Are FDA Approved Bioidentical Hormones Better Than Compounded Hormones? by MAGNOLIA on APRIL 1, 2013

Recently, while searching around on the Internet for a list of FDA approved bioidentical hormones for one of my readers, I ran across an article at The Huffington Post written by a fellow women’s health writer and advocate, Staness Jonekos, entitled “10 Hormone Therapy Facts that Every Woman Should Know.“

I have had the good pleasure of meeting Staness during a short trip to NYC last fall.  I’ve also had an online relationship with her for a few years now.  She is a sweet and wonderful woman who, like me, is very passionate about women’s health issues. So when I ran across her article I naturally stopped to read it.

It was a good article, written and published in 2010, with some well researched information on hormone replacement therapy.  Much of what Staness had to say I agreed with.  However, there was some of it I did not.  But, it was the comments in response to the article which I actually found to be the most compelling. Not only were they impassioned, but some were just downright hostile.

So what was it exactly in Staness’ article which set off such a comment section firestorm?  She challenged the credibility of Suzanne Somers’ work, and the safety of compounded bioidentical hormones based on her negative personal experience with them. According to her article, compounded bioidentical hormones are not FDA regulated, therefore they are unsafe and shouldn’t be taken.

She also quoted several “reputable” medical organizations like NAMS (The North American Menopause Society) and The Endocrine Society to bolster her position.

Now look, I’m not a Suzanne Somers devotee.  Truth be told, I’ve never even read any of her books.  So I’m not going to jump to her defense.  I’m also not going to call into question Staness’ personalexperience with compounded bioidentical hormones.  I believe Staness (and every woman) owns the copyrights to her personal experience, and I’m not going to tell her it is false.

What I have a problem with, however, is what I always have a problem with.  Statements which draw hard lines and which also presume to own all of the science and facts to back-up a specific position.  This attitude, which pervaded most of Staness’ article, seemed to be what upset so many people, several of them medical professionals and physicians themselves. If you would like to read the article yourself, you can find it here.

Here’s A “Fact” for You

There are equally credible, competent, and highly educated physicians and medical professionals on both sides of every medical debate. Why do you think they’re called “debates?”  For every medical study that is used to support a particular medical position, there is another medical study which can be used to support an opposite position.

So while I respect the science and medical facts that Staness used to make her case, I have to disagree with her over-arching point, that unless something is FDA approved, it is not safe and therefore should not be taken.

Critics of compounded bioidentical hormones and alternative remedies for perimenopause symptoms, often point to the fact that they are not FDA approved or regulated, which is true – sort of. Most bioidentical hormones are not FDA approved, and therefore, are not regulated by a federal government regulatory agency.

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Hospira recalls sodium chloride after copper particles found April 1, 2013 | By Eric Palmer

Hospira has issued another recall, at least its fourth this year, as it continues to struggle to meet FDA expectations at its key sterile injectables plant. The plant has been an ongoing source of disappointment for the company, even as problems there and at other plants have been a gift to competitors who are boosting sales of products that Hospira has had trouble getting to market.
Hospira ($HSP) said in an FDA MedWatch that copper particles were found in a 1000-mL flexible container of its 0.9% sodium chloride injection, a product used as a source of water and electrolytes. Tests found that the particles contained copper, zinc and lead. Hospira warned that the particles might clog small blood vessels or potentially cause copper toxicity. It said it is looking for the root cause of the copper contamination.  
The company asked providers to quarantine any of a specific lot of the sodium chloride, which was distributed to pharmacies and distributors between January and March. That would have been during the time that FDA inspectors were crawling over Hospira's Rocky Mount, NC, plant during a re-inspection that the company had hoped would demonstrate it was making sufficient progress to further ramp up production. Instead, inspectors left behind a 21-page Form 483, detailing 20 places where manufacturing continued to fall short.


