photography: Sidney Meynard 24 america s Pharmacist December

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1 24 america s Pharmacist December photography: Sidney Meynard

2 Filling the Gap As drug shortages mount, compounding pharmacists help hospitals help patients By Chris Linville As a clinical pharmacist responsible for non-sterile compounding at Children s Medical Center in Dallas, Lisa Ashworth has a lot on her plate. We are one of the busiest children s hospitals in the United States, Ashworth says. We dispense about three million doses per year through our in-patient pharmacy. About 60 percent of those three million are either sterile or non-sterile compounded medications. We also have two outpatient pharmacies on campus. December 2011 america s Pharmacist 25

3 3 million 60% We dispense about three million doses/yr. through our in-patient pharmacy, with 60% of those being sterile or non-sterile compounded medication. Ashworth is a 35-year veteran of pharmacy compounding. Along with her duties at Children s Medical Center, she is also serving as vice-chair in her second fiveyear cycle of the US Pharmacopeia Compounding Expert Committee. She is also a member of the International Academy of Compounding Pharmacists (IACP), a trade association representing more than 2,000 pharmacists and technicians who focus upon the specialty practice of pharmacy compounding. As someone who professes a long love for compounding pharmacy, Ashworth is proud that the hospital is capable of producing medications in a pinch. When the shortage of Tamiflu occurred in 2010, we made it in large volumes, because we see so many kids she says. So when a pharmacy somewhere is maybe compounding small amounts of Tamiflu in a shortage, we re making gallons. Not only do we have the outpatient pharmacy dispensing bottles of it for a 5 10 day supply, we also have patients in house who have contracted the flu and gotten sick enough to be in the hospital and needed the medication. However, despite its best efforts, the hospital has struggled to keep up with a rash of drug shortages in the last year. The Food and Drug Administration says that some 200 drug shortages occurred by fall 2011, compared to 178 in all of (See sidebar on page 29.) What has been lost in the discussion about medication shortages is the role that compounding pharmacists can play in filling the gap, Ashworth says. As a former pharmacy owner, she appreciates what they do. Compounders have really spent a lot of money training their staff and upgrading their facilities, to be able to meet these needs, she says. And I really think they need to be given big kudos for having done that and being available to fill the gap in these difficult times. It s out of control we have not been able to get some electrolytes and it s been really touch and go on a few other medications. Critical Care Medications Scarce Ashworth says that the hospital has had shortages of electrolytes such as sodium chloride, sodium phosphate, potassium chloride, potassium phosphate, and magnesium sulfate, to name several. All of these electrolytes go into IV fluids for patients who depend on it for nutrition, she says. These are for total parental nutrition, basically fats, amino acids, and sugar, along with electrolytes given intravenously for people who have either had an intestinal surgery, or have had cancer treatments and can t eat because they have mouth sores. Patients who can't eat still have to have nutrition in order to live and get well. For Ashworth, it s a source of frustration to be in such a precarious position, being unsure if needed medications will be available. It s out of control, and has been for awhile, she says. There have been a few times when we have not been able to get some electrolytes and it s been really touch and go on a few other medications. One reason for the shortages was that medications were recalled due to contamination and delaminating glass. There s only one or 26 america s Pharmacist December

