Glass Bits Force Recall of Daptomycin

Four lots of the intravenous antibiotic drug daptomycin (Cubicin) have been recalled because of glass particles found in some vials, the FDA and the drug's manufacturer said.

No injuries have been reported, but the contamination could result in thromboembolism or granulomas, the FDA said.

The affected lot numbers are 950453F, 090203F, 201703F, and 201653F, with expiration dates ranging from Dec. 6, 2013, to Sept. 1, 2015. The lots were shipped from May 2011 to March of this year, according to a statement from manufacturer Cubist Pharmaceuticals posted on the FDA's website.

Cubist said it was notifying customers by telephone and letter. All hospitals and clinics with inventories of daptomycin should check them for vials with the recalled lot numbers and contact the company if any are found. Cubist will arrange for return and replacement of recalled daptomycin vials.

The contamination appeared to originate with a third-party supplier, according to Cubist, which said it had "suspended all manufacturing with the supplier until corrective and preventative measures have been taken."

Label directions for daptomycin specifically call for healthcare providers to check vials for visible particulates before administering the drug to patients, the firm noted. Vials containing particulates should not be used.

http://www.medpagetoday.com/HospitalBasedMedicine/GeneralHospitalPractice/41283

HCM City hospitals face drugs shortage - Vietnam

The Pham Ngoc Thach Hospital is facing a shortage of more than 100 drug items, said Nguyen Huy Dung, director of the hospital.

Doctors are having to prescribe drugs not in the hospital's approved medicine list to replace missing ones so that patients can get enough drugs for treatment, Dung said.
A representative of the Hospital for Traumatology and Orthopaedics anticipates that 20 per cent of more than 300 drugs in the hospital's inventory would be out of stock by early September. It is already cleaned out of three drugs.
Leaders at several State-run hospitals have said that hundreds of drugs would run out of stock if swift action is not taken and the centralised bidding procurement system, which was set to begin operating in June, continues to be delayed.
Patients with health insurance are having to purchase prescribed drugs at drug stores and hand over invoices to the city's Social Insurance Agency to get refunds, according to doctors at the An Binh Hospital.
Centralised bidding
In mid-May, the city's People's Committee asked the newly-established Public Asset Procurement Division under the Department of Health to conduct centralised bidding for procuring drugs that State-run healthcare institutions need.
The move was aimed at finding supplies of quality drugs at competitive prices for the city's public hospitals.
Previously, State-run healthcare institutions in the city purchased drugs through their own bidding procurement processes, resulting in differences in drug prices between hospitals.
While waiting for the new office to complete procedures and preparations for the centralised bidding procurement, the People's Committee approved until June the extension of purchase contracts that were made last year and had expired in March.
The Department of Health then petitioned the People's Committee to permit hospitals to further extend contracts with drug distributors to restock drugs from July until the centralised bidding system can begin delivering drugs, now expected to happen between November and December.
As the People's Committee did not approve the petition, hospitals are facing drastic shortages of drugs.
"The centralised bidding procurement is a necessary measure to eliminate shortcomings in drug pricing at public hospitals," said Nguyen Tan Binh, director of the Department of Health.

"There has been significant difference in prices, up to 20 per cent, between two hospitals that are just several metres from each other. That is unacceptable," Binh said at a conference held on Monday to discuss the centralised bidding procurement process.

Drug efficacy and competitive prices are the most important factors in procurement, he said.
Nguyen Duy Thuan, official with the Pharmacy Department at the HCM City University Medical Centre, expressed concerns about the risk of enduring drug shortages, saying it would be difficult for pharmaceutical enterprises who win the bids to supply enough medicines to all public hospitals in the city.

If only one pharmaceutical enterprise won a bid, there will be no replacement drugs in case of unexpected impacts, said Nguyen Quoc Binh, head of the Cho Ray Hospital's Pharmacy Department.
Pham Khanh Phong Lan, deputy director of the department, said domestic pharmaceutical enterprises should be given priority in the centralised bidding processes.

The department is considering several measures to prevent drastic shortages of drugs at hospitals while waiting for the centralised bidding procurement to begin working, Lan said.

http://english.vietnamnet.vn/fms/society/83056/hcm-city-hospitals-face-drugs-shortage.html

Drug shortage looms as pharma policy hurts margins - India

MUMBAI: A shortage of essential medicines is looming across major parts of the country, with drug companies reporting lower orders from wholesalers, mainly on account of reduction in trade margins due to the new pharma policy. Drug companies say that wholesalers have stopped the purchase of widely prescribed medication like painkillers, anti-infectives, cardiac and antibiotics — part of the national list of essential medicines — mainly in states including Gujarat, Karnataka, Tamil Nadu, West Bengal and Jharkhand, but other states may also be impacted.

While seeking the help of drug regulatory authorities across states to prevent such a shortage, the industry says that consumers may soon be hit by the lack of availability of these medicines.

Interestingly, the government has not clearly specified margins to wholesalers as per the new Drug Price Control Order 2013 while it mentions that retailers will get a 16% mark-up on the notified ceiling price, down from 20% which they received earlier. According to the DPCO 1995, margin to wholesalers was 10% of the maximum retail price, which now has been interpreted by companies to reduce it to 8%.


"We are witnessing a reduction in orders (from trade)", an executive with a pharma company said, adding "there is panic in the market, but it may not lead to a shortage of medicines".

The three industry associations — Indian Pharmaceutical Alliance, Organisation of Pharmaceutical Producers of India and Indian Drug Manufacturers Association — have in a recent communication to state drug regulatory authorities of the states concerned, saying that there may be a potential shortage of essential medicines on account of lower orders placed by distributors.

"Wholesalers and retailers have stopped purchases of NLEM products citing various issues, including the margin specified under Para 7 of the DPCO 13," the letter says.


The impact was visible in July, with the basket of products where ceiling prices were announced showing a drop of 2.2% as against a 10.8% growth for the balance drugs, according to research firm AIOCD Awacs.

Sources in retail trade said that they have started keeping a lower inventory as a strategy to rationalize costs. As against an inventory of 45 days, now we keep stocks for 14 to 21 days, said a chemist, who is part of AIOCD, an organization which represents over seven lakh chemists.

Experts termed this as a "mere tussle" between pharma companies and trade, with both trying to get the better of the other.

The industry bodies have asked the state drug commissioners to determine availability of medicines in their states so as to prevent a shortage.

An AIOCD official had earlier told TOI: "The industry should maintain margins at the existing level, especially for drugs in which ceiling prices are unchanged. There are 100-odd formulations in which the prices have not gone up."

There may be a little disruption in certain medicines or chemists may also shift to keeping brands and companies which offer high margins, if not resolved soon. Fearing that their drugs may not be picked up by trade, certain companies like Blue Cross and Win Medicare have said that they would maintain status quo in margins, which is 20% to retailers and 10% to wholesales, sources said.

http://timesofindia.indiatimes.com/business/india-business/Drug-shortage-looms-as-pharma-policy-hurts-margins/articleshow/22177310.cms

Specialty Compounding's Response to Attorney's Claims

CORPUS CHRISTI - The compounding company at the center of the alleged tainted IVs investigation issued a response to attorney Thomas J. Henry's claims.

Specialty Compounding says testing by the pharmacy's independent lab and by federal and state agencies on samples of their calcium gluconate infusion product has not yet proven an association between Specialty Compounding's medication and the affected patients.

The company statement goes on to say that its top priority is patient safety and ensuring all recalled products are promptly returned to the pharmacy.

On Tuesday, Henry issued a statement saying he's investigating 10 deaths of patients who may have been exposed to the recalled medication.

The FDA had recalled the medications from the firm after reports that patients being treated at Corpus Christi area hospitals developed bacterial infections.

http://www.kristv.com/news/specialty-compounding-s-response-to-attorney-s-claims/

Cubist Pharmaceuticals Issues Voluntary Nationwide Recall

LEXINGTON, Mass.--(BUSINESS WIRE)--August 29, 2013-- 

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling four lots of CUBICIN(R) (daptomycin for injection) to the user level due to the presence of particulate matter found in a number of vials from these lots.

