Poole’s Pharmacy Care understands the importance of pharmaceutical compounding, and has more than 12 years of compounding experience.
Our pharmacy has a state of the art compounding lab equipped with the most up to date compounding technology to best meet all your compounding needs.
What is Bio-Identical Hormone Replacement Therapy (BHRT)?
What is a compounding pharmacy?
A compounding pharmacy is a special kind of pharmacy that specializes in the preparation of medications by mixing raw ingredients. Until the advent of the pharmaceutical industry in the 1950’s, compounding was the way virtually all pharmacists practiced. In the 1930’s and 1940’s, approximately 60% of all medications were compounded, as opposed to about 1% today.
Today, compounding pharmacies specialize mainly in the preparation of medicines that are customized to meet the needs of specific patients. This includes preparing medicines for patients who have allergies to certain ingredients found in mass-produced drugs; liquid versions of solid medicines to make them easier to swallow; flavored medicines for children; cream or gel-based versions of a medication for topical application (as well as other delivery methods); medicines that have been discontinued by a manufacturer; or medicines of a different dosage or concentration than that which is typically available. Compounding pharmacies allow for more flexibility, options, and customization than are typically available from pharmaceutical companies.
Why is pharmacy compounding important?
1. LIMITED DOSAGE STRENGTHS: The pharmaceutical industry supplies only limited strengths of drugs. One size does not fit all and it is often necessary to change the strength of a drug for patients, through compounding.
2. LIMITED DOSAGE FORMS: The pharmaceutical industry supplies only limited dosage forms; generally only an oral solid (tablet or capsule) and/or injection are manufactured. This does not address the needs of children, premature infants, the elderly, and special needs patients.
3. HOSPICE and PALLIATIVE CARE: End-of-life therapy involves the compounding of many different and unique dosage forms to allow patients to live out their lives free of pain and discomfort. Many combinations of drugs are used for these patients who cannot swallow medications and who don’t have the muscle mass that is required to receive multiple injections each day. Other methods include compounded medications for oral inhalation, nasal administration, topical/transdermal, and rectal use.
4. DISCONTINUED DRUGS: The pharmaceutical industry has discontinued thousands of drug products over the past 25 years, many due to economic considerations. These were very effective and important medications. The only way they are now available is through pharmacy compounding.
5. DRUG SHORTAGES: With over 70% of all bulk drug chemicals being imported for the U.S. pharmaceutical industry and for compounding, commercially manufactured drugs become unavailable for various reasons. In many cases, these can be compounded to help “bridge the gap” until the commercial product comes back on the market.
6. SPECIAL PATIENT POPULATIONS: Included here would be pain management patients, bio-identical hormone replacement therapy (BHRT) patients, sports injury patients, dental patients, dermatological patients, environmentally and cosmetic sensitive patients, and other patients who are being treated successfully with compounded medications prescribed by physicians.
7. VETERINARY COMPOUNDING: Animals can be grouped into various categories, including small, large, herd, exotic, and companion groups. There are relatively few medications available for animals, and those medications that are available are for specific species and diseases. In most cases, for an animal to be satisfactorily treated, a compounded medication may be necessary.
Is compounding safe?
The U.S. Food and Drug Administration (FDA) has stated that compounded prescriptions are ethical and legal as long as they are prescribed by a licensed practitioner for a specific patient and are compounded by a licensed pharmacist. The bulk drug substances used in a compounded medicine must qualify for use in compounding either via FDA-approved lists or via a listing in the U.S. Pharmacopoeia National Formulary (USP/NF), published by an independent standard-setting organization. Previously marketed drugs that have been found to be unsafe or ineffective and have been removed from the market may not be compounded.
Because compounding pharmacies mix ingredients in small batches in-house, there has been some inquiry as to whether compounded medicines are as safe as their pharmaceutical company counterparts. Pharmaceutical companies are regulated by the FDA and must meet strict facility and quality control standards to ensure their products are safe and that each batch is consistent. Compounding pharmacies are regulated by state boards of pharmacy; thus, each state will have a different set of standards.
In general, the quality control and regulation of pharmaceutical manufacturers is better than that of compounding pharmacies. Of course, it is important to keep in mind that many compounding pharmacies are very responsible regarding quality control practices and laboratory technique, and the medicines produced in those facilities are safe to use.
When choosing a compounding pharmacy, you may wish to inquire about the specific standards, testing, raw materials, and quality control practices that the pharmacy uses to ensure the safety and quality of their medications.
We at Poole’s Pharmacy Care would gladly show you around our compounding laboratory and answer any questions you may have.