Friday, May 30, 2014

National saline shortage affecting local hospitals

OMAHA, Neb. —A short supply of a common medical product is affecting hospitals locally and nationwide.

Saline solution is used every day in the emergency room or in the back of a rescue squad, but it’s in such short supply, local hospitals are ordering it from Spain.
“This sort of thing is something that is frustrating for physicians across the board. It doesn't matter the specialty. When it’s something you use frequently, in this case on a daily basis, we don’t have, yes, it gets frustrating. Luckily, there are some alternatives,” said Dr. Paul Schenarts, chief of trauma surgery at Nebraska Medical Center and physician medical director of the Omaha Fire Department's EMS.
Doctors are unsure when production will pick up, but they do know how valuable it is to have on hand.
“Patients who are dehydrated, bleeding, didn’t have appropriate blood pressure,” Schenarts said.
Schenarts said it is common to have a drug shortage but not saline solution. In January, the Federal Drug Administration attributed the shortage to flu season, but now, Schenarts said the situation is in part centered on manufacturers.
“Companies have a tendency to try to make medications that have a higher profit,” he said.
Schenarts said the $1.05 liter of saline is now selling for $9-$10 because the demand is so high.
Hospitals and first responders are using alternatives, which doesn't put anyone's life at risk. It just draws a little more stress to emergency situations.
“Our response has been exactly that -- give it to the patients that need it, don’t give it to the patients who don’t,” Schenarts said.

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Missouri attorney general wants the state to produce its own lethal injection drugs

shortage of the drugs needed to carry out lethal injections has caused states that want to keep executing inmates to scramble as they look for alternatives. Some states have found new methods of obtaining the drugs needed for lethal injections, while others have discussed returning to old options like the firing squad or the gas chamber.
In Missouri, which was supposed to execute an inmate via lethal injection just last week and which has struggled with finding the necessary drugs, the state’s top law enforcement officer offered a new solution on Thursday: Producing lethal injection drugs in Missouri.
Lethal injection is the main way executions are carried out in this country, but the necessary drugs are simply not widely available after European officials and companies objected to the use of the drugs in executions. States have responded by contemplating other execution methods, and while most states have only talked about these methods without making any changes, last Tennessee officially made the electric chair its backup method of execution.
Chris Koster, the Missouri attorney general, said in a speech Thursday that creating the drugs in the state would deal with both the drug shortage as well as the secrecy currently surrounding the process.
Lethal injections require “an uneasy cooperation” involving pharmaceutical companies producing the drugs, medical professionals helping to administer them and state officials responsible for overseeing the executions, said Koster, who was speaking at a Bar Association of Metropolitan St. Louis conference.
The recent drug shortages complicated the lethal injection process, causing the state to obtain the drug pentobarbital (or a similar substitute) from sources that only sell them if their identities are hidden, he said.
“As a matter of policy, Missouri should not be reliant on merchants whose identities must be shielded from public view or who can exercise unacceptable leverage over this profound state act,” said Koster, according to written remarks provided by his office.
Koster, a Democrat and a supporter of the death penalty, said producing the drugs in the state “would improve the high level of public transparency” necessary for executions.
Rather than relying on hidden merchants, Koster said state lawmakers should set aside money for a laboratory to produce the necessary drugs in Missouri.
The secrecy currently involved in the process has been criticized by attorneys for inmates as well as reporters, who have argued that the state has to reveal who is producing the execution chemicals. Multiple media outlets, including the Associated Press and the Guardian, filed a lawsuit earlier this month in an attempt to force the state to reveal the source of its lethal injection drugs.
“The perimeter of secrecy around the lethal injection process in Missouri has expanded” as it has grown include the people selling the drugs, he said. “While this creeping secrecy is legal, it may not be prudent.”
Missouri has executed four people in 2014, which is as many people as the state executed between 2006 and 2013.
The botched execution of Clayton Lockett in Oklahoma last month drew worldwide attention, reviving a debate over the death penalty and the way it is carried out in the United States. An execution in Texas, set to be the first since the botch in Oklahoma, was halted hours before the injection after a court cited the intellectual disability of inmate Robert James Campbell.
As a result, Missouri’s scheduled execution of Russell Bucklew last week would have been the first in the country since the Oklahoma episode. That execution was halted, reinstated and halted again during a judicial back-and-forth before the Supreme Court ultimately stayed the execution and sent it back to lower courts. Attorneys for Campbell and Bucklew had criticized the secrecy involved in the lethal injection process in both states.

