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?)
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. …