Confusion over the rules governing drug compounding has been an issue for many years. However, concerns about the safety and quality of compounded sterile products (CSPs), spurred by an outbreak [ Read More ]
Conquering the Cancer Care Continuum – Series Three: First Issue
Good Manufacturing Practice: A Nurse’s Perspective
Beth Faiman, PhD(c), MSN, APRN-BC, AOCN
As a nurse practitioner and a researcher whose focus is on supportive care in cancer, many of my patients and their caregivers look to me for answers to their questions regarding over-the-counter (OTC) supplements and prescription drugs used to treat various disorders. Oftentimes, patients seek my opinion concerning appropriate OTC and prescription drugs for treating such conditions as peripheral neuropathy. One of the most common questions I receive is: What over-the-counter drugs can I take to treat my peripheral neuropathy symptoms?
The answer to this question is not an easy one. By all means, I am aware of the multiple OTC and prescription drug trials conducted in various tumor types over the last 2 decades in the area of peripheral neuropathy prevention and treatment. Of the existing oral OTC supplements used to treat this condition,1-4 many are obtained easily but none have been clearly shown to decrease neuropathy symptoms in patients with cancer who are undergoing chemotherapy. OTC supplements are appealing to patients, as many of these agents are readily available and relatively inexpensive compared with prescription medications. But what monitoring practices are in place for clinical trials designed to investigate the safety and efficacy of new OTC supplements and prescription drugs? Should nurses and clinicians be concerned that most OTC supplements are not regulated by the US Food and Drug Administration (FDA)?
According to the FDA, the definition of a drug—whether OTC or prescription—is any substance “…intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.…”4 Clinical trials of new or existing OTC supplements are costly to conduct because FDA trials are heavily regulated. Enhanced regulation leads to increased costs—with the purpose of protecting the clinical trial participants.
All agents investigated within clinical trials, and that are intended to treat disease or mitigate symptoms, require the use of a New Drug Application (NDA) and investigational new drug (IND) process. In addition, all drug trials within the United States must adhere to the governmental FDA Code of Federal Regulations (CFR) Title 21 regulations.5 Unfortunately, important and potentially pivotal drug trials, which are costly to perform, are not conducted because of limited funding or a lack of qualified researchers and personnel to carry out the studies.
Current good manufacturing practice (cGMP) is an essential component of new drug research, and ensures the quality and consistency of each compound through a variety of processes covered under CFR Title 21 regulations.5-7 The CFR Title 21 regulations outline personnel, equipment, facilities, and manufacturing considerations for drug trials. Additional areas include drug processing, packaging, labeling, and distribution of the drugs, all of which are carefully monitored. Identity, strength, and drug purity are also confirmed by following cGMP.
How do cGMPs impact nursing practice? It is within the scope of practice for nurses to recommend OTC drugs in the outpatient setting. When approached with the question of which OTC supplement or prescription drug is best to take to mitigate a particular symptom, I first consider the following: (1) the level of evidence and (2) whether the drug was investigated under the auspices of an FDA-regulated trial.
I have firsthand knowledge of the importance of cGMP and the role played by the FDA in a recent clinical trial8in which I held the NDA/IND. This randomized trial evaluated the use of a readily available OTC agent for the treatment of cancer-related neuropathy symptoms. Through my experience, I observed that the strict nature of clinical trials is magnified further when an NDA/IND is requested. Aware of the rigorous processes and controls of FDA-regulated trials with a focus on drug safety and consistency of a compound, I looked to see if OTC and prescription drugs were evaluated in this manner in this particular trial.
Should nurses and clinicians be concerned that not all OTC agents are regulated by the FDA? The short answer is “yes”. Taking any drug is associated with risks. OTC drugs can interact with other medications, may lead to increased side effects, and can contain chemicals that are not consistent among lots. Yet, if cGMPs are in place, compounds can be safely evaluated and recommended to patients. Patients should be reminded to report the use of all OTC supplements to their providers.
Nurses play a critical role in the care of patients. Knowledge of cGMPs is imperative when one evaluates the risks and benefits associated with the use of OTC supplements and prescription drugs by patients. Future research will be required for many available drugs, thus elucidating the safety and efficacy of both OTC and prescription medications.
- Stubblefield MD, Vahdat LT, Balmaceda CM, et al. Glutamine as a neuroprotective agent in high-dose paclitaxel-induced peripheral neuropathy: a clinical and electrophysiologic study. Clin Oncol (R Coll Radiol).2005;17:271-276.
- Wang W-S, Lin J-K, Lin T-C, et al. Oral glutamine is effective for preventing oxaliplatin-induced neuropathy in colorectal cancer patients. Oncologist. 2007;12:312-319.
- Albers J, Chaudhry V, Cavaletti G, Donehower R. Interventions for preventing neuropathy caused by cisplatin and related compounds. Cochrane Database Syst Rev. 2007;24:CD005228.
- Tariman JD, Love G, McCullagh E, Sandifer S; IMF Nurse Leadership Board. Peripheral neuropathy associated with novel therapies in patients with multiple myeloma: consensus statement of the IMF Nurse Leadership Board. Clin J Oncol Nurse. 2008;12:29-36.
- US Food and Drug Administration. US Department of Health & Human Services. CFR - Code of Federal Regulations Title 21. Washington, DC; 2013. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed August 19, 2014.
- O’Donnell K, Greene A, Zwitkovits M, Calnan N. Quality risk management: putting GMP controls first. PDA J Pharm Sci Technol. 2012;66:243-261.
- Vargo S, Dana B, Rangavajhula V, Rönninger S. A risk-based auditing process for pharmaceutical manufacturers. PDA J Pharm Sci Technol. 2014;68:104-112.
- Glutamine in preventing peripheral neuropathy in patients with multiple myeloma receiving bortezomib. NCT01783522. http://clinicaltrials.gov/show/NCT01783522.