Showing posts with label massachusetts. Show all posts
Showing posts with label massachusetts. Show all posts

Tuesday, July 9, 2013

Pols to remedy weak oversight at compounding pharmacies Tuesday, July 9, 2013 -

by Chris Cassidy

Lawmakers today will announce details of a highly anticipated bill toughening oversight of compounding pharmacies after last year’s deadly nationwide fungal meningitis outbreak.
“We beefed up what the governor did,” said state Rep. Jeffrey Sanchez (D-Jamaica Plain), the chairman of the Joint Committee on Public Health, referring to a bill filed earlier this year by Gov. Deval Patrick. “The governor’s piece was a great first start, but ours really enhances what he did.”
Sanchez said the bill is intended to make compounding drugs — the process of mixing specialized prescription medications — safer by creating more transparency, without causing a shortage. The new rules would establish a public database of compounders’ track records, require labels on medications and specialty licenses, and allow the Board of Registration in Pharmacy to levy fines of up to $25,000.
- See more at: http://bostonherald.com/business/healthcare/2013/07/pols_to_remedy_weak_oversight_at_compounding_pharmacies#sthash.oRZcfUNf.dpuf

Tuesday, February 5, 2013

Press Release from MA Board of Pharmacy with List of Pharmacies

For Immediate Release - February 05, 2013

Department Of Public Health Announces Update on Unannounced Pharmacy Inspections

Governor’s budget provides additional resources for enhanced pharmacy inspections and oversight

