DEA Issues Final Rule on Safe, Secure Disposal of Controlled Substances

The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for “ultimate users” to dispose of unused or unwanted pharmaceutical controlled substances. The regulations allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. According to the DEA, it has expanded the entities that may be authorized collectors in response to public concerns regarding ultimate users’ ability to have convenient disposal options. The rule also establishes standards related to each element of the disposal process, including the transfer, delivery, collection, destruction, return, and recall of pharmaceutical controlled substances. Also in response to comments, the DEA has relaxed some of the proposed security requirements related to storage and destruction of controlled substances. The rule is effective October 9, 2014. 

FDA Issues Draft Guidance on Communicating New Risk Information about an Approved Drug Product - Comment Opportunity

This post was written by Jillian W. Riley.

On June 6, 2014, the US Food and Drug Administration (FDA) issued a draft guidance addressing the distribution of new risk information to health care providers (HCPs) and health care entities (HCEs). The draft guidance defines “new risk information” as “information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already identified in the approved labeling or otherwise refines risk information in the approved labeling in a way that does not indicate great seriousness of the risk.” The draft guidance is not intended to address risk information that is newly identified, but that which was not available at the time FDA approved the labeling. Acknowledging the evolving nature of a drug’s safety profile, the draft guidance is aimed at helping sponsors better communicate “new risk information” in order to allow HCPs and HCEs make the best decision for each patient.

Through the guidance, FDA lays out criteria for determining the appropriate circumstances under which to distribute “new risk information” to HCPs and HCEs. FDA does not intend to object to the distribution of new risk information as long as the distribution is consistent with the criteria established in the draft guidance.

The criteria are broken into two categories, those governing the data source and those governing the distribution. Both criteria categories must be met in order for a drug company to distribute new risk information that rebuts, mitigates, or refines risk information in the approved labeling.

Data source criteria include the following:

  • The study or analysis should meet accepted design and other methodologic standards and be sufficiently well-designed and informative;
  • If the data rebuts a prior determination about a causal connection between the drug and an adverse event, the study or analysis should be at least as persuasive as the data it is rebutting;
  • The conclusions should give appropriate weight and consideration to all relevant information in the safety database, including contrary or otherwise consistent findings; and
  • The study or analysis should be published in an independent, peer-reviewed journal.

Distribution criteria include the following:

  • The reprint or digital copy should be accompanied by a cover sheet that clearly and prominently discloses:
    • The study design, critical findings, and significant methodology
    • That the information is NOT consistent with certain risk information in the approved labeling
    • That FDA has not reviewed the data; and
    • Any financial interests or affiliations between the study author(s) and the drug company;
  • The reprint or digital copy should be accompanied by the approved product labeling;
  • The reprint or digital copy should be separate from any promotional material; and
  • Any statements made by a drug company representative to a HCP or HCE concerning the reprint should be consistent with the content and the disclosure information.

Comments on the draft guidance should be submitted by August 20, 2014.

FDA Initiative Opens Door to Easily Accessible, User-Friendly Data

This post was written by Jennifer Pike.

Yesterday, the U.S. Food and Drug Administration (FDA) made available data on millions of reports of drug adverse events and medication errors made to FDA between 2004 and 2013. The release of the data is part of FDA’s new data sharing initiative, openFDA, which is designed to make it easier for developers, researchers and the public to access data collected by FDA. OpenFDA organizes large amounts of publicly-available data in a structured, computer-readable format and makes it possible for users to instantaneously search and pull the data for their own use. . According to Walter Harris, FDA’s chief operating officer and acting chief information officer, “openFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public, and protect public health.”

For now, openFDA will begin as a pilot program with data involving the drug adverse event and medication error reports. FDA will later expand openFDA to include data on product recalls and product labeling.

