What follows is the debut of a new weekly feature here at Health Reform Watch. Each Monday morning, we will provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think. Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.
1. Reuters reports that German drugmaker Fresenius Kabi halted shipments of the anesthesia drug propofol to United States distributor Morris & Dickson for over four months in 2012 and 2013, after Morris & Dickson accidentally sent twenty vials of the drug to the State of Missouri for use in executions.
2. In related news, the Associate Press reports that, on Friday, October 11, 2013, the Governor of Missouri directed the State’s Department of Corrections to reschedule what would have been the first execution in the United States to use propofol and “to modify the State of Missouri’s execution protocol to include a different form of lethal injection.”
3. The Milwaukee Journal Sentinel, MedPage Today, and the Washington Post broke the story that, beginning in 2002, drug companies paid annual fees of between $20,000 and $35,000 to an organization called IMMPACT in return for which they were permitted to attend a total of 16 meetings at which academics, government researchers, and Food and Drug Administration officials developed consensus recommendations for the design of clinical trials of pain medications.
4. Ed Silverman of Pharmalot interviews Marc Rodwin about the symposium issue of Journal of Law, Medicine & Ethics he organized to analyze the effects of institutional corruption on pharmaceutical law and policy.
5. Finally, Scott Burris supplies historical context for California’s decision to allow lay bystanders to administer the opioid antagonist drug nalaxone to individuals who have overdosed.
On January 10, 2013, New York City Mayor Michael Bloomberg announced that the City’s eleven public hospitals will comply with voluntary emergency room guidelines aimed at stemming the abuse of prescription opioid painkillers.
The New York City Emergency Department Discharge Opioid Prescribing Guidelines (“Guidelines”) highlight that the federal Emergency Medical Treatment and Active Labor Act (“EMTALA”) “does not require the use of opioid analgesics to treat pain.” Given their risks, “[o]pioid analgesics should not be considered as the primary approach to pain management in discharge planning for patients.”
According to the Guidelines, only when deemed professionally appropriate to prescribe these drugs, emergency department (“ED”) prescribers should prescribe no more than a short course of short-acting opioid analgesics, such as hydrocodone (e.g., Vicodin), immediate-release oxycodone (e.g., Percocet), and hydromorphone (e.g., Dilaudid), for acute pain. The Guidelines define “short course” as no more than three days’ worth of medication for most patients.
ED providers should altogether avoid prescribing long-acting or extended release opioid analgesics, like OxyContin, Methadone, and Duragesic patches, however, because they “are not indicated in the management of acute or intermittent pain.”
The Guidelines further recommend that EDs as a matter of policy refuse to replace prescriptions for opioid analgesics that are claimed to be lost, stolen, or destroyed. In rare instances, it may be reasonable to dispense a single dose of the medication from the ED, but only where the ED physician “confirmed the need directly with the patient’s physician.”
An article in the New York Times reports some critics’ concerns that the Guidelines will prevent doctors from providing care to poor and uninsured patients who may use EDs as their primary source of medical care. In addition, Dr. Alex Rosenau, president-elect of the American College of Emergency Physicians, is quoted as criticizing the Guidelines for preventing him from being a professional and using his judgment.
In fairness to the Bloomberg Administration, the Guidelines expressly note that they are not intended to apply to “patients in palliative care programs or with cancer pain.” They further recognize that they “do not replace clinical judgment in the appropriate care of patients nor are they intended to provide guidance on the management of patients while they are in the ED.”
This suggests doctors retain the ability to exercise their professional judgment to deviate from the Guidelines in appropriate cases. Indeed, Dr. Rosenau apparently does not speak for the New York State Chapter of the American College of Emergency Physicians, which endorses the Guidelines, according to Bloomberg’s press release.
But implicit in the Guidelines is the assumption that appropriate prescribers are available to provide palliative care or substance abuse treatment to patients with needs that demand more than the Guidelines permit.
The number of uninsured Americans remains significant, even with the Affordable Care Act’s reforms. Many individuals with health insurance, moreover, have difficulty finding specialists who participate in their plans or may have to wait weeks or months for an available appointment. How are ED prescribers supposed to know which patients will be able to secure a timely follow-up appointment and which ones require ED discretion?
