Compound drugs are drugs prepared by a pharmacist that are uniquely formulated to meet a specific individual’s need when there is no commercial drug mixture which adequately addresses it. Compound drugs are formulated in accordance with a licensed practitioner’s prescription or medication order. As treatment continues, the prescriber, patient and pharmacist are able to adjust the formulation to best fit the needs of the patient.
According to the Professional Compounding Centers of America (PCCA), a U.S. based association, which acts as the independent compounding pharmacy’s complete resource for fine chemicals, devices, equipment, training and support, aside from concerns about substance abuse, compound drugs are often used because a patient may require a different strength or dosage than what is contained in the manufactured drug. Some patients may require the addition of flavors to a medication to make them more palatable, which can be especially helpful for getting children to take their medicine.
Compounding also allows pharmacists to reformulate the drug to exclude an unwanted, nonessential ingredient, such as gluten or dyes that patients may be allergic to. If a patient’s digestive tract becomes irritated when taking a certain medication orally or if the patient has difficulty swallowing, pharmacists are often able to change the form of a given medication, creating a suppository, topical gel, ointment or spray based on the type of medication and the affected area.
All of these alterations are meant to allow the patients to better comply with their treatment regimes by avoiding unpleasant or unwanted side-effects that prevent them from taking their medication as prescribed.
Compound drugs are often used for pain management, as the topical gels and ointments applied locally to the affected area bypass the other organs in the body, thus reducing the risk of dependence and limiting the drugs impact on the body’s internal organs. In cases where pain medications are used over a long period of time, patients build a tolerance to traditional pain medications necessitating higher and higher doses, which can cause damage to the internal organs and increase the risk of overdose. This does not occur with compound medications because the medications are not absorbed by the body in the same way as the traditional medications.
Avoiding side effects and other risks are a common reason prescribers choose to use compound pharmacies. According to Blake Powers, COO of QmedRX, a Florida based compound pharmacy established in 1990, “[narcotic pain medications] are taken by mouth and so the whole body will absorb this pain medication. With this, obviously, there are concerns about cognitive impairment. When you have people who want to go to work everyday or school or just even operate a moving vehicle, they don’t want to have these cognitive side effects.”
Compound drugs are considered to be just as effective as traditional pain medications and can often replace these riskier medications altogether. A 2013 survey of nearly 3,600 chronic pain sufferers nationwide, conducted by Patient Outcomes Analytics (POA), found that over 83 percent of respondents reported a ‘significant reduction in their pain’ after using compound prescription topical pain creams. Five percent of respondents claimed the creams completely eliminated their pain, and 38 percent reported reducing their use of other oral pain medications while using the creams.
“The survey confirms what prescribing doctors have known for some time; that locally applied creams, customized and formulated to meet the specific needs of each individual, are capable of delivering significant benefits, with the potential of reducing addiction for untold thousands of Americans,” said Alexis Bennett, co-principal investigator of the study in a press release regarding the survey results.
The traditional oral narcotic medications used in pain management, such as Vicodin and Oxycontin, are still the most utilized medications. According to Powers, compound pharmacies only fill around 10 percent of prescriptions with the other 90 percent filled by mass produced medications at traditional pharmacies. “Big Pharma really has the lion’s-share of the market. I think we went through a period in the 80’s where we had this one size fits all mentality…And that is the mindset of manufacturers today, what can we mass produce that will serve most of the needs of the medical community.”
However, with the increased abuse of prescription medications and the rise in the popularity of compound pharmacies, “what lot doctors are becoming more aware of is that one size doesn’t fit all. Maybe we have a child or there are certain allergies that the patient has or certain side effects that we don’t want. And so what compound pharmacies provide doctors is the ability to prescribe that optimal medication for a specific patient.”
A 2011 report in the journal Pain Medicine estimates the societal cost of prescription opioid abuse at $55.7 billion, when considering all health care, workplace, and criminal justice costs. “The costs of prescription opioid abuse represent a substantial and growing economic burden for the society. The increasing prevalence of abuse suggests an even greater societal burden in the future,” said Bennett referring to the study.
Bennett hopes that these topical, compound creams “[can] ease that burden by reducing the need for narcotics while providing the relief that patients need to lead fuller lives, with the result of reduced patient pain and suffering and a reduced cost of healthcare.”
Blake Powers sees compound medications as a rising trend as doctors have become increasingly concerned about prescription drug abuse. “We are a pharmacy that elects not to provide any kind of oral narcotics, we see that as a problem of something that is easily abused, so instead we have alternate medications, topical pain medications so you can apply them directly, locally to the affected area where there is absorption, there is pain relief without the side effects of these oral opiates… [Thus,] you can treat your pain without the unnecessary side effects of these oral medications or the risk of substance abuse”
“Often times when a physician writes to a compound pharmacies it’s a last ditch effort, patients are really suffering from chronic pain and that is why compound pharmacies are so important, because we work with the doctors to problem solve, to see what’s working and what’s not working to arrive at the best medication possible,” said Powers when asked about the importance of compound pharmacies in today’s medical landscape.
Despite these facts, many medical professionals and insurers are still not convinced of the efficacy of compound drugs, claiming they are unproven and costly. The FDA considers the use of compound drugs “ethical and legal as long as they are prescribed by a licensed practitioner,” but since theses drugs are not subject to the same rigorous FDA approval process as manufactured drugs, many individuals worry about contamination or impurities in the medications because of the lack of oversight.
According to The Atlantic, in 2012 an outbreak of fungal meningitis was traced back to a contaminated steroid drug distributed by the New England Compounding Center in Framingham, Massachusetts. In total, 751 people became ill, 64 of whom died. This incident led to increased regulation of compound pharmacies at both the national and, in many cases, the state level.
While there have been setbacks, compound drugs are increasingly becoming an option in cases where there is a risk of drug abuse or dependence. Alexis Bennett of POA concludes her statement by saying, “With more than 100 million Americans in chronic pain, and prescription drug abuse an epidemic, we need to employ all therapies that work and are safe to resolve the problem.” For many patients and practitioners, compound drugs are becoming the solution to that problem.