Showing posts with label drug shortage. Show all posts
Showing posts with label drug shortage. Show all posts

Wednesday, September 11, 2013

Physicians Against Drug Shortages Challenge the Controlled Drug Market for Hospital


We have written previously about the shortage of lifesaving drugs in the United States. This crucial topic is addressed in a recent New York Times editorial by Margaret Clapp, former chief pharmacy officer at Massachusetts General Hospital, Michael A. Rie, associate professor of anesthesiology at the University of Kentucky College of Medicine and co-chairman of Physicians Against Drug Shortages, and Phillip L. Zweig, executive director of Physicians Against Drug Shortages. They note 302 drugs were in short supply as of July 31, up from 211 a year earlier.
The editorial asks: "Policy makers apparently failed to ask the important question: How could this happen in a free-market economy? That would have steered them to the giant purchasing organizations that control the procurement of up to $300 billion in drugs, devices and supplies annually for some 5,000 health care facilities. These cartels have undermined the laws of supply and demand."  
The drugs  
Many of the drugs are sterile injectables, which are cheap, and generally administered in hospitals and outpatient clinics and sold through hospital purchasing organization contracts, not through retail pharmacies or pharmacy benefit managers.  
The scarce or unavailable drugs include anesthetics, chemotherapeutic agents, antibiotics, nutrients for malnourished infants, painkillers and even intravenous solutions. Physicians have been forced to improvise with less desirable or more expensive substitutes.  
For example, "One study reported in an issue of The New England Journal of Medicine last December found that children with Hodgkin's disease were at greater risk of relapse because the most effective generic, mechlorethamine, wasn't available. Propofol, the preferred anesthetic for many surgical procedures, is scarce because there's just one supplier of the generic in the United States in full production."
Improvisation  
They write: "Improvisation has caused some patients to wake up during operations — or not at all. A March 2012 survey by the American Society of Anesthesiologists, in which about 3,000 members responded (out of around 50,000), attributed six deaths, as well as other adverse outcomes, to shortages of drugs."  
The meningitis case study  
Citing the recent public health emergency: "A deadly outbreak of fungal meningitis, which was first identified last September in Tennessee, was triggered by shortages of a steroid painkiller, prompting providers to turn to the now bankrupt New England Compounding Center, which, as a so-called compounding pharmacy, was not held by the Food and Drug Administration to the same stringent standards as regular drug manufacturers. The pharmacy's sister company, Ameridose, which has also been closed, had supply contracts with five of the largest American hospital purchasing organizations: MedAssets, Novation, Premier, HealthTrust and Amerinet. This tragedy had killed 63 and sickened 749, according to the Centers for Disease Control and Prevention.
The Government Accountability Office is investigating the role of the group purchasing organizations in the shortages and the meningitis debacle. The agency's report is expected in 2014."  
Temporary imports 
"The F.D.A. has permitted temporary imports, which almost surely have created shortages in other countries. That's because there is finite global manufacturing capacity; production cannot be ramped up overnight. Hospitals are rationing medications, while their pharmacists spend untold hours scrambling to find them.
The economic root cause is simple: the purchasing organizations have squeezed manufacturers' operating margins to razor-thin levels. By awarding select suppliers exclusive contracts in return for exorbitant (and undisclosed) "administrative," marketing and other fees, they have reduced the number of suppliers to just one or two for many generics. Further, they've crimped investment in maintenance and quality control, resulting in adverse F.D.A. inspections and plant closings."  
- See more at: http://www.policymed.com/2013/09/physicians-against-drug-shortages-challenge-the-controlled-drug-market-for-hospital.html#sthash.K9Mu4eF0.dpuf

Wednesday, April 3, 2013

Drug shortages spur debate over role of compounding pharmacies

By Jaimy Lee
Posted: April 3, 2013 - 3:15 pm ET

Persistent drug shortages have led healthcare providers, pharmacists and others to debate the role of compounding pharmacies as alternative sources of drugs in short supply.

