Monday, June 30, 2014

Is there no solution: Saline shortage creates issue for US hospitals

Is there no solution? Hospitals experiencing saline shortage
The lack of saline could spell the most expensive drug shortage in history (Picture: Alamy)
Hospitals across the US are desperately searching for a solution after manufacturers started rationing saline - the salt and water mix used to clean wounds, mix medications and hydrate patients.
Bizarrely, making bags of salt and water is a deceptively complex process, with manufacturing taking up to three weeks due to a 30-step procedure to ensure the saline is sterile.
Drug companies say they won’t be able to catch up with demand until next year.
‘To make one of these drugs is very complex, even though the drug itself is simple,’ said Valerie Jensen, the director of the drug shortage program at the Food and Drug Administration.
The Food and Drug Administration has tried to deal with the shortage by importing saline from abroad but economists have warned it’s not a sustainable solution as all countries have to supply their own hospitals.
‘There is no spot market,’ said FDA economist Marta Wosinska.
‘You can’t buy it like pork bellies or grains or oil.’
Hospitals have developed protocols to conserve supplies, but with the shortage set to continue through to the end of the year, experts have warned the increased demand for saline and labour costs will make it the most expensive drug shortage in history.

State unveils plan to regulate pharmacies

State inspectors who monitor compounding pharmacies that custom mix drugs will be required to have special training, under compromise legislation unveiled Sunday by Massachusetts lawmakers. Adding one pharmacist with expertise in the most risky type of compounding to the board that regulates the industry, would also be mandated under the legislation.
In addition, the bill would require hospital pharmacies, which currently are not subject to routine monitoring by the state’s pharmacy board, to be inspected by state regulators and follow Massachusetts rules by June 2015.
The legislation comes after tainted drugs produced in 2012 at a Massachusetts commercial compounding pharmacy, New England Compounding Center, sickened 751 people, killing 64.
The Massachusetts House and Senate last fall each issued different proposals aimed at closing loopholes that investigators said led to the deadly fungal meningitis outbreak from the tainted drugs, and the compromise package issued Sunday includes many key proposals from both.
“With this legislation, we’ll go from a state with essentially unregulated pharmacy compounding substances to a state which will provide patients with some of the best patient care in the country,” said state Senator John F. Keenan.
“It’s a very good bill . . . that broadens scope and really serves to protect the patients in the commonwealth of Massachusetts,” Keenan said.
“This closes a lot of the loopholes that currently exist,” said Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, a group that represents most compounders. “This potentially can be a model for the rest of the country.”
After the meningitis outbreak, some state inspectors testified at a public hearing that they didn’t have the expertise they needed to effectively monitor pharmacies, such as New England Compounding, that do the most risky type of compounding — mixing drugs that are injected into the body.
The fungal meningitis outbreak was traced to an injectable steroid manufactured at New England Compounding.
“If they are not trained properly, they don’t know what they are looking at,” Brown said.
The compromise legislation also expands the pharmacy board from 11 to 13 members, and would require that eight of its members be pharmacists, including one with expertise in so-called sterile compounding, which is the type of drug mixing done at the now-defunct New England Compounding.
The company closed following the meningitis outbreak.
Governor Deval Patrick last year proposed legislation to decrease the number of pharmacists on the board to four members, saying he believed that fewer pharmacists on the board would mean stronger oversight. He said he believed it would bring a greater range of professional perspective to the board.
The pharmacists association fought that move, saying the field had become so complex, the board needed pharmacists who understood the issues.
The compromise legislation also will require out-of-state pharmacies that ship products to Massachusetts to be licensed by the state and subject to its rules.

Other portions of the package would require inspectors to conduct both planned and unplanned inspections of all licensed compounding pharmacies, and to assess penalties up to $25,000 for each violation by a pharmacy, and up to $1,000 a day for each violation that continues beyond the date prescribed for correction.

