Sunday, September 1, 2013

UPDATED Question of the Day September 1, 2013 How Many Clinics Does a Compounding Veterinary Pharmacy Have to Sell To Before It is Considered Doing More than Traditional Compounding? This one claimed to sell to 9000 veterinary clinics nationwide in 2009 and 11000 in 2012.


Huntington mixes up the right prescription for Roadrunner Pharmacy

[PRESS RELEASE]  San Diego, CA, October 26, 2009 – Huntington Capital mixes up the right prescription for Eaton Veterinary Pharmaceutical, Inc. (dba “Roadrunner Pharmacy”).
Huntington Capital Fund II, LP (“Huntington”), a San Diego based private equity mezzanine fund focused on providing growth capital financing to established lower middle-market businesses throughout California and the Southwestern U.S., is pleased to announce its recent investment in veterinary compounding company Eaton Veterinary Pharmaceutical, Inc. (dba “Roadrunner Pharmacy”).  The purpose of the financing is to support growth and new product development. Founded in 1999, Roadrunner is one of the leading compounding pharmacies in the nation, providing veterinarians and their patients with off the shelf and custom pet medications. Unlike human medical doctors, veterinarians do not have the luxury of a wide variety of commercially available pharmaceuticals.  Eaton has a staff of highly trained pharmacists and prescriptions are compounded in house and shipped out next day air free of charge.
“Roadrunner is the exact type of growth opportunity that we are looking to support in this type of environment,” noted Huntington Partner Tim Bubnack.  “The company is led by an entrepreneur that has done a fantastic job of bootstrapping the business while successfully leading exponential growth over the last few years. In general, we believe that consumers are going to continue to spend money on non-discretionary type items, including medication for their household pets, no matter what is happening in the overall macro environment.  We continue to see this play out in the company’s overall performance.  Outside of their core business, we are also very excited about the potential of several FDA approved medications that are currently in development stage by the company.”
Eaton Veterinary Pharmaceutical, Inc (dba “Roadrunner Pharmacy”)
Roadrunner Pharmacy is one of the leading veterinary compounding pharmacies in the nation.  Located in Phoenix, Arizona, the company currently sells to over 9,000 veterinary clinics nationwide.  Roadrunner is committed to providing the highest quality custom medications at reasonable prices, with all new prescriptions shipped next day air free of charge.  For more information, please visit the company website at www.roadrunnerpharmacy.com.
Huntington Capital
Based in San Diego, CA, Huntington Capital is a leading mezzanine capital provider to lower middle market companies throughout California and the Southwestern United States.  Founded in 2000, Huntington is currently operating out of its second fund, Huntington Capital Fund II, which it raised in 2008 with $78 million in capital commitments from a group of leading institutional investors.  Huntington seeks to invest in established lower middle market businesses generating between $10 million and $75 million in revenues across a broad range of industries; investments are typically structured in the form of growth capital, buyout or acquisition financing ranging between $1.0 million and $6.0 million.  The firm has invested in approximately 35 companies since its founding.  Partners Morgan Miller, Barry Wilson and Tim Bubnack lead Huntington’s management team. For more information, please visit the company website at www.huntingtoncapital.com.
quoted from here

See here for figure of 11000 in 2012

HUMAN-ANIMAL MEDICINE: COMMUNICATING ACROSS THE SPECIES DIVIDE



On June 25th, 2013, the Animal Health Institute (AHI), along with the American College of Preventive Medicine and the Association of American Veterinary Medical Colleges brought together physicians, veterinarians, policymakers, academics and industry stakeholders for a panel discussion. The event on Capitol Hill focused on the nexus between human and animal health and examined the differences and similarities between physicians and veterinarians knowing that they treat different types of “patients.”
AHI recently posted several videos from the discussion.
A video recap of the event is available on our YouTube Channel.
For individual presentations, please visit the event page on healthyanimals.org.

Pharmacists: Partnering with physicians to curb the national prescription drug abuse crisis


Editorial for Special Pain Section
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Recent American Medical Association (AMA) resolutions addressing the increase in verification calls received from pharmacists about controlled substances describe such calls as “inappropriate interference with the practice of medicine.” These resolutions additionally call for legislative advocacy to stop pharmacists’ request for patient information when determining prescription legitimacy. While it’s important to note that the AMA is working closely with professional pharmacy organizations, including the American Pharmacists Association, to address concerns, it’s equally imperative that we understand the events leading up to this impasse.
For nearly a decade, Florida has been recognized as the “pill-mill” capital of the United States. Efforts by law enforcement to combat this plague largely failed prior to the establishment of the Florida Prescription Drug Monitoring Program (E-FORCSE). “Pain management” clinics thrived, and millions of doses of the drugs oxycodone, morphine, hydrocodone, hydromorphone, methadone, and alprazolam were prescribed and subsequently dispensed at local pharmacies. As Walgreens is the nation’s largest pharmacy chain, inevitably many of these local pharmacies were units of Walgreens.
In an unprecedented move, DEA in September 2012 halted shipments from the Jupiter, FL–based Walgreens distribution center and suspended registration. DEA cited “failure to maintain effective controls against the diversion of controlled substances into other than legitimate medical, scientific, and industrial channels.” Furthermore, the Settlement and Memorandum of Agreement (MOA) between DEA and Walgreens cited alleged “dispensing … of controlled substances to individuals Walgreens knew or should have known were diverting controlled substances …” Among other stipulations of this MOA, Walgreens agreed to implement numerous policies and programs that ultimately ensure that controlled substances only be dispensed for a legitimate medical purpose or by a practitioner acting within the usual course of medical practice.  
continue to read here

