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Background: Delta-8 THC is a federally unregulated psychoactive cannabis product rising in popularity. However, little is known regarding its retail availability. Method: We assessed Delta-8 THC retail by calling locations with alcohol, tobacco, and/or consumable hemp retail licenses in Fort Worth, Texas, before and after Texas announced ongoing litigation surrounding Delta-8 THC legality. We linked census block area deprivation index (ADI) scores (1–10; 10 = most disadvantaged) to locations. Logistic regression models examined associations between license type, ADI, ADI*license type interaction, and Delta-8 availability at each time. Results: Retail availability was 11% at Time 1 (n = 133/1,223) and 9% at Time 2 (n = 94/1,026). Alcohol (aORTime1 = 0.18, 95%CI = 0.12,0.28; aORTime2 = 0.14, 95%CI = 0.08,0.24), tobacco (aORTime1 = 15.13, 95%CI = 6.78,33.74; aORTime2 = 12.39, 95%CI = 4.97,30.91), and consumable hemp licenses (aORTime1 = 21.85, 95%CI = 7.91,60.39; aORTime2 = 22.93, 95%CI = 6.92,75.98) were associated with Delta-8 THC retail availability; ADI scores were borderline but not statistically significant. The multiplicative interaction at Time 2 indicated locations with both high ADI scores and alcohol retail licenses had higher odds of selling Delta-8 THC. Differential associations between ADI and Delta-8 THC availability were observed based on those with (b = 0.007) or without (b = −0.023) alcohol retail licenses. Conclusions: Both timepoints had similar proportions of Delta-8 THC retailers, indicating that despite the uncertain legal landscape in Texas, interest in Delta-8 did not appear to be declining. Geographic socioeconomic disparities were observed among locations with alcohol retail licenses. Future regulations may include minimum distances from specific locations (e.g., schools), particularly in more disadvantaged areas. Increasing the compliance of Texas Delta-8 THC retailers to have the required hemp license is important for surveillance and product safety. [ABSTRACT FROM AUTHOR]

Objective To measure sales of antibiotics without a prescription in pharmacies in China in 2017 and 2021, before and during the coronavirus disease 2019 (COVID-19) pandemic, and determine the factors associated with such sales. Methods We conducted cross-sectional surveys using the simulated patient method in retail pharmacies in 13 provinces in eastern, central and western China in 2017 and 2021. At the pharmacies, the simulated patients (trained medical students) reported that they had mild respiratory tract symptoms and asked for treatment, using a three-stage process: (i) request some treatment; (ii) request antibiotics; (iii) request specific antibiotics. We used multivariable logistic regression analysis to determine factors associated with sale of antibiotics without a prescription. Findings Of the pharmacies visited in 2017, 83.6% (925/1106) sold antibiotics without a prescription; this figure was 78.3% (853/1090) in 2021 (P-value: 0.002). After excluding pharmacies prohibited from selling antibiotics because of COVID-19, this difference was not significant (83.6% versus 80.9%; 853/1054; P-value: 0.11). Factors significantly associated with selling antibiotics without a prescription in both 2017 and 2019 were: location in central and western China compared with eastern China; being in a township or village compared with in a city; and presence of a counter where antibiotics were dispensed. Conclusion Although laws became stricter between 2017 and 2021, antibiotic sales without a prescription were still common in pharmacies across China. Existing regulations need to be more strictly enforced, and pharmacy staff and the public should be made more aware of the risks of antibiotic misuse and dangers of antimicrobial resistance. [ABSTRACT FROM AUTHOR]

The author comments on regulation of cannabis retailers in the U.S. Topics discussed include consequences of the concentration of licensed cannabis retailers in economically disadvantaged areas, significance of statewide implementation of local policies that have been shown to be effective, and reason prevention of cannabis use by adolescents remains an important public health priority.

Purpose Opioid misuse and overdose deaths remain a public health concern in the United States. Pennsylvania has one of the highest rates of opioid overdose deaths in the country, with Philadelphia County's being 3 times higher than the national average. Despite several multimodal interventions, including use of SBIRT (screening, brief intervention, and referral to treatment) methods and naloxone distribution, the rate of overdose deaths remains high. Methods To gain insights on strategies for improving access to naloxone and naloxone distribution by pharmacists in Philadelphia County, a study was conducted in 11 community pharmacies (chain and independent) in Philadelphia. Twenty-four pharmacists were recruited and completed SBIRT and naloxone trainings. Each pharmacy elected to have at least 1 pharmacy champion who received additional training on and helped develop pharmacy site–specific naloxone dispensing protocols. Results Pre-post survey results showed a reduction in stigmatizing attitudes regarding naloxone dispensing and an increase in pharmacists' understanding of the standing order and appropriate naloxone use. There was an increase in pharmacists' self-reported confidence in their ability to appropriately identify, discuss, and dispense naloxone to patients. All pharmacies increased their average monthly dispensing rate following protocol implementation. Conclusion Pharmacists who received both trainings were more likely to change naloxone dispensing practices, leading to an overall increase in naloxone dispensing by community pharmacists. The study addressed overall gaps in pharmacists' knowledge, reduced stigma, and prepared pharmacists to address opioid use and overdose prevention with their patients. The described pharmacist-led patient counseling and intervention service for overdose prevention may be explored as a model for other community pharmacies to adopt to improve naloxone dispensing and similar interventions to reduce overdose deaths. [ABSTRACT FROM AUTHOR]