Friday, June 27, 2014

Shortage of Saline Has Hospitals on Edge

Hospitals across the country are struggling to deal with a shortage of one of their essential medical supplies. Manufacturers are rationing saline -- a product used all over the hospital to clean wounds, mix medications, and treat dehydration. Now drug companies say they won't be able to catch up with demand until next year.
That leaves San Francisco General Hospital's materials manager, Reid Kennedy, in a fix. Kennedy is in charge of managing all the gloves, bandages, bedpans, and IV solutions for all the medical floors, emergency room, and operating room.
He first got a call last year from his vendor telling him they might not be able to deliver his full order.
"We were put on notice that it was going to be tight," he said.
Then things got worse in January. The flu season hit much harder than expected, and sick people flooded into hospitals. Saline bags flew off the shelves to treat dehydration, and demand far outstripped supply.
"The flu season knocked us out as an industry," Kennedy said. Though hospital administrators say the shortage hasn't affected the quality of patient care, Kennedy uses the word "crisis" to describe the shortage.
It's Harder to Make Than You Think
But can salty water really be that hard to come by? Kennedy pays $1.57 per bag. Why can't drug companies just whip up some more?
"To make one of these drugs is very complex, even though the drug itself is simple," said Valerie Jensen, the director of the drug shortage program at the Food and Drug Administration. "It takes about 3 weeks to make one batch of normal saline from start to finish."
She says the key challenge is making sure saline products are sterile. More than 30 steps and a range of supplies are involved in producing sterile saline. Jensen says FDA inspectors have reason to keep a close eye on any drug injected intravenously. She says they've found some nasty things in IV drugs: bacteria, mold, glass particles.
"These are issues that absolutely would be a safety risk for patients," she said.
That's why the FDA sets strict quality standards for the facilities that manufacture saline and other IV drugs. But the agency has to find a delicate balance between safety and supply.
Some suppliers suggest keeping up with the FDA's standards is too onerous and may be playing a part in the shortage.
"A lot of variables came together to create this," said Scott Crandall, director of medical supply contracts at Novation, a group buying organization in Texas that manages contracts for San Francisco General and 2,000 other hospitals across the country. He's been hearing from manufacturers that increased FDA scrutiny is interfering with drug production.
"During the last year, all suppliers had issues in their facilities where they had to correct certain things the FDA found," Crandall said.
Some of those corrections were serious. Hospira, one manufacturer of saline, issued a recall earlier this year because of leaks in its saline bags. Before that, Baxter, another manufacturer, found particles in its saline vials and had to recall four lots. Both companies say the recalls had no bearing on the current shortage.
Flu Season Causes Headaches
But Crandall says inspections and maintenance require shutting down machines. And when machines aren't operating, less saline is getting shipped. Last winter, he says maintenance closures "slowed production down, 10 to 20 percent."
So the industry was already behind when the flu season hit.
The procurement director for a group of dialysis centers says his supplier, Baxter, told him the main problem was winter weather. Snow and ice storms in the Midwest were delaying trucks headed for California.
"As the weather got worse, we began to see more and more backorder issues," said Colin Carthen of Satellite Healthcare, which runs 70 dialysis centers across the U.S. Each patient comes in three or four times a week, and each time goes through 1 to 2 liters of saline to clean the blood and prevent clotting. At the worst of the shortage, Carthen realized the health of 6,000 patients depended on the administrative magic tricks he could perform behind the scenes.
