Partial Filling of Prescriptions for Schedule II Controlled Substances
2020-12-16 2021-01-28 2021-02-01 2021-02-01 2021-02-01 2021-01-25 2021-01-26 2021-01-25 2021-02-01 2021-02-01
DEA-2020-0035-0006 DEA-2020-0035-0021 DEA-2020-0035-0022 DEA-2020-0035-0025 DEA-2020-0035-0028 DEA-2020-0035-0012 DEA-2020-0035-0016 DEA-2020-0035-0013 DEA-2020-0035-0023 DEA-2020-0035-0030
05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/DEA-2020-0035-0006 https://api.regulations.gov/v4/comments/DEA-2020-0035-0021 https://api.regulations.gov/v4/comments/DEA-2020-0035-0022 https://api.regulations.gov/v4/comments/DEA-2020-0035-0025 https://api.regulations.gov/v4/comments/DEA-2020-0035-0028 https://api.regulations.gov/v4/comments/DEA-2020-0035-0012 https://api.regulations.gov/v4/comments/DEA-2020-0035-0016 https://api.regulations.gov/v4/comments/DEA-2020-0035-0013 https://api.regulations.gov/v4/comments/DEA-2020-0035-0023 https://api.regulations.gov/v4/comments/DEA-2020-0035-0030
Eric Madonna Connor Raegan Sonia Caitlyn Brittany Amanda Rebecca Kaleh
Parks Reece Rezzonico Kartupelis Klein Nitsch Cox Hirz Tharp Owen
I live with a person who suffers from chronic pain and takes her prescription as directed by her pain management doctor. Even with the help of her prescription, she is not fully pain free and often can not leave the house to take care of her personal needs. Having to make multiple trips to her pharmacy would put her in a situation where she may have to travel while in a great deal of pain; this would be unfair to her. The amount of medication prescribed to a patient should be made at the discretion of treating doctors. Furthermore, enough medication should be prescribed to a responsible patient to minimize the financial burden and health risks associated with multiple trips to a pharmacy. The potential abuse of schedule II medication by some irresponsible individuals should not negatively impact patients who use their prescriptions responsibly and rely on them to help them live as close to a normal life as possible.  Proposal Comment: Docket No. DEA-469Under the proposed rules for Partial Filling of Prescriptions for Schedule II Controlled Substances-Proposed Rule by DEA on 12/04/2020  ID: DEA-2020-0035, the DEA must take steps to provide alternatives to the opioid crisis by creating partial refill options that can be opted by the provider or client in order to better customize legitimate opioid prescriptions to minimize deterrence and burdensomeness on providers, clients and our society, given the opioid epidemic plaguing our country. Between 2006 and 2016, average days of supply per prescription increased from 13.3 to 18.3 days, an overall relative increase of 37.6% (CDC, 2018). Although this is a steady decrease in gradual reductions of average days of supply per prescription since 2006, the progress has been slow. This trend could be greatly impacted by this proposal with the potential reduction of excess in-home opioids which this proposed rule would cultivate.At a minimum, a patient should be able to direct their decision to obtain fewer opioids than the full prescription in order to mitigate concerns for opioid overuse by themselves, family or other community aspect. Consuming opioids beyond the experienced management period for which they are intended can set up a patient to have beginnings of new dependence issues. Furthermore, this practice would parallel the inpatients prerogative when they choose the minimum level of pain medication for adequate pain management. In regard to provider notification by the pharmacist, as a DNP graduate student I believe that the potential increase in costs and clinicians time do not warrant this action. I do agree that a partial refill upon dispensation does warrant an electronic pharmacy record depicting the controlled substance dispensation quantity and the requesting party be it the provider or patient. ReferenceCenters for Disease Control and Prevention (2018). 2018 Annual surveillance report of drug-related risks and outcomes. https://www.cdc.gov/drugoverdose/pdf/pubs/2018-cdc-drug-surveillance-report.pdf I am in support of Docket No. DEA-469 for Partial Filling of Prescriptions for Schedule II-Controlled Substances for several reasons.  One, this proposal should have a positive economic impact on individuals.  I suggest partial fillings should result in lower copay with the additional partial filling copay, if needed, to not exceed the amount of one full prescription fill.  Unused prescriptions drive demand for opioids and the reduction of such medications could presumably decrease drug prices.  Secondly, allowing the individual the opportunity to opt for a partially filed prescription promotes patient-centered care allowing them to contribute to their own treatment plan.  Partially-filled prescriptions will decrease the number of unused medications diminishing the opportunity for drug diversion and misuse.  Increased prescribing practices from providers has contributed to the growing epidemic (AAFP, 2020).  With limited data to support the effectiveness of long-term opioid analgesic use for pain management, limiting the supply for potential abuse should be promoted.  In response, to the alternative approaches I believe allowing the pharmacist to dispense the partial fill as requested without consent or notification to the prescribing practitioner is the most appropriate and cost-effective approach.  Agreeably, a situation arising in which a provider refusing a partial fill seems nonexistent.  As we attempt to confront the opioid epidemic plaguing our country, we must find effective, evidence-based alternatives to adequately manage pain and not consequently create more opioid abusers in the process.  American Academy of Family Physicians (2020). Chronic pain management and opioid misuse. A public health concern (position paper).  