OIG Examines Medicare Part B Payments for Compounded Drugs

The HHS OIG has examined Medicare Part B payments for compounded drugs and Medicare Administrative Contractors' (MAC) procedures for reviewing and processing claims for compounded drugs, in light of safety concerns involving a 2012 meningitis outbreak and increased scrutiny of compounded drugs. According to the OIG, neither CMS nor MACs tracked the number of Part B claims or payment amounts for compounded drugs, nor do Part B claims contain information that can be used to systematically identify claims for compounded drugs. The OIG observes that the current “inability to track claims for compounded drugs and identify the compounding pharmacies limits the ability of CMS and MACs to take steps that could stop payments for compounded drugs produced in violation of the [Federal Food, Drug, and Cosmetic] Act. The OIG therefore recommends that CMS (1) establish a method to identify Medicare Part B claims for compounded drugs, (2) explore the possibility of requiring providers to identify on Part B claims the pharmacy that produced the compounded drug, and (3) consider conducting descriptive analyses of Part B claims for compounded drugs.

CMS Call: National Partnership to Improve Dementia Care in Nursing Homes (May 20)

On May 20, 2014, CMS is hosting another call to discuss the National Partnership to Improve Dementia Care in Nursing Homes, which includes as a goal reducing the use of unnecessary antipsychotic medications in nursing homes. This call will focus on efforts to monitor enforcement rates and track surveyor training completion; the role that activity professionals play in the mission to improve dementia care; and nonpharmacologic care approaches.

Congressional Health Policy Hearings

 A number of Congressional committees have held hearings recently to address various health policy issues, including the following:

FDA to Overhaul an OTC System That "Isn't Working"

This post was written by Kevin M. Madagan and Jillian W. Riley

The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”

Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.”  Additional details are available after the jump.

THE CURRENT SYSTEM

The FDA’s announcement highlights a number of challenges associated with the current OTC drug review process (sometimes referred to as the OTC Monograph Process, OTC Monograph, or OTC Drug Review), a process that has not changed in more than 40 years. FDA sees the biggest challenges as the following:

  • The large number of products currently on the market for which there are not yet final monographs. Much of the OTC marketplace is still not covered by final monographs, and data may be insufficient for FDA to determine safety and/or efficacy. An unintended consequence of the enforcement discretion given to products marketed in accordance with tentative final monographs (TFMs) is that it creates negative incentives for sponsors to conduct studies or otherwise respond to safety concerns, as to do so may slow the final monograph process.
  • The current system’s limitations on FDA’s ability to change the monograph to address new safety or efficacy issues. The current process is not sufficiently agile to adapt quickly to new safety concerns that arise either during the rulemaking process or after issuance of a final monograph.
  • The inability of the current OTC Drug Review to easily accommodate innovative changes to OTC products. According to the notice, the FDA generally thought at the time it established the OTC drug review process “that safety and effectiveness evaluations for the various active ingredients would be fairly straightforward and would not need continuous reexamination over time.” Yet, FDA has learned that this is not the case. Scientific advances have given rise to new information about how drugs interact with the body, changing how FDA evaluates drugs. This is particularly relevant in the context of pediatric OTC products, as the preferred approach to pediatric dosing has changed since the OTC drug review was instituted. The current OTC drug review process relies on extrapolated data from an adult population to determine pediatric dosing, however, as opposed to the currently accepted practice of relying on data from actual use in the pediatric population.

THE PROPOSED OVERHAULS

After discussing what it views as the current shortcomings with the system, the FDA asks for input as to how it can improve and modernize the OTC process. FDA is looking for changes to the existing framework or ideas for a complete replacement. The Agency presents some ideas as a starting point for discussion, as noted below. The FDA wants to hear all ideas – from detailed proposals to initial thoughts as to why the current process is not fully successful, noting that public comments “need not be comprehensive to be useful.”

The following are some of FDA’s preliminary proposals to modernize the OTC drug review program for which it seeks public input:

  • Identify a streamlined process that would allow a prompt resolution of existing tentative final monographs. FDA is considering ways to more efficiently bring TFMs to closure.
     
  • Issue monographs by administrative order. FDA is examining streamlining the monograph process to mimic the device reclassification process put in place by the Food and Drug Administration Safety and Innovation Act. Under this proposed process, monographs could be established by administrative order, after issuance of a proposed order for public comment.
     
  • Issue regulations to require product-specific information and expand the use of guidance. FDA is raising the possibility of new regulations that could require sponsors to submit limited information about individual products prior to marketing. This could be similar to, but less detailed than, a new drug application (NDA).
     
  • Expand the NDA deviation process. The OTC drug review process provides for an NDA deviation process. A sponsor applies for this deviation by showing that the product complies with all the conditions of a monograph except for the deviation, and provides FDA adequate data to demonstrate the safety and effectiveness of the product with the deviation. FDA questions why industry has not utilized this option and seeks input as to whether this process could be improved to increase utilization.

