In early April, the Homeopathic Pharmacopeia Convention of the United States (HPCUS) held its annual meeting. During the four-day event, multiple committees, the board, and the general membership came together for reports and ongoing action.
The highlight of the General Membership meeting was a presentation by Rick Lostritto, Ph.D. of the U.S. FDA’s office of Pharmaceutical Quality. Dr. Lostritto emphasized that a quality system both minimizes consumer risk while improving product quality; it requires senior management commitment to be proactive. He noted that ICH Q10 is not stated as applying to homeopathic products, however, its approaches may be applicable. Dr. Lostritto pointed out that the objectives of ICH Q10 include developing and using effective monitoring and control systems as well as identifying and implementing appropriate product quality improvements (process improvements variability reductions, etc.). These steps are fundamental to good manufacturing practices and are supportive of every business’s objectives.
Dr. Lostritto spoke of sources of variability input that could impact homeopathic drug products. These include suppliers that are consistent and trustworthy, as well as being willing to meet corporate quality needs; he singled out containers and enclosures as being the root cause for many stability failures. Equipment materials need to be consistent in their properties and performance, and should not adversely impact drug products. He spent time discussing aspects of the dilution process and asked if it was feasible to validate the process at intermediate dilutions, especially to ensure that surface activity does not adversely impact the measurement of attenuation components. He also noted there appear to be many approaches to succussion and asked: If this is a critical step, are specific standards with measurable end points called for? We can expect to hear more of Dr. Lostritto’s thoughts on this as he is tentatively scheduled to be a presenter at an AAHP webinar in late June.
During the four-day meetings, the HPCUS board approved the following: quality control specifications and tests for 20 monographs, two new sponsored monographs, two small changes in the Guidelines for Manufacturing Homeopathic Medicines, a new Homeopathic Drug Stability Guidelines Document and a revision to the Homeopathic Good Manufacturing Practices document, plus attenuation changes for 11 monographs. All of these are being prepared for posting on www.hpus.com and should be available before the end of the month.
The Monograph Review Committee and Pharmacopeia Revision Committee continued their review of sponsored monographs; the outcome of their work will be on a subsequent board agenda later in 2016. The Clinical Evidence Working Group continues to draft and fine-tune a new guidance document to provide recommendations for the steps necessary, through clinical case reports, to verify important symptoms elicited in homeopathic provings submitted to the HPCUS.
The Council on Pharmacy (CoP) initiated the first steps for addressing substances listed under California Proposition 65. Some of these substances are officially monographed in the HPUS and the restrictions in California may have an impact on the pharmacopeia’s OTC attenuation levels. During the course of upcoming meetings, the extent and impact of those Prop 65 listings will be determined and appropriate steps recommended. The CoP also discussed and reiterated the principle that monographed substances, for which the overwhelming uses require medical monitoring and intervention, should not be available OTC at any attenuation; while the HPCUS recognizes this has an impact on practitioners who do not have prescribing privileges, it is not within the role of the Convention to address licensing related issues.
Concurrently, the Toxicity and Safety Committee is looking at additional monograph substances for which new toxicological information needs to be evaluated for its potential impact on OTC attenuation levels.
Finally the Standards and Controls Committee drafted quality control specifications and tests for a dozen more monographs; these will be finalized at an Autumn meeting.
All of the committees scheduled telecons and or meetings during the coming 12 months. The level of member’s activity and the volunteer input is truly impressive; in 2015, more than 2,500 hours of time were volunteered in meetings, telecons, preparation / follow-up, and travel!