Compounding for animal patients: contemporary issues.

Department of Pharmacy Sciences, School of Pharmacy and Health Professions, Creighton University, 2500 California Plaza, Omaha, NE 68178, USA.

Journal of the American Pharmacists Association: JAPhA (impact factor: 1.48). 44(3):375-84; quiz 384-6.

 

ABSTRACT

To provide background information relating to the growth observed in veterinary compounding, discuss positive contributions made to animal health via compounding, present compounding practices that are in the best interest of patient care, present documents available to pharmacists to use for guidance when practicing veterinary pharmacy, and emphasize the need for education among stakeholders on the subject of veterinary compounding.
The Animal Medicinal Drug Use Clarification Act of 1994, compliance policy guide section 608.400, the American Veterinary Medical Association Position Statement on Compounding and Extralabel Drug Use Algorithm; supporting data from veterinary and pharmacy literature documenting the practice of veterinary compounding are referenced (SilverPlatter Medline 1966-2002 and International Pharmaceutical Abstracts; 1970 through December 2002; no restrictions; search terms, veterinary AND compounding).
By the author.
By the author.
Requests for compounding of products for veterinary uses are common in community pharmacy, and these preparations fill many clinical, dosing, and drug-administration needs in the care of companion animals. However, like other elements of pharmacy compounding, preparation of veterinary products falls into a legally gray area that is the subject of current scrutiny by the U.S. Food and Drug Administration (FDA). Pharmacists involved in this practice should keep the best interests of the animal in mind; recognize limitations about safety, effectiveness, and stability of compounded formulations; and avoid preparing products similar in ingredients and purpose as commercially available, FDA-approved products. Situations in which compounding becomes manufacturing invites enforcement action by FDA. The dispensing of compounded products should be based on a valid veterinarian-client-patient relationship and comply with federal acts, FDA's compounding compliance policy guide, and other such resources.
All pharmacists and pharmacies engaged in any type of veterinary pharmacy practice must be aware of the contemporary issues facing their profession. Best patient care practices, education, and open communication among stakeholders will play a critical role in the practice and future regulation of veterinary compounding.

Source: PubMed

What Did FDA Miss At New England Compounding?

By Ed Silverman

 Two months ago, the FDA inspected the New England Compounding Center, the pharmacy that has been linked to 590 cases of fungal meningitis, including 37 deaths (see this), and found a variety of disturbing conditions. These included ‘greenish-black foreign matter’ on sterilization equipment and air conditioning that was turned off each night despite the need to control room temperatures (back story with link to FDA report).

Similarly, the Massachusetts Department of Public Health conducted its own inspection in October and ran across some of the same things, such as a leaking boiler adjacent to the a clean room and wet floor surfaces, including a “tacky mat” that were soiled with black debris (here is the state report).

Nonetheless, more than a dozen people who have filed federal lawsuits against the NECC, which is located alongside a recycling plant that is owned by one of the two individuals who also run the compounder, received permission from a judge to conduct their own inspection (here is the order). Why? The plaintiffs believe the regulators may have missed some important pieces of evidence.

In an affidavit filed in the litigation, Tom Irmiter of Forensic Building Science, who has been retained by the plaintiffs to conduct the inspection, maintains there is no evidence that the FDA and state inspectors examined the overall condition of the building as a potential contributor to the contamination. And so he proposes to dissect the walls, ceiling, roof and foundation (here is the affidavit).

“Here’s an entity undergoing tremendous turmoil. We believe the preliminary (state) report that was issued is missing some things that may yield some other signs,” says Mark Zamora, an attorney for Chad Green, who claims he developed a joint infection and abscess due to an NECC medicine. “The FDA conducted testing of the vials, a baseline test for contaminants in May and released an eight-page inspection and observation report, which I think candidly revealed an overwhelmed agency struggling to come with an outbreak.

“But no one has access to raw data and we think they missed some things. For example, the garbage dump is yards from the facility. They didn’t examine the HVAC. We’re concerned with what may be found in the clean room. I think they did a decent job of explaining source contamination of product itself. But for us, we want to know how how did the material get in the vials? And if it’s the vial, did it come from the company that supplied the product or from the company that made the finished product?”