Objectives. To examine early impacts of laws that require naloxone to be prescribed to patients at increased overdose risk. Methods. Using data from 2014 to 2018 from a large pharmacy chain, CVS Pharmacy, we examined the effects of naloxone-prescribing mandates 90 days before and after they took effect in Arizona, Florida, Rhode Island, Vermont, and Virginia. We compared the number of naloxone doses initiated directly by prescribers and by pharmacy standing order, prescriber specialty, pharmacies dispensing, and payor type by applying linear models and the χ2 test. Results. Naloxone-prescribing mandates increased pharmacy naloxone provision 255% from 90 days before to after implementation. This approach appeared to engage more prescribers (1028 before to 4285 after), complement ongoing naloxone provision under pharmacy standing orders, expand geographic reach (from 40% to 80% of pharmacies dispensing), and broaden the naloxone payor mix in 4 (P <.05) of 5 states. Conclusions. Mandating the prescribing of naloxone quickly expands access to this life-saving medication for more people in more places. Other states should consider mandating the coprescription of naloxone to individuals at increased risk of overdose. [ABSTRACT FROM AUTHOR]

Background: Dispensing of antibiotics without a prescription (DAwP) has been widely practised among community pharmacies in Saudi Arabia despite being illegal. However, in May 2018, the law and regulations were enforced alongside fines. Consequently, we wanted to evaluate the impact of these changes.Methods: A study was conducted among 116 community pharmacies in two phases. A pre-law enforcement phase between December 2017 and March 2018 and a post-law enforcement phase one year later. Each phase consisted of a cross-sectional questionnaire-based survey and a simulated client method (SCM) approach. In the SCM, clients presented with either pharyngitis or urinary tract infections (UTI). In SCM, for each phase, all 116 pharmacies were visited with one of the scenarios.Results: Before the law enforcement, 70.7% of community pharmacists reported that DAwP was common with 96.6% and 87.7% of participating pharmacies dispensed antibiotics without a prescription for pharyngitis and UTI respectively. After the law enforcement, only 12.9% reported that DAwP is still a common practice, with only 12.1% and 5.2% dispensing antibiotics without prescriptions for pharyngitis and UTI respectively.Conclusion: law enforcement was effective. However, there is still further scope for improvement. This could include further educational activities with pharmacists, physicians and the public. [ABSTRACT FROM AUTHOR]

Background: In recent years there have been growing concerns regarding non-prescription codeine use in Australia. Efforts to mitigate risks associated with non-prescription codeine, such as addiction and toxicity, have been primarily through two initiatives; regulatory changes restricting their availability, and voluntary live-recording supply of non-prescription codeine combination analgesics (CCAs). This study sought to explore the supply of CCAs in the climate of regulatory change.Methods: Eighty University of Sydney pharmacy students mystery-shopped 34 community pharmacies across metropolitan Sydney, Australia from August 2016 to November 2017, with scripted symptom-based (SBR) or direct product requests (DPR) for a CCA. Questions asked, staff involvement, regulatory compliance, voluntary recording, and product(s) supplied were recorded.Results: Of 158 total visits, a non-prescription CCA was supplied in 101 instances. Sixty-one (60%) of these supplies complied with the legislative requirement for a pharmacist to supply the medicine. Voluntary recording was surmised to have been utilised 13 times (13% CCA supplies). CCAs were supplied less frequently in 2017 DPR scenarios compared to 2016 DPR scenarios (64% vs 86%; p = 0.024), and a greater proportion of 2017 DPR supplies were compliant with the legislative requirement of pharmacist supply (72% vs 46%; p = 0.041). No difference in proportion of sales surmised to have been voluntarily recorded was observed between the years. Interactions involving pharmacists resulted in less frequent supply of codeine than those without (58% vs 82%; p = 0.012).Conclusion: Mandatory legislative regulation of pharmacist supply of non-prescription codeine was more likely to be complied with than voluntary recording. Compliance with pharmacist supply for DPRs appeared to improve following the announcement of regulatory change to prescription-only, whereas voluntary recording of supply did not appear to change. [ABSTRACT FROM AUTHOR]

This paper describes novel tobacco control laws passed in New York City in 2017. These laws are designed to improve the city's strategy of using price to decrease tobacco consumption, and over time, change the city's landscape by making tobacco less accessible. [ABSTRACT FROM AUTHOR]

