Massachusetts Cannot Ban Hydrocodone-Only Medications, Federal Judge Rules

A US District Judge has ruled that Massachusetts may not ban the prescribing and dispensing of hydrocodone-only medication products that have been approved by FDA. Following months of controversy surrounding FDA’s decision to approve Zohydro^™ ER, the first hydrocodone-only medication to be approved by FDA, Governor Deval Patrick declared the state’s opioid addiction epidemic to be a public health emergency. As part of the state’s response, Patrick ordered an immediate prohibition on prescribing and dispensing of all hydrocodone-only products. Zohydro ER manufacturer Zogenix, Inc, filed a three-count complaint alleging that the state’s ban on the medication was unconstitutional. Rya W. Zobel, US District Judge ruled (PDF) that the state’s emergency ban on the drug is preempted by federal law. Further, Zobel notes, “If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health.”

FDA Developing Track and Trace Standards as Part of DSCSA Implementation

To protect consumers from drugs that may be counterfeit, stolen, or tainted, Food and Drug Administration (FDA) is advancing efforts to implement an advanced track and trace program. The Drug Supply Chain Security Act (DSCSA), enacted as Title II of the Drug Quality and Security Act in November 2013, authorizes FDA to create and implement a prescription drug tracking system that will make it possible to identify and track certain prescription drugs throughout the distribution process. “The ultimate goal is to identify each individual prescription drug package in a way that will enable rapid and accurate verification of the legitimacy of the product, which will be an important tool in the fight against counterfeit drugs,” states Ilisa Bernstein, PharmD, JD, deputy director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research in an FDA Voice blog entry. Bernstein also indicates that FDA will be issuing a draft guidance document with initial standards by November 27, 2014. The agency will host a public workshop on the standards May 8–9, 2014. The DSCSA will be the topic of a continuing pharmacy education session at the NABP 110th Annual Meeting on May 17, 2014, in Phoenix, AZ.

DEA Take-Back Day Is Saturday, April 26

Consumers will have the opportunity to dispose of unneeded or unwanted medications at a Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day collection site on Saturday, April 26, 2014. On this day, from 10 am to 2 pm, consumers may safely dispose of unwanted medications at one of thousands of collection sites coordinated by DEA and provided by law enforcement agencies and community organizations in all 50 states and United States jurisdictions. This is the eighth DEA Drug Take-Back Day. Additional information and a link to the DEA online collection site locator are available on the AWARXE® website. DEA Take-Back Days are a unique opportunity for consumers to safely and legally dispose of unneeded medications, including prescription controlled substances, such as certain pain medications, since these drugs can only be returned to law enforcement personnel. The take-back service is free and anonymous, with no questions asked. Sites will accept tablets, capsules, and all other solid dosage forms of unwanted medication. Personal information may be blacked out on prescription bottles, or medications may be emptied from the bottles into the bins provided at the events. DEA collected more than 3.4 million pounds of unwanted medication for safe and secure disposal during the previous seven take-back days combined.

South Africa - Chemo drug shortage at Charlotte Maxeke - Jack Bloom

CHEMO SHORTAGE HITS CANCER PATIENTS AT JOBURG HOSPITAL

A shortage of a key chemotherapy drug has halted treatment for certain cancer patients at the Charlotte Maxeke Johannesburg Hospital.

Patients who need to be treated with Gemzar chemotherapy have been told that it is not available as the supplier has not been paid.

Gemzar is a chemotherapy drug used to treat non-small cell lung cancer, pancreatic cancer, metastatic breast cancer, and ovarian cancer.

In one case, a breast cancer patient's chemotherapy was halted in the middle of a multi-week treatment, which is extremely dangerous.

This chemo drug shortage is totally unacceptable as it is endangering the lives of vulnerable patients.

We need swift action to procure this drug and answers as to why medicine shortages continue to happen at Gauteng state hospitals.

Lookout List

Labetalol Carp 4ml

Today's Shortages

ASHP/FDA
Ampicillin Sulbactam
Dexmedetomidine
Memantine Hydrochloride
Morphine Inj.
Nitrgoglyercin inj.
Piperacillin Tazobactam Inj.
Prochorperazine Edisylate Inj.
Sufentanil Inj.
Sulfacetamide and Prednisolone Opthalmis Ointment

Today's Shortages

ASHP/FDA
Caffeine and Sodium Benzoate Inj.
Ciprofloxacin Inj.
Cisatracurium Inj.
Dacarbazine Inj.
DTAP
Fluromethalone Opthalmic Ointment
Flourouracil Inj.
Hydromorphone Hydrochloride Inj