Dataset Information

Availability and Cost of Naloxone Nasal Spray at Pharmacies in Philadelphia, Pennsylvania, 2017.

ABSTRACT:

Importance

Despite the increasingly important role of pharmacies in the implementation of naloxone access laws, there is limited information on the impact of such laws at the local level.

Objective

To evaluate the availability (with or without a prescription) and cost of naloxone nasal spray at pharmacies in Philadelphia, Pennsylvania, following a statewide standing order enacted in Pennsylvania in August 2015 to allow pharmacies to dispense naloxone without a prescription.

Design, setting, and participants

A survey study was conducted by telephone of all pharmacies in Philadelphia between February and August 2017. Pharmacies were geocoded and linked with the American Community Survey (2011-2015) to obtain information on the demographic characteristics of census tracts and the Medical Examiner's Office of the Philadelphia Department of Public Health to derive information on the number of opioid overdose deaths per 100?000 people for each planning district. Data were analyzed from March 2018 to February 2019.

Main outcomes and measures

Availability and out-of-pocket cost of naloxone nasal spray (with or without a prescription) at Philadelphia pharmacies overall and by pharmacy and neighborhood characteristics.

Results

Of 454 eligible pharmacies, 418 were surveyed (92.1% response rate). One in 3 pharmacies (34.2%) had naloxone nasal spray in stock; of these, 61.5% indicated it was available without a prescription. There were significant differences in the availability of naloxone by pharmacy type and neighborhood characteristics. Naloxone was both more likely to be in stock (45.9% vs 27.8%; difference, 18.0%; 95% CI, 8.3%-27.8%; P?Conclusions and relevanceDespite the implementation of a statewide standing order in Pennsylvania more than 3 years prior to this study, only one-third of Philadelphia pharmacies carried naloxone nasal spray and many also required a physician's prescription. Efforts to strengthen the implementation of naloxone access laws and better ensure naloxone supply at local pharmacies are warranted, especially in localities with the highest rates of overdose death.

SUBMITTER: Guadamuz JS

PROVIDER: S-EPMC6563583 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Availability and Cost of Naloxone Nasal Spray at Pharmacies in Philadelphia, Pennsylvania, 2017.

Guadamuz Jenny S JS Alexander G Caleb GC Chaudhri Tanya T Trotzky-Sirr Rebecca R Qato Dima M DM

JAMA network open 20190605 6

<h4>Importance</h4>Despite the increasingly important role of pharmacies in the implementation of naloxone access laws, there is limited information on the impact of such laws at the local level.<h4>Objective</h4>To evaluate the availability (with or without a prescription) and cost of naloxone nasal spray at pharmacies in Philadelphia, Pennsylvania, following a statewide standing order enacted in Pennsylvania in August 2015 to allow pharmacies to dispense naloxone without a prescription.<h4>Des ...[more]

PMID: 31173125

Similar Datasets

Project description:OBJECTIVE:To assess the availability and price of naloxone as well as pharmacy staff knowledge of the standing order for naloxone in Pennsylvania pharmacies. METHODS:We conducted a telephone audit study from December 2016 to April 2017 in which staff from Pennsylvania pharmacies were surveyed to evaluate naloxone availability, staff understanding of the naloxone standing order, and out-of-pocket cost of naloxone. RESULTS:Responses were obtained from 682 of 758 contacted pharmacies (90% response rate). Naloxone was stocked (ie, available for dispensing) in 306 (45%) pharmacies surveyed. Of the 376 (55%) pharmacies that did not stock naloxone, 118 (31%) stated that they could place an order for naloxone for pickup within 1 business day. Responses by pharmacy staff to questions about key components of the standing order for naloxone were collected from 581 of the 682 pharmacies who participated in the survey (85%). Of the 581 pharmacy staff members who stated that they either stocked or could order naloxone, 64% correctly answered all questions pertaining to understanding of the naloxone standing order. The respective median out-of-pocket prices stated in the audit varied by formulation and ranged from $50 to $4000. Staff from national pharmacies were significantly more likely than staff from regional/local chain and non-chain pharmacies to correctly answer that a prescription was not required to obtain naloxone (68.5%, 57.7%, and 52.4% respectively, (P?=?0.0045). CONCLUSIONS:Multiple barriers to naloxone access exist in pharmacies across a large, diverse state, despite the presence of a standing order to facilitate such access. Limited availability of naloxone in pharmacies, lack of knowledge or understanding by pharmacy staff of the standing order, and variability in out-of-pocket cost for this drug are among these potential barriers. Regulatory or legal incentives for pharmacies or drug manufacturers, education efforts directed toward pharmacy staff members, or other interventions may be needed to increase naloxone availability in pharmacies.