In India, manufacturing, storing, transportation, distribution, and dispensing of drugs are licensed and regulated under the drugs and cosmetic act, 1940; Indian Medical Council Act, 1956; the Pharmacy Act, 1948; and the Narcotic Drugs and Psychotropic Substances Act, 1985. Prescribing and dispensing medicines at the same time to their patients by registered medical practitioners (RMPs) is a well-known practice in all systems of medicine across the country. Further, the kind of branded medicines a patient gets from the clinics will come wrapped in a huge profit margin for RMPs, and this has been an alternative source of income to them. Dispensing and selling of medicines by RMPs at their clinics to their patients may represent a significant potential conflict of interest with the medical ethical principles, namely autonomy, beneficence, and non-maleficence and it raises various ethical and legal challenges. This article focuses on the ethical and legal issues of this practice and emphasizes the need for a proactive and dynamic approach to meet the rising demand for quality healthcare in India. [ABSTRACT FROM AUTHOR]

Telehealth will enable new models of care to emerge as health care continues to undergo significant changes. Health insurers, providers, and pharmacy benefit managers are merging, which will consolidate market share among fewer large companies. Recently, retail giants such as Walmart and Amazon have announced plans to compete in the health care industry. As these organizations seek to provide convenient and affordable access to care, telehealth will play a significant role in the competition for market share and will create new opportunities for innovation. Additionally, the increasing adoption of telehealth by retail outlets and vertically integrated health care organizations raises new policy questions in such areas as information access, privacy and security, the combination of health and consumer data, and ways to foster provider independence amid increasing consolidation. [ABSTRACT FROM AUTHOR]

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The article explores the scheduling of opioids in the U.S. Topics discussed include the rise in abuse of opioids; state approaches fail to effectively combat the abuse epidemic; and uniform system of monitoring opiate drugs to prevent doctor and pharmacy shopping across state lines and help quash the rise of opiate drug abuse.

In Stormans, Inc. v. Wiesman, 794 F.3d 1064 (9th Cir. 2015), the Ninth Circuit held that a Washington state law requiring pharmacies to stock and distribute a representative sample of all types of drugs persons in their area might require did not violate the Stormans' free exercise rights nor any substantive due process right as applied to punish them for their religiously-motivated refusal to stock and distribute abortifacients. Despite a lengthy finding of fact by the district court below demonstrating deliberate targeting of religious objectors in the drafting and implementation of the law, the Ninth Circuit found the law unproblematic and ruled in favor of the State. Upon the Supreme Court's denial of the. Stormans' application for a writ of certiorari, Justice Alito wrote a lengthy dissent mourning the significance of this case within free exercise jurisprudence. However, given the diminished status of free exercise rights within the realm of religious exemptions to neutral laws that has existed since Employment Division v. Smith, this note addresses the Stormans' substantive due process claim as a more viable source of protection for religious objectors within the Court's current jurisprudence. This note takes issue with the Ninth Circuit's framing and analysis of the due process right that the Stormans were seeking recognition of, and argues that i f the courts are truly applying Glucksberg's "deeply rooted" test, to determine what substantive rights the Due Process Clause protects, then the Stormans' right, to conscious as healthcare providers should be recognized and protected. [ABSTRACT FROM AUTHOR]

Objectives: California 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.Design: Interviewer-administered survey.Setting and Participants: Fresno and Kern Counties, CA. Pharmacists and other pharmacy staff (n = 404) at 212 pharmacies.Outcome Measure: Self-reported nonprescription pharmacy sales to known or suspected IDUs.Results: Overall, 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.Conclusion: This 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. [ABSTRACT FROM AUTHOR]

Objectives: Gaps in vaccination coverage leave populations vulnerable to illnesses. Since the 1990s, there has been a growing movement to improve vaccination access by giving pharmacists the authority to administer vaccines according to state laws. Understanding the variation of pharmacist vaccination laws over time is critical to understanding the effect of improving access to vaccination services.Methods: We identified relevant statutes and regulations with the use of Westlaw legal databases. A 4-stage coding process identified 220 legal variables of pharmacist vaccination authority. Each jurisdiction's laws were coded against these 220 legal variables. The resulting legal dataset was then evaluated to determine whether jurisdictions expanded or restricted pharmacist vaccination authorities over time.Results: From 1971 to 2016, jurisdictions made 627 changes to statutes and regulations relating to pharmacist vaccination authority. There were 85 expansions, 3 restrictions, and 22 regulatory clarifications. Eight changes were deemed to be unclear, and 479 changes did not substantively alter the scope of pharmacist vaccination authority.Conclusion: Collectively, the laws in 50 states and DC paint a clear picture: the scope of pharmacists' vaccination authority is expanding. Jurisdictions are allowing pharmacists to administer more vaccines to younger patients with less direct prescriber oversight. This clear expansion of pharmacist vaccination authority stands in contrast to the reservations expressed by some physician groups for pharmacists as vaccination providers. However, laws in some states still do not permit pharmacists to vaccinate according to the Advisory Committee on Immunization Practices recommendations. [ABSTRACT FROM AUTHOR]