4 Demonstrating Quality In a Time of Need As compounding pharmacies work to close the gaps created by a deepening drug shortage, raising their profile and highlighting their competencies in the health care universe is a major priority for the Pharmacy Compounding Accreditation Board All hospitals are accredited because payers look for external validation, says PCAB Executive Director Joe Cabaleiro, RPh. Consider accreditation as validation that your pharmacy meets national quality standards. PCAB standards are a set of best practices all compounders should follow. Whether considering accreditation or not, I would encourage pharmacists to download the standards [ and consider implementing them. Cabaleiro says that in a shortage situation, when there may be pressure to provide more medications to keep the supply chain moving, attention to detail is critical. Generally, a pharmacy will be compounding in batches that go to more than one patient therefore, any lapse, any error, is magnified by the number of patients affected, he says. In addition, for many of these medications, patients may already be in some state of health compromise, which further magnifies any lapses. Therefore, compounders working on shortages must increase the rigor of their compounding activities. As examples, Cabaleiro says testing, cleanroom behavior, facilities, and equipment must take into account the knowledge that medications are affecting the health of many patients. He also points out that compounding for shortages may require compounding in volume. Techniques and equipment may not ramp up well, he says. What works for a single patient's prescription may not translate to making 25, 50, or 100 dosage units. For example, different filtration techniques may be required. Cabaleiro says larger volumes may not be compatible with a particular pharmacy's equipment. While a small vessel may not block airflow in a laminar air flow (LAF) bench, a larger vessel required for a large batch might do so. He says that the autoclaves and ovens used to prepare sterile preparations must be adequate to the task; they should not be overloaded beyond capacity. These devices must be validated to assure that they perform as designed with larger volumes or batches. Obviously you don t want to rush, but doing the work in a timely manner is still important, Cabaleiro says. Compounding in volume may result in delays of the sterilization of finished preparations, he says. Even with larger volumes, sterilization of preparations should occur within four hours of preparation, if not sooner. A simple equation is that delay equals risk. Despite the advances in the profession, some medications may simply be beyond the skill set and expertise to provide a compounded product. That s certainly no cause for shame, Cabaleiro says. Pharmacists must pay special attention to projects that may be particularly complex. Be meticulous in assuring that master formulation records result in a preparation that is equivalent to the product in short supply, he says. In some cases, compounders may not have the technology to prepare an equivalent compounded preparation. Know and understand your limitations. As with most endeavors, when trying to promote your professional bona fides, Cabaleiro says that the personal touch can go a long way. Let your facility demonstrate your commitment to quality, he says. Invite potential customers for a tour of your facility. Introduce them to your staff. You can also use a tour to point out details such as your cleanroom, equipment, and testing logs. Show potential customers a history of test results. It s all about proving your quality. cl two manufacturers of all these medications, so they can t keep up with demand. But even with that, we don t go upstairs and tell patients, Oh well, your electrolytes are on shortage. We can t give you your TPN today. We don t do that. We find a way to treat the patient as long as we know that it s safe, and we evaluate all of their options. Even though the shortages have been getting plenty of attention of late, Ashworth says that she has noticed a steady supply decline for about 15 years. I think it s been building over time, she says. We really saw this start in the mid-1990s when some hurricanes hit Puerto Rico, and knocked several of the drug manufacturing facilities there totally off line. A lot of products were discontinued or were in short supply. We ve had antibiotic shortages over the years due to different types of equipment or water contamination at plants. They might not have been using the right water or December 2011 america s Pharmacist 27

5 smaller shortage]. Another example illustrating compounding pharmacy s value occurred when the hospital needed dehydrated alcohol that s been on shortage, Ashworth says. We needed some for surgical procedures and we ve had to outsource that from a compounding pharmacy that s already preparing it. So it s easier for us to go outside and find the compounding pharmacy that s making it and testing their preparation for sterility and stability, and purchase it from them. That way we can have it when it is needed. Lisa Ashworth works in the compounding lab at the Children's Medical Center in Dallas. testing it properly at some of the plants that resulted in contamination of injectable drugs. When a company quits manufacturing, we start running into shortages because other manufacturers often can t keep up. Ashworth also mentions the many drug company mergers in recent years, which typically result in a smaller quantity of medications available. And of course, some manufacturers simply quit producing certain medications if the bottom line isn t profitable enough. Even with the resources possessed by Children s Medical Center, Ashworth says it can t compound enough medications by itself to meet its patients needs. That s where having relationships with outside facilities comes into play. To do it here, we would have to buy the raw chemical, make it from scratch, bottle it, and have it tested, she says. But we are not able to do that because it would require hiring more staff and getting them trained to know how to do that kind of work, and our patients need the medication now. To compound sterile injectable medications from raw materials requires a room that meets the regulations of USP Chapter 797 High Risk compounding, which we are not set up to do. So we turn to compounders outside of here to purchase those electrolytes from who are equipped to make them right now. I don t think we could keep up [even in a Supply Chain Strained However, even compounding pharmacies have been feeling the pressure. In the past, they typically only needed to provide a few weeks supply of medications, allowing hospitals to get by while the commercial drug was on back order. Now those weeks have stretched into months, which strain a compounding pharmacy s ability to create a longer lasting supply chain. Additionally, many companies that source APIs (active pharmaceutical ingredients) to compounders have had to seek new sources for raw materials. APIs allow The sad thing is that I don t think the public really understands, and I think there are a lot of physicians who don t understand. Many physicians just can t believe that we have drug shortages. pharmacists to create compounded alternatives when commercial medications aren t available. Most APIs for manufacturing and compounding come from outside the United States and must pass muster from the Food and Drug Administration. Reputable API suppliers will also subject all materials to meticulous testing and quality control protocols before they will make product available to their clients. Even though Ashworth is acutely aware of medication shortages, she says more awareness needs to be created among the general public and other health care providers. photography: Sidney Meynard 28 america s Pharmacist December

