Marco legal comparado de la dispensación de medicamentos en las oficinas de farmacia de los distintos Estados miembros de la Unión Europea / Comparative legal framework for the dispensing of medicinal products in pharmacies in the different member states of the European Union

La dispensación es el acto llevado a cabo por un farmacéutico o bajo su supervisión, destinado a garantizar que los pacientes reciban los medicamentos en las dosis precisas según sus requerimientos individuales, durante el periodo de tiempo adecuado, con la información para su correcto uso, y de acuerdo con la normativa vigente. Con el fin de comprender este acto se ha analizado previamente el concepto de medicamento, los estudios que debe cursar un farmacéutico, y la regulación de los conceptos de ordenación farmacéutica, así como de las oficinas de farmacia en la Unión Europea, con el objetivo final, de comparar el acto de dispensación en cada uno de países de la Unión Europea. Para realizar dicha comparación, se ha traducido, analizado e interpretado cada una de las normas que afectan directamente al acto de dispensación de medicamentos en cada Estado miembro. Los aspectos que se han investigado son: la obligatoriedad de presencia de un farmacéutico en la oficina de farmacia; la venta de medicamentos en establecimientos distintos de las oficinas de farmacia; la capacidad de sustitución de aquellos medicamentos sujetos a prescripción médica por el farmacéutico; y, la regulación de la venta online de medicamentos sujetos a prescripción médica. Si bien es cierto que se ha concluido que la presencia del farmacéutico es obligatoria en el 99% de los países, no se ha encontrado una armonía total en la normativa del resto de parámetros objeto de comparación en el presente trabajo de investigación.(AU)

Dispensing is the act carried out by a pharmacist or under his supervision, aimed at ensuring that patients receive the medicines in the precise doses according to their individual requirements, for the appropriate period, with the information for their correct use, and in accordance with current regulations. To understand this act, the concept of medicine, the studies that a pharmacist must take, the regulation of the concepts of pharmaceutical management, as well as the pharmacy offices in the European Union have been previously analyzed. Finally, compare the act of dispensing in each of the countries of the European Union. To make that comparison, each of the rules directly affecting the act of dispensing medicinal products in each Member State has been translated, analysed and interpreted. The aspects that have been investigated have been: the obligatory presence of a pharmacist in the pharmacy office; the sale of medicinal products in establishments other than pharmacies; the ability to replace those medicinal products subject to medical prescription by the pharmacist; and, the regulation of the online sale of medicines subject to medical prescription. Although it is true that it has been concluded that the presence of the pharmacist is mandatory in 99% of the countries, no total harmony has been found in the regulations of the rest of the parameters subject to comparison in this research work.(AU)

Accessibility of Pharmacist-Prescribed Contraceptives in Utah.

OBJECTIVE: To assess pharmacy participation in and accessibility of pharmacist-prescribed contraception after legislation effective in the state of Utah in 2019. METHODS: A secret-shopper telephone survey was used to assess participation in pharmacist-prescribed contraception. Geospatial analysis was used to map the distribution of participating pharmacies by population characteristics. RESULTS: Of all operating Class A retail pharmacies in Utah, 127 (27%) were providing pharmacist-prescribed contraception 1 year after implementation of the Utah standing order. Oral contraceptive pills were widely accessible (100%); however, other allowed methods were not (vaginal ring 14%; contraceptive patch 2%). Consultation fees and medication costs varied widely. Participating pharmacies were mainly concentrated in population centers. Assuming access to a personal vehicle, urban areas with a high percentage of Hispanic people (Utah's largest minority race or ethnicity group) have access to a participating pharmacy within a 20-minute driving distance. However, access in rural areas with a high percentage Hispanic or other minority were limited. We identified 235 (40%) census tracts with a high proportion of Utah's residents living below the poverty line or of minority race or ethnicity who also had low access to pharmacist-prescribed contraception. CONCLUSIONS: Although the pharmacy-based model is intended to increase access to contraception, practical availability 1 year after the authorization of pharmacist-prescribed contraception in Utah suggests that this service does not adequately serve rural areas, particularly rural areas with a high proportion of minorities and those living below the federal poverty line.