Beginning in 2012, there was a major meningitis outbreak that was attributed to the New England Compounding Center (NECC) in Massachusetts. There were reports of over 800 individuals sickened with meningitis and the death of 76 was reported. This multi-state outbreak of meningitis was investigated by the Centers for Disease Control, the Food and Drug Administration, and the state and local health departments. As a result, it was determined that the outbreak tied to a contaminated steroid injection produced by NECC. This product was manufactured by NECC, which is designated as a Compounding Pharmacy. This type of pharmacy is only authorized to create specific formulations of drugs to meet the needs of individual patients and in response to individual prescriptions. (Anonymous, 2017a) As a result of this outbreak, many different laws and requirements changed, as well as legal actions taken against employees of NECC. This paper describes some of the changes and legal actions taken. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of mandatory offer of generic substitution, introduced in South Africa in May 2003, on private sector sales of generic and originator medicines for chronic diseases.Methods: Private sector sales data (June 2001 to May 2005) were obtained from IMS Health for proton pump inhibitors (PPIs; ATC code A02BC), HMG-CoA reductase inhibitors (statins; C10AA), dihydropyridine calcium antagonists (C08CA), angiotensin-converting enzyme inhibitors (ACE-I; C09AA) and selective serotonin reuptake inhibitors (SSRIs; N06AB). Monthly sales were expressed as defined daily doses per 1000 insured population per month (DDD/TIM). Interrupted time-series models were used to estimate the changes in slope and level of medicines use after the policy change. ARIMA models were used to correct for autocorrelation and stationarity.Results: Only the SSRIs saw a significant rise in level of generic utilisation (0.2 DDD/TIM; P < 0.001) and a fall in originator usage (-0.1 DDD/TIM; P < 0.001) after the policy change. Utilisation of generic PPIs fell (level 0.06 DDD/TIM, P = 0.048; slope 0.01 DDD/TIM, P = 0.043), but utilisation of originator products also grew (level 0.05 DDD/TIM, P < 0.001; slope 0.003, P = 0.001). Generic calcium antagonists and ACE-I showed an increase in slope (0.01 DDD/TIM, P = 0.016; 0.02 DDD/TIM, P < 0.001), while the originators showed a decrease in slope (-0.003 DDD/TIM, P = 0.046; -0.01 DDD/TIM, P < 0.001). There were insufficient data on generic statin use before the policy change to allow for analysis.Conclusion: The mandatory offer of generic substitution appeared to have had a quantifiable effect on utilisation patterns in the 2 years after May 2003. Managed care interventions that were already in place before the intervention may have blunted the extent of the changes seen in this period. Generic policies are an important enabling provision for cost-containment efforts. However, decisions taken outside of official policy may anticipate or differ from that policy, with important consequences. [ABSTRACT FROM AUTHOR]

Background: In Zambia, antibiotics are categorized as prescription-only medicines. Antibiotics dispensed without a prescription pose a public health threat, which is a concern. Consequently, the aim is to ascertain the extent of non-prescription sales and dispensing of antibiotics in community pharmacies in Zambia.Methods: The practice of non-prescription sale and dispensing were assessed in 73 randomly selected community retail pharmacies, using a structured interviewer-administered questionnaire with simulated case scenarios.Results: Majority (97%) stated that clients frequently requested non-prescribed antibiotics. Interviewees usually asked clients' indications (94%), counselled on dosing (96%) and suggested changes to antibiotic choices (97%). All (100%) dispensed non-prescribed antibiotics. Commonly dispensed antibiotics included amoxicillin (52%), cotrimoxazole (25%) and metronidazole (23%). Non-prescription sale and dispensing of antibiotics was significantly associated with interviewees' professional qualification in four out of five simulations.Conclusion: Non-prescription sale and dispensing of antibiotics is widespread in Zambia. Concerted public and professional interventions are needed coupled with stronger regulatory enforcement to reduce this. [ABSTRACT FROM AUTHOR]

Objectives: California and Massachusetts are the only 2 states in the United States with municipalities that have local laws prohibiting the sale of tobacco products by pharmacies. The impacts of the tobacco-free pharmacy laws remain understudied. This study aims to fill this gap by examining the association between tobacco-free pharmacy laws and smoking prevalence among adults over time in California and Massachusetts.Design: This study used a series of cross-sectional surveys. The data source for this study was the Behavioral Risk Factor Surveillance Survey for each year from 2005 to 2013.Setting: The longitudinal changes in smoking prevalence at the city or county level were estimated and comparisons were made between cities or counties with tobacco-free pharmacy laws and those without the laws.Participants: The participants used to estimate smoking prevalence were representative of adults within California and Massachusetts.Intervention: The implementation of tobacco-free pharmacy laws was considered to be the intervention in this study.Main Outcome Measures: The outcome measures were smoking prevalence among adults. Mixed-effects negative binomial models were performed primarily to examine longitudinal changes in outcome measures.Results: The prevalence of smoking decreased in both states over time. In Massachusetts, there was a statistically significant decrease in smoking prevalence among cities with tobacco-free pharmacy laws compared with those without such laws. Despite the presence of an 8.6% decrease in prevalence after the implementation of tobacco-free pharmacy laws, this reduction was not statistically significant after controlling for the negative trend in smoking rates overall and other factors.Conclusion: This study evaluated tobacco-free pharmacy laws with regard to the real-world impacts. Our findings highlight the need for future research on the effects of tobacco-free pharmacy laws with a prolonged time span and a comprehensive understanding of the law's implementation and enforcement. [ABSTRACT FROM AUTHOR]

