Facts About Compounding
Talk with your doctor about compounded medications.
Millions
of Americans have unique healthcare needs that can't be met by off-the-shelf
prescription medications.
Because every patient is
different and has different needs, compounded medications are a
vital part of quality medical care. For many people, personalized medications - mixed safely by trained, licensed pharmacists - are the only way to better
health.
Pharmacists with Unique Skills
Pharmacists are
the only healthcare professionals who have specialized training and education in chemical properties
and can prepare alternate dosage-forms. In fact, each state requires that
pharmacy schools must, as part of their core curricula, instruct students about
compounding pharmaceutical ingredients. Compounding pharmacies are licensed and
regulated in the 50 states and the District of Columbia by their respective
state boards of pharmacy.
When your physician prescribes a compounded medication for your
condition, he or she is essentially sending you to a custom tailor of medicine,
who will prepare the exact dosage and form that is right for you. Compounded
medications are made just for you, allowing your doctor to specify the right active ingredients, dosage-form, strength, size - and even the
flavor - that is best for you. Your prescriber will give you a prescription just
like any other prescription, and let you know that you need to find a
compounding pharmacy to fill it for you.
Compounding pharmacies come in all sizes and configurations and are located
throughout the United States. Some fill a few prescriptions for compounded
medicines every day, some fill thousands. Some specialize in a few compounds,
such as bio-identical hormone replacement therapies, or medicines used by
urologists, ophthalmologists or veterinarians, while others provide a range of
compounded medicines for human and animal use.
When it comes to filling your prescription, you have options. You can take it
to a local compounding pharmacy. By law, you can’t e-mail your prescription to a
pharmacy, but you can mail it. This allows you to use any compounding pharmacy
you choose, perhaps one that will deliver your medication to your home. Of
course, your prescriber can fax or call your prescription to any compounding
pharmacy.
A Very Brief History of Compounding
Compounding medicine has been practiced by pharmacists since the
earliest days of pharmacy. In fact, there was a time when all medicines were
compounded. But since the advent of high-volume pharmaceutical manufacturing,
most people today are familiar only with manufactured medicines.
In the 1950s, pharmaceutical companies appeared and changed the way
medications were made. They were able to manufacture medicine on a large scale
to serve many patients. Around the same time, insurance companies started
affecting the way medicine was prescribed by doctors and filled by pharmacists,
changing the pharmacist’s role to dispensing more so than compounding. The
result was a decline in the need or reimbursement for compounding, and the large
chain pharmacies of today became the new norm. As long as people continue to
have unique needs for custom medications, or medications become commercially
unavailable, there always will be a need for compounding. That is why doctors
still write prescriptions for compounds today.
When to Consider Compounding
The basis of the profession of pharmacy has always been the “triad,” the
patient-physician-pharmacist relationship. Through this relationship, patient
needs are determined by a physician, who chooses a treatment regimen that may
include a compounded medication. Physicians often prescribe compounded
medications for reasons that include (but are not limited to) the following
situations:
- When medications are discontinued by or generally unavailable from
pharmaceutical companies, often because the medications are no longer
profitable to manufacture;
- When the patient is allergic to certain preservatives, dyes or binders
in available off-the-shelf medications;
- When treatment requires tailored dosage-strengths for patients with
unique needs (for example, infants);
- When a pharmacist can combine several medications the patient is taking
to improve compliance;
- When the patient cannot utilize the medication in its commercially
available form and a pharmacist can prepare the medication in a cream,
liquid or other form that the patient can easily take; and
- When medications require flavor additives to make them more
palatable for some patients, most often children.
Talk to Your Doctor About Compounding
Prescription compounding is a rapidly growing component of many physicians’
practices. But some may not realize the extent of the specialized medications
and dosage forms that modern compounding pharmacies offer.
If you have a prescription for a compound, get in touch with a compounding
pharmacy — one that is committed to providing high-quality compounded
medications in the exact dosage-form and strength prescribed by your physician.
Start by asking your doctor to recommend a compounding pharmacy. If he or she
has prescribed a compounded medication for you, chances are that he or she will
know where you can have the prescription filled in a safe, professional,
affordable, and convenient way. If your doctor recommends several pharmacies or
you decide to evaluate your choices, here are some things to look for:
- Experience: Some pharmacies compound medicines as
a sideline and some do nothing but compounding. Be sure that the pharmacy
has specific experience with the medicine you need. As in any area of
healthcare, you always want to deal with the professional who has the most
experience in a specific procedure.
- Affiliations: Check for professional affiliations
such as membership in the Alliance for Pharmacy Compounding (APC), the
American College of
Apothecaries (ACA), Professional
Compounding Centers of America (PCCA), and independent certifications
such as PharmacyChecker.
- Quality: Will your medicine be prepared on a
counter next to the greeting cards or in a climate-controlled laboratory? Are the ingredients purchased from FDA-registered suppliers? Is the
pharmacy
PCAB-Accredited?
- Convenience: Will you have to drive across the
city or the state to pick up your prescription or can you have it delivered
to your door? Can you refill online and pay with a credit card? Can you
refill 24/7? Can you track the progress of your order and its delivery? Will
the pharmacy assist you with insurance-claims processing? Does the pharmacy
have professionally trained staff members who can answer your questions?
Does it offer other resources that can help you understand your condition
such as user groups, forums, and online libraries?
You should be confident in the medication you receive from a compounding
pharmacy. Some compounded medications must be prepared under sterile conditions,
for example, and require complex facilities and equipment to do so properly. So, you should do what you can to ensure that the compounding pharmacy you select is
doing everything possible to ensure accuracy and quality for the drugs made
especially for you.
Start a conversation with your doctor. Ask questions.
- I heard about a treatment involving a compounded medication and
would like to know more. Are you familiar with this compounded medication?
- My regular pharmacy told me that my drug is backordered and
unavailable. Can I get it from a compounding pharmacy?
- I think I might have an allergy to an ingredient in my medication.
Could a compounded version of my medicine help?
- The person for whom I care is unable or refuses to take his
medicine. What options do I have for adding or changing the flavor or dosage
form?
- I take multiple drugs and have a difficult time swallowing so many
pills. Could a compounding pharmacy combine them into one capsule to make it
easier?
Ask These Questions If Your Doctor Recommends a Compounding Pharmacy
- Why do you recommend that pharmacy?
- Does the pharmacy specialize in compounding?
Ask These Questions About Compounding Quality
See a complete list of questions at
WedgewoodRx.com
- If you are compounding sterile preparations, do you conduct weekly lab
tests of air and surface samples in your clean room and other controlled
environments?
- Do you perform daily monitoring and documentation of your clean-room
temperature and humidity?
- Do you have systems in place for handling complaints and
investigating sterility failures and adverse events?
- Is every step of the compounding process from prescribing to
compounding and labeling through dispensing reviewed and verified by a
licensed pharmacist?
- Are your pharmacists, technical, and customer care staff dedicated
to compounding?
- Are you active members of the American College of Apothecaries and the
International Academy of Compounding Pharmacists?
- Are you
PCAB-Accredited?