As Congress addresses compounding pharmacies


M. Keith Hodges, owner of Gloucester Pharmacy and a member of the Virginia House of Delegates, writes in “First, do no further harm”:
As a pharmacist and small business owner, I can tell you for certain that provisions in a well-intended Senate proposal (S. 959) would hinder the ability of independent pharmacists across the country to compound medications for their patients who might not be able to get these vital prescriptions anywhere else.
Additionally, the measure would require pharmacies to report directly to the Food and Drug Administration when they are compounding medications to alleviate a drug shortage. State boards of pharmacy regulate the practice of pharmacy in each state. During the H1NI outbreak several years ago, when Tamiflu was in short supply, independent pharmacies utilized their compounding expertise to fill the void for countless children. As drug shortages continue to skyrocket with no relief in sight, Congress must make certain that patients receive all necessary medications in a timely manner, not create further delays by adding additional federal bureaucracy.
Niels Erik Hansen, president and CEO of Intelligent Hospital Systems in Winnipeg, writes in “Technology can make compounding safer”:
Medication compounding is a common practice in hospitals and pharmacies. Physicians prescribe combinations of medicines that are mixed in a single syringe or IV bag for a specific patient. To make these compounds accurately and safely, pharmacists must measure and combine drugs with meticulous care — for example, diluting a few milliliters of one drug and adding an equally small quantity of another. But despite the best efforts of pharmacy workers to mix medications perfectly, humans are not perfect.
One of the biggest advantages automated pharmacy compounding technology provides is removing the primary source of contamination and error — humans — from the compounding process. And automated compounding systems deliver many more benefits than the ability to make highly precise sterile compounds exactly right every time.
- See more at: http://blogs.roanoke.com/roundtable/2013/09/as-congress-addresses-compounding-pharmacies/#sthash.Si0OI6PO.dpuf

Technology can make compounding safer



Last year’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risks inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened almost 750 people and killed more than 60.

Virginia was one of 20 states impacted, with 54 cases of illness and five deaths. As this paper reported, some of those who became ill continue to struggle with symptoms almost a year later.

Although this outbreak is an egregious example of medication compounding gone awry, it is hardly an isolated incident. In addition to product recalls from compounding pharmacies in Georgia, Florida, Indiana, Nevada, New Jersey and Texas, among others, the Food and Drug Administration continues to investigate adverse patient reactions to steroid injections produced by a compounding pharmacy in Tennessee.

In December, the journal American Health & Drug Benefits reported that medication errors from injectable drugs harm more than 1 million patients annually in U.S. hospitals. Adverse drug events due to injectable medications cost U.S. health care payers between $2.7 billion and $5.1 billion annually, an average of $600,000 per hospital.

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Boundary Violations by Pharmacists--Crossing the Line by having Personal Relationships--Great Reminder by Dale J. Atkinson in Article Entitled Pharmacist Fills More than Just Prescriptions


Legal Briefs: Pharmacist Fills More than Just Prescriptions

 Topics: Pharmacists
By Dale J. Atkinson 
Originally published in the August 2013 NABP Newsletter 
Many licensed professionals are subject to codes of ethics and other standards of practice that limit and, in some cases, prohibit personal relationships with patients/clients. Indeed, such boundary violations are far too common in many of the mental health professions whereby a personal relationship ripens out of the professional relationship. In most cases, a specified period of time must expire between the termination of the professional relationship and the beginning of the personal one. Under some circumstances, such as a clinical relationship, a personal relationship may be forever prohibited. Of course, violations of boundary parameters subject licensees to administrative prosecution and ultimately to adverse actions against licenses.
Similarly, pharmacists have a unique relationship with patients, including access to confidential and sensitive information. Pharmacists are placed in a position of trust regarding medical conditions and treatments thereof. While apparently not commonplace in the sphere of pharmacy practice as illustrated by the lack of published case law, boundary violations are certainly a possibility.
The full article, which reviews a case involving a pharmacist using patient information to pursue a personal relationship, is available in the August 2013 NABP Newsletter (PDF; pages 148-149).

