The impact of the COVID-19 pandemic on addressing common barriers to pharmacy-based point-of-care testing.

Introduction: Pharmacy-based point-of-care testing has long had the potential to improve patient access to timely care, but adoption has been slowed by financial and regulatory barriers. The COVID-19 pandemic reduced or temporarily eliminated many of the barriers to pharmacy-based testing. This review examines how the changes brought on by may impact pharmacy-based testing after the pandemic.Areas covered: This review searched peer-reviewed, lay, and regulatory literature to explore the implementation of pharmacy-based COVID-19 testing. This includes a review of regulatory and financial changes that removed barriers to testing. Additionally, it reviews the literature related to the growth of pharmacy-based testing.Expert opinion: It is clear that the COVID-19 pandemic created an awareness and opportunity for pharmacy-based point-of-care testing. The changes made in response to the pandemic have the potential to increase the role of pharmacy-based testing, but additional regulatory changes and wider pharmacy adoption are still needed to maximize the value of such services.

Community Pharmacy Practice in Italy during the COVID-19 (SARS-CoV-2) Pandemic: Regulatory Changes and a Cross-Sectional Analysis of Seroprevalence.

Pharmacists in the community and the essential requirement to safeguard their own health have become fundamental since the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The aims of this paper were (I) to analyze the directives provided to pharmacists in 2020 regarding preventative safety measures to be adopted; (II) to determine the number of pharmacists who came into contact with SARS-CoV-2 in North-West Italy and relate this to the adopted preventative measures. The first aim was pursued by conducting a bibliographic research, consulting the principal regulatory sources. The second one was achieved with an observational study by administering a questionnaire and performing a serological test. The various protection measures imposed by national and regional legislation were analyzed. Two hundred and eighty-six pharmacists (about 8% of the invited ones) responded to the survey. Ten pharmacists reported a positive result to the serological test. Of the subjects who presented a positive result, three declared that they had not used a hand sanitizer, while two stated that they had not scheduled the cleaning and decontamination of surfaces. Two interviewees had not set up a system of quota restrictions on admissions. In four cases, a certified cleaning company had decontaminated the premises. The results of our study show that during the coronavirus disease 2019 (COVID-19) pandemic, the most pressing challenge for community pharmacists has been the protection of staff and clients inside the pharmacy; the challenge to be faced in the near future will probably be the management of new responsibilities.

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.

Professional practice following regulatory change: An evaluation using principles of "Better Regulation".

BACKGROUND: The provisions in place internationally to regulate the practice of healthcare professionals have undergone significant change. However, this changing regulatory environment as experienced by healthcare professionals in the practice setting has not to date been widely researched. OBJECTIVE: To describe the "lived experience" of pharmacists in community practice in Ireland of the model of regulation introduced by the Pharmacy Act 2007 and their perception of it as fulfilling the seven principles of "better regulation": Necessity; Effectiveness/Targeted; Proportionality; Transparency; Accountability; Consistency and Agility. METHOD: 20 community pharmacists purposively selected, shared their lived experiences of the Act, as implemented in a semi-structured interview. A qualitative content analysis incorporating a framework analysis based on the seven principles of better regulation was used to analyze the data. RESULTS: The Act and its implementation by the Pharmaceutical Society of Ireland (PSI) was not perceived by community pharmacists overall as fulfilling the principles of better regulation. While there was agreement that the Act was necessary, its implementation by the PSI was not viewed as being effective, targeted, proportional and consistent. The PSI was considered to act as a deterrence regulator that is not adequately transparent or accountable. The Act is not sufficiently agile to respond to changes in pharmacy practice. CONCLUSION: Community pharmacists acknowledge the need for the Pharmacy Act but perceive that the PSI needs to adopt a more responsive approach to implementation if the Act is to be considered a model of better regulation. The study findings are of interest as there is little published research on how regulation is experienced by healthcare professionals who are subject to its provisions. The principles of better regulation provide an effective qualitative methodology to examine models of professional regulation based on the "lived experience" of regulatees.

Improving community access to terminal phase medicines through the implementation of a 'Core Medicines List' in South Australian community pharmacies.