In a letter released April 2, the National Community Pharmacists Association urged the Food and Drug Administration to “preserve the role” of compounders in providing access to scarce drugs.

The advocacy group Public Citizen took the opposite stance, arguing that allowing patients to use those drugs puts them at a safety risk. The group also said compounders can exacerbate drug shortages by creating more competition for the few manufacturers that produce the generic sterile injectable drugs that have made up the majority of drug shortages.

“Under no circumstances should the FDA rely on unregistered facilities, such as companies manufacturing drugs under the guise of pharmacy compounding, to supply the market with unapproved products in times of shortage,” the group said in a comment letter.


Read more: Drug shortages spur debate over role of compounding pharmacies | Modern Healthcare http://www.modernhealthcare.com/article/20130403/NEWS/304039965#ixzz2PSqOmDv1
?trk=tynt 

Doctor Group Claims Drug Purchasing Organizations Causing Chronic Shortages

Frustrated with ongoing shortages of key drugs, a new grassroots group led by anesthesiologists is calling for the repeal of federal legislation that permits group purchasing organizations (GPOs) to engage in what they call collusive and anticompetitive activities. Several senior U.S. lawmakers have asked the Government Accountability Office (GAO), the investigative arm of Congress, to look into the allegations that GPOs are at least partly responsible for the nation’s drug shortages.
“We are convinced that the anticompetitive contracting and pricing practices, kickbacks and self-dealing of hospital GPOs are the root cause of this public health emergency,” said anesthesiologist Robert A. Campbell, MD, co-chair of the new group, Physicians Against Drug Shortages (PADS). “We’re launching a national campaign to build public awareness of these anticompetitive practices and press Congress to halt them,” said Dr. Campbell, who also is vice president of the Pennsylvania Society of Anesthesiologists and a state delegate to the American Society of Anesthesiologists (ASA).
Dr. Campbell described PADS as “a small group of physicians who met at the recent ASA meeting. After a totally unsatisfactory panel on drug shortages we chose to exchange emails and explore an economic explanation for drug shortages. Our solution will save at first $35 billion per year in health care costs. Once competitive forces are restored in the health care supply chain, even more savings will be realized.”
Any attempt to link GPOs to drug shortages is an “irresponsible and dangerous distraction,” countered Curtis Rooney, president of the Healthcare Supply Chain Association (HSCA), a trade association representing 14 GPOs, including the nation’s five largest. “The true cause of drug shortages is manufacturing problems, disruptions and barriers to entry in getting new suppliers online when there is a disruption in supply. The fact is that GPOs are taking a variety of creative and innovative steps to reduce drug shortages,” Mr. Rooney told Anesthesiology News.
Leveraging Purchasing Power
GPOs negotiate contracts with manufacturers and vendors of pharmaceuticals and other medical products on behalf of their customers, typically hospital groups and other large health care organizations. About 72% of all hospital purchases are made through GPO contracts.

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Recall at Compound Center Has Led to Shortages at Children's Hospital The Boston.com reported yesterday that the Pallimed Solutions, Inc. recall last month has left patients without a needed product. By Richard Hosford Email the author


A recall at a Woburn compounding facility last month is causing problems at a Boston hospital, Boston.com reported yesterday.
As reported on Woburn Patch, Pallimed Solutions, Inc. was ordered on March 22 by the state board that regulates compounding pharmacies to stop producing drugs that were supposed to be made in a sterile process and to quarantine the products in its possession. The compounding pharmacy voluntarily recalled over a dozen products after regulators found "foreign matter" in vials of drugs used for injections.
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Tuesday, March 26, 2013

VOL. 128 | NO. 60 | Wednesday, March 27, 2013 Shortages Impact Compounding Pharmacies


