- Email: [email protected]
Assessing pharmacists’ readiness to dispense naloxone and counsel on responding to opioid overdoses
SCIENCE AND PRACTICE Journal of the American Pharmacists Association 59 (2019) 550e554
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
RESEARCH NOTES
Assessing pharmacists’ readiness to dispense naloxone and counsel on responding to opioid overdoses Francis Melaragni, Carly Levy*, Jennifer Pedrazzi, Merissa Andersen a r t i c l e i n f o
a b s t r a c t
Article history: Received 20 November 2018 Accepted 8 April 2019 Available online 17 May 2019
Objectives: The United States declared the opioid crisis a Public Health Emergency in 2017 and recommended increasing access and availability of naloxone, a reversal agent for opioid overdose. In Massachusetts, there is a statewide standing order for naloxone, which allows pharmacists to dispense it without a prescription to any person at-risk of experiencing an opioid overdose or other persons who can assist individuals at-risk. The objective of this study was to determine whether pharmacists in Massachusetts have sufficient education and training to fulfill the duties associated with dispensing naloxone in community pharmacy settings. The researchers investigated the pharmacists’ ability to counsel patients both on naloxone and management of patients with an opioid overdose. Methods: At the time of the study, pharmacies could elect to have a standing order for naloxone. A randomized sample of 100 pharmacies was generated from the 792 pharmacies with a standing order. From this sample, 79 of the 100 pharmacies were visited on the basis of convenience and distribution in eastern and central Massachusetts. At each pharmacy, a validated 25-item survey was administered to pharmacists. Results: Fewer than half of participants knew that different formulations of naloxone possess different quantities. Although 52% of pharmacists indicated the need to call 9-1-1 when witnessing an opioid overdose, 8% knew to start rescue breathing, and 4% knew to place patients in the recovery position. Conclusion: Despite regulations requiring all pharmacies with a standing order to provide training on naloxone, many of the pharmacists surveyed did not have a strong understanding about naloxone products or its pharmacology. The level of education Massachusetts pharmacists possess on naloxone products and administration is not sufficient to counsel patients regarding this medication. Increasing training requirements in pharmacy schools and continuing education offers potential solutions to the lack of knowledge in the community pharmacy setting. © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Drug overdose is the leading cause of accidental death in the United States, with 70,237 lethal drug overdoses in 2017. Opioid use disorders are driving this epidemic, with 17,029 overdose deaths related to prescription opioids, and 30,571 overdose deaths related to synthetic opioids in 2017 (64.2% of all overdose deaths).1 Massachusetts was the first state to declare opioid-related deaths a public health emergency in
Disclosures: Funding to carry out this project was provided by the Faculty Development Committee at MCPHS University Boston in a grant worth $3900. No other financial or personal conflicts of interest pertain to the execution of this research. * Correspondence: Carly Levy, DHS, MPH, CPH, MCPHS University, 179 Longwood Avenue, Boston, MA 02115. E-mail address: [email protected] (C. Levy).
March 2014. As part of the emergency declaration, a statewide task force was formed; it included stakeholders from affected families, public health officials, law enforcement agencies, health care professionals, and community service agencies to focus on understanding the problem and developing countermeasures.2 Since 2014, the Massachusetts Department of Public Health (MDPH) has funded the Massachusetts Opioid Addiction Prevention Coalition to develop strategies to support healthier communities. Massachusetts has implemented several initiatives, including increasing the number of Recovery High Schools across the Commonwealth and providing increased funding to recovery centers and support groups.2 Massachusetts has made a concerted effort to increase access to naloxone, a reversal agent for opioid overdose. Part of this effort was to provide a standing order that enables
https://doi.org/10.1016/j.japh.2019.04.012 1544-3191/© 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE Pharmacists’ readiness to dispense naloxone
Massachusetts’ pharmacists to dispense naloxone. The total number of pharmacies in Massachusetts is 1072 (Board of Registration in Pharmacy, telephone call, November 2018). At the time of this study (July to September 2017), 792 Massachusetts pharmacies had a standing order in place. As of December 31, 2017, all Massachusetts pharmacies licensed by the Board of Pharmacy were required to obtain a standing order, maintain sufficient supplies of naloxone rescue kits or other approved opioid antagonists, and report annually the amount of naloxone dispensed.3 In 2018, the Governor signed An Act for Prevention and Access to Appropriate Care and Treatment of Addiction. This legislation mandated a statewide standing order to allow pharmacies to dispense naloxone, while lifting the current requirement that each pharmacy in the Commonwealth have its own pharmacy-specific standing order.4 Naloxone is an opioid antagonist that blocks the mu opioid receptor to decrease and reverse potentially fatal respiratory depression associated with opioid overdose. Naloxone is widely used by laypeople (i.e., family members and bystanders), and increased access to naloxone is recommended.5,6 In Massachusetts and other states with standing orders, naloxone can be dispensed without an encounter with a prescriber. Pharmacists are often the only licensed health care professionals who have an opportunity to be in direct contact with those obtaining naloxone. It is essential that pharmacists who dispense naloxone are in a position to accurately and confidently counsel the recipients on its proper administration, storage, and usage. This need for pharmacists to be able to counsel the layperson has been recognized by MDPH, and this was the basis for requiring that all licensed pharmacists employed at a community pharmacy with a standing order complete a 1-hour training session on the proper use and administration of naloxone. MDPH maintains a list of approved trainings.7 There are well-established guidelines to follow when managing a patient with an opioid overdose, and pharmacists need to be able to communicate these while engaging clients. The established guidelines include knowing how to recognize an overdose, what to say when calling 9-1-1, how to provide rescue breathing, proper administration of naloxone in the right time intervals, and the importance of placing the person in a recovery position when they are not breathing for the patient.8 In addition, the pharmacist needs to be able to counsel on proper storage, potential adverse effects, who should receive naloxone, the Good Samaritan Laws, and the disposal of excess medications. As licensed professionals, pharmacists are in a unique position to recognize and counsel at-risk patients. In this role, pharmacists can have an impact by discussing and counseling on naloxone and other harm reduction strategies in a proactive manner. Although not all pharmacists have the same positive attitudes toward overdose reversal agents or the confidence to intervene in high-risk patient populations, those who do can play an increasingly important role in saving lives.9 Freeman et al.9 found that pharmacists who were more confident in their ability to counsel patients on naloxone were more willing and likely to initiate dispensing of naloxone to high-risk patients. With appropriate training and education and a nonjudgmental, empathetic perspective, pharmacists can play a crucial role in helping those directly and indirectly affected by opioid use disorders.
