DC Metro Area Medical Malpractice Law Blog

Posted by Salvatore J. Zambri, founding member and partner

Following the recent debates over how to regulate the compounding pharmacy business, the Health, Education, Labor and Pensions Committee of the U.S. Senate has drafted a bill aimed to "make clear oversight responsibilities for pharmaceutical compounding and ensure safety for consumers." According to the news as posted on the Committee's Senate.gov website:

 "Draft legislation preserves the states’ primary role in traditional pharmacy regulation and clarifies FDA authority over those making sterile products without prescriptions and shipping across state borders."

As I have noted in earlier posts, the most challenging problem with compounding pharmacies has been determining who is in charge of regulating them. FDA Commissioner Margaret Hamburg indicated that the conflicting patchwork of state and federal laws regarding pharmacies has resulted in a lack of aggressive policing by the FDA.  The new bipartisan Senate bill requires compounding manufacturers to register with the FDA, report the drugs they make, and meet standards similar to those of drug manufacturers.

The International Academy of Compounding Pharmacists has criticized the bill for creating "more confusion and blurring the jurisdiction authority of regulators."  Its position continues to be that states should license and oversee compounding pharmacies and that the FDA should oversee and regulate pharmaceutical manufacturers.

Public Citizen, a consumer advocate and nonprofit organization has also weighed in on the proposed Senate bill to regulate compounding pharmacies. In its press room release on May 1, 2013, "Public Citizen to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety", Public Citizen criticizes the bill for actually weakening  existing FDA control and creating more ambiguity defining compounding pharmacies. An alternative suggested by Public Citizen proposes legislation that would:

"- Draw a single, clear line between traditional compounding and drug manufacturing, with no newly created category of second-tier, substandard drug manufacturers, called “compounding manufactures”;

- Provide adequate funding to the FDA to aggressively enforce existing laws against “compounding pharmacies” that cross the line into manufacturing;

- Strengthen the FDA’s authority to police the line between traditional compounding and drug manufacturing by requiring registration and granting the FDA authority to inspect for traditional compounding pharmacies, regardless of whether they engage in drug manufacturing activities; and

- Require clear, standardized warning labels to communicate to providers and patients who purchase traditional compounded products that the safety, efficacy and the accuracy of the product’s labeling have not been assessed by the FDA."

Posted by Salvatore J. Zambri, founding member and partner

A recent article published by BMJ Quality and Safety studied the diagnosis-related claims from the National Practitioner Data Bank maintained by the federal government for a 25 year period from 1986-2010. This study reviewed and cataloged the error type, outcome severity and payments of malpractice claims, comparing diagnostic error to other malpractice claims.  Of the 350,706 paid claims studied during this 25 year period, diagnostic errors accounted for 28.6% of the errors as well as the highest proportion of total payments (35.2%). "Diagnostic errors more often resulted in death than other allegation groups (40.9%) and were the leading cause of of claims-associated death and disability."

 Researchers contributing to this study concluded, "Among malpractice claims, diagnostic errors appear to be the most common, most costly and most dangerous of medical mistakes. We found roughly equal numbers of lethal and non-lethal errors in our analysis, suggesting that the public health burden of diagnostic errors could be twice that previously estimated. Healthcare stakeholders should consider diagnostic safety a critical health policy issue."

According to Johns Hopkins University School of Medicine neurologist David E. Neuman-Toker, one of the lead researchers in this study, "Diagnostic errors are the most common, the most costly and the most deadly of all medical errors.”  He also indicated that, “there are no public reporting requirements for measuring diagnostic accuracy or error,” because diagnostic errors are not always evident immediately, as contrasted to medication and surgical errors.

Hopefully, the medical community will use the information from the study to make changes that will lead to greater patient safety.

Posted by Salvatore J. Zambri, founding member and partner

The push to regulate compounding pharmacies is beginning to gain more attention on the national front. According to a congressional report released on April 15, 2013, the state-by-state examination last fall into the safety issues surrounding the common practices among compounding pharmacies demonstrates that states do not adequately track, regulate or inspect these pharmacies, exposing patients to unsafe drugs, disease and death.

