Tuesday, July 29, 2014

Are You Getting the Right Anesthetic?

When you're about to have surgery, the last thing you want to worry about is the efficacy of the drugs used to put you under. But with an acute shortage of anesthesia drugs, this is a real concern in the medical field.
According to a survey by the American Society of Anesthesiologists, 98 percent of anesthesiologists in the U.S. experienced a drug shortage in 2012. The causes, says Jeff Jacobs, an anesthesiologist in Fort Lauderdale, Florida and chair of the committee on ethics for the ASA, “are myriad.” Some drugs require raw materials from developing countries – say in Africa – where there might be a civil war. Many manufacturing plants in the U.S. are dated and have limited capacity. A lot of the drugs are also generics, so pharmaceutical companies are not incentivized to produce more of them, compared to high-cost specialty drugs.
These factors have created a stressful scenario for anesthesiologists. “We’ve come very close at times [to canceling surgery], but being a big system, we can borrow from other facilities,” says Chris Snyder, the drug information pharmacist who oversees shortages and recalls for Cleveland Clinic in Ohio.
Alternative Drugs
The vast majority – some 96.3 percent of doctors surveyed by the ASA – end up using alternative drugs, which may have different side effects than the routine drugs, or they import the same drugs from other manufacturers, often overseas, which may have different side effects.
David Rosen, an anesthesiologist in Chicago and president of the Midwest Anesthesiology Partners, recalls a new anesthetic used on elderly patients undergoing electroconvulsive therapy that turned out to be five times as strong as the routine drug. “We were having patients with really low blood pressure after the procedure, or they were not waking up after 45 minutes,” Rosen says. “We were lucky there was no harm done, but we were close.”
One of the most common anesthetics – propofol – became well-known when Michael Jackson died after taking a large dose of it. For many doctors, propofol is the induction drug of choice, used to sedate patients before other anesthetics are given. Manufacturing delays have caused shortages of propofol, forcing doctors to find alternatives.
“The beauty of anesthesia … it’s like a soup or a stew … there are lots of different things in it,” Rosen explains. “Just because I am out of propofol doesn’t mean I can’t take good care of you.” But if he’s out of toradol, a commonly used painkiller, “that’s when I’m adjusting more than I want to,” he adds. Generally speaking, to make up for a shortage of anesthetics, doctors end up using more narcotics, which can cause nausea and delayed awakenings.
Talk to Your Anesthesiologist
So what does all this mean for you? Anesthesiologists, much like pathologists, are sort of behind-the-scenes doctors with whom patients normally have limited contact, apart from five minutes before surgery, when patients are often too anxious to ask questions or hear answers. So put in a phone call to your anesthesiologist a few weeks before your procedure, Rosen says. “I like that people Google their procedure beforehand – it’s a good basis for asking more intelligent questions. But the best way is to ask questions of the people taking care of you.”
The first question to ask, he adds, is who is actually going to be taking care of you: an anesthesiologist, a nurse anesthetist (who, in 85 percent of cases nowadays, will administer drugs), a resident or the surgeon. Plastic surgeons, for example, often administer anesthetics for their own procedures, Rosen says.
Sometimes, sub-specialists are also involved, like pediatric anesthesiologists if children are being operated on, or those who specialize in pregnant women or the elderly.
“It’s definitely appropriate [for patients] to ask if any drugs are unavailable at this time, and how it affects what [doctors] are doing,” Rosen says. “Hopefully this will give patients some sense of confidence and put more pressure on the hospital administration that this is a huge problem we’ve been facing for many years.”
Rosen adds that a little bit of patient pressure could go a long way, too, because hospitals are increasingly concerned about patient satisfaction as well as safety issues – and sometimes last-minute drug substitutions can pose real safety concerns. “From an ethical point of view, if with a certain [alternative] anesthetic, increased morbidity or mortality really exists, then you have an obligation to discuss that with patients,” Jacobs says. And if patients are prone to potentially suffering adverse side effects [if they have a history of motion sickness, for example], then you may want to consider rescheduling surgery, he adds.