FDA: Not all Eli Lilly products covered by recall order

The Food and Drug Administration on Friday said certain products from pharmaceutical firm Eli Lilly may still be sold, citing a stay order from the office of Health Secretary Enrique Ona.

In Advisory 2014-043 dated May 30, the FDA said the following products, which have valid product registration, are allowed in the Philippine market:
  • Gemzar 200mg Powder for IV Injection, DR-XY40364
  • Humulin 70/30 Vial, DR-XY14545
  • Humulin N Vial, DR-XY6181
  • Humulin R Vial, DR-XY6180
  • Humulin 70/30 Cartridge, DR-XY23452
  • Humulin N Cartridge, DR-XY23454
  • Zyprexa 5mg Tablet, DR-XY22855
  • Zyprexa 10mg Tablet, DR-XY22856
  • Alimta 100mg Lyophilized Powder for Intravenous Infusion, DR-XY35204
  • Alimta 500mg Lyophilized Powder for I.V. Infusion, DR-XY31536
  • Gemzar 1g Powder for Injection, DR-XY42100
  • Cymbalta 60mg Capsule, DR-XY41867
  • Zyprexa Zydis 5mg Tablet, DR-XY37273
  • Forteo 250mcg/mL Solution for Injection, DR-XY29234
  • Byetta 250mcg/mL Solution for Injection (1.2mL) SC, DR-XY33256
  • Byetta 250mcg/mL Solution for Injection (2.4mL) SC, DR-XY33264
  • Effient 5mg Film-Coated Tablet, DR-XY37670
  • Effient 10mg Film-Coated Tablet, DR-XY37671
  • Cymbalta 30mg Capsule, DR-XY31173
  • Zyprexa Zydis 10mg Orodispersible Tablet, DR-XY37455

Earlier this month, the FDA fined the pharmaceutical firm P16 million for importing and distributing unregistered products.

FDA also ordered the recall of 15 Eli Lilly Philippines products after finding they were either unregistered or had falsified product registrations.

Covered by the recall order were:

  • Cialis 20 mg Tablet
  • Cymbalta 30mg Capsule
  • Humalog 100 units per mL Solution for Injection
  • Humalog Kwikpen 100u/mL Solution for Injection
  • Humalog Mix 25 Kwikpen 100iu per mL Solution For Injection
  • Humalog Mix 25
  • Humalog Mix 50 Kwikpen
  • Stratterra 10mg Capsule
  • Stratterra 18mg Capsule
  • Stratterra 25mg Capsule
  • Straterra 40 mg Capsule
  • Strattera 60mg Capsule
  • Prozac 20mg Capsule
  • Zyprexa Zydis 10mg Orodispersible tablet
  • Zyprexa Intramascular 20mg Powder for Injection

Dr. Kenneth Hartigan-Go, FDA director,  said at the time that only the following Eli Lilly products have a certificate of product registration:

  • Alimta 100mg Lyophilized Powder for Intravenous Infusion, FDA registration number DR-XY35204
  • Alimta 500mg Lyophilized Powder for I.V. Infusion, DR-XY31536
  • Gemzar 1g Powder for Injection, DR-XY42100
  • Cymbalta 60mg Capsule, DR-XY41867
  • Zyprexa Zydis 5mg Tablet, DR-XY37273
  • Forteo 250mcg/mL Solution for Injection, DR-XY29234
  • Byetta 250mcg/mL Solution for Injection (1.2mL) SC, DR-XY33256
  • Byetta 250mcg/mL Solution for Injection (2.4mL) SC, DR-XY33264
  • Effient 5mg Film-Coated Tablet, DR-XY37670
  • Effient 10mg Film-Coated Tablet, DR-XY37671

Zydus Cadila recalls over 10,000 bottles of allergy drug in US

Indian drugmaker Zydus Cadila is recalling 10,200 bottles of an allergy-relief drug in the United States after another drug for high blood pressure was found in one of the bottles, the U.S. Food and Drug Administration said on Friday.
The recall was voluntarily started by the company's U.S. unit, Zydus Pharmaceuticals USA Inc, on May 8, due to the presence of the high blood pressure medicine atenolol in a bottle containing the allergy drug, promethazine hydrochloride.
Promethazine hydrochloride is commonly used to treat allergic disorders, nausea, vomiting, difficulty sleeping, as well as for pre-operative sedation.
The FDA classified the recall as Class II, which means use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences.
The bottles being recalled carry an expiry date of September 2015, according to the FDA post.
A Zydus spokesman did not immediately respond to a request for comment.
Recalls of drugs are not uncommon.
However, Zydus's drug recall is the seventh this year by an Indian company, and follows those by other large drugmakers including Wockhardt Ltd, Ranbaxy Laboratories Ltd , Dr. Reddy's Laboratories Ltd, Lupin Ltd , Sun Pharmaceutical Industries Ltd and Glenmark Pharmaceuticals Ltd.
The incidents come at a time when the FDA has increased its scrutiny of Indian drugmakers after the agency banned exports from manufacturing plants of some top drugmakers, including Ranbaxy and Wockhardt, upon finding quality control lapses.

Dialysis drug recalled after patient death

A Fresenius solution used in hemodialysis machines has been recalled because of concerns over bacteria contamination following a patient death.
The U.S. Food and Drug Administration issued a notice this week of the recall, saying it had received one report of death and two reports of injury that may be related to use of Fresenius NaturaLyte Liquid Bicarbonarte Concentrate. Lab testing identified Halmonas, a bacteria typically found in water with high salt concentration, in the product during its shelf life, the FDA said.
Twenty-six dialysis centers in Tennessee were among those that received the product, said Jon Stone, a spokesman for Fresenius Medical Care North America. He did not identify the centers.
“We have notified all of our affected customers that the recalled product should be removed and are continuing to work with them to carry out the recall,” Stone said.
Forty-nine lots of the solution were recalled on April 10, followed by another nine lots on May 1. The last of the recalled product was distributed April 7.

Expensive Drugs Forcing Cancer Doctors to Weigh Price

When oncologist Yousuf Zafar at the Duke Cancer Institute prescribed an expensive pill for a young man with colon cancer two years ago, he assumed his patient could afford it because he had a job and private insurance.

Eight months later, Zafar was about to prescribe the drug a second time to the man, whose cancer had relapsed. This time, though, he was shocked when the patient told him his co-pay was $325 per week -- and he couldn’t afford it much longer.

With “one simple question, I could have saved him thousands of dollars, and distress,” said Zafar, who switched the man to an equally effective injected drug with no co-pay.

With new cancer drugs priced as high as $10,000 a month and more, and insurers tightening payment rules, patients who thought they were well covered increasingly find themselves having to make life-altering decisions about what they can afford. As a result, cancer doctors trained to weigh side effects and efficacy are being regularly pulled into delicate discussions on cost, an issue the American Society of Clinical Oncology meeting in Chicago will explore starting today. The group is working on an algorithm to rate the cost-effectiveness of oncology drugs to help doctors with those conversations.

“The amount of support we need to provide to patients in navigating the financial aspects of their care has increased substantially in the past few years,” said Neal Meropol, an oncologist at the University Hospitals Seidman Cancer Center in Cleveland, who is chairman of a panel on value in cancer care at the meeting.

Examining Value
In a first for the cancer meeting, researchers that review clinical results for certain studies have been told to examine the value of the treatments as well. Additionally, education sessions focusing on value will look at the cost issue from the perspective of patients, insurers, the drug industry and other countries with more cost constraints.

Global spending on cancer drugs alone rose 28 percent to $91 billion in 2013 from $71 billion in 2008, according to a report by the IMS Institute for Healthcare Informatics. At the same time, insurers are increasingly crafting their coverage plans to require that patients pay a percentage of an expensive drug’s cost instead of a fixed amount as a way to keep premiums down.

The costs can be a particular issue for cancer patients who suddenly have to take numerous drugs at once, while at the same time dealing with other expenses, such as for travel and hotels to get treated at hospitals far from their homes. Compounding the problem, a cancer diagnosis often results in decline in income because people can no longer work full hours.

Bankruptcies Rise
A 2013 analysis in Health Affairs found that cancer patients were 2.65 times more likely to go bankrupt than people without cancer. Another survey of 284 patients in Washington state found that 38 percent of colon cancer patients reported financial hardships as a result of treatment. The problems cited included having to refinance their home to pay for treatment or an income decline of more than 20 percent, according to the results in the Journal of Clinical Oncology.