Objectives: To examine barriers to nonprescription syringe sales (NPSS) in pharmacies by examining resistant pharmacists' willingness to provide syringes to people who inject drugs (PWID) and their current practices for provision or refusal.Methods: Qualitative, semi-structured, in-depth interviews with community pharmacists in California, Kansas, Mississippi, and New Jersey. Participants include seventeen community pharmacists who expressed ethical concerns about providing syringes drawn from a larger sample of 71 community pharmacists participating in a study of ethical decision-making. Analysis captures pharmacists' descriptions of their experiences providing syringes to suspected PWID.Results: Pharmacists who identified syringes as a key ethical issue exhibited significant ambivalence about providing syringes to PWID. Most of these pharmacists were aware of harm reduction logics, but endorsed them to varying degrees. Moral concerns about supplying PWID with syringes were mediated by law and organizational policy. Many pharmacists who considered syringes an ethical challenge allayed their concerns by creating informal policy and engaging in deterrence practices designed to dissuade PWID from coming to the pharmacy.Conclusions: As heroin abuse rates continue to rise, pharmacists are undoubtedly integral allies in the fight to prevent the spread of communicable diseases like HIV/AIDS and Hepatitis C. Education should be aimed at identifying barriers to NPSS resulting from resistant pharmacists' attitudes and practices. Increased education paired with favorable law and organizational policy and decentralization of syringe provision could increase access to clean needles and decrease public health risks. [ABSTRACT FROM AUTHOR]

Background: A community pharmacy real-time electronic recording program, ProjectSTOP, enables Australian community pharmacists to verify pseudoephedrine requests. In Western Australia the program was available for voluntary use from April 2007 and became mandatory November 2010. This case study explores the effectiveness of the program by reviewing the total requests for pseudoephedrine products, and the proportion of requests which were classified as 'denied sales' before and after mandatory implementation. Seasonal and annual trends in these measures are also evaluated.Methods: ProjectSTOP data recordings for Western Australia pharmacies between 1 December 2007 and 28 February 2014 were analysed. Data included a de-identified pharmacy number and date of each pseudoephedrine product request. The total number of requests and sale classification (allowed, denied, safety, or not recorded) were calculated for each month/pharmacy. The potential influence of mandatory reporting using ProjectSTOP was investigated using a Regression Discontinuity Design. Correlations between sales from the same pharmacy were taken into account by classifying the pharmacy number as a random effect. The main effects of year (continuous variable), and season (categorical variable) were also included in the model.Results: There was a small but steady decline in the total requests for pseudoephedrine per month per 100,000 population (per pharmacy) from the time of mandatory reporting. The number of denied sales showed a steady increase up until mandatory reporting, after which it showed a significant decline over time. Total sales were heavily influenced by season, as expected (highest in winter, least in summer). The seasonal pattern was less pronounced for denied sales, which were highest in winter and similar across other seasons. The pattern over time for safety sales was similar to that for denied sales, with a clear change occurring around the time of mandatory reporting.Conclusion: Results indicate a decrease in pseudoephedrine product requests in Western Australia community pharmacies. Findings suggest ProjectSTOP has been successful in addressing suspicious sales and potential diversion however ongoing data review is recommended. [ABSTRACT FROM AUTHOR]

Background: Reforms in the health-care sector, including the pharmacy sector, can have different rationales. The Swedish pharmacies were prior to 2009 organized in a state-owned monopoly. In 2009, a liberalization of the ownership took place, in which a majority of the pharmacies were sold to private owners. The rationales for this liberalization changed profoundly during the preparatory work, making it probable that other rationales than the ones first expressed existed. The aim of this study was to explore the underlying rationales (not stated in official documents) for the liberalization in the Swedish pharmacy sector, and also to compare the expectations with the perceived outcomes.Methods: Semi-structured interviews were conducted with representatives from key stakeholder organizations; i.e., political, patient, and professional organizations. The analysis was performed in steps, and themes were developed in an inductive manner.Results: One expectation among the political organization participants was that the ownership liberalization would create opportunities for ideas. The competition introduced in the market was supposed to lead to a more diversified pharmacy sector. After the liberalization, the participants in favor of the liberalization were surprised that the pharmacies were so similar. Among the professional organization participants, one important rationale for the liberalization was to get better use of the pharmacists' knowledge. However, all the professional, and some of the patient organization participants, thought that the counseling in the pharmacies had deteriorated after the liberalization. As expected in the interviews, the post-liberalization pharmacy sector consists of more pharmacies. However, an unexpected perceived effect of the liberalization was, among participants from all the stakeholder groups, less access to prescription medicines in the pharmacies.Conclusions: This study showed that the political organization participants had an ideological basis for their opinion. The political stakeholders did not have a clear view about what the liberalization should lead to, apart from abolishing the monopoly. The perceived effects are quite similar in the different stakeholder groups, and not as positive as were expected. [ABSTRACT FROM AUTHOR]

