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Saturday, August 31, 2013

Iowa Board of Pharmacy Rules Regarding Pharmacy Benefit Managers


Pharmacy Benefit Managers
Today, more than 210 million Americans nationwide receive drug benefits administered by pharmacy benefit managers (PBMs). It is estimated that there are fewer than 100 major
IA Vol. 27, No. 2
PBM companies in the United States. The Iowa Board of Pharmacy office routinely receives numerous questions about the activities of PBMs. In Iowa, PBMs are regulated by the Iowa Department of Commerce, Insurance Division. Current law resides in Iowa Code, Chapter 510B and administrative rules are located in 191 Iowa Administrative Code, Chapter 59. The law and rules have been in effect since 2007-2008. A copy of Iowa law and rules for PBMs is included as an insert to this issue of the Newsletter. PBMs are required to obtain the approval of the prescribing practitioner prior to request- ing any drug substitution under Iowa Code §510B.6. A PBM may not substitute an equivalent prescription drug contrary to a prescription drug order that prohibits a substitution. PBMs are required to develop an internal system to record and report complaints. These requirements are contained in 191 I.A.C. 59.5(1). The Iowa Insurance Division has drafted some specific instructions for pharmacists who wish to file a complaint against a PBM, which are available online at www .iid.state.ia.us/file_a_complaint. PBMs are required to submit a summary of all complaints filed against them with the Iowa commissioner of insurance on a quarterly basis. Forty-eight PBMs are listed in the online directory of the Pharmacy Benefit Management Institute at www.pbmi.com/pbmdir.asp. None of these companies are located in Iowa. In 2012, the five largest PBMs in the US were Express Scripts of St Louis, MO; CVS Caremark of Scottsdale, AZ; Prime Therapeutics of Eagan, MN; OptumRx of Irvine, CA; and Catamaran of Lisle, IL.

quoted from Iowa Board of Pharmacy September 2013 Newsletter

Kudos!! New Mexico Board of Pharmacy Law Updates Provided from now until End of Year


Law Update Reminder
In 2013, the Board has been offering two law updates each month in the Albuquerque, NM, area. Both updates are avail- able on the same Friday. One update is offered from 9 am to 11 am. The other update is offered from 2 pm to 4 pm. To reserve a space, contact Jessica Chavez-Lance at 505/222-9830 or Jessica .Chavez-Lanc@state.nm.us.
Law Update Schedule (Albuquerque) September 13, 2013
October 25, 2013
November 15, 2013
December 20, 2013
Law Update Schedule (around state)
These law updates are scheduled for 7 pm to 9 pm. September 10, 2013 – Clovis, NM
September 17, 2013 – Farmington, NM
September 24, 2013 – Taos, NM
October 29, 2013 – Hobbs, NM
November 19, 2013 – Las Cruces, NM
The New Mexico Society of Health-System Pharmacists (NMSHP) will host a law update on Sunday, October 6, 2013. Please contact NMSHP for information and to reserve a spot. 

New Mexico Pharmacy Statute Change Relating to dangerous drugs


Statutory Change
During the 2013 legislative session, the statute 26-1-16.J. NMSA was revised. The revised statute says that a pharmacist may dispense a quantity not to exceed a 90-day supply of a dangerous drug by combining valid fills. The prescription must not state an indication specifically prohibiting a combined fill. And also, the medication cannot be a CS.

quoted from New Mexico Board of Pharmacy September 2013 Newsletter 

New Mexico Board of Pharmacy Disciplinary Action 2013


Disciplinary Actions
Anastacia Barka, PT – License PT-1727. Respondent voluntarily surrendered her registration as a pharmacy technician (PT). Must pay investigative costs in the amount of $500.
James Gaynor, RPh – License RP-4407. Respondent entered into a stipulated agreement with the New Mexico Board of Pharmacy. Respondent pled no contest to Board allegations that he filled a personal prescription for alprazolam. Must pay investigative and fine costs in the amount of $750.
Daniel Hall, RPh – License RP-6813. Respondent voluntarily surrendered his registration as a pharmacist. Must pay inves- tigative and fine costs in the amount of $1,362.
Madana Harvey, DDS – License CS-216894. Respondent volun- tarily surrendered her controlled substance (CS) registration. Must pay investigative costs of $100.
Kelly Kemper, RPh – License RP-5290. The Board found by a preponderance of the evidence that respondent Kelly Kemper unlawfully obtained a CS. Pharmacist license was revoked for a period of three years. May reapply after three years. Within 90 days, must pay investigation and Board costs of $1,121.17.
Lillian Lovato, RPh – License RP-6262. New Mexico Monitored Treatment Program (MTP) reported to the Board that respon- dent had violated terms of her contract. The Board suspended respondent from the practice of pharmacy until her successful completion of MTP contract.

North Dakota Board of Pharmacy Quality-Related Events – Errors and Continuous Quality Improvement



By Howard C. Anderson, Jr, RPh
The Board, at its July 18, 2013 meeting, voted to move ahead with a rule to require a continuous quality improvement (CQI) program in all North Dakota pharmacies.
The Board already has a requirement in all of its telepharma- cies, central sites, its hospitals, and for sterile product preparation.
ND Vol. 2, No. 4
Many states have mandated reporting of errors that cause mortality or significant morbidity. The North Dakota Board feels this is too late in the process, as harm has already occurred.
It is the intent of the new requirement to focus on quality- related events (QREs), which are the precursors of errors (those that get out of the pharmacy’s hands and put the patient at risk).
The rule will require recording of QREs and analysis of them to identify places where changes can be made to prevent errors from occurring. Errors are also reported and serious analysis (gap analysis) is conducted to determine why we have a gap between our expected outcome (a perfect prescription or more importantly, a good patient outcome) and what actually occurred (an error of some kind resulting in a poor patient outcome).
The rule will include discovery protection (a lawyer cannot ask for your CQI report so he or she can find potential clients or reveal that you had six near misses to bolster his or her case before the judge or jury).
The rule will include a reference to reporting to a patient safety organization (PSO) to provide federal protection under the 2005 Patient Safety and Quality Improvement Act.
The North Dakota Pharmacists Association has a co-marketing agreement with a PSO and an excellent online CQI program. The Board will also have manual QRE recording forms on its Web site should you not choose to utilize an online CQI program. The Board will ask you to analyze your internally recorded QREs in lieu of the computer-assisted analysis.
Look for the rule hearing announcement, and of course the proposed rule will be published. 

