Never in the history of mankind have so many drugs been available, and never has it been more important for medical professionals to understand fully both their indications and the regulations that govern them. With increasing availability and potential lawsuits come more guidelines, which can in turn create confusion. This work can be a useful tool in preventing the latter. Although the author refers specifically to EU guidelines and directives, the accelerated changes in pharmaceutical medicine are worldwide, and this is indeed an international industry.
As expected, new words, phrases and agencies appear in this field regularly. The third edition of this essential desk reference (55 pages longer than the second) has been updated, as its preface states, with the intention of keeping pace with “[…] a rapid increase of new guidelines issued by health authorities as well as in adaptations of those that already exist”. Just a few of the terms added in the first four pages: Abstinence Syndrome; Academic Study; Actual Marketing; Adaptive Design; Added Benefit; Additives; Additional Monitoring; Adjuvant; and Adolescent. One term in these same pages was deleted: Activities of Daily Living. Helpful cross-references are provided, making the work more useful for students: Pill Counting is crossed to Compliance; Ointment to Formulation; Investigational Plan to Protocol; Phytonutrient to Functional Food; and Nuisance Variable to Confounder. A new term for this reviewer (who was a bit baffled by its inclusion here): “Parouzzi Principle – Given a bad start, trouble will increase at an exponential rate”. A few terms are included that would seem self-evident: Sales Reps; Results; Report; Prescription; and Age.
Appendices follow the 265 pages of definitions. A very thorough Abbreviations/Acronyms key is 32 pages long; Recommended Reading is divided by subtopics such as Standard Textbooks, Drug Research & Development, Clinical Trial Design and Epidemiology; and Useful Websites is similarly subdivided by topic. A quick link check revealed that four of the first ten websites listed had outdated addresses (perhaps due in part to the more widespread use of the .eu domain recently), though the agencies were found easily with a name search. Although not intended to be an exhaustive treatment of the subject, as a basic reference this is an essential purchase for all health care collections.
