Safeguarding Patient IV Medications

Each day, nurses administer compounded IV medications to patients with the expectation that the therapies are accurate and sterile. They assume that the same quality and performance oversight that exists for nursing medication administration practices also applies to sterile compounding.

But due to the lack of verification methods in the compounding of IV medications, this is a risky assumption. Executives across the board typically presume that their facilities’ IVs go through the same level of protection and verification as other medication forms (i.e., barcoded verification for dispensing, packaging, and restocking), yet these standards often are not on par with industry best practices.

Consequently, the risk of harm to patients is very real. For example, a recent study conducted at Brigham and Women’s Hospital in Boston revealed that 12.5% of manually prepared compounded solutions failed accuracy measurements.1 In 2014, a fatal error occurred when the wrong medication2 was put into a pharmacy-labeled IV bag. The nurse trusted the label on the bag, which matched the physician order, and because verification of compounded medications occurred prior to delivery to the nursing unit, she unknowingly administered a paralyzing agent instead of the prescribed antiseizure medication. The patient went into respiratory arrest, followed by cardiac arrest, and then died.

In past decades, it was not uncommon for nurses to perform compounding processes. While much of that responsibility has since shifted to the pharmacy, manual compounding is still done on some nursing units where pharmacy operations are not 24/7, or when emergent needs exist. Therefore, pharmacists and nurses share a common goal in the medication management process: adhering to the Five Rights of Medication Administration. These guidelines, aimed at reducing medication errors and overall adverse effects, encompass guarantees to ensure the right patient, the right drug, the right dose, and the right route at the right time. Nurses and pharmacy professionals must work together to create transparency and support a culture of patient safety.

 

The Compounding Process
The manual compounding processes in many pharmacy departments today are inherently prone to error. Studies point to inaccuracies of 5% to 15% in commonly used sterile compounding procedures related to overfill in IV bags, syringe accuracy and reconstitution of medications.

While other areas of pharmacy operations have undergone extensive re-engineering in recent decades to introduce electronic safeguards, high-risk IV compounding remains one of the last areas considered for basic safety technology, such as barcode scanning and gravimetric measuring. The 10th Annual State of Pharmacy Automation survey,3 for instance, found that only 15%4 of hospitals use barcode medication verification in the initial and critical stages of IV solution preparation.

Oversight of compounded sterile preparations is also fundamentally flawed because it frequently depends on a simulated account of procedures rather than documented proof. Common practice is for pharmacy technicians to compound IVs without the benefit of barcode scanning of the medication to ensure the correct medication and concentration is being used. Furthermore, insertion of the medication into the diluent involves the pharmacy technician drawing the medication into the syringe and immediately putting it into the diluent, without the benefit of pharmacist verification. After the fact, the pharmacy technician takes the syringe that was used, pulls back on the plunger to indicate how much medication was removed from the vial and put into the diluent, and the pharmacist verifies the medication and dose by visual inspection.nurse hands IV bag

Equally critical is the fact that many clean rooms are not innately “clean.” While hospital pharmacies understand the importance of achieving USP 797 compliance, many resource-strapped pharmacy directors are still on a quest to reach that goal. One study5 found that bacterial contamination still occurs at a rate of 5.2%, even when USP medium-risk level compounding practices are followed.

While manual processes are problematic, maintaining staff members’ sterile compounding competencies is another challenge. Pharmacy technicians are typically charged with completing sterile compounded preparations, but staff turnover can run as high as 15% to 18%, creating ongoing training issues.

 

SEE ALSO: Earn CE: Prevention of Medical Erroirs

Safer Compounding Processes
Manual compounding shortfalls such as these mean that nurses can flawlessly complete the Five Rights and, through no wrongdoing on their part, still administer an IV solution that results in grievous harm-as in the 2014 mislabeling scenario. It is therefore vital that nurse leaders understand current IV preparation challenges to better support pharmacy in the quest to design more stringent IV preparation standards.

The first step to safer compounding is education about best practices and regulatory compliance. For example, in areas where manual compounding needs to occur on nursing units, best practice guidelines recommend use of a specific area that is clutter-free, interruption-free and well-lit.Critical to success is a willingness to create a collaborative culture of patient safety.

Another strategy is to remove human error as much as possible. Advances in pharmacy robotics can ensure that sterile preparations are completed in a direct compounding chamber, within a completely isolated ISO class 5 environment, thus eliminating the potential for human contamination and error.

Comprehensive technology solutions also can offer bar code verification to help confirm ingredients and final product verification; digital imagery to provide visual confirmation of steps taken to prepare an IV compound (as opposed to relying on recollection and drawback syringes); and gravimetrics, the industry gold standard for ensuring accuracy by calculating the specific gravity of a solution to detect that the right amount of each ingredient has been added.

For environments with space limitations, advanced solutions exist to address barcoding, digital imagery and gravimetrics when robotics simply cannot be deployed. These technologies require more rigorous oversight of potential human factors associated with contamination than robotics, but they are an optimal choice compared to manual processes. Consider how technology could have impacted the 2014 medication error case and resulting patient death. If the medication vial had been scanned against the patient label during production, the preparer could have been alerted to the mistake and the adverse outcome prevented.

 

Raising the Bar
Working together with pharmacy colleagues, nurse leaders can raise awareness with clinical and operational staff about the safety of IV medications and the need for better processes. In the mission to prevent medication errors-a high priority goal-those who start the conversation can help elevate the role of nurses and pharmacists in the daily work of delivering optimal patient care.

 

References

1. The 10th Annual State of Pharmacy Automation. IV workflow Management. Pharmacy Purchasing and Products. 2015;2(8):54.

2. Moore W. Wrong drug put in IV bag led to fatal Bend hospital error. http://www.ktvz.com/news/st-charles-to-issue-results-of-fatal-drugerror-probe/30115104

3. Cohen M, et al. Addressing a trifecta of overlooked IV medication risks. 2015. http://s3.proce.com/res/pdf/Trifecta_Announce.pdf

4. IV Workflow Management. Pharmacy Purchasing and Products. 2015;12(8):54. http://www.pppmag.com/newsletter/in_the_loop/august_2015.html

5. Trissel LA, et al. Using a medium-fill simulation to evaluate the microbial contamination rate for USP medium-risk-level compounding. Am J Health Syst Pharm. 2005;62(3):285-288.

6. American Society of Health-system Pharmacists (ASHP) Midyear Clinical Meeting & Exhibition, New Orleans, December 6-10, 2015.

 

Carole Farmerie and Patricia Manni are senior executive nurse consultants for Omnicell. Bastiaan Moulart is a senior director of IV solutions at the company.

About The Author