Project description:ObjectivesTo examine the availability of naloxone in community pharmacies and examine differences in naloxone availability across pharmacy location, pharmacy type, and areas of greater opioid overdose mortality.MethodsA cross-sectional design was used to conduct a telephone survey of community pharmacists. A list of community pharmacies was obtained from the Georgia Board of Pharmacy; 25% were randomly selected, stratified across the National Center for Health Statistics rural-urban codes. The primary outcome was pharmacist-reported naloxone stock status. Predictor variables included urban and rural location, pharmacy type, and opioid related mortality rates. Descriptive statistics and multivariable logistic regression were performed using StataCorp. 2017 Stata Statistical Software: Release 15.ResultsOf the 600 pharmacies randomly selected, 166 pharmacies were not called because they were not open to the public or had known corporate policy prohibiting the release of stock information, or because of undisclosed reasons. Of the 434 called, 330 (76%) answered and agreed to participate and were included in the analysis. The majority were metropolitan (66%) and chain pharmacies with 4 or more locations (62%). Only 31% reported that naloxone was available for same-day purchase, 65% did not carry naloxone and 3% indicated that it was out of stock. Chain community pharmacies (CVS, Walgreens, etc.), were more likely than independent pharmacies to have naloxone for same-day purchase (45% vs 24%; OR = 2.106, 95% CI 1.124-3.943), and areas with high opioid mortality rates were more likely to have naloxone than areas with low mortality rates (38% vs. 24%; odds ratio 1.866 [95% CI 1.059-3.290]).ConclusionPatients in Georgia face barriers accessing the potentially life-saving medication naloxone. Most community pharmacies (69%) did not have naloxone stocked. Naloxone was less likely to be available from independent pharmacies and in areas of lower than average opioid mortality rates. Additional strategies are needed to increase access to naloxone in an effort to combat the opioid epidemic.

Project description:Background and aimsTake-home naloxone can prevent death from heroin/opioid overdose, but pre-provision is difficult because naloxone is usually given by injection. Non-injectable alternatives, including naloxone nasal sprays, are currently being developed. To be effective, the intranasal (i.n.) spray dose must be adequate but not excessive, and early absorption must be comparable to intramuscular (i.m.) injection. We report on the pharmacokinetics (PK) of a specially produced concentrated novel nasal spray. The specific aims were to: (1) estimate PK profiles of i.n. naloxone, (2) compare early systemic exposure with i.n. versus i.m. naloxone and (3) estimate i.n. bioavailability.DesignOpen-label, randomized, five-way cross-over PK study.SettingClinical trials facility (Croydon, UK).ParticipantsThirty-eight healthy volunteers (age 20-54 years; 11 female).Intervention and comparatorThree doses of i.n. (1 mg/0.1 ml, 2 mg/0.1 ml, 4 mg/0.2 ml) versus 0.4 mg i.m. (reference) and 0.4 mg intravenous (i.v.) naloxone.MeasurementsRegular blood samples were taken, with high-frequency sampling during the first 15 minutes to capture early systemic exposure. PK parameters were determined from plasma naloxone concentrations. Exploratory analyses involved simulation of repeat administration.FindingsMean peak concentration (Cmax ) values for 1 mg (1.51 ng/ml), 2 mg (2.87 ng/ml) and 4 mg (6.02 ng/ml) i.n. exceeded 0.4 mg i.m. (1.27 ng/ml) naloxone. All three i.n. doses rapidly achieved plasma levels > 50% of peak concentrations (T50%) by 10 minutes, peaking at 15-30 minutes (Tmax ). For comparison, the i.m. reference reached Tmax at 10 minutes. Mean bioavailability was 47-51% for i.n. relative to i.m. naloxone. Simulation of repeat dosing (2 × 2 mg i.n. versus 5 × 0.4 mg i.m. doses) at 3-minute intervals showed that comparable plasma naloxone concentrations would be anticipated.ConclusionsConcentrated 2 mg intranasal naloxone is well-absorbed and provides early exposure comparable to 0.4 mg intramuscular naloxone, following the 0.4 mg intramuscular curve closely in the first 10 minutes post-dosing and maintaining blood levels above twice the intramuscular reference for the next 2 hours.