 
 
Product Description  Lot #    Expiration Date  First Ship Date  Last Ship Date 
CUBICIN(R)           950453F  12/06/2013       05/31/2011       06/27/2011 
(daptomycin for 
injection) 500 mg 
NDC 67919-011-01 
                     090203F  09/07/2014       01/12/2012       01/23/2012 
                     201703F  08/31/2015       03/4/2013        03/7/2013 
                     201653F  09/01/2015       03/12/2013       03/18/2013 
 
 

No adverse events have been reported to date in association with a product complaint of vials containing glass particulates.

Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine and discontinue distribution of all recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EST, Monday through Friday, to arrange for return and replacement of affected lots.
The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious.

As noted in the package insert for CUBICIN, parenteral drug products should be carefully inspected visually for particulate matter prior to administration. Healthcare providers should not use any CUBICIN vials containing particulate matter.

Patient safety is Cubist's top priority and the Company wants to ensure that patients and the healthcare professionals using CUBICIN are aware of this recall and of what actions, if any, they should take. Cubist is arranging for return of recalled product. An internal investigation has preliminarily identified the root cause as a manufacturing issue with one of our suppliers. Cubist has suspended all manufacturing with the supplier until corrective and preventative measures have been taken.
For healthcare professionals and pharmacists with questions regarding this recall may contact Cubist Medical Information at (877) 282-4786 between the hours of 8 a.m. to 5:30 p.m. EST, Monday through Friday.

Adverse events or quality problems experienced with the use of this product may also be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

http://online.wsj.com/article/PR-CO-20130829-908229.html

FDA Approves Third Drug in BD Simplist Prefilled Injectable Line of Products

BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company) (NYSE: BDX )announced today that the U.S. Food and Drug Administration (FDA) has approved the third drug to be offered in the new BD Simplist™ line of ready-to-administer prefilled generic injectables. The third BD Simplist product to launch is Ondansetron Injection, USP 4mg/2mL (2mg/mL), an injectable antiemetic.

Ondansetron Injection, USP which is used to prevent postoperative nausea and vomiting, is currently on the FDA drug shortage list due to recent demand increases and supply issues faced by other manufacturers.1,2 Ondansetron Injection, USP also can be used with initial and repeat courses of emetogenic cancer chemotherapy.

"We're proud to be expanding our BD Simplist products with a drug like Ondansetron Injection, USP which is in high demand among clinicians and fills a need for an intervention that can be administered quickly," said Mark Sebree, President, BD Rx. "As we establish our product line with a third drug approval, we are seeing even further indication of the positive response to our new BD Simplist prefilled injectables especially among repeat customers."

http://www.benzinga.com/news/13/08/3875068/fda-approves-third-drug-in-bd-simplist-prefilled-injectable-line-of-products?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+benzinga+%28Benzinga+News+Feed%29

Park Pharmacy & Compounding Center Recalls Two Lots of Sterile Preparations

The Food & Drug Administration has discovered many issues with drug products that are meant to be sterile this year. The issues have often occurred at compounding pharmacies, which create specialized medical products for patients with unique needs. For instance, Specialty Compounding recently recalled all of its sterile medications due to reports about bacterial infections. Now, another compounding pharmacy is having issues with sterility assurance. Due to unclear lab methods used to test sterility, Park Pharmacy & Compounding Center is recalling two lots of Methylcobalamin and Multitrace-5 Concentrate vials.

According to the FDA, investigators have discovered that the pharmacies may have received inaccurate laboratory test results due to the manner in which sterility was assessed. The method of testing led to the FDA questioning if the results obtained by the laboratory are reliable. Park Pharmacy & Compounding Center states that “there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products.” However, if microbial contamination exists in the products that are intended to be sterile, then patients can contract life threatening bacterial infections.

The recall affects injectable forms of Methylcobalamin 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013 and Multitrace-5 Concentrate 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013. The products are high doses of specific vitamins and minerals. According to Mayo Clinic, Methylcobalamin is a form of Vitamin B-12. The recalled products were sold directly to customers or to physician offices in June and July 2013. The products were only sold in California, Florida, New Mexico and Indiana.

Currently, the company is preparing for the return of all recalled product lots and is informing customers about the recall. The company recommends that consumers stop using the recalled products and contact the company for information on returning any unused product. Consumers can contact Park Pharmacy & Compounding at 949-551-7195 or by email at info@parkrx.com weekdays 9 a.m. to 5 p.m. PST.

http://www.newsomelaw.com/blog/2013/08/29/park-pharmacy-compounding-center-recalls-two-lots-sterile-preparations

Recall: Six Drug Products from JCB Labs

CB Laboratories has issued a recall of six lots of sterile drug products. During the FDA's recent inspection of Front Range Labs for sterility and other qualities, the FDA was concerned about inaccurate and unreliable lab test results for sterility assurance.

The following compounded products are being recalled:

• Sodium thiosulfate, 25% (250 mg/mL) - Lot numbers 130701@9 (Exp. 12/28/13), 130709@6 (Exp. 1/5/14) and 130717@2 (Exp. 1/13/14)
• Sodium citrate, 4% solution for injection, 30 mL multiple dose vial - Lot number 130710@4 (Exp. 1/6/14)
• Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, 30 mL multiple dose vial - Lot number 130620@2 (Exp. 12/17/13)
• Acetylcysteine, 20% solution for inhalation, 4 mL single dose vials - Lot number 130627@5 (Exp. 8/26/13)

The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8, 2013 through August 20, 2013.
JCB is notifying its customers and is arranging for the return of all recalled product lots.
For more information call (316) 773-0405 or visit FDA.gov.

http://www.empr.com/recall-six-drug-products-from-jcb-labs/article/309187/#

FDA Concerns Over Testing Co. Trigger Compounder Recalls

Law360, New York (August 28, 2013, 7:00 PM ET) -- Two compounding pharmacies are recalling products after federal regulators encountered problems with sterility testing by a contractor that serves more than 100 compounders across the country, the U.S. Food and Drug Administration said Tuesday.

Both recalls involved specialty drugs tested by Colorado-based Front Range Laboratories Inc., which, according to the FDA, is used by compounders in 32 states to verify purity and quality.

While no reports of patient harm have emerged, the FDA said it couldn’t rule out the prospect of microbial contamination in the recalled...

http://www.law360.com/articles/468420/fda-concerns-over-testing-co-trigger-compounder-recalls 

FDA Announces Recall of Drug Product Lots - JCB Laboratories

JCB Laboratories is issuing a recall of lots of sterile drug products to the user level due to concerns of sterility assurance following a recent inspection by the U.S. Food and Drug Administration of Front Range Laboratories of Loveland, Colo., one of the contract testing labs used by JCB.

The following compounded products are subject to the recall:

•     Sodium thiosulfate, 25% (250 mg/mL) - Lot numbers 130701@9 (Exp. 12/28/13), 130709@6 (Exp. 1/5/14) and 130717@2 (Exp. 1/13/14)
•     Sodium citrate, 4% solution for injection, 30 mL multiple dose vial - Lot number 130710@4 (Exp. 1/6/14)
•     Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, 30 mL multiple dose vial - Lot number 130620@2 (Exp. 12/17/13)
•     Acetylcysteine, 20% solution for inhalation, 4 mL single dose vials - Lot number 130627@5 (Exp. 8/26/13)

JCB has not received any reports of adverse events related to this recall to date. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8 through Aug. 20, 2013.

In the recent inspection of Front Range Labs, the FDA states it "observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."

Out of an abundance of caution, JCB has discontinued its relationship with Front Range and is now testing products at a different laboratory.

"Our top priority is to protect patient safety," says Brian Williamson, PharmD, President and CEO of JCB Laboratories. "We have never had to issue a recall, but we believe this action is a reflection of our tradition of total transparency and our commitment to the highest quality standards. We regret any inconvenience this recall may cause our valued customers."

http://www.cemag.us/news/2013/08/fda-announces-recall-drug-product-lots#.UiETbVNCXx4

Four die after receiving recalled drugs

Four people have now died in a case allegedly tied to pharmaceutical products manufactured by Cedar Park-based Specialty Compounding.

Last week, the Federal Food and Drug Administration announced a national recall of all of the company's products after reports surfaced out of a Corpus Christi hospital that 17 patients had become infected with bacterial infections after receiving injections of one of the company's products.

 

Four of the patients have now died, but a spokesman for the Texas Department of State Health Services said that the cause of the deaths is still under investigation, and at this time no link has been established between the medications and the deaths.

