Friday, June 27, 2014

Task Force on Compounding
President Anderson introduced Larry Trissel, R.Ph., Chair of the Task Force on Pharmacy Compounding. President Anderson explained that Mr. Trissel would present the task force report, and the Board would vote on whether to accept the report, but no action would be taken until a later date.
Mr. Trissel directed the Board's attention to the final report of the task force, which included a list of the task force members. (See Attachment #33.) Mr. Trissel recognized task force members Ben Fry, R.Ph., and Pat Downing, R.Ph., who were also present. Mr. Trissel reported that the task force held two meetings, on September 5, 2002, and January 17, 2003. The task force was charged with:
reviewing current federal and state requirements for pharmacy compounding;
reviewing current standards of practice for pharmacy compounding; and
making recommendations to the Board regarding standards for pharmacy compounding in Texas that provide necessary compounded medications while protecting the health, safety, and welfare of the public.
Mr. Trissel directed the Board's attention to the written task force report (See Attachment #33). He then made a brief presentation to the Board that included the following comments:
The task force recognized . . . there could be no doubt that the need for compounding of patient-specific preparations is essential to the proper conduct of modern therapies.
. . . the task force also recognized and agreed that the current Texas pharmacy rules regarding pharmacy compounding have already included some important and necessary safeguards that may not be in place in some other states.
. . . the task force also recognized that the repeated incidents of improperly prepared and contaminated sterile preparations that have injured and killed patients in other states have pointed to a potential problem that could happen in Texas.
Although the task force believed additional quality assurance functions are necessary, there also was recognition that the United States Pharmacopeia (USP), the official drug standards setting body for the United States, is in the process of issuing a comprehensive delineation of the necessary requirements for sterile compounding. . . . specifically designated to set appropriate and necessary quality assurance standards for pharmacy compounding that can be enforced by the state boards of pharmacy.
It was the consensus of the task force that the best approach the Texas State Board of Pharmacy could take for the citizens of Texas is to adopt these USP requirements and enforce them for all categories of pharmacies located in Texas and for Class E pharmacies that send compounded preparations into Texas.
The task force also reached consensus on the need to enhance pharmacists' training and education with regard to compounding and pharmaceutical calculations. To this end, additional continuing education requirements specific to compounding have been recommended. In addition, the task force has suggested that the Texas State Board of Pharmacy formally recommend to appropriate educational associations and institutions that education and training in compounding and pharmaceutical calculations receive greater emphasis (or be reintroduced in some cases) in pharmacy school curriculums providing strengthened and more thorough understanding of the complexities involved.
. . . the task force agreed that the principal distinction of compounded preparations compared to manufactured drug products is the patient-pharmacist-physician relationship that exists in compounding that does not exist in manufacturing. . . . The task force agreed unanimously that any preparation compounded by a pharmacist for a specific patient in response to a valid prescription or medication order was clearly compounding and not manufacturing. . . . there was less agreement on what proportion of a compounding pharmacy's business needs to be patient-specific to qualify as a pharmacy and not be a manufacturer. . . . A suggestion was made by Mr. Peacock to equate obtaining and recording the identities of patients who received pharmacy-compounded preparations administered by practitioners in their practices after the actual administration with conventional patient-specific prescriptions and medication orders for purposes of this determination . . . the majority of the task force members (but not all) agreed to recommend to the Board that a maximum of 5% of all prescription medications dispensed in the previous 12 months be permitted to be non-patient-specific compounded dosage units for an establishment to be considered a pharmacy and not a manufacturer, if the patients' identities could be obtained after the fact of drug administration.

(See Attachment #33 for the complete text of Mr. Trissel's comments.)
President Anderson recognized Karen Tannert, R.Ph., a member of the task force, who was also in the audience.
The Board discussed the recommendations of the task force. Mr. Trissel answered questions posed by the Board. Mr. Downing advised the Board that he did not agree with the 5% restriction. The Board felt that Mr. Peacock's suggestion to obtain patient-specific information was innovative. Ms. Dodson pointed out that any rules the Board passes will have to match federal regulations.
Ms. Tannert advised the Board that the 5% recommendation fell within the limits established by the Food, Drug, and Cosmetic Act.
Following additional discussion, the motion was made by Mr. Caldwell to thank the task force for their efforts and accept the report, as presented. The motion was seconded by Mr. Brimberry and passed unanimously.
The Board directed staff to:
draft rules, based on the recommendations of the task force;
submit the draft of the rules to the task force for review and comments; and
present the suggested rules to the Board at the May 2003 Board Meeting.
Mr. Brimberry advised the Board that he had copies of materials from an NABP meeting in Chicago that compare USP guidelines and FDA rules concerning compounding, if anyone would like to have a copy. Ms. Dodson advised the Board that currently TSBP's rules concerning compounding are more stringent than NABP's recommendations.

