Editor’s Note: Terri Lewis is a frequent contributor to editorial content for the National Pain Report. She is a patient advocate and educator and a parent and daughter of persons with chronic pain. She is a PhD in Rehab counseling and currently teaches rehabilitation counseling to allied health clinicians, physicians, and counselors in Taiwan.
Global Patient Safety Day. Sounds exciting doesn’t it? Let’s pause to reflect on the reason why we mark the need for putting patient safety on the calendar. Consumers like ’Mary’ (whose name has been changed because of her ongoing insurance litigation) know why this is important.
In 2007 Mary was minding her own business at a stop sign when she was hit from the rear by another driver.
Her injuries resulted in surgical repair of moderate injuries to her spine. In the course of this, her hospital provider, a large university medical teaching hospital in southern California, utilized pharmaceutical materials that resulted in the onset of a fungal infection within the lumbar spine. The cure, worse than the injury, left Mary struggling for survival, in a state of permanent disability and job loss while coping with the onset of chronic, intractable pain which has created another treatment problem all by itself.
Fighting for the right to utilize and keep the long term disability plan that she paid for while applying for SSDI have been hard enough. But fighting her treatment provider for medical records that confirm the source of her infection and the resultant injuries so that she can continue to deal with insurers and work toward recovery has been a nightmare.
California has experienced a number of outbreaks associated with contaminated pharmaceuticals. In 2005, and again in 2012 with the NECC outbreak of contaminated compounded drugs delivered nationwide. Until the passage of the DQSA in 2014 there were no national obligations for states to track and trace pharmaceuticals as they moved from manufacturing or compounding source to the patient through the treatment provider systems. As a result, untold numbers of consumers have been exposed to pharmaceuticals that have imposed secondary injuries, perhaps without their knowing that this is the source of their illness and failure to recover from interventional procedures.
Mary is still working to understand the implications of her treatment from 2007 – 2009 at this major teaching hospital and the long term implications for her regarding the fungal infection she acquired. A request to her hospital provider for information about the more than 25 pharmaceuticals she received during her hospitalizations resulted in this response sent to her in July of this year:
“We are in receipt of your request dated … for documentation from your medical record regarding drug manufacturer names names and lot numbers for medications used during your hospital stay from 2007 -2009. I reviewed your record and did not see this information so I contacted the … department. I was informed that our standard practice is to only develop this information when the pharmacist mixes medication for a specific patient and this was not done in your case. I also learned that the vendor may keep records of shipments but that multiple boxes are shipped per month and there isn’t a direct connection to any single patient.”
The hospital cannot provide Mary with information about the vendors used to supply the drugs that resulted in her fungal infection and it is not clear that the hospital has been able to determine which drugs were most likely the cause of her additional illness. Therefore the ability to determine the source of her infection, to determine whether to modify inhouse infection control systems, or to track and trace troubled supplies back to the vendor is not possible with the system in place even in 2015. Her fungal infection was confirmed by the National Institutes of Health but is hard to identify for treatment. Her continuing symptoms remain troublesome and elusive, her disability permanent and progressive.
What rights do patients have under the DQSA? With any procedure that involves pharmaceuticals, patients have the right to specific information:
- the label name
- source with FDA registration number
- lot number
- expiry information
Consumers should insist that they be provided this information and that it be placed into their medical records. Consult with your treating provider’s safety program manager and ask them to explain to you how they track medications through their systems to guarantee that you will be provided with medications from a safe supply source. Ask for their adverse event statistics associated with pharmaceuticals dispensed within their system.
Like Mary, your life may depend on it.