Corpus Christi attorney Thomas J. Henry’s website says that 19 people have retained Henry’s firm claiming injuries tied to products involved in the recall, including the families of the four patients who allegedly died after developing bacterial infections linked to the calcium gluconate treatments.

According to the Corpus Christi Caller-Times, the Corpus Christi Medical Center says that it will be notifying 114 patients who received a treatment that may be linked to the Specialty Compounding recall.

Officials in Texas are working with the Centers for Disease Control and Prevention to analyze samples of the bacteria taken from infected patients, but results of the tests are not expected until next week.
Texas health officials told the CDC that patients who received calcium gluconate manufactured by Specialty Compounding developed bloodstream infections, and the CDC says that an intact sample of the calcium gluconate made by the firm showed growth of bacteria of the specific bacteria found in the infected patients.

The company has voluntarily recalled all the products it has manufactured and distributed since May 9 and a company spokesperson told Hill Country News though a written statement that the company is cooperating with authorities, and that, "Our top priority is patient safety and ensuring that all recalled products are promptly returned to the pharmacy."

The statement goes on to say, "The source of the bacteria has not been identified. Results from laboratory testing on samples of our calcium gluconate infusion product, which was distributed to hospitals only within Texas, are expected later this week and we will keep the public apprised of the process."

http://www.hillcountrynews.com/news/article_08080730-1019-11e3-aeff-0019bb2963f4.html

Today's Shortages

ASHP/FDA
Cefotaxime Injection
Ceftazidime Injection
Doxycycline Capsules and Tablets
Prednisone Tablets

Local pharmacist lobbies in Washington

Lake Ozark joined a nationwide effort to preserve patient access to compounded medications as part of the International Academy of Compounding Pharmacists (IACP) 2013 Compounders on Capitol Hill 19th annual conference and legislative event, held June 1-4, 2013.

Hagan and more than 515 community pharmacists, pharmacy technicians and pharmacy students either traveled to Washington, D.C., to meet with their federal House and Senate delegations in face-to-face meetings or sent in letters as part of a virtual campaign.

“This trip gave us a chance to speak directly to members of Congress and voice concerns on behalf of our patients, whose access to pharmacy compounds directly impacts their health care,” Hagan said.  “Some of our profession’s most active pharmacists gathered in our nation’s capital to take the voice of compounding to the Hill.”

“Compounding pharmacists came to Washington to speak with their Senator and Congressional representatives about several specific issues that directly affect their patients,” said IACP President Wade Siefert, RPh, FIACP.  “We are particularly concerned that the new Senate legislation (S.959) as currently written could impede our patients’ access to pharmacy compounding. We are working closely with our respective state representation, and the Senate HELP Committee to resolve issues with the proposed legislation.”

“These visits to Congress came at a particularly critical time for compounding pharmacies across the country and for the patients whom they serve. Our IACP members are mindful of the terrible tragedy that occurred last year with the New England Compounding Center meningitis outbreak. We never want to see another situation like this, again,” said IACP Executive Vice President & CEO David G. Miller, RPh. “We also believe it’s vital that patients and practitioners continue to have access to compounded medications prepared by licensed pharmacists who are following the necessary guidelines and who are helping patients and practitioners with personalized medication solutions each and every day.”

Read more: http://www.lakenewsonline.com/article/20130828/NEWS/130828850/1994#ixzz2dUWfSAH3

Letter from NCPA on s.959

With two weeks remaining in the Congressional August recess, it's our understanding that House and Senate staff continues to informally negotiate on compounding legislation. NCPA continues to have concerns with the most recent version of the Senate proposal (S. 959) and feels the House discussion draft circulated by Rep. Morgan Griffith (R-VA) better addresses the underlying causes of the tragic Meningitis outbreak caused by New England Compounding Center (NECC) while preserving traditional compounding.

Please contact Senators Mikulski at (202) 224-4654 and Cardin at (202) 224-4524 and Representative Van Hollen at (202) 225-5341 (or click here to send them an email) and urge them to support the House of Representatives approach in regards to compounding.

Tell your elected officials to support the House approach because it:

Maintains state board of pharmacy oversight of traditional compounding.
Adequately addresses office use of compounded medications
Preserves the ability of pharmacies to engage in anticipatory compounding, so long as it is based on historical patterns
And urge them to oppose overreaching aspects of the Senate approach including:

Allowing FDA to unilaterally establish a “do not compound” list.
Requiring pharmacies to report directly to FDA when compounding a drug that is in short supply
Providing an exemption to hospital pharmacies from these regulations
With Congress potentially debating this legislation in September, it is vital that you make your voice heard on this important bill. Since negotiations are fluid, NCPA will provide updates in the weeks to come on the status of these legislative efforts.

Thank you for your action on this important matter, and please feel free to share any feedback you receive in your contacts with your Congressional offices.

Sincerely,

Michael Rule
Associate Director of Public Affairs and Grassroots Advocacy
National Community Pharmacists Association

Wellness Pharmacy recalls sterile products

This recall was initiated after the firm was notified that Food and drug Administration (FDA) investigators observed methods used by Front Range Labs to assess sterility and other qualities (e.g., strength and stability) may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on these lots. FDA has concerns that test results obtained from Front Range Labs may not be reliable.

If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening. Wellness Pharmacy has yet to receive any reports of adverse events related to this recall.

Recalled medications were distributed to individual patients and physician offices nationwide. The liquid medications are in either clear or amber sterile vials ranging in size from 1ml to 50ml. They can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size.

Wellness Pharmacy is notifying customers by phone and regular mail. Patients and physicians should immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy.

http://www.consumeraffairs.com/recalls/wellness-pharmacy-recalls-sterile-products-082713.html

Pharmacy’s drug recall in effect as patients move to sue

A Corpus Christi law firm that is representing 59 people for possible exposure to tainted drugs has obtained court orders requiring the Cedar Park company that made the drug to preserve all documents and other evidence in the case.

A Nueces County judge ruled that Specialty Compounding cannot move, change or dispose of purchase orders, pharmaceutical logs and other records that the law firm of Thomas J. Henry said it would seek in connection with future legal action against the company.

http://www.statesman.com/news/news/local/pharmacys-drug-recall-in-effect-as-patients-move-t/nZd2M/

Today's Shortages

ASHP/FDA
Cefazolin Injection
Cephalexin Oral Suspension
Dexamethasone Sodium Phosphate
Ketamine Injection
Polymyxin B Sulfate Injection
Rocuronium Injection
Sodium Chloride Concentrated Solution for Injection
Tobramycin Injection

http://www.ashp.org/Drugshortages/Current/?sort=2

Outsourced Hospital Sterile Compounding: A New and Safer Era To Come

Hospitals often rely on outside vendors to provide anticipatory supplies of compounded sterile preparations, yet these entities are held to inconsistent and often inadequate safety standards based on their home state of operation. The benefits of outsourcing can be felt in several ways, including extended beyond-use dating that reduces waste, labeling improvements that reduce medication errors, and enabling pharmacy staff to provide hands-on patient care rather than mixing CSPs.

However, without rigid, consistent safety standards, tragedies such as the recent NECC outbreak may continue to occur. This article provides an overview of sterile compounding considerations, how hospitals can properly vet outside vendors, and current federal legislation aimed at improving patient safety.

Download to read this article in PDF document:
http://www.pharmacypracticenews.com/download/SR1328_NoPrint.pdf

Park Pharmacy & Compounding Center Issues Recall

Park Pharmacy & Compounding Center is voluntarily recalling two lots of the products Methylcobalamin and Multitrace-5 Concentrate for injection. The FDA has observed that methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results and may be unreliable.

The lots being recalled are Methylcobalamin 5mg/mL 30mL Amber Vials, Lot #06132013@1 with an expiration date of December 10, 2013 and Multitrace-5 Concentrate 10mL Amber Vials, Lot #05212013@20 with an expiration date of November 17, 2013.

The prescription preparations were sold during June and July of 2013, in the following states: California, Florida, New Mexico and Indiana. The products would have been sold directly to customers and to physician offices by prescription.

Park Pharmacy & Compounding Center is notifying its customers and is arranging for the return of all recalled product lots.

http://www.empr.com/park-pharmacy-compounding-center-issues-recall/article/309103/#

Sterility Concerns at Three More Pharmacies Prompt Recalls

Three more compounding pharmacies are recalling products due to concerns that some of their products may not be sterile, the US Food and Drug Administration (FDA) has announced.