"I called up a clinical person that I knew, and said, 'Well, what happens if we run out of saline?' Because I was really afraid," he remembers. "And they were just like, 'Yeah, it gets ugly, fast.'"
Carthen says he's lucky that didn't happen. Every day, he spent hours on the phone with suppliers and clinical staff, juggling and rerouting supplies so everyone had enough.
Keeping the Supply From Drying Up
Hospitals have developed new clinical protocols to conserve supplies during the shortage. Nurses at San Francisco General are using smaller saline bags when possible, and transitioning patients who still need hydration to drink water from cups a little sooner than they did in the past. Kennedy has spent hours talking with pharmaceutical and clinical staff about when to use these conservation measures, to make sure there is enough saline to go around.
"Pie is a good analogy. Now I'm going to use 16 slices of pie instead of eight slices of pie, and I'll be able to feed 16 people instead of eight," he said.
The FDA is trying to mitigate the shortage by importing saline from Spain and Norway. But FDA economist Marta Wosinska says that's not a sustainable solution, since those countries have to supply their own hospitals.
"There is no spot market. You can't buy it like pork bellies or grains or oil. You cannot go on a marketplace and order a certain amount," she said.
U.S. companies also don't have the capacity to ramp up production. They only have so many machines, and a lot of them are tied up producing other essential drugs. Building new facilities is hardly an option.
"We're talking about hundreds of millions of dollars and it would take 3 to 5 years," Wosinska said.
The drug companies don't face any real penalties if they don't come through with saline supplies. Contract loopholes release them from paying any fees to their customers if a drug shortage is industry-wide, as this one is.
Both Baxter and Hospira, the top two saline producers in the country, say they are doing all they can to maximize production. Each points a finger at the other for contributing to the shortage.
"We saw increased demand amid decreased product availability from competitors as the main driver," a Baxter spokesman wrote in an email.
A Hospira spokesman countered: "Hospira began seeing stronger demand for its saline products in late 2013 when another manufacturer began to experience manufacturing issues."
Hospira reported a 20 percent increase in U.S. net sales of its injectable drugs between January and March, citing "increased volume due to competitor supply issues," in its latest quarterly financial report.
"The Most Expensive Drug Shortage in History"
The burden ultimately falls on hospitals, clinics, and dialysis centers to come up with their own workarounds. And all that staff time adds up. Hospitals spend $216 million a year on the labor costs of managing drug shortages, according to Erin Fox, a professor at the University of Utah College of Pharmacy.
Now that the industry has indicated the saline shortage will extend through the end of the year, Fox estimates this will be the most expensive drug shortage in history.
"IV fluids impact almost every single patient and every single floor. That means you have to educate and get a message out to multiple groups of people rather than a selected group, like for an anesthesia drug or a cancer drug," Fox said.
For now, the actual cost of saline is steady. Hospitals are protected under contracts that keep prices locked through next year. But Novation's Scott Crandall says that is very likely to change when those contracts expire.
"The suppliers have already signaled to the market that they plan on increasing price significantly," he said. "And when I say that, it could double and triple in some aspects."
Fox says that would be far better than the current situation.
"It is far cheaper for hospitals to pay $3 a bag for saline and have a consistent and quality product -- not recalled due to contaminants or leakage," she said, "than it is to potentially delay elective surgeries or make workarounds that change weekly or daily due to inconsistent supply."

