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Compounding Basics

What is Compounding?

Compounding is the Art and Science of Creating Personalized Medications

illus-talk-to-doctor-compounding Pharmacy compounding is the art and science of preparing personalized medications for patients. CompoIMG_0625[1]unded medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.

Find out more about compounded medications:

  • Specialty Compounding: Compounding is a useful tool in varied areas of medicine
  • Alternative Medication Forms: Making medications more effective and easier to take
  • Compounding Answers: Answers to common compounding questions

A Brief History of Compounding At one time, nearly all prescriptions were compounded. With the advent of mass drug manufacturing in the 1950s and ‘60s, compounding rapidly declined. The pharmacist’s role as a preparer of medications quickly changed to that of a dispenser of manufactured dosage forms, and most pharmacists no longer were trained to compound medications. However, the “one-size-fits-all” nature of many mass-produced medications meant that some patients’ needs were not being met. Innovative Compounding Technology & Techniques Meet Patient Needs Fortunately, compounding has experienced a resurgence as modern technology and innovative techniques and research have allowed more pharmacists to customize medications to meet specific patient needs. Trained, BCPS pharmacists can now personalize medicine for patients who need specific:

  • Strengths
  • Dosage forms
  • Flavors
  • Ingredients excluded from medications due to allergies or other sensitivities

Medical Conditions

Pain-related conditions that can be treated with Compounded Pain Creams

ARTHRITIS

Arthritis is inflammation in one or more joints, causing pain and stiffness. The two major types of arthritis are osteoarthritis, typically caused by normal use and wear of joints, and rheumatoid arthritis, which is an autoimmune disease, though there are other forms (such as gout). Arthritis can also result form an underlying condition, like lupus or psoriasis.

CARPAL TUNNEL SYNDROME

Carpal tunnel syndrome occurs when the median nerve, which controls sensation in the palm side of the thumb and three middle fingers, is pressed or squeezed at the wrist. The carpal tunnel is a narrow passageway in the wrist through which the median nerve and tendons pass. This channel can be narrowed by swelled tendons or some other irritation, causing the median nerve to be compressed. Carpal tunnel syndrome can cause burning, tingling, itching or numbness and affect the grip and movement of the palm and fingers.

EPICONDYLITIS

An epicondyle is a projection on the surface of a bone’s condyle (a prominence at the end of the bone) where ligaments and tendons attach. Epicondylitis is inflammation of or damage to the area of the epicondyle, usually resulting from repetitive use. Two common types of epicondylitis are tennis elbow and golfer’s elbow. Tennis elbow, also known as lateral epicondylitis, is an overuse injury to the area of the lateral (outside) epicondyle of the elbow end of the humerus, while Golfer’s elbow (medial epicondylitis) is an overuse injury to the area of the medial (inside) epicondyle.

FAILED BACK SYNDROME (FBS)

Failed back syndrome (FBS) (also known as failed back surgery syndrome (FBSS) or post-laminectomy syndrome) is a condition characterized by persistent back and/or leg pain following back/spinal surgeries. It is a chronic pain syndrome and multiple factors can contribute to the onset and development of FBS, such as residual or recurrent disc herniation, persistent post-operative pressure on a spinal nerve, altered joint mobility, joint hypermobility with instability, fibrosis (scar tissue formation), depression, anxiety, sleeplessness and spinal muscular deconditioning. Systemic disorders, including diabetes, autoimmune disease and peripheral blood vessel disorder/peripheral vascular disease, can predispose a patient to the development of FBS. Smoking is a risk factor for poor recovery.

FIBROMYALGIA

Fibromyalgia is a common musculoskeletal condition characterized by long-term, widespread pain, particularly at tender points in joints, muscles, tendons, and other soft tissues. Fibromyalgia has also been linked to fatigue, morning stiffness, sleep problems, headaches, numbness in hands and feet, depression, and anxiety. Fibromyalgia can develop on its own or alongside other musculoskeletal conditions such as rheumatoid arthritis or lupus.

GOUT

Gout is a form of arthritis (joint inflammation) that results from abnormally high levels of uric acid in the bloodstream, which then causes inflammation, pain, and tenderness in joints. Gout can affect only one joint (acute gout) or cause repeated episodes of inflammation and pain in multiple joints (called chronic gout). Excesses of uric acid occur when the body either produces too much uric acid or has difficulty eliminating uric acid. Gout can be aggravated by obesity, weight gain, alcohol consumption, high blood pressure, and certain types of foods.

