What’s pharmaceutical compounding and why is it needed?
Compounding is the development of a pharmaceutical preparation – a drug – by an authorized pharmacist to fulfill the exceptional needs of an individual patient when available drugs do not fulfill those needs. A patient may not have the capacity to take the commercially available drug, or a patient may require a drug that’s now in shortage or discontinued.
These are a couple examples of the ways a compounding pharmacist can customize medications with a physician’s prescription to meet with a patient’s needs:
—Fix dosage or strength.
—Flavor a medication, for example to make it more palatable for a youngster.
—Reformulate the drug to exclude an unwanted, nonessential ingredient, including a dye or gluten a patient is allergic to.
—Change the sort of the drug for patients who, for example, have difficulty swallowing or expertise stomach upset when taking oral drug.
—Compounding pharmacists can put drugs into other dosage forms suitable for patients’ exceptional needs, topical creams, suppositories, or particularly flavored liquids. Compounding doesn’t duplicate drug that is commercially available products.
How is pharmaceutical compounding different from drug production?
Compounding is the preparation of an individual drug to satisfy the prescriber’s exact specifications and to be dispensed directly to the patient or the prescriber. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy (see below question on legal supervision of compounding versus manufacturing). Compounded drugs are not for resale by the patient or prescriber.
Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA). These items are sold to drugstores, health care practitioners or others authorized under national and state law to resell them.
What’s a compounding pharmacy?
While all drugstores do some kinds of compounding, this is more common or the main focus of a small piece of American drugstores.
All accredited pharmacists learn during their four years of pharmacy school to perform basic compounding. Additionally, all drugstores have compounding tools including a mortar and pestle for grinding substances, graduated cylinders for measuring scales for weighing solids, liquids, for mixing stuff spatulas, and pill tiles on which to work. When requested by doctors with such tools and applying their knowledge, all pharmacists normally prepare non-sterile compounded products.
Of the roughly 56,000 community-based drugstores in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all their time compounding preps that are special for patients. Preps in these drugstores are more likely to be sterile and non-sterile. Compounding additionally occurs in hospital pharmacies and at other health care facilities.
Who controls compounding pharmacies? Do compounding pharmacies follow exactly the same regulations as drug makers?
All pharmacists and pharmacies involved in compounding are subject to oversight by both state and federal authorities.
The practice of compounding is regulated by state boards of pharmacy. Pharmacists engaged in compounding are expected to follow proper processes for the types of trainings that are compounded.
The Drug Enforcement Administration (DEA) has supervision for any controlled substances used in the preparation of compounded medications. Controlled substances include narcotics such as hydrocodone, amphetamines and similar drugs, and drugs like those used for stress and sleep disorders.
In addition, the United States Pharmacopeial (USP) Convention dilemmas standards that apply to compounding. This quasigovernmental organization identifies the chemical composition of drugs and also problems practice standards. Two standards in particular are important to compounding pharmacists.
The USP standard is a national standard for the procedure, testing and verification of any compounded sterile preparations. It provides guidance on preventing microbial contamination and other deviations in compounded sterile products regardless of setting (for example, hospitals, community pharmacies) and who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others).
USP provides similar guidance for infertile preparations that are compounded in medical care settings. It describes types of compounding (straightforward, average, complex); defines terms such as beyond-use date and stability; and supplies criteria for compounding pharmacists to follow in preparing various drug preparations.
Compliance carries the force of law in many states based on regulations or legislative acts passed by legislatures and boards of pharmacy.
The pharmacy profession recently created an accrediting body for compounding pharmacies. The Pharmacy Compounding Accreditation Board (PCAB) was established by eight pharmacy organizations, for instance, American Pharmacists Association, and is governed by a Board of Directors made up of representatives of the National Association of Boards of Pharmacy, USP, the International Academy of Pharmaceutical Compounding, and several drugstore practitioner organizations, including APhA. An onsite survey provides the chance to to attest they have achieved a superior level of quality assurance acknowledgement for non-sterile and sterile compounded preparations to compounding pharmacies. This provides consumers with a powerful indicator of the quality of products they receive from accredited drugstores.
How would patients understand if their drug is compounded? Do anything differently?
Inquire. Drugs that are compounded can be received by a patient from an average community pharmacy or a specialty compounding pharmacy, or physicians or other health professionals can administer compounded drugs in clinics or medical offices. Patients can request the person administering the pharmacist or a medicine dispensing a prescription whether it was prepared in a compounding pharmacy or made by a drug company.
Patients can ask whether the compounding pharmacy is accredited, if a prescription calls for a compounded drug. State on PCAB’s site organizes lists of accredited compounding pharmacy.
Does a compounding pharmacist have unique training?
Compounding is a fundamental activity to the practice of pharmacy. Pharmacists are taught in pharmacy school how to properly compound medicines, and many states examine skills and their compounding knowledge before issuing permits.
No state now requires a special kind of training, and no nationally accepted specialty exists for pharmaceutical compounding.
Are there alternatives to using a compounding pharmacy?
A health care provider will prescribe a compounded drug only when those available don’t meet your needs. If you do not comprehend why you’ve been prescribed a particular formulation, ask your doctor. If you’re concerned about taking a compounded drug and you and your doctor agree that you can tolerate the commercial drug, you may even ask if there’s any evidence that you will do better on the formulation that is compounded.