Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies
2021-04-26 2021-06-02 2021-06-02 2021-06-02 2021-06-04 2021-04-21 2021-06-02
CDC-2021-0031-0003 CDC-2021-0031-0004 CDC-2021-0031-0008 CDC-2021-0031-0007 CDC-2021-0031-0010 CDC-2021-0031-0002 CDC-2021-0031-0005
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/CDC-2021-0031-0003 https://api.regulations.gov/v4/comments/CDC-2021-0031-0004 https://api.regulations.gov/v4/comments/CDC-2021-0031-0008 https://api.regulations.gov/v4/comments/CDC-2021-0031-0007 https://api.regulations.gov/v4/comments/CDC-2021-0031-0010 https://api.regulations.gov/v4/comments/CDC-2021-0031-0002 https://api.regulations.gov/v4/comments/CDC-2021-0031-0005
Amanda Kelly Casey Colleen malloy Sophia Anna Ashley
Isac Burns Richman White Demuynck Stein Darby
I strongly support development of this toolkit to help facilitate greater access to sterile syringes through pharmacies. Given 90% of Americans live within 5 miles of a pharmacy, they serve as critical access points for the distribution of syringes - which in turn, reduces the burden of costly conditions including HIV, hepatitis, endocarditis, etc. In NC, we are in the planning phase of developing a pharmacy-based syringe service program. This toolkit will help tremendously in the creation of that program and others.  Docket No. CDC-2021-0031I am writing in reference to the above proposal for a harm reduction toolkit in community pharmacies. As a public health student, I am interested in impactful, easily implemented, and low-cost strategies to mitigate the opioid crisis in the United States and its associated morbidity and mortality.This initiative by the Centers for Disease Control and Prevention (CDC) is intended to support community pharmacists with education and training to build understanding and skills related to non-prescription drug sales (NPSS). Focusing on this sector of healthcare providers could ultimately facilitate increased access to sterile syringes resulting in a direct impact on reducing bloodborne pathogens, such as hepatitis C virus (HCV) and Human Immunodeficiency Virus (HIV) which are commonly associated with needle sharing among persons who inject drugs (PWID).Urban and rural areas alike are seeing spikes in HCV, HIV, and co-infection related to the opioid crisis. The incidence of HCV has increased four-fold in the last decade and most in adults aged 20-39 (CDC). The CDC estimates that co-infection of HCV and HIV occurs in 25% of PWID. Needle sharing occurs more commonly in young PWID (age 18-29), with nearly half of PWID reporting that they share needles (CDC). Community pharmacists contribute to harm reduction strategies as they are often the final healthcare provider contact for prescription opioids. Pharmacists already have increased responsibilities in harm reductions strategies as screeners for drug diversion and drug-seeking behavior. Increased participation by pharmacists in syringe service programs (SSPs) may depend on low resource, time-efficient training and education.Studies from other countries suggest that pharmacists are both willing and are empowered to play a larger role in needle exchange programs. The North America Syringe Exchange Network currently lists 360 (SSPs) across 43 states. SSPs have been associated with a 50% reduction in HIV and HCV incidence (CDC). Wider adoption of programs, however, can depend on state and local laws governing sales of syringes and pharmacist understanding of these rules. Assessing community pharmacists willingness to participate in a non-prescription syringe sales (NPSS) is essential to successful implementation of successful SPSS initiatives. A 2015 study of community pharmacists in Kentucky showed that, of the 1282 participants, 39.1% were not willing to provide clean needles/syringes yet 30.0% were very willing to do so (Goodin 2018). Of the community pharmacists who felt that a needle exchange program could have an impact on public health they were 3 times more willing to provide clean needles and, to a lesser degree, dispose of needles compared with chain/supermarket pharmacists.  A study of Indiana pharmacists showed that syringe sales were strongly associated with a supportive belief regarding syringe access for injection drug users and their comfort level in selling syringes (Meyerson 2018). However, pharmacists located in communities with high rates of overdose-related mortalities were 56% less likely to sell syringes. The barriers to selling syringes most often cited were not wanting to attract the wrong customer (55.4%) and personal disagreement with supplying injection drug users with syringes (46.3%).This pilot program seeks to further pharmacists understanding of, and skills with, the delivery of NPSS services. The program aims to correlate pre- and post-test responses with syringe sales during the six-week period. It would be interesting to see what the correlation would be over a longer period, perhaps 90 days, to see if there is a significant change in syringe sales overall and if the number of individual customers had increased and/or number of visits per customer to the pharmacy. A longer-term outcome of interest would be the incidence of new HIV and HCV diagnoses in communities served by participating pharmacies.It would also be interesting to see what the perceived barriers of NPSS for pharmacists are at baseline and if education and training can effectively overcome them. While increasing a pharmacists comfort level with selling syringes to PWID may be addressed through the pilot programs education component, overcoming personal beliefs regarding injection drug users may prove more challenging. The pharmacist can play a key role in harm reduction strategies for bloodborne pathogens associated with injection drug use. This proposed CDC program could demonstrate how a relatively low time commitment from participating pharmacists would result in expanded NPSS. This important initiative will provide insight into baseline skills and perception of NPSS and the effectiveness of training/education both by post-test surveys and change in NPSS as a result of the program.  