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

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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	http://www.accessdata.fda.gov/cms_ia/importalert_5.html
IA-16-39	Detention Without Physical Examination of Processed Seafood and Analogue Seafood (Surimi) Products for Listeria Monocytogenes	http://www.accessdata.fda.gov/cms_ia/importalert_44.html
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	http://www.accessdata.fda.gov/cms_ia/importalert_48.html
IA-16-81	Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella	http://www.accessdata.fda.gov/cms_ia/importalert_49.html
IA-25-05	Detention Without Physical Examination of Dried Fungus (Mushrooms) from Hong Kong and PROC for Filth	http://www.accessdata.fda.gov/cms_ia/importalert_81.html
IA-45-02	Country Wide with Firms exempt - Attachment B containing illegal or undeclared colors(green List)	http://www.accessdata.fda.gov/cms_ia/importalert_118.html
IA-45-02	Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors	http://www.accessdata.fda.gov/cms_ia/importalert_118.html
IA-52-01	Detention Without Physical Examination of Brassware From India	http://www.accessdata.fda.gov/cms_ia/importalert_121.html
IA-53-06	Detention Without Physical Examination Of Cosmetics Containing Illegal Colors	http://www.accessdata.fda.gov/cms_ia/importalert_130.html
IA-54-15	DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM	http://www.accessdata.fda.gov/cms_ia/importalert_1137.html
IA-61-07	Detention Without Physical Examination of Domperidone	http://www.accessdata.fda.gov/cms_ia/importalert_166.html
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.	http://www.accessdata.fda.gov/cms_ia/importalert_176.html
IA-66-41	Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.	http://www.accessdata.fda.gov/cms_ia/importalert_190.html
IA-78-01	Detention Without Physical Examination Of Penis Enlargers And Erection Maintaining Rings	http://www.accessdata.fda.gov/cms_ia/importalert_226.html
IA-80-04	Attachment B - Warning Letters Issued (Level 3) - Continued defects and violative analyses	http://www.accessdata.fda.gov/cms_ia/importalert_229.html
IA-86-07	Detention Without Physical Examination of and Guidance for *** Impact-Resistant Lenses in Eyeglasses and Sunglasses ***	http://www.accessdata.fda.gov/cms_ia/importalert_237.html
IA-86-11	DETENTION WITHOUT PHYSICAL EXAMINATION OF CONTACT LENSES DUE TO MICROBIOLOGICAL CONTAMINATION	http://www.accessdata.fda.gov/cms_ia/importalert_1133.html
IA-89-16	Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection	http://www.accessdata.fda.gov/cms_ia/importalert_601.html
IA-99-05	Detention Without Physical Examination Of Raw Agricultural Products for Pesticides	http://www.accessdata.fda.gov/cms_ia/importalert_258.html
IA-99-08	Detention Without Physical Examination Of Processed Foods for Pesticides	http://www.accessdata.fda.gov/cms_ia/importalert_259.html
IA-99-19	Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella	http://www.accessdata.fda.gov/cms_ia/importalert_263.html
IA-99-20	Detention Without Physical Examination Of Imported Food Products Due to NLEA Violations	http://www.accessdata.fda.gov/cms_ia/importalert_264.html
IA-99-23	Detention Without Physical Examination Of Raw Fresh Fruits And Vegetables Due To The Presence Of Pathogenic Contamination	http://www.accessdata.fda.gov/cms_ia/importalert_266.html
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	http://www.accessdata.fda.gov/cms_ia/importalert_401.html
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

June 01, 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.

 

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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.

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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

ScripsAmerica's Specialty Pharmacy Records Monthly Revenue of $1.6 Million in May

Arizona Pharmacy Association Annual Convention June 26-29, 2014

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

www.azpharmacy.org/resource/resmgr/.../2014_pre-program_mailing.pd...

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18 hours ago - continuum of medication therapy to eliminate silos ... at the Arizona Pharmacy Association Annual Convention. Rooms are ... Sterile Compounding and Safety in.