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ABSTRACTThe presence and migration of heavy metals from food and drug packaging materials into consumables pose significant health concerns. This study explored the effects of vanadium, arsenic, cadmium, and mercury contained in the digest of packaging materials on biofilms formed by standard strains of Escherichia coli ATCC 25923, Pseudomonas aeruginosa ATCC 27853, Klebsiella pneumoniae ATCC 70063, and Enterococcus faecalis ATCC 29212. Results showed that vanadium at 1.2 µg/ml promoted strong biofilm formation in all tested bacteria, while cadmium (1 µg/ml) and mercury (6.6 µg/ml) supressed biofilm formation. Arsenic at 0.6 µg/ml initially facilitated biofilm formation, but its effectiveness decreased with higher concentrations. This interference of heavy metals digests on biofilm formation in the gut microbiota is a concern, as leached heavy metals into food when consumed could disrupt the balance of human intestinal flora and homeostasis.

Kiyomi Sadamoto,1– 3 Mikio Murata,2,4 Masaho Hayashi,2,4 Hiroyuki Ura,1 Kiyoshi Kubota2,4 1Department of Clinical Pharmacy, Shonan University of Medical Science, Yokohama, Kanagawa, Japan; 2MECSION, General Incorporated Association, Hiratsuka, Kanagawa, Japan; 3Sadamoto Clinic, Ninomiya, Kanagawa, Japan; 4Department of Clinical Pharmacy Yokohama University of Pharmacy, Yokohama, Kanagawa, JapanCorrespondence: Kiyomi Sadamoto, Tel +81-45-921-0111Fax +81-45-821-0116Email kiyomi.sadamoto@gmail.comBackground: Blister packs with paperboard backing, which is useful for displaying instructions and information, are the most popular type of packaging for osteoporosis drugs in Japan. However, the main users of drugs are the aged, who often find blister packs difficult to open or drop their pills during opening. In this study, we compared different types of blister packs in terms of usability and handling.Methods: We conducted a subjective and objective study to compare commonly used blister packs with newly designed ones that have a jagged notch designed to hold a pill temporarily and a perforated line that enables the pack to be held easily in one hand. Regarding subjective data, packaging and sensory tests were performed. The participants in the sensory test were healthy older adults and patients with rheumatoid arthritis (RA). We also measured the pinch power of all participants.Results: A comparison of several items, including opening status, prevention of pill dropping, and understanding of the instructions, using a numerical rating scale revealed no significant differences between ordinary (type A) and newly designed (type B) packaging. However, the scores for type B were the same or better than those for type A for every evaluation item. In addition, more than 85% of the participants reported preferring to use type B. More than 80% of the participants in both groups reported dropping pills using type A, which seemed to be related to their preference for type B. In the evaluation by the examiner (objective study), all participants could successfully remove their pills without dropping using type B, including those in the RA group who had difficulty handling packages.Conclusion: These findings suggest that the new type of blister pack assessed in this study (type B) is preferable among older and shows promise for a universal design.Keywords: drug packaging, paperboard backing, older adults, new design, rheumatoid arthritis, universal design

