key: cord-0936252-4e5hcvoh
authors: Al Mazrouei, Nadia; Ibrahim, Rana M.; Al Meslamani, Ahmad Z.; Abdel-Qader, Derar H.; Ibrahim, Osama Mohamed
title: Virtual Pharmacist Interventions on Abuse/Misuse of Over-the-Counter Medications during COVID-19 versus Traditional Pharmacist Interventions
date: 2021-02-12
journal: J Am Pharm Assoc (2003)
DOI: 10.1016/j.japh.2021.02.003
sha: 90b37ca3f549bc4bb243975b91683bed4bace83a
doc_id: 936252
cord_uid: 4e5hcvoh

Objective This study aimed to investigate frequency, nature, and clinical significance of pharmacist interventions on Over-the-Counter (OTC)medicines with abuse potential across community pharmacies with and without virtual care. Materials and Methods In this prospective observational study, a trained research team observed the dispensary team of 12 community pharmacies in the UAE, of which 6 were operating virtual pharmacy care. A standardized data collection form was used to include information about dispensing of OTC medicines and pharmacist interventions on those with abuse/misuse potential. Clinical significance of interventions was evaluated by a multidisciplinary committee. Results The Frequency of pharmacist interventions on OTC medicines with abuse potential across pharmacies with and without virtual services was 83.2% versus 91.0%. While the Frequency of pharmacist interventions on OTC medicines with misuse potential across pharmacies with and without virtual services was 79.8% versus 41.2%. The proportions of significant interventions across pharmacies with and without virtual services were 19.7% versus 10.5%. Cough medicines were dispensed significantly more across pharmacies with virtual care (25.6% vs 9.7%, p=0.04). Asking the patient to seek the advice of addiction specialist (adjusted odds ratio (AOR) = 4.11; p=0.001) versus refusing to sell the drug were more likely to be associated with pharmacies with virtual services versus pharmacies operating traditional pharmacy services. Discussion The use of information technology tools in pharmacy settings enabled the pharmacists to intervene on OTC medicines with misuse potential, but limited their ability to detect potential OTC abusing due to absence of physical contact with the patients. Conclusion Virtual pharmaceutical care is a potential approach to reduce OTC medicines abusing/misusing, but needs some improvements regarding detection of these cases. The UAE is the first country in the region to implement and regulate virtual pharmacy practice.

Over-the-counter (OTC) medications are commonly administered by patients for minor ailments, without physician order (1,2). These medications have been used for a broad range of conditions, including cold, heartburn, headaches, and musculoskeletal pain (3) . Despite the good safety profile, these medicines can still induce severe adverse events such as fatality and addiction (4, 5) . Lack of awareness of several risks with regard to OTC medications and underestimation of the potential risks might have contributed to these consequences because many patients think the easily accessible drugs harmless (6, 7) . The global prevalence of self-medication is extremely high, and thus the risk for abuse of OTC medicines is high worldwide (8, 9) . In a UAE study, 51% of participants from the public indicated that they usually use OTC medicines without medical consultation (10) . The literature has shown that analgesics are the most common medications associated with OTC misusing and cough medicines with OTC abusing (3, 11) . Community pharmacists are reachable healthcare professionals and can play a crucial role in preventing adverse events related to the use of OTC. Nevertheless, the delivery of healthcare to the public has been challenging following the outbreak of coronavirus disease 2019 (COVID-19) (12) . In this regard, virtual healthcare services have been increasingly recognized as an efficient approach to increase access to care and combat the pandemic since it minimized the risk of COVID-19 transmission by reducing in person contact among individuals (13, 14) .

