How outsourced compounded sterile products can help healthcare providers meet today's challenges

Healthcare facilities, including ambulatory surgery centers, face many challenges providing high quality care.

Some of the most common issues for healthcare providers today include:

• Having the right medications in the operating room when they need them
• Improving efficiency between the pharmacy and operating room
• Minimizing drug waste
• Limiting the impact of drug shortages
• Staying compliant with regulators
• Standardizing medications and concentrations
• Promoting operating room efficiency while maintaining safe practices
• Tracing drugs from pharmacy to the patient
• Reducing the risk of human error

Ready to use compounded sterile products can help overcome many of these challenges, especially when healthcare providers partner with outsourcing facilities like PharMEDium.

PharMEDium was among the first entities to voluntarily register with the U.S. Food and Drug Administration as a Human Drug Compounding Outsourcing Facility under section 503B of the Federal Food, Drug and Cosmetic Act. The company works with hospitals and ambulatory surgery centers to promote patient safety while easing the supply chain burden to ensure hospitals and surgery centers have the drugs they need.

Since the passage of the Drug Quality and Security Act in November 2013, the FDA has been charged with federal oversight of sterile compounding facilities and conducts rigorous inspections. The Drug Quality and Security Act eliminated the patchwork of state laws and provided clear oversight to regulatory bodies.

Prior to the federal law passage, regulatory bodies at the state level licensed facilities to compound medications. The inspection process varied by state. Many times, there were questions as to whether manufacturing regulations were appropriate or should outsourcing facilities be regulated as a pharmacy.

"When the state inspectors used to come in, some would inspect to USP <797> standards, some would not," says Mr. Kruzynski. "Now when the FDA comes in, they are here for three to five days observing every phase of our operation. The amount of oversight is greatly enhanced. We signed up for this because we believe it is the only way to ensure strong oversight of all outsourcing facilities compounding drug products. Consistent standards lead to the highest quality which is difficult to achieve when an organization is governed by 50 different licensing standards."

Formed in 2003, PharMEDium grew from servicing 700 hospitals to more than 2,800 hospitals today and is looking to expand further into ambulatory surgery centers (ASC) as more procedures make their way into outpatient settings.

"With the migration from inpatient to outpatient facilities, there are nearly as many surgeries performed outside of the hospital now as there are inside the hospital," says Mr. Kruzynski. "There is a lot of crossover between surgeons and anesthesiologists between these settings. They want to use the same products and processes in the outpatient setting as they do in the inpatient setting to ensure consistent quality care."

However, that can be difficult. Drug shortages are one of the biggest issues for healthcare providers, especially in the outpatient setting. Traditionally, drug companies have stocked hospitals first — especially with drugs on a shortage — and surgery centers sometimes were left without. ASC providers could either locate alternative drugs or cancel procedures; neither scenario was ideal.

Other times, a single-use vial might contain more drug than is necessary for a single patient’s episode of care, leaving the surgery center to dispose of the extra drug instead of using it for another patient. "PharMEDium's Outsourcing Facilities can prepare two doses of 5 mL instead of one dose of 10 mL when the patient only needs 5 mL. We can also prepare larger batches to optimize drug use for the ASC," says Mr. Kruzynski.

PharMEDium's preparation labeling includes numerous safety features and barcoding to help reduce medication errors. The labels and barcodes make the contents readily apparent to help minimize the likelihood of the wrong drug or dosage being administered.

PharMEDium products offer extended dating up to 90 days to maximize drug supply. Real-time stability testing, specific to drug manufacturer, concentration, fill volume, container and diluents, ensures clinical effectiveness through the labeled expiration date. Sterility is ensured through process validation, sterile closure integrity testing and ongoing preparation testing allowing providers to be confident in the sterility and stability of PharMEDium's preparations.

"We've seen situations where there are as many as 60 different drug therapies being administered to a patient. These include patient-controlled analgesia, epidurals, sedatives, electrolytes and antibiotics. The reality is that various drugs would be mixed by the hospital pharmacy, but now our customers look to us to supplement their resource needs," says Mr. Kruzynski. "Our teams compound drugs so that the hospital's clinicians can focus on direct patient care."

Among pharmacists, there is a trend for more pharmacy graduates to pursue PharmDs to become clinical experts. Their expertise goes beyond just mixing drugs and preparing orders in the pharmacy, they often join clinical care teams to work side-by-side with physicians and nurses to develop appropriate therapies for their patients.

"When you look at how the drugs are prepared and administered in surgery centers, it looks easy," says Mr. Kruzynski. People don't realize how long it takes to mix everything together to make a compounded drug and if there is a syringe, cap or label, there is the possibility for error. Working with an outsourcing facility helps to mitigate these inefficiencies.

Working with an outsourcing facility like PharMEDium also eliminates the constant ordering and updating for new drugs. After working with customers for a while, PharMEDium can identify patterns for how a healthcare provider orders specific drugs allowing them to take proactive steps to help minimize the impact of a drug or container shortage.

The added value of working with an outsourcing facility includes:

• Improve reliability of drug supply
• Help reduce drug waste
• Help minimize medication errors
• Increased compliance with drug preparation regulations
• Improve convenience of drug administration
• Reduce labor burden associated with drug prep
• Reduce administrative burden of tracking medication

PharMEDium prefilled syringes ship with a tamper evident cap, MEDGUARD. This capping system provides an increased level of confidence that the product remains sterile until the cap seal is broken.

PharMEDium provides sterile compounded preparations to hospital pharmacies and ASCs as an extension of their sterile preparation for IV and epidural therapy requirements, using FDA-approved sterile drugs and sterile containers. PharMEDium helps meet the demands placed on hospitals and ASCs to ensure patients receive their medications on time and as prescribed. It is the company's mission to be the preeminent provider of choice for our customers and to attain the highest degree of integrity in the compounding of sterile preparations.

This article is sponsored by PharMEDium.

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