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NCSL Legisbrief Jun 2015(1) The Pew Charitable Trusts identified 27 compounding incidents that resulted in 89 deaths since 2001. (2) Unlike drug manufacturers, compounding pharmacies are...
(1) The Pew Charitable Trusts identified 27 compounding incidents that resulted in 89 deaths since 2001. (2) Unlike drug manufacturers, compounding pharmacies are generally not required to report adverse events associated with their products to the FDA. (3) Federal law on drug compounding was updated in 2013 to create a new group of compounders called "outsourcing facilities." Over 50 facilities in 23 states are now registered with the FDA.
Topics: Drug Compounding; Humans; Outsourced Services; Pharmacies; United States; United States Food and Drug Administration
PubMed: 26137607
DOI: No ID Found -
Disaster Medicine and Public Health... Jun 2020The aim of this study was to investigate the basic preparedness of rural community pharmacies to continue operations during and immediately following a disaster.
OBJECTIVES
The aim of this study was to investigate the basic preparedness of rural community pharmacies to continue operations during and immediately following a disaster.
METHODS
In 2014, we conducted a telephone survey (N = 990) of community pharmacies in 3 rural areas: North Dakota/South Dakota, West Virginia, Southern Oregon/Northern California regarding whether they had a formal disaster/continuity plan, offsite data backup, emergency power generation, and/or had a certified pharmacy immunizer on staff. Logistic regression and chi square were performed using Stata 11.1.
FINDINGS
Community pharmacies in rural areas (≤50.0 persons/mile2) were less likely to have emergency power (odds ratio [OR] = 0.59; 95% confidence interval [CI]: 0.32-1.07) or certified pharmacy immunizer on staff (OR = 0.47; 95% CI: 0.34-0.64). Pharmacies in lower income areas were less likely to have emergency power and offsite data backup or a formal disaster plan (OR = 0.70; 95% CI: 0.49-0.99) compared with pharmacies in higher income areas. Community pharmacies in areas of higher percent elderly population were less likely to have emergency power (OR = 0.54; 95% CI: 0.39-0.73), or certified pharmacy immunizer on staff (OR = 0.65; 95% CI: 0.47-0.91) compared with chain pharmacies in areas with lower percent elderly population.
CONCLUSIONS
Being in a rural, low-income, or high-elderly area was associated with lower likelihood of basic preparedness of community pharmacies.
Topics: California; Civil Defense; Humans; Logistic Models; North Dakota; Odds Ratio; Oregon; Pharmacies; Rural Population; South Dakota; Surveys and Questionnaires; West Virginia
PubMed: 31370915
DOI: 10.1017/dmp.2019.57 -
PloS One 2021Evaluation of patients`satisfaction towards pharmacy services is of utmost importance to ensure the quality of care. It helps in identifying domains requiring...
BACKGROUND
Evaluation of patients`satisfaction towards pharmacy services is of utmost importance to ensure the quality of care. It helps in identifying domains requiring improvements to provide high quality pharmacy services to ensure the provision of enhanced pharmaceutical care. The current study aims to ascertain the extent of satisfaction towards pharmacy services among patients attending outpatient pharmacies in Kingdom of Saudi Arabia.
METHODS
A hospital-based cross-sectional study involving 746 patients attending outpatient pharmacies of various public hospitals was conducted from 01 January to 15 February 2020. Information on socio-demographic profile of the study subjects along with their satisfaction towards outpatient pharmacy was extracted by using a 23-items questionnaire. These questions were divided into two domains including 7 questions related to the pharmacy facilities (questions from 1F to 7F) and 8 questions for pharmacy services (questions from 1S to 8S), where F and S denotes facilities and services, respectively. The cumulative satisfaction score was estimated by a 5-item Likert scale with a maximum score of 5 for each item. The relationship between demographics and satisfaction scores was evaluated by using appropriate statistics.
RESULTS
There were 746 patients with male preponderance (58.8%). The overall satisfaction score was 2.97 ± 0.65. Satisfaction towards pharmacy services scored lower (mean score: 3.91 ± 0.77) than pharmacy facilities (mean score: 4.03 ± 0.66). Items related to patient`s counseling (3F, 2S, 3S, 6S) scored least during the analysis. Older patients (p = 0.006), male gender (p<0.001), Saudi nationality (0.035), patients attending primary care centers (p = 0.02), and patients with chronic illnesses were significantly associated with lower satisfaction score.
CONCLUSION
This study reported that the satisfaction level of patients attending outpatient pharmacies was low and differed among various socio-demographic groups. Approximately one-half of the patients were not satisfied with outpatient pharmacy services. These findings underscore the dire need for managerial interventions including the hiring of trained professionals, onsite training of pharmacy staff, initiation of clinical or patient centered pharmacy services, evaluation of patient`s response towards the services and appropriate controlling measures, irrespective to the type of hospitals.