These days Duke’s Zafar makes a point to warn patients when he prescribes a drug that might have high co-pays. For some pills, he checks with the pharmacy in advance to find out what the patient’s co-pay will be, so financial assistance can be arranged or alternative treatments can be found.

Second Tier

Cancer patients, focused on saving their lives, are reluctant to bring up the cost issue with their doctors, fearing they might be switched to a second-tier treatment, said Chris Tribble, Zafar’s colon cancer patient.

In addition to the treatment costs, Tribble, who lives in Statesville, North Carolina, -- 120 miles from Duke’s Durham location -- had to pay for 90 nights in motels over the last two years while he was treated. He also had to pay $1,000 to meet separate insurance deductibles for a home health nurse to treat a post-surgical infection.

“When you’re diagnosed with cancer and getting treated, you’re assuming that whatever the doctor is telling you, that’s going to be the very best drug,” Tribble said by telephone. “You don’t feel there is an alternative.”

So if the doctor doesn’t raise the subject, “the patient may not ever bring it up,” he said.
Tribble, 40, is now cancer free. If Zafar hadn’t given him an opening to discuss his co-pays, he would have borrowed money to pay for the pill, without ever knowing there was a similar injected drug that would cost him nothing, he said.

Patients Wincing
Meropol, at the Seidman Cancer Center, says he first started hearing patients “wince” about costs 10 years ago after drugs such as Avastin from Roche Holding AG (ROG), based in Basel, Switzerland, and Erbitux from Bristol-Myers Squibb Co. and Eli Lilly & Co. hit the market.
Now, Avastin has been joined by many more-expensive drugs, and roughly one-third of his patients have some difficulties with the costs of their treatment, he said.

Often, the problem can be solved by enrolling patients in co-pay assistance or free drug programs, or by switching them to a less expensive drug when that is available, as is the case for some expensive narcotics used to treat cancer pain or anti-nausea drugs used for chemotherapy side-effects.

One of his patients, though, stopped treatment in part due to cost and the cancer progressed, he said.

At the Fred Hutchinson Cancer Research Center in Seattle, doctors in the gastrointestinal oncology department routinely ask the pharmacy to look into what a patient’s co-pay will be before they prescribe certain expensive pills, said Veena Shankaran, an oncologist there. The idea, she said, is to find out whether cost will be an issue before the patient ends up at the pharmacy with a big bill.

Switching Medicines
Several times, she has switched therapies for advanced cancer patients because of cost issues, while another time a patient obtained money from family members to pay for a treatment that was going to cost her $2,000 in the first month.

For costly painkillers and other drugs to treat side effects, there often are less expensive substitutes. For chemotherapy drugs for which there are no substitutes, patients often qualify for co-pay assistance from various foundations or companies.

While the idea that patients need to have “skin in the game” to prevent overuse of brand-name drugs may make sense for ordinary ailments, said Shankaran, “for a disease like cancer, it ends up being counterproductive because people have so many costs over so long, it ends up being a huge burden.”

Patient Care
High drug costs are already affecting patient care, research suggests. Alan Venook, an oncologist at the University of California at San Francisco, said he treated four patients several years ago who relapsed after they stopped taking Gleevec for gastrointestinal stromal cancer because of financial difficulties. He published details on three of the cases in 2010 in the New England Journal of Medicine. One patient eventually died, Venook said in a telephone interview.
A 2013 study led by Duke’s Zafar of 164 patients applying for co-pay assistance found that nearly 45 percent reported skipping drugs or not appropriately filling cancer-related prescriptions due to cost.

Meanwhile, leukemia patients were 70 percent more likely to temporarily stop taking Gleevec and 42 percent more likely to skip doses of the chronic myeloid leukemia drug from Novartis AG (NOVN), if there were had higher than normal co-pays, compared with patients who had lower co-payments, according to an analysis of insurance claims data by researchers at the University of North Carolina and Harvard Medical School published this year in the Journal of Clinical Oncology.

Custom-drug makers to come under voluntary oversight

Complex, custom-made medications produced in factorylike pharmacies, including several in Arizona, are distributed to hospitals across the country with almost no state or federal oversight — a loophole dramatized by a deadly 2012 meningitis outbreak linked to tainted steroids from one of those facilities in New England.
That outbreak could just as easily have happened in Arizona or anywhere else. Illnesses and deaths linked to it spread across 20 states.
There is no accurate count of how many of these facilities — in effect, large-scale custom drugmakers that ship to hospitals and doctors offices — exist in the U.S. because they are totally unregulated. And because nobody tracks them, it is unclear how many are in each state or the destinations of their shipments.
At least two in Arizona have been cited in the past six months by the U.S. Food and Drug Administration, one for unsanitary conditions and another for a contaminated injection. Next month, the Arizona State Board of Pharmacy is expected to review the findings of joint state and federal inspections of the facilities in Deer Valley and Mesa.
The nation learned of these shadow drugmakers when an injection formulated at Massachusetts' New England Compounding Center was linked to the meningitis outbreak that ultimately was associated with the deaths of 64 people and illness among 750 others. The outbreak underscored lax regulation of drug-compounding facilities, which manufacture unique combinations of medicines for specific conditions and illnesses.
Since 2012, federal and state officials across the country have struggled to regulate such facilities. A federal law enacted in November as a response to the meningitis outbreak created voluntary regulations for these facilities for the first time, but it remains unclear how many facilities will opt in.
The FDA began cracking down on these facilities, inspecting 42 of the biggest operations in the country in 2013. The two Valley companies cited by the FDA were a part of the push.
Custom drugs, often mixtures of several different medicines, are serving an increasingly important purpose in the pharmaceutical industry, which is facing a drug shortage that, in part, is spurring a trend toward personalized medicine.
Anyone who has taken these drugs likely had a prescription written by a doctor for a unique mixture tailored to specific ailments. The patient may need medication that is out of stock, or need substitute ingredients because of drug allergies.
Everything from human pain-relief creams to hormone pills for dogs can be dispensed to patients who order them online, purchase them at a Walgreens or CVS, or pick them up at a local mom-and-pop apothecary.
By law, the state pharmacy board is responsible for inspecting and regulating smaller-scale compounding pharmacies that serve individual patients. The FDA is responsible for overseeing the licensed drug manufacturers that run large facilities and must meet stringent testing and production requirements.
The custom-drug facilities fall somewhere in between, and they are now the focus of state and federal regulators.
"They are performing a necessary activity in that they are making products that other companies aren't going to make, or in a specific dosage form that will be useful to the hospital. But because they're really operating as a manufacturer, they need to have that regulatory oversight," said Sandra Shire, who teaches in the Regulatory Science Concentration in the Clinical Research Management master's degree program at Arizona State University's College of Nursing and Health Innovation.
"That's what the outbreak brought to light, that there were pharmacies that were participating in manufacturing who were not being regulated as manufacturers and that didn't adhere to current good manufacturing practices," said Shire, a former FDA investigator.
New federal law
Last November, President Barack Obama enacted the federal Drug Quality and Security Act, designed to rein in these large facilities.
The law outlines reporting and inspection requirements and defines the larger compounding facilities that produce sterile drugs as "outsourcing facilities." Those that agree to register under the voluntary new category agree to be held to federal standards for manufacturers.
FDA officials believe roughly 700 to 1,000 facilities are compounding sterile drugs and shipping them to other states. As of May 16, only 42 companies were registered with the FDA as outsourcing facilities under the new law.
Two are located in Arizona — Banner Compounding Pharmacy in Chandler and Avella Special Pharmacy of Deer Valley.
Avella was one of the two Valley facilities cited by the FDA during its 2013 targeted inspections of large compounding facilities. It produces both individual, smaller-scale compounds and larger ones. In a warning letter, FDA inspectors said that Avella was producing a significant number of drug products without valid individual prescriptions and that there were unsanitary conditions in the lab.
Avella recalled two products and registered as an outsourcing facility. Construction has begun for a new sterile pharmacy at the Deer Valley location, which company officials said is the only branch that ships drugs out of state. The company has purchased new equipment and hired an FDA consultant and additional technical staff.
"We looked at is as a chance to improve," said Linda Cappellini, Avella's director of laboratory services.
RxFormulations, based in Mesa, was the other cited by the FDA after inspectors found microbial contamination in a vial of injection medicine. There was "irregularly shaped floating matter" in the unused product, the FDA said. The company recalled the product. Company officials declined to comment.
RxFormulations is not registered under the new law.
FDA officials acknowledged that there is uncertainty over companies that produce sterile compounded drugs but choose not to register as outsourcing facilities.
The program's voluntary nature puts the onus on state and federal regulators to increase communication so that state inspectors can notify the FDA when they find facilities that qualify as outsourcing facilities, said Gabrielle Cosel, drug-safety manager at the Pew Charitable Trusts. The Washington, D.C.-based non-profit supported the federal law's passage.
The law gives large sterile-drug-compounding facilities a regulatory home that has been lacking, and hospitals and clinics now have a choice to purchase drugs from an FDA-approved facility, Cosel said.
Regulators and pharmacy-industry experts hope the market will drive more facilities to register as outsourcing facilities and weed out some of the bad actors.
Although it can be a costly initial investment, registering as an outsourcing facility could have long-term benefits for the compounder, Shire said. Hospitals may prefer to contract with registered facilities over unlicensed operations to decrease their liability.
State oversight
While experts agree that the law is a crucial first step in holding sterile-drug compounding operations accountable, even supporters of the law acknowledge that questions linger over how it will play out. The FDA has not yet released guidelines that could answer some remaining questions.
It is clear that large outsourcing facilities are under federal jurisdiction and that small traditional pharmacies are under state jurisdiction. But it is unclear who would regulate those that produce both types of drugs, which would fall under both state and federal watch, said Chris Topoleski, director of federal regulatory affairs at the Maryland-based American Society of Health-System Pharmacists, which supported the new federal law.
"I think an area where there will be a little bit more clarification needed will be for those entities that are registered as pharmacies and do a fair amount of sterile compounding — kind of a dual operation," Topoleski said.
State boards do not yet know how much authority they would have in overseeing outsourcing facilities. The law requires state regulators to alert the FDA of any state warnings, enforcement actions or any concerns they have with existing or potential outsourcing facilities.
Outsourcing facilities are not required to be licensed by the state as a pharmacy. So, in states like Arizona, state regulators would not have oversight over such facilities unless a new category was added to state law.
The uncertainty has prompted state pharmacy boards across the country to push their legislators to create laws and rules that would give state regulators some authority over outsourcing facilities.
At a national conference in Phoenix last week, board leaders shared the status of efforts in respective states and said they wanted to see some uniformity in state involvement.
Regulators from Idaho, Minnesota, Nevada, Texas, Virginia and other states said they want to see their state lawmakers adopt similar definitions for outsourcing facilities and allow states to inspect the facilities along with federal regulators.
Definitions and laws in place at the state level are especially important given that outsourcing facilities make interstate shipments, and standards should be in place to keep all the facilities in check, they said.
There is no clear chain of command in the federal law's provisions, and state boards are advocating for clarity, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
Legislators from states across the country are beginning to pay attention, especially in light of the New England outbreak, Catizone said. There needs to be leadership among state legislators to figure out state authority and make resources available for state regulators, he said.
"Unfortunately, what we hear all the time in the legislature is, 'Show me the dead bodies,' " Catizone said. "We have the dead bodies, and we should not have had those dead bodies in the first place."