This includes remote pharmaceutical services, which have been used in the US to increase access to pharmaceutical care (15) . Several studies presented information technology in healthcare as a potential tool to maintain asthma control (16), reduce adverse drug events (17) , minimize medication dispensing errors, and improve pharmacist interventions (18) . Following the current crises, which has posed unprecedented difficulties in healthcare delivery worldwide, the roles of community pharmacists have been legally expanded in many countries to involve providing remote services, such as virtual consultation, home delivery of medications, and remote optimization of dosing regimen (19, 20) . These services have been effective in reducing the burden on the healthcare sectors and minimizing medication dispensing errors (13) . Despite the barriers, the United Arab Emirates (UAE) joined the health informatics race in 2013 when the health officials of Abu Dhabi implemented a sophisticated regulatory regime for telemedicine across the country (21) . In 2019, Dubai Health Authority (DHA) launched the "Doctor for Every Citizen Initiative" to enable healthcare providers in Dubai to use the latest digital technology in order to enhance efficiencies in care delivery (21) . In light of COVID-19, UAE health authorities have issued circulars regulating the delivery of virtual pharmacist services during the COVID-19 (22) . The UAE managed to balance between precautionary measures and healthcare delivery during the pandemic by upgrading the remote health services provided by outpatient clinics, pharmacies, and hospitals using smart technology and digital communication systems (13) . These tools comprise fast web access, video conferencing software, phone calls, home delivery of medications, and social media websites (13) . Therefore, this study aimed to measure whether information technology can be used by pharmacists to identify potential abuse/misuse of OTC medications, and if implementation of virtual services can improve the clinical effects of pharmacist interventions on OTC abuse and misuse.

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This is a prospective, observational, comparative study conducted over a period of 2 months (From August 2020 to October 2020) in community pharmacies operating remote services (intervention group) and pharmacies operating traditional pharmacy services (control group) across the UAE. Trained researchers conducted a direct observation on the pharmacy dispensary team for ten days to collect data related to the dispensing of OTC medications and the nature of pharmacist interventions. This study was approved by the Ethics Committee at the University of Sharjah. Using G* Power software (23), and considering the power =0.8, α ≤ 0.05, and the effect size = 0.8, the sample size for this study was decided to be 12 community pharmacies (6 for each group). An effect size of 0.8 means that the score of the average pharmacy in the intervention group (with virtual services) is 0.8 standard deviations above the average pharmacy in the control group (without virtual services), and hence exceeds the scores of 79% of the control group

The total number of community pharmacies in the UAE is 2703, of which 880 (32.55%) are based in the Capital region (Abu Dhabi), 775 (28.67%) in the Central region (Dubai), and 1048 (38.78%) in the Northern region (Ajman, Fujairah, Ras al Khaimah, Sharjah and Umm al Quwain). Each Emirate was stratified geographically into districts based on the density of pharmacies. The Capital and the Central regions were divided into seven and nine areas (districts), respectively. While the Northern region was divided into 13 areas with districts. Areas from each region were listed in decreasing order, coded with numbers and entered into a computer software, at which three areas from each region were selected randomly. Pharmacies from each area were listed alphabetically, and then coded with numbers. A random sample of community pharmacies was invited from each area, proportionate to the relative proportion of pharmacists in the region, that is, 4 (32.55%, 4/12) from the Capital region, 3 (28.67% (3/12) from the Central Region and 5 (38.78% (5/12) from the Northern Region. To recruit the sample (n=12), we invited 29 pharmacies, of which 14 refused participation and 3 were excluded. Reasons for exclusion were the size of the pharmacy is very small (less than 50m 2 ), intermittent working days (close more than one day per-week), incomplete implementation of virtual services, and light workload (less than 35 items dispensed a day). Community pharmacies operating remote services were assigned to the intervention group and pharmacies with traditional pharmacy services were allocated to the control group (Figure 1) . The allocation ratio was 1:1. Pharmacies were eligible to the intervention group allocation if they are operating virtual pharmacist services using information technology tools. These services include remote consultation, remote prescription refills, home delivery of medications, and remote medication review (Figure 2 ). Pharmacies were excluded from the intervention group if the used tools are not adequate to perform complete virtual services, not following precautionary measures, and not following the standards of pharmacy practice issued by health officials in the UAE. Pharmacies in the control group were included if they were operating traditional pharmacy services, following precautionary measures, and working on a J o u r n a l P r e -p r o o f regular basis. Among all pharmacies included in this study, electronic patient record, electronic prescribing system, and automated medication dispensing cabinets were not implemented.