https://www.aafp.org/about/policies/all/chronic-pain-management-opiod-misuse.html Partial Filling of Prescriptions for Schedule II Controlled Substances, Docket No. DEA-469Although the Drug Enforcement Agency (DEA) regulations provide three exceptions, generally speaking, a pharmacist cannot partially fill a controlled-II prescription for a patient (Heesters, 2020). The DEA is, however, proposing to amend the regulations where a pharmacist would be able to partially fill a controlled-II prescription as authorized under the Comprehensive Addiction and Recovery Act (CARA). According to the Wyoming Department of Health (2021), 65 people died in Wyoming from an opioid overdose in the year 2018. An estimated 10.3 million people aged 12 and older misused opioids in the year 2018 (HHS, 2020). Misuse of prescription drugs is a problem both nationally and state-wide. If permitted, this will expand opportunities for a partial filling of schedule II-controlled substances in certain instances which will ultimately reduce waste, lower the use of controlled substances, and reduce the potential for addiction, overdose, and diversion. Thus, I support the DEAs proposed rule for partial filling of prescriptions for schedule II-controlled substances. ReferencesHeesters, M. (2020). DEA proposes rule to expand partial filling of schedule II prescriptions; Will the benefit be cost-effective. https://www.fdalawblog.net/2020/12/dea-proposes-rule-to-expand-partial-filling-of-schedule-ii-prescriptions-will-the-benefit-be-cost-effective/U.S. Department of Health and Human Services (HHS). (2020). Opioid crisis statistics. https://www.hhs.gov/opioids/about-the-epidemic/opioid-crisis-statistics/index.html#:~:text=In%202018%2C%20an%20estimated%2010.3,and%20808%2C000%20people%20used%20heroin.Wyoming Department of Health. (2021). Opioids. https://health.wyo.gov/publichealth/prevention/substanceabuseandsuicide/opioid-information-wyoming/ After reviewing the proposed rule for Partial Filling of Scheduled II Controlled Substances, from the patient perspective I agree with the cost savings and safety aspects of partially filling. The patient may only wish to fill part of a prescription based on monetary and/or safety factors. This gives the patient an option regarding their own health care and outcomes, and can lend to patient empowerment and engagement. The partial filling option may also increase community safety, decrease waste, and potentially decrease abuse of schedule II prescriptions. However, these choices are often left to the patient and proper education will be required to reap benefits from such a rule. From the providers perspective, I question if this additional option results in time, cost and waste savings. It is difficult to estimate how many unused medications are currently in homes, therefore estimating safety, cost, and waste benefits is not exact. Further, how likely will patients choose to utilize a partial fill when they are suffering from an acute problem that would require two trips to the pharmacy in 72 hours versus one trip. How often will a patient choose to fill one week at at time or 3 days at time, within a 30 day fill period. There are some instances in which a patient might choose this route, though I believe it is the exception not the rule. From the providers perspective, I believe this rule increases the amount of time a provider will spend writing and sending prescriptions, and it increases the amount of education required for the patient to properly understand the available options regarding schedule II substances. Visit time required for the provider to understand the patients circumstances and needs if the patient is willing to utilize the partial fill option should be considered and calculated. I believe the majority of providers have the patients best interests and health at heart. I also believe most providers will do what they can to facilitate best practices and patient safety, with or without the proposed rule. The proposed ruling embodies these concepts; however, ultimately this rule relies on patient understanding and compliance. The DEA is estimating over $640 million in costs savings with this propsed rule. While economics are always a driving factor, time is at a premium. I question if this rule will facilitate the desired change and cost savings.   Being a nurse and student, I see people come in every day who are addicted to schedule II substances.  Many of these patients were seen by an older family practice MD who would prescribe these medications without assessing other options first.  Practitioners who I have recently worked with have attempted discontinuance of these schedule II substances, but patients have not tolerated the change well, requiring the need for a renewed prescription.  Allowing partial fill of medications eliminates the possibility of extra medication be stored for potential future use.  Preuss, Kalava,  King (2020) report that 55-65% of people obtain schedule II-controlled substances from a friend or relative that received the prescription in the past.  