HEARING DETAILS

FDA will hold the public hearing March 25 and 26, 2014, at FDA’s White Oak Campus in Silver Spring, Maryland. The registration deadline is March 12, 2014, and FDA will be accepting comments until May 12, 2014.

__________________________________________________
1 http://online.wsj.com/news/articles/SB10001424052702304275304579395813156008466?mg=reno64-wsj&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB10001424052702304275304579395813156008466.html (this article requires a subscription).

CMS Call on Partnership to Improve Dementia Care in Nursing Homes (Feb. 26)

On February 26, 2014, CMS is hosting a call to discuss the National Partnership to Improve Dementia Care in Nursing Homes, which includes as a goal reducing the use of unnecessary antipsychotic medications in nursing homes. This call will focus on the role of surveyors in the implementation of the partnership, the importance of leadership, and the correlation between proper pain assessment and antipsychotic medication use.

Drug Distribution Security Legislation Signed into Law

This post was written by Kevin Madagan.

On November 27, 2013, President Obama signed into law H.R. 3204, the “Drug Quality and Security Act” (the “Act”), bipartisan drug distribution security legislation. Among other things, the sweeping measure: clarifies current federal law and regulatory oversight regarding pharmacy compounding; establishes a uniform, national drug tracking and tracing framework; mandates national licensure standards for wholesale distributors and third-party logistics providers; and preempts state product tracing requirements. The following is an overview of the Act and highlights of initial FDA implementation guidance.

Clarification of federal law and regulatory oversight regarding pharmacy compounding

The Act clarifies current federal law and regulatory oversight by distinguishing between traditional compounders and outsourcing facilities. It also requires enhanced communication between FDA and state regulators about compounding entities.

An outsourcing facility is a facility that compounds sterile drugs by or under the direct supervision of a licensed pharmacist, is registered with FDA as an outsourcing facility, and complies with all standards governing such facilities. Outsourcing facilities will need to comply with certain adverse event reporting requirements and report biannually (June/December) to FDA the drugs compounded during the previous 6-month period. FDA will subject outsourcing facilities to risk-based inspections. The benefit to registering as an outsourcing facility is that drugs compounded in such facilities will be exempt from new drug requirements, labeling requirements, and track and trace requirements. However, new labeling standards will apply to drugs compounded in outsourcing facilities. For instance, the label for a drug compounded in an outsourcing facility will need to contain the statements: “This is a compounded drug” (or a reasonable comparable alternative statement that prominently identifies the drug as a compounded drug) and “Not for resale.” The statement “Office Use Only” will be required on the labels of drugs that are dispensed or distributed other than pursuant to a prescription for an individual identified patient.

The Act requires enhanced communication between FDA and state regulators about compounding facilities. Specifically, state boards of pharmacy must submit information to FDA describing any “actions taken against compounding pharmacies” for issues pertaining to compounding, including, for example, “the issuance of a warning letter, or the issuance of sanctions or penalties, by a state for violating the state’s pharmacy regulations pertaining to compounding.” State boards of pharmacy must also submit any information “expressing concerns” that a compounding pharmacy “may be” acting contrary to federal pharmacy compounding laws. The federal government must consult with the National Association of Boards of Pharmacy before implementing these mandatory reporting standards, and then must “immediately” notify “state boards of pharmacy” when it receives one of these mandatory reports or when it determines that a pharmacy is acting contrary to federal pharmacy compounding laws.

FDA recently issued numerous statements and draft guidance documents about how it interprets and intends to implement these and other requirements of the Act.

Uniform, national drug tracking and tracing framework

The Act establishes a uniform, national drug tracking and tracing framework to track prescription drugs from the manufacturer to the pharmacy. It does this by requiring manufacturers to serialize prescription drugs at the unit level. The Act then establishes unit-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers).

National licensure standards for wholesale distributors

Beginning January 1, 2015, the Act requires any person who owns or operates an establishment that engages in wholesale distribution to report the following information to the Secretary on an annual basis: (1) each state by which the person is licensed and the appropriate identification number of each such license; (2) the name, address, and contact information of each facility at which, and all trade names under which, the person conducts business. Wholesale distributors must also report to the Secretary “within a reasonable period of time and in a reasonable manner” (as determined by the Secretary) any “significant disciplinary actions, such as the revocation or suspension of a wholesale distributor license,” taken by a state or the federal government.