Topics: Adolescent; Adult; Cross-Sectional Studies; Female; Humans; Male; Middle Aged; Outpatients; Patient Satisfaction; Pharmacies; Pharmacists; Primary Health Care; Saudi Arabia; Surveys and Questionnaires; Young Adult
PubMed: 33793604
DOI: 10.1371/journal.pone.0247912 -
JAMA Psychiatry Nov 2020Methadone maintenance is an effective treatment of opioid use disorder, but federal regulations in the US restrict methadone dispensing to opioid treatment programs...
IMPORTANCE
Methadone maintenance is an effective treatment of opioid use disorder, but federal regulations in the US restrict methadone dispensing to opioid treatment programs (OTPs). In Australia, Canada, and the UK, patients can obtain methadone maintenance from community pharmacies.
OBJECTIVE
To compare driving access to methadone maintenance treatment between OTP and pharmacy dispensing models.
DESIGN, SETTING, AND PARTICIPANTS
This descriptive cross-sectional study assessed driving times from census tract mean centers of population to OTPs and pharmacies. Census tracts from the 50 US states and the District of Columbia (based on the 2010 US Census) were included if their population was greater than 0, if their mean center of population (MCP) was within 3 miles of the road network, and if the 1-way driving times from the census tract MCP to both an OTP and a pharmacy were 12 hours or less. Data analyses were performed from November 15, 2019, to April 18, 2020.
MAIN OUTCOMES AND MEASURES
The primary outcome was the population-weighted mean driving time from census tract MCPs to OTPs and pharmacies in the US. Census tract MCPs are population-weighted geographic centroids of residents living in each census tract. Driving times were estimated using historical average driving speeds.
RESULTS
All 1682 unique locations of OTPs were included, and 69 475 unique pharmacy locations were included after geocoding. A total of 72 443 census tracts were included in the analysis. The mean population-weighted driving time from census tract MCPs was 20.4 minutes (95% CI, 20.3-20.6 minutes) to OTPs and 4.5 minutes (95% CI, 4.4-4.5 minutes) to pharmacies (P < .001). Differences in driving time, distance, and cost between 1-way trips ending at OTPs and pharmacies were largest in micropolitan and noncore counties.
CONCLUSIONS AND RELEVANCE
In this study, population-weighted mean driving times from US census tract MCPs were longer to OTPs than to pharmacies.
Topics: Ambulatory Care Facilities; Automobile Driving; Cross-Sectional Studies; Humans; Opiate Substitution Treatment; Pharmacies; Time Factors; United States
PubMed: 32667648
DOI: 10.1001/jamapsychiatry.2020.1624 -
Journal of Evaluation in Clinical... Feb 2023To ensure that quality medicines are available to the populace.
RATIONALE
To ensure that quality medicines are available to the populace.
AIM AND OBJECTIVE
To provide a new perspective for drug sampling and testing using a risk-based approach globally, and provide a reference for improving the efficiency of the drug sampling and testing programme in China.
METHOD
This study used a combination of theoretical analysis and problem analysis. First, we analysed the high-risk drugs that should be given attention to theoretically in the drug sampling testing programme based on the healthcare reform in China. Second, this study leveraged on data on the sampling and testing of drugs extracted from self-constructed data by the China Food and Drug Administration (CFDA). The integrated and structured data sets were used to conduct an innovative analysis that identifies the actual content of the drug sampling and testing programme and contrasts them with the theoretical content to understand the problems. This study used quantitative and qualitative approaches for data analysis.
RESULTS
Following analysis, we discovered that there is still a big gap between the reality of drug sampling and testing in China and the ideal state of the objective requirements of healthcare reforms. The major sources of risk are the retail pharmacies or hospital pharmacies in the distribution chain of drugs; however, the CFDA sampled mostly drugs from drug manufacturers. Additionally, the CFDA did not sample adequate essential medicines, bid-winning drugs (especially those with large price drops in centralized procurement), biological products and other high-risk drug varieties. The high-risk drugs produced by companies or enterprises with a history of noncompliance, especially bid-winning enterprises in centralized procurement, were not sampled.
CONCLUSION
We suggest that the major content of drug sampling and testing in China should focus on the link of drug utilization, varieties of drugs with large price drops in centralized procurement and bid-winning enterprises with a history of noncompliance.
Topics: Humans; Pharmaceutical Preparations; Drugs, Essential; China; Pharmacies
PubMed: 35719019
DOI: 10.1111/jep.13725 -
International Journal of Clinical... Feb 2018Background Pharmacists are increasingly involved in patient care. This new role in a complex healthcare system with demanding patients may lead to moral dilemmas. There...