By Jennifer Johnson Backer

 Updated 2:49PM
In recent years, the U.S. Food and Drug Administration has reported an increase in the number of drug shortages and discontinuations.
The number of drug shortages reported to the FDA gained 41 percent to 251 shortages in 2011, compared to 178 shortages reported in 2010. The agency says it continues to see an increasing number of shortages, including drugs used to treat cancer, anesthetics used for patients undergoing surgery, drugs needed for emergency medicine and injectable drugs. The FDA also has reported a spike in the number of medications that have been discontinued.
Brett Wright, the owner of Benevere Pharmacy in Collierville, says he’s noticed an increase in the number of his clients requesting medications that are no longer commercially available.
Wright, who is a pharmacist by training, opened Benevere Pharmacy in May. The pharmacy specializes in custom-making medications that are tailored to meet the medical needs of an individual patient. Sometimes compounding is needed because a patient may be allergic to a certain dye, or an elderly patient may need a medicine in a liquid or suppository form that is not available. In other cases, compounding is necessary because a drug has been discontinued altogether.
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Thursday, February 28, 2013

FDA's Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says Wednesday, February 27, 2013 from Pharmaceutical Law & Industry Report ®



By Bronwyn Mixter 
The Food and Drug Administration's Center for Drug Evaluation and Research is working on creating a new office of pharmaceutical quality, FDA Commissioner Margaret A. Hamburg said Feb. 22.
Speaking at the Generic Pharmaceutical Association's (GPhA) annual conference, Hamburg said the new office would not impose any new quality requirements but rather enforce existing quality standards.
“We must be strategic and have systems in place for continual quality surveillance,” Hamburg said. “Quality is one of our highest priorities” in 2013, she added.
In 2012, CDER Director Janet Woodcock said CDER was exploring the idea of creating a new Office of Pharmaceutical Quality (OPQ) to oversee quality throughout the lifecycle of a drug (10 PLIR 1196, 9/14/12).
Generic User Fees
Hamburg also said the Generic Drug User Fee Amendments of 2012 (GDUFA) is moving forward, and “it is going to make an enormous difference.”
The generic drug user fees give FDA the funding it needs to reduce the backlog of generic drug applications, Hamburg said.
Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011--known as sequestration--are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).
Biosimilars
FDA is moving forward with creating a biosimilars pathway, Hamburg said. A pathway to approve biosimilars was created in a 2010 law, but FDA is still implementing it.
In 2012, FDA issued three draft guidances for industry on biosimilars, and the agency “is moving forward to finalize” these guidances, Hamburg said (10 PLIR 173, 2/10/12).
“So far FDA has yet to receive an application for a biosimilar product,” Hamburg said. “We are ready” and “eager to engage in that next stage of the process.”
Hamburg said FDA has met with several manufacturers about developing biosimilar products.
Additionally, Hamburg said FDA is seeking public comments on its strategic plan to prevent drug shortages. FDA published a notice requesting comments in the Feb. 12 Federal Register (78 Fed. Reg. 9,928) (11 PLIR 206, 2/15/13). The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the development and implementation of a strategic plan for enhancing FDA's response to preventing and mitigating drug shortages, according to the notice.

The Federal Register notice requesting comments on FDA's drug shortage plan is at http://www.gpo.gov/fdsys/pkg/FR-2013-02-12/pdf/2013-03198.pdf.

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Wednesday, February 27, 2013

February 27, 2013 FDA Strategic Plan to Address Drug Shortages, Solicitation for Comment - See more at: http://www.policymed.com/2013/02/fda-strategic-plan-to-address-drug-shortages-solicitation-for-comment.html#sthash.RZdGQEmp.dpuf


Earlier this month, the Food and Drug Administration (FDA) released a notice for public comment in the Federal Register regarding ideas stakeholders and the public may have for combating drug shortages.  As noted on FDA’s own blog, the agency believes that despite the progress made over the last year, even more can be done and is therefore turning to the American public for advice. 
Comments due by Thursday, March 14, 2013.  The Docket Number is FDA-2013-N-0124. 
Background 
As we previously wrote this summer, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) on July 9, 2012.  Section 1003 of FDASIA adds section 506D to the Federal Food, Drug, and Cosmetic Act (the FDCA) to require the formation of a task force to develop and implement a strategic plan for enhancing the Agency's response to preventing and mitigating drug shortages.  Section 506D of the