For the purpose of ensuring uniformity with respect to wholesale distribution standards, the Act requires the Secretary to establish additional wholesale distribution standards governing: (1) the storage and handling of prescription drugs, including facility requirements; (2) the establishment and maintenance of records of the distribution of such drugs; (3) the furnishing of a bond or other equivalent means of security; (4) mandatory background checks and fingerprinting of facility managers or designated representatives; (5) the establishment and implementation of qualifications for key personnel; (6) the mandatory physical inspection of any facility to be used in wholesale distribution; and (7) the prohibition of certain persons from receiving or maintaining licensure for wholesale distribution (e.g., persons convicted of a felony for conduct relating to wholesale distribution). In addition, if a state chooses not to establish a licensing program for a wholesale distributor, the federal government must license the distributor and collect reasonable fees to cover the costs of administering a federal licensing program for entities in such states.

National licensure standards for third-party logistics providers

Beginning one year after the date of enactment of the Act, a facility of a third-party logistics provider must report to the federal government on an annual basis: (1) the state by which the facility is licensed and the appropriate identification number of such license; and (2) the name and address of the facility and all trade names under which such facility conducts business. If a state chooses not to establish a licensing program for a third-party logistics provider, the federal government must license the provider and collect reasonable fees to cover the costs of administering a federal licensing program for entities in such states. The Act also allows for a third-party accreditation program to be developed to license providers and requires the federal government to issue regulations regarding the standards for licensing third-party logistics providers. Third-party logistics providers will be subject to periodic inspection by their licensing authority and must provide the applicable licensing authority, upon a request by such authority, a list of all product manufacturers, wholesale distributors, and dispensers for whom the third-party logistics provider provides services.

Preemption of state product tracing requirements

The product tracing requirements set forth in the Act preempt state product tracing requirements, including paper or electronic pedigree systems. Preemption resolves a long-standing problem facing the drug distributor industry: the increasingly complex, and often conflicting, state pedigree requirements, many of which are not fully established or have staggered implementation deadlines.

Congressional Panels Continue Focus on ACA Insurance Enrollment, Security, and Cost Issues, and Other Health Policy Topics

Congress continues to examine issues associated with enrollment in qualified health plans under Healthcare.gov.  For instance:

In other policy areas, the Senate Special Committee on Aging has scheduled a December 11 hearing on “Protecting Seniors From Medication Labeling Mistakes,” along with a December 18 hearing entitled “The Future of Long-Term Care Policy: Continuing the Conversation.”  In addition, on November 20, the House Energy and Commerce Subcommittee on Health held a hearing on public health legislation. Specifically, the Subcommittee is considering the following bills: H.R.610, to provide for the establishment of the Tick-Borne Diseases Advisory Committee; H.R.669, to enhance awareness about unexpected sudden death in early life; H.R. 1098, to reauthorize certain traumatic brain injury and trauma research programs; H.R.2703, to provide liability protections for volunteer practitioners at community health centers; H.R.1281, to reauthorize newborn screening programs; draft legislation to reauthorize the poison center national toll-free number, national media campaign, and grant program; and draft legislation to reauthorize a controlled substance monitoring program. 

HHS Seeks Comments on Draft National Action Plan for Adverse Drug Event Prevention

The HHS Office of Disease Prevention and Health Promotion is soliciting public comment on the draft National Action Plan for Adverse Drug Event Prevention. The document focuses on the use of surveillance, prevention, incentives and oversight, and research to reduce adverse drug events. It identifies current federal activity across inpatient and outpatient settings, as well as transitions of care, with a focus on the three drug classes associated with high levels of harm. It also highlights opportunities to advance these efforts through cross-federal partnerships and coordinated resources. Comments will be accepted until October 4, 2013. 

FDA Proposes New Rule to Exercise its Administrative Detention Authority for Drugs

This post was written by Jennifer Pike.

