American Pharmacists Association Issues Public Comment on CDC Notice

WASHINGTON, June 12 -- Ilisa B.G. Bernstein, senior vice president for pharmacy practice and government affairs at the American Pharmacists Association, has issued a public comment on the Centers for Disease Control and Prevention notice entitled "Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies". The comment was written on June 4, 2021, and posted on June 8, 2021:

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The American Pharmacists Association (APhA) is pleased to submit our comments to the Centers for Disease Control and Prevention (CDC) in support of the proposed information collection project titled Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies, published in the Federal Register on April 5, 2021 (86 FR 17604).

Founded in 1852, APhA is the largest association of pharmacists in the United States representing the entire pharmacy profession. APhA members practice in community pharmacies, hospitals, long-term care facilities, specialty pharmacies, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and government facilities. Our members strive to improve medication use, advance patient care, and enhance public health.

Pharmacists are important providers on the patient's health care team and play a critical role in the following situations, among others:

* caring for patients with acute and chronic pain and/or substance use disorder (SUD) and opioid use disorder (OUD) including prescribing medications, as authorized;

* providing medication management;

* dispensing, and educating patients about opioid and non-opioid pain medications, including risks and safe storage and disposal;

* educating patients about nonpharmacologic therapies;

* aiding in harm reduction efforts by furnishing the opioid overdose reversal agent naloxone; and

* Participating in syringe services programs (SSPs), including providing nonprescription sterile syringes (NPSS) to people who inject drugs (PWID) in order to prevent the transmission of bloodborne pathogens such as HIV and hepatitis C virus (HCV).

APhA has longstanding House of Delegates' Policy, which reflects member and profession policy position, supporting the sale and safe disposal of sterile syringes. Specifically, APhA's policies state:

1999

Sale of Sterile Syringes

* APhA encourages state legislatures and boards of pharmacy to revise laws and regulations to permit the unrestricted sale or distribution of sterile syringes and needles by or with the knowledge of a pharmacist in an effort to decrease the transmission of blood-borne diseases./1

2001

Syringe Disposal

* APhA supports collaboration with other interested health care organizations, public and environmental health groups, waste management groups, syringe manufacturers, health insurers, and patient advocacy groups to develop and promote safer systems and procedures for the disposal of used needles and syringes by patients outside of health care facilities./2

2005, 1990

Needle/Syringe Exchange Programs in the Prevention of Blood-Borne Infectious Diseases

* APhA supports distribution of educational materials on the risks of sharing needles/syringes with respect to the spread of human immunodeficiency virus (HIV) and other blood-borne infectious diseases.

* APhA supports needle/syringe exchange programs when part of a comprehensive approach in the prevention of the spread of HIV and other blood-borne infections./3

In addition, in 2019, APhA's House of Delegates passed policy supporting pharmacists' roles in providing people who inject non-medically sanctioned psychotropic or psychoactive substances with sterile syringes, needles, and other safe injection equipment:

2019

Patient-Centered Care of People Who Inject Non-Medically Sanctioned Psychotropic or Psychoactive Substances

* APhA supports pharmacists' roles to provide and promote consistent, unrestricted, and immediate access to evidence-based, mortality- and morbidity-reducing interventions to enhance the health of people who inject non-medically sanctioned psychotropic or psychoactive substances and their communities, including: sterile syringes, needles, and other safe injection equipment, syringe disposal, fentanyl test strips, immunizations, condoms, wound care supplies, pre- and post-exposure prophylaxis medications for human immunodeficiency virus (HIV), point-of-care testing for HIV and hepatitis C virus (HCV), opioid overdose reversal medications, and medications for opioid use disorder.

* APhA urges pharmacists to refer people who inject non-medically sanctioned psychotropic or psychoactive substances to specialists in mental health, infectious diseases, and addiction treatment; to housing, vocational, harm reduction, and recovery support services; and to overdose prevention sites and syringe service programs./4

Accordingly, APhA was pleased to see CDC's intention to test its Harm Reduction Toolkit for Non-Prescription Syringe Sales in community pharmacies and believes that the agency's estimate of 73 annual burden hours for this information collection is reasonable.

Pharmacists are one of the most accessible health care providers in the nation, with nearly 90% of Americans living within five miles of a community pharmacy./5

Thus, pharmacists are well-positioned to provide sterile syringes to people who inject drugs and serve as a point-of-entry to the healthcare system to connect patients with SUD/OUD treatment, support, and recovery services. As CDC notes, "If people who inject drugs use an [syringe services program] SSP, they are more likely to enter treatment for substance use disorder and reduce or stop injecting."/6

APhA agrees with CDC that pharmacists can benefit from education and tools to build their NPSS-related skills and to support the delivery of NPSS in the community pharmacy setting.

APhA particularly appreciates the opportunity for pharmacists and pharmacy personnel to test the online NPSS training videos via pre-test and post-test online surveys. CDC might also want to capture pharmacists' attitudes towards NPSS in the pre-test survey instrument, in order to help determine whether education and training can effectively overcome potential negative attitudes. APhA expects that the number of syringe customers and service referrals and usage of the resource website for PWID will increase as pharmacists and pharmacy technicians become more aware of and comfortable with NPSS efforts as a result of training and education efforts.

Conclusion

Thank you for the opportunity to provide these comments in support of CDC's proposed information collection project titled Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies. If you have any questions or require additional information, please contact Karin Bolte, Director, Health Policy, at kbolte@aphanet.org or by phone at (202) 5582727.

Sincerely,

Ilisa BG Bernstein, PharmD, JD, FAPhA

Senior Vice President, Pharmacy Practice and Government Affairs

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Footnotes:

1/ JAPhA 39(4): 447 July/August 1999(Reviewed 2003)(Reviewed 2006)(Reviewed 2008)(Reviewed 2009)(Reviewed 2014)(Reviewed 2019).

2/ JAPhA 41(5): Suppl.1:S9 September/October 2001(Reviewed 2007)(Reviewed 2012)(Reviewed 2017).

3/ Am Pharm 30(6):45 June 1990 (JAPhA 45(5):556 September/October 2005) (Reviewed 2009)(Reviewed 2014)(Reviewed 2019).

4/ JAPhA 59(4):e17July/August 2019.

5/ NCPDP Pharmacy File, ArcGIS Census Tract File. NACDS Economics Department.

6/ CDC Syringe Services Programs (SSPs) FAQ, https://www.cdc.gov/ssp/syringe-services-programs-faq.html, last accessed June 1, 2021.

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The notice can be viewed at: https://www.regulations.gov/document/CDC-2021-0031-0001

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