BOSTON — The Massachusetts Department of Public Health (DPH) today provided an update on the unannounced inspections of 40 sterile compounding pharmacies across Massachusetts as part of a broad range of actions put forth by Governor Deval Patrick to strengthen oversight of the compounding pharmacy industry.
DPH began unannounced inspections of compounding pharmacies last fall, following the fungal meningitis outbreak caused by the New England Compounding Center in Framingham. Over the course of the unannounced inspections, partial or complete cease and desist orders were issued to 11 pharmacies for a range of violations. DPH cited another 21 pharmacies for minor deficiencies that have since been corrected or are currently being addressed through corrective measures.
“While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts,” said DPH interim Commissioner Dr. Lauren Smith. “These findings underscore the need for additional budget resources and legislation the Governor has proposed to further strengthen our monitoring of this industry.”
The Patrick-Murray Administration launched a series of aggressive initiatives to ensure that the significant harms resulting from substandard sterile compounding are never allowed to happen again.
At the Governor’s direction, the Board of Pharmacy issued new regulations that require sterile compounding pharmacies in Massachusetts to report volume and distribution to the state for the first time.
A $1 million investment in the Governor’s FY14 budget will enable the Board to hire additional inspectors to continue the unannounced pharmacy inspections. The Governor is also directing DPH to strengthen inspector training requirements toensure that all inspectors are pharmacists with at least five years of clinical experience.
The Governor’s budget supports more than 30 new full time positions across DPH to enhance the department’s capacity to protect public health and safety and meet its regulatory responsibilities.
Building on recommendations released by the Commission on Pharmacy Compounding, Governor Patrick filed legislation earlier last month that would require a special license for sterile compounding, create monetary fines for violations of law and regulations, institute whistleblower protections, require licensing of out-of-state pharmacies that do business in Massachusetts, and reorganize the Board of Pharmacy’s structure to include more members who are not practicing in the industry they are responsible for regulating.
Eleven pharmacies have been subject to partial or complete cease and desist orders as part of the unannounced inspections since October. Eight of the 11 pharmacies have submitted corrective plans.
Pharmacies that receive a notice of deficiency or cease and desist must submit a written plan of correction to the Board of Pharmacy. They must then implement the corrective measures and perform renovations, if necessary, and then pass re-inspection to ensure compliance with USP 795 and 797. Cease and desist orders will remain in place until this process is complete.
  • Apothecare South Shore in Brockton was ordered on December 20 to cease and desist all sterile and non-sterile compounding and quarantine all prepared sterile compounds in its possession. The pharmacy was found to be non-compliant with required standards for facility design and controls, storage of hazardous medications, and the preparation and dispensing of sterile medications. Apothecare South Shore has submitted a plan of correction.
  • Baystate Home Infusion in Springfield was ordered on December 12 to cease and desist all sterile compounding. The pharmacy was found to be non-compliant with required standards for the preparation of sterile medications. Baystate Home Infusion has submitted a plan of correction.
  • Home Infusion Solutions in Falmouth was ordered on December 27 to cease and desist all sterile compounding. The pharmacy was found to be non-compliant with regard to its facility design and controls, and the preparation of sterile medications. Home Infusion Solutions has submitted a plan of correction.
  • Lenox Village Pharmacy in Lenox was ordered on December 12 to cease and desist all sterile compounding and quarantine all prepared sterile compounds in its possession. The pharmacy was found to be non-compliant with required standards with regard to its preparation of sterile medications.
  • OncoMed Pharmaceuticals in Waltham was issued a cease and desist notice on November 21 due to issues with the storage of chemotherapy drugs. OncoMed Pharmaceuticals has submitted a plan of correction.
  • PalliMed Solutions Pharmacy in Woburn was issued a partial cease and desist notice on November 27 to halt the production of sildenafil citrate. Inspectors found that the pharmacy had prepared and distributed sildenafil citrate using improper components. PalliMed Solutions Pharmacy has submitted a plan of correction.
  • PharmaHealth Pharmacy in New Bedford was issued a cease and desist order for all sterile compounding on February 1 after inspectors found evidence the pharmacy was engaged in sterile compounding despite an earlier statement that it was not sterile compounding. The pharmacy was cited with having non-compliant clean room engineering controls and sterile compounding practices, and insufficient personnel training and environmental monitoring.
  • PharMerica in Brockton was ordered on December 27 to cease and desist all sterile compounding. The pharmacy was found to be non-compliant with facility design and controls, and its preparation of sterile medications. PharMerica also has locations in Rhode Island and New Hampshire. As a result of the investigation of the Massachusetts facility, the Rhode Island and New Hampshire boards of pharmacy were notified. PharMerica in Brockton has submitted a plan of correction.
  • Western MA Compounding Center in West Springfield was ordered on December 6 to cease and desist all sterile compounding, and quarantine all prepared sterile compounds and sterile medications in its possession. The pharmacy was found to be non-compliant with required standards for preparation and dispensing sterile medications, and the storage and handling of hazardous medications. Western MA Compounding Center has submitted a plan of correction.
  • West River Pharmacy in Marlborough was ordered on December 20 to cease and desist all sterile compounding, and quarantine all prepared sterile compounds in its possession. The pharmacy was found to be non-compliant with required standards with regard to facility design and control. West River Pharmacy submitted a plan of correction last month.
  • Whittier Pharmacist in Bradford was issued a full cease and desist on November 28. Upon inspection, Board staff noted significant deficiencies in the structure and engineering of the clean room.
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FEBRUARY 5, 2013 Marlborough Pharmacy Among 32 To Fail Surprise Inspection


A Marlborough compounding pharmacy is one of 11 that have been completely or partially shut down due to violations found during unannounced inspections by the state.
According to a press release issued by the state's Department of Public Health (DPH), surprise inspections were done at 40 sterile compounding pharmacies across Massachusetts as part of actions instituted by Gov. Deval Patrick last fall with the intention of strengthening oversight of the industry. The changes followed a fungal meningitis outbreak linked to Framingham's New England Compounding Center that was responsible for 45 deaths and nearly 700 illnesses across 20 states, according to the federal Centers for Disease Control and Prevention. NECC was subsequently shut down and later filed for bankruptcy protection.
Each of the 11 pharmacies must submit a written plan of correction to the state's Board of Pharmacy, then implement the corrective measures, perform any necessary renovations and pass another inspection before returning to operational. Eight of the 11 pharmacies have submitted corrective plans, including West River Pharmacy in Marlborough, the DPH said.