South Africa - Charlotte Maxeke runs short of key chemo drug - Jack Bloom


Another shortage of a key chemotherapy drug has hit cancer patients at the Charlotte Maxeke Johannesburg Hospital.
Patients were told yesterday that the Oxaliplatin chemotherapy drug was not available from the supplier, and would possibly only be available at the end of July.

Oxaliplatin is used to treat colorectal cancer, usually together with other chemotherapy drugs.

In April this year there was a shortage of Gemzar for the treatment of breast cancer.

It is highly distressing that life-saving chemotherapy is interrupted because of drug shortages.

In the case of Mr Derrick Liebenberg (54), he was supposed to have his second dose of Oxaliplatin this week, but may not even get his third scheduled dose to treat his colon cancer.

More than 100 other cancer patients across the province will have their survival chances lowered by this drug shortage.

The Gauteng Health Department needs to explain why it has not managed to get reliable suppliers of chemotherapy drugs.

Emergency procurement from overseas should be considered to get vitally needed chemo drugs.

Vietnam parents take infants abroad for vaccination given local drug shortage

A number of Vietnamese people have chosen to take their newborns to neighboring countries for vaccination considering the current dire shortage of local vaccines against childhood diseases.
According to Do Tuan Dat, director of Company for Vaccine and Biological Production No.1 (Vabiotech), demand for vaccines within the first six months of 2014 has risen by at least two or three times compared to the same period of last year.
Even less used vaccines against minor complaints such as chickenpox have also been in short supply since late last year.
Dat’s company imported 25,000 doses of chickenpox vaccines in late April, which now have run out of stock, Dat said, adding that 10,000 doses will be imported by the end of this month.
Nguyen Nhat Cam, director of the Hanoi Preventive Health Center, puts the scarcity of vaccines down to the outbreaks of several diseases, including measles.
Thousands of children have contracted measles and at least 111 have died of the disease since it recurred in Vietnam late last year.
Meanwhile, Quinvaxem, the made-in-Korea vaccine against five deadly childhood diseases, diphtheria (D), tetanus (T), pertussis (P, whooping cough), hepatitis B (HepB), and Haemophilus influenza type b (Hib), was once suspended after at least 15 deaths and dozens of cases of severe allergic reactions among local infants were reported in 2013.
Many local parents have switched to serviced vaccinations, resulting in the deficiency of 5-in-1, 6-in-1 and 3-in-1 vaccines even though Quinvaxem has been re-used since November last year.
There are even not enough vaccines for newborns who come for their second or third vaccinations.
Cam added that 5-in-1 vaccines will not be available until late next month, while he is not sure when 6-in-1 ones will be available again on the market.
To make matters worse, Dat noted that to lure and keep their clients, large hospitals which offer obstetrical services generally “hoard” a large volume of vaccines to make sure babies who are delivered by their facilities are adequately vaccinated.
Concerned about their babies’ health, more and more families have taken their children to neighboring countries for 6-in-1 or 5-in-1 vaccinations.
In mid-June 2014, L.P., of Ho Chi Minh City, took her 4-month-old infant to Singapore for a 6-in-1 shot.
She said that the three-day trip cost her some VND9 million (US$424), excluding accommodations, as they stayed at her friend’s place.
“My baby’s third shot is in this August, if 6-in-1 vaccines aren’t available in Vietnam by that time, I will take her to Singapore again despite the costs,” she sighed.
Meanwhile, H.L., also in HCMC, took her baby to Bangkok, Thailand for a 5-in-1 vaccination.
The hospital offered vaccine packages to infants aged one to 18 months for 9,600 baht ($292), excluding examination fees and other expenses.
L. only paid some VND2 million for one shot.
T.H., also from HCMC, who just took his 6-month-old infant to Singapore for a 6-in-1 vaccination, noted that vaccination in Singapore does not cost much more compared to international hospitals in Vietnam.
Shots range from VND1 to 3 million each.
However, H. paid SG$240 ($188) for one shot including examination fees.
Chau Do, a Vietnamese expat in Singapore, who worked as an interpreter at several hospitals in the city state, noted in recent months an unexpected rise in the number of Vietnamese parents who take their infants there for vaccinations.
People typically go there on weekends, or during business or leisure trips, Do added.
Meanwhile, Assoc. Prof. Phan Trong Lan, head of the HCMC Pasteur Institute, cautioned that though vaccines and vaccination schedules in other countries bear several similarities to those adopted in Vietnam, there are a few differences.
“As vaccines and schedules have been experimentally proved to be suitable for Vietnamese infants, in certain cases, vaccines used in other countries might be inappropriate for disease-causing viruses popular in Vietnam. Differences due to races are also present,” he warned.
Taking newborns on such long trips also considerably increases their risks of getting infected with viruses. 
In addition, infants need to be monitored at least 24 hours after immunization for their post-vaccination reactions, which also poses a major difficulty for Vietnamese parents.
Countries also vary in their way to monitor vaccination history, Prof. Lan stressed.
In case of such a vaccine shortage, he strongly advised parents to consult doctors for replacement vaccination schedules.