Third Question of Day June 26, 2014 If traditional Compounders are only compounding patient specific compounds and following all the rules such as no commercially available that works and outsourcing facilities compounded larger quantities then how much money would traditional compounders make? Is this why traditional Compounders fight so hard to be able to compound for office use? Greed and money? The needs will be met by outsources who are regulated by the FDA so Compounders cannot argue consumers will have to do without the drugs.

Huge list of veterinary and compounded drugs--Enforcement Report - Week of June 25, 2014

Enforcement Report - Week of June 25, 2014

FDA Warns GSK plant

Flulaval is the company’s older flu drug, which has been to some extent superceded by Relenza – but FDA inspectors noted “deviations from current good manufacturing practice (CGMP) requirements” in its production at GSK’s plant in Quebec.

Continue to read here

Numbing medications can harm teething babies, FDA warns Published: June 26, 2014 6:24 PM

Read here

Stability of hydroxyprogesterone caproate alone and in a compounded pharmaceutical product Yang Zhao⇑, Joseph Bettinger, Steve Caritis and Raman Venkataramanan

Here

340B contract pharmacy arrangements

Pharmacy Service Company Settles Whistleblower Suits

By THE ASSOCIATED PRESS

Omnicare agreed to pay $124 million to settle two whistle-blower lawsuits that claimed the company engaged in a kickback scheme with skilled-nursing facilities across the country.

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Drugs in racing: BHA plans zero tolerance policy on steroid use

The British Horseracing Authority (BHA) has announced a new zero tolerance approach to the use of steroids in the sport.

Under the new rules, horses cannot be injected with steroids at any time.

Lengthier bans have also been introduced for horses breaking the rules, from six to 14 months.

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Accused killer wants jury to hear execution details

An accused killer, battling the possibility of death by lethal injection, believes the jury asked to condemn her should be told exactly how she will die; and that the drugs injected into her veins might cause her to writhe and gasp like two men executed earlier this year.

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Buyers Should Be Wary of Sites Claiming to be Legitimate Internet Pharmacies from Other Countries, Consumer Reports Advises

Buying medications online from other countries is dangerous since many websites claiming to be an Internet pharmacy from a particular country are not located in that country and are in fact operating illegally, as reflected in an article from Consumer Reports. “Most Internet pharmacies claiming to be Canadian are not,” Carmen A. Catizone, MS, RPh, DPh, executive director/secretary of NABP toldConsumer Reports. “Frequently, they are fake storefronts selling cheap generics from third world countries.” The article also indicates that even drugs that do come into the US from Canada fall into a “regulatory no-man’s land” that may leave consumers with little recourse if there is a problem with a medication. Instead of purchasing medication through potentially illegal online drug sellers, Consumer Reports suggests patients ask their health care providers about ways to receive discounts on both generic and brand-name medications.

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Stephen Dank suspected of forgery by pharmacist, doctor in Essendon supplements scandal 7.30 By Louise Milligan

Stephen Dank, the sports scientist at the centre of the Essendon supplements saga, has been suspected of forgery by both a pharmacist and a doctor who worked closely with him.
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21 Oklahoma death row inmates sue state over execution protocol Nearly two dozen inmates are suing the state Corrections Department and several of its employees, asking the court to allow them a say in whether or not they can be lethally injected with the same mixture of drugs used in a botched execution in April.

Nearly two dozen inmates are suing the state Corrections Department and several of its employees, asking the court to allow them a say in whether or not they can be lethally injected with the same mixture of drugs used in a botched execution in April.

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Oklahoma death row inmates sue to halt execution

Two months after a botched execution in Oklahoma, 21 death row inmates in the southern US state filed suit against prison authorities on procedures to put convicts to death.

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The standardization of nonsterile compounding: a study in quality control and assessment for hormone compounding.

The standardization of nonsterile compounding: a study in quality control and assessment for hormone compounding.

Int J Pharm Compd. 2014 Mar-Apr;18(2):162-8
Authors: Wiley TS, Odegard RD, Raden J, Haraldsen JT
Abstract
Sterile and nonsterile compounding of medication has attracted much attention over the last few years due to the onset of various infections and negative compounding practices. This paper reports on the standardization of compounded hormones utilizing the Wiley Protocol, which provides nonsynthetic bioidentical estradiol, progesterone, dehydroepiandrosterone, and testosterone in a transdermal topical cream base for women and men in a standardized dosing regimen. Here, we present data from 2008 through 2012, which details the process of standardization and quality testing of the hormones through submission of random compounded samples for quality control and assessment. Pharmacies delivering the Wiley Protocol were required to follow the same compounding formulation, as well as submit random samples for quarterly testing. Sample concentrations were tested using high-performance liquid chromatography. We found that pharmacies that submitted samples had a 91% passing rating with a percent of target of 98.6% +/- 8.4%. It was also determined that pharmacies that prepared more compounded cream had a higher passing rating than those that prepared limited quantities. We found that standardization across multiple pharmacies could be achieved through quarterly testing of submitted samples by a third-party laboratory when following necessary procedures as defined by the Wiley Protocol. It was also determined that experience and training were a critical factor in the mixing of compounded prescriptions, with high consistency and accuracy providing patient safety.

PMID: 24881121 [PubMed - indexed for MEDLINE]

More...

Second Question of Day June 26, 2014. Is Congress going to support the task it gave the FDA to do and provide it with the necessary funding to try to get the runaway, out-of-control compounding pharmacies and pharmacists who care nothing about safety and only about money and who continue to invoke fear in the public claiming they will not have access to the drugs they "want?"

Kentucky oncology practice and its manager plead guilty to purchasing and selling unapproved chemotherapy drugs

Hematology and Oncology Center (HOC) PLLC of Somerset, Kentucky has pleaded guilty to federal charges that the firm purchased and sold unapproved and improperly labeled chemotherapy drugs. HOC’s former office manager, Natarajan Murugesan, also pleaded guilty to assisting with these activities, which are violations of the Federal Food, Drug, and Cosmetic Act. The charges were brought by the U.S. Attorney’s Office for the Eastern District of Kentucky.

Agents from the FDA’s Office of Criminal Investigations led this investigation with assistance from the U.S. Department of Health and Human Services’ Office of Inspector General.

“The FDA commends the U.S. Attorney’s Office, Eastern District of Kentucky, for pursuing these allegations and for helping protect U.S. consumers from potentially receiving counterfeit, ineffective, or contaminated medicines,” said Philip Walsky, acting director of the FDA’s Office of Criminal Investigations. “The FDA is committed to ensuring that consumers have access to high-quality drugs that are safe and effective."

The criminal charges relate to a civil settlement agreed to in January 2014 by HOC, Murugesan, and N Mullai, M.D. Dr. Mullai was not charged criminally. Under the earlier civil settlement, HOC, Murugesan, and Mullai agreed to pay $2,000,000, plus interest, to resolve charges that they violated the False Claims Act. These charges included submitting false claims to the Medicare program for misbranded, unapproved chemotherapy drugs administered through HOC’s Somerset, Kentucky, clinic.

HOC obtained substantial amounts of chemotherapy drugs and other cancer treatment drugs from a foreign drug distributor in Canada operating under the name Quality Specialty Products (QSP). These drugs were obtained from Turkey, India, the European Union, and other international locations.

Often, the drugs arrived at HOC with labels and dosage instructions in foreign languages. In 2012, the FDA sent letters to medical practices, including HOC alerting them that the cancer medicines they purchased from QSP were unapproved and potentially counterfeit.

Quoted from here

Finding the Cause of Thrombosis in Some Immunoglobulin Treatments

More incidents of bad compounding in the past

Pseudomonas Bloodstream Infections Associated with a Heparin/Saline Flush --- Missouri, New York, Texas, and Michigan, 2004--2005

Weekly
March 25, 2005 / 54(11);269-272

On January 26, 2005, CDC was notified of four cases of Pseudomonas fluorescens bloodstream infection among patients at an oncology clinic in Missouri. All patients had received a heparin/saline flush to prevent clotting of indwelling, central venous catheters. The flushes were preloaded in syringes by IV Flush and distributed by Pinnacle Medical Supply (Rowlett, Texas). On January 31, a nationwide alert against use of all heparin or saline flushes preloaded in syringes by IV Flush was issued by the Food and Drug Administration; the company recalled these products. As of February 15, state and local health departments and CDC had identified a total of 36 Psuedomonas species infections in patients in four states who were administered the heparin/saline flushes from multiple lots. This report describes the ongoing investigation and provides recommendations for investigation and management of potential cases.

