Introduction
Pharmaceutical compounding is the art, science, and practice incorporated in the pharmaceutical industry with an aim of creating a particular pharmaceutical product or service predominantly to meet the special need of a patient (Pinkerton & Santoro, 2015). The practice of pharmaceutical compounding exists through a combination of medical strategies to change the form of medication for a patient with special needs. According to the Food and Drug Administration (2012), “pharmacy compounding is a practice a licensed pharmacist combines, mixes, or alters ingredients in response to a doctor’s prescription to create a medication tailored to the medical needs of an individual patient” (p. 1). Pharmacists combine pharmaceutical ingredients, add flavors in the manufactured medicines or extract, certain medical components to alter the taste or texture of the medicine. Pharmaceutical compounding is a practice and art of modern medication that routinely occurs in the cases that demand intravenous or parenteral medication and for other forms of medication requirements.
Compounding Pharmaceuticals is an acceptable practice in the medical fraternity and a practice that has been helpful in providing instant treatment solutions for the patients who demand special chemotherapy solutions (Lipinski, 2000). However, pharmaceutical compounding has recently become a controversial practice since the scientists discovered serious lapses in the art, science, and practice of compounding pharmaceutical products (Pinkerton & Santoro, 2015). Although compounding of pharmaceutical drugs has been an efficient treatment remedy, the U.S Congress, and medical specialists have raised serious arguments on the manner in which various medical practices are applying this medication practice. Considering the way the physicians are encountering several dilemmas in the use of commercially available FDA-approved treatment drugs and recommending medicines specifically tailored to meet the special medical needs of individual patients, trends and the market for the compounded drugs have reshaped (Lipinski, 2000). Since the compounded medicine has received special attention, its consumption trends in the market have changed, and their market size has significantly changed.
Proposed Study or the Research Issue Explored
Compounded drugs created to meet the special demands of individual patients have become a treatment norm in the practice of medicine (Ventola, 2011). Regardless the imminent ethical and legal dilemmas surrounding the commercial production of compounded drugs that come through the compounding pharmaceuticals, the market and demand for the compounded medicine is still growing (Ventola, 2011). What the FDA fears most is that compounded drugs are creating a special demand in the medical practice because the drugs personalize medical treatments. Since the inception of the practice of compounding drugs emerged in the medicine practice, several changes in the FDA-approved medical therapies have emerged, as the compounded drugs seem to bring a new way of delivering personalized treatments to the patients (Ventola, 2011). The intended research seeks to evaluate the issues surrounding compounded medicine and especially its market size in the American pharmaceuticals, its status in the market, and its trends in the American pharmaceutical market.
Compounded medicines have brought new treatment solutions, and their market seems to bring unique market opportunities and risks in the American pharmaceutical markets. Due to the rising demands for the specialized treatments created by the medically necessary reasons, compounded medicines are slowly influencing the manner, in which the pharmaceutical companies competes in the American pharmaceuticals and the way physicians deliver treatments to people with special medical demands. Nowadays, because pharmacists have begun commercial reproduction of compounded drugs, these medicines have immersed themselves into the American Pharmaceutical market and formed their industry. Therefore, studying the impact of the compounded pharmaceuticals in the American pharmaceutical markets requires an evaluation of the industry trends, an analysis of the concentration of the compounded pharmaceuticals market, and an analysis of the market size of the compounded medicine. This research paper examines the three aspects of the compounded pharmaceuticals to give a broad synthesis of the compounding pharmacy industry.
Rationale for the Study/Significance and Reasons
The need to assess the industry of the compounded medicine comes into significance when considered the increased reliance on the compounding techniques and compounded medicines to offer medical solutions in special treatment cases. Tailoring medicine to meet the specific needs of personalized drug treatments is becoming a treatment priority even as the medical experts explain that there are serious implications for the continued use of the compounded drugs. Despite the increasing controversies in the U.S Congress concerning the growing use of compounded drugs and the increasing reliance on compounding techniques to offer exceptional treatment remedies, FDA-approved medicines are slowly losing market to the compounded drugs. As the U.S government seeks to find ways that can offer guidelines for the reasonable use of compounded medicines to avoid altering with the public significance of the FDA-approved products, it is important to assess the market trends, the industry size, and the market concentration of the commercially compounded medicines.