Such a move is predictable, but could also yield some interesting clues that might underscore the need for modifying regulatory inspections. As the attorney notes, the existence of contamination is obviously a key element of any inspection, but learning how the contamination occurred is equally crucial. A leaky boiler and the failure to use air conditioning may have been culprits here, but maybe there is more to the story.

Story found here

Tennessee Board of Pharmacy Reminds Pharmacies of Difference Between Compounding and Manufacturing

Board Rules for Compounding Reemphasized
In the wake of the tragic events causing harm and loss of life across
the country, including several deaths in Tennessee, due to the fungal
meningitis outbreak, it is important to review the current definitions
and rules for Tennessee-licensed pharmacies practicing the art of
compounding. 
To start this discussion, it is important to understand the difference
between compounding and manufacturing. Refer to the following
definitions:
Tennessee Code Ann. §63-10-204 Definitions.
(4) “Compounding” means the preparation, mixing, assembling, packaging or labeling of a drug or device:
(A) As the result of a prescription order or initiative based on
the prescriber-patient-pharmacist relationship in the course
of professional practice;
(B) In anticipation of prescription orders based on routine,
regularly observed prescribing patterns; or
(C) For the purpose of, or as an incident to, research, teaching
or chemical analysis and not for sale or dispensing;
(12) “Dispense” means preparing, packaging, compounding or labeling for delivery and actual delivery of a
prescription drug, nonprescription drug or device in the
course of professional practice to a patient or the patient’s
agent by or pursuant to the lawful order of a prescriber;
(21) “Manufacturer” means any person, except a pharmacist
compounding in the normal course of professional practice,
engaged in the commercial production, preparation, propagation, conversion or processing of a drug, either directly or
indirectly, by extraction from substances of natural origin or
independently by means of chemical synthesis, or both, and
includes any packaging or repackaging of a drug or the labeling
or relabeling of its container and the promotion and marketing
of such drugs or devices;
(13) “Distribute” means the delivery of a drug or device, other
than by administering or dispensing, to persons other than the
patient or the patient’s agent;
Therefore, be advised that the patient-specific prescription via the
prescriber-patient-pharmacist (also known as the three-legged stool)
is required for the pharmacist to prepare and dispense a compounded
prescription.
To sell a manufactured drug without a prescription in Tennessee, (ie, office or hospital use) a wholesaler/manufacturer/distributor
(W/M/D) license, issued by the Tennessee Board of Pharmacy, is
required as discussed in the July 27-28, 2011 Board meeting minutes:
A company with the business model of providing admixture
pharmacy services, appeared before the board to ask for permission to operate as a pharmacy in Tennessee. The representative
explained that the company would compound sterile preparation in anticipation of institutional pharmacies’ prescription
orders and it would be based on the institution prescriber’s
routine prescribing patterns. The compounded admixture is
not patient specific but the company would like to send the
admixture to institutions based on past usage of the product.
After discussion, a member of the Board made the motion that
based on the business model discussed with this company, it
would be necessary that they be licensed in Tennessee as a
manufacturer/wholesaler/distributor. Furthermore, the motion
stated that if they decided to dispense patient specific, they
would have to be licensed as a pharmacy as well. The motion
was seconded and carried.
Currently, there are pharmacies licensed by the Board that carry
both W/M/D and pharmacy licenses. However, be advised that Food
and Drug Administration and Drug Enforcement Administration
(DEA) regulations may require licensure or other certifications to also
manufacture drug products for sale, purchase, or transfer.
For pharmacists practicing the art of sterile compounding under a
pharmacy license for patient-specific prescriptions, it is advised
to review the current Tennessee Board of Pharmacy rules found at
the following Web link: www.state.tn.us/sos/rules/1140/1140-07
.pdf. Board rules require documentation to be completed and readily
available, including flow hood certification, pre-filter records, training,
and policies and procedures
http://health.state.tn.us/Boards/Pharmacy/index.shtml
December  2012