The Markey Report, "State of Disarray," findings and conclusions:

• "State boards of pharmacy generally do not know which pharmacies engage in compounding, do not know whether pharmacies ship compounded drugs across state
  lines, and do not know which pharmacies manufacture large quantities of compounded
  drugs.
• Only thirteen state boards of pharmacy know which pharmacies are providing sterile compounding services and only five of these states have inspectors that are trained to identify problems with sterile compounding.
• States typically do not maintain pharmacy inspection records that enable them to identify systemic and repeated compounding pharmacy safety problems that originate either in-state or out-of-state.
• States are unable to effectively police compounding pharmacy activities in other states. Moreover, when issues arise with out-of-state pharmacies, states do not consistently inform the origination state or the FDA.
• Despite general increases in state board of pharmacy budgets, the number of pharmacy inspectors has remained consistently low. Furthermore, states usually do not distinguish between inspections of traditional and compounding pharmacies."

Congressman Markey is among those who support legislation to give the Food and Drug Administration more authority over compounding pharmacies.  A scheduled hearing of a House Energy and Commerce subcommittee will be held on Tuesday, April 16, 2013 to focus on this issue.

I will continue to update our readers on this critical consumer issue as more attention is given to the safety problems of compounding pharmacies. 

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Posted by Salvatore J. Zambri, founding member and partner

The Office of the Inspector General of the Department of Health and Human Services recently released a special fraud alert regarding physician-owned entities. "This Special Fraud Alert addresses physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs)." 

"To report suspected fraud involving physician-owned entities, contact the OIG Hotline at
http://oig.hhs.gov/fraud/report-fraud/index.aspor by phone at 1-800-447-8477 (1-800-HHS-TIPS)."

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Posted by Salvatore J. Zambri, founding member and partner

The FDA has announced that Clinical Specialties Compounding Pharmacy is recalling all sterile products due to lack of sterility assurance.  We have reproduced the FDA notice in its entirity for our readers.

 "Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance

 [Posted 03/21/2013]

AUDIENCE: Health Professional, Pharmacy, Patient

ISSUE: Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.

BACKGROUND: This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.

RECOMMENDATION: Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company. Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 Monday through Friday between the hours of 10 am to 5 pm EST, or e-mail at clinicalrx@bellsouth.net. Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/21/2013 - News Release - FDA]

[03/20/2013 - Press Release - Clinical Specialties ]

Related MedWatch Alert

[03/18/2013 - Press Release - Clinical Specialties ]"

As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.

Do you have any questions about this post?

 Posted by Salvatore J. Zambri, founding member and partner

 A recent U.S. Food and Drug Administration (FDA) press release announced the voluntary recall of all compounded products by Medprep Consulting, Inc. due to potential mold contamination.  We are including the complete FDA press release along with a listing of all the products in the recall.

 "Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination

Contact
Consumer:
732-493-3390

Media:
Angelo J. Cifaldi, Esq., R.Ph.
Satish V. Poondi, Esq., R.Ph.
Counsel for Med Prep Consulting Inc.
(732)855-6096

FOR IMMEDIATE RELEASE – March 17, 2013 – Tinton Falls, NJ., Med Prep Consulting, Inc. is voluntarily recalling all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance.

Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients. To date, no injuries or illnesses have been reported.

The products are used for a wide range of therapeutic uses for hospitalized inpatients and outpatients, and, patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physician’s office practice facilities and clinics. All of these products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.

Included in the recall are the following product list:

All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic mail and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

Product complaints related to this recall should be reported to 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
  www.fda.gov/MedWatch/getforms.htm.
• Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787
• Fax: 1-800-FDA-0178"

As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.

Do you have any questions about this post?

Posted by Salvatore J. Zambri, founding member and partner

In a move prompted by pressure from Congress and health-care watchdogs, the FDA launched a series of aggressive surprise inspections of large compounding pharmacies last week. Among their findings so far: contaminated drugs, medications without expiration dates, and drug containers "not clean and sterilized." The inspections of about 30 facilities are expected to continue for the next two months and could result in fines and possible suspensions of their licenses. This new program of aggressive inspections is aimed at regulating the multibillion-dollar industry that custom mixes medications for individual patients, hospitals and clinics. As I have posted previously, the compounding pharmacy industry has fallen between the regulatory cracks.

According to Howard Sklamberg, director of compliance for the FDA's Center for Drug Evaluation and Research, inspectors do not know exactly what they may find during these inspections, since compounding pharmacies currently do not have to register with the FDA, nor tell them what medications they produce. "A lot of these firms are behaving like manufacturers and producing like manufacturers, yet they are trying to operate under the law as if they were a small pharmacy."  According to the Washington Post's investigative series, "The FDA is seeking authority from Congress to require registration, which would allow the agency to demand that firms release detailed information about operations and give it greater authority to require that safety problems be fixed."

Patient safety should be the ultimate goal for compounding pharmacies instead of making as much profit as possible and resisting oversight by the FDA or other regulatory agencies.  Profit should never be put ahead of patient safety.