Objectives The goal of this study was to determine whether pharmacists in Massachusetts were prepared to provide education on naloxone, which is now more accessible in Massachusetts through the standing order. The researchers posit increased education would benefit pharmacists’ preparation to engage with at-risk patients and other community members to prevent further fatalities. Methods Before data collection, approval was obtained from the Massachusetts College of Pharmacy and Health Science University Institutional Review Board. Approximately 10 Bostonarea pharmacies were visited to pilot test the survey, after which the questions were adjusted accordingly. The questions were validated using subject matter experts and individuals experienced in survey design. The survey consisted of 2 parts: a section for the pharmacists to answer objective questions on naloxone and a section for the researcher to evaluate the pharmacists’ knowledge and confidence on a Likert scale. A randomized sample of 100 pharmacies was generated from all pharmacies in Massachusetts with a standing order for naloxone as of July 1, 2017 (a comprehensive map of locations visited is in Appendix 1). From this random sample, 79 pharmacies in eastern and central Massachusetts were visited during business hours in July through September, 2017. It is important to note that pharmacy selection was based on geographic location and proximity to the researchers. In addition, the study was conducted before the requirement for pharmacies to have a standing order and have rescue kits of naloxone available. At each pharmacy, a validated 25-item survey was verbally administered to licensed pharmacists to assess knowledge about naloxone administration and other essential response steps to manage opioid-related overdoses. After the interview, the researcher answered the remaining 6 questions. Informed consent was obtained from all participants before beginning. A 100% response rate was desired, but 4 of 79 pharmacists declined to participate. With 75 participants, there was a 95% response rate for the pilot survey. All 4 pharmacists who declined cited being too busy to participate. The questionnaire objectively assessed pharmacists’ knowledge through qualitative and quantitative questions. Items on the survey included recognition of opioid overdose and initial response, available naloxone formulations, concentration of naloxone in current formulations, dispensing procedures, and the protocol for administering naloxone and rescue breathing (the full-length survey is in Appendix 2, available on JAPhA.org as supplemental content). Results Eight percent (8%) of pharmacists interviewed correctly selected how many forms of naloxone are approved by the U.S. Food and Drug Administration, and 44% indicated the different formulations possess different quantities of the drug. Sixtynine percent of pharmacists knew that naloxone is only appropriate for opioid overdose, and it is not effective for alcohol or barbiturate overdose. Forty-four percent of
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SCIENCE AND PRACTICE F. Melaragni et al. / Journal of the American Pharmacists Association 59 (2019) 550e554
Table 1 Responding to opioid overdose with naloxone administration Question and response Witnessing an opioid overdose, what should you do before administering naloxone? Stimulate Call 9-1-1 Provide rescue breathing or cardiopulmonary resuscitation Place person in recovery position if breathing Other Witnessing an opioid overdose, what should you do after administering naloxone? Not sure Stay with person Place person in recovery position Provide rescue breathing Administer additional doses of naloxone if person is not breathing
pharmacists were aware naloxone should be administered to someone who has overdosed and is pregnant, and less (33%) knew it could be administered to a minor. Only 4% of pharmacists were able to identify all the standard steps that should be done before and after administering a naloxone dose. Table 1 demonstrates that although 52% of pharmacists indicated the need to call 9-1-1 when witnessing an opioid overdose, 8% knew that individuals responding to opioid overdoses should start rescue breathing, and only 4% knew to advise placing the patient in the recovery position. In addition, 17% mentioned that they knew individuals administering naloxone could administer a second dose. Most pharmacists (87%) indicated there is no risk in giving a second naloxone dose, but just 66% selected the appropriate time of 25 minutes to administer the next dose. Of the pharmacists interviewed, only 50% recommended naloxone to people filling opioid prescriptions. Overall, 70.67% of pharmacies promoted the availability of naloxone. The data indicated that 65% of pharmacists (n ¼ 49) had not assembled the nasal naloxone adapter, including pharmacists at 14 of the 24 (58.33%) locations carrying the Amphastar nasal naloxone with adapter. Nearly all the pharmacies (98.67%) sold syringes without a prescription, but only a total of 5 (6.67%) of the pharmacies offered syringe disposal on site. The majority of pharmacists (81.33%) recognized that they would benefit from additional training. Only 17.33% of pharmacists said that they would not benefit from additional training, and 1 pharmacist (1.33%) stated that they might benefit from additional training (Table 2).
No. of responses (%)
No. of responses, n
28.87 51.55 6.19 3.09 10.31
28 50 6 3 10
2.94 61.54 11.54 6.73 17.31
3 64 12 7 18
Discussion Despite Massachusetts regulations requiring training on naloxone for all pharmacists who work in a pharmacy with a standing order, this study demonstrates that surveyed pharmacists, as a whole, are inadequately trained and insufficiently knowledgeable about dispensing and counseling on the proper usage of naloxone for opioid overdoses. As accessible leaders in the health care community, they should be able to communicate the well-established guidelines to follow when dealing with someone who has overdosed from opioids. In addition, as drug experts, pharmacists should be able to counsel on the mechanism of action, administration, proper storage, and potential adverse effects of naloxone. Our results showed that the pharmacists in Massachusetts might not currently have the expertise required in this field of study, and additional education and training could be of great benefit. With appropriate training and education, pharmacists can help to reduce opioid-related deaths. Our study showed that improvement is necessary when it comes to pharmacists’ understanding of the naloxone product and pharmacology. Given that 2 of the 4 formulations are used widely in community-based settings, the researchers expected pharmacists would have a better understanding of the different types of naloxone. It is vital for pharmacists to know the difference between the naloxone products, as each contains a different quantity of drug per dose. Thirty-one percent of surveyed pharmacists responded that naloxone could be
Table 2 Survey responses from pharmacists in Massachusetts Question Does your pharmacy currently have naloxone (Narcan) available? Do the different FDA-approved forms of naloxone possess the same quantity of drug? Have you completed training for naloxone dispensing and storage? Have you dispensed naloxone to anyone? Have you assembled a naloxone nasal spray kit? Can naloxone be administered to someone who is pregnant? Can naloxone be used for barbiturate or alcohol overdoses? Are there any risks to a giving a second dose of naloxone? Can someone in your pharmacy tell me a location to safely dispose of prescription opioids? Does your pharmacy make any attempt to promote the availability of naloxone? Does your pharmacy sell nonprescription syringes? Does your pharmacy allow syringe disposal? Would you benefit by having additional training on naloxone and rescue breathing? Abbreviation used: FDA, U.S. Food and Drug Administration.
