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Everything about compounding medications, personalized medicine, and compounding pharmacies

What: What is compounding medications?
What is Compounding?
"Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are "made from scratch" - 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."

Professional Compounding Centers of America (PCCA)
What is Compounding?
"Millions of patients have unique health needs that off-the-shelf, manufactured medications cannot meet. For these patients, personalized medication solutions - prescribed by licensed practitioners and prepared by trained, licensed pharmacists - are the only way to better health."

International Academy Of Compounding Pharmacists (IACP)
What Are Compounding Pharmacies?
"The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can't be met by commercially available drugs, says Linda D. Bentley, JD, chair of the FDA practice group at the Boston offices of Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo P.C."

Despite Risks, Compounded Meds Fill Key Void
""At some point in your life," says LIUNA General Secretary Treasurer and LHSFNA Labor Co-Chairman Armand E. Sabitoni, "your health care provider may write you a prescription for a compounded drug. Although these made-to-order medications are specially formulated for you, they are not subject to Food and Drug Administration (FDA) approval. Instead, oversight is through the pharmacy board in the state where the compounded medication is prepared.""

Laborers' Health and Safety Fund of North America
Compounding pharmacies: A costly challenge
"By the beginning of recorded history, pharmacists were already recognized as specialists in the work of preparing medicines. The mortar and pestle, even today the iconic symbol of the pharmacist, comes from this traditional work of carefully preparing medicines in all their various forms.
While pharmacists have come a long way from their ancient roots, there is still sometimes a continuing need for the pharmacist's earliest skill set. Today, in addition to their many other responsibilities, pharmacists sometimes formulate customized medicines (not available from a manufacturer). We call this pharmacy compounding."

Benefits: Why choose compounding medication and its benefits?
Why Do Patients Need Access to Compounded Medicines
"Over the last few years, more and more stories have appeared in the news regarding compounded medications. Recently, the New England Compounding Center (NECC) came under scrutiny after more than 400 patients who received a medication from NECC contracted fungal meningitis."

News / Blogs: News and blogs about compounding medications
Pharmacies Turn Drugs Into Profits, Pitting Insurers vs. Compounders
"It may be the biggest thing in diaper rash treatment, a custom-made product to soothe a baby's bottom at the eye-popping price of $1,600.
This is no Desitin or Balmex, or any other brand found in stores. This cream is blended to order in a pharmacist's lab.
Does it work better than the common treatments? There is little evidence either way. But the sky-high prices commanded by such compounded medicines are drawing the ire of health insurance companies that must pick up the bill. They say the industry is profiteering at their expense."

The New York Times
Should doctors and patients be informed when high-risk pharmacy compounded products are used?
"The fungal meningitis outbreak that's been gripping the country since last fall has now affected 678 patients and caused 44 deaths. Contaminated steroid injections tied to the outbreak have led to a wake-up call about a dangerous gap in regulatory oversight of compounding pharmacies that mix some injectable medications. In an earlier blog, I noted that such compounded preparations are not approved by the FDA and pharmacies also are generally not FDA-inspected. So there is inherent risk when a compounding pharmacy acts as a manufacturer using non-sterile drug powder. In most states, including Pennsylvania, compounding pharmacy sterile processes do not undergo intensive state inspection.
Should these conditions warrant disclosure to those prescribing and administering the medication and to patients who receive the compounded medications? Do healthcare providers even consider whether they have an ethical and legal obligation to inform end users when they dispense high risk sterile products (injectables made from non-sterile ingredients) prepared by a compounding pharmacy. To do that, doctors who inject these products need to be informed of the source. We decided to probe into pharmacy staff viewpoints about whether or not such transparency should be a part of the picture."
Frequently Asked Questions and Answers: Frequently Asked Questions and Answers about compounding medications
Compounding and the FDA: Questions and Answers
"In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient."

Frequently Asked Questions About Pharmaceutical Compounding
"Compounding is the creation of a pharmaceutical preparation - a drug - by a licensed pharmacist to meet the unique needs of an individual patient when commercially available drugs do not meet those needs. A patient may not be able to take the commercially available drug, or a patient may require a drug that is currently in shortage or discontinued."