In hopes of making changes in the future, assessing the new proposed rule of partial filling of prescriptions for schedule II-controlled substances would allow patients the option of lower cost prescriptions, decrease chances of medication dependence or overdose, and reduce the frequency of medication use from people other than the individual prescribed. One question I do have is if the patient fills a partial prescription and then fills the other portion of the prescription at a later date, would the patient be charged two separate co-pays?Preuss, C., Kalava, A.,  King, K. (2020). Prescription of controlled substances: Benefits and risks. StatPearls. https://www. ncbi.nlm.nih.gov/books/NBK537318 Docket No. DEA-469 Partial Filling of Prescriptions for Schedule II Controlled SubstancesAs a registered nurse of 15 years and current APRN student I support the proposal of partial filling for schedule II prescription medications as requested by the practitioner OR the patient in accordance with state law. There are many reasons a practitioner or patient may request a partial fill including cost, need, and effort to limit exposure. For these reasons it is vital that the patient have the ability to request a partial fill with or without written permission from the practitioner. This process poses little to no risk given that the patient will not receive a number of pills beyond what the original prescription indicates, they will only have 30 days to fulfil the remainder of the prescription, and the practitioner will have access to information regarding the dispensed medication. Allowing the patient to request a partial fill is an excellent example of empowering the patient to participate in shared decision making regarding their use and need of schedule II controlled substances.   Partial Filling of Prescriptions for Schedule II Controlled SubstancesDocket No. DEA-469The proposed rule to conform and delineate DEA regulatory requirements for partial filling of prescription for schedule II controlled substances in the Comprehensive Addiction and Recovery Act of 2016 is necessary for proper auditing by the DEA and clear guidance for practitioners and pharmacists. I support the proposed rule to specify the quantity to be dispensed for partial filling of a prescription and allow the patient to request a partial filling through alternative means. Firstly, as a nurse practitioner student, I can appreciate the clear guidance and communication when prescribing a schedule II controlled substance for my patients safety and sustaining compliance with the DEA. Secondly, allowing a patient to partially fill a prescription by way of phone or written request is necessary for an acute condition where the patient is unable to be physically present. By passing the proposed rule, accurate dispensing and recording of schedule II controlled substances are supported and the patients access to their prescription is more easily attained. Docket No. DEA-469, Partial Filling of Prescriptions for Schedule II Controlled Substances. Thank you for the opportunity to comment. My name is Rebecca M Tharp. I have been a registered nurse for nearly 13 years and am presently a doctoral family nurse practitioner student. As a future provider, I believe the partial filling of schedule II-controlled substances will help reduce unnecessary waste, avert risky disposal of unused narcotics, prevent theft of unused portions for illegal use or sale of narcotics, allow for reduced prescription costs for patients, and empower patients in greater shared decision-making. The need for pain relief and the use of opioid analgesics has been a double-edged sword as practitioners walk the fine line between undertreatment and overtreatment, especially amid todays opioid state of crisis (Preuss et al, 2020). Addiction to opioids has been extremely problematic in our society for decades and is the very reason the Controlled Substance Act of 1970 exists. Preuss et al (2020) noted that extreme risk of addiction and further substance use is a known factor for schedule II-controlled substance use. Therefore, partial filling of schedule II-controlled substances will help to alleviate this crisis and should be implemented. References: Preuss, C.V., Kalava, A.,  King, K.C. (2020). Prescription of Controlled Substances: Benefits and Risks. Treasure Island, FL: StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK537318/ Partial Filling of Prescriptions for Schedule II Controlled Substances, Docket No. DEA-469 My name is Kaleh Owen and I have practiced as a registered nurse (RN) for eight years. I am currently attaining a graduate degree through the family nurse practitioner (FNP) program at the University of Wyoming with the intention to impact the health and wellness of my community and all individuals I encounter during my practice. I appreciate the aim of the DEAs proposed rule for partial filling of prescriptions for schedule II controlled substances. While the rule may address diversion and improper disposal of such medications, I believe there is a potential for harm in implementing the rule. First, without parameters enacting criteria for consideration of prescribing schedule II medications, practitioners implicit biases may dictate the selection of the option for partial filling. Racial and ethnic disparities exist in healthcare of the United States. To illustrate, black patients are less likely to be prescribed pain medications, and if they do receive a prescription, they receive lower quantities (Hoffman et al., 2016).  Next, a patients socioeconomic factors must be considered, which may impact the ability to fill the remainder of the prescription, including access to healthcare, affordability of medications, and transportation means. With fear of the unknown, I believe patients will be less likely to request partial filling on their own. The prescribing of such substances must include shared decision making between the practitioner and patient to achieve the best outcome. Discussion should consist of potential risks, proper disposal, and address patients fears. The proposed rule does not take the place of shared decision making and informed care. Kaleh Owen, BSN, RN, CMSRNReferenceHoffman, K.M., Trawalter, S., Axt, J.R.,  Oliver, M.N. (2016). Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites. Proceedings of the National Academy of Sciences of the United States of America, 113(16), 4296-4301. https://doi.org/10.1073/pnas.1516047113