Monday, February 25, 2013

Drug Shortages in the United States

 
By Rina Shah, U.S. Office of Personnel Management on National Healthcare Operations,
Washington, DC1
Introduction
According to the American Society of Health System Pharmacists (“ASHP”), there are currently about 200 drug shortages, ranging from the Acetazolamide Injection to the Zoster Vaccine Live.2 A recent study claimed that these numerous drug shortages are not as bad as they seem because they are limited to a few disease areas and generic injectables.3 Despite the purportedly limited scope, drugs that are vital to treating major diseases such as childhood leukemia and breast cancer are part of the current shortages.4 Due to concerns about delays in treatment, increased morbidity and mortality, and higher healthcare costs,5 manufacturers and the government have been attempting to remedy the issue. As government legislation is still pending and other responses are fairly recent, there has not been any reliable information to indicate whether these strategies are working.
Causes of Drug Shortages
The source of drug shortages varies from drug to drug, but the primary reasons are manufacturing problems combined with increased demand.6 For example, a shortage of the dopamine injection was reported by ASPH on November 17, 2011.7 The reasons for the shortage were listed by one manufacturer as a manufacturing delay and by another as increased demand.8 Another drug that is currently experiencing a shortage, the tobramycin injection, is reportedly in short supply because of manufacturing delays.9

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Sunday, February 17, 2013

The European Medicines Agency Mitigating Drug Shortages in Europe


Feb. 13, 2013
The European Medicines Agency (EMA) recently released a proposal for how it can help mitigate potential and real drug shortages stemming from manufacturing problems, reported FiercePharmaManufacturing.  The six-page proposal notes that “Recent unexpected disruptions to the manufacturing supply chain due to manufacturing/GMP (good manufacturing practices) compliance problems have resulted in acute and chronic shortages of important medicinal products in the European Union (EU) requiring changes to prescribing information, and initiation of patient allocation programs.” 
The Reflection Paper is concerned with public health crises that arise due to unforeseen disruptions within the manufacturing process, caused by manufacturing/GMP compliance problems and affecting medicinal products for human use, independent of their route of authorisation, where a need for co-ordination of the assessment and risk reducing actions at a Community level has been identified. Supply disruptions not caused by manufacturing/GMP compliance problems fall outside the scope of this Reflection Paper. 
EU legislation currently requires mandatory pre-notification by Marketing Authorisation Holders (MAHs) of disruption of supply in the case of permanent or temporary cessations and for manufacturers of medicines in the case of any defect that could lead to an abnormal restriction in supply. 
It will be interesting to see if the Food and Drug Administration (FDA) and the EMA work together on this proposal, perhaps by entering into a Memorandum of Understanding (MoU). 
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Sunday, February 10, 2013

- U.S. Food and Drug Administration Approved 30% More Drugs in 2012


NEW YORK, NY (Marketwire) 02/08/13 A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index (IBB), the SPDR S&P Biotech ETF (XBI) and the First Trust Amex Biotechnology Index ETF (FBT) have all gained over 20 percent in the past year, outperforming the broader markets by a good margin. Research Driven Investing examines investing opportunities in the Biotech Industry and provides equity research on Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) and Santarus, Inc. (NASDAQ: SNTS).
Access to the full company reports can be found at:
www.RDInvesting.com/OPTR
www.RDInvesting.com/SNTS
Bloomberg recently reported drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago. Oncology drugs lead the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.
The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman, Sandy Walsh. "These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of FDA's drug review staff."

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Monday, January 28, 2013

GPOs to Blame for Drug Shortages, Says Physicians Group


Roxanne Nelson
Jan 24, 2013


Over the past few years, there have been unprecedented shortages of a large number of essential drugs, including chemotherapeutic agents. Although a number of reasons have been cited, including the limited number of manufacturers, increased worldwide demand, shortages of raw materials, and production problems, none of these really address the root cause.
According to Physicians Against Drug Shortages, the blame can be laid firmly at the feet of group purchasing organizations (GPOs). The real reason for the current situation is that there is no free market for drugs, medical devices, or healthcare supplies in the United States.
This accusation is apparently being taken seriously; 6 senior Congressman are calling on the Government Accountability Office to investigate the role of GPOs in drug shortages and the recent meningitis outbreak related to compounding pharmacies.
"These shortages are simply unacceptable in our free-market economy," said Phillip L. Zweig, MBA, executive director of Physicians Against Drug Shortages.