Front Range Laboratories, in Loveland, Colorado, are at the center of 2 of the recalls.

On Monday, JCB Laboratories recalled 6 lots of sterile drug products to the user level because of concerns about sterility assurance following a recent FDA inspection of Front Range Labs, one of the contract testing labs used by JCB. The products, lot numbers and expiration dates are:

Product    Lot # (expiration date)
Sodium thiosulfate 25% (250 mg/mL)   
130701@9 (12/28/13)

130709@6 (1/5/14)

130717@2 (1/13/14)

Sodium citrate 4% solution injection, 30 mL multiple-dose vial    130710@4 (1/6/14)
Sodium citrate 4% w/gentamicin, 320 mcg/mL multiple-dose vial    130620@2 (12/17/13)
Acetylcysteine, 20% solution for inhalation, 4 mL single-dose vials    130627@5 (8/26/13)


The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8 through August 20, 2013.

After an inspection of Front Range Labs, the FDA issued an alert to pharmacies on August 21 stating that "the methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."

"Out of an abundance of caution, JCB has discontinued its relationship with Front Range and is now testing products at a different laboratory," the company said.

JCB has not received any reports of adverse events related to this recall to date, the company said. However, if there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

JCB is notifying its customers by telephone, email, fax, and mail. To return product or request assistance related to this recall, users should contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8 AM. and 5 PM CDT.

Similar Concerns at Second Pharmacy

Concerns at Front Range Labs has also prompted Wellness Pharmacy, Inc, in Birmingham, Alabama, to recall 6 products. They are:

Product    Lot #    Expiration date
dexpanthenol 250 mg/mL    130605@52    12/2/2013
magnesium sulfate 50%    130613@38    12/10/2013
methylcobalamin 1 mg/mL    130612@49   
12/9/2013

10/19/2013

sodium phenylbutyrate 200 mg/mL SDV PF    130621@28    10/19/2013
R.L. glutathione 100 mg/mL SUV PF    130710@27    1/6/2014
ascorbic acid (cassava) 500 mg/mL PF SUV    130711@13    1/7/2014


The recalled medications were distributed to individual patients and to physician offices nationwide. These liquid medications are in either clear or amber sterile vials ranging in size from 1 mL to 50 mL, the company said. The medications can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size.

Wellness Pharmacy is notifying its customers by telephone and regular mail of this recall. "Patients and physicians should immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy," the company advises.

To return medication or request assistance related to this recall, patients and physicians should contact Wellness Pharmacy at 205-879-6551 or 800-227-2627, Monday through Friday, between 9 AM and 4 PM CDT.

Testing Issues at Third Pharmacy

On Friday, Park Pharmacy & Compounding, in Irvine, California voluntarily recalled to the consumer level 2 lots of methylcobalamin 5 mg/mL 30 mL amber vials with lot # 06132013@1 and an expiration date of 12/10/2013.

The company also recalled multitrace-5 concentrate 10 mL amber vials for injection with lot # 05212013@20 and an expiration date of 11/17/2013, to the consumer level.

This recall was also prompted by a recent FDA inspection of the laboratory used by this pharmacy, although the laboratory was not named in the company release posted on the FDA Web site.

The prescription preparations were sold during June and July of 2013, in California, Florida, New Mexico, and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).


"To date there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products. We are voluntarily recalling the products as a precautionary measure for the safety of our patients," the company said.

Park Pharmacy & Compounding is notifying its customers by phone and mail and is arranging for return of all recalled product lots. Customers with product being recalled should stop using it and contact Park Pharmacy & Compounding to arrange for return of the unused product. Customers with questions regarding this recall can contact Park Pharmacy & Compounding at 949-551-7195 Monday through Friday, 9 AM to 5 PM PST, or at info@parkrx.com.

http://www.medscape.com/viewarticle/810085

Update on S. 959 and Vet Compounding

Back in July we wrote about a proposal coming before the U.S. Senate that, if passed, threatened to ban pharmacies from compounding medications prescribed by veterinarians to treat dogs, cats, and horses.

We examined why this would be so detrimental to family pets, and Dr. Sara Huber explained how
compounding medications might sometimes be the only way a veterinarian can accurately dose small breeds, puppies and kittens.

Now we'd like to update you on the status of that legislation, and if it still poses a threat to the medical care of our family pets.

A fellow blogger - Amy of Sebastian the Sensitive Soul -  has a pharmaceutical background and was particularly concerned about this.

So she decided to write her senator and let him know she opposed anything that would ban veterinarians from offering compounded medicines to family pets.

Senator Pat Roberts wrote her back and assured her that he has long been an advocate for local
pharmacies and referenced a "significant amount of misinformation" that was circulating about the proposed legislation.


Here is a direct quote from his response to her (used with permission):

"S. 959 makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the Food and Drug Administration. This legislation clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation." (emphasis mine)

Hey, that all sounds pretty good to me. It is ethical and moral to ensure the safety of compounded medications, especially after the 2012 meningitis scare where tainted pharmaceuticals from a compounding manufacturer in Framingham, MA resulted in illness to over 700 people. 

But please note what he did not mention. Not once did he address her concerns with regard to animals and veterinarian-prescribed medications. I wanted to know why, so I dug deeper. 

So, are animals addressed
in this legislation or not?

After hours of poring over the actual wording of the legislation itself, including strikethroughs from previous iterations of the proposed bill, I've found out a few things:

One: on May 22 this legislation, known as S. 959, was passed by the Senate Health, Education, Labor and Pensions (HELP) Committee. It currently awaits consideration on the floor of the U.S. Senate.

Two: anyone who is brave enough, has the time, or is suffering from insomnia can read the progress of this proposed bill for themselves, online at a website called GovTrack.us. It includes previous wording as well as the final wording the HELP Committee passed on to the Senate floor.

Three: oh yes, animals are mentioned quite a bit in the wording of this bill, 41 times in fact. And it's interesting to note that they're almost exclusively in the parts of the proposed legislation that have been deleted.


Will pharmacies like this one continue to have the freedom
to compound prescriptions for our pets?
The organization that brought this to our attention, My Meds Matter, expressed a concern that big drug
companies were trying to add an unrelated amendment to this bill that would forbid veterinarians from writing compound prescriptions for family pets.

They urged people to write their congressmen and ask that these provisions be removed from S. 959.

I'd count this a win - it appears they were successful.

I have signed up to follow the progress of this legislation via email updates from the Gov Track web site. It will be interesting to see how the wording changes once it passes from the Senate to the House of representatives.

Currently, 39 of the 41 references to animals have been removed from the proposed legislation.
Here are the two that are left:

Reference #1:
In the definitions section of the bill, a "DISPENSER" is defined as a retail pharmacy, etc, etc... and "does not include a person who dispenses only products to be used in animals."

In most cities, this exclusion is meaningless, as most veterinarians use human compounding pharmacies to fill their prescriptions.

Reference #2:
"Not later than November 1, 2016, the Comptroller General of the United States shall conduct a study and submit to Congress a report on the safety of animal drug compounding and the availability of safe and effective drugs for animals." [S. 959, section 102 (d)]

This second one is worth keeping an eye on, for if it's true that big pharma is trying to eliminate a veterinarian's ability to compound drugs for family pets, here might be their next opportunity to try to restrict that.  

Whew! This was one of our more difficult posts to wade through, both from a writing and reading standpoint, we know!

Thanks for hanging with us because, although it's not exactly a fun blog post, we think it's an important one.

http://www.atonkstail.com/2013/08/update-on-s-959-and-vet-compounding.html

Today's Shortages

ASHP/FDA
Atracurium Injection
Cyclopentolate/phenylephrine Ophthalmic Solution
Dextrose (25%) Injection
Diazepam Injection
Methylene Blue Injection
Methylergonovine Maleate
Phenylephrine Hydrochloride Injection
Potassium Phosphate Injection
Sodium Phosphate Injection
Sterile Empty Vials

http://www.ashp.org/Drugshortages/Current/?sort=2

JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor

JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug products to the user level due to concerns of sterility assurance following a recent inspection by the U.S. Food and Drug Administration of Front Range Laboratories of Loveland, Colo., one of the contract testing labs used by JCB.

