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.
Filed under: Fraud & Abuse, New Jersey, Prescription Drugs
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.
Filed under: Global Health Care, Pharma, Prescription Drugs
Last week, the blog Concurring Opinions featured a symposium on Madhavi Sunder’s new book, From Goods to a Good Life: Intellectual Property and Global Justice. A chapter relevant to health law scholars is available online, here. The chapter focuses on access to drugs in less developed countries (LDCs), and makes the following case:
Not too long ago, an HIV-positive diagnosis was tantamount to a death sentence — for people in the East and the West, in the South and the North. The drug companies that perfected the antiretroviral therapies invested princely sums to find these miracle cures. To justify their investment, they rely on the promise of a patent . . . . Thus patents have saved countless lives. But this structure has its limits. Indeed, the evidence is mounting that in crucial ways patents fail to promote the health of people in the developing world, and in some cases in the developed world as well.
The chapter begins by telling the moving story of Thembisa Mkhosana, one of thousands of South Africans who cannot afford the third-line antiretroviral treatments needed to survive AIDS. “My blood test results have worsened dramatically,” Mkhosana told a reporter, “And now I suddenly have fever and am in pain. I’m really worried.” ”I know that I’m going to die,” she said, but “who is going to look after my children?” Her story appears in this video.
Mkhosana’s plight raises difficult interpretive issues. Is she “collateral damage” from a patent system that depends on the strict rules that deny her access to the medicine she needs? Or is this an entirely avoidable tragedy, a consequence of misapplied and misinterpreted laws? Sunder makes the case for the latter view very convincingly, while providing a compact and accessible account of the development of international patent policy over the past 20 years.
Sunder acknowledges the importance of patent law to incentivizing the development of new drugs. However, as she wisely notes, one can’t squeeze blood from a stone, however important the “skin in the game” ideology has become to advocates of “free-market” healthcare. According to Sunder, “creation of generic drug markets for the poor ought not significantly impact the bottom line of Big Pharma, which derives only 5 to 7 percent of its profits from this part of the world.” It may well be possible to make up for some of that figure by cutting back on promotional budgets in the developed world. It’s also a rather trivial figure compared to tax avoided or evaded on the tens of trillions now hidden away in tax havens.
On the other hand, Big Pharma has a number of justifications and excuses for aggressive assertion of their patents. Spokesmen aver that they are only concerned about what would happen to their profit margins if drugs circulated in an uncontrolled manner. They claim that, if poor countries are permitted to manufacture vast quantities of their drugs, those countries may sell them on the black or grey markets. That, in turn, would reduce the return on such drugs in the developed world, leaving less money for research in the future. Sunder responds that, “The grey-markets concern is a valid one—but . . .the World Trade Organization has begun to craft creative solutions to this problem (requiring generic drugs made for developing world markets to be distinctively labeled, for example).” As surveillance of both people and goods is better perfected by state security apparatuses and RFID technology, the grey market concern should also become more technologically manageable, enabling finer-grained and more effective price discrimination.
Access to drugs is a key area where ordinary markets simply can’t be expected to achieve humane and rational results. In 2008, the purchasing power of the average American dog was higher than that of forty percent of the world’s population. Given the extensive extant involvement of the U.S. government both in the domestic pharmaceutical industry and in the international negotiations determining its powers and duties abroad, there is a special moral obligation for U.S. citizens and politicians to assure the widespread and equitable distribution of lifesaving drugs. As Sunder states:
Economists call the millions of people who need a drug but cannot afford it “dead weight loss.” But the millions who die needlessly because of the patent system—a number that some scholars calculate as nine million in the developing world annually—are more than an inefficiency in the system. . . . We must both adopt alternative mechanisms for developing and distributing medicines to the poor (including prizes), and fully support the use of compulsory licenses by developing countries to treat their sick poor. Patent law cannot draw the line at rectifying market failure. Our law must contend with moral failure as well.
Sunder’s eloquent case for access to drugs commends respect and admiration for the Health Impact Fund, Knowledge Ecology International, Medecins sans Frontieres, and other groups for trying to close this gap.
X-Posted at Bill of Health.