NABP Implements Action Plan to Assist States in Regulating Compounding Pharmacies

Supporting state board of pharmacy efforts to enforce compounding
regulations, NABP is implementing a four-part action plan centered
around inspection of nonresident compounding pharmacies and creating
an information-sharing network of regulatory details on such pharmacies.
Focusing on inspections of nonresident compounding pharmacies and
sharing this data among boards of pharmacy nationwide was determined
by NABP and its member state boards of pharmacy to be key to preventing
future tragedies like the current meningitis outbreak.
NABP developed the action plan at a November 2012 meeting of board
of pharmacy executive directors where the attendees expressed a strong
commitment to correcting system failures that allowed the meningitis
outbreak to occur, and implementation began quickly thereafter. The Iowa
Board of Pharmacy recently requested NABP to develop an inspection
program for entities that are licensed by the state as nonresident pharmacies
and dispensing compounded drugs in Iowa. Those in attendance expressed
their support of this inspection initiative, which became a cornerstone of
the four-part action plan.
In the first part of its action plan, NABP shared the list of nonresident
compounding pharmacies provided by the Iowa Board with other NABP
member boards of pharmacy and began coordinating the collection of
information on these pharmacies. The boards’ collaboration on this data
helped NABP identify the initial pharmacies to inspect. NABP believes that
the list provided by Iowa represents a significant number of nonresident
pharmacies dispensing compounded drugs across the country.
Implementing the inspection program is the second part of the action
plan and is currently underway. Initial results will reveal whether the selected pharmacies are compounding pursuant to a prescription in compliance
with state regulations, or instead are engaging in manufacturing. Entities
that refuse inspection may be subject to disciplinary action by the Iowa
Board and such actions will be shared with all of NABP’s member boards.
The third part of the action plan includes NABP collecting and maintaining data on the compounding pharmacies identified by the Iowa Board
and by other boards of pharmacy. Initial data collected from the boards
and the inspection reports will be stored in an NABP Pharmacy e-Profile,
allowing the Association to disseminate pertinent public information
among state boards. Ultimately, states will be able to submit inspection
reports and other related information to NABP for inclusion in pharmacies’
e-Profiles. The network will be made available at no cost to boards for use
in making licensure and registration determinations for pharmacies, and
may also help to identify pharmacies whose operations are more akin to
manufacturing than compounding.
As the final part of the action plan, NABP plans to schedule immediate
and ongoing training of board of pharmacy inspectors and compliance officers via Webinar and field training opportunities. NABP will also continue
cooperative efforts with Food and Drug Administration and legislators to
address the regulatory quagmire that exists when traditional compounding
is exceeded and manufacturing may be occurring.

Source found here

Office Use in South Dakota

Medication Requests for ‘Office Use’
The Board receives frequent advice from pharmacists
related to prescriptions the pharmacy may receive from a
prescriber indicating “for office use” on the prescription.
SDCL 36-11-2 (22) defines this. “Prescription drug order”
is a written or oral order of a practitioner for a drug or drug
device for a specific patient. Therefore, a prescription that
is not patient-specific is not valid. If a practitioner requests
medication from a pharmacy, this transaction is considered
a wholesale distribution. For non-controlled substances,
the invoice must contain the name, strength, and dosage
form of the medication, date of the transaction, and name
and address of the seller and the purchaser. For controlled
substances (CS), the record must contain all the information
stated above, as well as the Drug Enforcement Administration
(DEA) numbers of the both the seller and the purchaser.
If the medication is a Schedule II CS, the purchaser must
execute a DEA Form 222 to the seller prior to the transaction.
Records for CS transactions must be maintained in
a readily retrievable manner for a minimum of two years.