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Yes (n) 100% 30.67% 96% 78.67% 34.67% 44% 16% 1.33% 97.33% 70.67% 98.67% 6.67% 81.33%
(75) (23) (72) (59) (26) (33) (12) (1) (73) (53) (74) (5) (61)
No (n)
Not sure (n)
0
0 25.33% 0 0 0 46.67% 14.67% 12% 0 0 0 0 1.33%
44% 4% 21.33% 65.33% 9.33% 69.33% 86.67% 2.67% 29.33% 1.33% 93.33% 17.33%
(33) (3) (16) (49) (7) (52) (65) (2) (22) (1) (70) (13)
(19)
(35) (11) (9)
(1)
SCIENCE AND PRACTICE Pharmacists’ readiness to dispense naloxone
used for alcohol and barbiturate overdoses as well, showing that pharmacists may be improperly counseling patients on naloxone usage outside its use for opioids. Especially vulnerable populations, such as pregnant women and children, may be at greater risk of going without necessary treatment, because the majority of pharmacists interviewed were not aware that naloxone could be administered safely in these populations. By relaying drug safety information about naloxone, pharmacists might be able to help prevent opioidrelated deaths. Approximately half of pharmacists could not articulate what one should do after an opioid overdose. Although 52% mentioned they would instruct those responding to an overdose to call 9-1-1, few participants mentioned vital steps such as rescue breathing or placing the patient in the recovery position when appropriate. This raises concern because community members think of pharmacies as a safe place to turn to in times of emergency, but the results show that pharmacists currently might not have the knowledge to offer proper guidance. Only 17% of pharmacists offered that one should administer a second dose of naloxone if the person having an overdose had not started to breathe on their own. The need to use additional doses of naloxone, when available, is often a necessary step to reverse overdose from long-acting and synthetic opioids.10,11 Although dispensing naloxone without education and counseling could still make an impact in the community, it would be beneficial if pharmacists could counsel patients appropriately on how to respond to an opioid overdose. The final question asked whether pharmacists thought they would benefit from additional training on naloxone and opioid overdose. An overwhelming 81.33% stated yes, supporting our argument that pharmacists in Massachusetts would benefit from additional training. However, pharmacists answered this question directly after being quizzed on the topics of naloxone and opioid overdose, perhaps realizing that their knowledge was lacking. In reality, not all pharmacists are likely to be as willing to take on additional training voluntarily. As long as this health care epidemic continues, pharmacists might be expected to share naloxone information with patients and other community members. Required continuing professional education on opioid overdose and naloxone administration could be an appropriate venue to ensure that pharmacists are confident and able to play the crucial role their communities may need. The pharmacy profession has an opportunity to prevent deaths from overdoses and provide patients a chance at recovery. The limitations of the study include the pharmacies visited being in clustered areas. From the random sample of 100 pharmacies, 79 pharmacies were selected to interview on the basis of proximity to Boston and Worcester. This cohort limited the potential of information to be gathered from the more rural areas of western Massachusetts, Martha’s Vineyard, and Nantucket. Busier locations were less likely to engage in the survey, and 4 pharmacists denied participation, stating that they were too busy or understaffed. Our study applies only to pharmacies in Massachusetts with naloxone standing orders, and it cannot be generalized to other states or pharmacies without standing orders for naloxone. In comparison to the total number of pharmacies in Massachusetts with a standing order for naloxone at the time of the study (N ¼ 792), a
relatively small number of pharmacists were interviewed (n ¼ 79; approximately 10%). Although there might have been more responses if the survey were conducted online or via postal mail, there were some benefits to interviewing the pharmacists in person. First, the pharmacists could not prepare for the questionnaire. Second, the interviewers were able to capture the pharmacists’ time, whereas they might have ignored a paper or e-mailed survey. There were limitations evident in the design of the survey. When it comes to training, the survey did not ask what type of training pharmacists received, just whether they had been trained. In addition, some survey questions assumed that respondents had basic knowledge about first aid and cardiopulmonary resuscitation, which could be clarified for future studies when it comes to inquiring about recovery positions and breathing. The survey did not explicitly ask whether pharmacists knew that a second dose could be administered, but instead how long they needed to wait to administer a second dose. A better survey would preface that question with whether it would be permissible to administer a second dose. The survey asked about the 4 naloxone formulations approved by the U.S. Food and Drug Administration, which could be interpreted differently depending on a pharmacist’s knowledge. A future survey might remove “not sure” as an option, as respondents may have been more likely to select this answer and skew data. Another limitation is that the data are a cross-section of pharmacists’ knowledge in Massachusetts and might not reflect additional education or training the pharmacists might have received after the study. A future study could consider longitudinal data before and after an educational intervention. Conclusion The findings of this study should highlight the shortfalls of pharmacists’ knowledge of naloxone and overdose management in Massachusetts. Increased naloxone and opioid overdose training should be implemented for pharmacy students in Massachusetts, so that as practicing pharmacists, they can reduce opioid overdose deaths in the community. In addition, the survey results indicated that training requirements for licensed pharmacists are not adequate. Hands-on training or additional interactive training modules for pharmacists could be beneficial and should be explored. References 1. Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and OpioidInvolved Overdose DeathsdUnited States, 2013e2017. MMWR Morb Mortal Wkly Rep. 2019;67:1419e1427. 2. A comprehensive strategy to end opioid abuse in Massachusetts. Executive Office of Health and Human Services website. Available at: http://www. mass.gov/eohhs/feature-story/end-opioid-abuse-in-mass.html. Accessed February 13, 2018. 3. Policy No. 2017-03: Naloxone Dispensing via Standing Order. Executive Office of Health and Human Services website. Available at: https://www. mass.gov/files/documents/2017/10/12/policy-2017-03.pdf. Accessed February 23, 2018. 4. Policy No. 2018-04: Naloxone Dispensing via Standing Order. Executive Office of Health and Human Services website. Available at: https://www. mass.gov/news/dispensing-of-naloxone-by-standing-order. Accessed February 6, 2019. 5. Boyer, Edward W. Management of opioid analgesic overdose. New Engl J Med. 2012;367(2):146e155.