Since September is National Childhood Cancer Awareness Month –a calendar of events can be found here– a review of relevant recent and pending federal legislation seemed appropriate. The Food and Drug Administration Safety and Innovation Act (FDASIA), which the President signed into law on July 9, 2012, included a number of provisions that it is hoped will speed development of drugs to treat childhood cancers and other rare diseases. As Peter L. Saltonstall, who heads up the National Organization for Rare Disorders (NORD), explains here, the central purpose of the FDASIA was to reauthorize the Prescription Drug User Fee Act, but several separately-introduced bills “of particular importance to rare disease patients and supported by NORD” were incorporated into it. These included the Creating Hope Act, which was powerfully advocated for by Kids v Cancer and the bi-partisan Congressional Childhood Cancer Caucus.
The Creating Hope Act expands the FDA’s priority review voucher (PRV) program– which was passed to incentivize the development of treatments for neglected tropical diseases, malaria, and tuberculosis– to cover rare pediatric diseases, including childhood cancers. Under the program, “[t]he [FDA] shall award a priority review voucher to the sponsor of a rare pediatric disease product application upon approval by the [FDA] of such rare pediatric disease application.” The fully-transferable voucher can be redeemed for review of–and action on–another new drug application within just six months. In an influential 2006 article in Health Affairs, David Ridley and colleagues estimated that if a “voucher speeds FDA approval by a year, it could increase the present value of sales of a blockbuster drug by more than $300 million.”
While a voucher worth as much as $300 million would seem to add up to an attractive “pull” mechanism, the PRV program for neglected tropical diseases has, unfortunately, not lived up to expectations. Only one company, Novartis, has received a PRV, for an anti-malaria drug which was already approved and marketed outside the United States. Writing at The Incidental Economist earlier this year, Kevin Outterson characterized the PRV program as “unsuccessful” and its extension to rare pediatric diseases as “disappointing.” More promising, Professor Outterson suggests, are “push” mechanisms like the Innovative Medicines Initiative (IMI) in Europe, described here, which will, among other things, funnel $738 million to antibiotics researchers between now and 2020, with the initial goals of “building and training networks of researchers, facilitating and increasing the exchange of research data, and improving the efficiency of clinical trials on new antibiotics through better laboratory tests and better trial design” and the long-term goal of “speed[ing] up the development of much-needed antimicrobial drugs.” Notably, the IMI was established with $1.23 billion of European Union funds and an impressive $1.23 billion of “mainly in kind contributions (consisting mostly of research activities)” from the European Federation of Pharmaceutical Industries.
The National Pediatric Research Network Act of 2012, which is currently pending in the House and Senate, bears some similarities to the IMI’s antimicrobial drug development effort. The Act would appropriate government funds to support the establishment and operation of a network of pediatric research consortia that would conduct “basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research” and “train researchers in pediatric research techniques.” The Act provides that “an appropriate number of such awards” must be awarded to consortia that, among other things, agree to “conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions[.]”
Childhood cancers are not specifically mentioned in the text of the National Pediatric Research Network Act, however, and, should it pass, the Network it establishes is likely to focus on other rare pediatric diseases. An existing network, the Children’s Oncology Group (COG), which is principally supported by the National Cancer Institute, “unites more than 8,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer.” COG “has nearly 100 active clinical trials open at any given time … include[ing] front-line treatment for many types of childhood cancers, studies aimed at determining the underlying biology of these diseases, and trials involving new and emerging treatments, supportive care, and survivorship.” The existence and success of COG — it’s “research has turned children’s cancer from a virtually incurable disease 50 years ago to one with a combined 5-year survival rate of 80% today,” although it has suffered from budget cuts in recent years–likely explains why advocates have turned their attention to pull mechanisms like the Creating Hope Act that build on existing incentives aimed at increasing industry investment in drug research.
Another model for increasing industry involvement is to require it. This could perhaps be described as a strong pull mechanism. The Pediatric Research Equity Act (PREA) takes this approach, requiring, with some exceptions, that a sponsor of a new drug application study that drug in children. FDASIA, as the FDA summarizes here, makes PREA “permanent — no longer subject to reauthorization every five years[,] … requires earlier pediatric study plan submission by drug manufacturers subject to PREA and gives FDA new authority to help ensure PREA requirements are addressed in a more timely fashion.” PREA, though, has not worked to generate research into pediatric cancer treatments, and the FDASIA reforms will not change that. In remarks delivered at the 2nd Annual Childhood Cancer Summit in September 2011, Dr. Peter Adamson, the Chair of the Children’s Oncology Group, explained that an exception to PREA’s requirements “can be granted for most new cancer drugs, as the common cancers observed in adults essentially do not occur in children.”