Sunday, July 27, 2014

After Arizona, here’s a guide to the drugs used in lethal injections

Before the execution of Joseph R. Wood III in Arizona — an unusually drawn-out process that took nearly two hours, prompting an official review — Wood’s attorneys had argued that the lethal injection should be delayed until the state released more information about the drugs that would be used. After the Supreme Court lifted a stay of execution that was in place, Dale Baich, one of Wood’s attorneys, said that the looming execution came “with serious questions remaining about the drugs.”
Part of this stems from the fact that Arizona, which announced earlier this year that it would change the drugs used in lethal injection, was going to use a new drug combination that had not been used in the state before. But part of this also relates to an ongoing shortage of lethal injection drugs, one that has left states effectively experimenting with the drugs.This drug shortage is why Arizona used a different combination of drugs, and this drug shortage has resulted in a strange situation where different states are using different drugs for different executions, with the same states altering what they use from one execution to the next (and having the executions play out in different ways). So what drugs are being used and where? Why are they using different drugs? Here is a primer: A standard formula and a shortageFirst, some background. Until 2010, there was a fairly typical three-drug combination used for lethal injections, according to the Death Penalty Information Center. Inmates were killed utilized an anesthetic, a paralytic drug and a drug that stopped the heart. Most of the lethal injections carried out in 2009 and 2010, for example, used a three-drug combination that included the anesthetic sodium thiopental. (Ohio opted to just use sodium thiopental in an execution that year, but more on that in a moment.)
However, Lundbeck, the Danish company that had supplied the drug, protested its use in lethal injections. States began seeking out the drug from compounding pharmacies, but some lacked the necessary supplies of pentobarbital to keep using it. So some began using the sedative midazolam hydrochloride — and we want to emphasize the some states part. It has cropped up in less than half of the executions so far this year, while pentobarbital has been used in all of the others. (Here’s a longer look at the drug shortage and how states have responded.)
Here is a little more broken down by drug:
This anesthetic has been used in the most executions so far this year, cropping up on its own in more than half of the 26 lethal injections that have taken place. Oklahoma, Texas, Missouri and Georgia have all used it.
Oklahoma executed Michael Wilson in January using pentobarbital and two other drugs. In the first of several troubling episodes this year, Wilson’s final words, delivered seconds after the injections began, were: “I can feel my whole body burning.”
This drug has been used in 10 executions this year. Florida, Ohio, Oklahoma and, now, Arizona have all utilized it — and they have seen results that ranged from unusual to disturbing, according to eyewitnesses.
The Oklahoma execution, which used midazolam and two other drugs, was the most high-profile execution in the U.S. in recent memory. Clayton Lockett grimaced and clenched his teeth, witnesses said, causing the state’s Department of Corrections to halt the execution. He still died a short time later, and an initial autopsy pointed to a problem with the placement of the IV rather than the drugs.
But it wasn’t the first troubling execution involving midazolam to occur this year. In January, Ohio put Dennis McGuire to death using midazolam and hydromorphone — the same combination used in Arizona on Wednesday. This combination had not been used before in the U.S., but Ohio turned to it because of the drug shortage. It took McGuire nearly half an hour to die, and he spent part of that time gasping for air. Ohio state prison officials said in a review of the incident that McGuire did not suffer, but did say they will increase the dosage of the two drugs for future executions.
Florida wasn’t the first state to use midazolam in an execution. Last October, William Happ’s execution lasted 14 minutes; the Associated Press reported that it seemed Happ was conscious longer and moving more than other inmates killed using the earlier lethal injection formula.
Sodium thiopental 
Florida used this drug in the execution of Angel Diaz in 2006, which was so unusual — it lasted for 34 minutes and required a second dose of the chemicals — that then-Gov. Jeb Bush (R) suspended executions in the state and established a commission, which found that the execution team failed to ensure proper IV access during the execution and failed to follow the state’s execution protocols.
Before the drugs, problems with veins
There have also been problems related to just finding a way to deliver the drugs. While there are no indications that this was a problem in Arizona, difficulties placing an IV in a vein was a factor in at least two mishandled executions – Clayton Lockett in Oklahoma and Angel Diaz in Florida.
This also cropped up during a 2009 execution in Ohio, when the state tried to kill Romell Broom, only to eventually halt the execution because despite repeatedly sticking him with a needle, they were unable to find a suitable vein. (He remains on death row.) It also took about 30 minutes to properly place the IV in Kenneth Biros’s arm during his execution in 2009, when hebecame the first person executed with a single drug (sodium thiopental) rather than a three-drug combination.
Similarly, it took the execution team in Georgia about 30 minutes to find a vein to inject Brandon Rhode the following year. The same thing has happened several times in recent years.