Harm reduction toolkits are a significant step in the right direction for preventing the spread of infectious disease. Reducing the harm associated with drug use is an important factor that oftentimes is looked upon negatively or overlooked. However, research has shown increasing access to clean syringes does not increase injection frequency, drug use or disposing of syringes in an unsafe manner. This proposed project has the potential to positively impact communities around the country. However, there is one big question I had when reading this notice; how will this harm reduction toolkit address stigma surrounding the purchase and sale of syringes?  The over-the-counter sale of non-prescription syringes is already legal, yet this does not appear to have a big impact on decreasing needle sharing; why is that?Stigmatizing language has significantly impacted individuals ability to access clean syringes. Research has shown stigma against individuals who use drugs is a huge public health issue. Many communities have implemented policies surrounding this issue based off stigma. This can easily be seen through attempts to implement needle exchange programs. Many communities across the country have tried to implement needle exchange programs. However, false ideas that these programs lead to more substance use and needles being improperly discarded have led to shutting down these programs. Promoting over the counter needle sales may meet less pushback in communities than needle exchange programs have, but addressing community wide stigma is still going to be a big issue when trying to get individuals to utilize this program. It is important to create an atmosphere where individuals feel like human beings and feel valued and respected; this is before someone even steps foot inside a pharmacy. There is a lack of research available regarding individuals experiences purchasing sterile syringes over the counter in community pharmacies. However, the research that does exist brings to light stigma and rejection individuals have faced when trying to purchase over the counter syringes. A 2018 study in the Harm Reduction Journal (https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-019-0327-1 ) sought to understand the experience of retail pharmacy syringe purchases in Arizona. All participants in this study were refused when trying to purchase non-prescription syringes in community pharmacies. A 2015 study in California interviewed 46 individuals who repeatedly cited stigma regarding syringe access. Although legal to purchase, participants were often denied syringe purchases and felt stigmatized and embarrassed. This experience also discouraged participants from attempting to go to a different community pharmacy to buy a syringe. This is a pattern that is repeated in research done in states across the country. Although technically legal, many individuals who have attempted to buy syringes have been rejected. Many of these individuals have been rejected based off the individual beliefs and comfort levels of pharmacists. It can be difficult for someone to have the courage to go into a pharmacy to purchase a needle; being rejected once could potentially keep them from ever trying to purchase a syringe within a community pharmacy again. Therefore, the community pharmacy training is vital for the harm reduction toolkit for non-prescription syringe sales in community pharmacies to be successful.  I am glad the CDC is working to implement an in-field demonstration and evaluation of a training for pharmacy personnel. I wanted to emphasize the importance of addressing stigma in this training. Providing the tools to prevent needle sharing does not do anything unless the distribution process is set up in a way that makes consumers feel comfortable and confident. Overall, this training, as part of the harm reduction toolkit has the potential to do a lot of good, and I am looking forward to see the results of this project.  Harm reduction in conjunction with shame reduction are important and yet still underutilized approaches when tackling the opioid epidemic. Yes, it would be the ideal for those suffering from addiction to attain and maintain sobriety, but this is a challenge for many; a lifetime goal not so readily achieved. With this in mind it is important to foster safe habits for those consuming/misusing both prescription and non-prescription opioid drugs, in particular for persons who inject drugs (PWID). PWID tend to associate with others that consume opioid drugs, sharing both drugs and injection supplies such as syringes. This has led to an increase in Human immunodeficiency virus (HIV), Hepatitis C (HCV) and many other blood borne infections among PWID. With this in mind many cities across the United States have implemented or encouraged community organizations that manage exchange programs that allow individuals to trade used needles for clean ones. These programs are hugely beneficial to their communities, and provide wonderful data of the benefits that clean syringes provide. It seems sensible to utilize this information to expand access to clean syringes to every community in the United States. Further, with so many Americans living within accessible distance to local pharmacies, these pharmacy locations present as ideal hubs for non-prescription syringe sales (NPSS) and information on safe injection practices. Now it would seem rather small in scale to only feature 12 project pharmacies, for a short 6 week data collection period, in the in-field demonstration and evaluation, but perhaps this will serve as a jumping off point providing preliminary data that could be utilized to justify the expansion of such programs.  