Posted in: Triangle Times Today
Volume 2 | Issue 10 | October 2023
Enhancing Precision Through Medication Management
Establishing a medication management program is key to ensuring pharmaceuticals and biologicals are administered in a safe and effective manner. Medication Management is a multifaceted responsibility that aims to safeguard against errors and prevent patient harm or even death related
to non-compliance with prescribed medications or drug interactions. AAAHC Medication Management Standards apply to any organization that uses drugs or pharmaceutical medical supplies and samples, regardless of the presence or absence of an onsite pharmacy. Applying the AAAHC Standards can help organizations build a program that promotes patient safety.
From providing oversight to the development and implementation of safe systems through policies and procedures based on best practice and prevailing laws, organizations can ensure that there are mechanisms in place to safely and effectively manage single- and multidose medications/vials and look-alike, sound-alike medications.
Single-dose medications are to be used on one patient, immediately upon opening and then discarded. Once opened, they cannot be stored or reused. AAAHC Standards require that if not administered immediately, all medications (injectable, oral, etc.) removed from the original container or packaging are labeled in a standard format in accordance with law, regulation, and standards of practice. According to the Centers for Disease Control and Prevention, multidose medications/vials should only be kept and accessed in a dedicated clean medication preparation area, away from immediate patient treatment areas. As soon as a multidose medication/vial is opened in an immediate patient care area, it becomes a single-dose medication for that particular patient. When a multidose medication has been opened, it should be dated and discarded within 28 days unless the manufacturer specifies a different date.
AAAHC Standards also require that the medication inventory is monitored to track the presence or absence of high-alert medications and medications with confused drug names, and that procedures are in place to prevent errors. In 2001 the US Food and Drug Administration (FDA) initiated the name differentiation project and, in conjunction with the Institute for Safe Medication Practices (ISMP), has established the FDA List of Established Drug Names Recommended to Use Tall Man Lettering. Tall Man Lettering (TML) uses selective capitalization to help differentiate look-alike, sound-alike (LASA) drug names, helping to make them more distinguishable, for example, vinBLAStine versus vinCRIStine and CISplatin versus CARBOplatin. Used along with color or bolding, it draws attention to the differences between look-alike drug names, reducing medication errors by alerting clinicians and helping them select the right medication. Organizations should refer to the FDA or ISMP to determine which medications they have in stock that require special safeguards such as TML to reduce the risk of medication errors and patient harm.
The Institute for Healthcare Improvement (IHI) also recommends separating drugs that look or sound alike and consider storing LASA medications in the pharmacy, not on patient care units. Other ways to promote safety include limiting the availability of multiple drug strengths and labeling drugs with both generic and trade names (making them easier to distinguish) and using warning labels or electronic alerts in ordering systems. Finally, looking for opportunities to involve and educate staff and patients on medication safety and reinforcing policies reduces errors.
Frequently Asked Questions: Medication Management
Is there a length of time before medications must be administered?
United States Pharmacopeia (USP) <797> 2023, recommends that “Administration begins within 4 h following the start of preparation.” And “The preparation involves not more than 3 different sterile products.”. For more information, refer to key changes in USP requirements ashp.org/-/media/assets/pharmacy-practice/resource-centers/compounding/docs/USP-797-Key-changes.pdf
What is the expiration requirement for multidose vials?
Multidose vials are dated when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Note: This is different from the expiration date for the vial. The multidose vial can be marked with either the date opened or the beyond-use date as per ASC policies and procedures, so long as it is clear what the date represents, and the same policy is used consistently throughout the ASC.
What is the expectation when an expired medication is on back order?
Organizations may use an alternative or verify through FDA if the drug is on back order or has an extended use date. Evidence of the shortage or extended use as listed on the FDA website should be made available to staff and surveyors. Drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide the FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. FDA: fda.gov/drugs/drug-safety-and-availability/drug-shortages
Do AAAHC Standards address drug storage and security?
AAAHC Standards require drug storage and security, including recordkeeping, are maintained to ensure the control and safe dispensing of drugs (including samples), to minimize medication errors, and to prevent diversion in compliance with prevailing laws and regulations.
Can organizations still use Look Alike/Sound Alike?
AAAHC Standards require that procedures are in place to prevent errors from medications with confused drug names.
What are the requirements for medication disposal containers?
The EPA released a 10-step Blueprint for Managing Pharmaceutical Waste in US Healthcare organizations (Oct 2022). EPA: epa.gov/system/files/ documents/2022- 0/10_step_blueprint_guide_final_9-22.pdf
Conferences and Exhibits
- Becker’s ASC Business and Operations of ASCs
- IHI Forum — Institute for Healthcare Improvement
- Onsite, Dec 7–8 (Las Vegas)