Case Study: Updating & Revising HPUS Monographs
By Eric Foxman, Pharm. (Ret.), AAHP Secretary
What is the process through which the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) revises monographs? What role can subscribers and non-members play in this activity? The HPCUS Standards and Controls Committee (S&C) has just completed such a revision; this case provides an insight into the process.
George Bernstein is a consultant known to many in the industry due to his familiarity with homeopathic drug products and production methods and through his participation in a number of AAHP webinars. George contacted the HPCUS with a question raised by a lab contracted by one of his clients. The lab was having trouble obtaining the acceptance results of one test specified in the HPUS monograph for Substance A. A quick look revealed no one else had yet reported the same problem regarding that particular test for Substance A. At least one other lab was proactively contacted regarding their experience; they reported they used that test infrequently but had no record of any problems.
Members of the S&C reviewed the history of this monograph’s Quality Control (QC) tests. The test under question was adapted from the German Homeopathic Pharmacopoeia (GHP) monograph for Substance A more than 20 years ago. The historical review was accompanied by a broader search, and it was determined that the GHP monograph for Substance A was subsequently discontinued in favor of the European Pharmacopoeia’s (EP) monograph and QC test(s).
The S&C reviewed the historical information, their collective experiences with the tests for Substance A, the transition from the GHP and French Pharmacopoeia monographs to the EP monograph, and the QC tests in the current EP monograph for Substance A. The S&C unanimously concluded the HPUS monograph be updated and should direct subscribers to utilize the QC test method in the current EP.
The HPCUS contacted George about this change (which will be posted in the coming weeks), so he could convey this information to his client and their contract lab.
Coincidentally, a different subscriber reported difficulty in obtaining usable results from one of the tests for Substance B; this began a process of review and related research. This process was completed during the same S&C meeting; the collected experiences of the S&C members over the past 20 years suggest the existing HPUS test provides valid acceptance results. This second subscriber is being contacted with this conclusion and a question as to whether the data inputs may be incorrect causing the invalid results.
Notice of the Substance A QC changes will be distributed through an upcoming HPUS Updates Notification Emails. (Sign up for these free emails here.) These will also be covered in a short, concise webinar, What’s New in the HPUS and What’s Coming?, which will take place Wednesday, June 8, from 12:00-12:30 pm EDT. Find out more and register.
All subscribers and users of the HPUS should feel free to contact the HPUS with similar questions. Even typographical errors or phrases that might need clarification can be pointed out. Your input will help improve the HPUS and make it more useful to all subscribers. The HPCUS will address your input as circumstances allow, and will make any necessary updates.
For those interested, the process of submitting an entirely new monograph for consideration in the HPUS was addressed in a 2020 article, How To Submit Monographs To The HPUS.