Farmacias comunitarias de Ecuador y España. Aspectos legales / Ecuador and Spain community pharmacies. Legal aspects

INTRODUCCIÓN: La necesidad de estándares de calidad de los servicios farmacéuticos, para garantizar el uso seguro, responsable y efectivo del medicamento, ha hecho que a través de los años se produzcan una serie de cambios en los sistemas sanitarios. Existe además, una lucha para posicionar a la farmacia y a farmacéuticos como ejes potenciales para promulgar la protección de la salud. Fruto de estos cambios, se evidencian diferencias estructurales en los modelos de farmacia entre países desarrollados y países en vías de desarrollo. El presente estudio realiza un análisis comparativo del modelo de oficina farmacia entre los países de Ecuador y España, diferenciando las legislaciones alusivas al funcionamiento de las farmacias y comparando los modelos de oficina de farmacia. MÉTODO: Estudio comparativo basado en investigación documental, en lo referente a normativas y legislación de las farmacias comunitarias de Ecuador y España. RESULTADOS: En el presente trabajo se analizan la legislación vigente que regula la farmacia española y ecuatoriana, en referencia al establecimiento de nuevas farmacias, propiedad farmacéutica, prohibición de cadenas de farmacia, así como la calidad de la formación del farmacéutico comunitario. CONCLUSIONES: En países de Latinoamérica, como en el caso de Ecuador, la farmacia adopta un modelo más liberal, refiriendo a la desregularización de la apertura de nuevas farmacias, temas de propiedad, sistema de planificación territorial, así como la no presencia del profesional farmacéutico; dando lugar a un sistema con un fuerte enfoque comercial; incidiendo de esta forma sobre la función ideal que debe llevar a cabo la farmacia comunitaria

INTRODUCTION: The need for quality standards in pharmaceutical services, that provides a safety, responsible and effectiveness use of medication, has led several changes in health systems over the years. There is also a struggle to position the pharmacy and pharmaceutical professionals as potential axes to enact health care. As a result of these changes, there are structural differences in pharmacy models between developed and developing countries. The present study sets out to provide a comparative analysis of Ecuador and Spain pharmacy office model, differentiating legislations concerning the functioning of pharmacies and comparing the pharmacy office models. METHOD: Documentary based research and a comparative study, regarding regulations and legislation of community pharmacies in Ecuador and Spain. RESULTS: In this paper, the current legislation that regulates the Spanish and Ecuadorian pharmacy is analyzed, in reference to the establishment of new pharmacies, pharmaceutical ownership, prohibition of pharmacy chains, as well as the quality of the training of community pharmacists. CONCLUSIONS: In Latin American countries, as in the case of Ecuador, the pharmacy adopts a more liberal model, referring to the deregulation of the opening of new pharmacies, property issues, territorial planning system, as well as the non-presence of the professional pharmacist; resulting in a system with a strong commercial focus; thus emphasizing the ideal role to be played by the community pharmacy

'It's just basically a box full of disease'-navigating sterile syringe scarcity in a rural New England state.

BACKGROUND AND AIMS: Injection drug use has increased in non-urban communities in the United States where sterile syringe access is limited. This study aimed to characterize how people who inject drugs in a predominantly rural state navigate syringe scarcity. DESIGN: Qualitative study. SETTING: New Hampshire (NH), USA. At the time of our study, syringe services programs were illegal in NH but pharmacies could sell ≤ 10 syringes without prescription. PARTICIPANTS/CASES: Twenty people aged ≥ 18 years who injected at least once in the past 30 days were recruited through provider referral, street-based recruitment and snowball sampling. MEASUREMENTS: Semi-structured interview guide. Verbatim transcripts were coded based on interview guide constructs and emergent themes. Analysis focused on pharmacy syringe access, unofficial syringe sources and related impacts on syringe sharing and reuse FINDINGS: Participants could identify no local pharmacies that sold syringes without prescription. Pharmacy purchase in neighboring counties, or across state lines, required private transportation and this, along with purchaser identification requirements, presented substantial access barriers. Interstate travel also exposed participants to vigilant policing of interstate highways and potential criminal justice involvement. Many participants thus resorted to informal syringe sources closer to home including purchasing syringes on the street, using discarded syringes, breaking into biohazard containers and constructing improvised syringes out of salvaged syringe parts, metals and plastics. Repeated re-use of syringes until they were no longer operational was common. Overall, syringe scarcity gave participants few options but to engage in syringe sharing and re-use, putting them at risk of serious injection-related infections. CONCLUSIONS: Limited sterile syringe access contributes to an environment in which people who inject drugs report that they are less able to refrain from risky injection practices.