quoted from the North Dakota Board of Pharmacy September 2013 Newsletter

Vermont Board of Pharmacy Public Hearing Scheduled for October 2, 2013 Regarding Rule Changes


Board Public Hearing
The Board has recently completed a review of the Rules Governing the Practice of Pharmacy. The Board will hold a public hearing on the proposed rule amendments, additions, deletions, and corrections on October 2, 2013, as part of its regularly scheduled meeting. The meeting is open to all and the Board will take testimony – positive, neutral, or negative – on the proposed changes. All individuals working in the profes- sion as well as any other interested individuals are encouraged to review the proposed changes and comment accordingly.
For more information or if you have questions, please contact the Board office.

quoted from Vermont Board of Pharmacy September 2013 Newsletter 

New Law in Vermont Relating to Pharmacy-Act 75


New Laws for Vermont
In response to seemingly increased opioid addiction and methamphetamine abuse in the state, the 2013 Vermont Gen- eral Assembly passed and Governor Peter Shumlin signed Act 75. The act was formerly known as H.522 (House Bill 522).
There are several provisions that affect the practice of pharmacy and pharmacists in the state of Vermont. It is the responsibility of all pharmacists to be familiar with the law, conversant with it, and to abide by its provisions in the course of their practice of the profession.
All prescriptions for regulated drugs shall be made to the order of an individual patient, dated as of the day of issue, and signed by the prescriber. The prescription shall bear the full name, address, and date of birth of the patient. In the event the prescription is for an animal, the name and address of the owner of the animal and the species of the animal.
All prescriptions shall also bear the full name, address, and registry number of the prescriber. If the prescription is written, it shall be in ink, indelible pencil, or typewritten and shall be signed by the prescriber. A written prescription for a controlled substance (CS) shall contain the quantity of the drug written both in numeric and word form.
Only a patient for whom a prescription was written, the owner of an animal for which a prescription was written, or a bona fide representative of the patient or animal owner may pick up a prescription for a Schedule II, III, or IV CS. Prior to dispensing a Schedule II, III, or IV CS, a pharmacist shall require the individual receiving the drug to provide a signature and show valid and current government-issued photographic identification as evidence that the individual is the patient for whom the prescription was written, the owner of the ani- mal for which the prescription was written, or the bona fide representative of the patient or animal owner. If the patient does not have valid, current government-issued photographic identification, the pharmacist may request alternative evidence of the individual’s identity, as appropriate.
The legislation requires the Vermont Board of Pharmacy to adopt rules to define which persons shall be considered bona fide representatives of a patient. To that end, the Board has proposed the following rule definitions.
“Bona fide representative of a patient” as referred to in 18 V.S.A. §4201(26) means an individual who is authorized by law or known to the patient and authorized by the patient to receive drugs dispensed by prescription for the patient.
“Bona fide representative of an animal owner” as referred to in 18 V.S.A. §4201(26) means the owner of an animal or a person authorized by the owner to receive drugs dispensed by prescription for the animal.
“Alternative evidence of the individual’s identity” as referred to in 18 V.S.A. §4201(26) means documents that reasonably permit a pharmacist to conclude that the individual is who he or she purports to be.
The adoption of the aforementioned proposed definitions will be part of a public hearing the Board will hold on Wednes- day, October 2, 2013.
quoted from the Vermont Board of Pharmacy September 2013 Newsletter 

West Virginia Board of Pharmacy Sets Deadline for Out-Of-State Board Sets Deadline for Mail-Order Pharmacy PIC Licensure



As mentioned in the last issue, the legislature passed “The Larry W. Border Pharmacy Practice Act,” House Bill 2577, on April 13, 2013, setting an effective date of July 1, 2013. As it was going through toward passage, some noticed that the language would require every pharmacist practicing “pharma- cist care” in West Virginia to have a West Virginia pharmacist license. This is not a surprising concept, of course; that is, until people noticed that the language would require all out- of-state pharmacists dispensing from mail-order pharmacies into West Virginia to be licensed in this state, which would be a new burden if implemented. There are approximately 360 active mail-order permits issued by the West Virginia Board of Pharmacy, with the vast majority of those being out-of-state permits. So, the act was amended to provide that only the pharmacist-in-charge (PIC) of the out-of-state mail-order pharmacy would have to be licensed as a West Virginia pharmacist; the other pharmacists working under the PIC would simply need a valid pharmacist license in the state where the pharmacy is located. The Board noted that the PICs around the country would need some time to reciprocate their licenses to West Virginia. So, the Board voted to allow until July 1, 2014, for the out-of-state mail-order pharmacies and their PICs to become compliant. If you are one of those PICs, the Board looks forward to working with you through the licensing and reciprocation process in the coming weeks. 

quoted from the West Virginia Board of Pharmacy September 2013 Newsletter

NABP Model Act Amended to Address Shared Service Concept, Medication Reuse Programs, and Internet Pharmacy Safety