Of additional note, as important as this proposed data collection is to understanding how crucial NPSS truly is to public health it would seem to be only a starting point. The question remains what will be garnered from this information, and what further steps could be taken to protect those that suffer from addiction, and in particular PWID. Harm reduction tactics far exceed NPSS, including such avenues as opening Safe Injection Sites (SIS). While cities like Philadelphia, Pennsylvania battle with federal courts in their efforts to open a local SIS within their community, the United States loses approximately 128 people each day to the misuse of prescription and non-prescription drugs (National Institute on Drug Abuse, 2020). All while, according to the American Medical Association (who supports the utilization of SIS) 11 countries globally are home to 120 SIS that save lives every day (https://www.ama-assn.org/delivering-care/opioids/will-us-get-its-first-supervised-drug-consumption-sit). For decades such SIS have functioned internationally serving their respective communities. The goal of such SIS locations is to foster safe environments for PWID providing them with clean injection facilities, equipment and access to medical care in the event that an overdose does occur. The opening of such sites in the US would also allow the opportunity to provide PWID with educational materials on clean injection practices, addiction treatment options, primary care treatment options and other preventive services. They certainly could provide a large opportunity in addiction treatment and care within the United States.  In 2017, the Department of Health and Human Services (HHS) declared the opioid crisis a public health emergency, and committed to tackle the misuse of both prescription and non-prescription opioid drugs with their five-point strategy:  (1) better addiction treatment, and recovery services; (2) better date; (3) better pain management; (4) better targeting of overdosing reversing drugs; and (5) better research. Considering these commitments it is ideal that they actually invest accordingly. So, yes the CDC should move forward with harm reduction toolkits and data collection on such resources. Yet still, in the ideal they are also keeping in mind the vast many ways to implement harm reduction tactics. Hopefully this is merely a jumping off point, and that other approaches that embrace not just harm reduction, but also shame reduction approaches are fostered.  Dear Mr. Zirger,As a candidate pursuing Masters in Public Health (MPH) and Doctor of Medicine (MD) degrees, I would like to voice my support for the proposed demonstration project, the Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies, which will evaluate pharmacist training materials, harm reduction kits, and publicly available online resources that seek to improve outcomes among persons who inject drugs (PWID). Based on data from the Centers for Disease Control and Preventions (CDC) National Vital Statistics System (NVSS) (https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm), drug overdose deaths have risen to the highest number ever recorded in the year since the outbreak of the COVID-19 pandemic  with over 90,000 lives lost during the 12-month period ending in October 2020. The steep rise in drug use-related morbidity and mortality makes all effort to implement effective harm reduction strategies both timely and necessary.  Syringe service programs (SSPs) that provide sterile injection equipment, testing for infectious diseases associated with injection drug use (e.g., HIV, hepatitis C virus), overdose education materials and naloxone kits, and/or referrals to general and addiction-related health care services, have been shown to significantly reduce many of the negative and potentially fatal health consequences experienced by PWIDs  without increasing drug use (Abbasi, 2017; Baker et al., 2020; Childs et al., 2021; Hawk, Vaca  DOnofrio, 2015). Indeed, the CDC has consistently called for improving nationwide access to SSPs that offer sterile needle and syringe exchange as critical to reducing the transmission of HIV (Abbasi, 2017). Despite the robust evidence base, SSPs have often been met with political opposition, particularly in non-urban areas disproportionately impacted by the burdens of drug use and dependence (Baker et al., 2020; Childs et al., 2021); however, resistance to strategies proven effective in reducing harm among PWIDs has been shown to stem predominately from stigma more than prior poor experience, meaning local engagement has and will continue to be essential to realizing approaches that meet individuals and communities where they are. Although medical offices and other health care facilities have not necessarily been preferred sources of sterile equipment exchange due to systems-wide stigmatization and criminalization of drug use, recent analysis of qualitative interviews with key informants from community-based organizations serving PWIDs has confirmed the importance of distinguishing local champions of harm reduction programs as a primary strategy in mitigating the challenges of SSP implementation (Childs et al., 2021). Indeed, the identification of implementing sites with wide population coverage is a necessary next step to addressing needs that have rapidly changed during the COVID-19 pandemic.Notably, polling in the United States reliably places pharmacists among the most trusted professions, where the majority of Americans (64%) rate the honesty and ethics of pharmacists as high or very high (Reinhart, 2020). Given likely routine interaction with many undiagnosed PWIDs, community pharmacists who have trusting relationships with consumers are in a unique position to screen and facilitate access to sterile injection equipment via non-prescription syringe sales (NPSS), which do not require authorization from another licensed prescriber. And as essential personnel, pharmacists are already positioned to reach individuals and communities with the highest need. The pre-test/post-test survey of pharmacy personnel NPSS knowledge, as well as the quantification of syringe sales and health care services referrals, will provide crucial feedback on the effectiveness of the project in increasing