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Pharmacy Compounding: A critical and valuable healthcare practice

Millions of patients have unique health needs that off-the-shelf, prescription medicines cannot meet. They rely on customized medicines – prescribed or ordered by licensed physicians and mixed safely by trained, licensed compounding pharmacists – to treat their unique conditions.

Compounded prescriptions are ideal for any patient requiring unique dosages and/or delivery devices. Examples include, but are not limited to bio-identical hormone replacement therapy (BHRT), infertility, wound therapy, hospice, chronic pain management, sports medicine, and gastroenterology.

With a physician’s consent, a compounding pharmacist can change the strength of a medication, alter its form to make it easier for the patient to ingest, or add flavor to make it more palatable. The pharmacist also can prepare the medication using several unique delivery systems, such as a sublingual troche or lozenge, a lollipop, or a transdermal gel or cream that can be absorbed through the skin. For those patients who are having a hard time swallowing a capsule, a compounding pharmacist can make a liquid suspension instead.

Compounding methods offer women a long-awaited choice in individualized, bio-identical hormone replacement therapy that, from the consumer’s viewpoint, has its place along side mass-produced, one-size-fits-all synthetic hormones.

Doctors who use compounding pharmacists do so because they want to be able to adjust dosage, particularly estrogen replacement therapy, so as to administer as little as absolutely necessary to address symptoms, which just isn’t possible with the one-size-fits-all treatments offered by drug companies.

Back to basics

In the days before giant pharmaceutical companies began to patent and peddle their products en masse, each and every pharmacist was a custom compounding pharmacist.

Physicians would instruct their local pharmacist to formulate (tailor make) a particular medication required in the treatment of their patients’ specific needs.

In the 1930s and 1940s, approximately 60 percent of all medications were compounded. With the advent of drug manufacturing in the 1950s and ‘60s, compounding rapidly declined. The pharmacist’s role as a preparer of medications quickly changed to that of a dispenser of manufactured dosage forms

Compounding pharmacists have the freedom to work with therapeutic drugs, scripts, scheduled poisons and natural herbs. They are licensed to tailor drugs to the needs of the individual.

Within the last two decades, compounding has experienced a resurgence as modern technology and innovative techniques and research have allowed more pharmacists to customize medications to meet specific patient needs.

Compounding pharmacists provide:

• a choice of individualized BHRT or synthetic HRT treatment protocols, in adherence to a doctor’s prescription
• a referral service for women looking for a GP prescribing BHRT in their area
• medication advice to patients and their physicians
• advise on health insurance reimbursement process

Near monopoly isn’t good enough

Not surprisingly, as custom-mixed hormones grow in popularity, drug makers like Wyeth, the biggest seller of prescription hormones, have petitioned the Food and Drug Administration (FDA) to investigate the sale and marketing of these compounded bio-identical hormones, calling to impose far-reaching restrictions on physicians’ ability to prescribe and pharmacists’ ability to prepare and dispense bio-identical hormones.

According to L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP), “Pharmacy compounding is performed by responsible, trained professionals who have strong relationships with their patients and their patients’ physicians. The successful practice of pharmacy compounding is predicated on full, open and honest communication between these three groups of people.”

In response to Wyeth’s Citizen Petition filed with the FDA October 2005 (Docket: 2005P-0411 - Seeking FDA Actions to counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs that Endanger Public Health), the IACP filed these salient points in their comments to the FDA :