India May Offer Financing to Help Drug Makers Upgrade Facilities

Faced with a crackdown by the FDA on its domestic pharmaceutical industry, the Indian government is reportedly planning to provide financing to drug makers so they can upgrade their manufacturing facilities and meet U.S. standards.
The government is considering offering subsidies to drug makers and an announcement could be made next month as part of the planned budget for fiscal 2015, according to The Financial Express. The Small Industries Development Bank of India is expected to be one of the institutions to partner with drug makers, particularly smaller players that aspire to tap the large U.S. market.
“More than the top producers that are already cash rich, a financing scheme is likely to benefit small and medium-sized businesses that have to bear interest costs ranging from 12% to 18%, depending on the source of funds,” Ranjit Kapadia, a senior vice president at Centrum Broking, tells the paper.
The move comes not long after FDA commissioner Margaret Hamburg traveled to India to impress upon government and industry officials that the agency is concerned about the veracity of the pharmaceutical supply chain and planned to increase its scrutiny of wayward manufacturers.
Over the past year, the agency has issued warning letters to several Indian drug makers and last year, the FDA also issued 21 so-called import alerts that allow the agency to ban products from entering the U.S. One widely known example is Ranbaxy Laboratories, which is prevented from sending products from four of its plants in India and is also operating under a consent decree that requires improvements before the FDA will bless its facilities.
The quality-control problems have spurred debate in the U.S. about the reliability of generic drugs – the Indian drug makers that were identified as having substantive problems are big suppliers to the U.S. – and have also prompted the Indian pharmaceutical industry and regulatory authorities to acknowledge a need to upgrade facilities.
Much is at stake, because Indian drug makers are so dependent on the U.S. market. Last year, 26 percent of Indian pharmaceutical exports were to the U.S., which made this the largest export market for the industry, according to India Research & Ratings. And Indian drug makers have 523 manufacturing plants registered with the FDA, which is the largest number outside the U.S.

Thursday, June 26, 2014

Hospitals Soon See Donuts-to-Cigarette Charges for Health

You may soon get a call from your doctor if you’ve let your gym membership lapse, made a habit of picking up candy bars at the check-out counter or begin shopping at plus-sized stores.
That’s because some hospitals are starting to use detailed consumer data to create profiles on current and potential patients to identify those most likely to get sick, so the hospitals can intervene before they do.
Information compiled by data brokers from public records and credit card transactions can reveal where a person shops, the food they buy, and whether they smoke. The largest hospital chain in the Carolinas is plugging data for 2 million people into algorithms designed to identify high-risk patients, while Pennsylvania’s biggest system uses household and demographic data. Patients and their advocates, meanwhile, say they’re concerned that big data’s expansion into medical care will hurt the doctor-patient relationship and threaten privacy.
“It is one thing to have a number I can call if I have a problem or question, it is another thing to get unsolicited phone calls. I don’t like that,” said Jorjanne Murry, an accountant in Charlotte, North Carolina, who has Type 1 diabetes. “I think it is intrusive.”
Acxiom Corp. (ACXM) and LexisNexis are two of the largest data brokers who collect such information on individuals. They say their data are supposed to be used only for marketing, not for medical purposes or to be included in medical records.
While both sell to health insurers, they said it’s to help those companies offer better services to members.

Bigger Picture

Much of the information on consumer spending may seem irrelevant for a hospital or doctor, but it can provide a bigger picture beyond the brief glimpse that doctors get during an office visit or through lab results, saidMichael Dulin, director of research and evidence-based medicine at Carolinas HealthCare System.
Carolinas HealthCare System operates the largest group of medical centers in North Carolina and South Carolina, with more than 900 care centers, including hospitals, nursing homes, doctors’ offices and surgical centers. The health system is placing its data, which include purchases a patient has made using a credit card or store loyalty card, into predictive models that give a risk score to patients.
Within the next two years, Dulin plans for that score to be regularly passed to doctors and nurses who can reach out to high-risk patients to suggest interventions before patients fall ill.

