USP Quality Review

No. 60, Issued 05/97

Conclusions

Health care practitioners consider reporting certain drug product quality concerns to a national reporting program very important. They think that current reporting mechanisms are easy to use. Many health care practitioners who currently use the USP PRN have done so for many years.

On the other hand, health care practitioners may be underestimating the importance of their role in the discovery, correction, and improvement of drug product safety and quality concerns.

Clearly, practitioners should be encouraged to report all quality concerns so that USP PRN can discover important quality-related trends. Only with practitioners' cooperation can USP, regulators, and manufacturers improve or revise processes and standards in order to maintain the high quality, safety, and efficacy of drug products in the United States.