Compounding
Compounding is the process of combining of two or more drugs. Practitioners in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them.Importantly, compounded drugs have not been approved by the FDA. Quality requirements for compounded drugs differ depending on the setting where compounding occurs. Drugs compounded in outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements. Drugs compounded by a licensed pharmacist in a state-licensed pharmacy, or federal facility, or by a physician, in accordance with the conditions of section 503A of the FD&C Act, are exempt from compliance with CGMP requirements. These facilities may be subject to less stringent quality standards set in state law or policy. Such standards may differ from state to state and therefore is crucial that practitioners understand what quality requirements are applicable to their practices that engage in compounding.
Reconstitution
Reconstitution is the process of adding a liquid diluent to a dry ingredient to make a specific concentration of liquid.In some cases, reconstitution is necessary because a medication doesn’t remain stable long enough to be distributed in solution form, so it comes from the manufacturer in a powdered or crystalized form and must be “reconstituted” with a liquid prior to being administered parenterally by injection. It is crucial to follow the reconstitution instructions from the manufacturer and to maintain a thorough understanding of who can engage in reconstitution and when it is legally appropriate in accordance with state and federal guidelines.
Piggybacking
An IV piggyback, also known as an IVPB or secondary infusion, is a method of administering medication through an intravenous (IV) line. It involves attaching a smaller bag of medication to the primary IV line and allowing it to infuse intermittently. The primary bag contains maintenance fluids or flush, while the secondary bag contains the medication that needs to be administered.
This method is commonly used when multiple medications need to be administered through the same IV line. The use of an IV piggyback can help reduce the risk of infection and minimize the number of needle sticks required for clients who require multiple medications. In other words, piggybacking allows medications to be administered without interruption of the primary IV fluids. When “piggybacking” it is important to ensure that this is done compliantly to avoid increased risk of contamination and infection, as well as negative adverse reactions.
Despite which of these methods are being employed by your practice, certain disclosures are legally required depending upon which practice(s) you may be engaging in. Considering the rapid growth within the IV therapy industry, compliance with administrative and regulatory federal and state law is more crucial than ever so that when governmental enforcement agencies have the opportunity to catch up with the industry, your healthcare businesses are protected from unforeseen enforcement and related fall out.