Pharmacists' Patient Care Process: State "Scope of Practice" Priorities for Action.

To fully engage in the Pharmacists' Patient Care Process, pharmacists must be able to (1) participate in a Collaborative Practice Agreement, (2) order and interpret laboratory tests, (3) prescribe certain medications, (4) adapt medications, (5) administer medications, and (6) effectively delegate tasks to support staff. Each of these activities is dependent on state scope of practice laws, but these laws are not binary. Various state-level restrictions allow us to view these activities on a continuum from more restrictive to less restrictive. This continuum will allow pharmacy and public health stakeholders to identify priorities for action in their states.

Community Pharmacies in Poland-The Journey from a Deregulated to a Strictly Regulated Market.

Community pharmacies are the primary entities providing drugs to individual patients in Poland. The pharmacy market has been changing for many years due to significant changes in market regulations. These changes significantly affect the profitability of pharmacies, which may impact the quality of pharmacotherapy. The small number of pharmacies, which resulted from changes in the law in 2017, can influence the level of patient care. The article presents the community pharmacies market in Poland. Particular attention is paid to the legal regulations affecting community pharmacies and the impact of these regulations on the overall shape of the market. The Polish system's specificity, including the pharmacy market indicators, has been compared with data from other European Union countries.

[Regulation of drug prices in nineteenth-century Bazilian pharmacy]. / O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista.

On November 5th, 1808, D. João de Bragança issued a license about the practice of druggists and the price of drugs and ordered the creation of a regulation to tax the cost of medicines marketed in Brazil. First published on 1809, the Regimento dos preços dos medicamentos... gained new editions in the following years and became an indispensable working tool for those involved in the making and trading of drugs at this time. This paper situates historically and sheds light on a document briefly explored by the researchers of the history of the Brazilian pharmacy, taking into account that it was one of the first initiatives of the Luso-Brazilian government in line with the pharmaceutical activity in Brazil in the nineteenth century.

Em 5 de novembro de 1808, dom João de Bragança promulgou um alvará sobre o exercício dos boticários e o preço das drogas e ordenou a criação de um regulamento para taxar o custo dos medicamentos comercializados no Brasil. Publicado pela primeira vez em 1809, o Regimento dos preços dos medicamentos... ganhou novas edições nos anos subsequentes e tornou-se um indispensável instrumento de trabalho para os envolvidos com a feitura e o comércio dos remédios. Este texto situa historicamente e destaca esse documento brevemente explorado pelos pesquisadores da história da farmácia brasileira, visto ter sido uma das primeiras iniciativas do governo luso-brasileiro condizentes com a atividade farmacêutica no Brasil no século XIX.

O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista / Regulation of drug prices in nineteenth-century Bazilian pharmacy

Resumo Em 5 de novembro de 1808, dom João de Bragança promulgou um alvará sobre o exercício dos boticários e o preço das drogas e ordenou a criação de um regulamento para taxar o custo dos medicamentos comercializados no Brasil. Publicado pela primeira vez em 1809, o Regimento dos preços dos medicamentos... ganhou novas edições nos anos subsequentes e tornou-se um indispensável instrumento de trabalho para os envolvidos com a feitura e o comércio dos remédios. Este texto situa historicamente e destaca esse documento brevemente explorado pelos pesquisadores da história da farmácia brasileira, visto ter sido uma das primeiras iniciativas do governo luso-brasileiro condizentes com a atividade farmacêutica no Brasil no século XIX.

Abstract On November 5th, 1808, D. João de Bragança issued a license about the practice of druggists and the price of drugs and ordered the creation of a regulation to tax the cost of medicines marketed in Brazil. First published on 1809, the Regimento dos preços dos medicamentos... gained new editions in the following years and became an indispensable working tool for those involved in the making and trading of drugs at this time. This paper situates historically and sheds light on a document briefly explored by the researchers of the history of the Brazilian pharmacy, taking into account that it was one of the first initiatives of the Luso-Brazilian government in line with the pharmaceutical activity in Brazil in the nineteenth century.

Widespread illegal sales of antibiotics in Chinese pharmacies - a nationwide cross-sectional study.