OBJECTIVES: Difficulties accessing medicines in the terminal phase hamper the ability of patients to die at home. The aim of this study was to identify changes in community access to medicines for managing symptoms in the terminal phase throughout South Australia (SA), following the development of a 'Core Medicines List' (the List) while exploring factors predictive of pharmacies carrying a broad range of useful medicines. METHODS: In 2015, SA community pharmacies were invited to participate in a repeat survey exploring the availability of specific medicines. Comparisons were made between 2012 and 2015. A 'preparedness score' was calculated for each pharmacy, scoring 1 point for each medicine held from the following 5 classes: opioid, benzodiazepine, antiemetic, anticholinergic and antipsychotic. RESULTS: The proportion of pharmacies carrying all items from the List rose from 7% in 2012 to 18% in 2015 (p=0.01). Multiple linear regression demonstrated that a monthly online newsletter subscription (p=0.04) and provision of a clinical service to aged care facilities (p=0.02) were predictors of pharmacies carrying all items on the List. Furthermore, multiple linear regression demonstrated that the provision of an afterhours service (p=0.02) and clinical services to aged care facilities (p=0.04) were predictors of pharmacies with a high 'preparedness score'. In responding to issues with supply of medicines at end of life, respondents were more likely to contact the prescriber if aware of palliative patients (p=0.03). CONCLUSIONS: These results suggest that there is value in developing and promoting a standardised list of medicines, ensuring that community palliative patients have timely access to medicines in the terminal phase.

The impact of law enforcement on dispensing antibiotics without prescription: a multi-methods study from Saudi Arabia.

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.

Supply of codeine combination analgesics from Australian pharmacies in the context of voluntary real-time recording and regulatory change: A simulated patient study.

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.

Unlawful dispensing practice of diazepam: a simulated client approach in community pharmacies in the north-west of Dar-es-Salaam region, Tanzania.

BACKGROUND: The use of psychotropic substances is controlled in most parts of the world due to their potential of abuse and addiction. Diazepam is one of the psychotropic substances which can be dispensed in community pharmacies in Tanzania. As per good dispensing practices and pharmacy laws, diazepam in the community pharmacies should strictly be stored in a controlled box and dispensed only by prescription. However, to our understanding little had been reported on availability and dispensing practices of diazepam in Tanzania. METHODS: A descriptive cross-sectional study which involved 178 randomly selected registered community pharmacies in Kinondoni district was conducted from January to March 2018. Simulated client approach was used to assess the availability and dispensers practice about dispensing of diazepam. Location of pharmacies was categorized as being at the centre or periphery of the Kinondoni district. Chi-squared test was used for the analysis of categorical data using SPSS version 23. The p-value of < 0.05 was considered significant. RESULT: The total of 178 community pharmacies were visited, the majority of the dispensers (89.1%) encountered were female. Most (69.1%) of the studied pharmacies were located at the centre of Kinondoni district. Diazepam was available in 91% of community pharmacies and 70% of dispensers issued diazepam without prescription. CONCLUSION: Diazepam was available in most of the community pharmacies in Kinondoni district, and the majority of the dispensers dispensed diazepam without prescription. This calls for the regulatory authorities to be more vigilant on the availability of diazepam and enhance the provision of ethical pharmacy practice in the community pharmacies.

Pharmacists' views on the upscheduling of codeine-containing analgesics to 'prescription only' medicines in Australia.