MUSCLE SPASMS

Muscle spasms are involuntary contractions of muscles and can be precipitated by a variety of conditions and factors. This can result from overuse and exhaustion, such as in athletes or those who perform strenuous work, or from preexisting conditions like atherosclerosis, systemic illnesses such as diabetes, anemia, kidney disease, or thyroid problems, or disorders of the nervous system such as multiple sclerosis.

MUSCULOSKELETAL PAIN

Musculoskeletal pain can occur in any of the muscles, ligaments, tendons, or bones in the body. Likewise, the causes of musculoskeletal pain are varied, including trauma, injury, spinal misalignment, repetitive movements or overuse. The resulting pain can be an aching over the entire body, a burning and twitching, or fatigue.

NEUROPATHIC PAIN

Neuropathic pain is caused by nerve fibers sending faulty signals to pain centers. These nerve fibers have impaired function, often due to some damage, injury, or other dysfunction. A range of conditions can cause neuropathic pain, including alcoholism, amputation, diabetes, multiple sclerosis, and shingles. Neuropathic pain can manifest as a shooting, burning pain, or as tingling and numbness.

PLANTAR FASCIITIS

Plantar fasciitis is irritation and inflammation of the plantar fascia: thick tissue at the arch of the foot, which connects the heel bone to the toes. The condition usually causes pain at the bottom of the heel or foot. A variety of factors can predispose a patient to developing plantar fasciitis, including foot arch problems (flat feet or high arches), long-distance running, sudden weight gain, and tight Achilles (back of the heel) tendons.

RADICULOPATHY

Radiculopathy is the technical term for a spectrum of conditions arising from neuropathy (dysfunction of a peripheral nerve) occurring at the root of the nerve (radix = “root”). This can result in (radicular) pain, weakness, numbness, and difficulty controlling specific muscles. Although radiculopathy occurs at the nerve root, pain and other symptoms can manifest in the extremity (a process called referred pain). For example, a nerve root impingement in the neck can cause pain and weakness in the forearm. Likewise, an impingement in the lower back or lumbar-sacral spine can produce symptoms in the foot. When more than one spinal nerve root is affected, the condition is called polyradiculopathy.

REFLEX SYMPATHETIC DYSTROPHY (RSD)

Reflex sympathetic dystrophy (RSD) is a condition characterized by diffuse pain, swelling, and limitation of movement following an injury, such as a fracture in an arm or leg. The symptoms are out of proportion to the injury and may linger long after the initial injury has healed.

SHINGLES

Shingles is a viral infection which causes a painful rash. Shingles is caused by the same virus as chickenpox. In those who have had chickenpox, the shingles virus lies dormant and can reactivate later in life, usually due to a compromised immune system or certain medications. Shingles is not life-threatening and most patients will recover and never have shingles again. Shingles is most often treated with antiviral and pain medications.

TMJ DISORDERS

The temporomandibular joint (TMJ) is located in front of the ear on both sides of the head and connects the upper jaw (maxilla) and lower jaw (mandible). The TMJ is a complex ball-and-socket joint incorporating muscles, tendons, and bones. A variety of complications can arise to inhibit its normal function and thereby impact an individual’s daily life. TMJ disorders (abbreviated as TMD) cause pain in the jaw area during normal daily activities like talking, yawning, or chewing. It is often difficult to identify the specific cause of an individual’s TMJ disorder, though TMD can typically be managed.

TENDINOSIS

Deterioration of a tendon is known as tendinosis. Tendons are tough, flexible bands of fibrous tissue that connect muscles to bones. Tendons glide smoothly and easily with the contraction of muscles, allowing movement. Tendon deterioration takes place when an injured tendon fails to heal properly. Although it typically occurs in middle-aged to elderly people, tendinosis can also affect younger people who exercise vigorously or who perform repetitive movements in the workplace.

TENDONITIS

Tendonitis is inflammation of a tendon. Tendons are tough, flexible bands of fibrous tissue that connect muscles to bones. Tendons glide smoothly and easily with the contraction of muscles, allowing movement. Inflammation of the tendon (often resulting from repetitive movement) will cause pain and further irritate the tendon. Tendonitis can occur in any of the body’s tendons, though it is most common in the elbow, shoulder, hip, knee, and Achilles tendons (located at the back of the heel). Joints afflicted with tendonitis can experience tenderness, mild swelling, and pain, particularly with movement.