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Wednesday, December 26, 2012

December 20, 2012 The Patient Access to Drugs in Shortage Act


As we have noted several times over the past two years, the ongoing battle to resolvedrug shortages has several distinct causes—one of them being drug pricing.  Specifically, the Medicare Modernization Act (MMA) and other government pricing policies have had unintended consequences affecting companies’ ability to make profits, particularly for the generic injectable drugs that have been so heavily in shortage.  The inability for companies to make profits on drugs has caused them to stop making the product, reducing production, or have left the entity unable to complete the necessary updates to its manufacturing facilities.  
Although the Food and Drug Administration (FDA) has taken several steps to address issues causing drug shortages, and Congress passed a new title in the Food and Drug Administration Safety and Innovation Act (FDASIA) to codify measures to reduce such shortages, more is still needed to address the impact the government’s pricing regime is having on drug shortages. 

Monday, December 10, 2012

Drug shortages worsen following pharmacy-related meningitis scare Six products supplied by a company that closed due to the outbreak are on the FDA’s critical shortage list.



By CHRISTINE S. MOYER, amednews staff. Posted Dec. 10, 2012
In October, NECC and Ameridose halted production. Ameridose’s closure is temporary.
Drug shortages are intensifying in some parts of the nation due to the recent closings of two specialty pharmacies in Massachusetts following a fungal meningitis outbreak.
During the outbreak that started in September, the New England Compounding Center and its sister company, Ameridose LLC, which was a major hospital drug supplier, recalled all of their unexpired products. NECC produced the injectable steroids that were linked to the ongoing meningitis outbreak in at least 19 states. More than 500 cases of the disease have been reported, and at least 30 deaths have occurred, said the Centers for Disease Control and Prevention.
Hospitals and other medical centers that relied on the companies for thousands of medications each month are scrambling to identify new sources for drugs, including antibiotics, lifesaving medicine and pain medications.
The FDA has listed more than 100 drugs in short supply in the U.S. in 2012.
Some hospitals are trying to boost their pharmacy capabilities so they can reconstitute and package drugs themselves rather than rely on specialty pharmacies that could have safety issues similar to those of NECC.
NECC and Ameridose “provided a service that many hospitals around the country were using,” said Anuj Goel, MPH, vice president of legal and regulatory affairs for the Massachusetts Hospital Assn. “But the impact in Massachusetts has been very severe, given the fact that [those companies are located in the state]. It was definitely a big hit.”
Boston-based Massachusetts General Hospital, which is New England’s largest hospital, is among the health centers that have been particularly hard-hit. About 17% of the nearly 400,000 doses of medication it uses each month were provided by Ameridose, said Padma Gulur, MD, the hospital’s director of inpatient pain services. A smaller amount of medication was produced by NECC.
“We have had to take [everything] in-house,” Dr. Gulur said. “Because obviously, in this environment, we’re not going to look for another manufacturer whose credentials we haven’t checked thoroughly.”
As a result, the hospital’s pharmacy, which once operated from 7:30 a.m. to 4:30 p.m., now functions around the clock. The pharmacy expanded its space to other sterile areas and is considering temporarily using one of the operating rooms, Dr. Gulur said.
Some new employees have been hired to help manage the increased workload. But most of the tasks are falling to existing staff, she said. For instance, nurses learned how to prepare certain injectable antibiotics, and anesthesiologists are reconstituting some of the medications they use.
Still, the hospital can’t produce all the medication it needs. So staff members are working to identify new sources for needed medications, Dr. Gulur said.
One challenge is that the closings of Ameridose and NECC come at the end of the year, when the nation’s supply of pain medication historically is low, Dr. Gulur said. The government limits the number of narcotics that can be manufactured for prescription medication each year.
Further complicating matters, six products supplied by Ameridose were on the Food and Drug Administration’s critical shortage list. That means the products were in short supply before Ameridose recalled its unexpired products and halted operation.