Background Codeine is the most commonly used opioid worldwide, and is available over-the-counter (OTC) in many countries. There is continual debate regarding the risk:benefit profile for OTC codeine. In Australia, codeine containing analgesics became 'prescription only medicine' from February 2018. However, there is currently limited knowledge on the views of community pharmacists on this upscheduling and the perceived impacts on clinical practice. Objective To investigate the views of community pharmacists on the recent codeine upscheduling in Australia. Setting Community pharmacists in Australia, predominately recruited from Victoria. Method A descriptive cross-sectional study was conducted using a pre-tested customised anonymous self-administered online questionnaire between March and May 2018. To capture a broad range of demographics, pharmacists were recruited via local industry contacts and the Pharmaceutical Society newsletter, with further recruitment through snowball sampling. Main outcome measure Pharmacists' opinions to targeted questions regarding the perceived advantages and disadvantages of the recent 2018 codeine rescheduling from both their perspectives and their perceived impact on patients. Results A total of 113 pharmacists completed the survey. Approximately 43% of pharmacists agreed/strongly agreed that they believed upscheduling will positively impact their ability to manage pain; while 30% were neutral. Approximately 54% of pharmacists agreed/strongly agreed that they believed upscheduling will positively benefit their patients; while 25% were neutral. Perceived advantages for codeine upscheduling included: increased pharmacist/patient engagement, and less codeine use leading to better overall risk:benefit outcome; while disadvantages included: fewer analgesic options, and increased burden for patients, General Practitioners, and the health system. Conclusion This study showed that the current views on the recent codeine upscheduling are quite mixed, with both advantages and disadvantages perceived. Improving education and up-skilling in this space is essential.

Impact of implementing a technology platform in community pharmacies to increase adult immunizations rates.

Over the course of this project, we utilized pharmacists at 159 community pharmacies in Nebraska and Iowa to administer vaccinations to adults 19 years of age or older with the objective of improving immunization rates in both states. We implemented a pharmacy-based technology platform and partnered with public health via the state immunization registries of both states to ensure that immunizations provided at the pharmacy were transmitted to the statewide registry, for which reporting is currently voluntary for health care providers. After using the technology platform for one year, an increase of immunization rates for influenza, herpes zoster, and pertussis vaccination rates by 37%, 12%, and 74%, respectively, was recorded in comparison to the prior year numbers. However, there was about 16% decrease in vaccination rates for pneumococcal vaccine. For the first time, the project's participating pharmacies in Nebraska reported immunization counts to their state's immunization registries. This project leveraged community pharmacies as healthcare destinations to achieve further gains in increasing immunization rates, improving the health of adults, and creating a community-wide network for prevention.

Attitudes towards sales and use of over-the-counter drugs in Sweden in a reregulated pharmacy market: a population-based study.

OBJECTIVES: To analyse attitudes towards sales and use of over-the-counter (OTC) drugs in the Swedish adult population. METHODS: Data were collected through the web-based Citizen Panel comprising 21 000 Swedes. A stratified sample of 4058 participants was emailed a survey invitation. Questions concerned use of OTC drugs, and attitudes towards sales and use of OTC drugs. Correlations between the attitudinal statements were assessed using Spearman's rank correlation. Associations between attitudes and participant characteristics were analysed using multinomial logistic regression. KEY FINDINGS: Participation rate was 64%. Altogether 87% reported use of OTC drugs in the last 6 months. Approximately 10% of participants stated that they used OTC drugs at the first sign of illness, and 9% stated that they used more OTC drugs compared with previously, due to increased availability. The statement on use of OTC drugs at first sign of illness correlated with the statement about using more OTC drugs with increased availability. Socio-demographic factors (age, sex and education) and frequent use of OTC drugs were associated with attitudes to sales and use of OTC drugs. CONCLUSIONS: Increased use due to greater availability, in combination with OTC drug use at first sign of illness illustrates the need for continuous education of the population about self-care with OTC drugs. Increased awareness of the incautious views on OTC drugs in part of the population is important. Swedish policy-makers may use such knowledge in their continuous evaluation of the 2009 pharmacy reform to review the impact of sales of OTC drugs in retail outlets on patient safety and public health. Pharmacy and healthcare staff could be more proactive in asking customers and patients about their use of OTC drugs and offering them advice.

Pharmacist Intentions to Prescribe Hormonal Contraception Following New Legislative Authority in California.

