Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments
OPEN Request for Comments Establishment of a Public Docket Dispensed in an Outpatient Setting on Safe Disposal With Opioid Analgesics Providing Mail-Back Envelopes and Education CDER 2021-715
2022-04-22 2022-04-22 2022-04-22 2022-04-27 2022-04-29 2022-04-29 2022-04-29 2022-04-29 2022-04-29 2022-05-02
FDA-2022-N-0165-0045 FDA-2022-N-0165-0053 FDA-2022-N-0165-0042 FDA-2022-N-0165-0057 FDA-2022-N-0165-0063 FDA-2022-N-0165-0065 FDA-2022-N-0165-0062 FDA-2022-N-0165-0064 FDA-2022-N-0165-0066 FDA-2022-N-0165-0068
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https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0045 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0053 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0042 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0057 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0063 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0065 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0062 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0064 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0066 https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0068
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Comment regarding: Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient SettingI think that regulation requiring a Mail-Back Envelope to be provided with every opioid analgesic will create a lot of waste and burden on the retail pharmacy.  I think regulation should look at making every retail pharmacy be able to take back unused narcotics for destruction.  Certainly having prepaid envelopes offered to each patient is fine but requiring them to be given even if not desired is wasteful. Whether there are specific opioid analgesic drug products for which requiring mail-back envelopes is more important from a public health perspective and, if so, which products. Although some opioids are more abused than others, all opioids have the potential to be abused or misused. Having exceptions will add confusion and inefficiencies. A pharmacist can provide a first-time education which can include the general purpose of the envelope, general information about unsafe disposal, etc. If there are exceptions, patients will come asking for help to sort or select the appropriate medications to place in the envelope. Patients will not retain after 6 months such details. It will be simple to have pharmacies stick a label stating: Must be safely disposed of according to the law. It is a single step that can be easily introduced into a pharmacy workflow. Patients will respond to a general call of disposing of by mail if there is a continuous message, not a bi-annual campaign.  It is more likely that a well-developed program that provides clear communication of the multiple alternatives to dispose of unused opioid have an impact. Repetition and reach are key to any public health effort. How pharmacies could develop and implement algorithms to determine when to provide a mail-back envelope, including how feasible or practical it would be for pharmacies to do so.How pharmacies could identify those patients who are most likely to have unused opioids to optimize the provision of mail-back envelopes to these patients and potentially positively impact the share of mail-back envelopes that are utilized to safely dispose of opioid analgesics. It can be difficult for a pharmacy to identify patients who potentially will have unused medicine. Therefore, pharmacies can have the envelope available and can target, based on past prescriptions, patients with possible unused opioids. As a one-time effort is great but not as an ongoing effort. Pharmacists promote in a general manner to dispose of all unused medicine and individually when providing medication therapy management (MTM). But not all patients have the benefit of an MTM service.  Whether requiring the provision of mail-back envelopes under the OA REMS should also include a requirement for patient counseling and/or provision of take-home materials on safe disposal at the point of dispensing.Having an envelope is a novel approach that will add cost to the manufacturer and to the dispensing of an opioid prescription. A pharmacist can provide a first-time education which can include the general purpose of the envelope, general information about unsafe disposal, etc. We need to look further into what causes residues or unused medications. An additional first-step strategy is to minimize risk and the possibility of having home residuals is educating doctors to prescribe fewer quantities for post-surgeries. A patient with a tooth extraction does not need a 7-day supply of therapy. A patient with shoulder surgery will visit the surgeon in a week, why give the patient 21-days of therapy?  The burden always falls outside the doctors realm. What pharmacists need is the capability of deciding approaches to avoid getting into the hands and homes of patients an amount of drug that, to start, is suspected and probable of converting to unused. While I appreciate the intent of this proposed program, I dont think the implementation would work. People may lose or misplace the envelope and many people may never use them. This creates a lot of waste and doesnt address the issue. Instead, I think that it makes more sense to have drop boxes for all unused medication in every pharmacy and those can be incinerated. For patients who are unable to get to a pharmacy, having an envelope as described available on request would help them.   Do you really think that it is easier to store an envolope until needed, find the envelope when it is needed, place the contents in the envelope, and take it to the post office/mail box than it is to flush a few tablets down the toilet?  It sounds like a gimmick to get more money for the post office. What you have done to the most needy population is criminal, chronically Ill people need their pain relief and because others use street drugs I have to lay in bed and cry in pain. Im in pain 24/7 because you have interfered with with my doctors ability to treat my pain properly your proposal doesnt go far enough to help the chronically Ill. I have considered suicide and considered street drugs I just havent gotten to the point that Ive made those moves. I dont want to leave my wife and daughters but Im not sure I can handle this pain much longer but you people dont care . Fuck You The idea of providing mail-back envelopes with opioid analgesics is a great idea to minimize opioid medications from lingering in our communities.  I would desire to see the mailers be recyclable to minimize waste and unintentional negative impact on the environment.  I also would recommend making acceptance of the mailer voluntary for the patient for similar reasons since the majority of chronic opioid prescriptions dispensed to individual patients will be consumed. Most pharmacies have drop boxes for returning unused medications. Because of the CDC guidelines and concerted effort to avoid prescribing pain medication to patients, there is little opportunity for diversion but much greater harm to patients as prescription opioids are now being overly policed by the DEA. Micromanaging every single pill dispensed to patients is a wasteful diversion from the true threat to public health from the manufacturing and trafficking of illicit deadly drugs, and it also interferes with the practice of medicine. If a pharmacy doesnt have a drop box, then mail back envelopes can be available at the pharmacy if asked for. Does the DEA now plan to start tracking how many prescribed pills that a patient takes? Will that become a new red flag for prosecution or justification for the DEA to make dosing recommendations which become de facto law? This is an absurd, unreasonable, and wasteful effort. People can obtain methods to destroy unwanted medications from their pharmacies. This is unnecessary, a huge strain on pharmacies, and provides dubious benefit. Studies show the majority of diverted medications are from health care facilities, not consumers. This is an unreasonable attempt to mitigate a problem that doesnt exist.  This is absurd. If you must send something to the patient then is should be an envelope or container that automatically renders drug unusable once place in envelope. Putting opioids into the mail in an envelope just increases risk of diversion.  Waste of money and pharmacist time as a valuable resource.  Also, this creates more opportunities for theft of opioids as they are circulated through the mail system with SO many chances for them to be taken.  NOT a good idea for SO many reasons.  We have safe disposal options already.