provision of harm reduction products to PWIDs. Because attitudes and beliefs regarding drug use and dependence have been shown to so significantly influence the experiences of individuals and communities with SSPs, the CDC Information Collection Review Office should consider incorporating a qualitative component into the evaluation, including targeted interviews or open-ended survey questions, in order to best understand the implementation and impact of the proposed project from the perspective of community pharmacists. Overall, SSP approaches like NPSS that provide safe injection equipment represent evidence-based strategies for reducing harm among PWIDs. The increasing morbidity and mortality associated with injection drug use during the COVID-19 pandemic absolutely necessitate the careful development, realization, and evaluation of expanded opportunities to meet individual and community need  such as that described by the proposed project. Sophia DemuynckThe George Washington University I am very pleased to see the CDC working to create a harm reduction-oriented toolkit for non-prescription sales of syringes in community pharmacies. In NC, the Department of Health and Human Services promotes these types of sales, so this toolkit will be useful for this promotion. One of the NC Opioid Action Plans strategies is to train pharmacists to provide and refer people to harm reduction services. The NC Board of Pharmacy and the NC Association of Pharmacists have been very supportive of non-prescription sales as an evidence-based practice, and this toolkit will help their promotion of non-prescription sales of syringes. The following flyer was created by the NC Harm Reduction Coalition with assistance and support from the NC Board of Pharmacy, and it is housed on the Board of Pharmacys website. http://www.ncbop.org/faqs/FAQsNonPrescriptionSyringeSalesNC.pdf  I am in full support of the proposed CDC regulation on the Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies. Increasing community access to sterile syringes would help to reduce the incidence of sharing needles among those using drugs. HIV and Hepatitis C virus (HCV) transmission can occur through shared syringe use. Among the population of people who inject drugs, a 2018 study found that syringe sharing is popular among all age groups, with younger people ages 18-24 reporting the highest incidence of sharing needles (48%), with findings concluding that 32% of the population shares syringes (Centers for Disease Control and Prevention, 2021). Thus, shared syringes during injection drug use are a major contributing factor to HIV transmission. According to the (CDC, 2021), In 2016, injection drug use (IDU) contributed to nearly 20 percent of recorded HIV cases among menmore than 150,000 patients. Among females, 21 percent (about 50,000) of HIV cases attributed to IDU. Additionally, women who become infected with a virus can pass it to their baby during pregnancy, regardless of their drug use. Thus, implementing the Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies can indirectly positively impact mother-to-child HIV transmission rates.Risk reduction programs known as Syringe Service Programs (SSPs) aimed to increase syringe access have been implemented in urban, rural, and suburban communities throughout the United States. The programs have successfully presented a direct between increased access to sterile syringes and a reduction in HIV/AIDs cases. While these programs have shown to help reduce viral infections alone, they cannot adequately supply the number of sterile syringes needed to prevent outbreaks. The existence of an SSP in an area, however, will not necessarily prevent an outbreak of HIV or HCV infection; in addition to substance use prevention and treatment services, PWID needs access to an adequate number of sterile syringes. The Joint United Nations Programme on HIV/Acquired Immunodeficiency Syndrome (AIDS) (UNAIDS) recommends the provision of 200 sterile syringes per injector per year for a high level of coverage. Access to sterile syringes can be provided through SSPs and through pharmacy sales. (Des Jarlais, 2015). The Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies would help meet the need to adequately supply sterile needs for this population which is at increased risk for HIV/HCV infection.Allowing sterile syringes to be sold in community pharmacies would in access to many injection drug users. In rural communities, injection drug use has increased, creating an increased need for sterile syringe access. According to (Havens, Oser, and Leukefeld, 2011), nonmedical prescription opioid users reported the prevalence of IDU to be 44.3%; and the majority of these IDUs were injecting controlled-release oxycodone formulations rather than heroin and/or cocaine. This rapid escalation in the number of IDUs puts this population at increased risk for HIV and other blood borne infections. The Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies would benefit such communities as pharmacies are readily accessible, typically within 20 miles from residential homes (Casey, Klingner, and Moscovice, (2002). The availability of sterile syringes in community pharmacies will prove to be equitable. Approximately 90% of the population lives within 5 miles of a community pharmacy (Kelling, 2015). Therefore, injection drug users in all communities will have access to sterile syringes. Thus, decreasing the need to share needles and reducing the risk for HIV and HCV infection. Additionally, increasing access to sterile syringes via community pharmacies will decrease the burden HIV costs have on the healthcare system. The lifetime healthcare costs for a person infected with HIV at age 35 is approximately $326,500, with about 1.2 million people in the U.S living with HIV/AIDS (Ritchwood, Bishu, and Egede, 2017). Therefore, the proposed CDC regulation on the Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies will only prove beneficial to public health and the healthcare system.  