In this fact sheet, Dr. Allen gives us 13 reasons why compounding is important. To read this imformative Com poundingTodayarticle, explaining why compounding is essential here
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Showing posts with label Loyd V. Allen. Show all posts
Showing posts with label Loyd V. Allen. Show all posts
Wednesday, April 10, 2013
Tuesday, February 12, 2013
Allen's Guidelines for Compounding Practices Contain Excellent Discussion on Stability, Expiration and Beyond Use-Date for Compounded Medications
Guidelines for Compounding Practices - chapter from The Art, Science, and Technology of Pharmaceutical Compounding, 4th edition (Washington, DC: American Pharmacists Association; 2012), author, Loyd V. Allen Jr. contains an excellent discussion of stability, expiration and beyond use-date. This article is reprint on the American Pharmacist's Association Website found here
Tuesday, November 20, 2012
Oklahoma Compounding Pharmacy Laws Some of Strictest in NPeople, Not Compounding, Real Issue Behind Meningitis Outbreak ation;
By L.L.
Woodard | Yahoo! Contributor Network – 15 hrs ago
Why Do We Have Compounding Pharmacies?
Allen explains though that as the big pharmaceutical companies grew and merged, there were some drugs still needed but no longer manufactured. Couple that with the growing number of medications for which there is a shortage each year, and you can see the continued need for compounding pharmacies.
Fungal Meningitis Outbreak 2012 Victim Count Continues to Rise
Oklahoma is not one of the 19 states that received shipments of NECC's tainted drug to its outpatient facilities. Meanwhile, in states such as Michigan, Tennessee, Virginia and Florida, nearly 14,000 people exposed to potentially tainted spinal and joint injections wait and watch for symptoms that may or may not develop.
Jerrod Roberts, owner of
Flourish Integrative Pharmacy, wants people to know that it is not the science
of compounding that is behind the current U.S. meningitis outbreak, but some of the
people working in the industry who are not following protocol, such as at the
New England Compounding
Center, NECC, at the center of the outbreak,
reported NewsOK.com .
Oklahoma Protects the Public with Strict Regulations for
Pharmacies
Loyd Allen, editor-in-chief of the
International Journal of Pharmaceutical Compounding headquartered in Edmond,
Okla., and a pharmacist of 50 years duration, has been active in helping the
state's legislators develop policy and regulations for pharmacies over the
years. Regulations have been in place for 40 years requiring pharmacists
practicing in Oklahoma to take continuing education
classes in order to renew their licenses, long before most other states put the
mandate into practice.
Air quality must be monitored in the
state's compounding
pharmacies, and monitor specific parts of a facility for microorganisms.
Allen explained to NewsOK.com that all the regulations would mean nothing if
there weren't inspectors to monitor facilities' adherence to the standards.
Allen also told the news source that had the U.S. Food and Drug Administration
had closed the NECC in 2006 when poor adherence to sanitation standards was
present, the current fungal meningitis outbreak would have been
averted.
Why Do We Have Compounding Pharmacies?
In the 18th and 19th centuries, all
pharmacies were compounding pharmacies; there were no pharmaceutical
manufacturers. But as the population grew and the demand for prescription
medications increased, pharmaceutical companies emerged and grew,
reducing the need for the corner druggist to compound all his customer's
prescription drugs.
Allen explains though that as the big pharmaceutical companies grew and merged, there were some drugs still needed but no longer manufactured. Couple that with the growing number of medications for which there is a shortage each year, and you can see the continued need for compounding pharmacies.
A compounding pharmacy is regulated to
manufacture, package and distribute medications prescribed by a physician for a
particular patient. What NECC was doing, in addition to having unsanitary
conditions, was manufacturing and distributing medications in mass quantities,
overriding its licensure requirements.
Fungal Meningitis Outbreak 2012 Victim Count Continues to Rise
Oklahoma is not one of the 19 states that received shipments of NECC's tainted drug to its outpatient facilities. Meanwhile, in states such as Michigan, Tennessee, Virginia and Florida, nearly 14,000 people exposed to potentially tainted spinal and joint injections wait and watch for symptoms that may or may not develop.
The case
count for fungal meningitis is now 490, with 34 resultant deaths and 11
cases of peripheral joint infection.
A number of people who have developed the
fungal infection are considering, or have already filed lawsuits, according to
PRweb . Congress continues to delve into exactly how this
public health disaster occurred and the FDA has asked for additional regulations
to increase its authority over compounding pharmacies nationally.
Smack
dab in the middle of the baby boomer generation, L.L. Woodard is a proud
resident of "The Red Man" state. With what he hopes is an everyman's view of
life's concerns both in his state and throughout the nation, Woodard presents
facts and opinions based on common-sense solutions.
Source found here
Tuesday, October 30, 2012
Dr. Allen, Expert on Compounding, Points Out Misrepresentations by the Press
Here is part of Dr. Allen's Editorial that appears in the Compounding Today Newletter:
Editorial: Misrepresentations by the Press
Those keeping up with the events in Massachusetts have no doubt read many accounts of the events and the answers to questions posed to pharmacy leadership by the press. Most reporters have very little, if any, knowledge of pharmacy compounding and are either unaware or seemingly don't care if they are not accurate and complete in their reporting.
