Continuing Education

Advocating for patients in an era of drug-delivery problems

Recent headlines have exposed serious drug-safety issues. No longer can patients feel confident that the drugs they need will be safe—or even available. As a nurse, you need to stay current on these problems so you can provide guidance to patients and act as patient advocate. This article addresses three critical drug-delivery issues—contamination of drugs prepared by compounding facilities, critical drug shortages, and infections caused by improper use of injectable drugs.

Since the mid-1960s, drug development and safety in the United States has been regulated closely by the Food and Drug Administration (FDA). Many laws currently in place were enacted many decades ago, after the morning-sickness drug thalidomide was found to cause serious birth defects. Some infants whose mothers had taken the drug were born without limbs or with severely malformed limbs. The resulting shock and outrage led Congress to enact laws to protect patients and ensure drug safety and efficacy. These laws established guidelines for drug development and evaluation, requiring proof of safety and efficacy before a drug is approved. Approved drugs may lose their approval if serious adverse effects emerge after sales begin. Drug-manufacturing facilities are inspected and held to strict standards.

For the most part, approved drugs used in this country are safe and effective when used as directed. But that doesn’t necessarily mean all precautions have been taken to ensure patient safety. Recent problems have shaken patient confidence. Understanding the cause of these problems is crucial to determining what the FDA, healthcare workers, and patients can do to prevent drug-related illnesses and deaths.

Problems involving compounding pharmacies

In September 2012, a cluster of serious and some fatal meningitis cases occurred across the country. They were traced back to spinal injection of steroids for pain relief. In all reported cases, the victims had received drugs prepared by the same compounding pharmacy in Massachusetts. More than 50 deaths and 680 illnesses have been linked to that facility; inspections there found meningococcal contamination and resultant contamination of sealed drugs. Further studies also turned up various bacterial contaminants. The pharmacy was shut down. (See What is a compounding pharmacy? by clicking the PDF icon above)

In recent years, efforts to limit healthcare costs and save provider time in preparing drugs have led compounding pharmacies to produce large amounts of some of the highest-risk drugs, often without a specific prescription for a particular patient. In many cases, these drugs are shipped across the country to various hospitals and clinics. In late March 2013, the FDA reported problems with a compounding pharmacy that was repackaging the powerful antineoplastic Avastin (bevacizumab) as an ophthalmic agent. Serious eye infections were reported, leading to a recall of all sterile products shipped from that facility. Of special concern to the FDA, the drug isn’t approved as an ophthalmic agent and warnings had been sent to providers about side effects of such use. The lesson learned from this incident was that despite publicity and efforts to curtail problems with compounding pharmacies, these problems are still occurring.

With our aging and increasingly mobile population, along with changes in the healthcare-delivery system and hospital outsourcing of certain time-consuming activities, many compounding pharmacies have become quite large. Typically, hospitals outsource drug compounding to save time and money, as outsourcing costs can be significantly lower than an individualized in-hospital approach. Over the past few years, the FDA has warned many large compounding facilities about going beyond the scope of their purpose.

Under current law, state health departments or pharmacy boards are responsible for monitoring compounding pharmacies—but most states aren’t equipped for this task. The Massachusetts compounding pharmacy at the center of the meningitis outbreak hadn’t been totally open with the state in describing the scope of its activities, and state agencies weren’t aware of potential problems until the FDA learned of reports of illness and death.

Who should be responsible for monitoring production and cleanliness standards in these facilities and for ensuring that products leaving them meet safety standards? That remains unclear. While the FDA has been reluctant to overstep the states’ authority, many states believe large compounding facilities (which prepare drugs in large quantities) should be under FDA control. With the current system, some things obviously have fallen through the cracks.

Since identifying the problem at the Massachusetts facility, the FDA and Massachusetts authorities have made surprise inspections at other large compounding facilities and have shut down four for failing to meet safety standards. Some believe this is a “too little, too late” approach. Nonetheless, this tragic example has brought an unaddressed issue to the forefront and should impel authorities to make needed changes to prevent similar incidents.

As this article is published, the debate continues and no clear answer has been found. Congress, the FDA, and the compounding pharmacies continue to debate the roles each should play in ensuring patient safety. In early May 2013,
Congress published a statement declaring that the FDA should be involved in oversight of large compounding pharmacies that prepare drugs for institutions or clinics, not just individual patients. The Institute for Safe Medication Practices (ISMP) has published guidelines on sterile-compound preparation, available at www.ismp.org/Tools/guidelines/IVSummit/IVCGuidelines.pdf.