Over-the-counter medicines were defined as medications which are sold without physician order. The term "abuse of a medication" is used in our study to describe the use of drugs for non-medical purposes, while "misuse of a medication" is applied to describe to the use of a drug for medical purposes, but in wrong manner, for instance, use over a prolonged period or at increased dosage (24,25). The significance of pharmacist interventions was divided into significant, moderate, and minor based on the seriousness of the health consequences in case of no interventions are performed. A pharmacist intervention that potentially prevented serious harm and possibly death from occurring was defined as a significant intervention (26) . The intervention that potentially prevented a temporary harm with no risk of hospitalization was defined as a moderate intervention. While the intervention that was performed based on a situation with no risk of patient harm was considered a minor intervention (27) . The significance of pharmacist interventions was evaluated by a committee of experts, comprising a general practitioner, a clinical pharmacist, and an internist. The research team adopted a validated method for quantifying and rating the responses of the committee (28) . After completing the data collection process, committee members were asked to rate clinical significance on a 10-pointscale from 0 (no harm) to 10 (death) and the mean score across all judges was used as an index of clinical significance of pharmacist interventions. A score of less than 3 represented a minor intervention, a score between 3 and 7 a moderate intervention, and a score of more than 7 a significant intervention. The internal consistency of the committee members was tested using the Kappa statistic. A Kappa value of below 0.5 was considered bad reliability, between 0.5 and 0.7 moderate reliability, between 0.7 and 0.8 good reliability, and above 0.8 great reliability (13,28).

We developed a standardized data collection form, which included information about frequency, nature, and reasons of pharmacist interventions related to the misuse/abuse of OTC medications. Information about the pharmacy dispensary team, such as experience, education, and country of graduation were also included. A preliminary piloting was conducted in 2 pharmacies (1 from each group) for 3 days. The purposes of the pilot study were to test the accuracy and appropriateness of the data collection form, time feasibility, the cooperation of the staff members, and the optimal approach for observation without affecting the J o u r n a l P r e -p r o o f patient privacy. After piloting, we set 10 days per pharmacy as a period for data collection. The main investigator instructed the researchers to have no interaction with costumers or patients. The data of the piloting test was not included in the final results.

The data collectors were 6 licensed pharmacists with at least 2 years of experience in community settings. They were recruited and trained on the professional practice of dispensing OTC medications, health informatics, and information technology tools. Furthermore, they were given training on accurate completion of the data collection form and correct use of operational definitions based on guidelines for reporting observational studies (29) . Each researcher collected data for 10 days (8:30 AM to 4:30 PM) at a community pharmacy. Data were sent to the principal investigator at the end of each research day, at which a final review against the inclusion criteria was carried out before addition to the final dataset. The types of data collected during the research can be divided into the following: 1) frequency and types of OTC medicines dispensed during the research, and this was crucial to determine the incidence of abuse/misuse of OTC medicines, 2) frequency and nature of potential abuse/misuse of OTC medicines, and 3) frequency and types of pharmacist interventions. In this regard, The data collectors observed three major types of interventions; 1) patient education on medication use, drug category, and suggestions to seek specialist's advice, 2) alteration on drug dose, dosage form, and duration, and 3) refuse to sell the drug. Pharmacists determined potential misuse or abuse of drugs either through getting information from patients in case of misuse (medical history, concurrent medications, allergies, and symptoms), or through specific indicators in case of drug abusing, for instance, asking for too much of a product at once, or behaving suspiciously, look drunk or high. Both pharmacy managers and staff signed a consent form demonstrating their willingness for participation.

The data were analysed using the Statistical Package for the Social Sciences, version 26 (Armonk, NY: IBM Corp, 2019)). To explore differences in frequencies, types, and significance of pharmacist interventions, frequency and types of OTC medicines, and number of patients received pharmaceutical care across intervention and control groups, chi-squared or Fisher's exact tests were used as appropriate.

To assess the association of each type of pharmacist interventions and clinical importance of interventions with community pharmacy status but with or without virtual services, a multivariable logistic regression model was constructed. The dependent variable was considered pharmacy status (with virtual services Vs without virtual services) and independent variables were types (all interventions versus refuse to sell the drug) and significance (significant and moderate versus minor) of pharmacist interventions. Refuse to sell the drug is a pharmacist intervention that was considered a reference for comparison between types of interventions, because it was a strict intervention, unlike other interventions, which included advice and giving the patient several choices. We decided to construct a multivariable logistic regression, because the data comprise two sets of independent variables. Descriptive results are presented as proportions (%) with 95% confidence intervals (CIs), while logistic regression results are presented as adjusted odd ratios (AORs) with 95% CI. Statistical significance was considered at p value < 0.05 (with a confidence limit at 95%).

