Monday, June 2, 2014

fei: Anti-Doping & Controlled Medication

The use of substances with the potential to affect equine performance, health or welfare and/or with a high potential for misuse are contrary to the integrity of equestrian sport and the welfare of the horses.
The FEI provides a list of substances prohibited for use in horses competing at FEI events – the FEI Equine Prohibited Substances List. This list consists of two groups of substances: banned and controlled medication. Banned substances are not permitted for use in horses competing. Controlled medications are acknowledged as substances with therapeutic veterinary benefits but are not permitted during FEI events because of the potential for their misuse.
Testing programmes and protocols are implemented to detect the presence of prohibited substances in horses competing. Urine and/or blood samples from horses tested are sent by courier to one of five FEI Laboratories.
Negative blood and urine analysis results within the programme are updated regularly on the website for Groups I and II only and can be accessed here.
Before giving any substance to a horse competing at FEI events, athletes and their support personnel should always check, if it is prohibited under the FEI Rules by using the FEI Prohibited Substances database. They should work with veterinary advisers to establish a safe withdrawal time before competing. Horses must never compete unless they are fit to do so. During events, the administration of treatments and supportive therapies must be authorised by the veterinary delegate or commission before administration, using the appropriate veterinary form. The veterinary forms are available by clicking here.
Permitted Substances of interest to equine feed industry
 
The FEI Rules and Regulations permit the use of certain substances such as:
  • B-vitamins, amino acids and electrolytes. These have always been allowed orally and in many cases this is still the preferred route of administration. However in some circumstances a veterinarian may prefer to administer them intravenously or intramuscularly.
     
  • Preventative or restorative joint therapies. Many of these products in the oral form (chondroitin, glucosamine, etc.) have always been allowed orally and in many cases this is the preferred route of administration. However in some circumstances a veterinarian may prefer to administer joint restorative therapy intravenously or intramuscularly. 
The FEI cautions however athletes, trainers, grooms and veterinarians against the use of herbal medications, tonics, oral pastes and products of which the detailed ingredients and quantitative analysis are unknown and could therefore contain one or more Prohibited Substances.  Moreover, the persons administering a herbal or so-called natural product to a horse or pony for health reasons or to affect its performance, who have been informed that the plant of origin or its ingredients do not violate the FEI regulations, may have been misinformed. The use of any herbal or natural product to affect the performance of a horse or pony in a calming (tranquillizing) or an energizing (stimulant) manner is expressly forbidden by the FEI regulations. The use of a calming product during competition may also have important safety consequences.
 
 
 
 
For the latest Equine Anti-Doping and Controlled Medication Regulations in place, please click here.
For medication control at FEI events, please refer to the Veterinary Regulations. We have added for your convenience the following educational documents:  Athletes' Guide to Anti-Doping (pdf) and How Testing Works (pdf).
Information on FEI Laboratories:
Other useful links:

60 Minutes Sports on Showtime Cleaning Up Horse Racing to Be Shown on June 4, 2014

watch preview video here

FDA Warns More Compounders Under New Authority in DQSA

 

Jun. 02, 2014

The FDA has warned two more compounding pharmacies for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities.
Read More

HORSE DOPING- A Compounded Tragedy by Rick Dennis June 2, 2014

Recently HBO aired a segment of Real Sports with Bryant Gumbel featuring a documentary on Horse Doping and its effects on Thoroughbred horses on the racetrack.
Besides exposing yet another ominous side of the horse industry, the documentary illustrated the abuse horses are receiving in the “The Sport of Kings” for the amusement and satisfaction of horse owners, track owners, trainers and spectators alike from modern drug preparations.

The outright disgusting side of the sport is clearly illustrated by a horse being put down on the far side of a racetrack. A simple hole was dug in the ground that contained the carcasses of euthanized horses. Not a very pleasant site for the general audience, especially animal lovers!  Notwithstanding, the main theme of the documentary is horse doping and its adverse effects drugs have on the on the racehorse.

continue to read here

Louisiana shelves execution secrecy law

A bill in Louisiana that would have given the state one of the toughest execution secrecy regimes in the US has been pulled by its Republican sponsor at the last minute.
Observers had expected the bill, HB 328, to go through without difficulty. It had already received the approval of both houses of the state legislature and was awaiting final agreement on amendments. Among its provisions HB 328 would have prevented the public from knowing the source of the state's lethal injection drugs.
But with just hours to go before the end of the assembly's legislative session its proposer, Joe Lopinto, killed the bill unilaterally. He told reporters from local papers that he had decided in the wake of the recent uproar over botched executions in other states to play a longer game.
“We passed a resolution today to study this issue. There’s no reason for us to rush through and pass piecemeal legislation that will only be a short-term fix for something that needs a long-term solution,” Lopinto told the Shreveport Times.