6 Drug Shortages Spike in 2011 Prescription drug shortages in the United States, which reached a record high in 2010, continue to escalate. In 2010, the Food and Drug Administration said 178 drug shortages occurred. As of Oct. 31, there were 232 shortages, according to the Drug Information Service at the University of Utah, which monitors numbers for the American Society of Health-System Pharmacists ( At its current pace the number will reach 278 by the end of In response to the situation, on Oct. 31 President Obama issued an executive order directing the FDA to more broadly enforce reporting requirements for manufacturers running low on drugs, expedite review of new prescription drug suppliers, and work with the Justice Department to prosecute potential price gouging. The FDA has very limited authority to combat shortages, and it cannot tell a company how much of a medication to produce. Although it requires sole producers of a drug to inform the agency if they're going to discontinue it, there is no penalty if firms don't report to the agency. The Drug Shortage Program within the FDA's Center for Drug Evaluation and Research reports that many of the scarce drugs are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer, drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding. The FDA said that more than half (54 percent) of shortages in 2010 were because of quality issues, such as sterility or drug impurities. Some were due to delays or manufacturing capacity problems, with 11 percent caused by discontinuation of a drug and 5 percent resulting from raw material shortages. The FDA maintains a website with information about shortages, including a frequently asked questions section ( DrugSafety/DrugShortages/ucm htm#q1). A July 2011 American Hospital Association (AHA) survey ( Survey-Drug-Shortages.aspx) said 99.5 percent of hospitals reported experiencing one or more drug shortages in the prior six months, with nearly half of the hospitals reporting shortages of 21 or more drugs. In the same survey, 82 percent of hospitals said they have delayed treatment while 69 percent said drug shortages resulted in patients' receiving medicines deemed less effective. Veterinary drug shortages have also been reported. "This is not a short term issue," said David G. Miller, RPh, president of the International Academy of Compounding Pharmacies. He stressed the role that compounding pharmacies play in filling the gaps, saying they continue to be a vital resource for our nation's health care system. IACP has introduced a Compounding Pharmacy Assessment Questionnaire (CPAQ) to assist hospitals, practitioners and non-compounding pharmacies identify and evaluate compounding pharmacies as they seek alternative sources for medications that currently are limited or in complete shortage status. We wanted to find a way to connect hospital pharmacies with local pharmacies, Miller said. We re looking to create a model like the physician-specialist model. In pharmacy, we don t have that. (Find out more about CPAQ in the January 2012 issue of America s Pharmacist.) cl The January 2012 America s Pharmacist will have more compounding coverage focused on medication shortages, including a new tool to enhance communications and collaborative opportunities between hospital and compounding pharmacies, along with insights from leading compounding material suppliers. Drug shortages have been reported in the media, but I don t think people realize the enormity of this, she says. The sad thing is that I don t think the public really understands, and I think there are a lot of physicians who don t understand. Many physicians just can t believe that we have drug shortages. They will ask you, how does this happen? So we need to educate everyone about this. And a big part of that involves highlighting the work that compounders are doing. I appreciate the job that they do, and I want everyone else to know about the good that they are doing right now to help with all of these shortages and to help with patient care, Ashworth says. They are doing a great job. If it weren t for them, hospitals could be turning patients away. Chris Linville is managing editor of America s Pharmacist. December 2011 america s Pharmacist 29