J o u r n a l P r e -p r o o f

There were no significant differences in the number, educational level, and experience of pharmacy staff across pharmacies with and without virtual services (p>0.05). Compared to the control group, pharmacies with virtual pharmaceutical services had a significantly higher frequency of customers who requested or received OTC medication (intervention group: 2036 vs. control group 1163, p=0.01). Of the customers who requested or received OTC medication using virtual pharmacy services, 20.7% were elderly (>65 years). While most of costumers who received traditional care aged less than 45 years ( Table 1) . The findings of this study indicate that antihistamine medicines were the most common OTC with abuse potential and analgesics were the most common OTC medicine with misuse potential.

The rate of potential OTC abuse across pharmacies with and without virtual services was5.8% versus 7.7%. While the rate of potential OTC misuse across pharmacies with and without virtual services was 13.7% versus 16.6%.. There were significant differences between pharmacies with and without virtual services for Types of OTC medications requested or prescribed with potential abuse/misuse (p=0.04). For instance, the proportions of cough medicines and codeinecontaining products across pharmacies with and without virtual services were 25.6% versus 9.7% and 14.1% versus 17.3%, respectively.

The Frequency of pharmacist interventions on OTC medicines with abuse potential across pharmacies with and without virtual services was 83.2% versus 91.0%.

While the Frequency of pharmacist interventions on OTC medicines with misuse potential across pharmacies with and without virtual services was 79.8% versus 41.2%. Most of the interventions on potential OTC abuse and misuse performed by pharmacists operating information technology tools were providing the patients with instructions about the medications (39.3%), suggesting another medication (21.9%) and asking the patient to seek the GP's advice (13.3%).

Providing the patients with instructions about the medications (AOR = 2.69; 95% CI, 1.45-5.99; p=0.03), asking the patient to seek the GP's advice (AOR = 3.66; 95% CI, 2.45-5.96; p=0.01), and asking the patient to seek the advice of addiction specialist (AOR = 4.11; 95% CI, 2.89-7.78; p=0.001) intervention types each versus refusing to sell the drug were more likely to be associated with pharmacies with virtual services versus pharmacies operating traditional pharmacy services. Table 2 summarizes the regression model used to describe the association between independent factors (types of interventions and the dependent J o u r n a l P r e -p r o o f variable (with vs. without virtual services). The proportions of significant and moderate interventions across pharmacies with and without virtual services were 19 .7% versus 10.5% and 28.1% versus 20.6%, respectively (Figure 3) . The internal consistency test showed that overall experts' opinions were agreeable by 73% (a=0.73). As mentioned earlier, pharmacists in both groups were alerted to the risk of OTC abuse and misuse by many indicators including the type of the drug requested, the amount of the drug requested, the time of patient appearance, and the voice the behaviour of the patient. Table 3 demonstrates several examples of potential OTC abuse/misuse, each with the pharmacist intervention, clinical significance, and type of pharmacy. Table 3 lists cases of potential abuse/misuse of drugs and associated pharmacists' interventions.

Our findings suggest that adopting information technology by community pharmacies enables them to identify and intervene upon abuse/misuse of OTC medicines. Furthermore, we found that elderly costumers are involved in requesting OTC medicines via virtual pharmacy services more than young people (<30 years). The plausible explanation is that older patients may represent a specific cluster of high-risk patients for developing COVID-19 with rapidly progressive clinical deterioration (30) . Therefore, several countries have restricted the movement of elderly to reduce the risk for infection (31) . However, As polypharmacy often increase with aging, the elderly population may in turn at higher risk of OTC medicines abusing (32, 33) . We believe that this is a major challenge for virtual care. Unfortunately, the association between age groups and the risk for OTC abusing was beyond the scope of this study due to practical reasons. To some extent, this study has helped to shed some light on this issue, and we urge the researchers to consider conducting extensive evaluation for the impact of virtual care on medication safety of elderly during the pandemic.