Read more: Hospira recalls sodium chloride after copper particles found - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/hospira-recalls-sodium-chloride-after-copper-particles-found/2013-04-01#ixzz2PLEEBBcX
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Compounding Medications for Pain Management

By Harbor Compounding, CEO

Posted April 02, 2013, at 11:15 a.m.

More and more patients today are turning back to compound pharmacies to create customized pain medications. There are several reasons for this reemergence of compound pharmacies, but the major reason why so many people are turning to these types of pharmacies to get their pain medications is because they are able to create medications that are easier for the patient to take.

What are Compound Pharmacies?

Compound pharmacies are pharmacies that prepare customized medications for patients. This was the original type of pharmacy, where a trained pharmacist tailored customized medications for specific patients based on their needs. Most of the pharmacies that are found on street corners in today’s world are not compounding pharmacies. The typical sterile pharmacy of today is mainly just a dispensary of pre-prepared medications. However, due to the fact that customized medications may be better for specific patients, especially those with specific medical conditions or allergies to certain medications, the compound pharmacy is making a comeback.Compounding pharmacy can be especially useful for creating patient specific compounded pain medications to help manage pain.

Why Choose a Compound Pharmacy?

Modern advancements in science and technology have allowed compound pharmacists to solve complex medical problems. Compound pharmacists work closely with the patient’s doctor to specifically tailor a medication for the patient’s individual needs and problems. The results can be more effective medications with fewer side effects. This is especially true of medications that are designed to help patient’s manage pain. For starters, a compound pharmacist may be able to produce a pain medication that is available in a different dosage than what can be found on the shelf. Pain medications can vary in their effectiveness according to their dosage, but higher dosages also tend to have more unwanted side effects. Some patient’s would benefit from a smaller dosage of Sterile Medication, but most ‘on the shelf’ medications for pain come in only 1 or 2 dosages. A compound pharmacist however can specifically create a pain medication based on any dosage that a doctor recommends. This can help eliminate over-dosage and the side effects that may be associated with over-dosage.

More reasons to choose a Compound Pharmacy

Compounded pain medications typically come in either capsule or tablet form. Taking a pain medication in pill form can sometimes irritate the patient’s stomach. They can also be difficult for some patient’s to swallow. A compound pharmacist can create Effective pain management in other forms to make it easier for the patient to take them. This can include suppositories, liquid medications, topical creams, vaginal creams, oral gels, lozenges, mini and regular troches and injectable medications. In addition, many compound pharmacies can find chemical compounds for pain medications that cannot be found anywhere else. Major drug producing companies don’t spend money developing medications that are not in high demand, but if a patient requires one of these lesser known Pharmaceutical compounding medications a compound pharmacist can create it for them. They can even help make the process of taking pain management easier by altering their taste and they can create medications for patients with specific allergy considerations.

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Question of the Day: 4/2/2013 Are FDA and State Inspectors Knowledgeable Enough and Consistent Enough Throughout the Nation to Inspect Compounding Pharmacies?

By consistent I mean at the FDA it appears that perhaps each district office is inspecting and writing compounding pharmacies up in an inconsistent manner.  For example, while a pharmacy in Oklahoma might be violating the rules and regulations in the same manner as a pharmacy in South Carolina, the one in South Carolina gets cited for the violation while the one in Oklahoma does not.   Do the inspectors have a clear understanding of all the issues they should be looking for at each compounding pharmacy?  Did they all receive the same training?

Compounder’s Recall Reignites Congressional Criticism of FDA

Drug GMP Report

April 2013 

 

A recent recall by a New Jersey-based specialty pharmacy has reignited congressional criticism that the FDA is not doing enough to protect the public from contaminated compounded drugs.

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SPAARx Issues Industry Letter to Inform Legislators and FDA About the Dissimilarity of Specialty Pharmacy vs. Compounding

FLORHAM PARK, NJ, Apr 02, 2013 (Marketwired via COMTEX) -- The Specialty Pharmacy Association of America (SPAARx), the largest national association representing the broad interests of the specialty pharmacy industry, today announced that it is launching a national advocacy initiative focused on pending federal and state legislation and regulation through agencies including the United States Food and Drug Administration (FDA) related to Compounding. The Association believes that a clear understanding of the differentiation between specialty pharmacy and compounding is critical to avoid unintended consequences.

