First Issue, Series Three

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Good Manufacturing Practice

Lillie D. Shockney, RN, BS, MAS, HON-ONN-CG

I am very excited to announce our Third Annual Conquering the Cancer Care Continuum newsletter series. These publications will continue to address highly relevant topics in oncology management. The first issue focuses on current good manufacturing practice (cGMP) and includes articles written by a clinical oncology pharmacist, an oncology nurse practitioner, and a regulatory lawyer. These perspectives, based on the faculty’s expertise and personal experience, explore a wide array of issues related to this topic, including regulation for the approval of novel drugs, the pros and cons of over-the-counter (OTC) supplements, and the importance of careful patient selection in clinical trials. Future issues in the series will discuss access to quality care, advances in side effect management, the impact of the Affordable Care Act on cancer care, and pediatric patient care.

Patients often assume that if a drug or supplement can be purchased over the counter, there should be no concerns about safety, efficacy, or drug-to-drug interactions that could negatively impact their cancer treatment or personal health. It is common for patients with cancer to ask oncology nurses which OTC drugs can be used to diminish specific side effects caused by the chemotherapy they are receiving. There are also situations in which patients decide to self-medicate with OTC medications and neglect to inform their healthcare providers, assuming that their actions are safe. The challenge we face is that there is a lack of evidence-based research on most of these substances, and the existing data do not provide a definitive answer as to what is and is not acceptable for use in patients with cancer. Although, anecdotally, we may have some information on what has worked for other patients, scientific data are not usually available. Furthermore, even when there is confirmation through research that certain OTC options diminish treatment-related symptoms, we do not know whether these substances will have an impact on the metabolism of the cancer therapy being administered. Clinical trials of new or existing OTC supplements are so expensive that few or none can be justified in the current world of healthcare. All agents investigated within a clinical trial setting require the use of a New Drug Application, a regulatory complexity that has costs of its own.

Despite the lack of definitive information about OTC drugs and supplements, nurses must be prepared to make recommendations about their use in the outpatient setting. When nurses are considering a specific recommendation, they would be wise to consider the following questions. What level of evidence-based research exists regarding the drug/supplement to date? Has this drug undergone investigation by the US Food and Drug Administration (FDA) as part of a clinical trial? Additionally, nurses need to stop and think twice before making recommendations. Given that not all OTC agents fall under the auspices of the FDA, there is risk that a patient may experience untoward side effects or drug reactions; he or she may also potentially lose the benefit he or she is receiving from his or her cancer therapy. If cGMPs are in place, however, there is a higher likelihood that an agent has been evaluated for safety, which may increase a provider’s comfort level in recommending it to patients.

Clinical oncology pharmacists are also in a pivotal position to counsel patients and need to rely on cGMPs. They, too, interact with cancer patients every day and need to be aware of clinical trials for which patients may be eligible at specific points in time. Some patients may express that they want to try “everything,” hoping for a miracle to happen by participating in a phase 1 clinical trial. Others who are very ill may want to leave as part of their personal legacy the decision to participate in a phase 1 clinical trial that may benefit the next generation of patients dealing with the same disease. Pharmacists are also involved in identifying later-stage trials that may be helpful to patients. They are directly involved in educating patients regarding various study designs as well as teaching about various investigational drugs. What pharmacists cannot do is guarantee the patient that the novel agent has been manufactured in accordance with cGMP. Additionally, the benefits of cGMP are not consistently followed globally. Drugs produced in one country may not be as highly regulated as they are in the United States. This results in inconsistent drug contents that may pose a danger to patients. We also know that patients will order drugs online and may or may not tell their oncology providers what they are taking and how they obtained it.

We rely on government agencies to ensure the safety of our drugs. Ensuring safety of compounded sterile products was thought to be managed relatively well, at least through consumers’ eyes, until a serious incident was uncovered in October 2012, when a compounding pharmacy failed to maintain a sterile technique and an outbreak of fungal meningitis occurred. This resulted in loss of trust in such specialty pharmacies. During that time, the FDA advised healthcare providers to discontinue using products manufactured by a specific compounding pharmacy and recalled all of the products it had manufactured. Though the Centers for Disease Control and Prevention was able to track down the source of this outbreak and stop the pharmacy chain from continuing to disperse these drug preparations, 751 people developed meningitis, of whom 64 died. This serious incident brought about the need for more scrutiny, and a new regulation was enacted in November 2013: the Drug Quality and Security Act. This act provided a major revision in the compounding of human drugs. It splits compounders into 2 categories—traditional compounders and outsourcing facilities. It is hoped that this law will increase the safety of drug manufacturing.

Many of us take drug manufacturing for granted to some degree. However, this is a serious mistake. We need to be diligent in staying abreast of what the FDA is doing, and we need to know which federal laws are associated with drug manufacturing. We also must be aware of which regulations and research are associated with OTC drugs and supplements before making recommendations to our patients, especially while they are receiving cancer treatment.

Uncategorized - November 4, 2014

Good Manufacturing Practice: A Pharmacist’s Perspective

JR is a 43-year-old man with a primary hepatocellular carcinoma. He was diagnosed 6 months ago with metastatic disease and today has been told that there are no remaining conventional treatment options available for the management of his cancer. To look at this patient is to see a young man [ Read More ]

Uncategorized - November 4, 2014

Ensuring Safety of Compounded Sterile Products: A New Regulatory Framework

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 of fungal meningitis infections that occurred in October 2012, have led to a fundamental change in the regulatory framework.1 In [ Read More ]