American Pharmacists Association
Frequently Asked Questions About Compounding
"Pharmacy compounding is the customized preparation of a medicine that is not otherwise commercially available. These medications are prescribed by a physician, veterinarian, or other prescribing practitioner, and compounded by a state-licensed pharmacist. A growing number of people and animals have unique health needs that off-the-shelf, one-size-fits-all prescription medicines cannot meet. For them, customized medications are the only way to better health."

International Academy Of Compounding Pharmacists (IACP)
Risks: Risks of compounding medicines
Compounded Drugs Mix Benefits With Possible Risk
"In the past few years, a battle has been raging over how to regulate the 3,500 compounding pharmacies across the United States.
These pharmacies mix drugs to individual specifications on site, but many people don't know that they even exist. Those relying on compounded drugs face significant challenges: Some have allergies to additives in mass manufactured drugs or need doses of medications that may only be in testing stages.
But the Food and Drug Administration is concerned about the safety of compounded drugs."

Pharmacy Compounding Primer for Physicians: Prescriber Beware
"Pharmacy-compounded drugs have been associated with quality defects, infectious disease outbreaks and other adverse events which, in some cases, have involved patient deaths. Because federal surveillance requirements do not exist for compounded drugs, the extent of quality and safety problems is unknown."

Potential risks of pharmacy compounding
"Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription. However, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients."

Compounded Drugs: Understand the Risks
"During the past few years, compounding pharmacies have received a lot of press. In 2012, a story involving a compounding pharmacy received national attention when as many as 14,000 people received contaminated injections of a steroid medication. A total of 751 patients contracted meningitis or other infections from the injections, and 64 people in 20 states died.
A year before this nationwide outbreak, ophthalmologists at Bascom Palmer Eye Institute in Miami were treating patients who had received intraocular injections of tainted Avastin. As early as November 2011, Roger A. Goldberg, MD, MBA, reported a series of 12 patients who developed Streptococcus endophthalmitis after injection with intravitreal bevacizumab.2,3 These 12 patients presented to Bascom Palmer with severe intraocular infections one to six days after receiving an intravitreal injection of bevacizumab. The injections occurred at four different clinics in south Florida, but all doses of bevacizumab were prepared by the same compounding pharmacy in Broward County."

Jobson Medical Information LLC
Risk Mitigation: Risk Mitigation
Reduce the Risk of Compounded Drugs
"State and federal legislatures are reviewing changes in law to increase the safety of compounded drugs. Even before new laws and regulations go into effect, ophthalmologists can take action to reduce the risk of administering compounded drugs."

Ophthalmic Mutual Insurance Company (OMIC)
How Can Physicians Reduce the Risks Associated With Compounded Intrathecal Medications?
"Medical professionals must be rigorous in evaluating the sources of the compounded medications that they prescribe for intrathecal delivery, said Joshua P. Prager, MD, MS, at the 16th Annual Meeting of the North American Neuromodulation Society. Ideally, prescribers should visit the facilities that compound the medications so that they can evaluate their operations. Dr. Prager, Director of the Center for Rehabilitation of Pain Syndromes at the University of California, Los Angeles, made his remarks in a lecture directed at physicians, surgeons, anesthesiologists, pain specialists, neurologists, and any physician who prescribes or uses compounded medications."

Neurology Reviews
Compounding Medications / Medicines
Compounding Pharmacies / Apothecaries
The information contained on this web site has been included for general informational purposes only and no person should make any medical decision in reliance upon the information contained herein.
All information contained in this web site is obtained from sources believed to be accurate and reliable. While all information presented is believed to be accurate and reliable, it is prepared "without audit." Due to the possibility of human or mechanical error as well as other factors, this information is provided "as is" without warranty of any kind and makes no representation, express or implied, as to the accuracy, reliability, completeness, or timeliness of this information, and is not responsible for any loss or damages incurred by parties using this information.
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