TRIGEMINAL NEURALGIA

Each of the two trigeminal nerves conducts sensory information from the lips, eye, nose, scalp, forehead, gums, cheek, and chin on one side of the face. Trigeminal neuralgia, also called tic douloureux, causes intense paroxysms of electric-shock-like pain in the areas of the face connected to the trigeminal nerve (fifth cranial nerve). A less common form of the disorder causes a more constant, dull, burning, or aching pain. Attacks can be triggered by stimuli as harmless as touching the face, brushing the teeth, applying makeup, or a soft breeze. A specific cause of trigeminal neuralgia is usually not identified, but it can be caused by multiple sclerosis or pressure on the trigeminal nerve by a swollen blood vessel or tumor. Though a person of any age may be affected, onset is typically after the age of 50. Antidepressant or anticonvulsants (such as Tegretol or Neurontin) may be effective treatments for trigeminal neuralgia. Neurosurgery may be necessary to relieve pressure on the nerve or to reduce nerve sensitivity.

Care Cream

Conditions that Wound Care Cream can aid WOUND CARE CREAM can be used for wounds caused by:

  • TRAUMA
  • CHEMICAL OR PHYSICAL SCALDS AND BURNS
  • PRESSURE
  • ADVERSE EFFECTS OF MEDICATIONS
  • METABOLIC DISEASES, SUCH AS DIABETES
  • SURGICAL PROCEDURES

Conditions that Compounded Scar Cream can treat SCAR CREAM can be used on both old and new scars caused by:

  • BURNS
  • SURGICAL PROCEDURES
  • SEVERE TRAUMA

SCAR CREAM can also help prevent the following scarring disorders:

HYPERTROPHIC SCARRING

Hypertrophic scars are raised and thicker than normal scars and are typically red or pink in color. Hypertrophic scarring is a result of excessive collagen production. Hypertrophic scars will sometimes gradually subside without treatment over the course of a year or more.

KELOIDAL SCARRING

When a wound heals and a scar forms, if excess collagen is produced, the scar will become elevated, rounded and firm. An overgrowth of collagenous scar tissue is known as a keloid. Keloids, unlike hypertrophic scars, extend beyond the bounds of the original wound. Keloids are noncancerous and pose no threat, although they can itch and cause mild discomfort. Removal is problematic because keloids usually grow back after surgical removal.

Cosmetic conditions that can be improved with Compounded Cosmetic Cream

AGE SPOTS

Age spots (also called liver spots, though they are not connected to the liver) are dark brown or grayish areas of pigment on the skin. Despite their name, age spots are not directly caused by aging (though they occur most commonly in adults over the age of 40). Sun exposure is the cause of age spots; as a result, they are most common on the hands, face, shoulders, and other areas frequently exposed to the sun.

BIRTH MARKS

Birthmarks can be present at birth or appear in the weeks after birth. They can be a variety of colors, including red, brown, or blue-gray. The precise cause of birthmarks is still unknown, although they are harmless.

FRECKLES

Freckles are caused by an increase in melanin (dark pigment). Contributing factors in the development of freckles are genetics and sun exposure. They are most common in those with fair skin and become more prominent with increased sun exposure.

SUN DAMAGE

Prolonged or repeated sun exposure causes the skin to produce more melanin, a dark pigment which not only gives the skin color but protects it from the sun. Over time this added pigment can cause a variety of discolorations, such as melasma (brown areas on the face), uneven pigmentation (irregular brown or red coloration), and age spots (see above).