Another potential concern with the Guidelines is how they may impact ED use by patients seeking opioid prescriptions.
It is possible that the Guidelines will drive up demand for painkillers from ED services at private emergency rooms in New York City and public or private emergency rooms in areas bordering New York City that are not bound by the Guidelines. As the New York Times article reports, although the City cannot impose the Guidelines on its 50 or so private hospitals, some already have agreed to adopt them, including NYU Langhone Medical Center and Maimonides Medical Center. If they don’t, it’s reasonable to predict demand for pain medications may spike at these facilities, which effect would not address the underlying problem but instead would just shift its locus.
ED use could even increase at hospitals electing to comply with the Guidelines. A patient who previously obtained a ten-day dosage of pain medication from a single ED visit, for example, might more than triple her ED use because now she may only obtain a three-day dosage in each visit. This risks exacerbating the ED high utilizer problem that so many current reforms aim to reduce.
There also seem to be holes in New York’s prescription monitoring program that limit its value as a tool to help ED physicians decide how to exercise their discretion.
For one, although the Guidelines recognize that prescribers can “access the New York State Controlled Substance Information (CSI) on Dispensed Prescriptions Program for information on patients’ controlled substance prescription history,” the Guidelines do not require ED prescribers to do so.
Even if ED physicians access the database, current law only requires pharmacists to update the registry every two weeks. While this may identify historical patterns of abuse, the reporting delay severely hampers the ability of physicians to timely identify concurrent or more recent doctor shopping.
Effective August 27, 2013, New York’s database arguably should become more valuable as a tool for identifying drug seeking behavior. Pursuant to Public Health Law Section 3343-a, prescribers in New York will have to check the database before prescribing controlled substances, and pharmacists will have to update the database in real time.
But importantly, subparagraph (2)(a)(v) of this law exempts ED prescribers from the requirement to check the database prior to prescribing controlled substances as long as the prescription does not exceed a five day supply, which the Guidelines generally prohibit. New York’s registry also will not contain information about prescribing in other states, such as bordering New Jersey and Connecticut.
Although not a substantive criticism of the Guidelines, it also is interesting to note the potential tension between this initiative and news that New York City’s public hospitals are negotiating to experiment with performance pay. As a recent article in Forbes chronicled, there is evidence that doctors overprescribe medications, including powerful narcotics, to help secure higher patient satisfaction scores and, in turn, greater compensation. If this performance plan goes through, it will be worth watching how ED doctors in New York City public hospitals balance the need to comply with the Guidelines with their desire to maximize their compensation.
Mayor Bloomberg rather cavalierly dismissed critics’ concerns about the Guidelines in his weekly radio show, reportedly responding, “[S]o you didn’t get enough painkillers and you did have to suffer a little bit. The other side of the coin is people are dying and there’s nothing perfect …. There’s nothing that you can possibly do where somebody isn’t going to suffer, and it’s always the same group [claiming], ‘Everybody is heartless.’ Come on, this is a very big problem.”
Certainly, prescription drug abuse is a very big problem. But that does not mean the Guidelines are the best we can do. We must continue to evaluate and revise our reform efforts.
Bloomberg’s announcement also touted the creation of NYC RxStat, which is a joint effort of the Mayor’s Task Force on Prescription Painkiller Abuse and the New York/New Jersey High Intensity Drug Trafficking Areas (HIDTA) Program to “leverage relevant public health and public safety data in support of monitoring and combating the problem of prescription painkiller abuse.”
Undoubtedly it is critical to bring together city, state, and federal agencies to address this cross-border problem by sharing data, assessing trends, and evaluating strategies to reduce prescription drug abuse. I hope part of its charge will be evaluating the Guidelines — and similar efforts in places like Seattle, Ohio, and Milwaukee — to address potential flaws and to make more effective use of prescription monitoring programs without denying appropriate care to patients in need.
 Although the Mayor’s press release states that the guidelines are included in the January 2013 Interim Report of the Mayor’s Task Force on Prescription Painkiller Abuse, this report references distinct, though related, evidence-based clinical guidelines for prescribing prescription painkillers that the New York City Department of Health and Mental Hygiene distributed to New York City providers in December 2011.