Goals and Objectives of the Study
- The intended research seeks to evaluate the market status of the compounded medicine through an assessment of the industry trends.
- The intended research seeks to establish the prominence of the compounded drugs by examining the concentration of their market.
- The intended research wants to establish the connection between the growing use of compounded medicine and consumer interest in personalized treatments
- The research intends to evaluate the individual physician and consumer interests in the use of individualized treatment options and products.
Methodology of the Study
The research paper used a secondary data triangulation technique. Data triangulation is a form of a non-primary research study that deals with the use of combined strategies, such as study groups or local and temporal information to deal with a certain research phenomenon. Since the paper did not involve the actual use of primary data to evaluate the research problem, triangulation of the data obtained from the printed articles, books, journals, and newspapers provided the researcher with an opportunity to analyze data related to the involved research inquiry. Therefore, the study took the approach of meta-analysis, in which multiple independent studies provided important data for the assessment of the issues raised in the research. A meta-analysis approach involves the analysis of both quantitative and qualitative data gathered from various independent studies to draw a conclusion about a certain research problem. The six peer-reviewed sources gave adequate information for the assessment of the identified research inquiry.
Literature Review
In the American pharmaceuticals, medical therapies are changing significantly due to the changing trends in the reliance on individualized treatment remedies rather than the commercially available, FDA-approved treatment options. With the changes in consumer demands that seem to reflect the personal needs of the patients in the medical practice, both the physicians and the patients are developing likeness towards the compounded drugs that offer optimal personalized drug treatments (Food and Drug Administration, 2012). The presence of limited federal regulations and policies that should govern the lawful reproduction and use of the compounded medicine has given a chance to the increased reliance on the use of the compounded medications. Therefore, to understand the present influence of the compounded medicines in the American pharmaceutical industry, it is important to examine the growing literature about the concentration of the compounded drugs in the market, the market size of the compounded drugs and the trends in the pharmaceutical industry.
Summary of the Industry Trends
Patients are gradually adapting to the use of compounded medicines in the United States and their positive reaction to these medicines has brought significant changes in the treatment trends. In medical research carried out between 2012 and 2013, the United Healthcare and Optum-Rx originations noted that the use of compounded medicines has increased by 35% since the year 2007 (Ventola, 2011). The 35 percent increase in the reliance of compounded drugs is due to the steady increase in the number of the pharmacies that are engaging in the commercial production of the compounded drugs. Based on a 2009 report about the compounding activities of the compounding pharmacies, about 2,500 Pharmacist Companies increased the levels of compounding practices in the United States (Pinkerton & Santoro, 2015). The 2,500 pharmaceutical firms, which were added to the compounding practices in the United States, increased the number of such entities to 7,500. Furthermore, the compounding pharmaceutical firms are marketing their drugs directly to the physicians.
Concerning the form of dependence on the compounded drugs, most of the compounded drugs are being imperative in the treatment of common disorders and especially those associated with bio-identical hormone problems. In a research of the American women that have increased their dependence on the bio-identical hormone therapies delivered through the compounded medicines, Pinkerton and Santoro (2015) discovered that most women are relying on the compounded medicines to treat menopausal problems. Using about 801 women aged between 45 and 60 years, with at least 1 episode of menopausal symptoms, Pinkerton and Santoro (2015) assessed the use of Compounded Hormone Therapy (CHT) among the American women. In their analysis, they discovered that approximately 2.5 million women in the United States with ages ranging between 40-60 years use CHT on an annual basis. This number accounts for about 28% to 68% of all the hormone therapies prescribed in the American hospitals, subsequently indicating an increased use of compounded drugs.
