In the wake of incidents in which compounding pharmacies have released contaminated products, hospital leaders are developing strategies and protocols to ensure patient safety.
This article appears in the October issue of HealthLeaders magazine.
It's a safe bet the fungal outbreak affecting patients who received contaminated steroid products prepared by the New England Compounding Center last fall has placed hospital leaders on a nervous edge, regardless of whether they were ever among that pharmacy's customers.
Though alarming for its size and scope—the outbreak led to the deaths of at least five dozen patients and sickened about 700 more in 20 states—it was not the first, or the last, such incident to cause harm on a large scale.
Some 20 serious errors involving preparation of products from compounding pharmacies since 2001 have resulted in 982 patients becoming ill, including at least 77 deaths in at least 32 states, according to a spring report from the Pharmacy Sterile Compounding Summit organized by the Pew Charitable Trusts and the American Hospital Association.
The harm caused blindness or vision loss, bloodstream infections, meningitis, and even strokes from drugs used for chemotherapy, parenteral nutrition, IV flushes, eye and spinal injections, and IV sedative solutions.
While state and federal legislators and regulators are looking at the issue and considering changes, leading healthcare providers are not waiting around.
"Until that time comes, we in hospital pharmacies have to do our own diligence to determine if the partners that we're using or want to use to provide outsourced products for our patients are going to meet our needs," says Bill Churchill, chief of pharmacy services at 747-bed Brigham & Women's Hospital in Boston.
"Every hospital that has the capability needs to drive its own bus on this. You need to take the bull by the horns."
Partly out of recognition that purchasing drugs from outside compounding pharmacies poses an avoidable risk, the 1,409-bed Scripps Health system in San Diego took steps two years ago to launch its own $3.5 million facility to serve as a centralized compounding pharmacy for its five hospitals, unifying smaller operations at each facility.
The move was facilitated by state legislation that set up a special pharmacy category under state licensing purview a year ago, and Scripps officials hoped to become one of the first health systems in the state to take advantage of the new law.
But the New England Compounding Center incident sped that process along, says Kenneth Scott, executive director of Scripps pharmacy operations. When Scripps leaders realized in October 2012 that the system had purchased some 11 products from NECC—from ophthalmic syringes and cardioplegia solutions to lidocaine ointments—they understood how close the issue came to impacting them.
While none of those products was among those connected to the fungal contamination of steroid drugs from that pharmacy, Scripps promptly returned all unused products or destroyed them, Scott says. Officials called all the doctors who had administered drugs from those lots and notified all patients who had received them to make them aware of the issues.
In the meantime, Scripps took steps to reduce its risks in other ways. It canceled contracts with all but two compounding pharmacies and brought a number of operations in house as it sped up plans to start its new central pharmacy, complete with the latest in robotic technology, and scheduled it to go live sometime this month.
"We began planning and constructing it because—the bottom line—we recognized that we prefer to provide products to our patients that are under our control," Scott says.
But there was another reason. "It was in line with our strategic objectives of standardization and operational efficiency, safety, and improved quality as we looked at our opportunities to improve cost," Scott says.
The new pharmacy project, which involves gutting and converting existing leased space in a nearby biotech industrial park, will save the hospital an estimated $1.2 million a year because it is cheaper to compound drugs within Scripps than to outsource.
In many operations, Scott says, "a human being won't even touch the products. From both from a sterility and stability aspect, we will be able to produce products probably better than those that are being outsourced and probably better than what we're doing in our inpatient pharmacy site."
Scripps President and CEO Chris Van Gorder says the move to a centralized compounding pharmacy was part of a conversion from "a fragmented and siloed approach" to one in which care is delivered with more integration.
The hospital couldn't afford "to install robotic pharmacy systems with the required state-of-the-art information and safety systems at each of our decentralized pharmacies. But by creating a centralized pharmacy, we could purchase and install those systems. In addition, we gained economy of scale and lower costs that create more value for the patient, and we can have better quality assurance and safety systems for the patient," he says.
Not all hospitals, however, have the capability of building their own central pharmacies to compound drugs for their patients.
But Brigham & Women's is doing the next best thing, says Churchill. Its team aggressively requests a lot of data and documentation, and then physically inspects the compounding pharmacy premises before signing the contract to purchase products, as well as in every year of the contract.
After the NECC outbreak, Brigham & Women's brought some operations in house. But it couldn't do that for everything it needed. It had to find another pharmacy to compound intrathecal pain pumps, for example, and it inspected three facilities, ultimately selecting one to replace NECC.
Brigham & Women's had hired or contracted with compounding pharmacy experts in quality management, microbiology, and pharmacy practice, and those conversant with the technicalities of U.S. Pharmacopeial Convention 797 safety and sterility standards. And it has also developed its own audit and inspection tool.