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6. Lim JK, Bratberg JP, Davis CS, Green TC, Walley AY. Prescribe to prevent: Overdose prevention and naloxone rescue kits for prescribers and pharmacists. J Addict Med. 2016;10(5):300. 7. Massachusetts Department of Public Health. Naloxone Rescue Kit. Available at: http://www.mass.gov/eohhs/docs/dph/quality/boards/ pharmacy/example-naloxone-standing-order-4-18-14.pdf. Accessed March 23, 2018. 8. Centers for Disease Control and Prevention. Preventing an opioid overdose. Available at: https://www.cdc.gov/drugoverdose/pdf/patients/Preventingan-Opioid-Overdose-Tip-Card-a.pdf. Accessed November 9, 2018. 9. Freeman PR, Goodin A, Troske S, et al. Pharmacists’ role in opioid overdose: Kentucky pharmacists’ willingness to participate in naloxone dispensing. J Am Pharm Assoc. 2017;57(2S):S28eS33. 10. Zuckerman M, Weisberg SN, Boyer EW. Pitfalls of intranasal naloxone. Prehosp Emerg Care. 2014;18(4):550e554.
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11. Faul M, Lurie P, Kinsman JM, Dailey MW, Crabaugh C, Sasser SM. Multiple naloxone administrations among emergency medical service providers is increasing, prehospital emergency care. Prehosp Emerg Care. 2014;21(4): 411e419. Francis Melaragni, MBA, Associate Professor, School of Pharmacy, Massachusetts College of Pharmacy and Health Sciences, Boston, MA Carly Levy, DHS, MPH, CPH, Assistant Professor of Public Health, School of Arts and Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston, MA Jennifer Pedrazzi, PharmD, Drug Safety Intake Associate III, Alexion Pharmaceuticals, Inc., New Haven, CT Merissa Andersen, PharmD, MPH, PGY-1 pharmacy resident, Mount Auburn Hospital, Cambridge, MA
SCIENCE AND PRACTICE Pharmacists’ readiness to dispense naloxone
Appendix
Appendix 1. Map of all surveyed pharmacy locations within this study.
Appendix 2. Pharmacy visit: Naloxone readiness survey 1. Location and time: Town/City: Date: Time: 2. Does your pharmacy currently have naloxone (Narcan) available? Yes No 3. Can I speak with a Pharmacist about this drug> Yes, right away. Yes, in ___ minutes. Not at this time. 4. Which forms of Naloxone does your pharmacy currently have in stock? Nasal (Amphastar) Nasal (Adapt Pharma) Auto injector (Evzio) Syringe based 5. How many forms of naloxone are approved by the FDA? 1 2 3 4 Not sure 6. Do the different FDA-approved forms of Naloxone possess the same quantity of drug? Yes No Not sure 7. Have you completed training for Naloxone dispensing and storage? Yes No Not sure
8. Have you dispensed Naloxone to anyone? Yes No Not sure 9. Have you assembled a naloxone nasal spray kit? Yes No Not sure 10. If I witness someone who has an opioid overdose, what things should be done before naloxone is administered (check all that are mentioned)? Stimulate Call 9-1-1 Provide rescue breathing or CPR Place person in recovery position Other 11. Can you describe how rescue breathing should be administered to a person who is having an opioid overdose? Yes Maybe No 12. Can naloxone be administered to someone who is pregnant? Yes No Not sure 13. Can naloxone be administered to a minor (someone 16 or younger)? Yes No Not sure 14. Can naloxone be used for barbiturate or alcohol overdoses? Yes
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SCIENCE AND PRACTICE F. Melaragni et al. / Journal of the American Pharmacists Association 59 (2019) 550e554
15.
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No Not sure What things should be done after naloxone has been administered (check all that are mentioned)? , Not sure , Stay with person , Place person in rescue position , Continue to provide rescue breathing , Administer additional doses of naloxone if person is not breathing Are there any risks to give a second dose of naloxone? Yes No Not sure How long before a second dose of naloxone can be administered? Immediately 2-5 minutes 5-10 minutes More than 10 minutes Where should naloxone be stored? Room temperature away from direct sunlight Refrigerator Other Unclear Can you or someone in your pharmacy tell me a location to dispose of excess prescription opioids? Yes Maybe No Does your pharmacy recommend naloxone to those who fill an opioid prescription? Yes No Only in some cases Does your pharmacy provide information about the Massachusetts Good Samaritan Law when naloxone is dispensed? Yes No In some cases Does your pharmacy make any attempt to promote the availability and efficacy of naloxone? Yes No Not sure Does your pharmacy sell nonprescription syringes? Yes No Does your pharmacy allow syringe disposal? Yes No Would you benefit by having additional training on naloxone and rescue breathing? Yes Maybe No The pharmacist was able to provide accurate information about the availability of naloxone (Strongly
agreedcorrect description of standing order, pricing, and availability; Strongly disagreedno correct information).
Strongly agree (1)
Somewhat Neither agree Somewhat agree (2) nor disagree (3) disagree (4)
Strongly disagree (5)
(1)
27. Comments 28. The pharmacist was able to provide accurate information about the administration of naloxone (Strongly agreedcorrect route, dose, time, indications; Strongly disagreedno correct information).
Strongly agree (1)
Somewhat Neither agree Somewhat agree (2) nor disagree (3) disagree (4)
Strongly disagree (5)
(1)
29. The pharmacist was able to provide accurate information about the administration of rescue breathing (Strongly agreedcorrect indications, description of opening the airway, pinching the nose, and correct mouth placement; Strongly disagreedno correct information).
Strongly Somewhat Neither agree (2) agree or Agree disagree (1) (3)
Somewhat Strongly Disagree disagree (5) (4)
Click to write Statement 1 (1)
30. The pharmacist was helpful, confident, and appeared well prepared when describing the administration of naloxone and rescue breathing.