Medicine shortage problem is far from solved, warns APPG

Shortages of branded medicines are now less visible than they were two years ago but the problem is still ongoing, according to the All-Party Pharmacy Group (APPG).
The APPG, who held an inquiry into drug shortages two years ago, believes the improvement can be explained by exchange rate fluctuations, with a strong pound leading to a decline in the parallel export of medicines intended for British patients, and that the underlying issues are still a concern.
“The problem is far from solved,” said Kevin Barron, Labour MP and the group’s chairman. “[Medicine] quotas imposed by manufacturers and some wholesalers remain in force. These are often opaque and inflexible, meaning that community pharmacists are still having to spend a large amount of their time negotiating to obtain the medicines their patients need.”
The group, who raise awareness of the pharmacy profession, claimed that pharmacists are having to ration medicines in order to manage drug shortages. It believes the government should be doing more to address the problem, suggesting the Department of Health (DoH) publish updated supply chain guidance addressing best practice in quota setting and management.
The APPG also noted the growing problem in the supply of generic medicines, which was not a concern when the inquiry was held. Some of the causes of generic shortages reflect the globalisation of the generics market, but that cannot be an excuse for “no action here in the UK”, says the APPG.
The statement follows an APPG meeting on drug shortages on 16 July 2014 with representatives from the pharmaceutical industry, wholesalers, the DoH and pharmacy bodies.

Drug shortage big issue for executions

The prolonged execution in Arizona looked troubling, but was it unconstitutional? The U.S. Supreme Court, which upheld the use of lethal injection six years ago, has held that “an isolated mishap” during an execution does not violate the Eighth Amendment. A question and answer look at the current state of executions.
Q: Why did Arizona use a two-drug combination that was also involved in a similar lengthy execution in Ohio?

A: After more than three decades of using the same three-drug combo to put hundreds of inmates to death with few problems, states have scrambled in recent years to find alternative drugs because of a shortage rooted in European opposition to capital punishment. Some states have obtained supplies of compounded pentobarbital, which doesn’t undergo the same type of federal regulations as regular pentobarbital, which is now unavailable. Other states, like Arizona, are turning to midazolam, a sedative, and hydromorphone, a painkiller.
Q: What caused the shortage?
A: Nine years ago, the European Union banned the export of products used for execution, citing its goal to be the “leading institutional actor and largest donor to the fight against the death penalty.” But beefed up rules in Europe have been felt most strongly in the United States, with shortages becoming chronic. In addition, U.S. manufacturers are now putting restrictions on the use of their drugs for executions.
Q: The Arizona execution lasted almost two hours. Doesn’t that constitute cruel and unusual punishment?
A: The answer depends on whether the inmate felt pain — the state says he didn’t — and whether any intentional actions to inflict pain can be proven. In addition, the U.S. Supreme Court has held that “an isolated mishap” during an execution does not violate the Eighth Amendment, “because such an event, while regrettable, does not suggest cruelty or a ‘substantial risk of serious harm,”’ according to a 1947 decision allowing Louisiana to return an inmate to the electric chair after a botched attempt a year earlier.
Q: Have death row inmates challenged any of the new drugs?
A: Defense attorneys have sued over compounded pentobarbital as posing a potential threat since its purity and effect can’t be guaranteed. Yet so far, executions with compounded pentobarbital in Missouri and Texas haven’t been problematic. Attorneys have also challenged the use of midazolam and hydromorphone, arguing that they could cause pain as inmates struggle to breathe.
Current legal challenges:
-- Oklahoma: Twenty-one death row inmates are seeking to halt any attempt to execute them using the state’s lethal injection protocols, which they allege present a risk of severe pain and suffering in violation of the U.S. Constitution. The inmates’ lawsuit followed the state’s botched April 29 execution of Clayton Lockett using a new three-drug method.
-- Missouri: Death row inmates claim the state’s refusal to name the drugmaker providing its execution drug, even privately to attorneys, makes it impossible to know whether the drug is suitable for an execution, or violates the constitutional guarantee against cruel and unusual punishment.
-- Ohio: Attorneys have unsuccessfully argued that the two-drug combo created an unconstitutional risk of suffering because of a phenomenon known as “air hunger” in which people experience terror as they strain to catch their breath.