Compounding Medications

  • Compounded Pain Cream

    COMPOUNDED PAIN CREAM is specifically designed to target and treat the site of pain with customizable formulations, while avoiding many of the complications common to other pain treatment methods. Pain Cream provides a flexible, convenient, and effective solution for a variety of pain-related conditions. Targeted Relief PAIN CREAMS ARE DESIGNED to administer high concentrations of pain medication directly onto the site of pain for targeted relief. Furthermore, our pharmacists can work with your doctor to create a custom formulation, designed to meet your unique needs. As a result, you get the combined benefits of precise dosing, personalized treatment, and the combined effect of multiple ingredients working together for optimal pain relief. Fewer Risks & Side Effects BECAUSE OUR PAIN FORMULATIONS are applied topically, they do not circulate throughout the entire body. This means you have powerful pain medication where you need it and less where you don’t. As a result, Pain Creams are less likely to interact with other medications being taken and cause fewer side effects than other pain medications. Finally, since Pain Cream is not absorbed throughout the entire body, the risk of dependence and addiction is virtually eliminated. PCCA Lipoderm® ALL OF OUR PAIN CREAMS are formulated using the anhydrous silicone base, PCCA Lipoderm®. Lipoderm® is the only transdermal base designed and proven to effectively deliver pain medication. Furthermore, Lipoderm® has been tested and proven to deliver up to 4 drugs simultaneously and to deliver medications more effectively and more quickly than other topical bases. Active Ingredients in COMPOUNDED PAIN CREAM

    BACLOFEN

    Muscle Relaxant / Antispasmodic. Helps reduce pain by relaxing muscles. Since topical use causes much less systemic absorption, the typical side effects (drowsiness, increased urination, mental confusion, constipation and fatigue) are usually not seen.

    CYCLOBENZAPRINE

    Muscle Relaxant. Helps control muscle spasms and tightness. A common side effect of this medication when taken orally is drowsiness, but this risk is reduced with transdermal medication.

    DICLOFENAC

    Anti-inflammatory (NSAID). Helps reduce inflammation and pain. Transdermal application reduces the risk of side effects, such as GI upset, and lowers the possibility of stomach ulceration. The FDA requests that physicians measure liver function periodically in patients receiving long-term therapy with diclofenac.

    GABAPENTIN

    Anticonvulsant. Works by 3 mechanisms to treat neuropathic pain (pain typically caused by damaged or misfiring nerve fibers). Best combined with ketamine for maximum synergistic effect.

    KETAMINE

    Analgesic (an agent used to relieve pain without loss of sensation). Helps reduce pain by interfering with the transmission of pain signals to the brain. Extensive research has been performed on the topical use of ketamine.

    KETOPROFEN

    Anti-inflammatory (NSAID). Helps reduce hormones which cause inflammation and pain. There is extensive research on transdermal delivery of ketoprofen.

    LIDOCAINE

    Topical Anesthetic. Helps reduce pain. The most common transdermal side effects are tingling and numbness at the site of application.

    TRAMADOL

    A mild opioid-like pain reliever.
  • Wound Care Cream

    WOUND CARE CREAM is custom compounded and specially designed to protect wounds and aid the body’s healing process, for quicker recovery and reduced risk of infection or other complications. Spira-Wash™ Gel ONE OF THE SECRETS behind the effectiveness of Wound Care Cream is Spira-Wash™ Gel, the base used in all of our Wound Care Formulations. Spira-Wash™ is specifically designed to aid the body’s healing process by acting as a protective barrier against the air, blocking out potentially harmful microorganisms and environmental toxins. Along with guarding against contaminants, Spira-Wash™ also creates a moist environment for the wound to heal in, which has been proven to speed healing by up to 50%. And unlike many comparable products, which protect the wound but also inhibit proper washing, Spira-Wash™ is water-washable, making cleaning and debridement of the wound as easy as possible. Meadowsweet Extract SPIRA-WASH™ GEL CONTAINS organic Meadowsweet Extract which can potentially provide antioxidant and additional healing properties. Meadowsweet Extract may also act as an anti-inflammatory and antiseptic. Research also suggests that Meadowsweet Extract possesses antimicrobial properties. Customization ALONG WITH THE NUMEROUS healing qualities found in every Wound Care Formulation we create, Wound Care Cream can also be customized at the request of your doctor. Our pharmacists will work with you and your physician to create a formulation that best suits your needs. Customized formulations can include antifungal protection, pain reduction, antimicrobial coverage (for gram-positive and gram-negative), and increased healing properties.