Objectives. To examine the impact of local laws prohibiting tobacco sales in pharmacies in California and Massachusetts, the only 2 US states in which such municipal laws exist. Methods. We analyzed longitudinally the tobacco retailer density at the city level from tobacco retailer license data in California (2005-2013) and Massachusetts (2004-2014). Results. After adjustments, the reduction in tobacco retailer density over time was 1.44 (95% confidence interval [CI] = 1.37,1.51) to 3.18 (95% CI = 1.11,5.25) times greater in cities with a tobacco-free pharmacy law than in cities without such a law. Conclusions. Tobacco-free pharmacy laws are associated with a greater reduction in tobacco retailer density over time in California and Massachusetts. [ABSTRACT FROM AUTHOR]

Background: Opioid overdose, which has reached epidemic levels in the United States, is reversible by administration of the medication naloxone. Naloxone requires a prescription but is not a controlled substance and has no abuse potential. In the last half-decade, the majority of states have modified their laws to increase layperson access to the medication.Methods: We utilized a structured legal research protocol to systematically identify and review all statutes and regulations related to layperson naloxone access in the United States that had been adopted as of September, 2015. Each law discovered via this process was reviewed and coded by two trained legal researchers.Results: As of September, 2015, 43 states and the District of Columbia have passed laws intended to increase layperson naloxone access. We categorized these laws into three domains: (1) laws intended to increase naloxone prescribing and distribution, (2) laws intended to increase pharmacy naloxone access, and (3) laws intended to encourage overdose witnesses to summon emergency responders. These laws vary greatly across states in such characteristics as the types of individuals who can receive a prescription for naloxone, whether laypeople can dispense the medication, and immunity provided to those who prescribe, dispense and administer naloxone or report an overdose emergency.Conclusions: Most states have now passed laws intended to increase layperson access to naloxone. While these laws will likely reduce overdose morbidity and mortality, the cost of naloxone and its prescription status remain barriers to more widespread access. [ABSTRACT FROM AUTHOR]

Background: Antimicrobial resistance (AMR) is a worldwide public health challenge, and non-prudent use of antibiotics is one of key drivers of AMR. In some countries antibiotics are often sold without a prescription at pharmacies. In Armenia this problem is also observed despite national regulation. The objective of this work was to identify perception of pharmacy staff on main barriers for dispensing antibiotics with a prescription at community pharmacies and perceived strategies for improving the situation in Armenia. Methods: Survey was conducted at community pharmacies in different regions of Armenia. Pharmacists and pharmacy technicians were asked to complete pretested questionnaire. Data were analysed with SPSS statistical software. Results: Despite most of professionals reported that they are aware about regulation, 78.4% of 241 participants indicated that patients can buy antibiotics at their pharmacy without a prescription from doctor. Most of participants reported that the percentage of patients whom antibiotics were sold without a prescription is high. More than a half of responders indicated the following barriers for dispensing antibiotics with a prescription at community pharmacies: lack of patients’ awareness about effectiveness and safety of antibiotics (61.0%), difficulties for doctors to prescribe using approved forms (60.6%), poor prescribing practice (56.4%). More than a half of professionals consider that it is necessary to introduce the following strategies: organizing public awareness campaigns (68.0%), organizing special training courses for physicians and pharmacists (63.9%), introducing Medicines and therapeutic committees at health facilities (54.8%). Conclusions: Patients can buy antibiotics without a prescription at community pharmacies in Armenia. There are certain barriers for dispensing antibiotics with a prescription at community pharmacies. Educational and organizational strategies can be helpful for improving the situation. [ABSTRACT FROM AUTHOR]

Pharmacy benefit managers (PBMs) potentially lower costs associated with prescription drugs through increased bargaining power with manufacturers. PBMs engage in selective contracting with pharmacies which has the potential to reduce retail competition, leading to increased prices. Proponents of "Any Willing Provider (AWP)" and "Freedom of Choice (FOC)" laws limiting this selective contracting claim increased retail competition will lower prescription drug spending. Examining the passage of such laws over the period 1991-2009, we find that AWP laws increase spending on prescription drugs by ~5% beyond any pre-existing trends in spending while FOC laws have no significant effect. [ABSTRACT FROM AUTHOR]

In a recent battle between reproductive rights and religious freedom, the U.S. Supreme Court, by a five to three vote, declined to review an appeal in Stormans, Inc v Wiesman, a case brought by a Washington state pharmacy owner and two pharmacists who held religious objections to emergency contraception. These petitioners brought a constitutional challenge to Washington state regulations that required pharmacies to dispense all lawfully prescribed pharmaceuticals. In 2015, the Ninth Circuit Court of Appeals ruled that these regulations did not violate the Constitution. The Ninth Circuit confirmed that pharmacies must comply with state regulations requiring access to drugs even if the owners of the pharmacies hold religious objections to the provision of certain types of drugs-here, emergency contraception. The pharmacy owners appealed this ruling, and in 2016, the Supreme Court declined to review the case, effectively leaving the lower court ruling in place. This article analyzes the Stormans case, the difference between it and a seemingly similar case regarding contraceptive access decided by the Supreme Court in 2014, the effects of the Stormans ruling on emergency contraception access in Washington state as well as the ruling's potential implications for public health. [ABSTRACT FROM AUTHOR]