Strongly agree (1)
Somewhat Neither agree Somewhat agree (2) nor disagree (3) disagree (4)
Strongly disagree (5)
(1)
31. Comments Abbreviations used: FDA, U.S. Food and Drug Administration; CPR, cardiopulmonary resuscitation.
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
RESEARCH NOTES
Assessing pharmacists’ readiness to dispense naloxone and counsel on responding to opioid overdoses Francis Melaragni, Carly Levy*, Jennifer Pedrazzi, Merissa Andersen a r t i c l e i n f o
a b s t r a c t
Article history: Received 20 November 2018 Accepted 8 April 2019 Available online 17 May 2019
Objectives: The United States declared the opioid crisis a Public Health Emergency in 2017 and recommended increasing access and availability of naloxone, a reversal agent for opioid overdose. In Massachusetts, there is a statewide standing order for naloxone, which allows pharmacists to dispense it without a prescription to any person at-risk of experiencing an opioid overdose or other persons who can assist individuals at-risk. The objective of this study was to determine whether pharmacists in Massachusetts have sufficient education and training to fulfill the duties associated with dispensing naloxone in community pharmacy settings. The researchers investigated the pharmacists’ ability to counsel patients both on naloxone and management of patients with an opioid overdose. Methods: At the time of the study, pharmacies could elect to have a standing order for naloxone. A randomized sample of 100 pharmacies was generated from the 792 pharmacies with a standing order. From this sample, 79 of the 100 pharmacies were visited on the basis of convenience and distribution in eastern and central Massachusetts. At each pharmacy, a validated 25-item survey was administered to pharmacists. Results: Fewer than half of participants knew that different formulations of naloxone possess different quantities. Although 52% of pharmacists indicated the need to call 9-1-1 when witnessing an opioid overdose, 8% knew to start rescue breathing, and 4% knew to place patients in the recovery position. Conclusion: Despite regulations requiring all pharmacies with a standing order to provide training on naloxone, many of the pharmacists surveyed did not have a strong understanding about naloxone products or its pharmacology. The level of education Massachusetts pharmacists possess on naloxone products and administration is not sufficient to counsel patients regarding this medication. Increasing training requirements in pharmacy schools and continuing education offers potential solutions to the lack of knowledge in the community pharmacy setting. © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Drug overdose is the leading cause of accidental death in the United States, with 70,237 lethal drug overdoses in 2017. Opioid use disorders are driving this epidemic, with 17,029 overdose deaths related to prescription opioids, and 30,571 overdose deaths related to synthetic opioids in 2017 (64.2% of all overdose deaths).1 Massachusetts was the first state to declare opioid-related deaths a public health emergency in
Disclosures: Funding to carry out this project was provided by the Faculty Development Committee at MCPHS University Boston in a grant worth $3900. No other financial or personal conflicts of interest pertain to the execution of this research. * Correspondence: Carly Levy, DHS, MPH, CPH, MCPHS University, 179 Longwood Avenue, Boston, MA 02115. E-mail address: [email protected] (C. Levy).
March 2014. As part of the emergency declaration, a statewide task force was formed; it included stakeholders from affected families, public health officials, law enforcement agencies, health care professionals, and community service agencies to focus on understanding the problem and developing countermeasures.2 Since 2014, the Massachusetts Department of Public Health (MDPH) has funded the Massachusetts Opioid Addiction Prevention Coalition to develop strategies to support healthier communities. Massachusetts has implemented several initiatives, including increasing the number of Recovery High Schools across the Commonwealth and providing increased funding to recovery centers and support groups.2 Massachusetts has made a concerted effort to increase access to naloxone, a reversal agent for opioid overdose. Part of this effort was to provide a standing order that enables
https://doi.org/10.1016/j.japh.2019.04.012 1544-3191/© 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE Pharmacists’ readiness to dispense naloxone
Massachusetts’ pharmacists to dispense naloxone. The total number of pharmacies in Massachusetts is 1072 (Board of Registration in Pharmacy, telephone call, November 2018). At the time of this study (July to September 2017), 792 Massachusetts pharmacies had a standing order in place. As of December 31, 2017, all Massachusetts pharmacies licensed by the Board of Pharmacy were required to obtain a standing order, maintain sufficient supplies of naloxone rescue kits or other approved opioid antagonists, and report annually the amount of naloxone dispensed.3 In 2018, the Governor signed An Act for Prevention and Access to Appropriate Care and Treatment of Addiction. This legislation mandated a statewide standing order to allow pharmacies to dispense naloxone, while lifting the current requirement that each pharmacy in the Commonwealth have its own pharmacy-specific standing order.4 Naloxone is an opioid antagonist that blocks the mu opioid receptor to decrease and reverse potentially fatal respiratory depression associated with opioid overdose. Naloxone is widely used by laypeople (i.e., family members and bystanders), and increased access to naloxone is recommended.5,6 In Massachusetts and other states with standing orders, naloxone can be dispensed without an encounter with a prescriber. Pharmacists are often the only licensed health care professionals who have an opportunity to be in direct contact with those obtaining naloxone. It is essential that pharmacists who dispense naloxone are in a position to accurately and confidently counsel the recipients on its proper administration, storage, and usage. This need for pharmacists to be able to counsel the layperson has been recognized by MDPH, and this was the basis for requiring that all licensed pharmacists employed at a community pharmacy with a standing order complete a 1-hour training session on the proper use and administration of naloxone. MDPH maintains a list of approved trainings.7 There are well-established guidelines to follow when managing a patient with an opioid overdose, and pharmacists need to be able to communicate these while engaging clients. The established guidelines include knowing how to recognize an overdose, what to say when calling 9-1-1, how to provide rescue breathing, proper administration of naloxone in the right time intervals, and the importance of placing the person in a recovery position when they are not breathing for the patient.8 In addition, the pharmacist needs to be able to counsel on proper storage, potential adverse effects, who should receive naloxone, the Good Samaritan Laws, and the disposal of excess medications. As licensed professionals, pharmacists are in a unique position to recognize and counsel at-risk patients. In this role, pharmacists can have an impact by discussing and counseling on naloxone and other harm reduction strategies in a proactive manner. Although not all pharmacists have the same positive attitudes toward overdose reversal agents or the confidence to intervene in high-risk patient populations, those who do can play an increasingly important role in saving lives.9 Freeman et al.9 found that pharmacists who were more confident in their ability to counsel patients on naloxone were more willing and likely to initiate dispensing of naloxone to high-risk patients. With appropriate training and education and a nonjudgmental, empathetic perspective, pharmacists can play a crucial role in helping those directly and indirectly affected by opioid use disorders.
