Why Pharmacy Compounding Has and
Continues to be a Medical Necessity
Providing a
Solution to Drug Shortages: Compounding
In
recent years, healthcare professionals and patients have had to deal with the
growing problem of drug shortages, which seriously affect the vital category of
sterile injectable drugs. According to the United States Food and Drug
Administration (FDA), in 2010 there were 178 drug shortages of which 132 were
sterile injectable drugs, and in 2011 those numbers increased to 251 drug
shortages of which 183 were sterile injectable drugs.[1] These shortages sometimes affect whole
classes of drugs including essential drugs for cancer treatment, cardiovascular
disease, and pain management. Causes
primarily include issues in production quality and manufacturing. According to the
American Society of Health-System Pharmacists, the end result for patients is
that drug therapy may be adversely affected, medical procedures may be
compromised or delayed, and medication errors may occur.[2] Compounding provides one solution to solving
drug shortages.
Compounding
pharmacies and pharmacists have been and continue to be called upon by
patients, healthcare providers, and hospitals to compound medications that are
commercially unavailable. Compounding
pharmacies are able to fulfill this need because they have access to the raw
materials and the technical expertise required to formulate the needed
medications. Patients can contact
compounding pharmacies directly to find prescribed medications that are in
short supply, healthcare providers can utilize compounding pharmacies for drugs
that are unavailable elsewhere, and hospitals can utilize compounding for
intravenous admixtures when the supply of key injectable drugs is unavailable.
The demand for compounded medications shows how essential compounding
has been and continues to be—particularly in the case of drug
shortages.
In addition to the FDA
drug shortages, there are many reasons why compounding continues to be a
medical necessity and is an essential part of the healthcare system. Even though many drugs are not on the FDA
drug shortage list, available supplies can still be limited. Manufacturers produce limited dosage forms,
limited strengths, and often discontinue older drugs as they lose market share
to produce newer and more profitable drugs.
Compounding is needed when drugs are not available in the needed
combinations or when drugs need to be repackaged into the correct dose. Treating rare medical conditions often requires
small supplies of compounded orphan drugs.
Compounding is needed for pediatric formulations, geriatrics
formulations, parenteral nutrition, cancer chemotherapy, pain management, and
bioidentical hormone replacement therapy.
Diagnosing and treating diseases can be done using nuclear compounding.
Compounding is needed for home healthcare, hospice, dental, dermatological, and
ophthalmological patients. When
patients cannot tolerate the commercially
available product due to non-intrinsic characteristics—such as dyes,
preservatives, ethanol, flavor, dosage or delivery method—compounding readily
resolves the issue.
The reasons why compounding is needed are endless, but, as a whole, compounding allows accessibility to
medications that are not easily available and provides flexibility for patients
to receive individualized care according for their health needs.
Compounding
pharmacies have always been in the background working to help meet patient
needs. Recently compounding has gained
national attention due to the meningitis outbreak stemming from the New England Compounding Center
(NECC) in Framingham, Massachusetts. As of the end of November 2012,
contaminated spinal injections of methlyprednisolone
acetate prepared by NECC have sickened several hundred people and killed more than
30 in multiple states. Due to the
serious problems at NECC, Ameridose, an FDA registered manufacturer with the
same founders as NECC, has voluntarily recalled all of its products.[3] The shutdown of these facilities has only
exacerbated the problem of drug shortages, which means that additional
demand may be placed upon compounding pharmacies to remedy the situation.
The
recent meningitis crisis may have negatively affected the field of compounding
even though NECC was not a compounding pharmacy but rather a drug
manufacturer. This distinction is
important to note because compounders work in a triad of patient, physician,
and pharmacist relationship that helps to ensure the safety of the medications
for the patient. Drug manufacturers mass
produce medications without taking into account the individualized needs of the
patient. Drug manufacturers are not compounders, and more oversight is needed
by the FDA to ensure patient safety when drug manufacturers masquerade as
compounding pharmacies. Despite the recent news, there are many healthcare
providers and patients that recognize the importance of and the need for compounding. Moving forward, compounding pharmacists can
use the spotlight of the meningitis outbreak to educate the general public that
compounding is safe, effective, and an essential medical necessity, especially
when faced with drug shortages.
November 21, 2012.
[2] Drug shortages. American Society of Health-System Pharmacists
Web Site. https://www.ashp.org/shortages.
Accessed November 21, 2012.
2012.