There is no study in the literature investigating virtual pharmacist interventions on potential abuse of OTC medicines before COVID-19. Thus, it is difficult to compare between the two periods. However, the literature has shown that adapting remote pharmacy services have been increased considerably since the beginning of the pandemic as well as the demands for OTC medicines. Therefore, we expect that virtual interventions on abuse of OTC medicines have increased.

The rates for potential abuse and misuse of OTC medications were not significantly different across pharmacies with and without virtual services. Nevertheless, it is extremely difficult to detect potential abuse without interviewing patients or observe their behaviors. Pharmacists operating virtual care could be unsighted, because physical appearance (look and behaviors) is vital in discovering individuals with intention of OTC abusing, (8) . Other behaviors such as requesting several bottles of the same drug without declaring a reason could indicating a potential abuse of OTC medicines, These are extremely difficult to observe remotely. Thus, we believe that virtual pharmacy services could increase the rate for potential abuse of OTC, because virtual care increases access to OTC medications (3). This implies the importance of training for pharmacists, particularly those operating virtual services. Further research is necessary to report and explain the impact of information technology on the rate of abuse of OTC medicines.

The proportion of pharmacist interventions on the abuse of OTC medicines in pharmacies with virtual services was relatively less than pharmacies without virtual services. As mentioned before, some practical issues blind the pharmacists operating virtual care to detect potential abuse of OTC medicines.

Interestingly, pharmacist interventions on misuse of OTC medicines were significantly higher in pharmacies with virtual care. It seems that virtual care enabled pharmacists and patients as well to share information more efficiently than traditional care, at which the costumers avoid the risk of COVID-19 transmission by purchasing OTC medicines and hurtling outside the pharmacy without providing adequate information to the pharmacist about why the request the medication or J o u r n a l P r e -p r o o f how they usually use it. However, the definitions of abuse and misuse of OTC medications are not unequivocal, and in many cases abuse/misuse of OTC medicines might be unnoticeable, especially when the costumers are out of sight. Thus, we recommend measures such as developing an early warning system, sharing information on OTC misuse with patients, and improving information technology tools to alert pharmacists the misuse potential of some products.

Our findings demonstrate that there was a group medication that seemed to have a higher potential of being misused.; antihistamine, analgesics, cough medicines, laxatives, and codeine-containing products. This aligns with several studies worldwide (34) (35) (36) . While no studies have assessed the possibility of association between certain types of OTC medications with abuse potential and virtual care, we found that the proportion of cough medicines with abuse potential is higher in pharmacies with virtual care compared to those operating traditional care. The UAE has made enormous efforts to reduce the risk of COVID-19 transmission by raising the awareness of the community about the importance of using remote healthcare services. This might have caused patients with alarming symptoms, such as cough and fever to seek virtual pharmaceutical care.

Our findings link specific types of pharmacist interventions to pharmacies with virtual services; one of these types is providing the patient with instructions about the medications. As noted before, information technology enables pharmacists to share information with patients freely without any concerns regarding the risk for COVID-19 transmission. Heimar de Fátima Marin (37) emphasized that information technology and social media are making it easier than ever for consumers to find timely, personalized healthcare information. Our findings are consistent with Heimar de Fátima Marin discussion as we found that interventions, such as asking the patient to seek addiction specialist or GP's advice are more likely to be associated with pharmacies providing virtual care. A second area of virtual care benefit comes in the form of improved trust and privacy that enable pharmacists to be engaged more in sensitive health cases, particularly in the Arabic region, where the stigma is widespread.

Interestingly, the proportions of significant and moderate pharmacist interventions were higher in pharmacies with virtual care compared to those operating traditional pharmacy services. This may be an indicator of the information technology effectiveness in making pharmacists more proactive in managing OTC medication abuse by enabling them to utilize their clinical skills and provide oral medication information while ma maintaining trust and privacy with patients.