“The recall has the potential to exacerbate one or more of those shortages,” the FDA said.
The six products on the critical shortage list are:
Sodium bicarbonate injection
Succinylcholine injection
Atropine sulfate injection
Bupivacaine hydrochloride injection
Lidocaine hydrochloride injection
Furosemide injection
“Drug shortages are two words that no one wants to hear — not patients, not health care professionals and not me,” said FDA Commissioner Margaret A. Hamburg, MD. “However, drug shortages are still a serious problem, one that may be temporarily impacted by [Ameridose’s] voluntary recall of all its unexpired products.”
Steps to ease shortages
There have been shortages of more than 100 drugs in the U.S. this year, the FDA said. The problem peaked in 2011, when 251 medications were in short supply.
Contributing to the shortages are production delays and quality issues. The FDA said too few manufacturers are producing the older and widely used generic sterile injectables to meet the nation’s needs. Many companies choose not to produce these products because they are not as profitable as other drugs and manufacturing them is complex, health experts say.
Shortages of lifesaving medication, including benzodiazepine drugs to stop seizures, have led emergency medical workers in the Memphis, Tenn., area to rely on compounding centers to create those products, said emergency physician Joseph E. Holley Jr., MD.
“If there are less compounding facilities around, there will be less opportunities to have those drugs made for us,” said Dr. Holley, EMS medical director for Memphis and surrounding municipalities.
To help limit the impact of the closures on existing drug shortages, health professionals should consider keeping medication on their shelves for the maximum amount of time that is safe, the MHA’s Goel said. In some cases, drugs in hospitals are discarded after 10 days, but they could be used safely for up to 15 days, he said.
In Massachusetts, the Public Health Council adopted emergency regulations in November to allow hospitals to share safe, compounded drugs with other hospitals in times of need, said Lauren Smith, MD, MPH, interim commissioner for the Massachusetts Dept. of Public Health. The rules took effect Dec. 1. The council is an appointed board of clinicians, professors and public health advocates.
“Part of the Dept. of Public Health’s mission is to work with hospitals to ensure that they have a plan in place to respond to any unforeseen emergencies,” Dr. Smith said. “These regulations provide another tool at our disposal to respond to any urgent situations that may arise, so we may protect the public health and ensure patient safety.”

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Saturday, December 8, 2012

Industry, GPOs Urge Dems Not To Confuse Compounding, Drug Shortage Issues


Two drug manufacturers and a trade group representing group purchasing organizations are pushing back against a recent request by House Democrats for Congress' investigative arm to probe the relationship between drug compounding, drug shortages and GPOs.


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Tuesday, December 4, 2012

Officials: Nat'l drug shortage having distinct effect in Az


Legislators to look at drug shortages Doctors, medical administrators testify at hearing



The staff at Anne Arundel Medical Center considered canceling some surgeries on a recent weekend because the hospital was running low on a common drug used to help bring people out from under anesthesia.
It is the kind of problem hospitals and doctors around the country continue to face as drug shortages that began a few years ago threaten the way everyday medicine is practiced.
The problem has persisted even after calls from Congress and President Barack Obama to find a solution and a federal investigation that found widespread abuses in the drug manufacturing and distribution system. Maryland lawmakers are jumping into the fray with plans to introduce legislation to tackle the issue at the state level.
On Tuesday, the Joint Committee on Health Care Delivery and Finance held a hearing to gather insights on what role the state could play.
Dr. Barry Meisenberg, chair of quality improvement and health systems research at Anne Arundel Medical Center, said the shortages force doctors to make tough decisions on how to treat patients. The hospital decided not to cancel surgeries that weekend, but Meisenberg said the issue was real.
"I used this as an example of how serious this has become," Meisenberg said.