Background Pharmacists are increasingly involved in patient care. This new role in a complex healthcare system with demanding patients may lead to moral dilemmas. There has been little research into pharmacy ethics, and existing data are limited by their retrospective nature and small sample sizes. A thematic overview of the moral dilemmas experienced by community pharmacists is still missing. Objective To make a thematic overview of moral dilemmas experienced in daily pharmacy practice. Setting Dutch community pharmacy. Methods Dutch community pharmacists wrote a narrative about a moral dilemma they had experienced in clinical practice. The narratives were analysed using qualitative content analysis to identify underlying themes. Main outcome measure Themes of moral dilemmas. Results Twenty-two themes were identified in 128 narratives. These moral dilemmas arose predominantly during pharmacists' contact with patients and other health professionals. The relationship between the pharmacist, patient and other health professionals was complicated by other parties, such as legal representatives, health insurance companies, and regulators. Conclusion The moral dilemmas experienced by community pharmacists are more diverse than previously reported. The main dilemmas arose in their professional contacts, frequently when their professional autonomy was challenged by the behaviour of patients and other health professionals.
Topics: Community Pharmacy Services; Ethics, Pharmacy; Female; Humans; Male; Morals; Narration; Pharmacies; Pharmacists
PubMed: 29159520
DOI: 10.1007/s11096-017-0561-0 -
Journal of the American Pharmacists... 2021Payment reform for pharmacists is both an important and urgent issue that needs to be addressed.
BACKGROUND
Payment reform for pharmacists is both an important and urgent issue that needs to be addressed.
OBJECTIVE(S)
The purpose of this paper is to assess the use of medically underserved areas, medically underserved populations, and primary care health professional shortage areas in The Pharmacy and Medically Underserved Areas Enhancement Act; and provide policy recommendations for national pharmacy associations to achieve provider status.
METHODS
Pharmacy location addresses were determined using public domain data from the National Plan & Provider Enumeration System (NPPES) National Provider Identifier (NPI) Registry. Medically Underserved Areas/Populations (MUAs/MUPs) and Health Professional Shortage Areas (HPSAs) were gathered through public data provided by the Health Resources and Services Administration as Keyhole Markup Language (KML) files. Addresses and KML files were analyzed and mapped using the geographic information software, QGIS. A series of maps depicting the location of all MUAs/MUPs, HPSAs, HPSA facility locations, and community pharmacy locations in the U.S. were then created. These maps were overlayed, and geoprocessing tools were used to create the analysis.
RESULTS
After analyzing all community pharmacy locations in the United States, we found that only 56% are located within a current MUA/MUP or HPSA. The percentage of pharmacies in healthcare underserved areas differs widely between states from the lowest in New Jersey of 18.26% of pharmacies to the highest of Guam, the Northern Mariana Islands and the Virgin Islands with 100% of pharmacies.
CONCLUSIONS
Aligning the pharmacist business model to be comparable to other health care professionals will ensure patients receive access to pharmacist-provided cognitive patient care services, which have higher value than product-centered services. Future attempts to recognize pharmacists as providers and allow for their reimbursement under Medicare Part B should consider strategies to increase the number of pharmacists that are eligible to participate in order to exemplify value to the public and elected leaders.
Topics: Aged; Community Pharmacy Services; Humans; Medically Underserved Area; Medicare; Pharmacies; Pharmacists; Pharmacy; United States
PubMed: 34531121
DOI: 10.1016/j.japh.2021.08.021 -
Research in Social & Administrative... 2017In 2006, the Ontario drug plan greatly reduced community pharmacy reimbursement for generic drugs. In exchange, a fee-for-service medication review program was...
BACKGROUND
In 2006, the Ontario drug plan greatly reduced community pharmacy reimbursement for generic drugs. In exchange, a fee-for-service medication review program was introduced to help patients better understand their medication therapy and ensure that medications were taken as prescribed. A qualitative study of community pharmacy implementation strategies was undertaken to inform a mixed methods evaluation of the program.
PURPOSE
To describe strategies used by community pharmacies to implement a government-funded medication review service.
METHODS
Key informant interviews were conducted with pharmacy corporate executives and managers, as well as independent pharmacy owners. All pharmacy corporations in the province were approached; owners were purposively sampled from the registry of the pharmacist licensing body to obtain diversity in pharmacy attributes; and pharmacy managers were identified through a mix of snowball and registry sampling. Thematic qualitative coding and analysis were applied to interview transcripts.
RESULTS
42 key informants, including 14 executives, 15 managers/franchisees, and 11 owners, participated. The most common implementation strategy was software adaptation to flag eligible patients and to document the service. Human resource management (task shifting to technicians and increasing the technician complement), staff training, and patient identification and recruitment processes were widely mentioned. Motivational strategies including service targets and financial incentives were less frequent but controversial. Strategies typically unfolded over time, and became multifaceted. Apart from the use of targets in chain pharmacies only, strategies were similar across pharmacy ownership types.