Center for Health & Pharmaceutical Law & Policy Introduces First Edition of Pharmaceutical and Medical Device Compliance Manual
The Seton Hall Law Center for Health & Pharmaceutical Law & Policy, American Health Lawyers Association (AHLA) and the Food and Drug Law Institute (FDLI) have released the first edition of the Pharmaceutical and Medical Device Compliance Manual. The Manual is a guide to deciphering the intricate web of federal and state laws and the practices of regulatory and enforcement authorities within the healthcare and life sciences arena, while also providing the practical skills needed to implement an effective compliance program.
Designed to aid health law attorneys, compliance professionals and others in the pharmaceutical and medical device field, the Manual explains the law in layman’s terms in addition to providing advice and guidelines on creating, managing, monitoring and auditing an effective compliance program, in essence, marrying legal expectations with the operational demands of business units.
The book was co-edited by Seton Hall Law Associate Dean Kathleen M. Boozang, J.D., LL.M., who founded the school’s Health Law program in 1990, ranked among the top 10 by U.S. News & World Report for the past 16 years; and by Simone Handler-Hutchinson, J.D. ’93, Executive Director of the Center for Health & Pharmaceutical Law & Policy.
Dean Boozang notes: “Over the last two decades the trend in government oversight has resulted in a regulatory environment of increased accountability among organizations across a number of sectors, with the health and life sciences industries being the subject of particular attention – a trend that shows no sign of waning. We produced this manual for compliance officers, health and life sciences lawyers and their clients to enable them to build a framework for creating and sustaining an effective compliance function.”
As co-editor, Ms. Handler-Hutchinson said, “Each chapter was written by a leading regulatory official, practicing attorney, or healthcare consultant who has either shaped the policies as an official and/or counsel in the nation’s regulatory agencies, served as counsel to or built compliance functions within life science corporations. They offer first hand, in-depth compliance insight and actionable advice.”
The Pharmaceutical and Medical Device Compliance Manual is available as a softbound book and a variety of eBook formats; it may be ordered by visiting http://law.shu.edu/compliancemanual.
The Seton Hall Law Center for Health & Pharmaceutical Law & Policy advances scholarship and recommendations for policy on the varied and complex issues that emerge within pharmaceutical and health law. Additionally, the Center is a leader in providing compliance training on the wide-ranging state, national and international mandates that apply to the safety, promotion and sale of drugs and devices. Seton Hall University School of Law, New Jersey’s only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching with a strong focus on experiential learning. Founded in 1951, Seton Hall Law School is located in Newark and offers both day and evening degree programs. For more information visit law.shu.edu.
The American Health Lawyers Association (AHLA) is the nation’s largest nonpartisan educational organization devoted to legal issues in the healthcare field. The Association’s 11,000 members practice in a variety of settings in the healthcare community. For information about our resources, publications, and educational offerings, visit www.healthlawyers.org.
- Professional liability for failing to report child abuse in New Jersey: In L.A. v. Div. of Youth & Family Servcs., the Appellate Division of the Superior Court of New Jersey held that an emergency room physician must stand trial for medical malpractice because he failed to report to the State that a two year-old child brought to the ER had ingested cologne. The applicable standard of care is established by N.J.S.A. 9:6-8.10, which requires “[a]ny person having reasonable cause to believe that a child has been subjected to child abuse or acts of child abuse” to report this information to the Division of Child Protection and Permanency (previously DYFS). Although this statute does not expressly mention neglect, the court held that it “requires the reporting of injuries resulting from conduct that is reckless, or grossly or wantonly negligent, but not conduct that is merely negligent.” The court further held “that the triggering of the obligation to report, especially in the context of civil litigation involving professional malpractice, does not require the potential reporter to possess the quantum of proof necessary for an administrative or judicial finding of abuse or neglect. All that is required by N.J.S.A. 9:6-8.10 is ‘reasonable cause to believe.’” Because the paramount concern is the safety of children, “a physician has ‘reasonable cause to believe’ that there has been abuse if a ‘probable inference’ from the medical and factual information available to the physician is that the child’s condition is the result of child abuse, including ‘reckless’ or ‘wantonly negligent’ conduct or inaction by a parent of caregiver. The inference need not be the ‘most probable,’ but it must be more than speculation or suspicion.” The court found that it was a jury question whether the doctor here failed to satisfy this standard of care. Because there is a jury question as to the doctor’s liability, the court also reversed the dismissal of the plaintiff’s claim against the hospital based on the doctrine of respondeat superior. As Charles Toutant highlighted in a recent article in the New Jersey Law Journal, health care professionals need to pay attention to this case. The court reminded in a footnote that more than professional liability could be at issue because it is a disorderly persons offense under N.J.S.A. 9:6-8.14, 2C:43-8 to fail to make the required report.