Rebecca J Bartlett Ellis,1 Deanna Hertz,2 Patrick Callahan,3 Todd M Ruppar4 1Department of Science of Nursing Care, Indiana University School of Nursing, Indianapolis, IN, USA; 2Ipsos Ltd., South Lake Tahoe, CA, USA; 3Becton, Dickinson and Company, San Diego, CA, USA; 4Department of Adult Health and Gerontological Nursing, College of Nursing, Rush University, Chicago, IL, USACorrespondence: Rebecca J Bartlett EllisDepartment of Science of Nursing Care, Indiana University School of Nursing, 600 Barnhill Drive, E423, Indianapolis, IN 46202, USATel +1 317 274 0047Email rjbartle@iu.eduPurpose: Medication nonadherence is a significant and multidimensional problem contributing to an increased risk of morbidity and mortality. Inconveniences in pharmacy and home contexts may increase nonadherence. This research examined inconveniences in pharmacy and home contexts associated with self-reported nonadherence, controlling for demographic and medication-taking covariates.Methods: Data from 4682 individuals who reported self-managing medications in an online marketing survey between October and December 2017 were analyzed in this secondary analysis. Nonadherence was dichotomized using a single question about likelihood to take medications as prescribed (adherence=always; nonadherence=most of the time, some of the time, never). Multivariable logistic regression with backwards elimination was used to examine the pharmacy (use of home delivery, number prescriptions picked up and visits to pharmacy) and home context (method used to organize/manage medications, satisfaction, and bother with management) variables and the demographic (age, sex, race/ethnicity, education, income, insurance) and medication (number of oral medications, medication changes and frequency of taking) covariates associated with nonadherence.Results: Overall, 25.8% of the responses indicated nonadherence. Nonadherence was more likely for individuals making fewer separate pharmacy trips (OR 0.98; 95% CI 0.97– 0.99); picking up fewer prescriptions (OR 0.96; 95% CI 0.93– 0.99); never, rarely or sometimes using mail order compared with always (OR 1.71; 95% CI 1.30– 2.26); not satisfied with managing medications (OR 2.13; 95% CI 1.42– 3.19); and using pill pouches and being bothered by them (OR 8.28; 95% CI 1.83– 37.31). Using pill pouches or a pillbox and not being bothered by them significantly decreased nonadherence likelihood. Younger and female respondents and those reporting medication changes in the last year were also more likely to report nonadherence.Conclusion: Though reasons for nonadherence are multidimensional, this study suggests that inconveniences in both the pharmacy and home context are important. Improving adherence requires addressing issues of inconvenience across the care continuum.Keywords: medication adherence, medication compliance, community pharmaceutic services, outpatient, drug packaging, behavior and behavior mechanisms, MeSH

The fast growth of counterfeiting medicines in the last two decades has created one of the biggest problems facing the pharmaceutical industry on the global level, resulting in loss of income, product withdrawal, loss of brand value, etc. But this is not only the problem of the intellectual property rights of the pharmaceutical industry, it is also the problem of the healthcare regulatory authorities, whose most significant concern is the risk to the public health. Pharmaceutical manufacturers, together with the wholesalers and retailers, have an essential role in the fight against counterfeit medicines by the implementation of different anti-counterfeit technologies for securing the supply-chain of medicines. The protection of drug packaging has a specific role in the drug development process, as well as in the fight against counterfeit medicine. The authenticity of the medicine and the forensic elements for protection on the packaging may be confirmed using different technologies. Tracking and tracing of pharmaceutical products in the supply chain, keeping electronic records for all stages of the distribution, and verification of the authenticity of a medicinal product is a key element and an effective solution for timely detection of counterfeit medicines and protection of intellectual property rights.

This work highlights the evidential value of examining plastic drinking straws to establish linkages between multiple sources for forensic intelligence, investigative or prosecution purposes. Plastic drinking straws are commonly encountered in drug cases, either as inhalational paraphernalia or as packaging material. However, to the best of our knowledge, systematic studies on the evidential value of straws have not previously been carried out. In this study, over 80 packets of clear and colourless straws—most of which were visually similar—were purchased from various commercial outlets in Singapore. Some physical characteristics (viz., polarizing patterns, thickness, circumference and mass per unit length) and the manufacturing marks of these straws were examined to assess their potentials for discriminating straws from different packets. Comparison of polarizing patterns yielded a discrimination of approximately 69%, while thickness, circumference, and mass per unit length measurements resulted in lower discriminations. Comparison microscopy of manufacturing marks was found to be the most discriminating among all techniques employed herein, with a discrimination of about 95%, even among straws with similar polarizing patterns.

Context: There are standards that allow establishing the microbiological and physicochemical stability of a medicine; however, beyond use date of drugs depends not only on these criteria, but also on individual institutional characteristics. The multiple factors that involve the allocation of the stability of a medication, if not properly articulated, can lead to therapeutic failures and adverse events in patients. Aims: To design an algorithm to determine the stability beyond use date of a drug in a high complexity healthcare institution. Methods: Pharmaceutical form, packaging, and administration route were defined for each drug. Physicochemical and microbiological stability were assigned to each product. An algorithm was built with the collected information. The stability beyond use date was the shortest time registered between microbiological and physicochemical stability, however, the information of the manufacturer was respected. Results: A total of 938 drugs were analyzed, which 606 (64.6%) were considered as single-dose and 332 (35.4%) as multiple-dose. The mean reason to assign a drug as a single-dose with 90.9% was pharmaceutical form unable to storage, tablet, capsule, and ampoule the most frequent. The main cause with 54.4% to assign a drug as multiple-dose was synthetic products with liquid and semisolid pharmaceutical forms whose packaging materials were allowed to storage after its first use. Conclusions: An algorithm was designed, which can assign the stability beyond use date of drugs using an easy and reliable, generating a more safety use inside the institution.