Concentration of the Market
The market for the compounded medicines has shown an upward trend in its development given the rise of various pharmacies that practice the commercial production of compounded drugs. A 2014 survey of the United States pharmaceuticals industry reveals that the compounded drugs began gaining fame in the pharmaceuticals market due to the shortage of the FDA-approved drugs (Pinkerton & Santoro, 2015). The looming crisis of drug shortage in the United States, coupled with the increased interest in the compounding of drugs has resulted in a considerable concentration of the commercially compounded medicines. In his research, Ventola (2011) discovered that the concentration of the compounded drugs in the United States is relatively high, as large-scale pharmaceutical firms have increased their efforts in the commercial production of compounded drugs. Due to the increased concerns about the rights of the patients in the medical facilities, their safety during treatments and their urge for drug efficacy, the market concentration of the compounded drugs is gaining momentum.
Due to unknown reasons, the numbers of FDA-approved drugs and the size of generic drugs that come under the regulations established by the Good Manufacturing Practices (GMPs) have reduced dramatically since 2009, leading to severe medical shortages in the United States. Favored by their ability to elude from the normal regulations of the GMPs that governs the favorable manufacturing of drugs, the numbers of pharmaceutical companies compounding medicines have increased. Government’s little attention to the practices of the pharmacies in the compounding of drugs has further propagated the concentration of compounded drugs in the American pharmaceutical industry. In the United States, pharmacists are often responsible for the traditional forms of drug compounding and only the conventional state pharmacy laws have the ability to regulate the compounded drugs. Such legal lapses are the strengths towards the growth and concentration of the compounded drugs in the pharmaceutical industry of the United States.
Findings and Insights
It is apparent that the U.S pharmaceutical industry is facing an increasing challenge in the commercial production and use of compounded medicines. Due to the repeated cases of drug shortages in the United States, the market size for the commercially compounded drugs has augmented, and the rates of consumption and reliance on the compounded drugs are considerably high (Food and Drug Administration, 2012). Since the year 2001-2011, Data from the University of Utah Drug Information Service shows that the United States has faced a considerable shortage in the availability of the FDA-approved drugs. In his review of the issue of drug shortages in the United States, Ventola (2011) discovered that the crisis of drug shortage is due to the ceased pharmaceutical products, discontinued productions, and increased prices of raw materials. These sudden trends in the manufacturing of FDA-approved medicines have given a chance for continued production and use of drugs compounded by commercial pharmacists. Below are some of the major issues.
After the United States had accomplished its decade with no solutions against a highly complex issue of the drugs shortage, giant pharmacist companies began commercializing the production and use of compounded drugs that until today, are not FDA-approved or recognized. Trends in the production and use of the compounded drugs tended to increase during the period between 2012 and 2013 when the pharmaceutical industry recorded a 35 percent increase in the use of compounding techniques and the reliance on compounded medicine. Female patients seem o the people highly associated with the use of compounded medicine as results show that approximately 2.5 million U.S women use compounded hormone therapies in the processing of dealing with bio-identical hormone problems. In research about the trends in the consumption of the compounded medicines, Corbett, Cuddeback, Lewis, As-Sanie, and Zolnoun (2014) discovered that women have increased their reliance on the Compounded Medical Therapies (CMTs).
Trends: Physician and Consumer interests in the Compounded Drugs
An upward trend in the liking of the pharmacist-compounded drugs seems to come from both the physicians and the consumers who have suddenly developed unique interests in the use of the compounded medicines (Pinkerton & Santoro, 2015). In a study of the American patients suffering from personal health problems, compounded medicines have created a room for the personalization of drug treatments. Most of the pharmacists compounding drugs have highlighted female personal health issues as the main factors creating demand for the compounding of medicines. In a research of how the trends in the compounding of medicines are following the personal health issues of women in California, Corbett et al. (2014) discovered some unique trends. Out of 653 pharmacies involved in the research, 200 of them responded to the research. In their research, Corbett et al. (2014), discovered that among the compounding reasons, otolaryngology contributed by 30%, dermatology by 28%, vaginal dryness by 70%, while low libido contributed by 29%.
