Monday, March 3, 2014

BOCA RATON, Fla.: TherapeuticsMD Reports Fourth Quarter and Full-Year 2013 Results - Medical - MiamiHerald.com

BOCA RATON, Fla.: TherapeuticsMD Reports Fourth Quarter and Full-Year 2013 Results - Medical - MiamiHerald.com

Question of the Day March 3, 2014 Should the number of states a compounding pharmacy is licensed in be a factor in determining how often states conduct inspections on that pharmacy because the risk of more wide-spread harm to public safety is greater?


Zynex Non-Sterile Compound Pharmacy Attains Licensing in 19 States

(Marketwired) -- 03/03/14 -- Zynex, Inc. (OTCQB: ZYXI), a medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, neurological diagnostics, and compound pharmacy, announced today that its subsidiary Zynex Medical, recently received its 19th state license for its non-sterile compound pharmacy.
Zynex Medical's compound pharmacy sells non-sterile topical and transdermal pain creams through its existing sales force. The market for pain cream has many similarities to the electrotherapy business, requiring a doctor's prescription and providing a recurring revenue stream. Zynex believes the market for topical and transdermal pain cream represents a $2 billion opportunity in the United States and the Company intends to be licensed in all 50 states by mid to late 2014.
Thomas Sandgaard, Zynex President and CEO, commented, "Compounded, non-sterile topical and transdermal pain creams complement our existing electrotherapy products and further diversify our offerings, allowing us to be a full service, non-invasive pain management company. We introduced topical and transdermal pain creams to our existing Zynex Medical electrotherapy sales force late last year, targeting in particular pain management doctors and physical therapists in the rehabilitation segment, where we already have a strong market presence. We believe this is a great opportunity for revenue growth beyond our traditional electrotherapy products."

About ZynexZynex, founded in 1996, operates under five primary business segments: Zynex Medical, NeuroDiagnostics, Monitoring Solutions, International, and Billing and Consulting. Zynex Medical engineers, manufactures, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation. Zynex Medical's product lines are fully developed, FDA-cleared and commercially sold world-wide. Zynex Medical also operates a non-sterile compound pharmacy providing topical and transdermal pain creams. Zynex NeuroDiagnostics sells the company's proprietary NeuroMove device designed to help recovery of stroke and spinal cord injury patients, and is expanding into markets for EMG, EEG, sleep pattern, auditory and nerve conductivity neurological devices through product development and acquisitions. Zynex Monitoring Solutions, currently in the development stage, was established to develop and market medical devices for non-invasive cardiac monitoring. Zynex International is dedicated to supporting sales and marketing of Zynex products worldwide through a network of medical distributors. Zynex Billing and Consulting division provides medical billing and consulting service for offices and hospitals.
For additional information, please visit: www.ir-site.com/zynex.
Safe Harbor StatementCertain statements in this release are "forward-looking" and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the ability to obtain state pharmacy licenses, the need to obtain additional capital in order to grow our business, our ability to engage additional sales representatives, the success of such additional sales representatives, the need to obtain FDA clearance and CE marking of new products, the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement from insurance companies for products sold or rented to our customers, acceptance of our products by health insurance providers, our dependence on third party manufacturers to produce our goods on time and to our specifications, implementation of our sales strategy including a strong direct sales force, the uncertain outcome of pending material litigation and other risks described in our filings with the Securities and Exchange Commission including the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2012.

Investor Relations Contact:
303-703-4906

I have posted this paper several times before but it is really one of the must reads on Drug Compounding for Veterinary Patients--


Submitted: September 23, 2004; Accepted: September 27, 2004; Published: September 22, 2005.
Mark G.Papich
11
Diplomate American College of Veterinary Clinical Pharmacology, North Carolina State University, College of Veterinary Medicine, Raleigh, NC 27606
 
read here

McGuireWoods LLP 2014 OIG Work Plan Released: Our Observations on Enforcement Part !

read here

Sunday, March 2, 2014

Drug Compounding by Dr Colleen Currigan (benefits for animals)