Geographic access to community pharmacies is an important aspect of access to appropriate medicines. This study aimed to explore changes in the number and location of pharmacies in New Zealand and determine whether some populations have poor geographical access to pharmacies. Pharmacy numbers in New Zealand have been declining since the mid-1980s, and, adjusted for population growth, there are now only half the number there was in 1965. While the urbanisation of pharmacies has been matched by loss of population in rural areas, the loss of pharmacies from smaller rural towns leaves many people with poor access to pharmacy services. [ABSTRACT FROM AUTHOR]

The article discusses a call for the development of uniform, intuitive legislation in Australia regarding the handling and dispensing of medicines and controlled drugs, focusing on Queensland's Health (Drugs and Poisons) Regulation 1996 and legal issues involving pharmacies and restricted drugs. According to the article, the regulatory aspects of medicines supplies are governed by individual Australian States and Territories. Interstate controlled drug prescription is examined.

El artículo presenta diversas sentencias del Tribunal de Justicia de la Unión Europea (UE) emitidas entre enero y abril de 2013, las cuales sientan jurisprudencia en Derecho de la UE. Los temas discutidos incluyen la disposición de que la aplicación de la Carta de los Derechos Fundamentales de la Unión Europea no debe contradecir el Derecho de la UE, el impuesto sobre el volumen de negocio y el reglamento sobre la apertura de nuevas farmacias.

The article mentions the significance of continuous quality improvement (CQI) programs for improving the safety and quality of community pharmacy practice. Topics discussed include the study on determination of knowledge in mandated CQI standards difference among pharmacies, use of survey questionnaire in the study and analysis of quantitative results by Mann-Whitney U test.

The article looks at 2012 health reforms in Italy related to liberalization and competition in the pharmaceutical industry, focusing on the impacts of community pharmacy deregulation on patients and the Italian National Health Service (INHS). The reforms roll back some restrictions on number of pharmacy licenses, hours of operation, and accessibility of non-prescription drugs. Other topics include pharmacy laws of other European Union countries, drug supply and demand, and INHS reimbursement.

In 2000, Korea enacted a controversial law prohibiting doctors from dispensing drugs. Doctors have opposed this law, and in theory, the law inconveniences patients. We assessed the relationship between patients' satisfaction with drug dispensation and their overall support for the law by using a logit model to determine the effects of the law on patients and which patients are likely to support the law. We employed random digit dialing and obtained a sample of 540 adults who had used drugs since the law was enacted. We collected the data through phone interviews. The results indicate that the respondents were generally dissatisfied with the law regardless of sociodemographic or regional characteristics. However, with other factors controlled for, those respondents from the same region as the ruling political party were significantly more likely to support the law. This implies that regional politics influenced the policymaking process through which the law was crafted and enacted. [ABSTRACT FROM AUTHOR]

The article presents information on the laws related to the sales of pseudoephedrine that have enforced to curb the illegal production of methamphetamine in the U.S. It also discusses the Combat Methamphetamine Epidemic Act of 2005 according to which limitations were set on the amount of pseudoephedrine that individuals could buy and retailers or pharmacists could sell along with the introduction of a logbook system which could help in keeping records of customers.

The increasing prominence of patent medicine vendors (PMVs) in healthcare provision makes information about how they operate of interest. This study assessed consumers' behavior and PMVs' performance in the treatment of childhood illnesses in rural and urban communities in South West Nigeria. Non-participatory observations were carried out in 163 licensed patent medicine stores in Oyo State, Nigeria. Many PMV shops (70.6% rural and 61.9% urban; p = 0.141); stocked non proprietary drugs. Clients often requested for drugs by name (75.4% urban versus 62.2% rural; p = 0.002) and PMVs mostly sold drugs as requested without questions (65.3% urban 57.8% rural; p = 0.07). Inappropriate treatment practices and invasive procedures were observed more often in urban PMVs shops (p < 0.001). PMVs functioned mostly as sales persons supplying clients' drug requests. Strategies to improve PMV treatment practices should include caregiver education to be effective. [ABSTRACT FROM AUTHOR]

The Court of Justice of the European Union has acknowledged the wide margin of the Member States in the design of their pharmaceutical services. After declaring the compatibility with the Treaty of the limitation of ownership of pharmacies to pharmacists in 2009, in the judgement delivered on 1 June 2010 in case Blanco Pérez y Chao Gómez (C-570/07 and C-571/07) concerning a preliminary ruling on distances and population requirements for the establishment of pharmacies in Spain, it has also confirmed the legality of said requirements. This commentary presents the background of said preliminary ruling, the national legislation that is at its origin and the reasoning of the Court. Finally some reflections are carried out as regards the impact of this case-law on the design of the pharmaceutical services and other sanitary professions in the Member States. [ABSTRACT FROM AUTHOR]