Asthma is a life-altering, chronic disease of heterogenous origin that features a complex interplay of immune and environmental signaling. Although very little progress has been made in prevention, diverse types of medications and delivery systems, including nanoscale systems, have been or are currently being developed to control airway inflammation and prevent exacerbations and fibrosis. These medications are delivered through mechanical methods, with various inhalers (with benefits and drawbacks) existing, and new types offering some variety in delivery. Of particular interest is the progress being made in nanosized materials for efficient penetration into the epithelial mucus layer and delivery into the deepest parts of the lungs. Liposomes, nanoparticles, and extracellular vesicles, both natural and synthetic, have been explored in animal models of asthma and have produced promising results. This review will summarize and synthesize the latest developments in both macro-(inhaler) and micro-sized delivery systems for the purpose of treating asthma patients.

Background: United States pharmacies repackage medications into multi-dose vials, enabling customized dosing for prescription drugs. Investment in infrastructure has made this the predominant approach to packaging for US prescriptions. Although recent changes to labeling now discourage the use of auxiliary labels (small stickers highlighting information germane to the safe and effective use), they are still allowed by USP, provided their use comes from an evidence-based perspective. Objectives: Evaluate how ‘interactive,’ placements of auxiliary labels (placement requiring physical manipulation of the warning to accomplish a task (e.g. opening)) garner attention as compared to those placed vertically or horizontally. Methods: Ninety-six participants were eye tracked while opening three prescription vials (each with an auxiliary warning label with a different placement: vertical, horizontal and interactive). Recall and recognition were tested subsequently. Linear mixed models were used to analyze the continuous variables while the binary response variables were analyzed using generalized linear mixed models. The effect of auxiliary labels was fitted as a fixed effect and the subject-to-subject variation was considered as a random effect in the model. Participants’ age, health literacy and sex were added to the models if their effect was statistically significant at alpha=0.05. Results: The placement of the warnings significantly impacted the time spent viewing the information they contained at alpha=0.05; people spent significantly longer on interactive placements (0.96; SD 0.13 seconds) than either, horizontal placements (0.27; SD 0.037 seconds) or those placed vertically (0.18 seconds; SD 0.035). Participants were equally as likely to see information presented in an interactive placement (90%; SD 3.8) or horizontal placement (78%; SD 05.5) but less likely to view warnings placed vertically (60%; SD 6.9). Free recall responses also supported the use of interactive placement (62%; SD 6.8 recall) as compared to horizontal placements which were 29%; SD 3.0 and 20%; SD 6.0 for vertical placements. Conclusions: Data provides evidence which suggests that interactive and horizontal placements out-perform auxiliary labels placed vertically on prescription vials with regard to garnering patient attention.

Background: Appropriate cold chain management is the foundation of safety and quality of vaccines. Objectives: This cross-sectional study was conducted to assess the cold chain management of the rural health units of Consolacion and Liloan, Cebu, Philippines on August to September 2017. Methods: Data was collected using a structured questionnaire, which was developed based on previous studies of cold chain survey. The questionnaire was administered to one personnel who is responsible for the storage and maintenance of vaccines in each public health center (PHC). Results: Of 42 targeted PHCs, only 52.4% (n=22) agreed to join in the study. The results of the study indicated that storage units and equipments were available in all 22 PHCs, even though only five of them (22.7%) stored vaccines. The majority of PHCs (90.9%, n=20) did not have access to a generator and only 9% (n=2) had a voltage stabilizer connected to the refrigerator. Refrigerators that were equipped with thermometer were only found in 68.2% (n=15) PHCs. No statistically significant relationship was found (p=0.159) between the statuses of PHCs to store vaccine and the level of knowledge of health professionals assigned to manage the vaccine. Conclusions: Primary health centers that store vaccines have at least one functional refrigerator and freezer and alternative power sources. Contingency plans in the event of mechanical and power failure as well as proper temperature monitoring are needed. Personnel handling vaccines must be updated on proper storage and transport of such like the use of cold boxes and ice packs to maintain cold chain. Improvement of cold-chain management for vaccines in Cebu City’s PHCs was necessary.