A specific comment I would like to address is that some reports have misquoted statements that say that compounders want lower standards. This is absolutely false! Pharmacists, pharmacy compounding leadership, and company CEOs involved in providing support to compounding pharmacies want strong quality standards, and they work hard for strong quality standards.
What many reporters do not understand is that there is a difference in Good Manufacturing Practices (GMPs) that are required for FDA-registered manufacturers and the legal standards for compounding developed by the United States Pharmacopeia (USP) and the state boards of pharmacy. USP standards are enforceable by both the FDA and the state boards of pharmacy.
To continue reading this editorial click here
Friday, October 19, 2012
Dr. Allen Suggest that there is no Need for New Laws And Regulations: We Just Need to Enforce the Laws and Regulations We Already Have
Loyd V. Allen, Jr., PhD, RPh, Editor-in-Chief of the International Journal of Pharmaceutical Compounding in his weekly new letter on Compounding makes some excellent points in his editorial. Here is part of this editorial:
Many in the public are "knee-jerking" and saying that "something must be done"! However, the bottom line is that pharmacists must obey the laws and regulations, and meet the required standards for whatever practice of pharmacy in which they are involved. If this happens, then the public is protected and the pharmacist has a successful practice in serving their patients.
No matter what laws, regulations, and standards are in place, if they are not followed, the public is put at risk, and death and sickness may result! It is important to let the public know that the majority of pharmacists adhere to the laws, regulations, and standards and we have the safest medication supply in the world. However, those that enforce the law may need to do a better job. I don't believe we really need any new laws or regulations, but we need better enforcement of those we already have; we also need reasonable clarification on differentiating compounding from manufacturing (i.e., when does a compounding facility become a manufacturing facility?).
Sunday, September 2, 2012
PowerPoint on Contemportary Pharmaceutical Compounding from Dr. Loyd Allen
Here is a PowerPoint Presentation entitled Contemporary Pharmaceutical Compounding from a well-respected expert in the field Dr. Loyd Allen. To view the PowerPoint can be viewed here.
Saturday, August 18, 2012
Dr. Loyd Allen's Editorial on Reimbursement Discrimination
In the current issue of Compounding Today, Dr. Loyd Allen makes some excellent points about reimbursement discrimination when it comes to FDA approved drugs versus compounded drugs. For example, Dr. Allen states:
To read the rest of Dr. Allen's comments click here.
They will pay for compounded medications when the patient is in the hospital (intravenous admixtures, TPN solutions, oncology cocktails, etc.) but will not pay for medications from an independent pharmacy for the same patient. To make things even more conflicting, in some cases it is the same independent pharmacies that are preparing the medications for the hospitals due to drug shortages, etc.
Tuesday, July 31, 2012
APhA Publishes Fourth Edition of The Art, Science and Technology of Pharmaceutical Compounding
July 25, 2012
WASHINGTON, DC – The American Pharmacists Association (APhA) recently published the fourth edition of the leading textbook on pharmaceutical compounding, The Art, Science and Technology of Pharmaceutical Compounding.
The book is geared to both student pharmacists taking laboratory classes and practicing pharmacists. In a logical and progressive format, it presents all the information a student needs to understand the purpose and processes of compounding. It includes the essential information on establishing, equipping and operating a compounding pharmacy. It discusses all aspects of good manufacturing practices for compounded medications and it features quality control measures for all aspects of compounding.
For practitioners who already compound prescription medications, the hardbound book is a ready reference featuring more than 200 sample formulations, including bases, vehicles and ingredient-specific preparations. Each formulation lists the necessary ingredients and gives step-by-step instructions for preparing the product. A new chapter emphasizes the importance of knowing the purity and form of all ingredients to ensure that the proper dose of a compounded product is delivered.
The book is authored by Loyd V. Allen Jr., PhD, Editor in Chief of the International Journal of Pharmaceutical Compounding, Edmond, OK, and Professor Emeritus at the College of Pharmacy, University of Oklahoma, Oklahoma City. Allen has written more than 200 refereed publications and abstracts in the scientific and professional literature. He is a principal author of Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems and he has written a monthly compounding column since 1988 for the trade journal U.S. Pharmacist.
To read remainder of news article and for information on ordering click here.
Friday, May 18, 2012
Why We Need and Must Have Compounded Medications
In the wake of the tragic deaths in Franck's (Florida), Apothecure (Texas) and Meds IV (Alabama), it is important to not lose sight of the fact that we need and must have compounded medications. If these medications were not available, some patients (both humans and animals) would suffer and some could die. This was explained by Loyd V. Allen, Jr., Ph.D., R.Ph., Editor-in-Chief, International Journal of Pharmaceutical Compounding, when he testified on April 19, 2007, before the U.S. Senate Special Committee on Aging in Washington, DC. During his testimony he explained:
Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For many of them a customized, compounded medication prescribed by licensed physicians or veterinarians and mixed by trained, licensed compounding pharmacists are the only way to better health. If customized medicines were not available, some of our most at-risk patients would needlessly suffer and some would die.