Major Lapse: Lack of Regulations against the Compounded Drugs
The United States is facing a dilemmatic situation in controlling the commercial production of the compounded drugs because of the lack of federal regulations and authorities that govern meaningful compounding practices (Gudeman, Jozwiakowski, Chattel, & Randell, 2013). In the United States, the federal government only has powers to regulate the production and distribution of branded and generic FDA-approved drugs, and not the compounded drugs. The FDA regulates and appraises the manufacturing practices and manufacturing facilities of the pharmaceutical companies, but does not monitor or inspect the activities of the pharmacies because pharmacies work under the procedures and rules set out by the States Boards of Pharmacy (Gudeman et al., 2013). Due to the lack of laws governing the compounding practices of pharmacies from the federal levels, the numbers of compounding pharmacies are increasing and slowly threatening the efforts of combating unprofessional treatment procedures in the United States. Given such legal lapses, the unprofessional use of compounding is increasing.
Conclusion
The Pharmaceutical Industry of the United States is facing a unique challenge brought about by the increasing production and reliance on the compounded medicine due to the increased levels of patient-oriented treatment demands, poor regulatory policies against the compounding pharmacies, and the rise of powerful large-scale pharmacies interested in compounding medicines. Besides, the repeated incidences of drug shortages have propagated the increased reliance on compounded medicines because the branded and generic FDA-approved medicines are in scarce. Due to the above-unprecedented circumstances in the America’s pharmaceutical industry, the number of compounded drugs seems to increase as its demand for giving solutions to common patient problems increase. Patients have reduced their dependence on FDA-approved medicines and resorted to the highly efficient and member-oriented drug options that mostly come through the compounded medical therapies. More serious is that the pharmacies have begun to market their medicines directly to the physicians.
Recommendations
An overhaul of the American pharmacies – The practices of the compounding medicines largely dominated by the giant American pharmacies may lead to severe health care implications in the American medical fraternity. An overhaul of the American pharmacies to control their compounding activities may help to reduce the commercial compounding of drugs.
Setting up regulatory boards against compounding pharmacies – The government of the United States needs to collaborate with the individual states to control the commercial production of the compounded medicines because only the state Boards of Pharmacy has control over the American pharmacies.
The establishment of the federal regulations to govern compounding: – Most state laws dealing with public health issues in the US have turned out to be ineffective due to easy manipulation, fraudulent activities, and unstable regulations. Setting up independent federal laws to curb the commercial production of compounded drugs may be a significant solution.
References
Corbett, S., Cuddeback, G., Lewis, J., As-Sanie S., & Zolnoun, D. (2014). Trends in pharmacy compounding for women’s health in North Carolina: focus on vulvodynia. South Medical Journal, 107(7), 433-436.
Food and Drug Administration: The Special Risks of Pharmacy Compounding. (2012). Web.
Gudeman, J., Jozwiakowski, M., Chollet, J., & Randell, M. (2013). Potential Risks of Pharmacy Compounding. Drugs Research & Development, 13(1), 1-18.
Lipinski, C. (2000). Drug-like properties and the causes of poor solubility and poor permeability. Journal of Pharmacological and Toxicological Methods, 44(2), 235-249.
Pinkerton, J., & Santoro, N. (2015). Compounded bio-identical hormone therapy: identifying use trends and knowledge gaps among US women. The Journal of the North American Menopause Society, 22(9), 926-936.
Ventola, C. (2011). The Drug Shortage Crisis in the United States: Causes, Impact, and Management Strategies. Pharmacology & Therapeutics Journal, 36(11), 740-757.