Background: Access to antibiotics without a prescription from retail pharmacies has been described as a major contributor to anti-microbial resistance (AMR) globally. In the context of high rates of AMR, the Chinese government has recently introduced strict policies regarding hospital antibiotic use, but the existing ban on antibiotic sales without prescription in retail pharmacies has not been strongly enforced. In 2016, a goal of prescription-only antibiotics by 2020 was announced. The objective of the study was to determine progress towards the 2020 goal, through estimating the proportion of retail pharmacies selling antibiotics without prescription across the three regions of mainland China. Methods: Using the Simulated Patient method, we conducted a cross-sectional survey across purposively-sampled retail pharmacies in urban and rural areas of 13 provinces in eastern, central and western China. Medical students presented a scenario of a mild upper respiratory tract infection, following a strict three-step protocol. They recorded the pharmacy characteristics, and details of their experience, including at which step antibiotics were offered. Results: Complete data were obtained from 1106 pharmacies. Antibiotics were obtained in 925 (83.6, 95% CI: 81.5, 85.8%) pharmacies without a prescription, 279 (25.2%) at Stage 1 (symptoms only described), 576 (52.1%) at stage 2 (asked for antibiotics), and 70 (6.3%) at Stage 3 (asked for penicillin or cephalosporins). There were significant differences between provinces, with antibiotic access (at any stage) ranging from 57.0% (57/100) in Zhejiang (81/82) to 98.8% in Guizhou. However, there were no significant differences in access to antibiotics by level of city, county, township or village (P = 0.25), whether the pharmacy was part of a chain or independent (P = 0.23), whether a licensed pharmacist was attending (P = 0.82) or whether there was a sign saying that prescriptions were required for antibiotics (P = 0.19). Conclusions: It is easy to obtain antibiotics without a prescription in retail pharmacies in China, despite the fact it is against the law. This must be addressed as part of the wider anti-microbial stewardship effort which could include intense enforcement of the existing law, supported by a public education campaign.

Facilitators and barriers to implementing pharmacist-prescribed hormonal contraception in California independent pharmacies.

In 2013, California passed legislation to expand the scope of pharmacist practice, including authorizing pharmacists to prescribe hormonal contraception. Pharmacist-prescribed contraception was largely unavailable across the state in 2017. This study aimed to identify barriers and facilitators to offering this service in California independent pharmacies. To do so, we thematically analyzed qualitative data from structured interviews with 36 pharmacists working in independent pharmacies in 2016-17. We found that pharmacists anticipated general benefits from expanding their roles to prescribe contraception, including increasing health care access and decreasing costs. In contrast, described barriers were concrete, including lack of financial incentives and business risks for independent pharmacies. Specific barriers to prescribing hormonal contraception included time required to screen and counsel women about contraception and concerns that pharmacist-prescribed contraception would increase liability and lead to patients seeking health care less frequently. This study suggests that incentives and barriers identified by the respondents are likely to have varied and unequal impacts, with immediate barriers being potentially prohibitive for pharmacists to prescribe contraception. For independent pharmacies, perceived business risks and lack of insurance reimbursement may outweigh professional support for prescribing contraception, limiting the public health impact of legislation that should increase contraceptive access.

Relationship between regulatory barriers to entry and pharmacy technician wages.

BACKGROUND: Pharmacy technicians are vital to the operation of pharmacies, and national pharmacy associations have advocated for mandatory education and training requirements. While these requirements may improve patient safety, there is a risk that laws and regulations which impose substantial education and training requirements on technicians could create barriers to entry which restrict the workforce and increase wages. OBJECTIVE: This study has two objectives: 1) Describe changes in barriers to entry and wages over time; and 2) Evaluate the correlation between changing barriers to entry and pharmacy technician wages. METHODS: Data come from Bureau of Labor Statistics Occupational Employment Statistics from 1997 to 2017 and National Association of Boards of Pharmacy Surveys of Pharmacy Law from 1997 to 2014. A barrier to entry was defined as adoption of registration, licensure, or certification. Wage data was adjusted to 2017 dollars using the Consumer Price Index. Ordinary least squares regression evaluated the correlation between the proportion of states which had at least one barrier to entry and wages. An interrupted time series model estimated the impact of adopting a barrier to entry on the trend in technician wages over time. RESULTS: Technician wages increased between 1997 and 2007 but remained flat between 2008 and 2017. A strong correlation was observed between the proportion of states which had at least one barrier to entry and technician wages (R2 = 0.93, p < 0.0001). However, the interrupted time series models did not identify any relationship between adoption of a barrier to entry and the trend in technician wages (p = 0.363). CONCLUSIONS: This research suggests adoption of legal/regulatory barriers to entry did not have a significant influence on the trend in technician wages over time. More research is needed to evaluate the impact of barriers to entry on non-wage practice variables, such as privileges and satisfaction.