- A supervising doctor in Vermont is not subject to professional discipline based solely on the unprofessional conduct of the physician assistant he supervised: The Vermont Supreme Court in In re Porter, 2012 Vt. 97, held that the state Board of Medical Practice may not find a doctor guilty of unprofessional conduct based only on the unprofessional acts of the physician assistant (PA) whom he supervised where the supervising physician met or exceeded all standards of care. The PA had admitted that his improper prescribing of opiates constituted professional negligence and unprofessional conduct. Under Vermont law, “[t]he supervising physician delegating activities to a physician assistant shall be legally liable for such activities of the physician assistant, and the physician assistant shall in this relationship be the physician’s agent” (emphasis added). 26 V.S.A. § 1739. The Court distinguished “between legal liability, typically at issue in a civil action or for a monetary penalty, and unprofessional conduct at issue in a professional licensing disciplinary proceeding.” Because the statute references only legal liability, the Court concluded that the statute “encompasses only the concept of civil liability, and does not render a supervising physician vicariously answerable or guilty for the unprofessional acts of his or her PA simply on the basis of their relationship.” That the statute made the PA the physician’s agent did not change the analysis because “agency theory applies in tort or contract cases, not professional responsibility actions.”
- Bill to permit advanced practice nurses to prescribe medication without supervision in New Jersey: New Jersey Senator Joseph Vitale introduced S.2354 on November 21 to permit advanced practice nurses (APNs) with more than twenty-four months or 2,400 hours of licensed, active advanced practice experience to prescribe medication without a joint protocol with a physician; reportedly Assemblywoman Nancy Munoz will introduce an Assembly version on December 3. Under current New Jersey law, although APNs may practice independently of physicians, they are only permitted to write prescriptions pursuant to a joint protocol developed with a collaborating physician. See N.J. Stat. § 45:11-49(b)-(c); N.J.A.C. 13:35-6.6; N.J.A.C. 13:37-8.1. According to a recent Health Affairs Health Policy Brief, eighteen states and the District of Columbia permit nurse practitioners, which are a type of APN, to prescribe without a doctor’s involvement. A 2010 report from the Institute of Medicine urged more states to move in this direction. Although the language of S.2354 is not yet available on the Legislature’s web site, Andrew Kitchenman reports in NJ Spotlight that it would make it easier for APNs to open their own practices. A study published in the November/December 2012 Annals of Family Medicine predicts that the United States will require nearly 52,000 additional primary care physicians by 2025 while noting that the number of internal medicine residents choosing primary care is decreasing. Given the existing shortage of primary care providers throughout the country and in New Jersey, which is expected to intensify with Medicaid expansion and increased coverage under the Affordable Care Act, S.2354 could help relieve the primary care supply pressures in New Jersey. Although this bill circumvents the turf battles between the State Boards of Medical Examiners and Nursing, it is sure to meet substantial pressure from physician groups in the State. The Health Affairs Health Policy Brief provides helpful context for this important debate.