DISCUSSION
Ontario community pharmacies appeared to have done little preplanning of implementation strategies. Strategies focused on service efficiency and quantity, rather than quality. Unlike other jurisdictions, many managers supported the use of targets as motivators, and very few reported feeling pressured. This detailed account of a range of implementation strategies may be of practical value to community pharmacy decision makers.
Topics: Community Pharmacy Services; Female; Financing, Government; Humans; Male; Medication Reconciliation; Ontario; Pharmacies; Reimbursement, Incentive
PubMed: 28462792
DOI: 10.1016/j.sapharm.2017.03.057 -
American Journal of Health-system... Feb 2022Producing compounded sterile preparations (CSP) of the highest quality and ensuring safe hazardous drug handling are well-established priorities for pharmacy...
PURPOSE
Producing compounded sterile preparations (CSP) of the highest quality and ensuring safe hazardous drug handling are well-established priorities for pharmacy departments. Maintaining compliance with United States Pharmacopeia general chapters 797 and 800 (USP <797> and <800>) must also be a priority for health-system leadership. This report describes how a pharmacy-driven multidisciplinary committee was created to provide USP <797> and <800> oversight within a multicampus Veterans Affairs health system and the facility and safety outcomes achieved.
SUMMARY
The Veterans Health Administration required facilities to establish an oversight committee to ensure USP-compliant CSP procedures and the safe handling of hazardous drugs in all aspects of the medication-use process. Spearheaded by the pharmacy department, the VA Palo Alto Health Care System (VAPAHCS) chartered the CSP Advisory Committee to achieve this goal.The membership was composed of department heads in the areas of pharmacy, nursing, environmental management services, engineering, facility planning, safety, industrial hygiene, employee health, supply chain services, infection control, and quality management and the health system's director's office. The medication safety officer served as the executive secretary for the advisory committee and was responsible for agenda development, minutes, and coordinating timely follow-ups on action items; the VAPAHCS deputy director served as chair. Monthly meetings were conducted to receive updates on targeted sterile compounding and hazardous drug handling objectives: environmental controls and monitoring, compliance with regulatory requirements, staff competency, hazardous drug exposure event analyses, and development of well-defined health-system policy to guide practice.
CONCLUSION
Taking a multidisciplinary approach to USP <797> and <800> compliance facilitated communications, created engagement, and ensured completion of action plans.
Topics: Humans; Pharmaceutical Preparations; Pharmaceutical Services; Pharmacies; Pharmacy; United States; Veterans
PubMed: 34724546
DOI: 10.1093/ajhp/zxab412 -
The Journal of Adolescent Health :... Feb 2019To evaluate the availability and accessibility of emergency contraception (EC) to adolescents in U.S. pharmacies across four Southwestern states, 3 years after the...
PURPOSE
To evaluate the availability and accessibility of emergency contraception (EC) to adolescents in U.S. pharmacies across four Southwestern states, 3 years after the federal Food and Drug Administration (FDA) removed age restrictions for over-the-counter sales of levonorgestrel-only pills.
METHODS
Using a mystery-caller approach, we trained male and female data collectors to phone pharmacies posing as 16-year-olds who wanted to prevent a pregnancy after recent unprotected sex. From April to May 2016, they called 1,475 randomly selected retail pharmacies in Arizona, California, New Mexico, and Utah and completed an online survey about their experience. Caller data were analyzed by state and pharmacy type (i.e., national chains, regional outlets, and individually owned outlets).
RESULTS
Of pharmacies contacted, 80.6% had EC available at the time of the call. Availability of EC varied by state (p < .01) and pharmacy type (p < .01), but not by rural/urban location. Even where EC was available, pharmacy personnel often hindered youths' access to EC by mentioning incorrect point-of-sale restrictions, keeping EC in restrictive store locations, or asking personal questions. Individually owned outlets presented significantly more barriers than larger chains. Overall, EC was completely accessible to an adolescent caller in only 28% of pharmacies. Lower EC accessibility was found in states with higher teen pregnancy rates.
CONCLUSIONS
This study found that EC is still not sufficiently available or accessible to adolescents in Southwestern states. Differences in accessibility vary significantly by state and pharmacy type and may be a contributor to teen pregnancy rates.
Topics: Adolescent; Contraception, Postcoital; Contraceptive Agents, Female; Cross-Sectional Studies; Female; Health Services Accessibility; Humans; Levonorgestrel; Nonprescription Drugs; Pharmacies; Pregnancy; Pregnancy in Adolescence; Southwestern United States; Young Adult
PubMed: 30661517
DOI: 10.1016/j.jadohealth.2018.08.030