Dataset Information

Adverse event associated with a change in nonprescription syringe sale policy.

ABSTRACT: To report and describe the possible correlation of a change in syringe sale policy at a community pharmacy with an adverse clinical outcome.Providence, RI, in summer 2009.27-year-old white woman with a long-standing history of chronic relapsing opiate addiction and human immunodeficiency virus (HIV)/hepatitis C virus (HCV) coinfection.The patient presented to the hospital emergency department with 5 days of severe diffuse pain, swelling in her hands and feet, and several days of rigors with fevers, sweats, and chills. She was diagnosed with sepsis resulting from a disseminated methicillin-resistant Staphylococcus aureus (MRSA) infection. The patient was treated with intravenous antibiotics, neurosurgical drainage of an epidural abscess, intensive care unit care for 1 week, and acute hospitalization for 8 weeks.Not applicable.A few weeks before the patient was hospitalized, pharmacists at her local neighborhood pharmacy decided to stop selling syringes in packages of 10. Instead, syringes were sold at a minimum quantity of 100. The patient did not know where to obtain sterile syringes and began reusing syringes.The patient introduced pathogenic bacteria from her skin into her bloodstream through unsafe injection practices. The change in syringe sale policy at her local pharmacy likely inadvertently contributed to this severe and life-threatening situation. Consideration of the implications of syringe sale policy must include an understanding of the barriers that influence individual pharmacist's decisions regarding particular store policies that affect over-the-counter syringe sales. Legalized sale of nonprescription syringes in community pharmacies alone is not enough to curb the epidemic of unsafe injection practices in the United States. All medical risks that are inherent in the use of unsafe syringes, including blood-borne viral pathogens (e.g., HIV, HCV) and bacterial infections (e.g., MRSA), should be considered.

SUBMITTER: Zaller ND

PROVIDER: S-EPMC3008769 | biostudies-literature | 2010 Sep-Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adverse event associated with a change in nonprescription syringe sale policy.

Zaller Nickolas D ND Yokell Michael A MA Jeronimo Alexandra A Bratberg Jeffrey P JP Case Patricia P Rich Josiah D JD

Journal of the American Pharmacists Association : JAPhA 20100901 5

<h4>Objective</h4>To report and describe the possible correlation of a change in syringe sale policy at a community pharmacy with an adverse clinical outcome.<h4>Setting</h4>Providence, RI, in summer 2009.<h4>Patient description</h4>27-year-old white woman with a long-standing history of chronic relapsing opiate addiction and human immunodeficiency virus (HIV)/hepatitis C virus (HCV) coinfection.<h4>Case summary</h4>The patient presented to the hospital emergency department with 5 days of severe ...[more]

PMID: 20833621

Similar Datasets

Project description:ObjectivesCalifornia Senate Bill 41 (SB41), effective January 2012, is a human immunodeficiency virus/hepatitis C virus prevention measure designed to expand syringe access among injection drug users (IDUs) by allowing pharmacies to sell syringes without a prescription. This study assesses self-reported implementation of SB41 and characterizes barriers amenable to intervention.DesignInterviewer-administered survey.Setting and participantsFresno and Kern Counties, CA. Pharmacists and other pharmacy staff (n = 404) at 212 pharmacies.Outcome measureSelf-reported nonprescription pharmacy sales to known or suspected IDUs.ResultsOverall, 29.3% of participants said their pharmacy would sell nonprescription syringes to a known or suspected IDU, whereas a far higher proportion (79.3%) would sell nonprescription syringes to a person with diabetes. More than one-half said that their pharmacy requires nonprescription syringe purchasers to enter their signature and name and address in a log book although that is not required under SB41. Fewer than 2 out of 3 participants (61.1%) knew that it is legal to sell nonprescription syringes to IDUs. That knowledge, as well as having syringe sales practices based on both store policy and discretion, were positively associated with IDU syringe sales after controlling for other factors. Working at an independent pharmacy, agreeing that only people with "medical conditions" such as diabetes should be able to buy syringes, and viewing syringe sales to IDUs as "not good business" were independently but negatively associated with IDU syringe sales.ConclusionThis study complements an earlier syringe purchase trial documenting low participation in voluntary nonprescription syringe sales under SB41 in Fresno and Kern Counties. In the absence of legislation requiring mandatory syringe sales, interventions should be developed to increase knowledge of the law and frame addiction as a medical condition, with a special focus on independent pharmacies. Informational interventions should stress the need to eliminate log book documentation requirements, which may serve as a barrier to IDU purchase.