Today's Shortages

Alprostadil Products
Ammonium Molybate Inj.
Aspirin Tablets
Ceftriaxone Sodium Inj.
Chloramphenicol Sodium Succinate Inj.
Chloroprocaine Inj.
Ciprofloxacin Inj.
Cyanocobalamin Inj.
Danorubicin Hydrochoride Inj.
Dexamethasone Sodium Phosphate
Famotidine Inj.
Fluorouracil Inj.
Haloperidol Lactate Inj.
Potassium Chloride Inj.
Synthetic Conjugated Estrogen
Tamoxifen Tablets
Vinblastine Inj,
Witamin E Aqueous Oral Solution

Official: Texas Can Keep Lethal Drug Source Secret

DALLAS — Texas’ prison system doesn’t have to reveal where it gets its execution drugs, the state attorney general said Thursday, marking a reversal by the state’s top prosecutor on an issue being challenged in several death penalty states.
Attorney General Greg Abbott, the Republican nominee for governor in the nation’s busiest death penalty state, had rebuffed three similar attempts by the Texas Department of Criminal Justice since 2010. His decision can be appealed to the courts.
The department argues that the compounding pharmacy providing the drug should remain secret in order to protect it from threats of violence. Lawyers for death row inmates say they need its name to verify the drugs’ potency and protect inmates from cruel and unusual punishment.
Similar legal fights are ongoing in other death penalty states, including Oklahoma and Missouri, but courts — including the U.S. Supreme Court — have yet to halt an execution based on a state’s refusal to reveal its drug supplier. The secrecy argument also was used ahead of a bungled execution last month in Oklahoma, though that inmate’s faulty veins, not the execution drug, were cited as the likely culprit.
The issue has put Abbott in a thorny position during an election year in Texas, where the death penalty is like gun rights: Candidates don’t get in the way of either. Holding firm would please death penalty opponents, who prison officials say want to target drug suppliers with protests and threats; reversing course goes against his vows of government transparency.
But his Democratic opponent, Wendy Davis, can’t easily exploit the issue. Portraying the law-and-order Abbott, who has been attorney general since 2003, as soft on crime would be implausible. She has said the information should be public.
Abbott’s latest decision is expected to be appealed, meaning it likely won’t take immediate effect.
It stems from an open records request filed ahead of the April executions of serial killer Tommy Lynn Sells and convicted killer Ramiro Hernandez-Llanas. Texas prison officials were using a new supply of pentobarbital, a powerful sedative, but they refused to name the supplier. The inmates’ attorneys said that violated the inmates’ rights and asked Abbott to step in. They made similar arguments in court, but those appeals were turned down.
The Associated Press also has filed a request for information about the compounding pharmacy under the Texas Public Information Act.
Death penalty states have been scrambling to find new sources of drugs after several drugmakers, including many based in Europe, refused to sell drugs for use in lethal injections. That’s led several states to compounding pharmacies, which are not as heavily regulated by the Food and Drug Administration as more conventional pharmacies.
Unlike some states, Texas law doesn’t specifically say whether prison officials must disclose where they get their lethal injection drugs.
Abbott rejected the same kind of security concerns in a 2012 opinion, ruling that the benefits of transparent government outweighed the prison system’s objection. But in March, his office argued in court that the threatening environment faced by companies supplying execution drugs had worsened.
If Abbott’s latest decision is appealed, it could eventually land in the Texas Supreme Court. There’s no timetable on such appeals, but they could “take a while,” South Texas College of Law professor Charles Rhodes said. He said the courts will have the final say.

Thursday, May 29, 2014

Today's Shortages

Cefazolin Inj
Dexamethasone Sodium Phosphate
Diltiazem Inj.
Doxycycline Capsules and Tablets
Famotidine Inj.
Haloperidol Lactate Inj.
Lactated Ringers
Levocarnitine Inj.
Lidocaine with Epi Inj.
Midazolam Inj.

Phenylephrine 2.5% and 10% Opthalmic Solution

Online remedy for drug shortages

The Therapeutic Goods Administration (TGA) has launched a new service to provide doctors, pharmacists and consumers with essential, up-to-date information about shortages of prescription medicines.
Developed through a partnership between Medicines Australia, the Generic Medicines Industry Association and TGA, the project includes a new website that will provide health professionals and consumers with information on current, anticipated and resolved medicine shortages.
Other key components of the Medicine Shortages Information Initiative are a subscription alert service and a Protocol for communication and management of shortages agreed with the prescription medicines industry.
New TGA service for health professionals
Congratulating all organisations involved in developing the new service, Assistant Minister for Health, Senator Fiona Nash said information on medicine shortages would “greatly assist health professionals to provide continuity of care”.
“This initiative is another excellent example of how industry and Government can and do work together for the benefit of health consumers,” Senator Nash said.
“Medicines Shortages, whether they affect thousands, hundreds or a small number of consumers, can be very difficult for the individuals involved,” she said.
“Changing medication, as a result of a medicines shortage, can have significant implications even if there is an alternative.”
The website features different ways of finding information and, where possible, links direct health professionals to information about substitute medicines or therapeutic alternatives.
“Medicine shortages can arise for a number of reasons, ranging from a lack of raw materials to a change in clinical practice leading to great demand for that medicine,” Senator Nash said.
“In the past, medicine shortages have arisen in medicines for cancer, anaesthetics used in surgery, medicines used in emergencies and electrolytes provided to patients on intravenous drip,” she said.
“This Initiative will help healthcare professionals and consumers to safely and effectively manage medicines shortages.”