  • Compounded Scar Cream

    SCAR CREAM is designed to soften, smooth, flatten, lighten and dramatically improve the overall appearance of both old and new scars. Scarring Disorders SCAR CREAM, while improving the appearance of preexisting scars, can also help prevent scarring disorders, including hypertrophic and keloidal scarring. Both hypertrophic and keloidal scars are the result of excessive collagen produced in the healing process. Due to the excess scar tissue, scars will appear raised, thick, and darker than typical scars. While hypertrophic scars remain confined to the area of the original wound, keloids extend into the surrounding tissue. Scar Cream is designed to prevent the excessive collagen production which causes these disorders. PracaSil™-Plus PRACASIL™-PLUS is the silicone base used in our Scar Cream. It is specifically designed for use in scar and skin treatments. PracaSil™-Plus reduces inflammation and buildup of scar tissue. It is also designed to create a resilient film on the skin, so that your scar receives as much exposure to the medication as possible. Pracaxi Oil PRACASIL™-PLUS CONTAINS Pracaxi Oil, which is derived from the pracaxi tree, found in the Amazon rainforest. Pracaxi Oil is rich in beneficial fatty acids and has historically been used for a variety of medicinal and cosmetic purposes. It can have anti-inflammatory, antioxidant, antibacterial, and antifungal properties. It is also used in hair and skin products to condition and smooth. Active Ingredients in COMPOUNDED SCAR CREAM

    PENTOXIFYLLINE

    Increases blood flow in the peripheral blood vessels. Pentoxifylline also blocks transforming growth factor beta 1 (TGF-β1), an enzyme which plays a role in cell growth, and decreases the formation of collagen, an important factor in scar tissue growth.

    TRANILAST

    An anti-allergic drug.Can inhibit collagen synthesis, reducing keloids and hypertrophic scars.

    VERAPAMIL

    A calcium channel blocker / vasodilator. Calcium is responsible for fibroblasts, which produce collagen, an important part of skin tissue growth. Fibroblasts also produce collagenase, which breaks down collagen. As a calcium channel blocker, verapamil decreases collagen and increases collagenase, to help break down scar tissue and halt its growth.
  • Compounded Cosmetic Cream

    COMPOUNDED COSMETIC CREAM is designed to lighten dark spots on the skin, resulting from a variety of factors. Active Ingredients in COMPOUNDED COSMETIC CREAM

    BUTYLATED HYDROXYTOLUENE

    An antioxidant.

    HYDROQUINONE

    Skin-lightening agent.

    SODIUM METABISULFITE

    An antioxidant and disinfectant.

    TRIAMCINOLONE

    A synthetic corticosteroid. Helps reduce inflammatory reactions.

Compounding Success Stories

 Compounding touches many lives.

Compounding is the art and science of creating personalized medicine. For patients, it can be life-changing, even lifesaving. It’s highly rewarding for pharmacists and practitioners as well, helping them solve some of health care’s toughest challenges.

And it makes for some really good stories. Stories of new beginnings and happier endings. Stories of strength, comfort and confidence. Stories of hope. Stories that illustrate just how powerful personalized medicine can be. You can see even more compounding success stories on www.ItsPersonal.net.


From Steven Branch, RPh, of Central Drug in Victoria, Texas

One of my favorite stories is about a five-year-old autistic boy who we helped. His mom came in the store frantic, asking for help, because he would not take his medicine. It was a fight each and every day for her.

I asked her what his main challenge was with taking the medicine, and she said texture and taste. Things have to have a certain feel in his mouth, and he likes lemon flavor – but just the right lemon flavor. So Jenny, my tech, and I went to work. It took several tries. I sat on the floor where I could be at eye level with him as we tried different versions. I cannot explain the feeling that came over me when we got it right. His whole demeanor immediately changed. His face brightened, his eyes sparkled and he just looked at me with this huge smile. It was great, and it still makes me cry five years later. (Source: PCCA Apothagram, March 2015)


From Leigh Ann Grasso, PharmD, of Annie’s Apothecary in Boerne, Texas

I have had great success with PCCA Formula #9957. Dentists and hygienists love this formula for pre-injection numbing. I’ve had requests to make the gel thicker and it’s worked well. We also have special requests to make it colorless or to add phenylephrine 2% to extend its duration of action (PCCA Formula #9849, Lidocaine HCl 10%/Phenylephrine HCl 2%/Prilocaine HCl 10%/Tetracaine HCl 4% Dental Gel).