Project description:BackgroundSpontaneous reports of adverse drug reactions (ADRs) form an essential component of both drug safety monitoring and patient safety initiatives. Pharmacists are well positioned to report ADRs, but many barriers exist to their doing so. Over the past decade, substantial changes have occurred with regard to drug regulations and medication safety initiatives, and it is possible that knowledge-based interventions may be needed to enhance ADR reporting by pharmacists.ObjectiveTo determine whether ADR reporting behaviours of pharmacists improved after release of a revised policy on the reporting of medication incidents.MethodsA telephone survey was administered to pharmacists practising in the Canadian Forces Health Services Group. Self-reported behaviours and perceived barriers related to ADR reporting were compared before and 3 months after the updated policy was released. Accuracy in participants' self-assessed ADR reporting was evaluated using independently derived workload statistics.ResultsDuring the second survey phase (after release of the revised policy), a greater proportion of respondents reported awareness of institutional policies on ADR reporting and declared that they were able to complete all necessary ADR reports during their assigned work hours. However, the number of ADR reports submitted did not increase. Participants' recall of their ADR reporting behaviour was corroborated by workload data. During the second survey phase, there was a noticeable reduction in the number of free-form comments mentioning lack of staff as a barrier to ADR reporting.ConclusionsRelease of a more comprehensive policy was not associated with an increase in the number of ADR reports generated by pharmacists in the study setting. Interventions to strengthen the organization's work processes for detection of ADRs and submission of individual ADR reports should be strongly considered, to reinforce and enhance existing ADR reporting behaviours among pharmacists.

Project description:BackgroundTaxanes are an essential class of antineoplastic agents used to treat various cancers and are a fundamental cause of hypersensitivity reactions. In addition, other adverse events, such as bone marrow toxicity and peripheral neuropathy, can lead to chemotherapy discontinuation. This study aimed to evaluate the safety of taxanes in the real world.MethodsTaxane-associated adverse events were identified by the Medical Dictionary for Regulatory Activities Preferred Terms and analyzed and compared by mining the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database from January 2004 to December 2019. Reported adverse events, such as hypersensitivity reaction, bone marrow toxicity, and peripheral neuropathy, were analyzed with the following signal detection algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), Bayesian confidence propagation neural network (BCPNN), and logistic regression methods. Adverse outcome events and death outcome rates were compared between different taxane groups using Pearson's χ2 test, whereas significance was determined at P < 0.05 with a 95% confidence interval (CI).ResultsA total of 966 reports of hypersensitivity reactions, 1109 reports of bone marrow toxicity, and 1374 reports of peripheral neuropathy were analyzed. Compared with paclitaxel and docetaxel, bone marrow toxicity following the use of nab-paclitaxel had the highest ROR of 6.45 (95% two-sided CI, 6.05-6.88), PRR of 5.66, (χ2 = 4342.98), information component of 2.50 (95% one-sided CI = 2.34), and empirical Bayes geometric mean of 5.64 (95% one-sided CI = 5.34). Peripheral neuropathy following the use of nab-paclitaxel showed a higher ROR of 12.78 (95% two-sided CI, 11.55-14.14), PRR of 12.16 (χ2 = 4060.88), information component of 3.59 (95% one-sided CI = 3.25), and empirical Bayes geometric mean of 12.07 (95% one-sided CI = 11.09).ConclusionsThe results showed that bone marrow toxicity and peripheral neuropathy were the major adverse events induced by taxanes. Nab-paclitaxel exhibited the highest potential for taxane-associated adverse events. Further research in the future is warranted to explain taxane-associated adverse effects in real-world circumstances.

Dataset Information

Adverse event associated with a change in nonprescription syringe sale policy.

Publications

Adverse event associated with a change in nonprescription syringe sale policy.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets