Compounding pharmacies work to navigate handling updates

Compounding pharmacies currently are gearing up for a change in USP’s Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. The updated chapter, which uses the National Institute for Occupational Safety and Health’s criteria and identification of hazardous drugs, becomes official on Dec. 1.  

Pharmacy technology companies are working to help compounding pharmacies meet these forthcoming standards and navigate the update.

Canada-based Synergy Medical uses a patented pick-and-place in their SynMed blister pack automation. Gentle suction removes the oral solid from the medication container and allows it to be gently dropped into the patient-specific blister. 

Synergy Medical director of marketing Samantha Cockburn said, “With SynMed, no surface other than the FDA grade stainless steel pipette is in contact with the drugs, substantially limiting the risk of cross-contamination.  Suction is applied through each pipette, and any pill powder is vacuumed through a series of filters, ending in a HEPA filter.”

“Antineoplastic drugs (Group 1 NIOSH hazardous drugs) are already handled differently, manually positioned in the blisters of a specific patient with the help of the SynMed Assist guidance system; they are outside of the automation,” Cockburn said.  

Further removing all Group 2 and 3 non-antineoplastic NIOSH hazardous drugs from blister pack automation could impact as many as 50 additional drugs, Cockburn explained. “This could mean a significantly less efficient production process, positioning all those pills by hand, but more importantly, would potentially increase the operator’s exposure to the hazardous drug.”

If this category of medication is left within the automation, all Group 2 and 3 HD containers will be clearly identified, and when a replenishment is required, the operator will be alerted and reminded to wear a gown and gloves.

“Certainly, if the pharmacist has any concern as to the safety of including a specific molecule inside the automated SynMed system, said medication should be positioned in the patient-specific blister card by hand,” said Cockburn.

PioneerRx, based in Dallas, Texas, has had an extensive compounding module built into its pharmacy software system, and in the last few months it has made enhancements to the module. 

“If the drug is on the NIOSH hazardous drugs list, we have the system pop up an alert that tells you, this is a hazardous drug. It’s in Table 2, which means that it occasionally carcinogenic and so that way the pharmacy can say, ‘This is a drug I need to use personal protection with,” said Josh Howland, vice president of clinical strategy at PioneerRx.

Mountain View Calif.- based Omnicell is using IV robotics to help pharmacies who do non-sterile compounding meet the forthcoming regulations.

Jim Stevenson, vice president of medication systems strategy said, “Our hazardous drug handling IV robotics allows the hazardous drug to be prepared and managed inside closed robotic systems. It minimizes the need for a human to actually touch the products and be involved in areas where they potentially could be exposed to any of these hazardous drugs during the preparation.” 

Finally, Kennesaw, Ga.-based KNAPP has an ATD-L1P high speed pill counter, for the fastest moving drugs that are processed in mail order and central fill pharmacies. This technology has the option for a centralized vacuum system that provides an almost dust-free environment.