• millions of Americans have unique health needs that off-the-shelf, prescription medicines cannot meet;
• compounding pharmacies operate within the physician/patient/pharmacy triad – no prescription is compounded and provided to patients without receipt of a prescription from the patient’s physician;
• BHRT preparations are compounded based on the needs of the individual, not mass-produced like Wyeth’s products;
• compounded BHRTs are not the same as Wyeth’s HRTs;
• compounding pharmacies have the right to advertise their ability to compound BHRT preparations and distribute educational materials;
• compounding pharmacist are not required to obtain FDA approval prior to compounding individualized prescriptions for BHRT products;
• the Women’s Health Initiative (WHI) cut short in 2002 did not determine BHRT carries the same risk as Wyeth’s products because it did not study BHRT;
• compounding pharmacists are health care professionals, not members of an “industry”;
• pharmacists that compound drugs upon receipt of prescriptions are not, by definition, manufacturers, packers, nor distributors of drugs;
• in order to meet the unique needs of a patient, compounding pharmacists cannot be expected to comply with current good manufacturing practices imposed on drug manufacturers;
• compounded drugs dispensed to patients are exempt from the requirement that they contain “adequate directions for use”;
• organizations that have filed in support of Wyeth’s petition are not independent but have financial links to Wyeth, and include:

• Society for Women’s Health Research
• Jacob’s Institute for Women’s Health
• American Medical Women’s Association
• National Association of Nurse Practitioners in Women’s Health
• National Black Women’s Health Project
• The American Society of Reproductive Medicine
• The North American Menopause Society

Leading the way

Professional Compounding Centers of America (PCCA) incorporating America, Canada and Australia are helping grow awareness of compounding at all levels of the healthcare system, providing relevant training and technical support to pharmacists and their staff, assisting pharmacists with meeting patient and doctor needs, while providing quality galenicals, equipment and devices to pharmacists.

PCCA has operated in the USA since 1981 and has more than 3500 members around the world in the USA, Europe, Canada, Brazil, Asia, Australia and New Zealand.

Their accredited training and education programs include clinical case presentations, pathology investigations and metabolic assessment, result interpretation, nutritional treatment protocols, and facilitating a forum for interaction and networking amongst peers.

PCCA’s Events Calendar for February 2006 include a ‘BHRT for Female Patients Symposium’ to be held in Birmingham, Alabama and a ‘Functional Endocrinology Symposium’ in Portland, Oregon.

And this coming July, an International Hormone Conference is to be held in Surfers Paradise, Queensland, Australia bringing together leading experts in Bio-identical Hormone Replacement Therapy (BHRT). Proudly presented by Professional Compounding Chemists of Australia and ARL Pathology, the conference objective is to provide delegates with the latest scientific research, clinical management and treatment protocols, and a thorough understanding of hormone biochemistry.

Take action to SAVE BHRT today!

If you need more convincing (on why you ought not to trust Wyeth to keep your best interests high on their agenda), I strongly urge you to get yourself a copy of Barbara Seaman’s confronting publication ‘The Greatest Experiment Ever Performed on Women: Exploding The Estrogen Myth’.

Not only will the book’s content blow your mind - particularly if you feel you have been treated like a “lab rat” - but you get a real sense of just how ‘crooked’ Wyeth’s dealings have been in the past.

This is not the first time that Wyeth has tried to use the government to protect its business and profits and to deny women access to hormone therapies they need. Years ago, Wyeth fought successfully to get FDA to block generic forms of its Premarin from entering the U.S. market. These generic versions would have slashed the cost to women of this off-the-shelf therapy. Then as now, Wyeth used its money and muscle to argue that the competitive offerings were not safe, and they succeeded in keeping them off the market. That has meant more money for Wyeth, and higher costs for women who rely on their off-the-shelf synthetic hormone treatment.

Ms Seaman poses the question: is the pharmaceutical industry itself driving the research, marketing, and use of hormone replacement therapy? Wyeth’s petition to the FDA to restrict access to valuable treatment provided by compounding pharmacists in the USA would suggest as much.

IACP is working aggressively to fight this repeat of commercial exploitation and preserve the pharmacists’ right to prepare, the patients’ right to take, and their doctors’ right to prescribe bio-identical hormones.

We need your help to stop this madness.

Catherine P. Rollins
Director, Making Plans Pty Ltd
www.natural-progesterone-advisory-network.com