Botched executions raise new questions

A botched execution in Arizona last week has sent many states scrambling to make sure their executions don't follow a similar grim scenario. 

It took Joseph Wood one hour and 57 minutes to die. He was administered a combination of midazolam and hydromorphone; it was the first time Arizona had used this combination of drugs to execute an inmate.  

Lethal injection has been the method of choice in the United States since 1976, and has be largely deemed the most humane way of executing prisoners without violating the Eighth Amendment, which forbids cruel and unusual punishment.  

Wood's execution in Arizona, in addition to the botched execution of Michael Lee Wilson in Oklahoma and Dennis McGuire in Ohio, has drawn attention to the method by which we execute are criminals.  

States with the death penalty previously obtained their execution drugs from Europe. The most commonly used drug is pentobarbital, which causes people to become unconscious to the point of death. This drug is often the primary ingredient, and is often mixed with pancuronium bromide, a paralytic, and potassium chloride, which stops the heart. However, in recent years European companies have refused to supply the United States with drugs for executions. States have instead had to turn to compounding pharmacies to get their drugs. 

In March of this year, Mississippi announced it would begin to receive its pentobarbital from a compounding pharmacy. Compounding pharmacies traditionally alter medications for specific users. They do not have to go through the same approval process that larger manufactures and traditional pharmacies do.  

"The MDOC uses pentobarbital, vecuronium bromide and potassium chloride in executions," said Grace Fisher, the communications director for the Department of Corrections.  

Mississippi has 50 inmates on death row. They will be the first in the state's history to be executed with drugs bought from compounding pharmacies.  

As of today, none of the 50 inmates on death row has a execution date set.  

There were six executions at Parchman in 2012. Two scheduled executions in 2013 were stayed, including that of Willie Manning of Starkville, whose execution was called off just hours before it was scheduled on May 6, 2013. Neither of the stays were attributed to the state's lethal injection methods.