OBJECTIVE:: Following a California law expanding pharmacists' scope of practice to include directly providing self-administered hormonal contraception to patients pursuant to a statewide protocol, this study aimed to assess California pharmacists' intentions to provide this new service prior to the protocol development and implementation. DESIGN:: Descriptive, nonexperimental, cross-sectional study. SETTING:: California between August and September 2014. PARTICIPANTS:: California pharmacists working in community pharmacies. INTERVENTION:: Invitations to participate in the online survey were sent to 1774 pharmacists. MAIN OUTCOME MEASURES:: Main outcomes included pharmacists' current practices, intentions to prescribe hormonal contraception, comfort performing various activities, knowledge about contraceptive methods, training needs, and barriers to prescribing. RESULTS:: A total of 257 responses (14.5% response rate) were received. Of those, 121 respondents met inclusion criteria and were included in the analysis. About half of the respondents (49.6%) reported working in a community chain pharmacy, 46.3% in an independent pharmacy, and 4.1% in other community pharmacy settings. The majority (72.7%) of pharmacists reported that they would likely provide this new service. Respondents reported being comfortable educating patients on short-acting (94.2%) and long-acting reversible contraception (81.7%), as well as identifying drug interactions with hormonal contraception (96.7%). Respondents indicated time constraints (74.4%), lack of reimbursement (63.6%), and liability concerns (62.0%) as barriers to prescribing hormonal contraception. CONCLUSIONS:: California pharmacists expressed strong intentions and comfort in prescribing hormonal contraception. Pharmacists' additional training needs and barriers should be addressed for successful implementation. This new service has great potential to increase access to contraception, potentially fostering increased use and adherence.

The Roles of Pharmacy Schools in Bridging the Gap Between Law and Practice.

Progressive pharmacy laws do not always lead to progressive pharmacy practice. Progressive laws are necessary, but not sufficient for pharmacy services to take off in practice. Pharmacy schools can play critical roles by working collaboratively with community pharmacies to close the gap between law and practice. Our experiences launching pharmacy-based point-of-care testing services in community pharmacy settings illustrate some of the roles schools can play, including: developing and providing standardized training, developing template protocols, providing workflow support, sparking collaboration across pharmacies, providing policy support, and conducting research.

Getting Paid for Clinical Services.

Increasingly, pharmacists are providing advanced, patient-centered clinical services. However, pharmacists are not currently included in key sections of the Social Security Act, which determines eligibility to bill and be reimbursed by Medicare. Many state and private health plans also cite the omission from Medicare as the rationale for excluding reimbursement of pharmacists for clinical services. This has prompted forward-thinking pharmacists to seek opportunities for reimbursement in other ways, allowing them to provide value to the health care system, while carving out unique niches for pharmacists to care for patients.

Exploring strategies to overcome extra-organisational challenges faced by community pharmacies in Sarawak, Malaysia.

OBJECTIVES: The aims of this research were to determine extra-organisational challenges (e.g. market competition, governing policies) faced by community pharmacies in Sarawak, the coping strategies employed to deal with these challenges and explore potential legislative changes that can attenuate the intensity of these challenges. METHODS: Survey questionnaires (n = 184) were posted to all eligible community pharmacies in Sarawak, Malaysia. The questionnaire included sections on participants' demographic data, extra-organisational challenges faced, coping strategies employed and proposals to improve community pharmacy legislations. Items were constructed based on the findings of a prior qualitative research supplemented with relevant literature about these issues. KEY FINDINGS: High levels of homogeneity in responses were recorded on various extra-organisational challenges faced, particularly those economy-oriented. Strategic changes to counter these challenges were focused on pricing and product stocked, rather than services provision. Highly rated strategies included increasing discounts for customers (n = 54; 68%) and finding cheaper suppliers (n = 70; 88%). Legislative changes proposed that might increase their share of the pharmaceutical market were strongly supported by respondents, particularly about making it compulsory for general practitioners to provide patients the option to have their medicines dispensed in community pharmacies (n = 72; 90%). CONCLUSIONS: Current legislative conditions and Malaysian consumer mindset may have constrained the strategic choices of community pharmacies to deal with the strong extra-organisational challenges. A long-term multipronged approach to address these issues and increased involvement of community pharmacists themselves in this agenda are required to influence practice change.

Encouraging comprehensive and consistent pharmacist education for provision of contraception.