- New York begins accepting applications for professional licenses from nonimmigrant aliens: Following the Second Circuit’s decision in Dandamudi v. Tisch, 686 F.3d 66 (Jul. 10, 2012), New York has begun accepting applications for thirteen professional licenses, including medical, podiatric, chiropractic, dental, pharmacy, and veterinary, from applicants who previously were categorically precluded from licensure because they are neither citizens nor legal permanent residents (LPRs). At issue in Dandamudi was New York’s requirement that pharmacists be citizens or legal permanent residents, which denied licensure to a “subclass of aliens known as nonimmigrants who are lawfully admitted to the United States pursuant to a policy granting those aliens the right to work in this country . . . .” Because the Circuit in Dandamudi found that these nonimmigrant aliens are a suspect class, “[a]ny discrimination by the state against this group is subject to strict scrutiny review.” The state had conceded that it lacked any compelling interest in treating this class differently, and thus the court found the New York law violated nonimmigrant aliens’ right to equal protection. Although limiting its ruling to equal protection grounds, the court also credited Supremacy Clause and preemption concerns with New York’s law because it stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress’ decision to admit these individuals to the country for the express purpose of working in these specialty professions. In reaching its decision, the Second Circuit expressly refused to follow decisions of the Fifth (see, e.g., Van Staden v. St. Martin, 664 F.3d 56 (5th Cir. 2011)) and Sixth (LULAC v. Bredesen, 500 F.3d 523 (6th Cir. 2007)) Circuits that required only rational basis review of statutes that treated nonimmigrant aliens differently than citizens or LPRs. Despite the circuit split created by Dandamudi, the United States Supreme Court on October 1, 2012 denied the petition for certiorari filed in Van Staden. Although the New York professions web site states that the time to seek a petition for certioriari in Dandamudi has not yet expired, a search of the Supreme Court’s online docket does not reveal that New York has filed a petition within 90 days of the decision or sought an extension of time in which to do so.
As this blog has chronicled (see here and here), New Jersey has begun implementing the 2008 legislation that authorized creation of a Prescription Drug Monitoring Program (“PMP” or “PDMP”). Although New Jersey’s PMP database has been collecting data for more than a year, the State has not yet issued implementing regulations to flesh out the details of the program beyond what the statute requires, such as the specific information and in what time frames pharmacies must make reports and the scope of interoperability agreements with other States. The Prescription Drug Monitoring Program Center of Excellence at the Heller School for Social Policy and Management at Brandeis University released “Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices” on September 20, 2012, which provides much for the State to consider as it moves forward.
As its title suggests, this White Paper aims to identify potential PDMP best practices, evaluate the evidence supporting labeling these as best practices, and survey the extent to which PDMPs throughout the country have adopted them.
After tracing PDMP development from its early roots in the 1980s and summarizing evidence suggesting that PDMPs are effective in improving the prescribing, and addressing the abuse, of controlled substances, the report identifies thirty-five potential best practices for these programs, including:
1. Standardizing data fields and formats across PDMPs to improve the comprehensiveness of data, comparability of data across states, and ease of integration with prescription information collected by potential PDMP collaborators, like Medicaid, the Indian Health Service, the Department of Veterans Affairs, and Department of Defense.
2. Reducing data collection intervals and moving toward real-time data collection to improve the utility of information collected for clinical practice and drug diversion investigations.
3. Integrating electronic prescribing with PDMP data collection to facilitate communication with electronic prescribers and facilitate monitoring of prescriptions as they are being issued as well as before and after they are dispensed.
4. Linking records to permit reliable identification of individuals (patients or prescribers), which is necessary for accurate analysis of trends and potential questionable behavior.
5. Determining validated and standardized criteria for possible questionable activity.
6. Conducting epidemiological analyses for use in surveillance, early warning, evaluation, and prevention to identify trends in prescribing and questionable behavior, which may inform public health objectives.
7. Providing continuous online access and automated reports to authorized users to encourage utilization.
8. Integrating PDMP reports with health information exchanges, electronic health records, and pharmacy dispensing systems to make it more efficient to access data.
9. Sending unsolicited reports and alerts to appropriate users based on data suggesting potentially questionable activity, such as doctor shopping or inappropriate prescribing.
10. Enacting and implementing interstate data sharing among PDMPs to address interstate diversion and doctor-shopping.
11. Securing funding independent of economic downturns, conflicts of interest, public policy changes, and changes in PDMP policies, such as from grants, licensing fees, general revenue, board funds, settlements, insurance fees, private donations, and asset forfeiture funds.
12. Conducting periodic review of PDMP performance to ensure efficient operations and to identify opportunities for improvement.