Of course, industry involvement could increase though profit-driven activity without additional pushes or pulls from government. Childhood cancers have not, thus far, been an industry focus. In the past twenty years, the FDA has approved just two drugs, clofarabine and erwinaze, to treat pediatric-specific cancers. It was not until this past August that the agency approved the first “pediatric-specific dosage form” of a cancer-fighting drug, everolimus. A story reported in Fortune’s September 3, 2012 issue entitled Rare Diseases Mean Big Profits (an online version is available here), suggests that there may be hope that the pace of development will accelerate. According to Fortune:
Wall Street skews bullish on Alexion[, a specialty pharmaceutical company that developed and sells the drug Soliris which is used to treat two rare disorders,] and its peers in the ultra-rare-disease market. With Pfizer and other big pharma companies facing devastating revenue drops as blockbuster drugs like Lipitor go off patent, niche players like Alexion look good because of their monopoly pricing power.
Soliris, Fortune reports, costs “around $400,000 per patient per year.” There may be, then, cause for hope that in the coming years the private sector will increase its investment in the surpassingly important search for treatments for childhood cancers and other rare pediatric diseases. I welcome your thoughts.
More than two years ago, the Federal Drug Enforcement Administration (DEA) issued interim final regulations permitting practitioners to issue and pharmacists to fill electronic prescriptions for controlled dangerous substances (“CDS”) (see, e.g., 21 C.F.R. § 1306.08). Regulations of the New Jersey State Board of Medical Examiners (N.J.A.C. § 13:35-7.4A(g)-(h)) and Board of Pharmacy (N.J.A.C. § 13:39-7.11(h)-(i)) similarly permit electronic CDS prescriptions, subject to certain requirements. But the State’s CDS regulations do not currently permit electronic CDS prescriptions (N.J.A.C. § 13:45H-7.8).
On August 20, 2012, Eric T. Kanefsky, the Acting Director of New Jersey’s Department of Consumer Affairs (“DCA”), proposed regulations to resolve this regulatory inconsistency. DCA would add a new rule, N.J.A.C. § 13:45H-7.20, which would permit “[a]n individual practitioner [to] issue, and a pharmacist [to] accept for dispensing, an electronic prescription for a controlled dangerous substance, consistent with the requirements of this chapter and Federal law.” This proposed rule would define “electronic prescription” as “a prescription that is transmitted by a computer device in a secure manner, including computer-to-computer and computer-to-facsimile transmissions.” DCA also proposes to amend N.J.A.C. § 13:45H-7.8 to expressly permit an electronic prescription for Schedule II narcotics “[i]f permitted by Federal law, and in accordance with Federal requirements.”
These Federal requirements, set forth in 21 C.F.R. Parts 1300, 1304, 1306, and 1311, include provisions intended to balance the desire to permit the use of modern technology while “maintaining the closed system of controls on controlled substances dispensing” (75 Fed. Reg. 16236). Thus, if DCA ultimately adopts these rules, New Jersey prescribers and pharmacists seeking to exercise their option to issue or fill electronic prescriptions will need to ensure that they comply with all Federal rules, including, as DCA’s proposed rule reminds, a requirement for a third-party audit by a DEA-approved certification organization to verify that the technology used satisfies DEA security standards (see 21 C.F.R. § 1311.300).
In addition to “eliminating any confusion that may exist with respect to filling electronic prescriptions for controlled dangerous substances,” DCA also believes that “[e]lectronic prescriptions are more efficient and less susceptible to errors.” With proper controls and checks, electronic prescriptions can make it more difficult for patients to try to fill fraudulent prescriptions by, for example, forging doctor’s signatures on stolen prescription blanks or altering the dosage that the doctor prescribed. Electronic prescriptions also support other health care reform initiatives, including increasing the use of electronic medical records, which can facilitate improved care coordination.
The public may comment on DCA’s proposal until October 19, 2012. But given the potential advantages of electronic prescriptions and the strong controls required by Federal law to prevent their abuse, I would expect the comment to be light and these regulations to be adopted.