the desired outcomes. 

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