On July 15, 2013, the Food and Drug Administration (FDA) published in the Federal Register a proposed rule that would amend 21 CFR Part 1 to implement FDA’s detention authority with respect to drugs intended for human or animal use. FDA’s detention authority is authorized by amendments made to the Food, Drug, and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act. Once finalized, FDA would be able to detain drugs encountered during an inspection that are reasonably believed to be adulterated or misbranded. According to FDA, the authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate. Comments on the proposed rule should be submitted in writing, or electronically at www.regulations.gov, on or before September 13, 2013.

New Draft Guidances from FDA Address Expedited Review, Safety Labeling and More

This post was written by Jennifer Pike

The FDA has recently issued a number of new draft guidance documents that provide insight on a range of issues, including expedited drug review programs, medical device reporting, importation of unapproved drugs for market launch, and safety labeling changes. A brief summary and link to each draft guidance document is provided below:

  • Expedited Programs for Serious Conditions: Drugs and Biologics – This draft guidance provides a single resource for information on policies and procedures related to FDA’s expedited drug development and review programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review. The draft guidance is intended to help industry better understand each program, including when the programs can be used and the features of each.
  • Medical Device Reporting for Manufacturers – This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. The document provides answers to frequently asked questions and includes a section on common reporting errors.
  • Pre-launch Activities Importation Request – This draft guidance describes FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for market launch, based on anticipated approval of a pending application (e.g., NDA, ANDA, BLA). It also describes the procedures for making such requests and the factors that FDA will consider in granting such requests.
  • Safety Labeling Changes: Implementation of Section 505(o)(4) of the FD&C Act– Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, which was added by section 901 of the Food and Drug Administration Amendments Act of 2007, authorizes FDA to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product. This draft guidance explains how FDA intends to implement section 505(o)(4), including a description of the types of safety labeling changes that ordinarily might be required under this section, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes.

OIG Focuses on Inappropriate Prescribing of Medicare Part D Drugs

The HHS Office of Inspector General (OIG) has issued two recent reports focusing on inappropriate prescribers practices involving drugs paid under the Medicare Part D program. In one report, the OIG concluded that the Medicare Part D program inappropriately paid for drugs (including controlled substances) ordered by individuals who did not have the authority to prescribe, such as massage therapists, athletic trainers, home contractors, interpreters, transportation companies, counselors, social workers, and chiropractors in 2009. In a related report, " Prescribers with Questionable Patterns in Medicare Part D," the OIG identified more than 736 general-care physicians who demonstrated what the OIG considers to be questionable prescribing patterns, such as prescribing extremely high numbers of prescriptions per beneficiary, using numerous pharmacies, prescribing a high percentage of Schedule II and Schedule III drugs, and prescribing a high percentage of brand-name prescriptions. Medicare paid $352 million for the Part D drugs ordered by these "extreme outlier" physicians. The OIG notes that while "some of this prescribing may be appropriate, such questionable patterns warrant further scrutiny." To address issues identified in the reports, the OIG recommends that CMS increase oversight of the Part D program by: requiring Part D plan sponsors to verify that prescribers have the authority to prescribe drugs; providing sponsors with additional guidance on monitoring prescribing patterns; increasing the Medicare Drug Integrity Contractor’s monitoring of prescribers; providing education and training for prescribers; ensuring that Medicare does not pay for prescriptions from individuals without prescribing authority; and following up on the prescribers identified in the reports. CMS concurred with the recommendations. The first report, "Medicare Inappropriately Paid for Drugs Ordered by Individuals without Prescribing Authority," is available here. To highlight its concerns in this area, the OIG has created a new "Spotlight" web page focusing on OIG enforcement efforts and investigations related to prescription drug diversion.

Health Policy Hearings

A number of recent Congressional hearings have focused on health policy issues, including the following:

CMS Call on Improving Dementia Care in Nursing Homes (July 10)

On July 10, 2013, CMS is hosting a provider call on its National Partnership to Improve Dementia Care in Nursing Homes. This initiative focuses on delivering person-centered, comprehensive, and interdisciplinary dementia care, while reducing the use of unnecessary antipsychotic medications in nursing homes (and eventually other care settings).

