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 custom-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 appropriate 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.  To find a compounder, visit the Professional Compounding Centers of America or the International Academy of Compounding Pharmacists.

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 International Academy of Compounding Pharmacists (IACP), the American College of Apothecaries (ACA) and 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

• 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?