Abstract: Background: Injecting drug users (IDUs) are at increased risk of acquiring and transmitting HIV and other bloodborne pathogens through the multi-person use of syringes. Although research has shown that increased access to syringes through syringe exchange programs (SEPs) is an effective strategy to reduce risky injection practices many areas of the United States still do not have SEPs. In the absence of SEPs, legislation allowing pharmacies over-the-counter sales of syringes has also been shown to reduce syringe sharing. The success of pharmacy sales however is limited by other legal stipulations, such as drug paraphernalia laws, which in turn may contribute to fear among IDUs about being caught purchasing and carrying syringes. Methods: Between 2003 and 2006, 851 out-of-treatment IDUs were recruited using street outreach in the Raleigh-Durham (North Carolina) area. Data were collected using audio-computer assisted interview (ACASI) technology. Multiple logistic regression analyses were performed to assess factors associated with purchasing syringes from pharmacies. Results: In our study sample, African-American IDUs were one-fifth as likely as white IDUs to report pharmacies as their primary source of syringes. Conclusions: Given the absence of syringe exchange programs and the relatively high prevalence of HCV and HIV among IDUs in the Raleigh-Durham area, the limited use of pharmacies as a source of syringes among African-American IDUs in this study sample is problematic. The study findings support the need for effective multilevel interventions to increase access to clean needles in this population, as well as for policy interventions, such as legalization of SEPs and elimination of penalties for carrying syringes, to reduce harm and eliminate the health threats posed by receptive syringe sharing. [ABSTRACT FROM AUTHOR]

Purpose. To discuss the role of restricted drug distribution systems in the implementation of risk evaluation and mitigation strategies (REMS), health-system pharmacists’ concerns associated with the use of specialty pharmacies and other restricted drug distribution systems, reimbursement policies for high-cost specialty drugs, supply chain models for traditional and specialty drugs, and emerging trends in the management of and reimbursement for specialty pharmaceuticals. Summary. Restricted drug distribution systems established by pharmaceutical manufacturers, specialty pharmacies, or other specialty suppliers may be a component of REMS, which are required by the Food and Drug Administration for the management of known or potential serious risks from certain drugs. Concerns of health-system pharmacists using specialty suppliers include access to pharmaceuticals, operational challenges, product integrity, financial implications, continuity of care, and patient safety. An ambulatory care patient taking a specialty drug product from home to a hospital outpatient clinic or inpatient setting for administration, a practice known as “brown bagging,” raises concerns about product integrity and institutional liability. An institution’s finances, tolerance for liability, and ability to skillfully manage the processes involved often determine its choice between an approach that prohibits brown bagging but is costly and one that permits the practice under certain conditions and is less costly. The recent shift from a traditional supply chain model to a specialty pharmacy supply chain model for high-cost pharmaceuticals has the potential to increase pharmaceutical costs for health systems. A dialogue is needed between health-system pharmacists and group purchasing organizations to address the latter’s role in mitigating the financial implications of this change and to help clarify the safety issues. Some health plans have shifted part of the cost of expensive drugs to patients by establishing a fourth tier of drugs with a large copayment based on a substantial percentage of the cost of the drug. The number and cost of specialty drugs are expected to increase in the future. New approaches and reimbursement models are emerging to manage the high cost of new pharmaceuticals. Conclusion. Health-system pharmacists can improve drug safety and manage costs by collaborating with group purchasing organizations, establishing policies for brown bagging, and making efforts to reconcile drug therapy provided in different settings through traditional drug channels and specialty pharmacies or other restricted drug distribution systems. [ABSTRACT FROM AUTHOR]

In 1963, the North Dakota Legislature amended the North Dakota Century Code to ensure that all licensed community pharmacies in the State are majority owned by pharmacists registered in the State. During the 2008-2009 legislative session, a debate arose about whether this law should be repealed. Those in favor of repeal attacked the law using the neoclassical arguments of efficiency, competition and lower prices. Those opposed to the law's repeal argued that pharmacists must own pharmacies in order to protect the public's welfare. This paper explores the arguments made for and against this law and draws two major conclusions. First, the arguments made by both sides are flawed because neither side fully incorporates the historical, physical and cultural characteristics of North Dakota communities into their analyses. Second, North Dakota legislators voted overwhelmingly to retain the law. Moreover, prima fascia evidence indicates that the legislators based their decisions on Institutional considerations. [ABSTRACT FROM AUTHOR]

El artículo presenta un análisis de los principales adelantos del Tribunal de Justicia de la Unión Europea en jurisprudencia sobre libertad de establecimientos y farmacias, en particular la propiedad de farmacias por profesionales no farmacéuticos. Las autoras centran la discusión en la compatibilidad de la jurisprudencia analizada con la normativa de España, especialmente en los casos de herencia de farmacias por personal no profesionales del ramo.

No-prescription Web sites are online pharmacies that supply controlled substances without a valid prescription. The authors present a comprehensive investigation and content analysis of no-prescription Web sites, including a review of the legal environment, an in-depth critique of policy and interventions, and suggestions to help monitor and shut down these illegal sites. [ABSTRACT FROM AUTHOR]