Your role as patient advocate

Compounding-pharmacy problems are largely beyond the nurse’s control. Nonetheless, make sure you’re informed and up-to-date on this issue so you can answer patients’ questions and help allay their fears. Question policies and procedures you believe could harm patients. Collaborate with the pharmacist as well; pharmacists can best explain the process of drug compounding and preparation, helping other healthcare team members understand the issues. Also, the latest information is available through pharmacy newsletters and alerts.

Drug shortages

Another serious drug-delivery issue is shortages of important drugs, most of them injectables. In 2010, 178 drugs were reported to be in short supply and no longer available for patient care. In 2011, when the shortages peaked, 215 drugs were in short supply—most of them liquid injectable drugs commonly used in critical care. Pa¬tients who needed these drugs were unable to get them. Emergency personnel reportedly were withholding morphine because they’d heard of a morphine shortage. In December 2012, an alarming report in The New England Journal of Medicine revealed a higher relapse rate in pediatric, adolescent, and young adult cancer patients when an acceptable substitute for a drug they were receiving wasn’t available due to shortages.

This potentially life-threatening situation led President Obama to sign an executive order in 2011.
As a result, letters were sent to drug manufacturers reminding them of their responsibility to report shortages or drug discontinuations. FDA staffing resources were increased to address the shortage and related public safety concerns and to ensure early notification of shortages. (See Why are drug shortages occurring? by clicking the PDF icon above)

Since the executive order, many of the issues underlying shortages are being addressed. Experts are encouraged by the decline in shortages between 2011 and 2012. The FDA and drug manufacturers have been working together closely to:

  • provide early warning of potential problems to alert prescribers they need to seek an acceptable alternative to drugs in short supply
  • encourage adoption of discontinued drugs by other manufacturers
  • find ways to make manufacturing plant inspections and penalties less costly.

Bottom line: We still have drug shortages, but the situation is improving.

Your role as patient advocate

You can take a proactive approach to help protect patients when a drug becomes unavailable. The FDA website at
www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm has a section devoted to current and anticipated drug shortages and explains what’s being done to address them. On the website of the American Society of Health System Pharmacists (www.ashp.org/shortages), you can search for shortages by drug name or current status of a shortage. Also, you can consult a pharmacist to learn of potential problems and seek solutions. Being well informed is the best way to learn the facts and avoid confusion about drug-shortage rumors and to prevent errors caused by misunderstandings or misinformation. The pharmacist also can help manage patients’ drug regimens and answer their questions.

Unsafe injection practices

According to a 2012 report by the Centers for Disease Control and Prevention (CDC), unsafe injection practices in clinics and private physician offices have led to more than 150,000 cases of illness since 2001—from hepatitis C to life-threatening methicillin-resistant Staphylococcus aureus (MRSA). In 2012, the CDC reported on investigations of local outbreaks of infections caused by improper injection practices. The agency concluded that the vast majority of injections in this country are given properly and under closely followed protocol—but about 5% don’t follow protocol and cause patient illness. In many cases, investigators found that small clinics or private offices were reusing single-dose vials and even single-dose syringes for more than one patient. Seeking to save money when fluid remains in the vial, some providers had instructed staff to swab the top of the vial and use the remaining drug for another patient; some clinics surveyed didn’t even reswab the vial. Potentially, this can cause drug contamination. Reuse of single-use syringes usually involved changing the needle, but in that case, the syringe might not be sterile.

Regular use of multidose vials for multiple patients also carries a high risk for contamination and isn’t recommended. Reasons for this practice include the desire to cut costs and poor understanding of contamination and injection protocol. Recently, ISMP urged hospitals to consider transitioning away from insulin pens due to numerous cases of contamination.

Most small clinics (such as pain, endoscopy, dental, and cardiology clinics) don’t fall under the strict inspection regulations that apply to facilities that treat Medicare or Medicaid patients. Experts have suggested ways to correct this problem. For instance, drug companies could be asked to make drugs in vials containing a dose that’s closer to the usual dose given and to produce syringes that can’t be used twice.

However, educating all healthcare providers seems to be the most efficient solution. In the past 2 years, North Carolina, New York, and Nevada have added educational requirements for licensing of healthcare professionals that include proper injection practices and safety. Still, even though review of protocols and safety practices by all healthcare providers who prepare or give injections may be the best way to end bad injection practices, employers concerned about immediate costs and waste from discarding partially full vials or buying more syringes may not want to take this step.

Your role as patient advocate

Because nurses typically administer injections, make sure you’re aware of the potential for infections related to unsafe injection practices. Review proper injection procedures and infection-control measures on a regular basis. Know that in partnership with the Safe Injection Practices Coalition, the CDC has launched the One & Only Campaign (one needle, one syringe, one patient) to raise awareness. Visit www.oneandonlycampaign.org to access training videos, reminder posters, and digital media kits.