Read more: http://www.cdispatch.com/news/article.asp?aid=35110#ixzz38gccfeP7

Illegal drugs threaten animals, too

Imagine waking up and finding your beloved pet on the floor convulsing, motionless or dead.
This was the real-life nightmare for horse trainers in both Lexington and Ocala, Fla. when they found their horses experiencing seizures and thrashing in their stalls. More than a dozen horses died or were severely injured, in some cases paralyzed, by illegally compounded medicines.
These horses were prescribed illegal drug concoctions that contained unsafe levels of pyrimethamine. By one account, 25 times the recommended amount, a deadly overdose.
There is legal and appropriate animal drug compounding. FDA-approved products may be modified (for example, adding flavorings, or turning tablets into a liquid) by a trained pharmacist on the order of a veterinarian to treat the medical needs of specific animals.
But some animal drug compounding pharmacies go far beyond those parameters, with deadly results. They mass produce and market drugs that mimic FDA-approved products, often using untested active ingredients, imported from countries that may not strictly control drug manufacturing.
These copies carry a cheaper price tag than approved drugs, but none of the consumer protection.
Why does this black market exist? It's both expensive and time-consuming to get FDA approval for a drug. For animal drugs, it can take up to 10 years and cost up to $100 million. But the process protects consumers and animals by ensuring that the approved drug is safe and effective.
FDA permits a limited amount of necessary compounding from bulk ingredients in order to make sure medical needs can be met when there is no approved drug. But these compounding pharmacies have taken the proverbial inch and run for murderous miles. Despite their attempts to muddy the waters with lawsuits and rhetoric, the law is clear: FDA and three federal appeals courts have ruled that compounding animal drugs from bulk substances is illegal.
The practice has caused harm to more than just horses. One university veterinary hospital has reported that dogs and cats are brought in, only to find they were being treated with illegally compounded drugs.
As a former FDA associate commissioner (and a current dog owner), I know the agency has rigorous enforcement authority. Pharmacies that engage in illegal manufacturing cannot be allowed to ignore the law and put animal health at risk in the name of selling a cheaper product.
For several approved animal drugs, FDA has sent warning letters to these pharmacies, but often they were ignored and the practices continued. Unfortunately there has been little to no follow-up by the agency. The FDA must have more strong and sustained enforcement to protect animal health.
What can you do? Talk to your veterinarian about treatment options for your pet. Ask if any drug being prescribed is FDA-approved. If not, and compounding is necessary, make sure the pharmacist preparing the compound has the credentials and license to do it safely and legally.
While that might sound obvious it is the only way to ensure the prescribed drug is what is best for your pet. If you have concerns about a pharmacy, check with your state board of pharmacy. At the same time, FDA must do its job of protecting our pets and animals by more regularly and aggressively enforcing the law and regulations.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a member of the Animal Health Institute's Board of Scientific Advisors.

Read more here: http://www.kentucky.com/2014/07/26/3352521/illegal-drugs-threaten-animals.html?sp=/99/349/#storylink=cpy

US FDA alerts healthcare professionals on recall of non-expired sterile drugs from Unique Pharma

The US Food and Drug Administration (FDA) is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.

The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products.

Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients, as these products may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

Unique Pharmaceuticals distributed these products nationwide. Most of the product labels include: Unique Pharmaceuticals, Temple TX USA 76502.

Two recent inspections of the Unique Pharmaceuticals facility conducted by the FDA revealed insanitary conditions that result in a lack of sterility assurance of drug products produced at that facility. These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.

On July 11, 2014 the FDA issued a formal request to Unique Pharmaceuticals to conduct a recall of all non-expired, purportedly sterile drug products. The FDA also requested that the firm cease sterile compounding operations. As a result of the FDA requests, Unique Pharmaceuticals has agreed to the recall and is ceasing sterile compounding operations until sufficient corrections are made at its facility.

“Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge health care professionals to follow recall instructions issued by the firm.”

To date, the FDA is not aware of reports of illness associated with the use of these products. Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their health care professional.

The FDA asks health care professionals and consumers to report adverse events or quality problems associated with the use of Unique Pharmaceuticals’ products to the FDA’s MedWatch Adverse Event Reporting programme by:  completing and submitting the report online at MedWatch Online Voluntary Reporting Form; or downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178 Unique Pharmaceuticals is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section 503B to the FDCA. Under section 503B, a compounder can elect to become an outsourcing facility. Outsourcing facilities:must comply with current good manufacturing practice requirements;will be subject to inspection by the FDA according to a risk-based schedule; and must meet certain other requirements, such as reporting adverse events and providing the FDA with certain information about the products they compound.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Zimbabwe: Govt admits failing to provide funds for vital drugs

HARARE - Paul Chimedza, deputy minister of Health and Child Care, has admitted that the country's hospitals are facing severe drug shortages which have compromised the treatment of patients.

