Safety Issues at Compounding Pharmacies

Months after tainted steroid shots made by a Massachusetts pharmacy set off the worst drug disaster in decades by killing 53 people and sickening 680 others, federal inspectors have found dozens of potentially dangerous safety problems at 30 specialized pharmacies. 

According to an article published in The Washington Post, inspectors from the Food and Drug Administration discovered tears in gloves worn by technicians, rust and mold in “clean rooms” and inadequate microbial testing that raise the risk of lethal contamination. They also found black particles in vials of an injectable medicine at a Florida company.  

These specialized pharmacies, also called compounding pharmacies, were inspected between February and April, and marks the first time that the FDA targeted them. They focused on firms that produce high-risk sterile products.

According to the inspections, the compounders are failing to ensure safety of their products.  
 

The FDA has also inspected about a dozen other compounding pharmacies in response to complaints about drugs from state authorities. After the inspections, multiple firms have recalled their products and others have temporarily suspended making drugs.

Communication

While surgeries carry some form of risk for a patient, many complications can be prevented through simple communication. There are many steps that patients can take before they even get to the hospital, and the most important is to make sure you’re informed about everything your procedure will include.  

Be sure to speak with your doctor about all aspects of the procedure. Direct communication with your surgeon regarding your concerns is the best way to gain an understanding, reduce misconceptions about surgery and plan your recovery.

Remember to talk with your surgeon about any medications you are taking for chronic conditions. Be sure to ask what to expect after the surgery and what you can do to help the recovery process. Patients also should know that their healthcare team will follow specific procedures to ensure the best possible outcomes. Prior to receiving anesthesia, for example, the surgeon may confirm your procedure as well as what body part and what side is involved.

Typically, this includes marking the actual site so it is visible during surgery while you are unable to talk. Many times, a surgeon also will prescribe an antibiotic to be taken shortly before the procedure. This is done to help prevent infection at the surgical site, which could slow recovery following an operation. Additionally, once you are sedated and in the operating room, your surgical team will conduct a formal pause before starting. This pause – called a time-out – allows the team to check the patient name and ID number, identify the procedure to be done, and check to be sure all equipment and medications are in the room. This process only takes a few moments but it plays a big role in reducing operating errors and ensuring patient safety.

Surgeons lead a very large team dedicated to providing you with a safe, positive experience both during and after surgery. This is a very big responsibility. Trust and open communication are integral pieces of the doctor-patient relationship and are paramount to a successful outcome and a positive patient experience.

Higher Infection Rate Linked to Understaffed Nurses

Taken from Nursing Center:

Understaffing of neonatal intensive care units (NICUs) is common and is associated with an increased risk of nosocomial infection in very low-birth-weight (VLBW) infants, according to a study published online March 18 in JAMA Pediatrics.

Jeannette A. Rogowski, Ph.D., from the University of Medicine and Dentistry of New Jersey in Piscataway, and colleagues conducted a retrospective study to examine the adequacy of NICU nurse staffing in the United States and its association with infant outcomes using data from all VLBW infants with a NICU stay of at least three days, discharged from the 67 NICUs in the Vermont Oxford Network in 2008 (5,771 infants) and 2009 (5,630 infants). Nurse understaffing was assessed relative to acuity-based guidelines using survey data from 2008 and for four complete shifts in 2009 to 2010.

The researchers found that, compared with guidelines, hospitals understaffed 32 percent of their NICU infants and 92 percent of high-acuity infants. On average, an additional 0.11 of a nurse per infant overall and 0.39 of a nurse per high-acuity infant would be required to meet minimum staffing guidelines. Infection rates for VLBW infants were 16.5 percent in 2008 and 13.9 percent in 2009. An understaffing level that was one standard deviation higher correlated with significantly increased likelihood of infection (adjusted odds ratios, 1.39 for 2008 and 1.39 for 2009).

"In conclusion, our findings suggest that the most vulnerable hospitalized patients, unstable newborns requiring complex critical care, do not receive recommended levels of nursing care," write the authors.

Alarm Fatigue

According to a news article published by The Joint Commission, the constant beeping of alarms and the overabundance of information transmitted by medical devices are causing “alarm fatigue” and is putting patients at risk.

Over a four-year period, The Joint Commission sentinel event database reported 80 alarm-related deaths and the U.S. Food and Drug Administration database reported more than 560 alarm-related deaths.

Alarms in patient rooms are there to alert caregivers of potential problems, but if they are not properly managed, safety can be compromised. Warning noises tend to desensitize caregivers and can cause them to ignore alarms or even disable them. Sometimes there are too many medical devices with alarms or individual alarms can be difficult to hear.