Medicamentos isentos de prescrição (MIP): o farmacêutico pode prescrever, mas ele sabe o que são? / Over the counter (OTC) drugs: the pharmacist can prescribe, but do they know what they are?

INTRODUÇÃO: Medicamentos isentos de prescrição (MIP) representam expressiva parcela de comercialização no mercado farmacêutico mundial e brasileiro e possuem importância no manejo de problemas de saúde autolimitados e na automedicação responsável, por meio da atuação clínica do farmacêutico. Assim, o objetivo do trabalho foi identificar os MIP mais comumente dispensados em farmácias comunitárias da região metropolitana de Belo Horizonte, bem como o perfil de conhecimentos dos farmacêuticos em relação a categorização legal desta classe de medicamentos. MÉTODOS: Trata-se de um estudo descritivo em que foram convidados a participar, via e-mail, todos os farmacêuticos responsáveis técnicos por farmácias comunitárias da região metropolitana de Belo Horizonte-MG (n=1.624; Outubro a Dezembro de 2017). A coleta de dados foi realizada por meio de questionário disponível na plataforma Google Docs®, onde requisitou-se aos farmacêuticos que listassem os cinco MIP mais dispensados por eles nos últimos 12 meses. RESULTADOS: Foram obtidas respostas de 108 farmacêuticos. Os MIP mais dispensados constituem fármacos ou associações de fármacos com efeitos analgésico e/ou anti-inflamatório. Além disso 35,2% dos farmacêuticos listaram ao menos um medicamento não considerado isento de prescrição. Dentre 468 medicamentos citados, 54 representavam medicamentos sob prescrição médica. CONCLUSÃO: Os dados encontrados indicam uma lacuna no conhecimento desses farmacêuticos em relação à categorização legal de medicamentos, a qual pode acarretar em implicações legais e em resultados clínicos negativos. Neste sentido, torna-se essencial desenvolver estratégias, por meio de aprimoramentos e educação, visando suprir problemas de conhecimentos e condutas profissionais

INTRODUCTION: Over the counter drugs (OTC) represent a significant market share in the global and Brazilian pharmaceutical market and are important in the management of minor ailments and to responsible self-medication through the pharmacist's clinical performance. Thus, the main of this research was to identify the OTC most commonly dispensed in community pharmacies in the metropolitan area of Belo Horizonte, as well as the knowledge profile of pharmacists regarding the legal categorization of this class of drugs. METHODS: A descriptive study with pharmacists in charge of community pharmacies in the metropolitan region of Belo Horizonte-MG (n=1,624, October through December 2017) were realized. The invitations to participate were made via e-mail. Data collection was performed using a questionnaire available on the Google Docs® platform, where pharmacists were asked to list the five OTC most dispensed by them in the last 12 months. RESULTS: Responses were obtained from 108 pharmacists. The most dispensed OCT are drugs or combinations of drugs with analgesic and/or anti-inflammatory effects. In addition, 35.2% of pharmacists listed at least one non-OTC drug. Of the 468 medicines mentioned, 54 represented medicines under medical prescription. CONCLUSION: The data indicate a gap in the knowledge of these pharmacists regarding the legal categorization of drugs, which may have legal implications and negative clinical results. In this sense, it is essential to develop strategies, through improvements and education, aiming to supply problems of knowledge and professional conduct

Review of purchases of unapproved medications by the Veterans Health Administration.