The authors noted, however, that good research evidence is not available to support the value of the vast majority of these potential best practices because “research in this area is scarce to nonexistent.” Thus, they suggested a prioritized research agenda with the goal of strengthening the evidence base for practices they believe have the greatest potential to enhance effectiveness of PMP databases and that can be studied using scientific techniques like randomized controlled trials or observational studies with comparison groups. Specifically, the report recommends focusing research and development on (a) data collection and data quality; (b) linking records to identify unique individuals; (c) unsolicited reporting and alerts; (d) valid and reliable criteria for questionable activity; (e) medical provider education, enrollment, and use of PDMP data, which includes the question of whether to require providers and dispensers to access the database; and (f) extending PDMP linkages to public health and safety.
The report makes valuable recommendations that will help guide policy makers as these programs continue to evolve. Despite its many strengths, however, the report gives short shrift to a critical area for ongoing monitoring — whether PMPs have a chilling effect that makes it more difficult for patients in pain to obtain appropriate, palliative care. Although this concern is mentioned in passing in various places in the report, it is not expressly incorporated into the authors’ conceptualization of how we should evaluate PDMP effectiveness. Indeed, it is dismissed as potentially overblown even though Appendix A to the report notes that twenty-three percent of Virginia doctors in a 2005 survey who believed their prescribing was being more closely monitored because of the PDMP “reported it had a negative impact on their ability to manage patients’ pain.” Admittedly, other studies summarized in the appendix found no chilling effect. But given the article’s critique of most studies as lacking empirical rigor and its call for more scientific study, it seems prudent to encourage empirical research to evaluate this concern. Recognizing that “an explicit goal of PDMPs is supporting access to controlled substances for legitimate medical use,” an August 20, 2012 [fee required to access] report from the Congressional Research Service suggested that “[a]ssessments of effectiveness may also take into consideration potential unintended consequences of PDMPs, such as limiting access to medications for legitimate use . . . .” (Although the August 20, 2012 CRS report does not appear to be available without charge on the internet, a July 10, 2012 version of this report is available here.)
With this caveat in mind, the Brandeis report undoubtedly is a valuable resource to policy makers and academics as they consider how to make the most appropriate and efficient use of PMPs. New Jersey can build on this knowledge base as it decides how to make use of its PMP. As the White Paper’s laundry list of potential best practices makes clear, the State has a plethora of options to research and consider. If New Jersey adopts the proposed regulations permitting electronic prescribing of controlled substances, for example, it should consider how it can integrate electronic CDS prescription records with its PMP. Given the statutory authorization to share data with other States, New Jersey also can learn from the experiences of States that are adopting standardized data formats and implementing interoperability agreements with other States.
The State also should evaluate the evidence that unsolicited reports increase the effectiveness of PMPs and whether legislation and/or regulations would be required to authorize their use in New Jersey. A related issue is what criteria to adopt to define potentially questionable behavior that would trigger an unsolicited report, which must balance the risks of false negative and false positive reports.
Similarly, the State may wish to explore the advantages and costs of moving toward a real-time database rather than its current design that requires dispensers to report at least twice per month. The Alliance of States with Prescription Monitoring Programs’ PMP Model Act 2010 Revision recommends that pharmacies submit data no more than seven days from when the script was dispensed, and Oklahoma is implementing real time reporting. (A recent study published in CMAJ found a 32.8% relative reduction among residents receiving social assistance in inappropriate prescriptions for opioids and a 48.6% reduction in inappropriate prescriptions for benzodiazepines within thirty months of implementation of a Canadian centralized database containing real-time prescription data.)
New Jersey also could study the experiences of various states like New York that are requiring certain prescribers and dispensers to register with the State’s PDMP and, in some cases, to check the database before authorizing or dispensing prescriptions for CDS. A research study underway in Utah may shed some light on whether mandating provider participation in PDMPs improves effectiveness.
In general, the State may wish to research how to strike the appropriate balance between educating prescribers, dispensers, and patients of the risks of prescription abuse and punishing those involved with diversion or abuse.
Because virtually all of these policy choices also involve substantial costs to research and implement, New Jersey might wish to pursue alternative sources of funding, such as grants available through the federal Harold Rogers Prescription Drug Monitoring Program or the National Association of State Controlled Substances Authorities.