The study has several limitations. First, it was conducted on pharmacies operating different trends of virtual services and this variation might have affected the major outcomes of the study. Second, this is a prospective study conducted directly on the dispensary team inside the pharmacy, and while most of the pharmacist interventions were observed and reported, sometimes, like in case of crowding or patients requesting privacy, interventions were missing. Absence of electronic patient record and lack of time, as it was extremely difficult to cover every single intervention that a pharmacist performed during the course of her/his J o u r n a l P r e -p r o o f duties or between courses of duties. Third, the impact of missing data related to pharmacist interventions were beyond the scope of this study's aims. Fourth, this study provides only a quantitative evidence of the number, types, and clinical significance of virtual pharmacist interventions on potential OTC medicines abuse.

Neither the acceptance of patients to the virtual interventions nor the appropriateness of these interventions were assessed. Fifth, although the research team was disguised, we have concerns regarding the impact of Hawthorn effect on the study's findings, as it was difficult to maintain the aims of the study hidden, especially in the presence of the pharmacy managers who were informed about the true purposes of the study. Sixth, the frequency of OTC medicines dispensed varied greatly between both groups. We suspect that this might have a minor impact on the findings of the study. Finally, this study was conducted on a few community pharmacies and examined only one component of virtual care; our findings may not reflect the habits and preferences of remote pharmacist interventions in other settings. Nevertheless, these drawbacks could be a foundation for future research.

The study demonstrates that digitalization of pharmacy services improves pharmacist interventions on OTC misuse and allows patients with alarming symptoms e.g. cough to receive remote pharmaceutical care, and reduces transmission of COVID-19. Furthermore, it enables elderly patients who are vulnerable to viruses to reach pharmacies without taking the risk of getting the infection. . The development of anearly warning system may further enhance the ability of remote pharmaceutical care to intervene and prevent OTC abusing.

J o u r n a l P r e -p r o o f J o u r n a l P r e -p r o o f 

Demographic factors affecting health services utilization: a causal model

Societal perspectives on over-the-counter (OTC) medicines. Fam Pract

Abuse of over-the-counter medicines: a pharmacist's perspective

Surveillance and uncertainty: community pharmacy responses to over the counter medicine abuse

Non-prescription medicine misuse, abuse and dependence: a cross-sectional survey of the UK general population

Factors that influence Italian consumers' understanding of over-thecounter medicines and risk perception

Safety of non-prescription medicines: knowledge and attitudes of Italian pharmacy customers

Over-the-counter medicine abuse -a review of the literature

A Systematic Review of Self-Medication Practices Among Adolescents

Prevalence and predictors of over-the-counter medication use among adolescents in the United Arab Emirates. East Mediterr Heal J = La Rev sante la Mediterr Orient = al-Majallah al-sihhiyah li-sharq al-mutawassit

Community pharmacists' experience of over-the-counter medicine misuse in Scotland

On the frontline against COVID-19: Community pharmacists' contribution during a public health crisis

Telepharmacy-Enabling Technology to Provide Quality Pharmacy Services in Rural and Remote Communities

Impact of telepharmacy services as a way to increase access to asthma care

Evaluating the impact of telepharmacy

Impact of telepharmacy in a multihospital health system

Role of Pharmacists in COVID-19 Disease: A Jordanian Perspective

The legal extension of the role of pharmacists in light of the COVID-19 global pandemic

Telemedicine in Middle Eastern countries: Progress, barriers, and policy recommendations

Department of Health AD. Remote Healthcare Platform

Statistical Power Analyses for Windows and Mac

Abuse/misuse of non-prescription drugs

Abuse of over-the-counter medicines: a pharmacist perspective

The significance of pharmacy interventions: An updated review in the presence of electronic order entry

Interventions by pharmacists in out-patient pharmaceutical care

Incidence, nature, severity, and causes of dispensing errors in community pharmacies in Jordan

Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies

COVID-19 and the elderly: insights into pathogenesis and clinical decisionmaking

Influencing Factors of Understanding COVID-19 Risks and Coping Behaviors among the Elderly Population

Clustering of elderly patient subgroups to identify medication-related readmission risks

Polypharmacy: a global risk factor for elderly people

Over-the-counter medicine abuse: a qualitative study

American journal of health-system pharmacy

Delphi survey of experts' opinions on strategies used by community pharmacists to reduce over-thecounter drug misuse

Chapter 10 -Patient Engagement and Digital Health Communities