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Posted by Salvatore J. Zambri, founding member and partner

The FDA recently announced a Class 1 Recall for DePuy Orthopedics.  We are reproducing the recall notice below for our readers in its entirety.  If you anticipate or have recently had knee replacement surgery, please consult with your surgeon regarding the type of implant and possible symptoms or issues related to it.

"DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall - Taper Connection May  Not Accommodate Physiologic Loads

[Posted 02/22/2013]

AUDIENCE: Orthopedics, Surgery, Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.

The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.

The affected devices were manufactured from 2008 to July 20, 2012. See the Recall notice for a list of affected product codes and lot numbers.

BACKGROUND: The LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.

RECOMMENDATION: On Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to DePuy.

DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/22/2013 - Recall Notice - FDA]"

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Posted by Salvatore J. Zambri, founding member and partner

The International Academy of Compounding Pharmacies has traditionally fought against FDA oversight for compounding pharmacies and has argued that state pharmacy board registration and control was sufficient. Under the current laws, pharmacies must register with and are licensed by the state boards of pharmacy, not the FDA.  For drug manufacturers, FDA registration is required and their products must have FDA approval.  

Following a recent investigative research article by the Washington Post about the lack of safety regulation for compounding pharmacies, the executive vice president of the organization now endorses, "FDA registration for what he describes as compounding manufacturers and supports giving the agency the power to enforce safety standards for these firms."  As the FDA commissioner argued before Congress several months ago, "non-traditional" compounders need a special category for stepped-up enforcements, but left open recommending whether the FDA or state pharmacy boards should be responsible for the enforcement. 

This new position by the International Academy of Compounding Pharmacies seems to acknowledge the need for more control by the FDA. Creation of a way to regulate "non-traditional" drug manufacturing is currently being debated on Capitol Hill. Compounding firms frequently use non-FDA-approved drugs as key ingredients and many of their drugs are not dispensed in pill form, creating a difficult regulation scenario. According to Sarah Sellers, executive director of the Center for Pharmaceutical Safety, her concern is that a new enforcement system would be set up for compounders that assumes they are using FDA-approved ingredients. “When people use FDA-approved ingredients, built into that are good manufacturing practices. But there is an entire group of compounding pharmacies that are not using FDA-approved drugs. I’m concerned they will end up creating a ‘good manufacturing practices light.' ”

As I posted previously, the safety problems with compounding pharmacies have been known for years. Finding a way to police the industry effectively is important for patient safety.

Posted by Salvatore J. Zambri, founding member and partner

After so many cases and deaths related to the New England Compounding Center's tainted steroid shots, new inspections have resulted in a report about conditions and practices that violated federal law aimed at maintaining sterile environments.  Sarah Sellers, a former FDA official who is now a consultant on quality and sterility issues, also reviewed the report. “The entire pharmacy was an incubator for bacteria and fungus,” she said. “The pharmacy knew about the contamination and did nothing.”

However, a more recent review of compounding pharmacy practices shows that these organizations have been tied to deaths and illnesses over the past decade and that those pharmacies have experienced safety problems for years. According to a recent Washington Post article, compounding pharmacies "mass-produce medications and ship them across state lines, often without individual patient prescriptions." Compound pharmacies supply about 40% of all intravenous medications used in hospitals and are not required to follow the safety rules that apply to commercial drugmakers. With such a lightly-regulated industry, neither state nor federal authorities did much to "systematically inspect and correct hazards posed by specialty pharmacies," resulting in practically no punishment for the pharmacies, even when their mistakes caused deaths. 

As further indication that this problem has been known for some time: "In 2007, a team of investigators from the Centers for Disease Control and Prevention issued an unusually blunt warning to hospitals and doctors: Compounded drugs had a higher risk of contamination than commercially manufactured drugs, and compounding pharmacies had 'generally lower quality-control standards than pharmaceutical manufacturers.' ”

The FDA has pressed Congress for more authority to regulate compounding pharmacies. FDA Commissioner Margaret Hamburg said, "Legislation is needed that would allow the FDA to routinely inspect 'non-traditional' compounding pharmacies, hold them to higher production standards and see records about the volume of drugs being made, as well as require compounders to report adverse events associated with their products."  State pharmacy boards have the primary responsibility for policing the compounding pharmacies, but they have an uneven record of enforcement. In addition, the regulatory standards that do exist for the compounding pharmacy industry has not kept pace with the rapid expansion pace of that business. By relying on gaps in laws and conflicting court rulings, these companies have fought enforcement orders and kept the FDA out of their facilities.

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