Also, question practices used at your facility to save money that could put patients at risk. Urge drug companies to make single-use vials in the most common dosages to prevent waste and protect patients. Advocacy by nurses who provide frontline patient care may have a larger impact than bureaucrats in bringing about this much-needed change.

The most important part of your advocacy role is to adhere to three crucial safeguards:

  • Never enter a single-use vial more than once.
  • Never reuse a syringe or needle.
  • Always follow recommended infection-control practices.

Education and advocacy: A potent duo

Solving drug-delivery problems may seem out of reach for nurses and patients, as these issues are largely system related. But through education and advocacy, you can take steps to keep patients safe from these problems—and other drug problems that could emerge in the future.

The best way to help patients stay safe is to teach them to advocate for themselves. Traditionally, the nurse has been the patient’s advocate in the clinical setting. But today, a patient may be seen in many different settings; in some, he or she may not see a nurse at all. What’s more, the patient and the healthcare professional who gives the drug typically are the only ones present during drug administration. This makes it all the more crucial for patients to act as their own advocates.

As a nurse and a patient advocate, one of your key goals is to help patients feel comfortable sharing information with healthcare providers and asking them questions about their health care, especially drugs. Teaching patients to provide feedback and input to providers is critical to good nursing care. Help them feel empowered to ask questions of healthcare practitioners without fearing their inquisitiveness or self-advocacy could affect the care they receive. (See Crucial patient-teaching points by clicking the PDF icon above.)

Keep in mind, too, that many patients are prescribed drugs by multiple providers, and some patients take over-the-counter drugs and nutritional or herbal supplements as well. What’s more, even if providers obtain a thorough drug history, only the patient knows what he or she is actually taking. (Just because a drug is prescribed doesn’t mean the patient’s taking it.)

Given the changes in our healthcare system and the information overload of the 21st century, today’s patient must be perceived as a key healthcare team member—and even take the lead. This will require a major shift in approach and attitude on the part of both healthcare providers and patients. Nurses can be pivotal in making this happen.

Selected references

Centers for Disease Control and Prevention. Information about additional medical products (non-MPA) from New England Compounding Center. Last reviewed November 5, 2012. www.cdc.gov/medicationsafety/recalls/necc/#advice. Accessed May 5, 2013.

Centers for Disease Control and Prevention. Multistate outbreak of fungal infection associated with injection of methylprednisolone acetate solution from a single compounding pharmacy—United States, 2012. MMWR Morb Mortal Wkly Rep. 2012;61(41):839-42.

Centers for Disease Control and Prevention. Protect patients against preventable harm from improper use of single–dose/single–use vials. Last reviewed May 2, 2012. www.cdc.gov/injectionsafety/CDCposition-SingleUseVial.html. Accessed May 5, 2013.

Chabner BA. Drug shortages – a critical challenge for the generic-drug market. N Engl J Med. 2011;365(23):2147-9.

Food and Drug Administration. Current drug shortages index. Last updated May 3, 2013. www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm. Accessed May 5, 2013.

Gehrett BK. A prescription of drug shortages. JAMA. 2012;307(2):153-4.

Institute for Safe Medication Practices. Proceedings from the ISMP sterile preparation compounding safety summit: guidelines for SAFE preparation of sterile compounds. November 2012. www.ismp.org/Tools/guidelines/IVSummit/IVCGuidelines.pdf. Accessed May 6, 2013.

Kuehn BM. Unsafe injection practices plague US outpatient facilities, harm patients. JAMA. 2012;308(24):2551-2.

Metzger ML, Billet A, Link MP. The impact of drug shortages on children with cancer—the example of mechlorethamine. N Engl J Med. 2012;367(26):2461-3.

Pollack A. Checks find unsafe practices at compounding pharmacies. The New York Times. April 12, 2013. www.nytimes.com/2013/04/12/health/unsafe-practices-found-at-compounding-pharmacies.html?_r=0. Accessed May 6, 2013.

Pugliese G, Gosnell C, Bartley JM, et al. Injection practices among clinicians in United States health care settings. Am J Infect Control. 2010;38(10):789-98.

Stokowski LA. Single-use vials—the debate continues. December 11, 2012. www.medscape.com/viewarticle/775682. Accessed May 6, 2013.

Wilson LE, Blythe D, Sharfstein JM. Fungal meningitis from injection of contaminated steroids: a compounding problem. JAMA. 2012;308(23):2461-2.

Amy M. Karch is an associate professor of clinical nursing at the University of Rochester School of Nursing in Rochester, New York.

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