OBJECTIVES: To initiate a call to action for community pharmacists and key stakeholders to encourage comprehensive and consistent education and certification for contraception services, especially in states where laws have been enacted for pharmacist prescribing of hormonal contraceptives. DATE SOURCES: Websites for several boards of pharmacy that have implemented pharmacist training for contraceptive prescribing. SUMMARY: From the authors' perspective of helping to implement laws that allow pharmacist prescribing of contraception in Oregon and Colorado, lessons learned have shown that it is better to have 1 consistent resource for pharmacist certification for the following reasons: 1) Boards of pharmacy are able to ensure patient safety because all pharmacists are providing the same level of care to every patient; 2) retail chain pharmacies and pharmacy managers are assured that all their pharmacists, regardless of state, are trained in a similar and appropriate manner; and 3) pharmacists can be reimbursed through medical insurance for the patient encounter because payers are able to identify and credential pharmacists who pass an approved and accredited certification program. CONCLUSION: New laws allowing pharmacists to prescribe contraception are expanding to other states, and the implementation of these laws provides an important increase in pharmacists' scope of practice. This exciting new prospect allows the pharmacy community of each state an opportunity to coordinate and learn from each other on best practices for implementation. Having a consistent training program was identified as being one key aspect of successful implementation.

On-the-ground application of the 'temporary recommendation for use' regulatory measure on off-label use of baclofen for alcohol dependence in France: a regional survey of community pharmacies.

The 'temporary recommendation for use' (TRU) is a French novel regulatory measure for off-label drug. The first TRU to be issued by the French drug agency (in March 2014) pertained to the off-label use of baclofen for alcohol dependence (AD). We performed a questionnaire-based survey of the on-the-ground application of the baclofen TRU among community pharmacies in northern France. A pharmacist from 70 of the 219 pharmacies contacted (response rate: 32.0%) completed the questionnaire. The mean ± standard deviation number of off-label baclofen prescriptions for AD was 2.3 ± 2.2 per pharmacy per month. 65.2% of these prescriptions were issued by primary care physicians. 65.7% of the pharmacists had never seen 'TRU' written on the prescription, and 80.3% delivered a prescription without checking whether the patient had been included by the prescriber in the TRU. The main criterion used to identify off-label prescribing was the patient's medical history (according to 74.6% of pharmacists) and the prescription of an above-threshold dose (73.1%). 87.1% of the pharmacists were aware of the baclofen TRU, and 42.9% had actually read the document. 17.9% of the pharmacists estimated that the TRU had changed their attitude to off-label baclofen prescription, and 29.9% (20 out of 67) of them wanted to be more involved in the TRU process. Community pharmacists were well informed about the off-label use of baclofen for AD and the TRU. However, a majority of baclofen prescribers did not fulfill the TRU requirements while a majority of pharmacists did not exert any control over these off-label prescriptions. In practice, in 2015 the TRU measure had thus a limited impact on both the baclofen prescribing and delivery practices.

A community-based partnership collaborative practice agreement project to teach innovation in care delivery.

BACKGROUND AND PURPOSE: To explore students' perceptions (self-assessment) of their preparedness to develop collaborative practice agreements (CPAs) before and after delivery of one CPA-focused classroom lectures and 2) a CPA development student project in partnership with a local community-based pharmacy. EDUCATIONAL ACTIVITY AND SETTING: A CPA-focused didactic lecture and subsequent project were given to second-year (P2) pharmacy students enrolled in a community pharmacy elective course at the University of Tennessee College of Pharmacy. Pre- and post-surveys were administered using an online survey platform to assess student perceptions. Responses for each survey question were summarized using frequencies, and chi-square analysis was conducted to assess the association between pre- and post-scores on each question. FINDINGS: Students were significantly more likely to rate themselves as prepared or completely prepared to develop a CPA in a community pharmacy setting (χ2=61.21, p<0.01) after the course and project. Students also noted that they felt they were prepared or very prepared to work within a team to develop and implement a CPA in a community pharmacy setting (χ2=37.60, p<0.01). SUMMARY: This study demonstrated that a didactic classroom lecture series followed by a student project partnered with a local community pharmacy improved perceived knowledge, preparedness, and ability to implement CPAs in a community pharmacy. Through intentional exposure of students to scope-of-practice expanding opportunities like CPAs, pharmacy educators can potentially accelerate the evolution of community pharmacy practice.