The Clinical Utility of Compounded Bioidentical Hormone Therapy A Review of Safety, Effectiveness, and Use (2020) / Chapter Skim
Currently Skimming:
2 An Overview of Compounding
2 An Overview of Compounding
Pages 29-42
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 29... ...
, dosage form, dose, dosing intervals, and route of administration when writing the prescription. The prescriber may also choose inactive ingredients, especially in cases where a patient has a documented allergy to an inactive ingredient, such as peanut oil.
|
From page 30... ...
. Patient populations that have traditionally benefited from customized compounded formulations include pediatric patients, people at the end of life who may have difficulty swallowing pills or capsules, or people with certain specific medical conditions for which a current FDA-approved medication does not exist (Kochanowska-Karamyan, 2016; USP, 2017)
|
From page 31... ...
Based on submitted testimony, certain 503A compounding pharmacies no longer function primarily as community pharmacies but rather as large corporations that dispense compounded preparations to thousands of patients across state lines.4 In 2013, Congress created a new category for compounding drugs in larger amounts at specialized compounding facilities, referred to in this report as 503B outsourcing facilities. Given that certain requirements are met, these compounding facilities can produce and ship large volumes of drugs across state lines and produce compounded preparations for third parties, such as hospitals, clinics, and physician offices without a prescription (Glassgold, 2013)
|
From page 32... ...
Compounding for Office Stock Hospitals, clinics, and health care practitioners can obtain non-pa tient-specific compounded drug preparations from outsourcing facilities registered under Section 503B (The Pew Charitable Trusts and NABP, 2018)
|
From page 33... ...
, established compounding text books and journals, or colleagues.b An MFR must include the following information (USP, 2014) : • Name, strength or activity, and dosage form • applicable, calculations involving quantities, concentrations, If strength • Identities, amounts, characteristics of all components • Complete preparation instructions, including description of neces sary equipment when appropriate • Container, closure system(s)
|
From page 34... ...
. Unlike manufacturing protocols for drugs that FDA approves to reliably ensure that a safe and effective product results every time, compounding procedures are not standardized nor tested for their ability to produce safe and effective drug preparations.
|
From page 35... ...
While all of these organizations recognize the importance of drug compounding, they also express concern regarding the lack of standardized, well-studied formulas; the scarce education and information on compounding provided to patients, prescribers, com pounders, and regulators; the lack of evidence on the safety or effectiveness of compounded bioidentical hormone therapy (cBHT) ; and the increasing exposure of patients to compounded preparations that pose greater risk
|
From page 36... ...
.6 The growing demand for compounded drugs is also reflected in their use to treat a wide spectrum of conditions across a range of therapeutic areas, including men's and women's health, pain management, sports medicine, dental care, veterinary care, pediatrics, hospice care, and in their use in the fields of allergy, dermatology, immunology, otolaryngology, oncology, ophthalmology, neurology, and rheumatology (Glassgold, 2013; McPherson et al., 2016; NABP, 2017) .7 Public health officials have become concerned about this expansion of the compounding market because it increases the number of patients with the potential to be exposed to drugs that have not undergone the same rigorous production processes and quality controls as FDA-approved drugs (FDA, 2017)
|
From page 37... ...
With this context in mind, the National Council for Prescription Drug Programs estimates that there are more than 32,000 pharmacies nationwide that broadly describe some compounding activities under their ffered o services (The Pew Charitable Trusts, 2016)
|
From page 38... ...
. These analyses project that by 2022 to 2024, the global compounding market will reach $10 to $14 billion, with a compounded annual growth rate of 4 to 6 percent (Bourne Partners, 2018; Global Market Insights, 2018; Market Research Engine, 2018; ReportsnReports, 2018; Zion Market Research, 2018)
|
From page 39... ...
REFERENCES American Pharmacists Association.
|
From page 40... ...
2018. Compounding pharmacies market size by therapeutic area (hormone replacement, pain management, dermatology applications, specialty drugs, nutritional supplements)
|
From page 41... ...
industry analysis report, application potential, price trends, competitive market share & forecast, 2018–2025. Selbyville, DE: Global Market Insights.
|
From page 42... ...
2018. Compounding pharmacies market by product type (oral, topical, mouthwashes, suppositories, injectables, and ophthalmic)
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.