NABP recently amended the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) in its effort to assist the state boards of pharmacy
as they work to protect the public health. Changes made to the
Model Act were incorporated as a result of the Executive Committee- approved recommendations of the Task Force on Phar- macy Practice Technology Systems, the Task Force on Internet Pharmacy Practice, the Task Force on Drug Re- turn and Reuse Programs, and the 2012-2013 Commit- tee on Law Enforcement/ Legislation.

continue to read at NABP September 2013 Newletter 

From NABP Association Supports Member Boards With Development of Electronic Resource for Verifying Pharmacy Licensure State Compounding Pharmacy Inspection Programs Continue and Iowa Inspection Program Update



NABP member boards continue efforts to ensure the safety of compounded drug products, including a new initiative undertaken by the Association.
At the request of member state boards of pharmacy, NABP has begun develop- ing an electronic resource
to facilitate the sharing of pharmacy licensure and related information among the states. The Verified Pharmacy ProgramTM (VPPTM), scheduled to launch by the end of 2013, will store licensee data and inspection report compo- nents in a uniform format. Data will be available to boards of pharmacy with the aim of supporting licensing decisions, of par- ticular interest when boards are considering applications for nonresident licensure.
In addition to developing VPP, NABP continues to conduct pharmacy inspec- tions, including surveys of compounding pharmacies, on behalf of the Iowa Board of Pharmacy and in partner- ship with state agencies in New Jersey.

Verified Pharmacy Program
Relevant data on li- censed pharmacies will be stored in VPP in the form of a pharmacy e-Profile. Pharmacy e-Profiles will allow NABP to collect and verify the following infor-
mation for reporting to the boards of pharmacy:
Pharmacy licenses (resi- dent and nonresident).
Pharmacist-in-charge
(PIC) licenses (resident and nonresident).
Disciplinary information.
The pharmacy e-Profile will also indicate whether
a qualified inspection has been performed by the resi- dent state or a designated agent.
Information in the pharmacy e-Profiles will be accessible to boards through the Board e-Profile Connect interface. The informa-
tion will also be proactively reported to boards.

In requesting that the Association initiate the de- velopment of VPP, member boards noted that the sys- tem would be particularly beneficial when considering applications for licensure from nonresident pharma- cies. Under the current system, boards may be asked to make licensing decisions about nonresident phar- macies with incomplete or outdated information. Chal- lenges creating this situa- tion include differing laws and regulations, as well as differing levels of resources from board to board. For example, some boards may not have the fiscal or human resources to conduct the same frequency and type
of pharmacy inspections as others with more robust budgets.
To help address the differences in regulatory structure and operations among the boards, VPP
will facilitate the sharing
of licensure information about pharmacies across
the country. Several exist- ing NABP programs and services are the foundation for the development of VPP, including the Electronic Li- censure Transfer Program® (e-LTP®); NABP Clear- inghouse, which includes disciplinary information; accreditation programs; and inspection services.

In fact, VPP is a natu-
ral extension of e-LTP, on which the Association was founded. In developing VPP, the Association is building on the success of e-LTP to create a means for boards to share information pertinent to the licensure of pharma-
cies. Pharmacy e-Profiles will allow boards to verify that a qualified inspection of the facility has been conducted and its licensure status
in other states. A future planned capability is for the
pharmacy e-Profiles to be in- terconnected with e-Profiles for pharmacists and pharma- cy technicians. This capabil- ity would assist boards in tracking PICs to ensure they meet state requirements, including verifying licensure and reviewing disciplinary information of both resident and nonresident PICs.
The primary impetus for the VPP was the linking
of the November 2012 mul- tistate fungal meningitis outbreak to contaminated injectable drugs com- pounded by the New Eng- land Compounding Center (NECC), a tragedy that brought to the forefront the need for boards to be able to verify inspection and other data when licensing nonresident pharmacies. More information about VPP and an application will be available on the NABP Web site by the end of Sep- tember 2013. In addition to initiating the development of VPP following the NECC compounding tragedy, some member state boards of pharmacy requested NABP’s assistance in conducting compounding pharmacy inspections.
Iowa Inspection Program
NABP began conduct- ing pharmacy inspections on behalf of the Iowa Board of Pharmacy in December 2012. As of press time, NABP surveyors have conducted inspections of 384 nonresident pharma- cies dispensing drugs to patients in Iowa. Inspec- tions are ongoing across the nation and as such are not consigned to any one state. Aggregate data reports with relevant survey findings are submitted directly to the Iowa Board. Trends from 

Medical Foods Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

Medical Foods Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

August 31, 2013 FDA Attempting to Restrict Medical Foods


by Alliance for Natural Health
Want to manage your diabetes this way? FDA says no. Action Alert! 
“Medical foods,” by federal definition, aren’t simply a diet plan prescribed by a doctor. They are foods that are specifically formulated and processed for a sick patient. They form a separate category from conventional foods and dietary supplements in that they are intended to meet specific nutritional requirements for the management of a disease or condition, and are used under medical supervision. These foods can be consumed orally or through a feeding tube.
Medical foods do not require FDA premarket approval. Manufacturers of such foods can make disease claims, which means they are exempt from the labeling requirement for health claims with its demand for random controlled trials. Medical foods do, however, have to follow current good manufacturing practices (cGMPs), facility registration, and other normal safety requirements.
The FDA has just issued an updated draft guidance on medical foods, and this new version drastically limits the number of medical conditions that medical foods can be used to manage. The guidance now uses “inborn errors of metabolism” (IEMs) to determine which diseases or conditions are included on the list. For example, inherited biochemical disorders in which absence of an enzyme interferes with the metabolism of protein, fats, or carbohydrates would be treatable with medical foods. The guidance excludes diseases resulting from essential nutrient deficiencies like scurvy and pellagra.
Outrageously, the guidance specifically excludes diabetes—both type 1 and type 2, as well as gestational diabetes—because, according to the FDA, diabetes can be controlled by simply managing or tweaking one’s normal diet (along with taking FDA-approved drugs, of course). According to the FDA, type 1 diabetics should use carbohydrate counting or the carbohydrate exchange system to match their insulin dose to their carbohydrate intake. And type 2 diabetes patients should simply restrict calories, eat regularly, increase fiber intake, and limit their intake of refined carbohydrates and saturated fats—in addition to taking prescribed drugs.
This is consistent with the usual FDA stance, which wants there to be as little competition as possible for approved drugs. By contrast, nearly all integrative physicians and even many conventional doctors would argue that diabetes requires very aggressive nutritional intervention, and medical foods can be a vital part of the treatment plan.
Merely tweaking one’s normal diet is not sufficient to provide enough nutrients to correct the condition. Leaving aside our nutrient-depleted soil, there’s the fact that many (or even most) people have extremely poor eating habits. Perhaps it’s because they haven’t been clearly taught about a proper diet for their disease, or perhaps they lack the discipline required to monitor their eating so carefully. Whatever the reason, making a few changes to the standard American diet will almost certainly not be enough to manage conditions like diabetes or nutrient-deficient diseases, whereas medical foods may.
For example, this ingredient list for the medical food for diabetes provides many of the essential nutrients required—including a number of specific vitamins, cinnamon, and plant sterols—all of which are essential toward managing diabetes.
Another problem with the FDA’s guidance is that since medical foods are, by definition, administered under medical supervision, the patient’s physician is fully qualified to decide whether the medical food is required or not. The FDA doesn’t need to override doctors’ judgment and tell them what’s necessary for their patient! Yes, doctors are often remarkably lacking in nutrition knowledge. But if so, the FDA is even more lacking.
Besides, medical foods can be used in addition to an overall treatment plan. We should therefore be encouraging consumer access to as many treatment options as possible. By narrowly limiting the conditions that medical foods can be used for, FDA is reducing patient access to nutritional interventions for disease—something the FDA seems to be doing on a regular basis. Famed health and constitutional law firm Emord & Associates put it this way:
The problem with FDA’s approach is that it eliminates beneficial products from the marketplace, requiring them to either proceed through the drug approval process or be marketed as dietary supplements with limited structure/function claims, thus depriving consumers of valuable information that can improve their health. Although some diseases and conditions that have special nutritional requirements can be managed through diet modifications alone, not all consumers are willing or able to make drastic diet modifications. If FDA’s new position stands, companies could resort to the DSHEA’s health claims provisions to spread information concerning a nutrient’s relationship with certain disease states.
We expect to see some serious pushback from manufacturers on this guidance. Several companies, such as Abbott Labs and Metagenics, are either manufacturing ingredients aimed at medical foods for diabetes, or have complete medical food products already on the market. As one spokesperson put it, “They are drawing a line in the sand which, especially in regard to diabetes, might not be that easy. This is more of a physician question; what if a patient is trying to modify their diet and it’s not working?”
Action Alert! Tell FDA they need to broaden their list of diseases and conditions for which medical foods may be administered, not restrict it! Especially let them know that diabetes patients need this kind of targeted nutrition therapy, and merely tweaking their regular diet is not enough. What we need are better medical foods, not the elimination of them. Another good idea would be to let supplement companies make medical foods, rather than just drug and medical products companies. Please send FDA your comments today!

Sept. 2, 2013 | Vol. 45 No. 34 FDA Warns Florida Compounder About Prescriptions, Contamination The FDA has warned a specialty pharmacy in Florida for compounding drugs without prescriptions, a key point in the agency’s push for more compounding oversight powers.


This article is viewable by subscribers only. To view this article, please select an option below.

How Congress Encourages Shortages Of Cancer Drugs



Source: Forbes, Aug 31 2013, 8:42am CDT
US Secretary of Health and Human Services Kathleen Sebelius (R) speaks alongside Food and Drug Administration (FDA) Commissioner Margaret Hamburg during the Daily Press Briefing in the Brady Briefing Room of the White House (Image credit: AFP/Gett ...
Continue reading on: Forbes

The State of Nebraska State Medicaid had stopped covering compounded medications in January 2011


January 2011

Compounded Prescriptions with APIs and Excipients
An API is a bulk drug substance, which is defined by the FDA as any substance that is represented for use as a drug and that, when used in the manufacturing, processing or packaging of a drug, becomes an active ingredient of the drug product. APIs may be included in extemporaneously compounded prescriptions and may serve as the active drug component in a compounded formulation.
State Medicaid programs have been informed by the Centers for Medicare & Medicaid Services (CMS) that many active pharmaceutical ingredients (APIs) and excipients used in compounding do not meet the definition of a covered outpatient drug as defined in section 1927(k)(2) of the Social Security Act and effective January 1, 2011, are not eligible for coverage as drugs in Medicaid programs. Therefore, Nebraska Medicaid will no longer cover such products for dates of service on and after January 1, 2011.
Lists of APIs and excipients identified in the Medicaid Drug Rebate system are posted on the CMS website at http://www.cms.gov/Reimbursement/02_Spotlight.asp. Please note that these are not definitive lists and additional products will be added as they are identified.
If you are treating a recipient who is currently receiving a prescription containing one of the APIs or excipients to be deleted, you must identify an alternative therapy that meets the definition of a covered outpatient drug and is eligible under the federal drug rebate program. Information regarding products covered by NE Medicaid can be found on the Drug Lookup posted at https://nebraska.fhsc.com.
If you have any questions regarding this bulletin please contact Barbara Mart, R.P., Pharmacy Consultant, at (402) 471-9301 or barbara.mart@nebraska.gov

quoted from here

Important!! WAFDO 2013 Annual Educational Conference Compounding Pharmacies Panel Presentations Are Now Available (Includes Presentations from FDA and on Iowa Inspections)

Compounding Pharmacies Panel
  • Contracting with the National BOP for Audits of Pharmacies that Compound Drugs -- Nancy Tay, Accreditation Director National Association of Boards of Pharmacy
  • FDA Interactions with National BOPs Audits of Compounding Pharmacies -- Dennis Baker, FDA Regional Food and Drug Director, Southwest Region
  • Veterinary Drug Compounding -- Miriam Burbach, FDA Director of Compliance, SEADO
Compounding Pharmacies
Tay Presentation
Baker Presentation
Burbach Presentation

Video: When are compounded drugs appropriate? Mar 7, 2013 By: Dawn Merton Boothe, DVM, MS, PhD, DACVIM, DACVCP VETERINARY MEDICINE

view video here

Journal Scan: How reliable are compounded trilostane products?




VETERINARY MEDICINE

What they did
Researchers evaluated 96 batches of compounded trilostane capsules in 15-, 45-, and 100-mg sizes purchased from eight different pharmacies. These were compared with 15-mg capsules made with the licensed product, capsules containing inert materials, and proprietary capsules in 30- and 60-mg sizes. All capsules were analyzed for content and dissolution characteristics and compared with the specifications for the licensed product.
What they found
There was a wide variability in drug content among the compounded trilostane batches—39% to 152.6% of label claim—compared with the variance for the controls, which was 96.1% to 99.6%. The average dissolution rate of the compounded batches was also lower than for the controls—76% vs. 85%, respectively.
Take-home message
The wide variability in content and the dissolution rates of compounded trilostane products may compromise effective management of patients being treated for hyperadrenocorticism. Patients may be overdosed or underdosed when these products are used, which may prompt owners to discontinue therapy and negatively impact patient care. If nonapproved capsule sizes are required, it is important clinicians be aware of the source of the trilostane being used.
Cook AK, Nieuwoudt CD, Longhofer SL. Pharmaceutical evaluation of compounded trilostane products. J Am Anim Hosp Assoc 2012;48(4):228-233.

Linke to abstract: http://www.jaaha.org/content/48/4/228.abstract?sid=573668c4-d209-47fb-bff5-3b8d48d12d39

Journal Scan: One month later... Effects of storage on compounded doxycycline Aug 19, 2013 By: Jennifer L. Garcia, DVM, DACVIM VETERINARY MEDICINE


Why they did it
This study sought to determine whether doxycycline suspension made from doxycycline tablets maintains the appropriate concentration after storage for four weeks.
What they did
The researchers made a suspension by mixing crushed 100-mg film-coated doxycycline hyclate tablets with a 50:50 mixture of syrup and suspension vehicles, which met the compendial requirements of the U.S. Pharmacopeia (USP) National Formulary. Two formulations were prepared (33.3 mg/ml and 166.7 ml/ml), and three batches of each strength were made and stored at either room temperature (71.6 to 78.8 F [22 to 26 C]) or a controlled cold temperature (refrigerated 35.6 to 46.4 F [2 to 8 C]). All preparations were protected from light.
Researchers measured doxycycline concentrations in all formulations at day 0 (date of preparation) and at days 1, 4, 7, 14, 21, and 28. The concentration was compared to a reference standard from the USP.
What they found
While concentrations remained within 90% to 110% of the reference standard for the first week, these levels dropped to < 20% by week 2 and remained at this level throughout (range = 14% to 18%). Storage temperature did not appear to have an effect on the loss of concentration. After seven days of storage, the quality of the formulations also diminished as noted by changes in consistency, visible separation of phases noted in the bottle, and a dark-brown band that appeared near the bottom of the bottle.
Take-home message
Use of compounded doxycycline beyond seven days may not be effective. Veterinarians should be cautious when using compounded medications and be sure to prescribe and dispense these medications in accordance with federal and state regulations.
Papich MG, Davidson GS, Fortier LA. Doxycycline concentration over time after storage in a compounded veterinary preparation. J Am Vet Med Assoc 2013;242(12):1674-1678.
Link to abstract: http://avmajournals.avma.org/doi/abs/10.2460/javma.242.12.1674

IACP List Donors and Amounts --Note on Website Reference Senate Bill 959



Thank you to the following for contributing to IACP:
$50,000 plus
Eric Vidrine  *
$25,000 to $50,000 
David Sparks  *
Ernest Gates  
Charles Leiter  
Chris Schulte  *
Kate James  *
Jerrod Roberts  *
$10,000 to $25,000      
Denise Orwick  
Wade Siefert  *
HeeJoo Park  *
Topi-Click Topical Dosing Applicator   
Denise Burnham  *
Gary McCrory  *
David J. Miller  *
Constance Hegerfeld  
David M. Smith  
Sam Pratt  
Scott Karolchyk  
$5,000 to $10,000      
Larry Curtis  *
Kipp Ladd  *
Georgia Pharmacy Assn - AIP  
Georgia Pharmacy Association  
Eddie Glover  
Dave Hill  *
Kevin Borg  *
Matt Buderer  *
Thomas Marks  
Mark Acker  
Marshall Tobin  
Richard Brisson  
Scott Popyk  
Rakesh Patel  
$2,500 to $5,000    
Dale Coker  *
William Beckman  
Jeffery Bray  *
Jeffrey Alan Barris  *
Kenny Walkup  *
Matthew Martin  *
Steve Pressman  *
Joseph Rossetti  
Alan Martin  
Dana Reed-Kane  *

Compounders Apparently Getting More Cease and Desist Letters from Manufacturers--Should We Anticipate More Litigation--Also Express Scripts States Compounded Drugs Using Bulk No Longer Covered


Member Alert: Letter Trifecta

IACP is aware of the three letters currently circulating to our members - the Aptalis Pharma letter regarding RECTIV, the Arnall Golden Gregory letter regarding Mitosol, and the Express Scripts letter stating that compounded drugs using bulk chemicals will no longer be covered.

Click here for a copy of the Aptalis letter.

Click here for a copy of the Arnall Golden Gregory LLP (Mitosol) letter.
Click here for the Express Scripts letter.
IACP will be sending all members an email and fax on how to handle these specific letters. In the meantime, please visit IACP's AdvanCE self-paced webinars on our website. Click here to access IACP's webinar, Sound & Fury: Responding to Manufacturers’ Cease & Desist Letters.

This webinar will answer your questions, “What should I do? Ignore it? Send it to my attorney? Comply with their request? Why did I get this in the first place? Who are these people anyway?” This program will help you understand what a “cease-and-desist” letter is, where it comes from, what it means, and what to do about it. Stay tuned for more information to come.

quoted from IACP website here

Report a Problem Reporting Unlawful Sales of Medical Products on the Internet

Report a Problem Reporting Unlawful Sales of Medical Products on the Internet

PBM Audit Lawyers: New Georgia Law Requires Licensure of Nonresident ...

PBM Audit Lawyers: New Georgia Law Requires Licensure of Nonresident ...: By Todd Mizeski, Esq. and  Jonathan E. Levitt, Esq. Effective July 1, 2013, Georgia began requiring nonresident pharmacies to ...

Question of the Day August 31, 2013 So is IACP's claim that the FDA has no jurisdiction to inspect laboratories that specifically service compounding pharmacies? So Are States Dropping the Ball by Not Inspecting these Laboratories?


FDA Warns Florida Compounder-Axium Healthcare Pharmacy-for lacking prescriptions and contamination


FDA Warns Florida Compounder for Lacking Prescriptions, Contamination
The FDA has warned a specialty pharmacy in Florida for compounding drugs without prescriptions, a key point in the agency’s push for more compounding oversight powers.
Axium Healthcare Pharmacy was inspected by the FDA back in March as part of an enforcement blitz prompted by an outbreak of meningitis linked to a compounder in Massachusetts. Outbreaks of infections tied to compounding concerns have since occurred in Tennessee and Texas.
Agency investigators said many of the products that Axium “manufactures and distributes” are unapproved and misbranded drugs because they aren’t backed by a valid prescription for individually identified patients. Many of those same products, intended for conditions that are not amenable to self-diagnosis and treatments by individuals who are not health practitioners, also lack adequate directions for use, the warning letter states.
The letter, posted Aug. 27, also notes FDA concern with Axium’s sterile drug production processes, which the agency said took place under unsanitary conditions. The letter chides Axium for poor gowning practices, namely that employees wore non-sterile gowns that exposed bare skin and allowed for extending arms over sterile, uncovered vials.
Employees also failed to move in a “slow, deliberative manner in the aseptic processing area,” the agency said.
A Form 483 issued after the March inspection stated that one lot of triamcinolone acetonide injectable solution, 60 mg/ml contained black particles. “One of the vials appeared to contain more than one of these particles,” the form reads. The agency also found a vial in one lot of chromium chloride injectable solution, 4 mcg/ml contained a cloth-like filament.
Axium recalled two lots of contaminated products due to the observations, the FDA said.
The Florida pharmacy now says it plans to leave the compounding business, which it says makes up less than one percent of its total revenue.
“Compounding is not part of Axium’s core strategy to grow in the specialty pharmacy business, so we made a business decision to close that operation,” the company said, adding that all of its sterile compounding practices were brought to a halt back in April.
Pharmacies that compound products without a prescription have drawn particular scrutiny from the FDA, especially after a meningitis outbreak last year was tied to drugs mixed at the New England Compounding Center. The agency believes that regulating traditional compounders, which make products based on valid prescriptions, should be left to the states. However, it has asked Congress for additional authority to go after the larger compounders that make products without a prescription and ship them to other states.
The Government Accountability Office agreed with the agency in a recent report outlining the need for clearer authority.
The Eighth Annual FDA Inspections Summit is your key to avoiding FDA enforcement actions. Discover how to leave no stone unturned — since many agency investigators have industry experience and know where to look. Register now.

quoted from here

Ga. to use compounding pharmacy for execution drug - DC News FOX 5 DC WTTG

Specialty Compounding's Response to Attorney's Claims Posted: Aug 30, 2013 5:18 PM Updated: Aug 30, 2013 5:21 PM


CORPUS CHRISTI - The compounding company at the center of the alleged tainted IVs investigation issued a response to attorney Thomas J. Henry's claims.
Specialty Compounding says testing by the pharmacy's independent lab and by federal and state agencies on samples of their calcium gluconate infusion product has not yet proven an association between Specialty Compounding's medication and the affected patients.
The company statement goes on to say that its top priority is patient safety and ensuring all recalled products are promptly returned to the pharmacy.
On Tuesday, Henry issued a statement saying he's investigating 10 deaths of patients who may have been exposed to the recalled medication.
The FDA had recalled the medications from the firm after reports that patients being treated at Corpus Christi area hospitals developed bacterial infections.

quoted from here

Pharmalot Blog--Anthem Blue Cross Blue Shield ends coverage for compounded medications as of November 1


Compounding Problems: Anthem Restricts Coverage Of Some Compounded Meds

More fallout from the compounding controversy. Anthem Blue Cross Blue Shield, one of the nation's largest insurers, has decided to end reimbursement of certain compounded medications as of November 1. Specifically, the insurer will not pay for compounded bulk powders or pharmaceutical adjuvants that are not approved by the FDA, according to a mailing that were sent to beneficiaries.
It is not clear if the policy applies across the board to both retail pharmacies and hospitals or whether Anthem has established a waiver policy for beneficiaries to appeal a reimbursement decision. We asked Anthem for comment and willl update you accordingly. A copy of the newsletter was obtained by Pharmalot.
The Anthem newsletter says that: "Due to the recent enhancement of the HIPAA (Health Insurance Portability and Accountability Act) standard for electronic submission of prescription drug claims, we now have the ability to better administer our drug benefits, as they pertain to compounded drugs. During a recent review, we learned that claims for certain compounded drugs have been submitted and paid as a prescription drug benefit.  For a compound drug to be covered it must contain at least one ingredient/drug that requires a prescription to obtain. Additionally, that ingredient/drug must also be approved by the Food and Drug Administration."

continue to read here

Second Question of the Day August 30, 2013 If IACP's claim is that the FDA only has jurisdiction to inspect compounders acting like manufacturers, then isn't the FDA applying the correct standards when it inspects "compounders acting like manufacturers" by applying cGMPs?

Alternatively, if states and not the FDA have the authority to inspect traditional compounders, as the IACP argues, then why would the FDA inspect "compounders acting as manufacturers"  and apply standards such as 797?  Again, it seems like IACP's argument is illogical.  

IACP Claims Another FDA Salvo Against Compounding?


Last week, the Food and Drug Administration issued a national statement  advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., located in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating.  According to the agency, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results.

Additionally, the FDA recommended that pharmacies not use this firm for sterility and other quality attributes at this time. Since that announcement, the agency has contacted many compounding pharmacies specifically requesting a recall of sterile medications tested by Front Range. Several IACP members have conducted additional in-house testing on their lots -- all showing and confirming that the Front Range results were aligned with their own.

In a statement to its clients, Front Range Laboratories stated: "We are not in the business of manufacturing and do not conduct business with entities that manufacture finished drug products. We are not aware of a single client registered with the FDA as a drug manufacturer. Yet, during this recent inspection, our operations were inspected against the FDA's Current Good Manufacturing Practice (or cGMP) regulations which, by definition, do not legally apply to compounding pharmacies unless they are acting as manufacturers."
 
Front Range adds that:  "For over 10 years of operation, Front Range Laboratories has relied on state law (boards of pharmacy) and United States Pharmacopeia (USP) guidance when performing all of our testing. Specifically, the methods we use to assess sterility and other quality attribute testing are put forth by USP. Patient safety is an ongoing and primary concern within our industry, and Front Range Laboratories has always been extremely diligent in adhering to applicable guidelines as put forth by the organizations that govern the compounding pharmacy community. Our exceptional safety record is proof positive of our actions."
 
Once again, the FDA is applying a different rulebook to inspections, this time to laboratories that specifically service compounding pharmacies. Rather than inspecting pharmacies to USP standards, as required by many state laws and pharmacy practice acts, the FDA has issued inspection reports citing pharmacies' violations of cGMPs. Now the laboratories are being held accountable to cGMP standards. Front Range is not the first testing lab to have been inspected in the past few months.  And shortly, final regulations will be put in place to further enable the agency to halt the importation of APIs including those which are not components of FDA approved drugs.
 
To date, there has been no evidence whatsoever that a compounded preparation tested by Front Range failed to meet USP standards nor have any medications been deemed sterile that have in actuality found to be non-sterile. IACP members should continue to use the laboratory of their choice and raise any concerns about previous or ongoing inspections of those labs with the operators. 

quoted from here

Thursday, August 29, 2013

State of Washington Board of Pharmacy Meeting Minutes for May 30, 2013 Includes a Number of Compounding Topics Including adding veterinary pharmacy to school programs

read minutes here

Iowa Board of Pharmacy Disciplinary List (Updated through July 2013)

can be found here

South Dakota Board of Pharmacy List of Non-resident Pharmacies in Good Standing as of 7/22/13

to view this list click here

Art of Compromise 101: Something to Think About-Why Compounding Pharmacists Should Be Singing a New Tune to IACP and IACP Should Be Relaying that New Tune To Congress

Sue Tuck Richmond
August 29, 2013
To compromise means to reach an agreement or a settlement of a dispute by each side making concessions. Compromise is something that happens all the time. Some people are better at compromising than others. Some people refuses to budge an inch from their position and stand firm.  There are times to take this hard-nosed approach; other times, however, compromise may be in the best interest of all parties.  Now it is in the best interest of all parties to compromise and pass meaningful federal legislation to protect the animals and humans from bad compounding pharmacies and pharmacists, while at the same time allowing the good compounding pharmacies and pharmacists the ability to continue to operate and provide a much needed service to the animals and humans who desperately need it. If IACP and other compounding groups do not compromise once and for all, they may end up in a lot worse position than if they had compromised.  If Congress, both the House and Senate,  doesn't compromise, the American public will continue to be in grave risk that could be greatly reduced with the protection of federal regulation.


Dr. Kenneth Woliner, MD, of Holistic Family Medicine, in Boca Raton, Florida, a physician who prescribes compounded medications for patients recently asked three pharmacists who he called in prescriptions to what they thought of Senate Bill 959 going through Congress after the most recent recalls from compounding pharmacies. As he expected all three opposed Senate Bill 959. When Dr. Woliner asked them why, all three had the same answer: "The IACP (their trade organization) opposes it."

Dr. Woliner pressed them further by saying, "Okay, I can understand 'Mom & Pop Compounding' might not like the extra regulation, but if they aren't shipping drugs across state lines (it is only over the last 10-20 years that compounders have marketed themselves to distant areas, even outside their home state), they aren't subjected to increased Federal oversight. And I can understand you, as a 'good' compounding pharmacy (nice pharmacists with experience, training, good hearts, and no violations from the state boards, 483 letters from the FDA, or tragic examples of patient infections, blindness, or deaths) don't like extra regulation, but doesn't it 'GET YOUR GOAT' to see 'bad compounding pharmacies' such as Paul W. Franck (Franck's Compounding Lab, but now Trinity Compounding Pharmacy) blind humans and kill polo ponies with their shoddy practices?" I, liked Dr. Woliner, would assume that the good compounders don't like the 'bad pharmacies' either, as it gives them all a bad name.