Health Policy Hearings

Recent Congressional hearings focusing on health policy include the following:

  • The House Energy and Commerce Committee held hearings on health insurance premiums under the ACA and drug compounding. The House Energy and Commerce Health Subcommittee also held a hearing on "Reforming SGR (Sustainable Growth Rate): Prioritizing Quality in a Modernized Physician Payment System," which reviewed draft SGR reform legislative language. A June 12 hearing will focus on the state perspective on the need for Medicaid reform, and a June 14 hearing will examine the federal government's response to the prescription drug abuse crisis.
  • A House Ways and Means Committee Health Subcommittee hearing addressed the “President's and Other Bipartisan Proposals to Reform Medicare," and the panel has scheduled a June 14 hearing to concentrate on proposals to reform Medicare post-acute care payments. 
  • The Homeland Security Committee held a second hearing on “Oversight and Business Practices of Durable Medical Equipment Companies.”
  • The Senate Special Committee on Aging held a hearing entitled “10 Years Later: A Look at the Medicare Prescription Drug Program." 

House Approves Drug Distribution Security Plan

This post was written by Kevin Madagan and Jennifer Pike.

The U.S. House of Representatives has approved by voice vote H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013. H.R. 1919 is a bipartisan bill intended to improve drug distribution security and protect against counterfeit pharmaceuticals. According to the bill’s sponsor, Rep. Bob Latta (R-Ohio), the bill would replace an unworkable patchwork of state laws by establishing a uniform national standard of tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers based on changes in ownership. The bill would also establish a collaborative process between the Food and Drug Administration and stakeholders to research ways to secure pharmaceutical distribution.

This voice vote follows on the heels of the recent unanimous vote by the Senate Health Education Labor and Pensions (HELP) Committee to combine the HELP Committee’s current draft of “S. 957, Drug Supply Chain Security Act” with their draft of “S. 959, Pharmaceutical Compounding Quality and Accountability Act” and move the legislation to the Senate floor for consideration.

OIG Report Examines High-Risk Compounded Sterile Preparations

This post was written by Nancy Sheliga.

The OIG has released a study entitled “High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them,” triggered by concerns caused by the recent outbreak of meningitis among patients receiving contaminated injections from a compounding center. The report found that 92% of hospitals used compounded sterile preparations (CSPs) in 2012, prepared either onsite at the hospitals themselves or outsourced to compounding pharmacies. Among these, higher-risk nonsterile-to-sterile compounding composed less than 1% of CSPs used in hospitals, but 85% of hospitals outsourced at least some nonsterile-to-sterile compounding. Among the reasons hospitals cited for outsourcing CSPs were the need to ensure an adequate supply of CSPs in the event of shortages, the need to obtain more stable CSPs and products with extended shelf lives, the ability to have products on hand when needed with less waste, and insufficient resources to prepare all CSPs on site at some hospitals.

Overall, hospitals reported few problems with the quality of CSPs obtained from outside pharmacies and they took few steps to ensure the quality of outsourced CSPs. However, over half of hospitals indicated that they have made changes or plan to make changes to CSP sourcing practices due to the recent meningitis outbreak, including decreasing CSP outsourcing, requesting more information on product quality from outside pharmacies, contracting with different outside pharmacies, changing the way CSPs are prepared in hospital facilities, increasing quality controls in hospital pharmacies, and expanding the capacity to prepare CSPs in-house.
The OIG notes that hospitals largely remain confident about the quality of outsourced CSPs, but “the meningitis outbreak raises questions about whether this confidence is well placed.” The OIG observes that vigilance is needed in this area and indicates that it plans to pursue additional work relating to the safety and quality of pharmaceutical compounding in hospitals, including work examining federal oversight mechanisms.

Lawmakers Float Draft Drug Distribution Security Plan; Comment Opportunity

This post was written by Kevin Madagan and Debra McCurdy.

Key members of the Senate Health, Education, Labor, and Pensions Committee have released a bipartisan draft legislative proposal intended to improve drug distribution security. The legislation addresses, among other things: lot-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers); a requirement that manufacturers serialize prescription drugs at the unit level; national licensure standards for wholesale distributors and third-party logistics providers; a requirement that members of the supply chain only transact with registered or licensed entities; and preemption of state product tracing requirements, including paper or electronic pedigree systems. The lawmakers will accept comments on the draft legislation until April 26, 2013. In a related development, the House Energy and Commerce Subcommittee on Health has scheduled an April 25 hearing on "Securing Our Nation's Prescription Drug Supply Chain,” which will focus on a House companion version of the draft “track and trace” legislation intended to secure pharmaceutical distribution. 