The following compounded products are subject to the recall:
    Sodium thiosulfate, 25% (250 mg/mL) – Lot numbers 130701@9 (Exp. 12/28/13), 130709@6 (Exp. 1/5/14) and 130717@2 (Exp. 1/13/14)

    Sodium citrate, 4% solution for injection, 30 mL multiple dose vial – Lot number 130710@4 (Exp. 1/6/14)

    Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, 30 mL multiple dose vial – Lot number 130620@2 (Exp. 12/17/13)

    Acetylcysteine, 20% solution for inhalation, 4 mL single dose vials – Lot number 130627@5 (Exp. 8/26/13)


JCB has not received any reports of adverse events related to this recall to date. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8, 2013, through Aug. 20, 2013.

In the recent inspection of Front Range Labs, the FDA stated it “observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time.” (http://www.fda.gov/Drugs/DrugSafety/ucm365920.htm, 8/21/13)

Out of an abundance of caution, JCB has discontinued its relationship with Front Range and is now testing products at a different laboratory.

“Our top priority is to protect patient safety,” said Brian Williamson, PharmD, President and CEO of JCB Laboratories. “We have never had to issue a recall, but we believe this action is a reflection of our tradition of total transparency and our commitment to the highest quality standards. We regret any inconvenience this recall may cause our valued customers.”

JCB has begun notifying its customers by telephone, email, fax and mail. To return product or request assistance related to this recall, users should contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8:00 a.m. and 5:00 p.m. CDT.

Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Any problems may be reported to the FDA’s MedWatch program via:

http://www.watchlistnews.com/2013/08/26/jcb-laboratories-issues-voluntary-recall-of-six-drug-product-lots-due-to-concerns-of-sterility-assurance-at-testing-vendor/

Improve scrutiny of tailor-made drugs

To ensure FDA oversight of large-scale compounding “pharmacies,” Congress may require some partisan healing of its own.

Southwest Virginians affected by a deadly meningitis outbreak last year wait impatiently for Congress to tighten regulatory control over drug compounding facilities like the one that produced tainted steroid injections linked to the disease.

There is hope — if the House and Senate can pull out of the mire of partisanship long enough to come together on a remedy that will protect the public.

Virginia’s 9th District Rep. Morgan Griffith says he is working on legislation to make it clear the federal Food and Drug Administration has authority to inspect compounding pharmacies like the one in Massachusetts linked to the tainted medicine. He hopes to file the bill next month in the House.
In the Senate, meanwhile, the Health, Education, Labor and Pension Committee unanimously approved a bill late last month to increase the FDA’s regulatory power over compounding pharmacies. It goes next to the full Senate, where it will meet industry opposition.

Compounding pharmacies custom mix drugs for patients in doses or forms generally not available commercially when standard formulations do not fit individual needs. Typically, the facilities fall under the oversight of state pharmacy boards because they turn out small numbers of customized formulas to fill special orders placed by doctors.

Investigators of the fungal meningitis outbreak last year, which killed two people in Southwest Virginia and a total of 63 in 20 states, linked the outbreak to injections of tainted steroids made by the New England Compounding Center. The facility, now closed, was geared up for mass production and nationwide distribution.

Griffith thinks that, under current law, the FDA could have treated NECC as a drug manufacturer and stepped in, but did not; the FDA commissioner says the agency needs a stronger law.

The Senate bill would create a separate category of compounding pharmacies that would fall under FDA oversight. A coalition of pharmacies associations, among other groups, opposes that route.
Its members say the Senate plan would give the agency the power to ban custom compounded bio-identical hormones doctors use to treat menopausal and PMS symptoms in women and low testosterone in men.

Griffith is working on a more narrowly focused bill, an effort that shows enough flexibility, at least, to acknowledge the need for regulatory control.

If it gains enough favor to pass in the Republican House, it would go to the Senate, where a somewhat broader bill has been reported out of committee with bipartisan support.

The hope is that tighter oversight will not become yet another victim of hyperpartisanship.

http://www.roanoke.com/opinion/editorial/2174176-12/improve-scrutinyof-tailor-made-drugs.html

Today's Shortages

ASHP/FDA
Haemophilus B Conjugate Vaccine

http://www.ashp.org/Drugshortages/Current/?sort=2

Malawi: Unicef Re-Affirms Drug Commitment Support to Communities

Mana — United Nations International Children's Emergency Fund (Unicef) Wednesday re-affirmed drug support to communities in the country.

This follows revelations that Primary Health Care (PHC) project - which was introduced by donor community in 2011 to respond to drug shortage problems that rocked the country is earmarked to phase out in November, 2013.

This was disclosed during a series of sensitization meetings conducted in Mzimba on Monday through Wednesday.

This was after communities expressed concern that phasing out of the project might lead to drug shortage problem in the country's hospitals and health centres.

Addressing participants on Wednesday in the area of Traditional Authority Mzukuzuku, Unicef Development Communications OfficerDennis Chiwaya emphasized that the project was initiated to respond to drug shortage crisis.

"The core purpose of the project was to respond to an emergency on drug shortage. Let me assure you that everything is being taken care of because the project cannot phase out while the crisis is still there," said Chiwaya.

Chiwaya commended the communities for the sense of ownership on the drugs that have been given to them since inception of the project.

However, Traditional Authority Mzukuzuku described the project as one of the best for the rural communities.

"I can assure you that even deaths caused by Malaria and other curable diseases have absolutely gone down in this area because of the drugs," said the T/A.

Mzimba District Hospital spokesperson Ellings Nyirenda confessed that it was a big challenge for a district hospital to procure drugs for health centres before the project was introduced.

Under PHC project, government contributes 55 per cent towards purchasing of the drugs, the sum is channeled to Central Government Medical Stores to sustain the project when the donors shall fully pull out. The meetings were jointly done by Ministry of Information and Ministry of Health.

http://allafrica.com/stories/201308240279.html

Dr Reddy's recalls Ranitidine tablets for microbial contamination

Hyderabad, 22 August: Dr Reddy's Laboratories Limited has initiated a voluntary recall of a few lots of Ranitidine Hydrochloride tablets of 150 mg strength in the US earlier this month, according to an enforcement report put out by the US Food and Drug Administration(US FDA),

The action comes in the wake of microbial contamination detected in the drug. "A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp," the report said.

"We have done a voluntary recall of five lots of our Ranitidine OTC because of microbial contamination. It is a class II recall. The product was manufactured at our facility in Shreveport, USA," the company spokesperson said when asked for a clarification on the development.

Ranitidine, an over the counter (OTC) drug, is indicated for short term treatment of active duodenal ulcer and also used to treat heart burn and acid indigestion. The company has initiated the recall of the drug on August 2 in Bridgewater city in New Jersey, according to the report. The tablets are distributed nationally, it said.

http://www.business-standard.com/article/companies/dr-reddy-s-recalls-ranitidine-tablets-for-microbial-contamination-113082200859_1.html

Drug Shortages Persist in Months After Surveys Make Headlines at ASCO

Plainsboro, NJ -- (SBWIRE) -- 08/21/2013 -- Cancer drug shortages continue to confound the best efforts of the Food & Drug Administration to head them off, in part because the agency has little authority to address what causes them to occur, according to a co-author of an attention-getting study about shortages.

Dr. Keerthi Gogenini, a medical oncologist with the Abramson Cancer Center at the University of Pennsylvania, helped present one of several studies that grabbed headlines at the June meeting of the American Society of Clinical Oncology. Evidence-Based Oncology, checked back with Gogenini and with the FDA on the current state of shortages for its August issue. EBO is an indexed news publication that is a supplement to The American Journal of Managed Care.

An FDA spokeswoman, Lisa Kubaska, PharmD, credited the 2012 Food and Drug Safety Innovation Act with allowing the agency to identify shortages and find temporary solutions, such as importations of drugs. But Gogenini said on the front lines, the picture is not that rosy, although she believes the FDA is doing what it can.

“There are factors that contribute to drug shortages that the agency has limited control over,” Gogenini said.

The FDA, Gogenini and multiple other experts attribute cancer drug shortages to quality control problems at large manufacturers. The trouble is, the FDA cannot force drug manufacturers to direct manufacturing resources to generics instead of branded drugs, which cost more. The 2012 legislation basically serves as an early warning system that gives the FDA time to come up with alternatives when a shortage looms.

The June surveys presented at ASCO, including the study conducted at the University of Pennsylvania, showed widespread effects of shortages. In the Penn study, 94 percent of oncologist and hematologists said patients’ treatment had been affected by shortages, and 13 percent reported that patient participation in clinical trials had been compromised.

Gogenini attributes shortages to the lack of redundancy across the manufacturing system, while others have blamed the low cost of generics, which give companies little incentive to invest in capacity for these drugs.

“There are few penalties for failing to supply critical drugs, and no incentive for companies to invest in ‘excess’ capacity,” Gogeini told EBO. “This is not something the FDA would have control over.”

http://www.sbwire.com/press-releases/drug-shortages-persist-in-months-after-surveys-make-headlines-at-asco-309876.htm

Doxycycline shortage shot in the arm for Hikma profits

The drug shortages that continue to plague healthcare providers also continue to provide opportunities for those drugmakers with the drugs that are needed. Jordan's Hikma Pharmaceuticals has again ridden shortages to higher profits, particularly a shortage of the antibiotic doxycycline.

The drug, used for treating a host of conditions--malaria, sexually transmitted diseases and Lyme disease--has been in short supply for months. Hikma is not a large company, so it's all relative. But how much did it benefit from the shortage? The company said that its generics business grew 136.6% to $132 million in the first 6 months of the year. "The generics business is benefiting from exceptional sales of doxycycline and generated strong profitability in the first half of the year," the company said. It was enough for the drugmaker to again raise its projections for the year.

Hikma CEO Said Darwazah acknowledged to Reuters that his company is benefiting from the fact that the FDA has been coming down on problems at competitors, forcing them to cut production while they fix problems at plants. "I think you would be seeing many product price increases because the cost of what the FDA is asking for is quite expensive ... and I hope Hikma will be there to benefit from that," he told the news service.

Darwazah would know. The Jordan-based company last year received a warning letter for its West-Ward division plant in Eatontown, NJ, and in November decided it must temporarily close it to get problems resolved. Last month Hikma said that the plant was slowly reintroducing products to the market. But the substantial growth in its generics sales has been enough to "more than offset" the costs of the ongoing remediation there, the company said Wednesday.

Hikma has faced other manufacturing challenges that many manufacturers do not. Being based in the Middle East, it has substantial business there and in North Africa. Darwazah told Reuters that the company has had to adjust the work hours at its operations in Egypt to account for the country's curfew, imposed because of ongoing strife there. But it hasn't interfered yet with production. "As of now we haven't seen and we don't predict any supply disruptions from Hikma," he said.

http://www.fiercepharmamanufacturing.com/story/doxycycline-shortage-shot-arm-hikma-profits/2013-08-22

Namibia: Drug Shortage Hits Govt Medical Stores

The Ministry of Health and Social Service's pharmaceutical warehouse at the Central Medical Stores (CMS) in Windhoek has run out of some medicine stock.

The ministry's public relations officer, Ester Paulus, confirmed the drug supply shortage at CMS but said she could not comment further.

Paulus, however, said the ministry is still investigating and that they would release a formal statement regarding the shortage of stock next week.

"We cannot say anything at the moment as we are still investigating," she said.

But inside sources yesterday said the government's inventory of drugs has been exhausted for a while now.

They also said that the situation is frustrating at some of the State hospitals because it appears as if the medical personnel is not doing its job of supplying essential medication to the patients.

A pharmacist at one of the State hospitals said the list of drugs that are currently out of stock is long.

"Some of the medicine has been out of stock since the beginning of the year and we are forced to improvise and look for substitute medicine," the pharmacist revealed.

The pharmacist further said a certain injection called propranolol that helps relieve hypertension has especially been in short supply since the beginning of the year.

"We have a formula where we calculate how much stock is needed for every product and we usually order an additional number for each product for the waiting period but now the supply of stock is below the demand if there is any supply at all," said the pharmacist.

According to the pharmacist, the situation has forced the hospital to order some of the stock from private suppliers, which is very expensive.

A nurse at one of the hospitals said that for a while now, there has been a shortage of Chlorohexidine oral-rinse in their wards. "Patients are really struggling because of this," the nurse said.

http://allafrica.com/stories/201308220845.html

Today's Shortages

ASHP/FDA
Cidofovir Injection
Dextrose (50%) Injection
Heparin Sodium Injection
Levothyroxine Oral Tablets
Methylprednisolone Acetate Injection
Nicardipine Hydrochloride Injection
Polymyxin B Sulfate Injection

Drug Shortages Persist, Despite Government Efforts

Despite government efforts and stopgap measures, drug shortages continue to persist in the United States, according to a new report.

The shortages include those in oncology, despite pronouncements from the government that state otherwise, according to Keerthi Gogineni, MD, MSHP, of Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

She is referring to an article published online in Evidence-Based Oncology (EBO), a supplement of the American Journal of Managed Care..

In the EBO report, Lisa Kubaska, PharmD, a spokesperson for the US Food and Drug Administration (FDA), notes that the 2012 Food and Drug Safety Innovation Act (FDASIA) has allowed the agency to identify shortages and find at least temporary solutions, including importing drugs from overseas.

But Dr. Gogineni, a medical oncologist, says that the "picture is not that rosy" for those working on the front lines of medicine. However, she does believe that the FDA is doing the best they can, given the limits of their authority in this issue.

  The 'picture is not that rosy' for those working on the front lines of medicine.
Dr. Keerthi Gogineni

Dr. Gogineni is the lead author of a survey that was presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO) that highlighted the continuing sporadic shortages of cancer drugs and the negative effect that they were having on patient care. She said the problem continues today, 2 months after the data were presented.

Differing Perspectives

In the EBO report, Dr. Kubaska notes that there has been 1 new shortage in 2013, of lomustine (CeeNU, NextSource Biotechnology, LLC) tablets. However, this was "resolved through import of a drug with unapproved packaging until the approved package could be made available."

Dr. Gogineni offers a different viewpoint on the issue. In her own practice, they have had "considerable difficulty acquiring this drug to treat patients with brain tumors. There is an ongoing attempt to obtain this drug by enabling NextSource Biotech [the manufacturer] to import the product but under a different trade name."

Theoretically, this should have made emergency supplies of the drug easier to obtain by July 2013, Dr. Gogineni notes, "but practically speaking, this has not been the case."

Both Dr. Kubaska and Dr. Gogineni are in agreement over the cause underlying the majority of shortages, in that they are due to quality control problems at several of the large manufacturing plants. Preventing shortages is a "top priority" for the FDA, contends Dr. Kubaska, and that passage of FDASIA has enhanced the agency's ability to anticipate potential drug issues via a new early notification system.

But this does not appear to be sufficient. "There are factors that contribute to drug shortages that the agency has limited control over," says Dr. Gogineni.

Combo of Factors

As previously reported by Medscape Medical News, an executive order signed by President Barack Obama and later the passage of FDASIA directed the FDA to broaden its reporting of potential drug shortages, which would theoretically give the agency sufficient time to prevent or reduce them. With early notification, the FDA can work with manufacturers to more quickly address quality issues that stifle production, along with finding additional companies to help increase drug output.

At the 2012 ASCO annual meeting, Sandra Kweder, MD, deputy director of the Office of New Drugs at the FDA, pointed out that the generic versions of sterile injectable cancer medications are most prone to shortages, which are often caused by manufacturing and quality problems.

For example, during a discussion held at the meeting, she said that one manufacturer recently discontinued production when metal shavings or particles of glass were detected in a product. Thus, the closure of even a single facility, even temporarily, can lead to shortages.

Dr. Kweder had emphasized that progress has been made, explaining that 50 drug shortages had been prevented since October 2011; in 2012, another 50 were prevented, simply because of early notification from manufacturers.

But shortages can also be attributed to other factors, including industry consolidation, increases in demand, and a lack of access to pharmaceutical ingredients. In a previous interview, Dr. Gogineni told EBO that "there are a combination of underlying reasons."

"There is little redundancy in the system," she said, and there is "a marked increase in new sterile injectable product applications without a concomitant increase in manufacturing capacity [which] has led firms to divert production to more expensive, branded agents."