Dr. Woliner then inquired what if the IACP is successful in preventing a Federal law from being enacted as it has been in the past. Then what? Allow things to continue as is, with massive recalls, people and animals sick and dying....

Dr. Woliner offered up this compromise, "Perhaps you, the supervising pharmacist, and owners of your pharmacy, should speak with David Miller and the IACP, asking the IACP to work out a compromise, to protect the things you cherish most, but to allow the Federal Govenment (through the FDA) the ability to regulate the rogue compounding pharmacies (that are truly manufacturers in disguise, with sales reps all over the country, etc), to prevent further tragedies that harm not just patients, but also the reputation of your profession."

All three pharmacists that Dr. Woliner spoke to this week responded, "That's something to think about."

IACP isn't it time to think about compromising.  By not compromising, you are not only protecting bad compounders and putting animals and humans lives at risk but you are also harming your good compounders--tainting them with the reputation of bad computers that is not deserved--simply because you refuse to compromise your position.


Question of the Day August 29, 2013 Why aren't more states denying or removing pharmacies approval to be Medicaid providers when the FDA finds numerous issues with the compounding pharmacies?


New York denies Mercaldo Apothecary pharmacy’s application to be Medicaid provider after investigation found pharmacy stocked expired drugs and unsanitary and unsafe condition

 

The state Office of the Medicaid Inspector General has denied the application of a Manhasset pharmacy for its enrollment application to be a Medicaid provider after an investigation found the pharmacy stocked expired drugs and operated under unsanitary and unsafe conditions.
In a press release Tuesday, Medicaid Inspector General James Cox said Mercaldo Apothecary, which operates as Maclennan Pharmacy at 588 Plandome Road, had been rejected as a Medicaid provider. 
According to the release, state investigators found 38 expired drugs among the pharmacy’s inventory, including one that had expired in 2006, according to the release. State regulations prohibit pharmacies from carrying expired drugs without segregating the drugs from other medications.
In addition, investigators found a dirty pharmacy refrigerator that did not have an inside thermometer and also stored food, which is prohibited, according to the release.
The pharmacy’s counter, the Medicaid inspector general said, was found to be dusty and cluttered, and investigators found the store appeared so disheveled that wheelchair access to its aisles was thought to be impossible. Federal regulations prohibit the enrollment of an applicant whose location limits access to those with disabilities into any program that receives federal reimbursement.
The pharmacy’s sink had no running hot water and its drain was clogged, according to the release. State regulations require that hot and cold water be available in a pharmacy’s compounding and dispensing area, according to the release.
“The fact that this provider violated so many of Medicaid’s pharmacy standards has a direct bearing on their ability to provide quality medical services or supplies to Medicaid patients,” Cox said in a statement. “And they will be prohibited from doing so as long as they continue to disregard basic standards meant to protect Medicaid consumers from such practices.”
According to the release, the pharmacy was referred to the state Education Department’s Office of Professional Discipline for continued investigation.
Anthony Mercaldo, a licensed pharmacist and the company’s vice president, said he was unaware of the conditions found by the state’s investigators and declined further comment, saying Maclennan “just received a nice article in the Manhasset Press about our decades and decades of service, and we don’t really want this out there.”
Mercaldo told Newsday the company initially applied for the Medicaid program as a “favor to a few customers,” but pulled its Medicaid provider application after Medicaid officials began trying to obtain “more and more information.”  
Mercaldo told Newsday the program was not worth the company’s small number of Medicaid customers.
“They kept coming back for more information and we kept providing them more and more information,” Mercaldo told Newsday of Medicaid officials. “At some point, we decided to stop the application.
quoted from here
 

While it is claimed that large-scale compounding pharmacies only make up 10% of the compounding market, they may supply much more (NY Times). The pharmacies inspected by the FDA are thought to be some of the largest outsourcers in the country. -


Prescription for Meningitis? Unsafe Pharmaceutical Practice Linked to Nationwide Death and Illness

Posted August 28, 2013 |

By: Tatum Brontë and Mark Zamora, Esq.



Last fall, the outbreak of fungal meningitis, which spanned across at least 20 states and took as many as 63 lives, was not an isolated event nor entirely unexpected. The outbreak joins the ranks of many other adverse events caused by the shady practices of drug manufacturing—practices the Food and Drug Administration has failed to gain authority over for nearly 15 years.

At the center? Lives lost and some injured for life. Traditional compounding is still a vital part of the drug industry today. What started as a way for local pharmacists to prepare tailor-made medicine made perfect sense; a liquid product for a mom to give her infant or a dose without an allergen (such as dye). Given their nature, compounding pharmacies fall under the state law and larger protective stipulations, including a 2002 protective ruling from the Supreme Court and the Food and Drug Administration Modernization Act of 1997 (FDAMA). For example, FDAMA exempts, under certain criteria, compounding pharmacies from registration and the obligation to permit access to records during an inspection.

In other words, compounding pharmacies are exempt from FDA oversight.

Where this gets ugly: Free from federal binds and offering drugs for cheaper prices (compare brand name Makena at $1,500 a dose to $25 offered by pharmacies), the demand for compounding pharmacy supply is growing. Now, with shipment across state lines and unregulated mass production, these “pharmacies” are comfortably in the grey area between state and federal jurisdiction. The risk? Lack of appropriate air filtration and insufficient microbial testing, among other risks of contamination—grounds for fungal meningitis and tainted medicine.

continue to read here