PURPOSE: Many medications that were marketed prior to 1962 but lack Food and Drug Administration (FDA) approval are prescribed in the United States. Usage patterns of these "unapproved medications" are poorly elucidated, which is concerning due to potential lack of data on safety and efficacy. The purpose of this project was to characterize purchases of unapproved medications within the Veterans Health Administration (VHA) by type, frequency, and cost. METHODS: VHA purchasing databases were used to create a list of all products with National Drug Codes (NDCs) purchased nationwide in fiscal year 2016 (FY16). This list was compared to FDA databases to identify unapproved prescription medications. For each identified combination of active pharmaceutical ingredient (API) and route of administration ("API/route combination"), numbers of packages purchased and associated costs were added. RESULTS: VHA pharmacy purchasing records contained 3,299 unapproved products with NDCs in FY16. After excluding equipment, nutrition products, compounding ingredients, nonmedication products, and duplicate NDCs, there were 600 unique NDCs associated with 130 distinct API/route combinations. The most commonly acquired product was prescription sodium fluoride dental paste (350,775 packages). The greatest pharmaceutical expenditure was for sodium hyaluronate injection ($24.5 million). Unapproved products accounted for less than 1% of overall VHA pharmacy purchasing in FY16. CONCLUSION: VHA purchased many unapproved prescription products in FY16 but is taking action to address use of such products in consideration of safety and efficacy data and available alternatives.

I could take the judgment if you could just provide the service: non-prescription syringe purchase experience at Arizona pharmacies, 2018.

BACKGROUND: Community pharmacies are important for health access by rural populations and those who do not have optimum access to the health system, because they provide myriad health services and are found in most communities. This includes the sale of non-prescription syringes, a practice that is legal in the USA in all but two states. However, people who inject drugs (PWID) face significant barriers accessing sterile syringes, particularly in states without laws allowing syringe services programming. To our knowledge, no recent studies of pharmacy-based syringe purchase experience have been conducted in communities that are both rural and urban, and none in the Southwestern US. This study seeks to understand the experience of retail pharmacy syringe purchase in Arizona by PWID. METHODS: An interview study was conducted between August and December 2018 with 37 people living in 3 rural and 2 urban Arizona counties who identified as current or former users of injection drugs. Coding was both a priori and emergent, focusing on syringe access through pharmacies, pharmacy experiences generally, experiences of stigma, and recommendations for harm reduction services delivered by pharmacies. RESULTS: All participants reported being refused syringe purchase at pharmacies. Six themes emerged about syringe purchase: (1) experience of stigma and judgment by pharmacy staff, (2) feelings of internalized stigma, (3) inconsistent sales outcomes at the same pharmacy or pharmacy chain, (4) pharmacies as last resort for syringes, (5) fear of arrest for syringe possession, and (6) health risks resulting from syringe refusal. CONCLUSIONS: Non-prescription syringe sales in community pharmacies are a missed opportunity to improve the health of PWID by reducing syringe sharing and reuse. Yet, current pharmacy syringe sales refusal and stigmatization by staff suggest that pharmacy-level interventions will be necessary to impact pharmacy practice. Lack of access to sterile syringes reinforces health risk behaviors among PWID. Retail syringe sales at pharmacies remain an important, yet barrier-laden, element of a comprehensive public health response to reduce HIV and hepatitis C among PWID. Future studies should test multilevel evidence-based interventions to decrease staff discrimination and stigma and increase syringe sales.

Availability of Naloxone in Pharmacies and Knowledge of Pharmacy Staff Regarding Dispensing Naloxone to Younger Adolescents.

PURPOSE: This study assessed the immediate availability of naloxone in pharmacies and the knowledge of pharmacy staff regarding naloxone dispensing protocols, especially as it relates to younger adolescents. METHODS: The primary sample included pharmacies in the 10 states with the highest number of opioid-related overdose deaths in 2016; in addition, pharmacies in the 2 states with the highest prevalence of opioid-related overdose deaths in 2016 were also contacted. Researchers simulated a routine conversation between pharmacy staff and a potential customer about the immediate availability of and requirements to purchase naloxone. RESULTS: The primary sample included 120 pharmacies (82.5% chain pharmacies; 50.8% rural). The majority (80.3%) had at least one form of naloxone in stock. Pharmacy staff were knowledgeable about prescription and third-party purchasing requirements. However, almost half incorrectly responded that there was a minimum age requirement to purchase naloxone. CONCLUSION: This study reveals barriers to obtaining naloxone, including a lack of immediate in-store availability and a common misperception that naloxone cannot be dispensed to minors.