Although the FDA is authorized to address quality issues, it is limited in its ability to increase manufacturing capacity. The agency can expedite reviews of "new" manufacturers, but it can take years for a manufacturer to boost up their capacity, says Dr. Gogineni. There are also few penalties for failing to supply critical drugs, and incentives for companies to invest in excess capacity are nonexistent.

"This is not something the FDA would have control over," she says.

Needs More Teeth


Richard Schilsky, MD, professor of medicine at the University of Chicago, Illinois, who also spoke on the subject during the 2012 meeting, agrees that "more" is needed.

ASCO is seeking a permanent solution to the problem of drug shortages, but this would probably require an act of Congress, according to Dr. Schilsky. Even though the FDASIA requires drug manufacturers to notify the FDA 6 months in advance of market withdrawals or manufacturing interruptions, it does not go far enough.

Dr. Schilsky, who is also a past president of ASCO, said that the association wants Congress to require manufacturers not only to give the FDA early warning of impending shortages but to also have some sort of penalties or fines for companies that do not comply.

The reporting requirement is in the legislation, but the penalties are not, Dr. Schilsky noted. "If there are no teeth in that legislation, some companies may decide not to report as required," he said.

American Journal of Managed Care: Evidence-Based Oncology. Volume 19, special issue 6, July/August 2013. Full text

http://www.medscape.com/viewarticle/809913

FDA not alone in acting on compounding pharmacies

The FDA this year has done an inspection sweep through the largest compounding pharmacies after being caught off guard last year when a nationwide fatal meningitis outbreak was tied to a compounder in Massachusetts. But the federal agency is not alone in trying to get on top of the issues. Authorities in Massachusetts, which have stepped up their own oversight, recently halted production at two drug compounders there. 

The Massachusetts Board of Registration in Pharmacy sent cease-and-desist notices to Medi-Son Solutions in Norwood and sister compounder CarePro in Quincy after an inspection found problems at Medi-Son, according to the Boston Globe. Hearings for the two facilities are in progress. Anne Roach, a spokeswoman for the Massachusetts Department of Public Health said the state stepped up enforcement after last year's outbreak of fungal meningitis that infected hundreds of people and killed dozens who were injected with pain drugs from New England Compounding Center (NECC) of Framingham. She said the state got an extra $1 million to pump up its efforts. It has inspected 37 compounders since the NECC deal, and only four passed, Roach said.

Neither of the closed compounders are among the more than 50 that the FDA has inspected since the NECC situation blew up. The federal agency is looking at large compounders that operate more like small drug manufacturers and often ship nationally. The FDA is supporting a bill that would establish clear authority of its oversight powers when it comes to compounders. The proposed law would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. They would not have to meet all of the strict regulations that drug manufacturers do, but the law would prevent them from continuing to make the most complex biologic drugs that are more easily contaminated. They also would have to kick in fees for the privilege of having FDA supervision.

Some members of Congress oppose extending the agency's authority, saying it just needs to use the powers it has to do a better job. But a situation that recently played out between the FDA and a compounding pharmacy in Texas is sure to feed the debate. The FDA last week updated a notice to healthcare providers to remind them not to use products produced by NuVision Pharmacy of Dallas. The FDA said questions of sterility were raised during an inspection of the facility. But the compounder is contesting the FDA's authority and findings. In a notice on its own website, NuVision says the FDA is judging compounders using manufacturing standards and that is not a manufacturer. It claims all of its products are sterile, tested by an outside lab and will provide oversight and that clients with concerns can have the results of those tests sent them as proof.

That fight is playing out even as the FDA last week said that another Texas compounder, Specialty Compounding of Cedar Park, TX, is yanking all of its sterile products after 15 patients at two Texas hospitals contracted bacterial bloodstream infections. Two of those patients have reportedly died.
http://www.fiercepharmamanufacturing.com/story/fda-not-alone-acting-compouding-pharmacies/2013-08-22

FDA To Regulate Compounding Pharmacies

After a deadly meningitis outbreak traced to a New England compounding pharmacy killed at least 50 Americans last year, the U.S. government is poised to step in and increase regulation of these niche facilities through the Food and Drug Administration (FDA). It could shake up an entire industry struggling to recover from a string of safety and health concerns after increased inspections.

Introduced in May, bill S. 959: The Pharmaceutical Quality, Security, and Accountability Act proposes federal oversight of an industry that allows pharmacists to create custom medications to suit specific patient needs. This includes combining, diluting or reconstituting an existing drug for patients who may have an allergy or sensitivity to commercially produced medications. The bill is still in committee and has not been put to a vote before the Senate or House.

The industry has functioned with few major incidents until the major meningitis outbreak last year. Here’s the latest on that story: CBS News reported earlier this month that the disaster began when 17,000 vials of a steroid were shipped to clinics and hospitals in 23 states last fall. The vials were contaminated with a fungus that killed at least 48 users and sent another 700 to seek treatment for persistent fungal infections.

It’s still unclear how the breakdown occurred, but it’s not the only incident that has patients concerned about the safety of the drugs produced in these facilities.

Since the fungal meningitis outbreak, the FDA has increased inspections at compounding facilities, finding a number of violations at pharmacies across the U.S.

USA Today reports that the FDA announced a voluntary nationwide recall of all sterile products from a Texas compounding pharmacy this month after reports that 15 patients at two Texas hospitals have developed bacterial bloodstream infections after they received injections from Specialty Compounding from Cedar Park, Texas.

This incident follows a report from The Salt Lake Tribune claiming that an inspection at the University Pharmacy Inc. in Salt Lake City was found to have multiple sanitation violations during safety inspections earlier this year.

The pharmacy was visited five times in February by FDA inspectors, who reported finding equipment and utensils used to mix injectable drugs were not sanitized frequently enough to prevent contamination.

“Spills and splatters of amber and white colored residue were observed in and around the equipment,” their inspection report says.

But opponents of the increased federal regulation say that states that are already tasked with regulating these facilities can handle the safe administration of compounding pharmacies. Toward this end, the Boston Globe reports that the state of Massachusetts Department of Health recently closed two compounding pharmacies, in Quincy and Norwood, after a surprise inspection revealed multiple safety violations.

“The Department of Public Health has made great strides to enhance oversight of the pharmacy industry in Massachusetts since last fall,” Roach said. “The Governor provided more than $1 million in new funding in this year’s budget to enable the Board to hire additional staff to enhance inspections of pharmacies.”

Some critics also believe that increased federal regulation could bring an end to the small “mom and pop” compounding pharmacies that are clinging to business in an era dominated by big drug manufacturers.

“The bill, S. 959, would subject mom and pop compounding pharmacies to many of the same regulations as the big drug manufacturers. If it were to pass, the result would be many small mom and pop businesses shutting their doors permanently,” writes Glenn Jacobs of the Daily Caller.

http://www.mintpressnews.com/after-deadly-outbreak-fda-to-regulate-compounding-pharmacies/167454/

Bill regulates compounding pharmacies

Pharmacies that sell sterile compounded drugs in California may soon have to meet stricter standards following nationwide reports of injury and death from contaminated medications. Opponents say the regulations would drive up costs and hurt consumers.

Sterile compounded drugs may be injected, inhaled or dropped into the eye. Unlike non-sterile compounded medications, which can be swallowed or applied to the skin, sterile drugs pose an increased risk for harm to patients because of how and where they are administered.

Compounded products accounted for up to 3 percent of the $320 billion spent on prescription drugs in the United States in 2011, according to a report from the California State Board of Pharmacy.


Licensed pharmacies may compound, or mix, both sterile and non-sterile drugs to customize prescribed medications by adjusting dosage strength, ingredients and formula to meet individual patient needs. They may also compound existing formulas to reproduce medications that are in short supply from manufacturers.

But the process of sterile compounding has produced some frightening results.

In October 2012, for example, the Massachusetts-based New England Compounding Center shipped tainted epidural steroid injections used to treat pain to 75 medical facilities in 23 states, including California.

The treatments were later linked to cases of fungal meningitis and other infections.

As of last month, of the 14,000 patients who received the injections, 61 people died and about 700 became ill.

Federal investigators found that the compounding facility had made the steroids with a contaminated powder and illegally operated like a pharmaceutical manufacturer, producing large quantities of drugs instead of individual orders, according to a BOP report.

In response, the state Board of Pharmacy authored Senate Bill 294, which aims to ensure that the process and tools for making sterile compounded drugs are safe.