Source found here

Just 4 of 40 Massachusetts compounding pharmacies passed surprise health inspections



The state ordered 11 compounding pharmacies to shut down all or part of their operations and cited another 21 for more minor violations, health officials said Tuesday in announcing the results of surprise inspections conducted in recent months. Only four of 40 compounding pharmacies in the state were fully compliant with regulations.
The Department of Public Health began the surprise inspections in the fall, after injectable steroids produced at a Framingham pharmacy were linked to a national outbreak of fungal meningitis and other infections. The tainted drugs have sickened nearly 700 people and been blamed for 45 deaths.
“While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts,” Dr. Lauren Smith, the department’s interim commissioner said in a press release of the inspections.
Compounding pharmacies are supposed to prepare doses and formulations of drugs for individual patients that are not available from drug manufacturers, and sterile compounders make injectable and intravenous medications that must meet the highest standards of purity. But state officials have said New England Compounding Center, the pharmacy that made the contaminated steroids, was mass-producing drugs and making what were supposed to be sterile injections in unsanitary facilities.
New England Compounding shut down in October, and two sister companies with common owners remain closed under temporary orders. With the previously announced closure of Waltham-based Infusion, that leaves just four compounding pharmacies that were found to be operating properly.
“These investigations are in most cases still ongoing,” Madeleine Biondolillo, director of the health department’s Bureau of Health Care Safety and Quality, told the state pharmacy board Tuesday morning. “There were some pharmacies that were willing to correct the problems and others that chose not to.”

Source found here

Mass. reprimands 32 drug compounders


State health officials issued cease-and-desist orders to 11 pharmacies and cited 21 others.

The crackdown, which hit all but eight of the known compounding pharmacies in the Bay State, was prompted by tainted spinal steroids produced at the now-shuttered New England Compounding Center in Framingham, Mass. The contaminated drugs have been blamed for 45 deaths.NASHVILLE, Tenn. -- In the wake of a nationwide fungal meningitis outbreak, Massachusetts regulators have shut down or cited 80 percent of the state's compounding pharmacies.
One of the firms named Tuesday, PharMerica, has facilities in Franklin, Knoxville and Memphis, according to Tennessee health licensing records. Based in Louisville, Ky., the firm also holds licenses to ship drugs into Tennessee from sites in Kentucky and Indiana. According to its website and filings with the Securities and Exchange Commission, the company provides pharmaceuticals to nursing homes and hospitals.


PharMerica was ordered to halt its sterile compounding operations in Massachusetts on Dec. 27 after the facility was found "non-compliant with facility design and controls and in its preparation of sterile medications," the Massachusetts Health Department said in a statement.
PharMerica officials did not respond late Tuesday to a request for comment.
The cease-and-desist order against the company's operations in Brockton, Mass., remains in effect although the company has submitted a plan of correction, department spokeswoman Anne Roach said.
After the Massachusetts action, Rhode Island officials inspected a PharMerica facility in that state and found unsterile conditions and unlicensed personnel performing as licensed technicians. They also found that compounding operations had been transferred from the closed Massachusetts facility without proper documentation. A cease-and-desist order on all sterile compounding was issued Jan. 10.
Source found here

Thursday, January 10, 2013

FDA quietly steps in to inspect a second Massachusetts pharmacy after determing it has federal authority

January 9th, 2013 // 3:58 pm @

Federal regulators have quietly stepped in to inspect another Massachusetts pharmacy similar to New England Compounding Center, the Framingham compounding company blamed for the national fungal meningitis outbreak that has sickened more than 660 people and killed 40.
Inspectors from the US Food and Drug Administration recently joined state officials in their ongoing surprise inspections of compounders to inspect one pharmacy because the regulators determined the company’s actions fell under federal jurisdiction, Dr. Madeleine Biondolillo, director of the state’s Bureau of Health Care Safety and Quality, said in an interview Tuesday.
Biondolillo declined to name the pharmacy inspected by the FDA, or discuss the precise reason the FDA stepped in, but said, “The FDA has authority over certain things and if they feel this registrant is performing business practices in their domain, that’s their call.
Investigators have said that New England Compounding violated state laws by mass producing drugs, behaving more like a manufacturer, which would fall under federal jurisdiction.
Biondolillo said the surprise inspections of sterile compounding pharmacies, ordered in October by Governor Deval Patrick, are nearly complete.
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Saturday, January 5, 2013