Objectives The goal of this study was to determine whether pharmacists in Massachusetts were prepared to provide education on naloxone, which is now more accessible in Massachusetts through the standing order. The researchers posit increased education would benefit pharmacists’ preparation to engage with at-risk patients and other community members to prevent further fatalities. Methods Before data collection, approval was obtained from the Massachusetts College of Pharmacy and Health Science University Institutional Review Board. Approximately 10 Bostonarea pharmacies were visited to pilot test the survey, after which the questions were adjusted accordingly. The questions were validated using subject matter experts and individuals experienced in survey design. The survey consisted of 2 parts: a section for the pharmacists to answer objective questions on naloxone and a section for the researcher to evaluate the pharmacists’ knowledge and confidence on a Likert scale. A randomized sample of 100 pharmacies was generated from all pharmacies in Massachusetts with a standing order for naloxone as of July 1, 2017 (a comprehensive map of locations visited is in Appendix 1). From this random sample, 79 pharmacies in eastern and central Massachusetts were visited during business hours in July through September, 2017. It is important to note that pharmacy selection was based on geographic location and proximity to the researchers. In addition, the study was conducted before the requirement for pharmacies to have a standing order and have rescue kits of naloxone available. At each pharmacy, a validated 25-item survey was verbally administered to licensed pharmacists to assess knowledge about naloxone administration and other essential response steps to manage opioid-related overdoses. After the interview, the researcher answered the remaining 6 questions. Informed consent was obtained from all participants before beginning. A 100% response rate was desired, but 4 of 79 pharmacists declined to participate. With 75 participants, there was a 95% response rate for the pilot survey. All 4 pharmacists who declined cited being too busy to participate. The questionnaire objectively assessed pharmacists’ knowledge through qualitative and quantitative questions. Items on the survey included recognition of opioid overdose and initial response, available naloxone formulations, concentration of naloxone in current formulations, dispensing procedures, and the protocol for administering naloxone and rescue breathing (the full-length survey is in Appendix 2, available on JAPhA.org as supplemental content). Results Eight percent (8%) of pharmacists interviewed correctly selected how many forms of naloxone are approved by the U.S. Food and Drug Administration, and 44% indicated the different formulations possess different quantities of the drug. Sixtynine percent of pharmacists knew that naloxone is only appropriate for opioid overdose, and it is not effective for alcohol or barbiturate overdose. Forty-four percent of
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Table 1 Responding to opioid overdose with naloxone administration Question and response Witnessing an opioid overdose, what should you do before administering naloxone? Stimulate Call 9-1-1 Provide rescue breathing or cardiopulmonary resuscitation Place person in recovery position if breathing Other Witnessing an opioid overdose, what should you do after administering naloxone? Not sure Stay with person Place person in recovery position Provide rescue breathing Administer additional doses of naloxone if person is not breathing
pharmacists were aware naloxone should be administered to someone who has overdosed and is pregnant, and less (33%) knew it could be administered to a minor. Only 4% of pharmacists were able to identify all the standard steps that should be done before and after administering a naloxone dose. Table 1 demonstrates that although 52% of pharmacists indicated the need to call 9-1-1 when witnessing an opioid overdose, 8% knew that individuals responding to opioid overdoses should start rescue breathing, and only 4% knew to advise placing the patient in the recovery position. In addition, 17% mentioned that they knew individuals administering naloxone could administer a second dose. Most pharmacists (87%) indicated there is no risk in giving a second naloxone dose, but just 66% selected the appropriate time of 25 minutes to administer the next dose. Of the pharmacists interviewed, only 50% recommended naloxone to people filling opioid prescriptions. Overall, 70.67% of pharmacies promoted the availability of naloxone. The data indicated that 65% of pharmacists (n ¼ 49) had not assembled the nasal naloxone adapter, including pharmacists at 14 of the 24 (58.33%) locations carrying the Amphastar nasal naloxone with adapter. Nearly all the pharmacies (98.67%) sold syringes without a prescription, but only a total of 5 (6.67%) of the pharmacies offered syringe disposal on site. The majority of pharmacists (81.33%) recognized that they would benefit from additional training. Only 17.33% of pharmacists said that they would not benefit from additional training, and 1 pharmacist (1.33%) stated that they might benefit from additional training (Table 2).
No. of responses (%)
No. of responses, n
28.87 51.55 6.19 3.09 10.31
28 50 6 3 10
2.94 61.54 11.54 6.73 17.31
3 64 12 7 18
Discussion Despite Massachusetts regulations requiring training on naloxone for all pharmacists who work in a pharmacy with a standing order, this study demonstrates that surveyed pharmacists, as a whole, are inadequately trained and insufficiently knowledgeable about dispensing and counseling on the proper usage of naloxone for opioid overdoses. As accessible leaders in the health care community, they should be able to communicate the well-established guidelines to follow when dealing with someone who has overdosed from opioids. In addition, as drug experts, pharmacists should be able to counsel on the mechanism of action, administration, proper storage, and potential adverse effects of naloxone. Our results showed that the pharmacists in Massachusetts might not currently have the expertise required in this field of study, and additional education and training could be of great benefit. With appropriate training and education, pharmacists can help to reduce opioid-related deaths. Our study showed that improvement is necessary when it comes to pharmacists’ understanding of the naloxone product and pharmacology. Given that 2 of the 4 formulations are used widely in community-based settings, the researchers expected pharmacists would have a better understanding of the different types of naloxone. It is vital for pharmacists to know the difference between the naloxone products, as each contains a different quantity of drug per dose. Thirty-one percent of surveyed pharmacists responded that naloxone could be
Table 2 Survey responses from pharmacists in Massachusetts Question Does your pharmacy currently have naloxone (Narcan) available? Do the different FDA-approved forms of naloxone possess the same quantity of drug? Have you completed training for naloxone dispensing and storage? Have you dispensed naloxone to anyone? Have you assembled a naloxone nasal spray kit? Can naloxone be administered to someone who is pregnant? Can naloxone be used for barbiturate or alcohol overdoses? Are there any risks to a giving a second dose of naloxone? Can someone in your pharmacy tell me a location to safely dispose of prescription opioids? Does your pharmacy make any attempt to promote the availability of naloxone? Does your pharmacy sell nonprescription syringes? Does your pharmacy allow syringe disposal? Would you benefit by having additional training on naloxone and rescue breathing? Abbreviation used: FDA, U.S. Food and Drug Administration.