Project description:CTX-M beta-lactamases were thought to be rare in the United States, but a recent study in Texas showed that up to 70% of extended-spectrum beta-lactamase (ESBL)-containing members of the Enterobacteriaceae family were CTX-M positive (J. S. Lewis, M. Herrera, B. Wickes, J. E. Patterson, and J. H. Jorgensen, Antimicrob. Agents Chemother. 51:4015-4021, 2007). We used PCR to detect CTX-M in all 291 extended-spectrum cephalosporin-resistant gram-negative bacteria isolated in our laboratory during 2007. Thirty (48%) Escherichia coli isolates, 6 (3%) Klebsiella sp. isolates, and 7 (100%) Proteus mirabilis isolates tested were CTX-M positive, with 15% of all Enterobacteriaceae tested being positive. The E. coli CTX-M groups were I (57%), IV (37%), II (3%), and not groupable (3%); three of the group IV isolates were positive for CTX-M-18, and three of the group I isolates were positive for CTX-M-15. One of seven positive P. mirabilis isolates was in group II, with the remainder being positive for a CTX-M-25-like beta-lactamase; and 33% of the Klebsiella sp. isolates were in group I or IV, with the remainder not being in groups I to IV. CTX-M-producing bacteria were isolated from urine (n = 13), blood (n = 13), wounds (n = 12), and the respiratory tract (n = 4). All 31 CTX-M-positive isolates tested for the presence of ESBL were confirmed to produce ESBLs by the use of tests recommended by the CLSI. Pulsed-field gel electrophoresis of the CTX-M-positive isolates showed that six P. mirabilis isolates were clonal and that there were seven different E. coli clusters. Five of seven P. mirabilis isolates were from blood cultures. The CLSI tests for the confirmation of ESBL production reliably detect these isolates if both cefotaxime and ceftazidime are tested, but only about half would be classified as a possible CTX-M producers on the basis of the antibiogram alone. A new panprimer set increases the ability to detect CTX-M-producing strains. CTX-M-positive bacteria are common in our geographic region, are often invasive, and, with the exception of P. mirabilis, are multiclonal.

Project description:ObjectivesThe objective of this study is to assess West Virginia pharmacists' stocking and dispensing practices of opioid-related medications and to identify the educational needs relating to providing naloxone in community pharmacies.DesignA cross-sectional, anonymous, 49-item survey was created and validated to assess the educational needs of West Virginia community pharmacists.SettingWest Virginia.ParticipantsThe data collection instrument was administered to 266 pharmacists currently licensed in West Virginia at 6 continuing pharmacy education events throughout the state from March 1 to June 15, 2016.Outcome measuresPharmacists' educational needs were determined using the Extended Parallel Process Model, which has 4 main constructs: perceived severity, perceived susceptibility, response efficacy, and self-efficacy. Pharmacists' stocking and dispensing of opioids and related medications were also assessed.ResultsPharmacists completed 157 surveys. They were mostly male (56.1%), full-time employees (67.5%), worked mostly in community pharmacies (69.4%), and had a mean age of 50.19 years (SD = 13.62). The newly adapted opioid perceived efficacy and perceived severity of opioid adverse events scales were tested for reliability and validity. Only 20.4% of the community pharmacists surveyed felt comfortable selling naloxone without a prescription. As for the other opioid-related medications, only 53.3% stocked buprenorphine and 74.8% stocked buprenorphine/naloxone.ConclusionsAs the most accessible health care providers, community pharmacists are acutely aware of how the opioid epidemic affects their communities. Some pharmacists in West Virginia are hesitant to stock and dispense opioids and opioid-dependence medications. Although this may decrease the flow of potentially abused drugs into the community, it may also restrict access to necessary therapy for patients with opioid use disorder. Furthermore, pharmacists in West Virginia are not yet comfortable stocking and dispensing naloxone. Tailored educational materials can help in controlling the pharmacists' fear and reinforce the benefits of over-the-counter naloxone use.

Dataset Information

Availability and Cost of Naloxone Nasal Spray at Pharmacies in Philadelphia, Pennsylvania, 2017.

Importance

Objective

Design, setting, and participants

Main outcomes and measures

Results

Publications

Availability and Cost of Naloxone Nasal Spray at Pharmacies in Philadelphia, Pennsylvania, 2017.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets