Could you face a disease outbreak? Fatal meningitis cases raise question
Could you face a disease outbreak? Fatal meningitis cases raise question
If you use compounding facilities, how do you know they’re safe?
By Joy Daughtery Dickinson, Executive Editor
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Like many outpatient surgery facilities, you face drug shortages. You might have felt relief that you’ve been able to rely on compounding pharmacies to obtain the drugs you need in the single-use dosage you need — until you learned about a nationwide meningitis outbreak from contaminated steroid medications originating at a Massachusetts compounding facility.
As many as 14,000 people received methylprednisolone acetate steroid shots, primarily for back pain, according to the Associated Press (AP).1 The Centers for Disease Control and Prevention (CDC) says that at least two lots distributed to 23 states were contaminated with fungus, AP said. At press time, the outbreak had left about 440 people sickened and 32 dead, according to the Centers for Disease Control and Prevention.
The facility at the epicenter of the outbreak, New England Compounding Center (NECC), Framingham, MA, has voluntarily recalled and ceased distribution of all of its products. Also, drug inspectors found sterility and other issues at the Westborough, MA, plant of Ameridose Sterile Admixing Services, a sister company NECC. Ameridose, which produced injectable drugs, voluntarily recalled all its unexpired products in circulation on Oct. 31. At Ameridose, no illnesses have been reported from the problems.
Many state officials across the country are conducting unannounced surveys of healthcare facilities to ensure they are complying with the voluntary recall, according to the Ambulatory Surgery Center Association. Don’t expect the scrutiny to end for outpatient surgery providers. “... [O]n survey, you can expect under the circumstances we have had, that surveyors will be very focused on the review of evidence that your drug recall policies and procedures are working,” says Sheldon S. Sones, RPh, FASCP, pharmacy consultant based in Newington, CT, and president of the Connecticut Patient Safety Organization. (See more on drug recall policies, p. 5.) Furthermore, outpatient surgery providers that use a compounding center might have legal liability if they fail to perform due diligence on compounding pharmacies and their processes, say some sources. However, don’t give up on compounding pharmacies, some advise.
“I think it’s very important that we don’t throw the baby out with the bath water,” Sones says. “There are excellent leaders in the compounding industry that have to be sought out with due diligence, usually with the aid and guidance of the facility’s pharmacy consultant.”
Outstanding compound pharmacies do exist, Sones says. “You just have to fish them out,” he says. “At the end of the day, any provider, in any level of services, who doesn’t share the commitment to excellence, will make those who engage that service vulnerable.”
Don’t rely solely on costs when selecting a compounding pharmacy, he advises. “Keep in mind that costs are just one element of the decision, because in my opinion, at the end of the year what drops to the bottom line for these products is minor in the whole big picture and pales to the pain and suffering of patients and litigation,” Sones says. Consider these suggestions for what criteria you should consider:
• Perform due diligence on compounding pharmacies.
The International Academy of Compounding Pharmacists has an excellent due diligence piece, named the Compounding Pharmacy Assessment Questionnaire (CPAQ), Sones says. (See Resource at end of the article.) “This five-page, multifaceted screen is a ‘must’ in my opinion to start the due diligence piece,” says Sones, who says it “makes sounds business practice.”
“I have all of my facilities asking compounders to complete and return this document,” he says.
Leaders at Sequoia Surgery Center in Visalia, CA, are questioning their compounding pharmacies after five of their patients who received steroid injections from the Massachusetts compounding facility under scrutiny went to the emergency department with flu-like symptoms. However, none of the patients tested positive for the fungal infection. The center notified about 250 patients to be alert to any symptoms.
“We are now checking with compounding pharmacies, asking them to provide us with their quality assurance information,” says Alex Lechtman, MD, FACS, co-managing partner at Sequoia Surgery Center.
• Ensure the compounding pharmacy is accredited.
While an individual facility might not be equipped to perform due diligence on the processes at a compounding pharmacy, you can rely on a consultant pharmacist, in collaboration with an accreditation group, Sones says.
In the compounding pharmaceutical field, the accreditation group is the Pharmacy Compounding Accreditation Board (PCAB). Sones says, “My posture is that if a compounder isn’t accredited, we have to look elsewhere.” (See more tips for locating a compounding pharmacy, below.)
Tips for Selecting a Compound Pharmacy
Source: Gayer SI, Gonazles S. Compounding. American Soc of Anes Newsletter 2012; 76(9):16-18. |
• Ensure suppliers will keep you notified about drug recalls.
You need a reliable flow of information from suppliers regarding drug recalls, says Sones. “The FDA has a web site for this [www.fda.gov/safety/recalls/default.htm], but that should augment a direct contact from manufacturers, not replace it,” he says. “I have asked our facilities to ask for their primary drug suppliers to send a confirmation in writing that they assume responsibility for this communication.”
Recalls such as the recent one involving the products tainted with meningitis have many outpatient surgery centers rethinking their use of compounding pharmacies, Lechtman says. His facility is no longer using a compounded pharmacy for the particular steroid injection involved in the meningitis outbreak. “But because of the nature of the field, and some of packaging , and especially the drug shortage in the United States for certain things, we feel we have no choice; we continue to use compounding pharmacies for some of our treatments,” he says.
Propofol is one example, Lechtman says. “It’s a great drug, it works well, and in order to provide service at the level we want to provide to patients, we need access to medications, and we can’t get it except for compounding pharmacies,” he says.
Consider having a policy that all recall notices will be responded to, and note that a review was conducted and no recalled item was in stock or was used, suggests Mark Mayo, executive director of the ASC Association of Illinois and principal in Mark Mayo Health Care Consultants, Round Lake, IL. “That way you document that you researched every item, even if you ‘know’ it probably does not apply to you,” Mayo says. “Better to have a proactive record.”
Tips for Selecting a Compound Pharmacy
- Perform an Internet license search on the pharmacy’s state board through the FDA website (http://1.usa.gov/NVbCAC).
- Request copies of the most recent state health department inspections.
- Consider requiring sterility test results with each batch or shipment, especially if the pharmacy assigns a beyond-use date (i.e., the expiration date assigned by the preparer which supersedes the manufacturer’s original expiration date) that goes beyond the microbiological limits set by USP <797>, a chapter of the United States Pharmacopeial National Formulary.
- When possible, visit the pharmacy as the appearance of the pharmacy on sales ads and brochures can be deceiving.
- Seek a compound pharmacy that is accredited by the Pharmacy Compounding Accreditation Board (PCAB).
- Use free assessment tools from the International Academy of Compounding Pharmacists (http://bit.ly/TNciY) and the American Society of HealthSystem Pharmacists (http://www.ashp.org/sterilecompounding).
Source: Gayer SI, Gonazles S. Compounding. American Soc of Anes Newsletter 2012; 76(9):16-18.
Reference
- Perrone M. FDA seeks more authority amid meningitis outbreak. Nov. 14, 2012. Accessed at http://apne.ws/rfsqun.
Resource
The International Academy of Compounding Pharmacists (IACP) has developed an assessment questionnaire to assist providers and non-compounding pharmacies identify and evaluate compounding pharmacies. IACP’s Compounding Pharmacy Assessment Questionnaire (CPAQ) provides a comprehensive checklist of what to look for in a compounding pharmacy practice and is based upon United States Pharmacopeia (USP) standards. The CPAQ document is available at http://bit.ly/TNciY1. IACP also offers a free Compounding Pharmacy Locator Service that can be accessed at (800) 927-4227 or via IACP’s website at www.iacprx.org.