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Yes (n) 100% 30.67% 96% 78.67% 34.67% 44% 16% 1.33% 97.33% 70.67% 98.67% 6.67% 81.33%
(75) (23) (72) (59) (26) (33) (12) (1) (73) (53) (74) (5) (61)
No (n)
Not sure (n)
0
0 25.33% 0 0 0 46.67% 14.67% 12% 0 0 0 0 1.33%
44% 4% 21.33% 65.33% 9.33% 69.33% 86.67% 2.67% 29.33% 1.33% 93.33% 17.33%
(33) (3) (16) (49) (7) (52) (65) (2) (22) (1) (70) (13)
(19)
(35) (11) (9)
(1)
SCIENCE AND PRACTICE Pharmacists’ readiness to dispense naloxone
used for alcohol and barbiturate overdoses as well, showing that pharmacists may be improperly counseling patients on naloxone usage outside its use for opioids. Especially vulnerable populations, such as pregnant women and children, may be at greater risk of going without necessary treatment, because the majority of pharmacists interviewed were not aware that naloxone could be administered safely in these populations. By relaying drug safety information about naloxone, pharmacists might be able to help prevent opioidrelated deaths. Approximately half of pharmacists could not articulate what one should do after an opioid overdose. Although 52% mentioned they would instruct those responding to an overdose to call 9-1-1, few participants mentioned vital steps such as rescue breathing or placing the patient in the recovery position when appropriate. This raises concern because community members think of pharmacies as a safe place to turn to in times of emergency, but the results show that pharmacists currently might not have the knowledge to offer proper guidance. Only 17% of pharmacists offered that one should administer a second dose of naloxone if the person having an overdose had not started to breathe on their own. The need to use additional doses of naloxone, when available, is often a necessary step to reverse overdose from long-acting and synthetic opioids.10,11 Although dispensing naloxone without education and counseling could still make an impact in the community, it would be beneficial if pharmacists could counsel patients appropriately on how to respond to an opioid overdose. The final question asked whether pharmacists thought they would benefit from additional training on naloxone and opioid overdose. An overwhelming 81.33% stated yes, supporting our argument that pharmacists in Massachusetts would benefit from additional training. However, pharmacists answered this question directly after being quizzed on the topics of naloxone and opioid overdose, perhaps realizing that their knowledge was lacking. In reality, not all pharmacists are likely to be as willing to take on additional training voluntarily. As long as this health care epidemic continues, pharmacists might be expected to share naloxone information with patients and other community members. Required continuing professional education on opioid overdose and naloxone administration could be an appropriate venue to ensure that pharmacists are confident and able to play the crucial role their communities may need. The pharmacy profession has an opportunity to prevent deaths from overdoses and provide patients a chance at recovery. The limitations of the study include the pharmacies visited being in clustered areas. From the random sample of 100 pharmacies, 79 pharmacies were selected to interview on the basis of proximity to Boston and Worcester. This cohort limited the potential of information to be gathered from the more rural areas of western Massachusetts, Martha’s Vineyard, and Nantucket. Busier locations were less likely to engage in the survey, and 4 pharmacists denied participation, stating that they were too busy or understaffed. Our study applies only to pharmacies in Massachusetts with naloxone standing orders, and it cannot be generalized to other states or pharmacies without standing orders for naloxone. In comparison to the total number of pharmacies in Massachusetts with a standing order for naloxone at the time of the study (N ¼ 792), a
relatively small number of pharmacists were interviewed (n ¼ 79; approximately 10%). Although there might have been more responses if the survey were conducted online or via postal mail, there were some benefits to interviewing the pharmacists in person. First, the pharmacists could not prepare for the questionnaire. Second, the interviewers were able to capture the pharmacists’ time, whereas they might have ignored a paper or e-mailed survey. There were limitations evident in the design of the survey. When it comes to training, the survey did not ask what type of training pharmacists received, just whether they had been trained. In addition, some survey questions assumed that respondents had basic knowledge about first aid and cardiopulmonary resuscitation, which could be clarified for future studies when it comes to inquiring about recovery positions and breathing. The survey did not explicitly ask whether pharmacists knew that a second dose could be administered, but instead how long they needed to wait to administer a second dose. A better survey would preface that question with whether it would be permissible to administer a second dose. The survey asked about the 4 naloxone formulations approved by the U.S. Food and Drug Administration, which could be interpreted differently depending on a pharmacist’s knowledge. A future survey might remove “not sure” as an option, as respondents may have been more likely to select this answer and skew data. Another limitation is that the data are a cross-section of pharmacists’ knowledge in Massachusetts and might not reflect additional education or training the pharmacists might have received after the study. A future study could consider longitudinal data before and after an educational intervention. Conclusion The findings of this study should highlight the shortfalls of pharmacists’ knowledge of naloxone and overdose management in Massachusetts. Increased naloxone and opioid overdose training should be implemented for pharmacy students in Massachusetts, so that as practicing pharmacists, they can reduce opioid overdose deaths in the community. In addition, the survey results indicated that training requirements for licensed pharmacists are not adequate. Hands-on training or additional interactive training modules for pharmacists could be beneficial and should be explored. References 1. Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and OpioidInvolved Overdose DeathsdUnited States, 2013e2017. MMWR Morb Mortal Wkly Rep. 2019;67:1419e1427. 2. A comprehensive strategy to end opioid abuse in Massachusetts. Executive Office of Health and Human Services website. Available at: http://www. mass.gov/eohhs/feature-story/end-opioid-abuse-in-mass.html. Accessed February 13, 2018. 3. Policy No. 2017-03: Naloxone Dispensing via Standing Order. Executive Office of Health and Human Services website. Available at: https://www. mass.gov/files/documents/2017/10/12/policy-2017-03.pdf. Accessed February 23, 2018. 4. Policy No. 2018-04: Naloxone Dispensing via Standing Order. Executive Office of Health and Human Services website. Available at: https://www. mass.gov/news/dispensing-of-naloxone-by-standing-order. Accessed February 6, 2019. 5. Boyer, Edward W. Management of opioid analgesic overdose. New Engl J Med. 2012;367(2):146e155.
