- New Clients
by Tammera J. Karr
We are not all the same – thank goodness, and for mega-pharmaceutical company’s and industrialized medicine that creates a problem solved by compounding pharmacies. The standardized dosage approach works well some of the time for some of the patients, it does not however take into account many factors that affect how a medication works in a set individual. What if the standard dosage available approach provided by pharmaceutical companies, is a contributor to the chronic over-prescribing of medications, including pain medications? Does a 90 pound woman need the same dosage of a medication as a 250 pound male? This is only the tip of the iceberg when determining medication needs for providers.
Other standardized medication issues come into play for patients also – what if you are a woman with estrogen dominance, experiencing hot flashes, elevations in blood pressure and anxiety? Your allopathic healthcare provider may prescribe an antidepressant, blood pressure medication and anxiety medication. Or a naturopath or integrative healthcare provider, may test and prescribe the hormone progesterone to normalize your levels and symptoms again; what if you need a small amount of the hormone estriol for vaginal dryness, or testosterone is what is needed?
For clients with allergies to gluten and many chemicals or medications a compounding pharmacy provides medications personalized to the needs of the patient – for some this isn’t just a preference it is a health risk to be forced into using medications with allergens. If the only option is to play roulette with which will kill you first, the illness or allergy, many will choose the illness.
The US Pharmacopeial Convention (USP) has released an overreaching draft proposal that may inadvertently crush many small compounding pharmacies. USP is a nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines (including compounded drugs), food ingredients, and dietary supplements. Since USP is considered an authoritative standard-setting body, it is very likely that these USP standards, like earlier ones, will be adopted into law.
“General Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings.” stated intention is to protect healthcare workers from exposure to hazardous drugs (HDs). However, many of the drugs in question are not hazardous, additionally, many compounding pharmacies—especially small traditional pharmacies—will be unable to implement the new standards and could be forced out of business.
Some of the problems with the new USP standards:
They are not within the USP’s purview or expertise. The USP is supposed to set standards to maintain the quality of drugs and drug components. Protecting compounding and environmental workers from hazardous exposures, is already covered under current law.
There has been no assessment by the USP on the extent to which the proposed standards would jeopardize patient access to compounded medicines.
The USP’s list of drugs considered “hazardous” is overly broad. It includes many commonly used medications such as azathioprine, carbamazepine, and clonazepam, all contraceptives and hormone replacement therapies that contain estrogen—which means bioidentical estriol also.
The USP is relying on the National Institute for Occupational Safety and Health’s (NIOSH) list of antineoplastic and other hazardous drugs (HDs) used in healthcare settings. NIOSH acknowledges there is little evidence, that some of these drugs are hazardous to healthcare personnel, and explains that the organization was enlisted to provide guidance to healthcare facilities, not to provide a mandate—yet the USP is using that same list in its entirety without proper review.
Many small pharmacies and healthcare facilities will be unable to comply with the requirements. The new standards require that HDs be unpacked from their shipping container and stored in negative-pressure rooms. These have to be entirely separate from so-called non-hazardous drugs. This would require many different physical spaces, which means new construction in most cases.
Most small compounding pharmacies simply cannot afford to build entirely separate rooms—in fact, a compounding pharmacy told us that the cost to build new rooms and buy the negative-pressure equipment could cost well in excess of a hundred thousand dollars. Some hospitals may have more money, but they and physicians’ offices may also lack the physical space for negative-pressure areas. Furthermore, the new standards do not discuss how to handle a combination of so-called hazardous and non-hazardous drugs—which many compounders mix on a daily basis. The requirement for separate rooms should be balanced with the level of risk compounders actually face, not to mention the economic burden being placed on them.
The impact will be far-reaching. While these standards will have the greatest impact on compounding pharmacies—small traditional compounding pharmacies in particular—they will also affect the day-to-day practices of every healthcare facility that receives, stores, compounds, and administers HDs: regular pharmacies, wholesalers, distributors, hospitals, clinics, and all long-term care and assisted facilities. In the most likely scenario, compounding pharmacies will simply stop making vital drugs that millions of Americans depend upon, while other healthcare facilities will pass the new costs on to the consumer.
Once again, regulators are not showing any common sense. To read more on this and take action go to: http://www.anh-usa.org/compounded-medications-even-more-at-risk
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