The feedback from dentists is that the gel doesn’t cause tissue sloughing when it’s left on the skin too long like manufactured topical dental anesthetics do. The hygienists love it because their pediatric patients don’t feel the pain from the needle at all. (Source: PCCA Apothagram, January 2014)


From Leigh Ann Grasso, PharmD, of Annie’s Apothecary in Boerne, Texas

Below is a patient testimonial we received after providing the following compounded prescription: flurbiprofen 10%/ketamine 10%/gabapentin 6%/cyclobenzaprine 2%/bupivicaine 1% in PCCA Anhydrous Lipoderm®. The patient was directed to apply 1-3 grams three times daily for pain:

“I’m a 64-year-old wood craftsman who has been in the construction industry and fine furniture business long enough to know a thing or two about working with old injuries. I have many aches and pains that I manage on a daily basis; I often have neck, elbow and back pain, but it’s endurable. I have an old knee problem that I’m awaiting surgery for. And the pain has been getting worse – swelling and hurting enough to make me wince.

I did as I was instructed with the medication – I applied three grams to my right knee and rubbed it in well, but gently. Within four or five minutes, I noticed that the entire affected area felt cooler. I continued doing my chores and tasks at my wood shop. Within a few more minutes, I noticed that I was able to walk around and go up a flight of stairs without my usual expectation of pain. After 30 or 45 minutes had gone by, I felt as if the swelling had gone down, and I was working at my usual shop pace. About three or four hours later, I went to apply a second dose and was pleasantly surprised to see that my knee appeared to look less swollen and felt less stiff. In the evening, my leg felt less stiff lasting throughout the night, so I was able to sleep without any discomfort. On the second day, I applied the medication twice and had the same results; my knee felt cooler and less stiff. I was able to work the entire day doing my usual shop chores. On the third day, I applied the medication in the morning because the swelling had returned. I felt relief within five to 15 minutes and worked in the shop all day. On the fourth day, I only had to apply the medication in the morning. And on the fifth day, I applied the medication in the morning and didn’t have to apply it again in the afternoon. Now the swelling and pain are gone!” (Source: PCCA Apothagram, January 2014)


From Kyle Anderson, CPhT, of MedQuest Pharmacy in North Salt Lake City, Utah

I had a gentleman call to thank us for saving his marriage. Apparently, he and his wife were just about to throw in the towel when she met with a physician that “put her on hormones.” After several months, he stated that they observed that each week had been progressively better than the last and that she was becoming happier and healthier all the time. The patient used compounded oral progesterone capsules, compounded oral thyroid capsules, and compounded topical estradiol cream. (Source: PCCA Apothagram, January 2014)


From Deborah A. Martinson, CPhT, of Keystone Pharmacy in Grand Rapids, Michigan

We had a new mom call on the telephone, frantic that she could not find a place to make Lansoprazole 3 mg/mL Oral Suspension (Flavorless) (BUD Study) (PCCA Formula #9673). She said she had been to other big box stores and they did not have all the ingredients to make this compound. She was almost in tears on the phone, wondering what she was going to do if she could not get this medication for her newborn who had gastric reflux.

At the time, I also was a new mom and knew how crazy you can feel, so we made this compound up right away for her. She walked in to get the medication and immediately began crying. She was so thankful that we were able to make this – and provide it to her child in a timely manner to relieve his suffering! (Source: PCCA Apothagram, February 2013)


From Katie Hillman, BS, CPhT, of Health and Wellness Compounding Pharmacy in Nashville, Tenn.

We had a 5-month-old infant come into our pharmacy with severe second-degree burns on her face. It was terrible to see such a young child with an injury that would likely leave behind permanent damage. However, after only eight days of using PCCA PracaSil™-Plus (PCCA #30-4655), her burns had vanished. We compounded PCCA Formula #10413 to treat her scarring. We also compounded PCCA Formula #5536 for her treatment. Our entire pharmacy was practically in tears! Days like that make me realize how much I love my job and how much we are able to help patients. (Source: PCCAApothagram, April 2014)


From Andrew Cannon, RPh, of City Drug in Evanston, Wyo.

We received this testimonial from a patient who is using a diclofenac sodium/cyclobenzaprine/baclofen/tetracaine cream:

“I’ve suffered from severe knee pain for more than 10 years. I would wake up in the middle of the night with intense pain in my knee that would radiate down to my ankle. I had X-rays taken and an MRI test, but the doctors couldn’t find anything wrong. Over-the-counter pain medications didn’t really seem to help, nor did physical therapy. When I heard about a compounded pain cream I was skeptical, but I was willing to try anything that might work. The compounded cream has brought me so much relief that I would recommend it to anyone suffering from chronic pain. Now I can sleep through the night – without the pain.” (Source: PCCA Apothagram, April 2014)


From Sharon Sims, RPh, of Gulf Breeze Apothecary in Gulf Breeze, Fla.