MASSACHUSETTS PLANS SOME OF STRICTEST CONTROLS OF COMPOUNDING PHARMACIES IN USA

Posted on 

The laws will be among the strongest in the country, said Kevin Outterson, a law professor at Boston University and a member of the expert panel that advised the state on how to curb abuses by companies like the New England Compounding Center, the Framingham pharmacy that made the tainted drug responsible for the nationwide meningitis outbreak.
The legislation would establish strict licensing requirements for compounding sterile drugs; let the state assess fines against pharmacies that break its rules; protect whistle-blowers who work in compounding pharmacies; and reorganize the state pharmacy board to include more members who are independent of the industry and fewer who are part of it.
Alec Loftus, a spokesman for the state’s Office of Health and Human Services, said that Mr. Patrick expected the new legislation to be passed quickly.
Daniel Carpenter, a professor of government at Harvard, said the proposed laws seemed sound and comprehensive. But he warned that if other states did not take similar steps, compounding pharmacies engaging in shoddy practices would just move to places with the weakest laws and the least oversight.
“The remaining question is not what Massachusetts is doing or will do, but will there be a minimum level of regulation like this in the rest of the states?” Professor Carpenter said.
The meningitis outbreak, first detected in September, was caused by contaminated batches of a steroid, methylprednisolone acetate, made by the New England Compounding Center. The drug was injected into about 14,000 people’s spinal area to treat back and neck pain.
As of Dec. 28, 656 people in 19 states had become ill with meningitis or other infections, like severe internal abscesses in the area where the drug was injected. Some have had both meningitis and spinal infections. The case count is expected to keep rising. Thirty-nine have died.
The New England Compounding Center was shut down, and inspections found extensive contamination. Investigations uncovered a long history of questionable practices that had drawn warnings from the state and the Food and Drug Administration.
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On Dec. 21, the company announced that it had filed for bankruptcy. Numerous lawsuits have been filed against it.
At the heart of the problem have been gaps in regulation that have allowed such companies to avoid both state and federal controls. The company called itself a pharmacy, and pharmacies are generally regulated by states, while large drug companies are regulated federally, by the Food and Drug Administration.
Compounding pharmacies mix their own drug preparations, like skin creams and cough syrups, supposedly for individual patients with special needs. But the New England Compounding Center began to act like a manufacturer, making and shipping large amounts of injectable drugs, for which sterility is essential. No state law equired it to obtain a license for this type of large-scale compounding, to follow good manufacturing processes or to let the state know it was shipping all over the country.
Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, said the company “was a manufacturer in pharmacy clothing.”
Governor Patrick said, “The tragic meningitis outbreak has shown us all that the board’s governing authority has not kept up with an industry that has evolved from corner drugstores to the types of large manufacturers that have been at the center of so much harm.”
Dr. Smith said she thought the most important part of the new legislation was the requirement of a license for sterile compounding. “Now we are going to have the ability to develop specialty licenses that will allow us to track and identify those pharmacies that are engaged in different practices that could potentially put higher numbers of individuals at risk, such as those who engage in sterile compounding,” she said.
Professor Carpenter said a particularly powerful part of the proposal is that it requires licensure for out-of-state pharmacies that ship medication to Massachusetts. The state, he said, is a huge market for injectable drugs.“Basically, if you think about the large hospitals, the amount of medical care that goes on in the state, it’s in a sense using the purchasing power of the state of Massachusetts to induce changes elsewhere,” he said.
The state has also taken other steps recently to rein in compounding, apart from the new legislation. It began conducting surprise inspections, and has required compounding pharmacies to report how much medication they are shipping and where, so that it can keep tabs on those that begin acting like manufacturers. It also requires the pharmacies to report when they become subjects of regulatory actions by other states or the federal government.
Abby Goodnough reported from Boston, and Denise Grady from New York.

