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Compounding Medications 20-664055 1 Hour Back to Course Index

 

 

COMPOUNDING MEDICATIONS

 

Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioner’s prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient.

Compounding frequently starts with a problem: the child who can’t swallow pills, the patient with a gluten allergy, the much-needed drug that’s in short supply. For whatever reason, many people aren’t served by mass-produced medications.  Compounded medications can be used for many different conditions, but are more frequently prescribed for topical and oral pain medications, thyroid or hormone replacement, and dermatology.  Because compounded medications are not one-size-fits-all, they can be tailored to a patient’s exact needs.

Special flavorings, unique dosage forms, innovative delivery methods – using these tools and more, compounding pharmacists work with prescribers to fill a gap in health care through customized. Compounding is a great option to explore for people who:

  • Have allergies to common mass-produced medicine fillers (casein, gluten, dyes, etc.)
  • Aren’t taking medication as prescribed due to unpleasant side effects or lack of improvement
  • Need custom medicine strengths and dosage forms (like creams or suppositories)
  • For patients, compounding can be life-changing, even lifesaving. And, it’s highly rewarding for pharmacists and practitioners, helping them solve some of health care’s toughest challenges.

The five most common types of pharmacy compounding formulas include:

  • Rapid dissolve tablets
  • Oral liquid vehicles
  • Cream medication
  • Oral chews and lozenges
  • Hormone supplements

 

Rapid Dissolve Tablets

Rapid Dissolve Tablets (RDTs), sometimes referred to as Orally Disintegrating Tablets (ODTs), dissolve quickly when placed under or on top of the tongue. Instead of requiring digestion for use in the body, the medication dissolves and immediately absorbs into the oral mucosa (lining of the mouth).  These are especially useful for patients who struggle with swallowing pills or those who have gastrointestinal and liver conditions. They may also be beneficial for patients who cannot chew or swallow on their own. Most formulas take only a few short seconds to fully dissolve, making it easier to take the medication quickly.

Pharmacists can only formulate certain medications as RDTs; the drug in question must have the right chemical structure for dissolving action in the first place. Generally, any drug that can be compounded into a liquid, injection, or patch can also be compounded into an RDT.  Drugs weighing over 500 milligrams, drugs that call for sustained-release action, and strongly bitter drugs are a poor choice.

 

Oral Liquid Vehicles

An Oral Liquid Vehicle (OLV) refers to liquid formulas that act as a carrier for a specific drug. This category includes liquid suspensions, elixirs, solutions, tinctures, and syrups. Rather than being an active medicine, the liquid itself simply dilutes the drug down to the correct dose (and often improves the flavor).

Like rapid dissolve tablets, a pharmacist can only compound certain medications in OLVs. The biggest concern is stability; some drugs (like doxycycline) rapidly break down when exposed to moisture. In the body, this is desired. Outside of the body in the bottle, it leads to drugs expiring much faster than they would in pill form. This is also why some OLVs must remain in the dark or in the refrigerator.

OLVs are especially helpful for parents (of kids or pets) because they make it easier to deliver and swallow medications. As the pharmacist can add flavoring, OLVs may make medication time less stressful, too. As expected, they’re also easier for people who struggle to swallow pills.

 

Cream Medications

Medication in the form of creams is one of the most common pharmacy compounding formulas. Compounded wound and scar creams treat problem skin issues right where they start – in the first few layers of the dermis. Unlike oral medicines, which are systemic and flow throughout most of the body, most creams (with the exception of steroids) remain local in the tissue. Not only is this safer, but it’s usually more effective, too.

Most wound and scar creams contain a combination of multiple substances or drugs.  Vitamin E is especially helpful for patients with scars because it encourages the body to heal, especially in the first three to six months after an injury. Steroids reduce severe inflammation, while antibiotic salves reduce or prevent infection. Numbing agents like lidocaine or benzocaine “turn off” nerves in the skin locally, reducing pain.

Some wound and scar creams also contain drugs like Retinol, Dimethicone, alcohol, glycerine, zinc oxide, or even silver nitrite, which is common when treating burns. Others may contain Vitamin D analogues, which are commonly used to treat Psoriasis and other autoimmune skin conditions.