We worked with a patient who has multiple sclerosis. Her compounded glycyrrhizic acid capsules helped her to remain mobile and perform daily activities. She was a lieutenant colonel in the Air Force and was very instrumental in our struggle with TRICARE’s threat to stop paying for compounds. We were in touch with national organizations through her contacts and she was featured in a local news story filmed in our pharmacy. In her story, she discussed why compounded medication was important to her. She explained how it helped her well-being, her ability to get out of bed, and helped to give her a normal life when living with such a debilitating disease. (Source: PCCA Apothagram, March 2014)

Compounding Answers

Do you have questions about pharmacy compounding? We have answers.

Pharmacy compounding is a long-established tradition that offers customized care to meet the specific needs of individual patients. Have you ever wished your child’s medicine tasted better, so they would accept it without a fuss? Or struggled to cut a prescription tablet in half because the pill wasn’t manufactured in the strength you required? Perhaps an ill loved one could have benefited from having multiple medications combined into a single dose. Compounding pharmacists provide solutions to all these problems, and more. Ask your prescriber or pharmacist today about customized compounding, or read on for more information…

 

What is compounding?        image

Pharmacy compounding is the art and science of preparing customized medications for patients. Its practice dates back to the origins of pharmacy, although compounding’s presence in the pharmacy profession has changed over the years. In the 1930s and ’40s, the majority of prescriptions were compounded. With the advent of mass drug manufacturing in the 1950s and ‘60s, compounding declined as the pharmacist’s role as a preparer of medications quickly changed to that of a dispenser of manufactured dosage forms. However, this “one-size-fits-all” approach to medication meant that some patients’ needs were not being met. Within the last few decades, however, compounding has experienced a renaissance as modern technology and innovative techniques and research have allowed more pharmacists to customize medications to meet a patient’s unique needs.
 

There are several reasons why prescribers and pharmacists provide compounded medications for patients. The primary reason for compounding is to avoid patient non-compliance, which means the patient is either unable or unwilling to use the medication as directed. Many patients are allergic to preservatives or dyes, or require a dosage that is different from the standard drug strengths.

With a physician’s consent, a compounding pharmacist can:

  • Adjust the strength of a medication
  • Avoid unwanted ingredients, such as dyes, preservative, lactose, gluten, or sugar.
  • Add flavor to make the medication more palatable
  • Prepare medications using unique delivery systems. For patients who find it difficult to swallow a capsule, a compounding pharmacist may prepare the drug as a flavored liquid suspension instead. Other medication forms include topical gels or creams that can be absorbed through the skin, suppositories, sublingual troches, or even lollipops.

Yes! Children and the elderly are often the types of patients who benefit most from compounding. It is common for parents to have a tough time getting their children to take medicine because of the taste. A compounding pharmacist can work directly with the physician and the patient to select a flavoring agent, such as bubblegum, grape, tutti frutti, or vanilla butternut, which provides both an appropriate match for the medication’s properties and the patient’s taste preferences. Just think – no more wasting medicine when a cranky patient spits it out! Compounding pharmacists also can help patients who experience chronic pain. For example, some arthritic patients cannot take certain medications due to gastrointestinal side effects. With a healthcare practitioner’s prescription, a compounding pharmacist may be able to provide these patients’ anti-inflammatory or pain-relieving medications with topical preparations that can be absorbed through the skin. Compounded prescriptions frequently are used to ease pain, nausea, and other symptoms for hospice patients as well.
 

Is compounding legal? Is it safe?

Compounding has been part of healthcare since the origins of pharmacy, and is widely used today in all areas of the industry, from hospitals to nuclear medicine. Over the last few decades, compounding’s resurgence has benefited largely from advances in technology, quality control and research methodology. The Food and Drug Administration has stated that compounded prescriptions are both ethical and legal as long as they are prescribed by a licensed practitioner for a specific patient and compounded by a licensed pharmacy. In addition, compounding is regulated by state boards of pharmacy.

Some insurance plans allow the patient to be reimbursed by sending in claim forms. While you may be paying a pharmacy directly for a compounded prescription, many insurance plans may cover the final cost.
 