Numerous media reports over recent weeks, including lead articles by The New York Times, The Wall Street Journal, The Boston Globe, The Washington Post, and others, have used the terms 'Specialty Pharmacy' and 'Compounding' interchangeably, which is inaccurate, misleading to the public and to legislators and regulators as they consider actions that could affect pharmacies that create compounded drugs, but specialty pharmacies as well.

In response, SPAARx is sending a letter to appropriate House and Senate Committees, the FDA Commissioner, and state legislators, that differentiates specialty pharmacy from compounding to help inform decision making. The Association supports the accreditation of compounding pharmacies by nationally recognized agencies with the necessary expertise to assess and confirm ongoing compliance with the highest standards for quality compounding. Most importantly, the Association wishes to inform the public that services provided by compounding pharmacies are poles apart from those services provided by specialty pharmacies.

"SPAARx believes that specialty pharmacy and the art and science of extemporaneous compounding are dissimilar," said Bill Sullivan, Interim Executive Director of the Specialty Pharmacy Association of America. Sullivan continued, "Specialty pharmacies dispense FDA approved and commercially available medications requiring patient-specific prescriptions. By comparison, compounding-only pharmacies prepare medications from FDA approved chemical ingredients and commercially available medications which may not require a patient-specific prescription at the time of formulation. New laws and / or regulations should take into account these significant dissimilarities and focus such actions on compounding as appropriate."

Earlier this year the Specialty Pharmacy Association of America endorsed a comprehensive Definition of Specialty Pharmacy in which no mention is made of the practice of compounding. The definition may be downloaded at: http://www.spaarx.org/documents/SPAARx Specialty Pharmacy - Definition.doc

About Specialty Pharmacy Association of America (SPAARx) SPAARx is the largest national Association solely dedicated to the interests of all individuals in the specialty pharmacy segment of healthcare. SPAARx is managed and governed by a board of directors comprised of executives from a diverse group of specialty pharmacies. This association is vendor-neutral and fully-aligned with the interests of all industry stakeholders. SPAARx is setting the standards, leading in advocacy and promoting the value of specialty pharmacy. The association's goal is to protect and promote common industry interests along with fostering professional growth within specialty pharmacy. To learn more about SPAARX or join today, please visit www.spaarx.org\

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Question of the Day: 4/1/2013 In increasing regulations and inspections to rein in bad compounders how do we keep from running off the good compounders who are so essential in both human and animal medicine?

ASHP Continues Efforts to Address Pharmacy Compounding

4/1/2013

The outbreak of meningitis caused by contaminated methylprednisolone acetate compounded by the New England Compounding Center last fall put the spotlight on sterile products outsourcing. In the aftermath of the incident, ASHP has workedwith policymakers, practitioners, and nationally recognized experts in compounding and manufacturing to develop new approaches to protect patients from preventable harm, and to give practitioners and organizations confidence that compounding outsourcers are appropriately regulated and inspected, and that the products they produce are safe.

Working with Experts

In February, ASHP partnered with The Pew Charitable Trusts, and the American Hospital Association to hold a Summit that explored the scope of pharmacy sterile compounding and the associated risk factors, the differences between sterile production expectations under Current Good Manufacturing Practices and United States Pharmacopeia <Chapter 797>, and oversight roles for states and the federal government. Recommendations from the Summit will be released in April.

 

Educating PolicymakersASHP has worked to educate policymakers and others about what distinguishes patient-care driven hospital and health-system based IV admixture services from commercial sterile compounding outsourcing.  ASHP has also advocated to preserve the important role that credible compounding outsourcers’ play to help supply hospitals and health systems with sterile products that are in short supply, customized dosage forms, high-risk level sterile preparations, and repackaged medications from FDA-approved products.