Allen also gave excellent examples of those who rely on compounded medications:
• Infants and children: Compounding pharmacists can transform medicines fromThese are important examples of why we need and must have compounded medications in the United States. The problems in the tragic cases do not suggested that the practice of compounded medications must be stopped; instead, the tragedies shows that the rules and regulations relating to compounding need to be complied with by pharmacies, doctors, veterinarians and enforced by state boards of pharmacy, state boards of medicine, state veterinary boards and the United States Food and Drug Administration. To read the entire transcript of Dr. Allen's testimony, click here.
hard-to-swallow pills intended for adults into syrups, elixirs, suspensions, and
emulsions for children, at the request of physicians. Flavors offered by
compounding pharmacists can make drugs more palatable to children. In
addition, premature infants often rely on lifesaving and life-sustaining drugs made
only in compounding pharmacies.
• Hospital patients: Many, if not most, of the lifesaving intravenous drugs given in
hospitals and clinics are compounded. Because hospital patients are often on
multiple medications, compounding them into one treatment saves the hospital
personnel time and the patient multiple injections or administrations.
• Cancer patients: Cancer treatment often involves special mixtures of cancer drugs
that are compounded pursuant to a doctor’s prescription. Pharmacists can
combine multiple drugs into one treatment, leading to shorter administration times
for cancer patients.
• Senior citizens: Elderly patients often have difficulty with traditional dosage
forms, such as pills taken orally. Compounding pharmacists create alternate
methods of delivery, like transdermal gels, to make it easier for the elderly to take
their medicine.
• Pets: Animals come in all shapes and sizes, so one-size-fits-all pharmaceuticals do
not always meet their needs. In many cases, a compounded medication may be
necessary for a non-food animal to be satisfactorily treated.
• Patients with allergies: Patients who are allergic to a preservative, dye, flavor or
other ingredient in commercial products can have their doctor write a prescription
for a compounding pharmacist to customize the same medication without the
offending ingredient.
• Menopausal women: Many women experience significant pain and discomfort as
their bodies’ progress through menopause. Doctors prescribe bioidentical
hormones for patients for whom synthetic hormone treatments may be ineffective
or produce undesired side effects. Several bioidentical hormone products are
available in FDA-approved, one-size-fits-all formulations from pharmaceutical
companies. However, physicians may determine that their patients have unique
needs that warrant prescribing a different compounded hormone treatment. This
often allows patients to take the smallest amount of a given hormone preparation
to treat their symptoms, in conjunction with the recommendation provided by the
Women’s Health Initiative study.
• Patients who require non-traditional dosage forms: Many patients are unable to
take medications orally or as injections – the traditional dosage forms for
manufactured drugs. Compounding pharmacists can create alternate methods of
delivery, like ointments, solutions or suppositories, to fit these patients’ unique
health needs. The pharmaceutical industry supplies only limited strengths of
drugs, which some patients cannot tolerate. It is often necessary for a doctor to
request a different strength of a drug for a patient through compounding.
• Patients who rely on discontinued drugs: Pharmaceutical manufacturers have
discontinued thousands of drug products over the years, due to low profitability.
For certain groups of patients, these were very effective, important, and
sometimes life-saving medications. Such medications are now only available if a
doctor prescribes them to be compounded.
• Hospice patients: End-of-life therapy involves the compounding of many different
and unique dosage forms to allow patients to live out their lives free of pain and
discomfort. Many combinations of drugs are prescribed by doctors and used for
these patients who cannot swallow medications and who don’t have the muscle
mass that is required to receive multiple injections each day. Compounding
pharmacists can provide alternate delivery methods such as oral inhalation, nasal
administration, topical, transdermal or rectal use.
Monday, April 16, 2012
Declarations Filed in Franck's district court proceeding
In the appeal to the 11th Circuit in the Franck's case, the court, pursuant to the federal appellate rules, is normally only allowed to consider what was part of the record in the district court. In other words, the appellate court cannot consider evidence or information that was not presented in the district court. In the district court, the parties filed a number of declarations or sworn statements by various individuals, including the following:
Declaration of Loyd V. Allen, Jr.
Declaration of Gigi S. Davidson
Declaration of William T. Flynn
Declaration of Paul W. Franck
Supplemental Declaration of Paul W. Franck
Declaration of Rick Pelphrey
Declaration of Kenneth Pettengill
Declaration of James B. Powers
Declaration of Dr. Robert C. Saunders
Declaration of Emma Singleton
Declaration of Kevin Stoothoff
Because these declarations were all apart of the record in the district court, they are part of the record on appeal and can be considered by the appellate court.
Declaration of Loyd V. Allen, Jr.
Declaration of Gigi S. Davidson
Declaration of William T. Flynn
Declaration of Paul W. Franck
Supplemental Declaration of Paul W. Franck
Declaration of Rick Pelphrey
Declaration of Kenneth Pettengill
Declaration of James B. Powers
Declaration of Dr. Robert C. Saunders
Declaration of Emma Singleton
Declaration of Kevin Stoothoff
Because these declarations were all apart of the record in the district court, they are part of the record on appeal and can be considered by the appellate court.
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