"We look for the facility's licenses, names of people who run the facility and their licenses, the pharmacists and their licenses," Churchill says. There are assessments of whether the facility has a separate negative pressure clean room, "so you don't get hazardous or toxic chemicals blowing around and contaminating another patient's drugs."
And there are inquiries about staff training and competency assessments as well as reviews of records, policy and procedure documents, and documents showing that the facility regularly tests for contamination in a variety of important preparation areas.
The process includes what Churchill calls a "system tracer."
"We ask them about a product we bought from them, the dates it was purchased, and we ask them to pull every record that was associated with that," including all testing and certification records, a list of all employees involved and their credentials, and continuing education requirements in the state they're licensed, Churchill says. "We want to see test results for fingertip touch testing and media growth testing. We want to see everything that employees have done to ensure that employees who worked on the product were competent to do so."
Even information about which laminar hood was used is reviewed, including when it was cleaned, certified, and tested, and those test results.
Inspectors need to be savvy to know how to interpret a compounding organization's information. "We have seen cases in the past where pharmacies we've inspected did not show us the real data," Churchill says. "Getting the truth is something you have to really insist on."
Another area to be aware of is to make sure that a compounding company has not made the FDA's so-called 483 list indicating the agency had an issue with the company during a recent inspection.
"We routinely check the FDA 483 list to see if any of our pharmacies are on it, and one of them was recently. We contacted them right away, and said, 'We need to know why you were cited and what you're doing about it, and how the case was resolved.' "
This is not the optimal way to ensure safety and quality, however, Churchill acknowledges. What is needed, he and others say, is a "national, unbiased" organization that would operate like The Joint Commission, specifically reviewing standards, inspecting and certifying compounding pharmacies in every state for hospital and other health provider use.
No such appropriate organization has come forward to fill that role as yet, Churchill says.
The hospital's executives say it's important to give Churchill's division as much support as it needs.
Angela W. Yaniv, PharmD, assistant director of pharmacy for sterile products for the 1,300-licensed-bed Cleveland Clinic, agrees the issue of compounding pharmacy safety presents "a very scary situation," but say it's one that hasn't affected the clinic because it outsources products rarely.
"But you need to be aware of who you're purchasing from and do your research, and not accept whatever marketing materials are offered. I've seen some that look very professional and claim the organization is compliant with USP 797—but you have to dig deeper to really know if that's the case."
Yaniv recommends that hospitals that must rely on outsourced compounding pharmacies might use a tool provided free by the American Society of Health-System Pharmacists Foundation, which ASHPF officials say has been downloaded more than 1,000 times since September 2012. The tool includes nearly 100 questions that a provider using products might reasonably be expected to find out.
For example, one of the questions in the ASHPF tool asks whether the pharmacy has "disclosed any disciplinary or punitive action by any regulatory agency, [e.g., FDA, state board of pharmacy] within the past 36 months."
She also suggests that through their group purchasing organizations, smaller hospitals might "find resources to periodically inspect outsourcing vendors that they're using."
J. Eric Morgan, PharmD, pharmacy director of 85-licensed-bed Prattville (Ala.) Baptist Hospital, echoes those concerns. And while his hospital uses a large compounding pharmacy company that so far has not had quality problems, he worries what might happen down the road when and if new regulations take effect, imposing requirements that curtail his ability to outsource drugs.
He says it's fine for larger hospitals to bring their compounding operations in-house, or even create their own elaborate pharmacy inspection system. But his is a much smaller organization.
"I have pharmacists here eight hours a day, but there are 16 hours a day that I physically do not have a pharmacist in the building," he says. Two sister hospitals 10 miles away in Montgomery have 24-hour pharmacies and manage orders remotely.
But that doesn't help him when he needs a compounded drug right away.
"I firmly believe that something needs to be done to clarify regulatory oversight, but it needs to be mindful of the fact that compounding pharmacies are a tremendous resource that small community hospitals badly need."
In the meantime, hospital leaders and pharmacy chiefs continue the struggle to ensure purity, dosage, and safety of these important drugs.
"In my 39-year career, this was the single most difficult situation that I've ever faced," says Churchill. "It was the one that caused me the greatest concern, the one that occupied the vast majority of my time. There were days upon days that went by where I didn't do anything but work on the
IV compounding situation and we're still doing things to refine our processes, do things better, bring in more robots, and change practices in a continual way.
"It isn't something where you take 10 minutes, fix it. This will linger until things sort out at the state and national level on who will have direct oversight."
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This article appears in the October issue of HealthLeaders magazine.