Buying Cigarettes

For a patient with asthma, the hospital would be able to score how likely they are to arrive at the emergency room by looking at whether they’ve refilled their asthma medication at the pharmacy, been buying cigarettes at the grocery store and live in an area with a high pollen count, Dulin said.
The system may also score the probability of someone having a heart attack by considering factors such as the type of foods they buy and if they have a gym membership, he said.
“What we are looking to find are people before they end up in trouble,” said Dulin, who is also a practicing physician. “The idea is to use big data and predictive models to think about population health and drill down to the individual levels to find someone running into trouble that we can reach out to and try to help out.”
While the hospital can share a patient’s risk assessment with their doctor, they aren’t allowed to disclose details of the data, such as specific transactions by an individual, under the hospital’s contract with its data provider. Dulin declined to name the data provider.

Greater Detail

If the early steps are successful, though, Dulin said he would like to renegotiate to get the data provider to share more specific details on patient spending with doctors.
“The data is already used to market to people to get them to do things that might not always be in the best interest of the consumer, we are looking to apply this for something good,” Dulin said.
While all information would be bound by doctor-patient confidentiality, he said he’s aware some people may be uncomfortable with data going to doctors and hospitals. For these people, the system is considering an opt-out mechanism that will keep their data private, Dulin said.

‘Feels Creepy’

“You have to have a relationship, it just can’t be a phone call from someone saying ‘do this’ or it just feels creepy,” he said. “The data itself doesn’t tell you the story of the person, you have to use it to find a way to connect with that person.”
Murry, the diabetes patient from Charlotte, said she already gets calls from her health insurer to try to discuss her daily habits. She usually ignores them, she said. She doesn’t see what her doctors can learn from her spending practices that they can’t find out from her quarterly visits.
“Most of these things you can find out just by looking at the patient and seeing if they are overweight or asking them if they exercise and discussing that with them,” Murry said. “I think it is a waste of time.”
While the patients may gain from the strategy, hospitals also have a growing financial stake in knowing more about the people they care for.
Under the Patient Protection and Affordable Care Act, known as Obamacare, hospital pay is becoming increasingly linked to quality metrics rather than the traditional fee-for-service model where hospitals were paid based on their numbers of tests or procedures.

Hospital Fines

As a result, the U.S. has begun levying fines against hospitals that have too many patients readmitted within a month, and rewarding hospitals that do well on a benchmark of clinical outcomes and patient surveys.
University of Pittsburgh Medical Center, which operates more than 20 hospitals in Pennsylvania and a health insurance plan, is using demographic and household information to try to improve patients’ health. It says it doesn’t have spending details or information from credit card transactions on individuals.
The UPMC Insurance Services Division, the health system’s insurance provider, has acquired demographic and household data, such as whether someone owns a car and how many people live in their home, on more than 2 million of its members to make predictions about which individuals are most likely to use the emergency room or an urgent care center, said Pamela Peele, the system’s chief analytics officer.

Emergency Rooms

Studies show that people with no children in the home who make less than $50,000 a year are more likely to use the emergency room, rather than a private doctor, Peele said.
UPMC wants to make sure those patients have access to a primary care physician or nurse practitioner they can contact before heading to the ER, Peele said. UPMC may also be interested in patients who don’t own a car, which could indicate they’ll have trouble getting routine, preventable care, she said.
Being able to predict which patients are likely to get sick or end up at the emergency room has become particularly valuable for hospitals that also insure their patients, a new phenomenon that’s growing in popularity. UPMC, which offers this option, would be able to save money by keeping patients out of the emergency room.
Obamacare prevents insurers from denying coverage because of pre-existing conditions or charging patients more based on their health status, meaning the data can’t be used to raise rates or drop policies.