Idaho Board of Pharmacy Recent Board Discipline



R.P., DO: CS registration revoked pursuant to Board of Medicine order.
K.N., PA: CS registration restricted pursuant to Board of Medicine order.
L.L., MD: CS registration revoked pursuant to DEA registration lapse. J.A., PA: CS registration revoked pursuant to Board of Medicine order. L.H., PharmD: License and CS registration revoked for diversion. J.M., Pharmacy Technician: Registration revoked for diversion. C.M., Pharmacy Technician: Registration revoked for felony
burglary convictions.
L.M., RPh: License and registration restricted for five more years
for not following an order of the Board, for Pharmacy Recovery
Network noncompliance.
L.W., RPh: Fined $5,000 and completion of three additional CPE
hours for illegally accepting the return of prescription drugs for
a period of five years.
R.L., PharmD: $500 fine and an additional six CPE hours for
failing to follow the instructions of a person writing, making, or ordering a prescription. 

quoted from Idaho Board of Pharmacy September 2013 Newsletter

Idaho Board of Pharmacy 2014 Proposed Rules


2014 Proposed Rules
The Board has held four negotiated rulemaking sessions in 2013, mostly focused on compounding rules in the wake of the New Eng- land Compounding Center tragedy and post-2013 changes to non- resident drug outlet law. Other rulemaking topics include secured delivery rooms and limiting Board-approved continuing pharmacy education (CPE) programs. The Board is very thankful for the im- mense amount of public input that has helped form these proposed rules, which are posted on the Board’s Web site. Upon printing of the proposed rules in the October Idaho Administrative Bulletin on October 2, 2013, a 21-day comment period will commence. On the 21st day, October 23, 2013, the Board will meet at the Idaho State Capitol to hear final verbal comments at an open public meeting. Written comments may be submitted to the Board at any time during the 21-day comment period. The Board will consider all comments on October 24, 2013, post the resulting pending rules on its Web site, print the pending rules in the January Idaho Administrative Bulletin, and request approval by the 2014 Idaho Legislature.
quoted from Idaho Board of Pharmacy September 2013 Newsletter 

Idaho Board of Pharmacy--Pharmacy Provision of Prescription Blanks



The Idaho State Board of Pharmacy has reviewed and consid- ered the provision of pre-printed, hard copy prescription drug order blanks containing compounding formulas, by a pharmacy to a prescriber, and has concluded it is legal. However, considering the best interest and safety of the public, the Board has concluded that the provision of hard copy prescription blanks containing pharmacy-specific information, such as pharmacy name or address, is prohibited. In reaching this conclusion, the Board considered the following law:
504. UNLAWFUL ADVERTISING.
01. Unlawful Advertising or Inducements. A licensee or registrant may not promote or induce, directly or indirectly, the provision of professional services or products through the dissemination of a public communication that contains a false, misleading, or deceptive statement or claim.
The Board’s decision is based upon the determination that the inclusion of pharmacy-specific information on such a prescription blank creates too great of a risk of being “misleading” or “decep- tive,” as the patient would likely be led to believe that his or her prescription drug order may only be dispensed by that specific pharmacy.
The Board also cautions pharmacies that engage in such provision of blanks containing controlled substances (CS), that blanks for CS are required to be on non-copyable paper as per Section 37-2725, Idaho Code, and that they may be deemed by Drug Enforcement Administration (DEA) to have been illegally prepared for the pre- scriber’s signature by someone other than the prescriber’s agent. 

quoted from Idaho Board of Pharmacy September 2013 Newsletter

Iowa Board of Pharmacy Update on Epilepsy Medications



A committee of the Board met with representatives of the Iowa Epilepsy Treatment & Education Task Force on June 12, 2013. The discussion focused on the proper handling of prescriptions for brand-name products, generic products, and branded generic products. The advantage of having the patient’s diagnosis on the prescription was also discussed. All parties agreed on the following course of action: (1) clarify, in Board rules, the difference between generics and branded generics vis-à-vis Iowa’s law for drug product selection; (2) clarify the proper method for dispensing products from morethan one company in a single prescription due to a drug short- age or other extenuating circumstance (ie, mixing two different generic products in the same prescription vial); and (3) educate pharmacists on the need to notify prescribers whenever a change is made in the dispensing of a patient’s epilepsy medi- cations. The Board will publish proposed changes in rules as soon as they are available and will continue to work with the members of the Epilepsy Task Force to resolve dispensing is- sues and ensure patient safety. A recent study in the Journal of the American Medical Association Internal Medicine has concluded that “changes in pill color significantly increase the odds of nonpersistence; this may have important clinical implications. Our study supports a reconsideration of current regulatory policy that permits wide variation in the appearance of bioequivalent drugs.”
Source: “Variations in Pill Appearance of Antiepileptic Drugs and the Risk of Nonadherence,” JAMA Intern Med. 2013; 173(3): 202- 208. Background: “Generic prescription drugs are bioequivalent
to brand-name versions but may not have consistent color or shape, which can cause confusion and lead to interruptions in medication use. This study sought to determine whether switching among different-appearing antiepileptic drugs (AEDs) is associated with increased rates of medication nonpersistence, which can have serious medical, financial and social consequences.


quoted from the Iowa Board of Pharmacy September 2013 Newsletter