He made the admission in the Senate on Thursday during ministers' question time.

MDC Senator Misheck Marava quizzed Chimedza on the stock levels of drugs in State hospitals.

"We are reading in the press about the drug shortages and also word is going round that the country's drugs or medical stocks are below the minimum levels. The citizens are in a sort of panic mood. Can you assure the country that we are safe?"

He spoke after the Daily News reported that State hospitals have run out of vital medicines, with the institutions prescribing even basic drugs for purchase at private pharmacies. The scarcity of drugs is creating grave problems for the poor.

Chimedza said the drug crisis was caused by government  under-funding the National Pharmaceutical Company (NatPharm), whose sole purpose is to procure drugs and distribute them to all State health institutions.

"The drug situation in the country is not up to the standard that we are satisfied with," Chimedza said.

"As government, we have failed to provide funds for our public entities. As a result, there is shortage of drugs in the central hospitals, provincial hospitals and district hospitals.

"The ministry of Health and Child Care has put a request to Treasury for $10 million which has to go to Nat Pharm but because of the shortage of funds, we were only allocated $3 million and  we have not received most of it at the moment." 

Chimedza said the country's health system was organised in a referral system where the lowest unit is called the rural health centre, followed by district hospital, provincial hospital, and the central hospitals which include Parirenyatwa, Mpilo and Harare hospitals.

He said the central and district hospitals were in a dire situation compared to the rural areas that were being funded by the donor community.

"Rural health centres, essentially drug level is at 80 percent  as most of them are supported by the multi-lateral partners," he said. "So there is a kit that is enough for the rural health centres so that they have their medicines that are used at that level that is adequate for the rural  communities." - See more at: http://www.bulawayo24.com/index-id-news-sc-health-byo-51251.html#sthash.yLPS7MM0.dpuf

Tuesday, July 22, 2014

Shortages of Prescription Drugs Reported Nationwide

From the corner pharmacy to the operating room, drug shortages are occurring nationwide, forcing healthcare professionals to make changes in their treatments, even in critical emergency care situations.

Oral drugs may suddenly become unavailable for weeks. Some have been in short supply for several years. Anesthesiologists often run short on common anesthetic drugs. When these shortages occur, physicians and pharmacists have to change drug treatments, recalculate doses, or even postpone treatments.
Surprisingly, the drugs that are in short supply are rarely high-ticket treatments. Instead, they are usually inexpensive generics. Drug wholesalers, and then pharmacies, run out of ordinary medications like atorvastatin (a statin drug used to prevent formation of cholesterol in the body), bupropion (an antidepressant), pantoprazole (used to block stomach acid and treat reflux or indigestion), and B-12 injection (cyanocobalamin, which helps the body produce red blood cells). Patients may wait for weeks to get a new supply of a common drug.  

Surgery, Emergency Care Are Often Impacted

Shortages become critical when they impact surgery or emergency care. Chris Snyder, R.Ph., manages drug shortage issues for the Cleveland Clinic, where more than 200,000 surgeries are performed annually. For the last three to four years, there have been shortages of anesthesia drugs, which put people to sleep and bring them out of anesthesia.
Snyder told Healthline that “a shortage of propofol could shut down our surgical suites.” Propofol is used to start and maintain surgical anesthesia. Bupivacaine, lidocaine, neostigmine, and atropine are other common drugs used for surgery. A disruption in supplies may mean it takes more time to put the patient under or to reverse anesthesia. “This makes the next case hold over and frustrates families,” said Snyder.  
Ordinary supplies like IV bags of saline injection may be manufactured from water and salt, but a shortage of these saline solutions can affect every hospital and ambulance operator in the nation. Adding new manufacturing lines for sterile products is an extremely complex process. The current shortage has forced the Food and Drug Administration (FDA) to allow importation of IV bags from Spain and Norway to meet demand. Most IV drugs that are diluted require saline to administer them.