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First Question of Day June 26, 2014 Isn't it interesting how we as humans hang on to things we really don't want or love simply because we don't want someone else to have it or we are afraid of the unknown without it. Do compounding pharmacists fight rules and regulations so hard because of this fear? They predicted the DQSA would cause patients not to have access to drugs they need and this has not been the case. In fact new compounding pharmacies are opening their doors everyday and existing ones are expanding and growing. Still Compounders try to invoke fear into the consumers. Why?

Ninth Question of Day June 25, 2014 Are compounding pharmacists and groups that represent them doing more harm to their reputation than good by continuing to fight measures to make the system more accountable and safe for the public?

Eighth Question of Day June 24, 2014 How many other doctors feel this way but will not say because profit is their motive also? ("[T]he driving motive is not the well-being of the patient but increased profit for the pharmacist and all too frequently for the pediatrician who may have a special business relationship with the compounding pharmacist.").

45 John H. Perrin, Pediatrician and Compounding Pharmacist: A Dangerous

Liaison, 150 Archives of Pediatric and Adolescent Medicine 224, 224 (1996)

Compounding for Animal Patients: Contemporary Issues Elaine Lust J Am Pharm Assoc. 2004;44(3)

Compounding for Animal Patients: Contemporary Issues

Elaine Lust
J Am Pharm Assoc. 2004;44(3)

The risk of animal compounded drugs delivered by transdermal methods has been pointed out since at least 2004; The concept of transdermal delivery of a drug has appeal for use in animals that are difficult to medicate. The potential risk of secondary human exposure must be considered. Likewise, the physical and chemical properties of some drugs preclude transdermal delivery.

Compounding for Animal Patients: Contemporary Issues

Elaine Lust

J Am Pharm Assoc. 2004;44(3)

Wednesday, June 25, 2014

Seventh Question of Day June 25, 2014 How can the DQSA be a knee-jerk reaction when deaths from bad compounding when people fighting to have better regulations have worked on the issue for years and received threats and pushback every step of the way?

Sixth Question of Day June 25, 2014. Does this make you question a few things? The owner of Doc's Pharmacy that compounded the medication given to George Stahl had these qualifications

Named pharmacist of the year in 1997 by Professional Compounding Centers of America, the 62-year-old Walnut Creek resident was also on the board of one of the industry's powerful lobbying organizations.

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Horwitz, the Doc's Pharmacy compounder, was considered one of the best. Horwitz taught PCCA courses on lozenge-making and was a member of the board of the International Academy of Compounding Pharmacists, a lobbying group with headquarters at PCCA's 100,000-square-foot office and warehouse complex.

PCCA President David Sparks has known Horwitz for more than a dozen years and spoke warmly of "his innovations, his willingness to share those innovations with others, and his enthusiasm."

PCCA supplied Doc's with the recipe for making betamethasone, advice on how to compound it, and the vials into which the mixture was decanted. Horwitz said he learned the "cold sterilization" technique of spraying alcohol on empty vials at PCCA, and then taught it to his own technicians, along with passing on PCCA's instructions to heat the sterilized vials after they were filled.

Source found here

Another prediction and warning from a pharmacist in 2002!!

But Larry Sasich, a pharmacist with the Washington, D.C., consumer group Public Citizen, warns that compounders are laying the foundation for "two classes of prescription drugs in America." One is manufactured drugs, closely monitored by the FDA; the other, compounded drugs, where quality is a matter of trust among doctor, pharmacist and patient.

Sasich sees no grounds for such trust. Pharmacy compounding, he contends, has become a haven for the sale of unapproved, ineffective and potentially dangerous drugs.

Quoted from here

More People Have Died From Bad Compounded Drugs than Compounders and Groups that represent them Want you to know about

I have posted this story before but am posting it again because while we tend to think of the NECC outbreak we forget about the cases that we're not reported, where covered up, no one made the connection between the death or illness and the bad compound or cases like George Stahl's death. Read about it here. But for his wife donating his organs, the bad compound might have been discovered. How many other people or animals have died and no one thought to investigate the compounded medication?