Drug compounding is not new, but there have been some recent high profile events, both in the human and the veterinary world, that have brought the issue back into prominence. These include the 2009 deaths of 21 polo ponies at the U.S. Open Polo Championship in Florida after an error was made when mixing a compounded medication for the ponies, and most recently the 2012 outbreak of human fungal meningitis, when contaminated medication was dispensed to physicians around the country from New England Compounding Center. These events may lead to legislative changes that affect the compounding of medications in veterinary medicine and those changes could impact the prescribing of medications for cats.
What exactly is ‘compounding’? My recent involvement on the American Veterinary Medical Association’s (AVMA) Clinical Practitioners Advisory Committee has taught me a lot about the ins and outs of compounding. The AVMA is working hard to educate veterinarians and pet owners about compounding by posting information on their website, www.avma.org, as well as holding educational webinars for veterinarians. Much of the information that I am including in this blog article came from the AVMA. Below are some compounding facts:
  • Compounding is the manipulation of a drug beyond that stipulated on the label. Examples include mixing, diluting, concentrating, flavoring, or changing a drug’s dosage form, in order to tailor the drug for a specific patient. In the cat world, compounded medications are widely used. Why?
    • Many of the drugs that we prescribe are not available in a strength that is appropriate for a cat. Thus manipulation of that drug is the only way we can dose it correctly for a feline patient
    • Knowing that cats can challenge the best of us when it comes to being medicated, unless we can somehow manipulate a drug to make it more acceptable to the cat (‘if it’s tuna flavored, I’ll consider it’), we run the risk that some of our patients simply will not get needed medication.
    • In other cases, a patient may resist oral medications altogether, no matter how the medication is manipulated. In these cases, there are some medications that can be made up into a gel that can be applied topically on the inside of the cat’s ear (known as a ‘transdermal’ or ‘across the skin’ application of drug). A very limited number of drugs have been studied and shown to work when given by this route, but one that is used commonly to treat overactive thyroid conditions in cats (methimazole) usually works quite well when given by the transdermal route.
  • Compounding is regulated by both the federal government (FDA, or Food and Drug Administration) and state governments.
  • Compounded drugs are not the same as generic drugs! A generic drug is a non-brand-name version of a drug. Generic drugs are approved by the FDA.
  • Compounded drugs are not FDA approved drugs. Even though compounding involves manipulating or tweaking already approved FDA drugs, when a drug is compounded, the new form may or may not perform in the same way as the approved drugs.
  • continue to read here

Body-builders, slimmers misusing veterinary horse drug Clenbuterol, health experts warn

Health experts are warning that a veterinary drug misused by some elite athletes is increasingly being abused by the general public.
The latest issue of the Medical Journal of Australia reveals there have been 63 cases of people overdosing on Clenbuterol in the past decade among the general public.
The number of cases increased from three in 2008 to 27 in 2012, according to the journal.
The prescription-only drug is legally used to help with breathing problems in horses.
Because of its anabolic properties, it has also been abused by some elite athletes in the past to boost their performance, leading to an official ban by the World Anti-Doping Agency and the International Olympic Committee.
Cyclist Alberto Contador and sprinter Katrin Krabbe were both banned for abusing Clenbuterol.
The medical journal says the drug's use has now spread to body-builders and slimmers.
Dr Jonathon Brett from Sydney's Royal Prince Alfred Hospital says the drug is often taken in high doses, and more than 80 per cent of people who abused the drug ended up in hospital.
He has called for its sale to be restricted.
Patients presenting with an overdoses have symptoms such as nausea, diarrhoea, vomiting, chest pains and other cardiac issues.
The medical journal says there has been one case of cardiac arrest.
quoted from here

Do horse racing officials in the U.S. need to do more to prevent doping?

take or check out results of survey and the comments being posted here

Horse Doping: Steroid action shows only way to stop drugs is frequency of testing


  • continue to read here

    1099 Sales Rep Positions for Compounding Pharmacy--Openings in TX, FL, AL, and SC

    Job description

    Company Description:

    Job Description:

    We represent a rapidly growing Compounding Pharmacy.

    We are looking for reps to market compounded medications to physicians.

    We offer the best/highest commissions in the industry. Full-time and Part-time reps are needed.
    This is a 1099 commission only position.

    Bring your business to us.

    We are presently looking for reps in TX, FL, AL and SC.

    We are licensed in many states and are rapidly growing.

    We work with every major insurance company. Additionally, we also accept Tricare and Medicare.

    We are looking for reps with existing compound business or experience selling in the pharmaceutical/medical field. Specialties include, but are not limited to:

    Dermatology
    Podiatry
    Pain Management
    Physiatry
    Rheumatology
    Obgyn
    Primary Care
    Internal Medicine
    Orthopedic Surgery
    Neurosurgery
    Wound Care
    General Surgery
    Neurology
    Pulmonology

    Please call or email for more information.

    561.450.9414
    physiciansfirstenterprises@gmail.com