Update:  On May 8, 2013, the House Energy and Commerce Health Subcommittee approved by voice vote an amended version of its “track and trace” legislation intended to secure pharmaceutical distribution.

Older Entries

January 11, 2013 — FDA Draft Guidance Addresses Clinical Trial Enrichment

January 11, 2013 — FDA Issues Two Final Guidances on Safety Reporting Requirements

November 28, 2012 — Upcoming FDA Public Meeting: Framework for Pharmacy Compounding/State and Federal Roles (Dec. 19)

November 12, 2012 — November Congressional Health Policy Hearings

October 15, 2012 — Short-Term Government Funding, FDA User Fee & Safe Doses Bills Signed into Law

September 27, 2012 — Senate Approves Legislation to Combat Medical Product Theft

July 31, 2012 — Congressional Health Policy Hearings

June 28, 2012 — Congress Clears FDA Safety & Innovation Act

June 27, 2012 — Health IT Pilot Targets Prescription Drug Abuse

June 27, 2012 — CMS Outlines Conditions for Provider Use of Repackaged Medications

June 27, 2012 — House Approves Medical Product Counterfeiting Act

June 18, 2012 — House Panel Clears Legislation to Address Medical Product Theft, Counterfeiting

May 31, 2012 — House, Senate Approve FDA User Fee/Drug Safety Bills

May 11, 2012 — House Panel Unanimously Approves FDA User Fee Act

May 11, 2012 — FDA Reports on Post-Approval Drug Safety Monitoring

March 29, 2012 — FDA Draft Guidance on Classifying Significant Postmarket Drug Safety Issues

March 29, 2012 — FDA Issues Guidance Update on Communication to the Public about Drug Safety

March 14, 2012 — Senate Approves Bill to Increase Counterfeit Drug Penalties

March 14, 2012 — Congressional Hearings on Drug Issues.

February 24, 2012 — Congressional Health Policy Hearings & Markups

January 25, 2012 — GAO Examines Prescription Pain Reliever Abuse

December 29, 2011 — FDA Guidance Regarding Responding to Unsolicited Requests for Off-Label Information

December 13, 2011 — Counterfeit Drug Penalties

November 10, 2011 — FDA Announces Review of Bar Code Final Rule

November 10, 2011 — President Issues Executive Order Regarding Drug Shortages

October 14, 2011 — FDA Issues Final Guidance on Risk Labeling for Prescription Drugs and Biological Products

September 29, 2011 — GAO Assesses DEA Prescription Drug Control Efforts

September 29, 2011 — Congressional Hearings Examine Variety of Health Industry Issues

September 26, 2011 — FDA Guidance on Reproductive and Developmental Toxicities

September 22, 2011 — Upcoming House Hearings on Drug Shortages, Device/Drug Regulations

September 8, 2011 — Upcoming Congressional Hearings on Health Care Industry Consolidation, Pharmaceutical Supply Chain Security

June 28, 2011 — FDA Proposed Rule to Amend Sterility Test Requirements for Biologicals

June 14, 2011 — GAO Report on FDA Tracking of Pediatric Research

May 13, 2011 — FDA Reestablishes Medical Imaging Drugs Advisory Committee

April 12, 2011 — Congressional Hearings This Week on FDA Medical Device Approvals, Drug Imports/Diversion

March 7, 2011 — FDA Draft Guidance Documents: Electronic Data Sets for Pharmacoepidemiologic Studies, Pharmacogenomics/Premarketing Evaluation, REMS Medication Guides

January 13, 2011 — FDA Meeting on Tracing and Tracking Prescription Drugs (Feb. 15-16)

October 28, 2010 — GAO Issues Two Reports Examining FDA Foreign Inspection Issues

October 15, 2010 — FDA Enters Agreement to Support WHO with Counterfeit Drug Efforts

September 30, 2010 — FDA Issues Final Rule, Draft Guidance on Clinical Trial Safety Reporting Requirements

September 28, 2010 — House E&C Committee Plans Hearing on Drug Safety Bill (Sept. 30)

