ATLANTA, Sept. 27, 2016 /PRNewswire-USNewswire/ -- The Association for Precision Pharmacy Services (APRXS) is joining with other medical watchdog groups to encourage the FDA to adopt regulations that will hold physicians' offices to the same levels of accountability as compounding pharmacies to ensure sterile conditions while preparing personalized medicines that include allergen agents.
Anyone who has been to a restaurant knows there is the possibility of ingesting a contaminated food item, but to minimize risk it's as simple as checking the grade of the health inspector's certificate on the wall. The food must be maintained below certain temperatures so as to avoid the growth of contaminants. A failing grade and the restaurant closes until it can be re-inspected. Why? To safeguard the health of diners who assume that food is prepared under sanitary conditions.
Doctors who administer allergy treatments currently mix solutions in non-sterile environments with sick patients sitting near by. But unlike restaurants, in the doctor's office there is no health inspector and they are expected to police themselves. Currently, physicians preparing and administering allergy shots in their offices are responsible for their own self-policing and have no monitored regulations ensuring patient safety. Busy physicians preparing office injections, which could involve dozens or hundreds of patient encounters, each with this many as 10 or more allergen transfers, are hard pressed to provide an adequate patient safety environment. Lack of educated supervision, poor documentation combined with ill-trained staff can subject patients to serious risks of infection and negative outcomes.
Unlike physicians' offices, compounding pharmacies, for example, must comply with the Compounding Quality Act (CQA) that includes meeting current good manufacturing practices, be subject to inspections by the FDA according to a risk-based schedule, and they must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
The importance of utilizing the prescribed labeling of patient-specific data as well as dose, expiration, strength, volume, and type of drug utilized must be closely tracked in the physician's office. If a sterility issue is identified and brought to the manufacturers attention and they declare the lot to have been sterile, little can be done about it because the issue stems from the physician's office.
"Our association is certainly not opposed to the physician's ability to store and mix allergens in their own offices," states Noah Hanson, Executive Director of APRXS. "We simply want to ensure that they follow the same sterility regulations as precision pharmacies in order to protect patients, both adults and children, from the prospect of infection from injections with tainted, adulterated, outdated or incorrectly compounded drugs. Consumers deserve to know the sterility conditions of their doctor's office when they go there for compounded allergy injections and our advice is don't be hesitant to ask."
Hanson further adds:
"The idea that the adoption of this regulation would restrict patients access to compounded allergens or even eliminate them is simply incorrect. According to APRXS, there are over 7,500 advanced services compounding pharmacies in the US. And claiming that Medicare patients would be prevented from receiving immunotherapy is no more than a scare tactic."
The regulatory submission is USP 797 and serves to revise USP 39 page 626 to improve clarity and reflect new science. It reduces the number of microbial risk categories to two; category one and category two, the former having a shorter beyond use date (BUD). It introduces the term "in use time" to refer to when a product to make a compounded sterile preparation (CSP) must be used after it has been opened.
Are You a Patient?
If you are worried that your allergy injections may not be sterile, voice your concerns to the U.S. Pharmaceutical Convention (USP) by phone at 1-866-492-3365.
About APRXS We are leading the effort to deliver personalized medical solutions to every patient. Our mission is to conduct effective advocacy for public policies that encourage the discovery of important new medicines and technologies for patients by pharmaceutical and biotechnology research companies that minimize side effects and improve overall patient outcomes, and to support the needs of our members that represent the precision medicine industry. To learn more, please visit: http://aprxs.org/
Contact: Noah Hanson, [email protected], 404-805-8093
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Anyone who has been to a restaurant knows there is the possibility of ingesting a contaminated food item, but to minimize risk it's as simple as checking the grade of the health inspector's certificate on the wall. The food must be maintained below certain temperatures so as to avoid the growth of contaminants. A failing grade and the restaurant closes until it can be re-inspected. Why? To safeguard the health of diners who assume that food is prepared under sanitary conditions.
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Doctors who administer allergy treatments currently mix solutions in non-sterile environments with sick patients sitting near by. But unlike restaurants, in the doctor's office there is no health inspector and they are expected to police themselves. Currently, physicians preparing and administering allergy shots in their offices are responsible for their own self-policing and have no monitored regulations ensuring patient safety. Busy physicians preparing office injections, which could involve dozens or hundreds of patient encounters, each with this many as 10 or more allergen transfers, are hard pressed to provide an adequate patient safety environment. Lack of educated supervision, poor documentation combined with ill-trained staff can subject patients to serious risks of infection and negative outcomes.
Unlike physicians' offices, compounding pharmacies, for example, must comply with the Compounding Quality Act (CQA) that includes meeting current good manufacturing practices, be subject to inspections by the FDA according to a risk-based schedule, and they must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
The importance of utilizing the prescribed labeling of patient-specific data as well as dose, expiration, strength, volume, and type of drug utilized must be closely tracked in the physician's office. If a sterility issue is identified and brought to the manufacturers attention and they declare the lot to have been sterile, little can be done about it because the issue stems from the physician's office.
"Our association is certainly not opposed to the physician's ability to store and mix allergens in their own offices," states Noah Hanson, Executive Director of APRXS. "We simply want to ensure that they follow the same sterility regulations as precision pharmacies in order to protect patients, both adults and children, from the prospect of infection from injections with tainted, adulterated, outdated or incorrectly compounded drugs. Consumers deserve to know the sterility conditions of their doctor's office when they go there for compounded allergy injections and our advice is don't be hesitant to ask."
Hanson further adds:
"The idea that the adoption of this regulation would restrict patients access to compounded allergens or even eliminate them is simply incorrect. According to APRXS, there are over 7,500 advanced services compounding pharmacies in the US. And claiming that Medicare patients would be prevented from receiving immunotherapy is no more than a scare tactic."
The regulatory submission is USP 797 and serves to revise USP 39 page 626 to improve clarity and reflect new science. It reduces the number of microbial risk categories to two; category one and category two, the former having a shorter beyond use date (BUD). It introduces the term "in use time" to refer to when a product to make a compounded sterile preparation (CSP) must be used after it has been opened.
Are You a Patient?
If you are worried that your allergy injections may not be sterile, voice your concerns to the U.S. Pharmaceutical Convention (USP) by phone at 1-866-492-3365.
About APRXS We are leading the effort to deliver personalized medical solutions to every patient. Our mission is to conduct effective advocacy for public policies that encourage the discovery of important new medicines and technologies for patients by pharmaceutical and biotechnology research companies that minimize side effects and improve overall patient outcomes, and to support the needs of our members that represent the precision medicine industry. To learn more, please visit: http://aprxs.org/
Contact: Noah Hanson, [email protected], 404-805-8093
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SOURCE Association for Precision Pharmacy Services (APRXS)