New Model

“The traditional rating and underwriting has gone away with health-care reform,” said Robert Booz, an analyst at the technology research and consulting firm Gartner Inc. (IT) “What they are trying to do is proactive care management where we know you are a patient at risk for diabetes so even before the symptoms show up we are going to try to intervene.”
Hospitals and insurers need to be mindful about crossing the “creepiness line” on how much to pry into their patients’ lives with big data, he said. It could also interfere with the doctor-patient relationship.
The strategy “is very paternalistic toward individuals, inclined to see human beings as simply the sum of data points about them,” Irina Raicu, director of the Internet ethics program at the Markkula Center for Applied Ethics at Santa Clara University, said in a telephone interview.

'Panic situation': Top doctor critical of drug shortage information sharing

Canada is facing a major drug shortage problem and authorities must do more to notify patients when supplies of the medications they rely on are dwindling, as well as investigate the causes of the shortages, says the president of the Canadian Medical Association.

There are now more than 500 drugs listed on Health Canada's drug shortages website. Recent additions to the list include the anti-inflammatory drug Naproxen and the epilepsy drug Valproic Acid.

CMA President Dr. Louis Hugo Francescutti said the growing list is a major concern for patients whose health depends on regularly taking medication.

He said the addition of Valproic Acid, which is primarily used to treat children, is particularly concerning, given how sensitive epilepsy patients are to any change in medication.
"There should be great concerns, simply because people who live with epilepsy are pretty well walking on egg shells," he told CTV's Canada AM.

"If they find a medication that works well for them in controlling their seizures, it gives them the freedom to go on and do their daily activities."

He said the problem is that patients often aren't aware that a medication they rely on is in short supply until they reach the pharmacy to fill their prescription. This can lead to a "panic situation," he said, in which the patient must contact their doctor and scramble to arrange an appointment and find a substitution.

"And the replacement medication should not be started abruptly," Francescutti said. "For people living with epilepsy this is a major problem (and) potentially could lead to death as well."

He added that patients may also face additional costs if a generic drug is no longer available, but the brand-name version still is.

The latest additions to the drug shortages website highlight the scope of the drug shortage problem, he said, adding that Health Canada's reporting website does not adequately address the issue.

The drug shortages website, which was launched in 2012, often reports the problem too late and reporting is on a voluntary basis, which means the list isn't comprehensive, Francescutti said.

But it appears that Health Canada is taking steps to assess the issue. The agency recently launched a public consultation website, where Canadians can give feedback on the way drug shortages are reported.

The consultation site is accepting submissions until July 5. Canadians can also participate by downloading a PDF form and mailing it to Health Canada.

Francescutti said he hopes people will participate and share their stories so that the government is encouraged to act.

"If we get more Canadians to share their personal experience then hopefully the government will move to a solution, rather than right now (with) a website that reports the problem," he said.

"We need to figure out why we have these continual drug shortages. Having a website that tells us we have a drug shortage may help a little bit, but in the past two years we've noticed that nothing has really improved," he said.

Francescutti said the problem is so widespread that, at least once a shift in his emergency department, he gets a call from a pharmacist informing him that a previously available medication is no longer in stock. He said this causes costly delays, as he and his colleagues are forced to make additional calls and assessments.

"It's very inefficient, and for folks with epilepsy this could potentially be life-threatening," he said.