Chemotherapy Drugs Are Cause for Worry

The patient’s stress may also increase dramatically when chemotherapy drugs are in short supply. “The problem has become magnified since 2011,” said Dr. Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology (ASCO). “The number of shortages, the frequency, and duration of shortages have all increased.”
When a drug is in short supply, there may be an alternative, but the alternative can be incredibly costly. One dose of brand name Abraxane (protein bound paclitaxel) costs roughly $6200, which is forty times the $150 cost of generic paclitaxel.
Schilsky explained that the time spent on solving these shortage issues is also costly. “The whole health system spends more time trying to solve this dilemma with great uncertainty about what is available and when,” said Schilsky. In the past, he adds, “We never had to postpone a patient’s treatment due to shortage. This is a full-time job — bartering and swapping out drugs.”  
The American Journal of Health-System Pharmacy published a nationwide survey of hospital pharmacy directors in 2014. More than two hundred pharmacy directors from hospitals that dispense chemotherapy drugs responded. During the previous twelve months, 70 percent reported an inadequate supply of chemotherapy drugs for patients, and 43 percent mentioned treatment delays. Additionally, 35 percent of respondents indicated a moderate to severe risk of death for patients when a drug was delayed or changed.  

What Is Causing the Short Supply?

There are many reasons why essential drugs are in short supply. PhRMA, the Pharmaceutical Research and Manufacturers of America, acknowledges drug shortages on its website, with a list of possible causes, and places “manufacturing challenges” at the bottom of the list. The American Society of Health-System Pharmacists (ASHP) maintains an up-to-date website of drug shortages, and includes analyses of shortages and their causes, including manufacturing problems, shortages of raw materials, and, sometimes, increased demand. ASHP’s pharmacists have found that in half of the drug shortages they have tracked, the manufacturers don’t know what caused the shortage.
"The problem has become magnified since 2011; the number of shortages, the frequency, and duration of shortages have all increased."
How is the overall drug supply managed in the U.S.? Unfortunately, supply and demand are precariously balanced by the free market system, in which competitive manufacturers hesitate to share information with each other.
Current business practices also cause drug shortages. Just-in-time (JIT) inventory management is used so that the pharmacy, drug wholesaler, and drug manufacturer all trim their supplies on hand. They do this in order to keep inventory costs down. Any blip in demand, caused by a sudden outbreak of illness, a change in medical treatments, or approval of a new generic drug, can cause sudden shortages.

The FDA Steps In

The FDA has taken an important role in managing drug shortages. The modern version of this federal agency came into being in 1906 with the Pure Food and Drug Act. The FDA is a regulatory agency designed to protect public health. It reviews applications for new drug products and generic versions of brand name products. The agency also carries out inspections of manufacturing facilities and has the power to shut down production when the facility does not meet its standards.
The FDA maintains a flock of inspectors, who must increasingly circle the globe to inspect drug manufacturing, since so much manufacturing now occurs outside the U.S. When manufacturing problems increase, the demand for more inspections may also impact shortages. The agency is subject to congressional approval of its annual budget, and any increases in inspection staff are part of the package that must be reviewed in budget debates.
Captain Valerie Jensen, R.Ph., associate director of the Drug Shortages Program in the FDA’s Center for Drug Evaluation and Research, told Healthline that new legislation in 2012, requiring manufacturers to notify the FDA of disruptions, discontinuation, or interruptions of drug supplies, has helped whittle the list of new drug shortages to 44 products in 2013, a big improvement from the peak of 251 shortages in 2011.
The recent shortage of saline solution occurred at the end of 2013 and involved many factors. “Companies were notifying us of tight supply, and did not expect a shortage at that time," explained Jensen. "They thought it would even out at end of year. Tightness continued and increased demand, and threw things into shortage.” No manufacturing problems were associated with the shortage and “they were at full production and couldn’t keep up with demand. Some of these drugs don’t have enough lines available to help. It takes three weeks to make a batch of a drug like saline, and it’s difficult to increase production.” The FDA made a rare decision in this case to allow importation of product from Spain and Norway until U.S. manufacturers could catch up.
Jensen also explained that another strategy from the FDA is to expedite reviews of critical drugs, which may include new makers of generic drugs. Generic manufacturers must now pay a user fee, which helps defray the cost of inspections and reviews. FDA inspections require a team of up to 25 staff members, and must include microbiologists, chemists, pharmacists, and others who represent the same skills needed to run the manufacturing facility.    