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6. Lim JK, Bratberg JP, Davis CS, Green TC, Walley AY. Prescribe to prevent: Overdose prevention and naloxone rescue kits for prescribers and pharmacists. J Addict Med. 2016;10(5):300. 7. Massachusetts Department of Public Health. Naloxone Rescue Kit. Available at: http://www.mass.gov/eohhs/docs/dph/quality/boards/ pharmacy/example-naloxone-standing-order-4-18-14.pdf. Accessed March 23, 2018. 8. Centers for Disease Control and Prevention. Preventing an opioid overdose. Available at: https://www.cdc.gov/drugoverdose/pdf/patients/Preventingan-Opioid-Overdose-Tip-Card-a.pdf. Accessed November 9, 2018. 9. Freeman PR, Goodin A, Troske S, et al. Pharmacists’ role in opioid overdose: Kentucky pharmacists’ willingness to participate in naloxone dispensing. J Am Pharm Assoc. 2017;57(2S):S28eS33. 10. Zuckerman M, Weisberg SN, Boyer EW. Pitfalls of intranasal naloxone. Prehosp Emerg Care. 2014;18(4):550e554.
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11. Faul M, Lurie P, Kinsman JM, Dailey MW, Crabaugh C, Sasser SM. Multiple naloxone administrations among emergency medical service providers is increasing, prehospital emergency care. Prehosp Emerg Care. 2014;21(4): 411e419. Francis Melaragni, MBA, Associate Professor, School of Pharmacy, Massachusetts College of Pharmacy and Health Sciences, Boston, MA Carly Levy, DHS, MPH, CPH, Assistant Professor of Public Health, School of Arts and Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston, MA Jennifer Pedrazzi, PharmD, Drug Safety Intake Associate III, Alexion Pharmaceuticals, Inc., New Haven, CT Merissa Andersen, PharmD, MPH, PGY-1 pharmacy resident, Mount Auburn Hospital, Cambridge, MA
SCIENCE AND PRACTICE Pharmacists’ readiness to dispense naloxone
Appendix
Appendix 1. Map of all surveyed pharmacy locations within this study.
Appendix 2. Pharmacy visit: Naloxone readiness survey 1. Location and time: Town/City: Date: Time: 2. Does your pharmacy currently have naloxone (Narcan) available? Yes No 3. Can I speak with a Pharmacist about this drug> Yes, right away. Yes, in ___ minutes. Not at this time. 4. Which forms of Naloxone does your pharmacy currently have in stock? Nasal (Amphastar) Nasal (Adapt Pharma) Auto injector (Evzio) Syringe based 5. How many forms of naloxone are approved by the FDA? 1 2 3 4 Not sure 6. Do the different FDA-approved forms of Naloxone possess the same quantity of drug? Yes No Not sure 7. Have you completed training for Naloxone dispensing and storage? Yes No Not sure
8. Have you dispensed Naloxone to anyone? Yes No Not sure 9. Have you assembled a naloxone nasal spray kit? Yes No Not sure 10. If I witness someone who has an opioid overdose, what things should be done before naloxone is administered (check all that are mentioned)? Stimulate Call 9-1-1 Provide rescue breathing or CPR Place person in recovery position Other 11. Can you describe how rescue breathing should be administered to a person who is having an opioid overdose? Yes Maybe No 12. Can naloxone be administered to someone who is pregnant? Yes No Not sure 13. Can naloxone be administered to a minor (someone 16 or younger)? Yes No Not sure 14. Can naloxone be used for barbiturate or alcohol overdoses? Yes
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No Not sure What things should be done after naloxone has been administered (check all that are mentioned)? , Not sure , Stay with person , Place person in rescue position , Continue to provide rescue breathing , Administer additional doses of naloxone if person is not breathing Are there any risks to give a second dose of naloxone? Yes No Not sure How long before a second dose of naloxone can be administered? Immediately 2-5 minutes 5-10 minutes More than 10 minutes Where should naloxone be stored? Room temperature away from direct sunlight Refrigerator Other Unclear Can you or someone in your pharmacy tell me a location to dispose of excess prescription opioids? Yes Maybe No Does your pharmacy recommend naloxone to those who fill an opioid prescription? Yes No Only in some cases Does your pharmacy provide information about the Massachusetts Good Samaritan Law when naloxone is dispensed? Yes No In some cases Does your pharmacy make any attempt to promote the availability and efficacy of naloxone? Yes No Not sure Does your pharmacy sell nonprescription syringes? Yes No Does your pharmacy allow syringe disposal? Yes No Would you benefit by having additional training on naloxone and rescue breathing? Yes Maybe No The pharmacist was able to provide accurate information about the availability of naloxone (Strongly
agreedcorrect description of standing order, pricing, and availability; Strongly disagreedno correct information).
Strongly agree (1)
Somewhat Neither agree Somewhat agree (2) nor disagree (3) disagree (4)
Strongly disagree (5)
(1)
27. Comments 28. The pharmacist was able to provide accurate information about the administration of naloxone (Strongly agreedcorrect route, dose, time, indications; Strongly disagreedno correct information).
Strongly agree (1)
Somewhat Neither agree Somewhat agree (2) nor disagree (3) disagree (4)
Strongly disagree (5)
(1)
29. The pharmacist was able to provide accurate information about the administration of rescue breathing (Strongly agreedcorrect indications, description of opening the airway, pinching the nose, and correct mouth placement; Strongly disagreedno correct information).
Strongly Somewhat Neither agree (2) agree or Agree disagree (1) (3)
Somewhat Strongly Disagree disagree (5) (4)
Click to write Statement 1 (1)
30. The pharmacist was helpful, confident, and appeared well prepared when describing the administration of naloxone and rescue breathing.
Strongly agree (1)
Somewhat Neither agree Somewhat agree (2) nor disagree (3) disagree (4)
Strongly disagree (5)
(1)
31. Comments Abbreviations used: FDA, U.S. Food and Drug Administration; CPR, cardiopulmonary resuscitation.