Wednesday, June 25, 2014

Generic Versions of Toprol XL, a Heart Drug, Are Recalled

For years, Dr. Harry Lever, a cardiologist at the Cleveland Clinic, has been warning nearly anyone who would listen of his growing suspicions about generic versions of a widely used heart drug, Toprol XL.
Patient after patient, he said, would visit his office complaining of chest pains or other symptoms after switching from the brand-name version, made by AstraZeneca, to a generic product, often one made in India. When he switched them back to the brand — or to another generic — the symptoms disappeared, he said. Dr. Lever wrote a letter outlining his concerns to the Food and Drug Administrationin 2012, and this year, he traveled to Washington to try to get the attention of Congress.
Dr. Lever could not prove that the generic drugs were to blame. “You see enough people and you get a feel, but it’s anecdotes,” he said in an interview Monday. “It’s not science.”
Now, Dr. Lever is feeling a sort of sad vindication. Two large Indian manufacturers, Wockhardt and Dr. Reddy’s Laboratories, have announced recalls over the last two months totaling more than 100,000 bottles because their products were not dissolving properly — therefore probably not working as they should. The drug is a beta blocker that treats high blood pressure and heart ailments.
The recalls are the latest in a string of recent problems involving generic drugs, especially those made in India. Wockhardt, for example, is now banned from exporting drugs to the United States that were manufactured in two Indian plants where F.D.A. inspectors uncovered serious problems.
The number of recalled bottles is relatively small compared with the 38 million prescriptions for the drug, known generically as metoprolol succinate, that were filled in the United States in 2013, according to the research firm IMS Health. The recalls are considered Class II, meaning they may cause temporary health problems but are unlikely to pose an immediate safety threat. They come as the F.D.A. is taking a closer look at the quality of generic drugs, which now account for more than 80 percent of prescriptions in the United States. In February, Dr. Margaret A. Hamburg, the F.D.A. commissioner, traveled to India to express her concerns about the safety of medicines manufactured there.
The agency is also more closely studying all extended-release products, like the two recalled products, which are more technically difficult to make. Earlier this year the agency put a call out to researchers to investigate the efficacy of generic versions of metoprolol succinate, which is best known by AstraZeneca’s brand name, Toprol XL
Even as the agency has stepped up its scrutiny of generics, however, it has maintained its long-held position that generic drugs are generally as safe and effective as the brand-name versions.
Dr. Lever and other critics of generic drugs say the agency needs to be more frank about the potential downsides to generics. “The doctors in this country need to know what’s going on, because we’re ultimately writing the prescriptions and we’re responsible,” Dr. Lever said. “There’s been this assumption that one generic is the same as another. Not in this case.”
Representatives for Wockhardt and Dr. Reddy’s did not return calls or reply to an email seeking comment. Ralph Neas, the president of the Generic Pharmaceutical Association, the industry trade group, said the F.D.A. thoroughly vetted generic drugs and a “bioequivalence designation assures U.S. patients and caregivers that generic medicines, regardless of the geographic location of origin, are the same medicine with the same active ingredients as the brand but at a lower cost.”
Mr. Neas also noted that generic companies supported a 2012 bill that increased funding — through industry-generated user fees — to scrutinize generic manufacturing, especially overseas.
Generic manufacturers have repeatedly stumbled in their attempts to copy Toprol XL, which lost its patent protection in 2006. In 2008, Sandoz, a division of the drug maker Novartis, recalled its version of the product, and in 2009, the manufacturer Ethex followed suit, as part of a wider recall of its products for quality problems.
Drug-industry experts said the drug has encountered manufacturing problems because it is an extended-release tablet. As these drugs have grown in popularity in recent years, they have posed additional challenges to generic companies seeking to replicate them. Brand-name companies not only initially hold patents on the active ingredient but also on the way a pill releases a drug. So even if the generic companies can match the ingredient once the patent expires, they must come up with their own methods for release of the drug into the body that do not infringe on a separate patent. They are usually successful, but not always.
In another recent case, the F.D.A. decided in 2012 that an extended-release generic version of Wellbutrin, the antidepressant, was not the equivalent of the brand-name product and said it would take a closer look at how well generic companies were making extended-release drugs. Like the longstanding complaints about Toprol, consumers had complained for years that generic versions of Wellbutrin were not working properly.
Christopher C. Kelly, a spokesman for the F.D.A., acknowledged in a statement that “there have been challenges in consistently manufacturing” metoprolol succinate and said the agency had consistently monitored manufacturing of the drug to prevent problems. He said in 2013, the F.D.A. undertook a “multidisciplinary investigation” of the efficacy and quality of each of the versions of metoprolol succinate available in the United States. The agency concluded then that all of the versions, including those made by Wockhardt and Dr. Reddy’s, were bioequivalent to the brand-name version.
He said the recalls were the result of the companies’ own tests.

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