FDA directed to meet with stakeholders on compounding drug legislation

The Senate Appropriations Committee directed FDA officials on Friday to meet with doctors, patients and pharmacists regarding implementation of a bill that affects compounded human drugs, following a request from Sen. Lamar Alexander (R-Tenn.).
The Compounding Quality Act, which was signed into law in November, removed provisions of the Federal Food, Drug and Cosmetic Act (FDCA) that the U.S. Supreme Court ruled unconstitutional in 2002.
Compounded drugs refer to prescription medications that are personalized by pharmacists to meet the exact dosage and strength requirements of individual patients.
“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak,” Alexander, the ranking member of the Senate Health, Education, Labor and Pensions Committee, said. “If FDA isn’t sitting down with doctors, patients and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.”
The Compounding Quality Act removed provisions of the FDCA related to compounded drugs that required compliance with current good manufacturing practices, labels that include adequate directions for use and FDA approval prior to marketing, according to the FDA.
Alexander led the call for the FDA to meet with stakeholders regarding implementation of the Compounding Quality Act after hearing concerns from doctors, patients and pharmacists.
The Senate Appropriations Committee said it was concerned that the FDA began to implement the Compounding Quality Act by issuing guidance and appointing members to the Pharmacy Compounding Advisory Committee without meeting with stakeholders first.
FDA was directed by the committee to meet with stakeholders to ensure ongoing access to safe compounded drugs.

Tuesday, May 27, 2014

Ambrose updates drug shortage

Health minister Rona Ambrose confirms work is being done to study the problem of drug shortages in the country. So far they’re continuing to have a voluntary reporting program where manufacturers let the ministries across Canada know about problems.
“If there is a drug shortage they have to be posted on a web site,” Ambrose said of the measures being taken during an LRT funding announcement in Edmonton. “The drug company also has to make sure that they not only post that there will be a shortage of a particular drug they have to say what other drug can be used in its place.”
“So there’s information not just at a high level from an industry point of view there’s also information for the physician to make sure they’ve got something there to provide their patients so at all levels this has to work,” she said.
Ambrose says she wants to give that system time, but is willing to demand more.
“We do need to have time to make sure we get that system right but I have no qualms of moving to a mandatory system for drug shortages should we need to do that.”
“I’m in consultation with my department on that,” she said “I’ve already announced formal consultations which is the right way to go obviously this has an impact not just on the drug manufacturers. Let’s remember this has an impact on provinces and territories.”
Ambrose told reporters the drug makers are reluctant to move to mandatory reporting.
“Some who are involved in this debate say that the problems we’re having with the voluntary system may not necessarily be helped through a mandatory program. I want to make sure what ever those problems are we’re addressing them. Whether we go to a mandatory program or in another way we’re addressing them. We’ve got to make sure what ever system we use is fixing the problems.”
Ambrose says the shortage is a world wide problem.

Penicillin shortage surprises Edmonton ER doctor

Edmonton emergency room physician Dr. Louis Francescutti says doctors are encountering drug shortages, including even common drugs like penicillin. 
Francescutti, who is currently the president of the Canadian Medical Association, recently wanted to prescribe the liquid form of penicillin to one of his patients in an Edmonton emergency room. One of his colleagues told him they had been out of stock for several weeks.
“We had 52 patients in the waiting room ...and to get frustrated by not having a medicine that last week was there, this week, it's not there, next week maybe, maybe not,” he said.
“And this isn't something that I remember practising medicine 10 years ago."
Alberta Health Services says the penicillin shortage is a Canada-wide issue that isn't limited to this province. Penicillin is still available but "may be in a different form than they are used to," spokesman Kerry Williamson said. 
Reporting of drug shortages may soon no longer be voluntary for drug manufacturers, federal Health Minister Rona Ambrose said Monday.
“What I've indicated now to my colleagues across the country, the other health ministers and to industry is that we're looking now to move to a mandatory drug shortages program.”
While there are penicillin alternatives, Francescutti says the shortage of such a common drug creates problems for doctors and patients, who may face delays at the pharmacy.
"Who knows how many patients have been inadvertently harmed by having to use your second drug of choice,” he said.
A 2012 report recommended that Health Canada set up drug monitoring teams.
Health Canada is holding consultations on the drug shortages over the next six weeks. The government is also reviewing its own drug shortages website.