Compounding may or may not cost more than conventional medication. Its cost depends on factors such as the type of ingredients and equipment required, plus the time the pharmacist spends researching and preparing the medication. Fortunately, compounding pharmacists have access to pure-grade quality chemicals which dramatically lower overall costs and allow them to be very competitive with commercially manufactured products.

Almost any kind! Compounded prescriptions are ideal for any patient requiring unique dosages and/or delivery devices.

Compounding applications can include:

  • Hormone replacement therapy (HRT)
  • Hospice
  • Pediatrics
  • Pain management
  • Ophthalmology
  • Dentistry
  • Otic (for the ear)
  • Dermatology
  • Medication flavoring
  • Neuropathy
  • Veterinary
  • Sports medicine
  • Infertility
  • Wound therapy
  • Podiatry
  • Gastroenterology
  • And many more!

Prescription compounding is a rapidly growing component of many physicians’ practices, but some may not realize the extent of compounding’s resurgence in recent years due to today’s climate of aggressive marketing by drug manufacturers. Ask your healthcare practitioner about compounding, or get in touch with a compounding pharmacy – one that is committed to providing high-quality compounded medications in the dosage form and strength prescribed by the practitioner. Through the triad relationship of patient, prescriber, and pharmacist, all three can work together to solve unique medical problems. Is custom compounding right for you? Ask your healthcare practitioner or pharmacist today about the benefits of personalized prescription compounding.

MOST MAJOR INSURANCE PLANS will cover your medication. For those who are not covered, we offer a competitive cash payment option. IF YOU HAVE ANY QUESTIONS regarding your medication or insurance coverage our Customer Care Representatives are available Monday – Friday 9 am to 5 pm (EST). PLEASE CALL 757-320-5141/800-372-5163 to speak to a representative.

FAQs

Are compounded medications approved by the FDA? The FDA was created in the 1930’s for the express purpose of regulating manufacturers who produce drugs that would be distributed to the mass population. Compounding pharmacists do not mass distribute and are regulated by individual state laws. The chemicals used by compounding pharmacies are obtained from FDA inspected and approved facilities. Aren’t FDA products safer and more effective? Not necessarily. FDA approved manufacturers have drug product recalls often. These recalls range from wrongly packed and mislabeled medications to improper potency to ineffective and dangerous medications. These recalls can affect thousands of people. Two recent examples of drug product recalls for safety are Rezulin and Propulsid. A recent example of a recall for incorrect packaging is MS Contin. Duragesic patches were most recently recalled for a manufacturing defect. Why don’t all pharmacies compound prescriptions? Most do. According to the American Pharmacy Association and the National Association of Community Pharmacists, compounding is done to some degree in 90% of all hospital pharmacies and 80% of all independent pharmacies. All pharmacists are permitted by law to compound as part of the practice of pharmacy; however, compounding pharmacists have learned skills above and beyond those they were taught in school. Compounding also requires a substantial commitment on the part of the pharmacy owner of time (each prescription is individually made in the pharmacy, not just transferred from one bottle to another) and money (for additional training and purchase of the specialized equipment that is required to make a quality product). There are now about 400 compounding only pharmacies in America, and many more in countries around the world. Compounding quality does vary along with the skill of the compounding pharmacist, and has an excellent safety record. What about quality control? A good compounding pharmacy like Bedei Compounding Pharmacy Services (BCPS) has in place stringent quality control procedures, some of which include non-sterile product testing and environmental controls. Detailed records should be kept for each and every compound. With detailed records, the lot number and expiration date of each chemical used can be traced if needed. Why are there so few studies on compounding? The majority of large studies are funded by drug manufacturers who are required to do so by the FDA in order to get a particular product approved for mass marketing. Some drugs (human hormones, for example) cannot be patented; therefore, there is no monetary incentive for any company to pay for an expensive drug study. Furthermore, there are published studies done for many ingredients used in compounded products. Will human hormones eventually prove to be as dangerous as synthetics? The hormone questions will always be with us. Hundreds of compounding pharmacists, thousands of physicians, and millions of patients believe that human hormones, in normal body ratios and amounts, are both safe and healthy. Many believe that hormone replacement therapy can help both women and men live longer and healthier lives. The key is to work with your health care provider and your compounding pharmacist to find the unique balance that is right for you.