Unlike commercial pharmaceutical manufacturers, which are regulated by the Food and Drug Administration, pharmacies are regulated by individual states.

The bill, introduced by state Sen. Bill Emmerson (R-Redlands), passed the Senate in May. It will be heard by the Assembly Appropriations Committee on Aug. 30.

If passed by the committee, it will be eligible to be heard on the Assembly floor before going back to the Senate for approval of any changes, said Kayla Williams, a spokesperson for Emmerson.

California is not the only state to take action. Sixteen states passed laws this year related to compounding pharmacies, according to the National Conference of State Legislatures.

“Recent events have made it clear that it’s necessary to increase oversight of sterile compounding pharmacies to ensure patient safety,” Emmerson said in a statement to the Acorn. “I have introduced SB 294 to strengthen consumer protection and provide consistent oversight of pharmacies that ship or dispense sterile drug products in California so we can do everything we can to prevent another patient injury or death.”

Regulations

The law would hold out-ofstate pharmacies to the same standards as facilities in California, requiring the nonresident pharmacies to obtain a license from the state Board of Pharmacy to compound or distribute sterile drugs in California.

A license would be issued only after an inspection of the pharmacy, which would also be subject to annual unannounced inspections.

Out-of-state compounding pharmacies that sell in California would be required to pay the board to inspect their facilities, a cost of around $780 per inspection.

California law currently requires out-of-state pharmacies that distribute sterile compounded drugs in the state to hold either a specialty license issued by the Board of Pharmacy or accreditation from a private agency.

Pharmacies with accreditation do not need a license from the board and are exempt from its regulations, including its inspections.

Under the new law, pharmacies would have to notify the board within 12 hours of recalling sterile drugs compounded by the pharmacy and within 10 days of receiving any disciplinary action from another state or suspension of any accreditation. The pharmacies must also provide the board with a list of the sterile drugs they compound.

Virginia Herold, executive officer of the Board of Pharmacy, said stronger measures are needed to protect the public from unsafe compounded drugs.

“The goal is to have a single standard so we don’t have erratic medications coming in,” Herold said. “We’re making sure that pharmacies that do high-risk compounding meet California standards. Pharmacies should be able to produce safe medication. . . . We do not want anyone to fear medication.”

Local impact

Lilit Pogosyan, a pharmacist at Park Compounding Pharmacy in Westlake Village, said she would welcome the new law. The multistep process of compounding drugs can leave room for error, she said.

“It does require knowledge and experience not taught in pharmacy school,” Pogosyan said, because “what we learn (at school) might not hold 10 years from now.”

But Vandana Parnami, owner of Simi Pharmacy Compounding & Medical Supplies in Simi Valley, said charging out-of-state compounding pharmacies $780 for inspections could deter them from getting licensed to sell in California, thereby reducing the availability of medicines and causing a spike in prices for consumers.

“I don’t think that is right,” she said. “Not many pharmacies want to be licensed by two states. Independent pharmacies cannot (afford it).”

Parnami, who opened her non-sterile compounding pharmacy a year ago, said the added restrictions would also be bad for her business. Common nonsterile medications she has compounded include liquid Tamiflu for kids, which she made when the manufacturer did not make enough to meet demand.

“If the cost is going to be high, I will think twice about going into sterile compounding,” she said.

Regarding the tainted medication produced by the NECC, Parnami said the pharmacy “didn’t follow existing policies and procedures.” One current requirement to get a sterile compounding license is a “clean room,” or sterile environment for compounding, which the Massachusetts pharmacy did not maintain in sanitary conditions.

“(Regulators) should have enforced those policies, not made more rules,” she said.

To verify if a pharmacy is licensed to sell sterile compounded drugs, visit the Board of Pharmacy website at www.pharmacy.ca.gov.

The site also contains a twominute video with instructions on how to buy prescribed drugs on the Internet.

Pharmaceutical websites may be verified through Verified Internet Pharmacy Practice Sites (VIPPS) or registered with LegitScript.com.

http://www.mpacorn.com/news/2013-08-23/Health_(and)_Wellness/Bill_regulates_compounding_pharmacies.html

Doctors worried about cancer drug shortage

It has been 17 months since I wrote a feature story about the drug shortage crisis in South Florida and, unfortunately, the problem has persisted for cancer drugs.

The American Journal of Managed Care released an article on Monday detailing a shortage of cancer drugs that has lingered for more than two years. It was based on studies presented to the American Society of Clinical Oncology.

Of the oncologists and hematologists surveyed by the University of Pennsylvania, 94 percent said their patients’ treatment had been affected by drug shortages between March and September of 2012. Of those who were impacted, 83 percent said they couldn’t provide standard chemotherapy at some point and 13 percent said patient participation in clinical trials had been compromised.

Doctors often responded by using different treatments or drugs, delaying treatment, skipping doses or reducing doses, according to the survey. However, some of the replacement drugs may not have enough clinical trial evidence or their ideal dosage amounts isn't clear, ASCO said.

South Florida medical providers told me similar things about impacts to patient care last year.
The ASCO told the American Journal of Managed Care that manufacturing plant closures and quality problems, industry consolidation and lack of access to ingredients are among the reasons for drug shortages. Another factor is the low Medicare reimbursement rate for certain generic drugs.

http://www.bizjournals.com/southflorida/blog/2013/08/doctors-concerned-over-cancer-drug.html

FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories

The U.S. Food and Drug Administration is advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating.

In a recent inspection, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time.

Front Range Labs is an independent laboratory performing quality control testing primarily for compounding pharmacies. FDA is working with Front Range to notify its customers and to determine if certain drugs should be removed from the market due to safety concerns. The FDA will update the public as new information becomes available or if products are being recalled.

We ask health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:

Compounding pharmacies: Massachusetts closes 2, FDA fights with 1 in Texas

The FDA is not alone in cracking down on drug compounders. State authorities in Massachusetts have been taking action after being caught off-guard last year when a nationwide, fatal meningitis outbreak was tied to a compounder there. It recently gave orders to halt operations at two compounders.

The enforcement illustrates the division of powers the FDA supports in legislation pending in Congress that would give it authority over the big players and leave local, more traditional compounders to the states. It also came as a compounding pharmacy in Texas is challenging the FDA's authority over its products.

The Massachusetts Board of Registration in Pharmacy sent cease and desist notices to Medi-Son Solutions in Norwood and sister compounder CarePro in Quincy after an inspection found problems at Medi-Son, according to The Boston Globe. Hearings for the two facilities are in progress. Anne Roach, a spokeswoman for the Massachusetts Department of Public Health, said the state stepped up enforcement after last year's outbreak of fungal meningitis that infected hundreds of people, dozens fatally, who were injected with pain drugs from New England Compounding Center (NECC) of Framingham. Only four of 37 compounders inspected passed their inspections, she said.

Neither of the closed compounders are among the more than 50 that the FDA has inspected since the NECC situation blew up. It is looking at large compounders that operate more like small drug manufacturers and often ship nationally.

The FDA wants Congress to clarify its authority over compounders and is supporting a bill that would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. They would not have to meet all of the strict regulations that drug manufacturers do, but the law would prevent them from any longer making the most complex biologic drugs that are more easily contaminated. They also would have to kick in fees for the privilege of having FDA supervision.

Some members of Congress oppose extending the agency's authority, saying it just needs to use the powers it has to do a better job. But a situation that is playing out between the FDA and a compounding pharmacy in Texas is sure to feed the debate. The FDA last week updated a notice to healthcare providers to remind them not to use products produced by NuVision Pharmacy of Dallas. The FDA said questions of sterility were raised during an inspection of the facility. But the compounder is contesting the FDA's authority and findings. In a notice on its own website, NuVision says the FDA is judging compounders using manufacturing standards and that is not a manufacturer. It claims all of its products are sterile, tested by an outside lab, and customers with concerns can have the results of those tests sent to them as proof.

That fight is playing out even as the FDA last week said that another Texas compounder, Specialty Compounding of Cedar Park, is yanking all of its sterile products after 15 patients at two Texas hospitals contracted bacterial bloodstream infections. Two of those patients have reportedly died.

http://www.fiercepharma.com/story/compounding-pharmacies-massachusetts-closes-2-fda-fights-1-texas/2013-08-21