continue to read here

CVS Hiring Compounding Pharmacist

Job: Pharmacist - Infusion Compounding



Click Here toApply Online
Map DataMap data ©2014 Google
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Recruiting In, Tampa, FL 33634
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Posted: 06/02/2014
Job Status: Full Time
Job Reference #: 169758BR

Jobing Description

Pharmacist - Infusion Compounding

Req ID 169758BR

Business Area Coram CVS/specialty infusion services

Job Category Pharmacist

Position Summary
Join the Coram CVS/specialty infusion services team as a Pharmacist working on the infusion compounding team. As part of an industry leader you'll support a business that provides cost-effective solutions and high-quality patient care for those receiving specialized and complex therapies administered in their homes.

Key responsibilities
* Obtain, interpret and evaluate all physician medication orders for therapeutic appropriateness, cost effectiveness, accuracy, safety and completeness.
* Participate in patient evaluation for acceptance, product selection, device selection and supply management.
* Directly supervise pharmacy support personnel in the appropriate compounding, packaging and labeling of compounded sterile products.
* Check compounded sterile products, computer order-entry and manage the pharmacy clean room suite to 797 requirements.
* Communicate clinical and technical information with other members of healthcare team.
* Assist in training and orientation of new employees, performance improvement activities and educational programs. Participate in on call rotation as indicated by staffing and business needs.

Required Qualifications
* Registered Pharmacist with current license in state of employment. Additional licensure may be required in multi state service areas.
* Minimum 1 year infusion therapy compounding experience.
* Must have and maintain current CPR certification if in direct contact with patients.
* Excellent customer service skills (written and verbal) a must.

Preferred Qualifications
* Home healthcare infusion therapy compounding experience preferred.

Education
B.S. or doctorate of pharmacy degree
Clinical Licensure Required Pharmacist

Job Type Full Time

Business Overview
Coram CVS/specialty infusion services is a leading national provider of specialty home infusion and specialty pharmacy services. The integration of Coram into CVS Caremark enables the company to offer enhanced, comprehensive infusion services; expanded payer access; and a national network of more than 85 locations, including 65 ambulatory infusion suites. Providing infusion therapies and services to over 20,000 patients each month, Coram cares for patients through all phases of their healthcare continuum, with services including clinical and compliance monitoring, and individual patient counseling and education.CVS Caremark, through our unmatched breadth of service offerings, is transforming the delivery of health care services in the U.S. Our energetic and service-oriented colleagues make a positive difference in the lives of our patients. As the nation's largest pharmacy health care provider, we offer exciting career opportunities embracing fresh ideas, new perspectives, a diversity of experiences, and a dedication to service to meet the needs of the many people and businesses relying on us each day.CVS Caremark is an equal opportunity employer. We do not discriminate in hiring or employment against any individual on the basis of race, color, gender, national origin, ancestry, religion, physical or mental disability, age, veteran status, sexual orientation, gender identity or expression, marital status, pregnancy, citizenship, or any other factor protected by anti-discrimination laws. Furthermore, we comply with the laws and regulations set forth in the following EEO is the Law Poster: EEO IS THE LAWFederal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. If you require assistance to apply for this job, please contact us by clicking
AA EEO CVS Caremark

Skills / Requirements

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Pfizer to pay $325M fine to third party payers • 8:39 PM

 
  • Without admitting wrongdoing, Pfizer (PFE +0.3%) agrees to pay $325M to certain third party payers to settle allegations that it defrauded insurers and other healthcare benefit providers by marketing Neurotonin for unapproved uses.
  • On April 21, the company agreed to pay $190M to settle litigation in New Jersey. The case was brought by Neurotonin buyers who accused it of taking steps to keep cheaper generic versions of the drug off the market.
  • In May 2004 PFE agreed to pay $430M and plead guilty to criminal charges for illegally marketing Neurotonin for unapproved uses.
  • The company acquired Neurotonin when in bought Warner-Lambert in 2000.
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Recalls, Market Withdrawals, & Safety Alerts Alexion Initiates Voluntary Nationwide Recall of Certain Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion Due to the Presence of Visible Particulate Matter in a Single Lot

Recalls, Market Withdrawals, & Safety Alerts Alexion Initiates Voluntary Nationwide Recall of Certain Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion Due to the Presence of Visible Particulate Matter in a Single Lot

Oklahoma: OSU and OVMA Summer Seminar June 6-7, 2014

more information found here

FDA Imports Modified in the Past 7 Days--Including Domperidone and other items


Import Alert
 
Desc Text
 
URL
IA-04-06
Detention Without Physical Examination and Surveillance of Enriched Pasta Products for Standard of Identity
IA-16-39
Detention Without Physical Examination of Processed Seafood and Analogue Seafood (Surimi) Products for Listeria Monocytogenes
 
IA-16-74
Detention without physical Examination of *** Uneviscerated Fish Or Partially Eviscerated Fish that are either Sat-Cured, Dried, Smoked
Acidified, Pickled, Fermented or Brined
 
IA-16-81
Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella
IA-25-05
Detention Without Physical Examination of Dried Fungus (Mushrooms) from Hong Kong and PROC for Filth
IA-45-02
Country Wide with Firms exempt - Attachment B containing illegal or undeclared colors(green List)
IA-45-02
Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors
IA-52-01
Detention Without Physical Examination of Brassware From India
IA-53-06
Detention Without Physical Examination Of Cosmetics Containing Illegal Colors
IA-54-15
DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM
IA-61-07
Detention Without Physical Examination of Domperidone
 
IA-66-13
Eagle Brand Medicated Oil Mfr. By Borden Co., Ltd, Singapore and imported by Anhing Cor.Los Angeles and is the new formulation of the product is exempt from detention as an unapproved new drug.
 
IA-66-41
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
IA-78-01
Detention Without Physical Examination Of Penis Enlargers And Erection Maintaining Rings
IA-80-04
Attachment B - Warning Letters Issued (Level 3) - Continued defects and violative analyses
IA-86-07
Detention Without Physical Examination of and Guidance for *** Impact-Resistant Lenses in Eyeglasses and Sunglasses ***
IA-86-11
DETENTION WITHOUT PHYSICAL EXAMINATION OF CONTACT LENSES DUE TO MICROBIOLOGICAL CONTAMINATION
IA-89-16
Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection
IA-99-05
Detention Without Physical Examination Of Raw Agricultural Products for Pesticides
IA-99-08
Detention Without Physical Examination Of Processed Foods for Pesticides
IA-99-19
Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella
IA-99-20
Detention Without Physical Examination Of Imported Food Products Due to NLEA Violations
IA-99-23
Detention Without Physical Examination Of Raw Fresh Fruits And Vegetables Due To The Presence Of Pathogenic Contamination
 
IA-99-30
Detention Without Physical Examination of All Milk Products, Milk Derived Ingredients and Finished Food Products Containing Milk from China
Due to the Presence of Melamine and/or Melamine Analogs
 
IA-99-34
DWPE of Drugs or Medical Devices from Firms without a Valid Drug or Medical Device Registeration
None

Kansas collaborative practice law becomes effective July 1, 2014

Hub on Policy and Advocacy
A new collaborative practice law in Kansas will become effective July 1, 2014. The state’s Gov. Sam Brownback signed Senate Substitution for HB 2146 into law on April 10, 2014, adding Kansas to the current national count of 48 states and Washington, DC, in which pharmacists have some kind of collaborative practice authority.
 
continue to read here

Pharmacist Steve: Clarification on HIPAA lawsuit against Walgreens

http://pathologyblawg.com/medical-news/clarification-on-hipaa-lawsuit-against-walgreens/

From the article:
Since HIPAA does not have a private right of action, common folks like you and I cannot use HIPAA directly in a privacy lawsuit, only the government can sue with HIPAA (civilly and criminally I might mention).  What private citizens have been doing, though, is proving to the court that if a HIPAA violation occurred, then this violation serves as a breach of duty by the health care professional in negligence cases, fiduciary duty cases, and straight forward violation of privacy cases.
Second, in a 2006 state court case (attached), the North Carolina Court of Appeals allowed HIPAA to be used to demonstrate the standard of care element in a psychiatric privacy case where the plaintiff sued for negligent infliction of emotional distress.  If one can use HIPAA as the standard of care and show HIPAA was violated, then the next logical step is that the health care professional breached a duty owed to the plaintiff by violating the standard of care.  After that, all that remains is proving damages.
As healthcare providers consolidate.. and pharmacy is no exception.. I would suspect that >50% of the “doors” are under the logo of maybe a dozen different names… the “pockets” tend to get “deeper”.. and attorneys love “deep pockets”.. We all know that HIPAA violations are part of the daily grind in the the Rx dept..
It is common knowledge that the surplus of attorneys makes the surplus of Pharmacists a non issue.. and how many of these HIPAA violations will just be settled.. however.. if you are a Pharmacist or a tech in a state that requires licensing.. and you are involved in “violating a standard of care”… could you also be brought before the BOP for unprofessional conduct ?

quoted from Pharmacist Steve blog post found here

APhA opposes DEA proposal to reschedule hydrocodone

n opposing DEA’s proposal to reschedule hydrocodone combination products from Schedule III to Schedule II, APhA’s government affairs team led the development and submission of a joint pharmacy stakeholder comment letter to the agency.
The joint pharmacy comments acknowledge the seriousness of prescription drug abuse but emphasize that rescheduling may not have an effect on decreasing abuse and would have a negative impact on legitimate patient access to these effective pain medications. 
The letter was signed by the American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, Academy of Managed Care Pharmacy, APhA, American Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, National Association of Chain Drug Stores, and National Community Pharmacists Association.
“It is important to remember that the vast majority of patients taking hydrocodone do so legitimately,” wrote the pharmacy associations. They highlighted that stricter requirements for Schedule II drugs related to prescribing and dispensing would restrict patient access and delay relief of pain, and that rescheduling hydrocodone combination products would introduce inefficiencies into the health care system and increase costs “at a time when policy makers are seeking ways to streamline processes and reduce costs.”

DEA rulemaking under way

DEA has begun the formal rulemaking process following a reclassification recommendation from the U.S. Department of Health & Human Services (HHS). The rescheduling of hydrocodone combination products was initiated by a petition from a physician in 1999, according to a DEA news release. In January 2013, an FDA advisory committee voted in favor of reclassification. In December 2013, HHS sent that recommendation to DEA. 
On February 27, DEA published in the Federal Register a proposed rule concluding that such medications “have a high potential for abuse, and abuse may lead to severe psychological or physical dependence.” Comments were due April 27. DEA is now evaluating the feedback from stakeholders.

NACDS joint letter

Also in response to the proposed rule, the Association signed the National Association of Chain Drug Stores’ (NACDS) joint letter that was cosigned by a number of pain-related advocacy groups outside of pharmacy.

Zohydro ER controversy continues

FDA’s approval of hydrocodone bitartrate extended-release capsules (Zohydro ER—Zogenix), a single-ingredient opioid without an abuse-resistant formulation, as a Schedule II controlled substance came on October 25, 2013—a day after the agency announced its intent to recommend that DEA reschedule hydrocodone combination products. On December 7, 2012, FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 11–2, with 1 abstention, against approval of the drug.
continue to read here

KUDOS! Must Read! OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

FDA seeking Expert Consultants for Priority Projects

Help Wanted: FDA Seeks Expert Consultants For Priority Projects / Agency is soliciting consultants who can provide technical assistance on such tasks as developing track-and-trace standards for drugs or analyzing Risk Evaluation and Mitigation Strategies. / “The Pink Sheet” June 2 2014 12:01 AM

FDA's Spring Regulatory Agenda Includes Compounding

FDA’s Spring Regulatory Agenda Includes 17 Rx Drug-Related Rules / FDA’s prescription drug regulations in the works include rules on generic drug labeling, compounding, bioequivalence reports and safety reporting for combination products. / “The Pink Sheet” June 2 2014 12:01 AM
 

June 2, 2014, 8:35 a.m. ET ScripsAmerica's Specialty Pharmacy Records Monthly Revenue of $1.6 Million in May

Arizona Pharmacy Association Annual Convention June 26-29, 2014

PDF]

Annual Convention Schedule At-a-Glance - Arizona ...

www.azpharmacy.org/resource/resmgr/.../2014_pre-program_mailing.pd...
18 hours ago - continuum of medication therapy to eliminate silos ... at the Arizona Pharmacy Association Annual Convention. Rooms are ... Sterile Compounding and Safety in.

Sunday, June 1, 2014

FACT: The Pew Charitable Trusts has identified over 20 pharmacy compounding errors associated with 1,086 adverse events, including 88 deaths, since 2001.

source found here

Pew Foundation Chart on US Illnesses and Deaths Associated With Compounded Medications

U.S. Illnesses and Deaths Associated With Compounded ...

www.pewhealth.org/.../us-illnesses-and-deaths-associated-with-compoun...
5 days ago - U.S. Illnesses and Deaths Associated With Compounded Medications. May 28, 2014; Project: Drug Safety Project. The Pew Charitable Trusts has identified over ...

IACP AdvanCE webinars relating to compounding

The May 1st IACP AdvanCE webinar Being a Successful Compounding Advocate: Tips for Working with Your Legislators presented by IACP’s Vice President of Government Affairs Cynthia E. Blankenship, Esq. and IACP’s Executive Vice President & CEO David G. Miller, RPh has been uploaded to the self-paced webinar library for your access 24/7. Please click here to view IACP AdvanCE’s self-paced online webinars that are available today.

Save the Date!
For more information about the 2014 IACP AdvanCE live webinars, please click here.

  • “Constructive Delivery” and the Controlled Substances Act
  • Building a Compounding Practice: Lessons Learned
  • Media, Growth, and Quality Improvement
  • Current Good Manufacturing Practices – A Compounding Pharmacy Perspective
  • Essentials of Non-Sterile Compounding

Capitol Connections CCH 2014 Report - International Academy of Compounding Pharmacists

Capitol Connections CCH 2014 Report - International Academy of Compounding Pharmacists

Updated Compounding Registered Outsourcing Facilities

Compounding Registered Outsourcing Facilities

FDA Warning Letter 2013 Allergy Laboratories, Inc. 10/4/13

2013 Allergy Laboratories, Inc. 10/4/13

Highlights From AP Interview With FDA's Hamburg

PRESCRIPTION DRUG ABUSE
Hamburg downplayed suggestions that the agency might remove a heavily criticized painkiller from the market if a harder-to-abuse version becomes available. She said better abuse-deterrent formulas are needed to prevent abusers from chewing, snorting or injecting pain relievers to get high.
"We feel very strongly that the current technologies available are not adequate to truly turn the tide on the epidemic of abuse, and we need continuing advancement in the field of abuse-deterrent technology," Hamburg said.
The FDA has faced months of criticism from elected officials, law enforcement and anti-addiction groups for approving the powerful painkiller Zohydro last October. The long-acting opioid is the first U.S.-approved pure form of hydrocodone, the most abused prescription drug ingredient in the country. Previously it was only available in lower-dose combination pills like Vicodin.
continue to read here

Texas: UTA professor laundered “drug money” police say | Arlington | News from Fo...

UTA professor laundered “drug money” police say | Arlington | News from Fo...

QPharma advises sterile pharmacy compounders to comply with new GMP regulations--"Based on the numerous warning letters that have been issued in recent months, it appears that many compounders are unaware of their regulatory obligations," said Jeff Boatman, QPharma's Senior Subject Matter Expert, Quality Systems and Medical Devices. "Due to the newness of the regulation and the unprecedented degree of validation, it is not surprising that some pharmacies are struggling with compliance."

QPharma, Inc. is advising sterile pharmacy compounders to be aware of their need to comply with new Good Manufacturing Practices (GMP) regulations.
In accordance with federal law, sterile pharmacy compounders that stockpile drug products are now required to register as Outsourcing Facilities — a completely new type of regulated business. Pending written agreements with each state, the U.S. Food and Drug Administration (FDA) is also prohibiting any compounding pharmacy from shipping more than 5 percent of its compounded products across state lines. Under this new classification, any sterile compounder that creates, fills, or packages a drug product without a specific prescription for each package created, or ships any appreciable amount of that product across state lines, is automatically considered an Outsourcing Facility and is subject to federal GMPs.
"Based on the numerous warning letters that have been issued in recent months, it appears that many compounders are unaware of their regulatory obligations," said Jeff Boatman, QPharma's Senior Subject Matter Expert, Quality Systems and Medical Devices. "Due to the newness of the regulation and the unprecedented degree of validation, it is not surprising that some pharmacies are struggling with compliance."
In addition to the GMP implications, individual state Boards of Pharmacy can dictate that sterile pharmacy compounders in their states are subject to process validation, regardless of their activities. For example, QPharma's home state of New Jersey has a pre-existing requirement that sterile compounders perform process validation initially for each drug class, and annually thereafter; while this regulation has been in effect for years, it has taken on new urgency as both federal and state regulatory authorities have begun aggressively inspecting compounders.
In its warning letters, FDA commonly recommends that compounders engage a third-party consulting firm for regulatory support. A leading compliance solutions firm, QPharma is at the ready to help sterile compounding pharmacies close potential compliance gaps and avoid significant penalties.
Source: QPharma 

Interesting Warning Posted Yesterday on Cafepharma from an anonymous source

         
  

To all you "sales reps" selling the "transdermal creams, be ready for the harsh reality of a new reimbursement. The insurance companies are well aware of what's happening and are already changing the reimbursement rates.

It's over!
 
quoted from here