 

Oral Chews and Lozenges

Like RTDs and OLVs, oral chews and lozenges make it easier for patients to take medication and may also increase treatment compliance. These unique formulas come in a variety of formats, including:

  • Gummies
  • Caramels
  • Soft chews
  • Hard candy
  • Chewable tablets

The most common oral chews and lozenges on the commercial market are vitamins, nausea drugs, and cough drops. Most patients are familiar with these options, but pharmacists can also compound many, many other prescription drugs into similar formulas.

In order for a pharmacist to compound a drug into an oral chew or lozenge, it must have a few special properties. Primarily, it can’t be extremely bitter or taste bad, and it can’t deliver an exceptionally high dose (over 500 mg). They should also be safe to mix with non-medicinal ingredients to create the chew or lozenge.

Some patients prefer certain drugs as chews or lozenges for specific reasons. For example, Nystatin , a drug that treats oral yeast infections (thrush), is often given as a lozenge because it keeps the drug localized in the mouth where it is most effective. Patients who are quitting smoking benefit more from oral nicotine lozenges from patches as the drug is faster-acting when absorbed through the mouth.

 

Hormone Supplements

Hormone supplements (called Hormone Replacement Therapy, or  HRT) work by providing by balancing hormone levels in the body. They are most commonly prescribed for the treatment of conditions like menopause, hypothyroid, hyperthyroid, gender reassignment, and certain reproductive conditions like PolyCystic Ovarian Syndrome (PCOS). They may also be prescribed to treat rarer conditions like adrenal gland insufficiency, benign or cancerous pituitary tumors, or autoimmune conditions like Hashimoto’s Thyroid disease.

Hormones come in two main forms: synthetic and natural. They may be bioidentical hormones, meaning they are an exact molecular match with the body’s natural hormones, or close matches instead.

While most hormones are available in commercially-available formulas, the doses don’t always match a patient’s condition or needs. The human body is remarkably sensitive to hormones; sometimes an adjustment of just a few micrograms is enough to throw off treatment.

Hormone compounding lets the pharmacist micro-adjust dose and change the delivery format to best suit the patient. Potential formats include topical creams (often best for estrogen replacement), pills, sublingual pills, and vaginal suppositories. Injectable solutions are an option, but are typically only prescribed for fertility treatment or advanced condition management due to increased risks.

 

What is unique about compounded medications?

Compounded medications aren’t commercially available. This means that the drug is not currently being made by a pharmaceutical company and therefore doesn’t have a trade or brand name like the typical prescription that would be filled at a local pharmacy. They are made at the pharmacy.

 

What is the advantage to a compounded prescription?

Again, compounds can be customized to fit specific needs. Custom strengths, and dosage forms can make a familiar medication easier to use. New ingredient combinations can also offer treatments that might not otherwise be available.

 

What kind of doctors typically write prescriptions for compounded medications?

Any doctor can write a prescription for a compounded medication.  The most prescriptions come from doctors in these fields:

  • Dermatologists (skin)
  • Pain specialists
  • Podiatrists (feet)
  • Endocrinologists (hormone imbalances and other endocrine disorders)
  • Veterinarians
  • Gastroenterologists (digestive system)

Compounded medications use equipment and raw ingredients that a typical retail pharmacy may not have.

 

Are compounded drugs approved by FDA?

Compounded drugs are not FDA-approved. This means that FDA does not verify the safety or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process for verification of safety, effectiveness, and quality. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed. 

 

What are the risks associated with compounded drugs?

Compounded drugs can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs. It is very important to trust the source of these medications.

Because compounded drugs are not FDA-approved, FDA does not verify their safety, effectiveness, or quality before they are marketed. In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient. This can lead to serious patient injury and death. 

 

Who can compound drugs?

Compounding commonly occurs in pharmacies, although it may also occur in other settings. 

Federal law addresses compounding by a licensed pharmacist in a state-licensed pharmacy, or federal facility, or by a physician, as well as compounding by or under the direct supervision of a licensed pharmacist in an outsourcing facility.

Outsourcing facilities are a category of compounders established in 2013 by the Drug Quality and Security Act. Outsourcing facilities are inspected by FDA according to a risk-based schedule and are subject to increased quality standards. 

 

Compounding medications is an often-forgotten practice, but one that is still very much in demand and can be a great service for patients.  Pharmacists capable of creating compounded drugs are highly sought after. It is a complicated science requiring specialized education and training. 

 

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