Time Is of the Essence

Snyder has researched drug supply issues for years, and says that the cause of a shortage of an individual drug can be quite simple and sudden. “When you only have two dominant players (suppliers) and lose half the market, the other company can’t order raw ingredients fast enough and reschedule the product lines," says Snyder. "You can’t have 50 percent capacity unavailable and make up the difference.”
Snyder went on to say that wholesalers base their stock on previous demand, and there is no advance warning system when the supply goes down.
Acknowledgment of the drug shortage problem and efforts to work on the causes has been picked up by medical societies like ASCO, and is being discussed in diverse meetings, such as the upcoming Parenteral Drug Association (PDA) (injectable drugs) Drug Shortage Workshop in Washington, D.C. in September, where industry and FDA leadership will strategize the shortage issue.

Troubleshooting Drug Shortages for Patients

How can physicians and patients ensure the right drug therapy is there when it’s needed, and what can the hospital staff do to ensure that surgery, cancer care, and other essential services are not disrupted by drug shortages?
Schilsky recommends encouraging doctors to be prepared for shortages and try to have a local plan in place. Patients should never let their pharmacy prescription bottles run completely empty, since shortages can make it difficult for their physician or pharmacist to change to an alternate product on short notice.
Snyder suggests that hospital employees should build relationships with key staff members, including the heads of medical departments, administrators, and pharmacists, to ensure patients get what they need. Therapeutic substitution, which is using a different drug than the one prescribed, but which has the same result, is a key strategy to managing shortages. A large health system with strong purchasing connections may buy products directly from manufacturers and hear about shortages more rapidly.
Employee physicians are key to the Cleveland Clinic’s success in managing shortages is employee physicians. They are motivated to work with the rest of the staff. Summing it up as the success of a team approach to solving drug shortage problems, Snyder concluded, “If you’re not demanding we make water out of wine, we can handle it.”

Recall Alert: Hospital unit dose ibuprofen, oxcarbazepine

American Health Packaging (Columbus, OH) has voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, American Health Packaging (AHP) has voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This voluntary recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine.
Ibuprofen 600 mg tablets are indicated for the relief of mild to moderate pain; for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis; and treatment of primary dysmenorrhea. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated.
Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure. Affected products as follows:
Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084-703-11, Lot #142588, Expiration Date, 01/2016. The drug product can be identified by physical description: white, oval-shaped, film-coated tablets, with "IP 465" printed on one side.
Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets, 300 mg, with outer carton NDC#: 62584-143-0 and individual dose NDC#: 62584-143-11, Lot #142544, Expiration Date, 02/2016. The drug product can be identified by physical description: yellow color, capsule shaped, film-coated tablets scored and debossed with '184' on one side and scored on other side.
To date, AHP has received 1 customer complaint which resulted in the investigation and recall of these drug products. AHP has not received any adverse event reports attributable to the mislabeled drug.
American Health Packaging initiated a voluntary product recall on July 1, 2014 as a safety precaution, and will continue to closely monitor for reports of adverse drug reactions and product complaints. Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers.
These hospital unit dose products were distributed nationwide beginning June 20, 2014. No other products or lots were affected by this incident.
Consumers who have received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST for instructions on returning the recalled product.
For medical information questions or product complaints related to Oxcarbazepine Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact American Health Packaging customer service at 1-800-707-4621 from 8am to 4pm EST.
Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at http://www.fda.gov/safety/medwatch/default.htm.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.