Source found in South Dakota Board of Pharmay Newsletter for January 2013 found here 

South Dakota Board of Pharmacy Compounding

From the South Dakota Board of Pharmacy Newletter for January 2013:

Staff Notes
As a result of the tragic events that occurred with the New England Compounding Center pharmacy in Framingham, MA, it is imperative that anyone compounding sterile products review their policies and procedures as it relates to the United States Pharmacopeia (USP) Chapter 797 document and ARSD 20:51:31 (Sterile Compounding Practices). The Board encourages you to print off the current version of USP Chapter 797. USP is making the document available free of charge on a temporary basis by visiting the following link: www.usp.org/usp-healthcare-professionals/
compounding/compounding-general-chapters/downloadusp-nf-general-chapter-pharmaceutical-compounding. If you are outsourcing sterile compounded products, the
Board would suggest that you visit the American Society of Health-System Pharmacists Web site (www.ashp.org) to review their Compounding Resource Center. They provide
guidelines on outsourcing sterile compounding services. It is essential for the safety of all patients that all the pharmacies that compound medications, regardless of setting, adhere to the very highest standards.

Source found here

Compounding Concerns for Animals Near and Dea

This article has been discussed here before but is so good I am resposting the link here

Fungal meningitis outbreak has slowed but isn't over yet

While the nation's fungal meningitis outbreak has slowed, it hasn't ended, according to health professionals.

Patients continue to seek treatment for meningitis-related symptoms more than four months into the outbreak, which has been linked to contaminated steroid injections given to treat back pain.

"We're seeing about two patients in, two patients out a day," said Laura Blodgett, a spokeswoman for Saint Joseph Mercy Hospital in Washtenaw County's Superior Township, which is the treatment center for local cases. "It's been holding steady."

As of Monday, 23 patients remained hospitalized at Saint Joseph Mercy.

While no new cases of cases of full-blown meningitis were reported in Michigan over the past six weeks, patients continue to seek follow-up care.

Patients also seek treatment for epidural abscesses, infections near spinal areas where the contaminated steroids were injected.

The number of abscesses and meningitis-related joint infections has continued to grow even as the number of cases of full-blown meningitis have leveled off.

Last week, the Michigan Department of Community Health reported three new cases of epidural abscesses. Medical professionals consider the abscesses dangerous because they could spread meningitis through a patient's body if left untreated.

Last week, the Michigan Department of Community Health reported three new cases of epidural abscesses. Medical professionals consider the abscesses dangerous because they could spread meningitis through a patient's body if left untreated.

According to the department, one of the 13 Michigan-related meningitis deaths has now been linked to an epidural abscess.

As of Friday, the department reported 232 overall cases including 64 cases of full blown meningitis, including 38 cases of meningitis with abscesses and 146 epidural abscesses alone. Other cases include 21 joint infections, including one with an abscess, and one meningitis-related stroke.

Meningitis is an inflammation of the membranes surrounding the brain and spinal cord.

Michigan Pain Specialists in Genoa Township was one of four Michigan facilities to have received the contaminated steroids.

The contaminated steroids were mixed at the New England Compounding Center, a now-closed facility in Framingham, Mass.

Michigan accounted for one-third of all cases recorded during the 19-state outbreak, according to figures released by the federal Centers for Disease Control and Prevention.

Source found here

Ed Silverman's Blog--KV Pharma Loses Another Battle Over Makena

Ed Silverman states at his Pharmalot blog on 1/4/13:

KV Pharmaceutical may have emerged from bankruptcy in hopes of marketing still more of its controversial Makena treatment for reducing the risk of premature births. But the troubled little drugmaker, which has consistently locked horns with the FDA, last week lost another battle with the agency over its efforts to fend off competition to its controversial drug.

This time, the FDA rejected a petition KV had filed in hopes of preventing agency approval of a generic version of Delalutin, an older version of Makena, or hydroxyprogesterone caproate. KV argued that the FDA should not approve a generic because this would violate its exclusive marketing rights for Makena under the Orphan Drug Act (here is the petition).

To continue reading this blog, click here

 

 

 

Veterinary compounding is one of the fastest growing areas of pharmaceutical compounding

In Extemporaneous Compounding Powerpoint Presentation by Debbie Walker, University of Florida, College of Pharmacy, she states that Veterinary compounding is one of the fastest growing areas of pharmaceutical compounding.  To view the entire power point, click here 

 

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