 

The Society has urged the Food and Drug Administration (FDA) to requirecompounding service providers that operate at the scale and scope of manufacturers to register with the agency, share details about their operations, and submit to routine inspections. Current discussions center on the FDA oversight of a “third category” of vendors—companies that prepare sterile preparations without patient-specific prescriptions and ship them across state lines. FDA is exploring what criteria must be met for these entities to be under the FDA's jurisdiction versus traditional state pharmacy scope of practice laws.

 

ASHP continues to work with Congress on strategies to address the regulatory gaps with respect to sterile preparations that are mass produced and often shipped to customers across state lines.  Much of the discussion thus far has focused on the third category of vendors and how broadly the category needs to be defined. Further, discussion has focused on ensuring there are no unintended consequences that would enable a large sterile preparation entity to bypass the New Drug Application and Abbreviated New Drug Application requirements set forth for manufacturers.

 

The Society is also collaborating with state affiliates to monitor activity in state legislatures and boards of pharmacy. California, Maryland, Massachusetts, New Jersey, South Carolina, Tennessee, and Virginia are among the numerous states taking action on compounding.

 

To support ASHP's continued advocacy efforts, a member survey is being conducted to gain information on sterile compounding and the use of outsourcing vendors by health systems.

Resources for Members

ASHP continues to provide members with up-to-date information on the compounding issue, including timely notification of compounded product recalls via the online Sterile Compounding Resource Center, news capsules, and ASHP Connect. The Society is also continuing its efforts to address drug shortages, which may play a role in the decision to obtain products from an outsourcing supplier. The Society continues to work closely with officials in the FDA’s Drug Shortages Program to help assess the situation and provide perspectives on the impact of shortages on patients and providers.

Read More• Experts Seek Strategies to Ensure Quality in Sterile Compounding• ASHP Makes Recommendations on Oversight of Pharmacy Compounding• ASHP Testifies to Senate Committee on Compounding• ASHP Provides Tools for Members to Deal with Aftermath of Compounding Incident

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Clark v. New England Compounding Pharmacy, Inc. et al

Clark v. New England Compounding Pharmacy, Inc. et al

Regulators scrutinize compounding pharmacies in Tennessee, nation (with video) by Kate Harrison

Compounding pharmacies see renewed attention after meningitis outbreak

Chattanooga-area compounding pharmacies have seen renewed attention from both customers and the Tennessee Legislature after a deadly meningitis outbreak that stemmed from a Massachusetts pharmacy. Access Family Pharmacy, which fills about 60 compounding prescriptions per day, has specialized in compounding prescriptions since 1962.

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Compounding pharmacies long have been able to fill the gap between mass-produced drugs and highly personal medical needs.

These pharmacies can customize a drug product into a liquid or a gas for patients who can't swallow pills. They can make a medication without specific allergens. They can flavor a medicine with mint or tropical fruit to be more palatable. And they can compound drugs that are on back order -- such as Tamiflu for children.

"Maybe [the patient] can't take something that's commercially made because it's one-size-fits all. Or it's something that's not commercially made and they've got to have it," explains pharmacist Phil Smith at Access Pharmacy, which has been compounding drugs in the Hixson store for more than 50 years.

But over the last few months, state and federal officials have said the gap that compounding pharmacies have filled has been far too unregulated, leading to abuse by certain pharmacies.

"It has been a crazy few months for compounding," said Smith. "We have been letting our customers know that our chemicals are tested, our manufacturers are FDA tested and approved. Things like that let people know what our quality standards are."

A deadly meningitis outbreak prompted heightened scrutiny from both state and federal regulators. Just last month, there were two more recalls of sterile compounded and repackaged drug products, first from a New Jersey compounding pharmacy after fungal contamination was found at a hospital. Days later, a compounding pharmacy in Martinez, Ga., recalled syringes of the drug Avastin after it received reports of eye infections among patients.

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