Growing a Compounding Practice: Successful Marketing to Underserved Populations.

In this article, we provide an example of an effective novel therapy plan (the Stanley Protocol) that compounders can offer or use as a template for other services to grow their pharmacy practice, expand their role in patient care, and provide essential assistance for prescribers. We also share our successful consultative strategy for marketing that plan, which consists of several elements: identifying a treatment vacancy in underserved populations, changing the paradigm of compounding services, developing strategies that reach target populations, and dedicating the time and effort necessary to implement those strategies. Since we introduced the Stanley Protocol to prescribers and patients in 2020, our compounding practice has grown substantially in a number of aspects, which we describe in detail in this article. We also provide 2 formulations that have proven effective in treating Protocol patients.

The Stanley Prostate-cancer Treatment Protocol for Erectile Dysfunction After Prostatectomy and/or Radiotherapy: A Case Report.

Even when a diagnosis of prostate cancer is anticipated, many patients are unprepared for the persistence and severity of sequelae such as erectile dysfunction, which frequently results from lifesaving treatment for that disease. Erectile dysfunction in particular can exert a powerful impact on quality of life as the patient's self-esteem diminishes, intimacy erodes, and a sustained level of stress and anxiety that impairs work performance and personal relationships becomes a part of his everyday experience. The Stanley Prostate-cancer Protocol for treating erectile dysfunction after prostatectomy and/or radiotherapy was developed to better assist the underserved patient population faced with that challenge. Feedback from patients and prescribers indicates that this program, even when initiated years after treatment for prostate cancer, is consistently effective in treating erectile dysfunction. The authors have also found that incorporating the Protocol into a range of pharmacy services can further the growth of a compounding practice. In this case report, the outcome of Stanley-Protocol therapy in a patient complaining of complete and persistent erectile dysfunction after prostate-cancer treatment is presented and formulations used in therapy for that disorder are provided.

Reversing Erectile Dysfunction and Urinary Incontinence After Prostatectomy or Radiotherapy: The Stanley Prostate-Cancer Treatment Protocol.

Although prostatectomy and radiotherapy yield excellent- long term survival rates for men with prostate cancer, adverse effects (erectile dysfunction and/or urinary incontinence with subsequent undesired lifestyle modifications, anxiety about the loss of intimacy, negative self-perception, and the effects of such stressors on work performance and family relationships) frequently afflict patients who have undergone these procedures. Surgeons who specialize in the treatment of prostate cancer are dedicated to ensuring the optimal clinical result but often do not provide information about the likelihood of experiencing those sequelae or the additional support and aftercare necessary to ensure posttreatment sexual and urologic function to their patients' satisfaction. In response to the needs of these underserved patients, the authors designed the Stanley Prostate-cancer Treatment Protocol for erectile dysfunction and urinary incontinence. The goal of the Stanley Protocol is to achieve an improved outcome after surgery or radiation therapy for prostate cancer via comprehensive therapy, patient monitoring, and detailed training. Each Protocol program is customized to address the individual patient's needs as he attains his desired level of sexual function and urinary control. Feedback consistently indicates that patients who participate in the Stanley Protocol achieve those goals, and the authors suggest that this program can be incorporated into any compounding practice to provide the same result. In this article, the most common questions that compounders ask about the Stanley Protocol are answered, an outline of that therapeutic guideline is presented, and formulations proven to optimize the outcome of prescribed treatment are provided.

U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies.

The reasons for which pharmaceutical compounding is the focus of intense state and federal scrutiny are now well known. Compounders are faced with an ever-increasing need to prove, by objective standards, the safety, purity, and potency of the formulations they dispense. They must also demonstrate their compliance with regulations often based on current good compounding practices designed for the pharmaceutical industry. In the U.S. today, rigorous unannounced state and federal inspections of compounding facilities are occurring more and more frequently. To achieve a successful outcome, communicating clearly and effectively with inspectors and having ready access to the information they request are as critical as proving compliance. This article describes the author's experience with an unannounced United States Food and Drug Administration inspection of his 503A compounding facility and his response to the findings. Readers will learn what to expect during such an inspection, how to prepare for that event, and how to achieve an excellent outcome. Those who would like more information about any of the topics presented are invited to contact the author at the address provided at the close of this article.