July 29, 2010 — House Committee Approves Health Legislation

July 29, 2010 — Congressional Health Policy Hearings

July 7, 2010 — FDA Seeks Comments on Draft Guidance on Changes to CMC Reportable Information

June 18, 2010 — Congressional Hearings on Health Care Fraud, Health Policy Issues

June 18, 2010 — FDA Meeting on Risk Evaluation and Mitigation Strategies (July 27-28)

June 18, 2010 — FDA to Post New On-line Information Regarding Safety Monitoring Issues for Recently-Approved Drugs and Biologics

June 8, 2010 — Upcoming Hearing on Antibiotic Development and Use

May 28, 2010 — Congressional Hearings

May 27, 2010 — DOJ Health Fraud Activities, Focus on Pharmaceutical Companies

May 25, 2010 — FDA and NIH Launch Safety Reporting Website

May 13, 2010 — FDA Experimental Study of Patient Information Prototypes

April 29, 2010 — April 2010 Congressional Hearings

March 31, 2010 — FDA Issues Proposed Rule on Clear and Conspicuous Standard for DTC Advertisements

March 31, 2010 — FDA Issues Guidance Document on Drug Pedigree Issues

March 31, 2010 — FDA Guidance on Content and Format of the Dosage and Administration Section of Labeling

March 15, 2010 — Congressional Hearings

March 8, 2010 — House Energy & Commerce Drug Safety Hearing Set for March 10

February 26, 2010 — FDA Listing of Drugs with Potential Safety Issues

February 12, 2010 — Draft Guidance on Assessment of Abuse Potential of Drugs

February 12, 2010 — Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

February 12, 2010 — Guidance on Complete Submissions for the Evaluation of Proprietary Names

December 21, 2009 — GAO Report on Drug Safety Oversight

December 4, 2009 — FDA Announces Safe Use Initiative for Drug Products

December 4, 2009 — FDA Issues Warning Letters to Web Site Operators

December 4, 2009 — FDA Guidance Documents

November 11, 2009 — Renal Dialysis Facility ESA Policies

October 30, 2009 — Drugs Approved on the Basis of Surrogate Endpoints

October 30, 2009 — Off-Label Cancer Therapies

October 15, 2009 — FDA Postmarketing Safety Reporting for Combination Products

October 15, 2009 — FDA Strategic Plan for Risk Communication

October 15, 2009 — FDA Guidance Documents

September 28, 2009 — Congressional Hearings

September 4, 2009 — FDA Proposed Rules on Electronic Reporting of Adverse Drug and Device Events

July 28, 2009 — FDA Workshop on Prescription Drug Risk Information

July 7, 2009 — AHRQ Off-Label Drug Use Report

June 8, 2009 — Toll-Free Numbers for Adverse Events Reporting

June 8, 2009 — FDA Sentinel System/Privacy & Security Issues

May 7, 2009 — Label Comprehension Studies for Nonprescription Drugs

April 23, 2009 — Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDA)

April 23, 2009 — Summaries of Effectiveness and Safety

April 6, 2009 — FDA Meeting, Comment-Period on Economically Motivated Adulteration

February 11, 2009 — FDA Listing of Drugs with Potential Safety Issues

January 27, 2009 — High-Risk Programs (Medicare, Medicaid, FDA)

January 27, 2009 — Good Reprint Practices

January 27, 2009 — Secure Supply Chain Pilot Program

January 27, 2009 — Good Importer Practices Draft Guidance

January 27, 2009 — Standardized Numerical Identification for Prescription Drug Packages

January 27, 2009 — Submission of Laboratory Packages by Accredited Laboratories

January 27, 2009 — AHRQ Web Site for Medical Therapeutics Information

January 12, 2009 — Draft Vaccine Safety Scientific Agenda

December 22, 2008 — Genotoxic and Carcinogenic Impurities in Drugs

December 5, 2008 — FDA/WebMD Partnership

October 30, 2008 — Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products

October 28, 2008 — New FDA Offices Opening Overseas to Improve Import Safety

October 22, 2008 — GAO Report on Drug Safety/Foreign Drug Inspections

September 10, 2008 — FDA Listing of Drugs with Potential Safety Issues

August 22, 2008 — Labeling Changes for Approved Drugs, Biologics, and Medical Devices

July 29, 2008 — GAO Drug Reports

June 3, 2008 — FDA Sentinel Initiative