Copy of Proposed Legislation in Massachusetts

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Expert: Pharmacy overhaul not enough

Jan. 5, 2013
 
Richard Weir / Boston Herald

 

Gov. Deval Patrick’s planned overhaul of the state Board of Pharmacy — a move aimed at boosting oversight of sterile compounding pharmacies after a deadly nationwide fungal meningitis outbreak — is a “great first step” but further action is needed, according to an expert on pharmaceutical compounding.
“I think it’s moving in the right 
direction,” said Sarah Sellers, a former U.S. Food and Drug Administration official who worked on compliance issues involving compounding and has become a crusader. “But (the measures) will not be enough to protect the public without additional 
efforts by the FDA.”
Until federal law changes, Sellers said, states like Massachusetts can help protect the public by posting the inspection findings of such pharmacies online.
 
“Transparency can be a very effective regulation tool … and an 
efficient way to rein in inappropriate practices,” she said.
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Proposed Compounding Bill in Massachuetts Would change Composition of State Pharmacy Board to Include Others Than Pharmacists!!

The recently proposed bill in Massachuetts would change the composition of the state Pharmacy Board, which is dominated by registered pharmacists, and provide for the appointment of a registered nurse, a physician, a pharmacy technician and three public members. It would make board members subject to financial disclosure requirements.

New drug compounding law proposed in Massachusetts

In the wake of a fungal meningitis outbreakthat has taken the lives of 14 Tennesseans, the governor of Massachusetts Friday proposed multiple changes in state laws and regulations governing compounding pharmacies, including the one blamed for the ongoing public health crisis.
Gov. Deval Patrick’s proposal, based in part on the recommendations of a special commission, would change the composition of the state board that licensed the New England Compounding Center and give the panel increased powers to regulate all compounding pharmacies located in Massachusetts or shipping drugs into Massachusetts from other states.
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Friday, January 4, 2013

Patrick announces legislation overhauling pharmacy board

1/04/2013 1:53 PM
By Kay Lazar and Chelsea Conaboy, Globe Staff
Governor Deval Patrick announced on Friday planned legislation to reorganize the state board of pharmacy to add professionals from other fields and to give the board the authority to regulate out-of-state compounding pharmacies that distribute drugs in Massachusetts.
The state board has been scrutinized following a national outbreak of fungal meningitis that has killed at least 40 people and has been blamed on tainted steroids produced at New England Compounding Center in Framingham. The Globe reported that regulators knew about problems at the facility but repeatedly failed to take concerted action requiring improvements.
 
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Mass. Gov. Proposes New Compounding Pharmacy Rules

BOSTON (AP) — Gov. Deval Patrick is proposing tighter regulations on compounding pharmacies following last year's deadly meningitis outbreak linked to a Massachusetts company.
Patrick said Friday he's filing a bill that would require compounding pharmacies obtain a special state license, create whistleblower protections for pharmacy workers, hire more inspectors and enforce new fines and penalties for compounding pharmacies that break the rules.
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Friday, November 30, 2012

Gov. may seek changes in Mass. pharmacy board


November 28, 2012, 11:24 am

BOSTON (AP) — Gov. Deval Patrick says the state board that oversees pharmacies is too heavily dominated by people who are pharmacists themselves and he might seek a change in the panel's makeup.
The state Board of Pharmacy has come under scrutiny in the aftermath of a national fungal meningitis outbreak that has claimed 36 lives and sickened hundreds of others. The outbreak has been linked to a steroid produced by Framingham-based New England Compounding Center, which is regulated by the board.
Patrick said Wednesday he has become concerned that 10-member board is largely made up of pharmacists and he'd like to see a "different blend of talent."
He told the "Ask the Governor" program on WTKK-FM that he expected to file legislation when state lawmakers return to Beacon Hill in January.



Source found here