There’s an outbreak – What do you do first? Take care of patients, say those with experience When you learn that a product you’ve administered at your facility is involved in a recall and a disease outbreak, your mind might be racing in multiple directions about what you need to do. The first priority? Your patients, say leaders at a surgery center that went through this process during the recent meningitis outbreak associated with tainted steroid injections. “As soon as you’re aware, contacting the patients as quickly as possible is critical,” says Alex Lechtman, MD, FACS, co-managing partner at Sequoia Surgery Center in Visalia, CA, which had administered steroid injections from the compounding pharmacy at the epicenter of the meningitis outbreak. When managers at Sequoia, realized that the recall had been expanded to include a larger number of their patients — about 250 — they called in the director of nursing, some charge nurses, and other ancillary staff to work through the weekend calling patients. “We choose to make personal contact and not wait for someone to get a letter,” says Gina Mayo, RN, BSN, director of nursing. During the phone calls, staff told patients that there was potential contamination of injections they had received, and they were provided with information from the Centers for Disease Control and Prevention (CDC), Lechtman says. “We told them that if they had any symptoms of meningitis — headaches, stroke-like symptoms, unexplained fevers — they were to contact their regular physician or present to the ED immediately,” he says. The timeline was such that by the time Sequoia and other providers learned of the outbreak, it had been months since most of their patients had undergone the injections. Staff reassured patients that most of the patients who contracted meningitis came down with symptoms within a few weeks. “The likelihood of them having any symptoms was low, due to timelines, but with an abundance of caution, we told them that if they had any concerns, call their doctor or go to the ED,” Lechtman says. The staff also referred patients to the CDC web site (http://www.cdc.gov/HAI/outbreaks/meningitis.html) and the FDA web site (http://1.usa.gov/QWKNdd). When you realize that patients should be alerted to potential exposure to products of concern, collaborate with your medical staff to agree on who should make the contact and what information should be provided, says Sheldon S. Sones, RPh, FASCP, pharmacy consultant based in Newington, CT, and president of the Connecticut Patient Safety Organization. Advise patients of the symptoms that should be cognizant of, Sones advises. “Thus, the level of drug recall/problems will dictate the degree of action taken,” he says. At Sequoia Surgery Center, most patients were reached via phone, but one patient in Guatemala was reached by email, Lechtman says. “Those people we couldn’t contact quickly by phone or other means, we had public health nurses going door-to-door to contact them,” he says. Some other facilities waited until Monday to start calling patients, but Sequoia managers didn’t want that delay, Lechtman says. “We did everything we’re supposed to, and more, to make sure our patients were well taken care of,” he says. The center also focused on being “open and honest and available” to the media so the message was reaching patients through that outlet as well, Lechtman says. Eventually the center will send patients a letter based on a national template. The letter will encourage patients to remain watchful over the next few months, says Mayo. (To see a template from the FDA, go to http://1.usa.gov/WtzsH4.) Work closely with local, state health authorities Being in constant contact with local and state authorities, including your state’s infectious disease leader, is critical, Lechtman says. “When updates came from the CDC, we were notified immediately,” he says. “If we had issues or problems, we contacted them immediately. Our local board sent public health nurses to homes of people we couldn’t get on the phone.” After receiving questions from patients and consulting with the center’s legal representative, the center opted not to cover the cost of meningitis testing for patients who had received the shots. “Right now our recommendation from our attorney is that they go through their insurance for their care, and that since we were not responsible in any way, that if they have questions, they could take it up with their own lawyer,” Lechtman says. For the future, outpatient surgery providers might want to consider a system such as barcode scanning or recording in each patient’s medical record the lot number of each medication and each product used on each patient, says Mark Mayo, executive director of the ASC Association of Illinois and principal in Mark Mayo Health Care Consultants, Round Lake, IL. “Otherwise you are alerting all patients over a time period — a shotgun approach — rather than targeting your notice just to those patients at risk,” Mayo says. |
Drug recall policies are a priority (The following excerpt is reprinted from the Nov. 4, 2012, issue of PHARM-ASC, written by Sheldon S. Sones, RPh, FASCP, pharmacy consultant in Newington, CT, and president of the Connecticut Patient Safety Organization.) Recent events have brought into focus the effectiveness of your current recall policy.... a key element of performance that insulates all of the stakeholders from drugs that should not be used in the facility. This is an important issue that impacts patient safety and facility liability. We should seize the moment to make sure that our policy and procedure regarding drug, equipment, and product recalls are in good stead. Can you say “yes” to all of these boxes? Your recall policy and procedure worked if:
Many of our facilities have secured letters of commitment from primary suppliers which states that they have received their request for compliance with their “Recall Policy and Procedures” and attest to their willingness to comply. This is a smart business practice to ensure that both the supplier and the facility understand their responsibilities for this important process. (See sample policy and procedure on drug recalls, below.) |
SURGERY CENTER Subject: Drug Recalls Policy: As an important element of our overall commitment to safe medication practices, xxxxxxxx SURGERY CENTER will promptly remove and document all drugs that have been recalled by the Food and Drug Administration and/or the manufacturers. Procedure:
Source: Sheldon S. Sones, RPh, FASCP, Pharmacy Consultant in Newington, CT. |
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