The Joint Commission recommends that health care organizations take the following actions:

• Ensure that there is a process for safe alarm management and response in areas identified by the organization as high risk.
• Prepare an inventory of alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions, and identify the default alarm settings and the limits appropriate for each care area.
• Establish guidelines for alarm settings on alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions; include identification of situations when alarm signals are not clinically necessary.
• Establish guidelines for tailoring alarm settings and limits for individual patients. The guidelines should address situations when limits can be modified to minimize alarm signals and the extent to which alarms can be modified to minimize alarm signals.
• Inspect, check and maintain alarm-equipped medical devices to provide for accurate and appropriate alarm settings, proper operation, and detectability. Base the frequency of these activities on criteria such as manufacturers’ recommendations, risk levels and current experience.

Since this is a growing issue, The Joint Commission is also considering creating this as a National Patient Safety Goal so health care organizations can be more educated on the matter.  

Product Recall






Photo Credit: CPSC.gov



Approximately 9,000 Imaginarium Activity Walkers have been recalled from Toys R Us due to a choking hazard.

Currently, the company has received five reports of the front wheels detaching, which can pose a risk to children. The recalled product has a model number of 5F5E972 which is located on the bottom.

No injuries have been reported as of right now. Consumers can return the product to an Toys R Us store and get a full refund or store credit.



Hand Hygiene

Taken from Becker's Hospital Review:
Here, Gina Pugliese, RN, MS, vice president of the Premier healthcare alliance's Safety Institute, explains why hand hygiene should be a patient safety priority, and how healthcare organizations can succeed in improving hand hygiene compliance.
Question: Patient safety includes a wide range of issues, from patient falls to medication errors and hospital-acquired infections. What one patient safety issue do you think should be a priority in hospitals and health systems?    

Gina Pugliese: Hand hygiene is one of the most important patient safety issues today. And, it is the single most important factor in preventing the spread of pathogens and healthcare-associated infections. Low compliance with this basic patient safety measure may represent a lack of compliance with other patient safety practices. Despite attention to public reporting, reduced reimbursement initiatives for certain healthcare-associated infections, and international attention by public health, professional and accreditation organizations, it has been a challenge to reach and sustain hand hygiene rates over 80 percent in many healthcare facilities.

Q: What are the biggest barriers to improving hand hygiene?
GP: All the systems must be in place to support hand hygiene and make it easy for staff to adhere. This includes staff education on the importance and indications for hand hygiene; convenient location of sinks and dispensers; all dispensers in working order and filled with hand hygiene products that are not drying or irritating to the skin and [that are] acceptable to staff. 

Q: What are the biggest opportunities for improving hand hygiene?
GP: The organizational culture must have the right balance between no-blame and individual accountability for noncompliance with safety practices. In most high reliability industries, such as the airline industry, once a reasonable safety rule has been scrutinized for strong evidence to support it, found to have no unintended consequences and then becomes implemented, a worker who fails to follow the rule becomes accountable for failure to comply. There needs to be a consistent, fair and transparent method to monitor adherence to recommended practices for hand hygiene and the behaviors for which staff will be held accountable.  

Some hospitals have been very successful with incentives and rewards to improve hand hygiene compliance. Any penalties for failure to adhere to patient safety standards must be understood by all staff and applied fairly and proportional to the infraction. Penalties are not intended for a busy or distracted caregiver that may forget to wash their hands, but rather habitual and intentional failure to perform hand hygiene despite education, repeat counseling and corrections of any identified systems issues. Penalties for failure to adhere to appropriate hand hygiene vary, and have included the linking of compliance to merit increases for salaried staff and temporary loss of clinical privileges for physicians.

Patient Safety App

After a mother died from a preventable medical error, her family took action into their own hands.

After getting knee surgery, Louise Batz was given two narcotics and a sedative; once the combination of medicine was in her system, she stopped breathing and suffered irreversible brain damage. Eleven days later, she was taken off life support and died. Because Batz displayed signs of sleep apnea, she should not have been given that combination of drugs. Her death was completely preventable.

After Batz’s death, her family co-founded the Louise H. Batz Patient Safety Foundation so other families wouldn’t have to endure the same traumatic experience of losing a loved one. With the help from a medical advisory board, they created The Batz Guide for Bedside Advocacy.

This guide is now an iPad app that allows patients and their loved ones a way to monitor medical care to improve safety. They can log medications, look up medical terms, track vital signs and more. The app can be downloaded for $2.99. The goal of the app is to facilitate communication by helping patients and families know which questions to ask in order to help prevent errors.

To read more, click here.