Deterioration of the medication adherence for elderly could result in wasteful medical expenditure in a long-term span as well as aggravating the patient's medical condition.Objective: This study surveyed the effect of one-dose package medication made up by a pharmacist on the patient's behavior towards medication, what is expected to be one of the measures to improve the medication adherence for elderly.Methods: With support activity of the Pharmacist Association in Ueda-city in Nagano Prefecture, Japan, the survey form of one-dose package was sent to 86 pharmacy directors located in Ueda-city. Results: The most frequent reasons of one dose packaging was “Patient’s request” though, “Large number of doses”, “Prevent the improper drug use” and “Improved medication adherence” which is considered that the pharmacists are willing to utilize one dose package for patient’s care in order to improve the medication adherence were chosen as well. The influences of one dose package for patient’s medication adherence were very positive, and most answers indicated that medication adherence was improved.Conclusion: It is noticed that the pharmacists were willing to dispense one dose packaging by own decision, not physician’s order, in order to improve the medication adherence, prevent improper drug use and optimize the medication therapy. It is also noticed that there are great improvement of patient’s compliance by one dose package, and patients felt advantage to reduce the improper drug use as well.

OBJECTIVE: To examine the extent to which district health teams could reduce the burden of malaria, a continuing major cause of mortality and morbidity, in a situation where severe resource constraints existed and integrated care was provided. METHODS: Antimalarial drugs were prepackaged into unit doses in an attempt to improve compliance with full courses of chemotherapy. FINDINGS:Compliance improved by approximately 20% in both adults and children. There were 50% reductions in cost to patients, waiting time at dispensaries and drug wastage at facilities. The intervention, which tended to improve both case and drug management at facilities, was well accepted by health staff and did not involve them in additional working time. CONCLUSION:The prepackaging of antimalarials at the district level offers the prospect of improved compliance and a reduction in the spread of resistance.

Background: It has been estimated that 10,000 patient injuries occur in the US annually due to confusion involving drug names. An unexplored source of patient misunderstandings may be medication salt forms. Objective: The objective of this study was to assess patient knowledge and comprehension regarding the salt forms of medications as a potential source of medication errors. Methods: A 12 item questionnaire which assessed patient knowledge of medication names on prescription labels was administered to a convenience sample of patients presenting to a family practice clinic. Descriptive statistics were calculated and multivariate analyses were performed. Results: There were 308 responses. Overall, 41% of patients agreed they find their medication names confusing. Participants correctly answered to salt form questions between 12.1% and 56.9% of the time. Taking more prescription medications and higher education level were positively associated with providing more correct answers to 3 medication salt form knowledge questions, while age was negatively associated. Conclusions: Patient misconceptions about medication salt forms are common. These findings support recommendations to standardize the inclusion or exclusion of salt forms. Increasing patient education is another possible approach to reducing confusion.

Abstract This PowerPoint presentation is part of a series of lectures entitled “Introduction to Patient Care” for first-year medical students at the Medical College of Wisconsin. The presentation is intended for medical students early in their medical school careers as a way of preparing them for the complexities of clinical care. It brings together different perspectives on interactions between physicians and the pharmaceutical industry and offers a basic introduction to students about guidelines from large physician groups as well as an overview of the literature about the impact on attitudes that gifting can have. The presentation also contains background information about the basics of FDA regulation and flaws in that system illustrated by real-world examples. Finally, it offers an anthropological perspective on physician-pharmaceutical interactions as a study of culture, both within the interaction and within the larger social context. Part of the richness of the advertising/anthropology discussion hinges on using current pharmaceutical advertisements in the presentation. The original version had an embedded advertisement, but as the ad is copyrighted material that will also go out of date, it has been removed. Advertisements can be preselected by presenters and inserted into the presentation as indicated. Presenters also have the option to ask students to bring advertisements (electronically or in paper format, provided one has the ability to project these to the group) that fit in the following categories: (1) scripting of the health care encounter, (2) families taking medication/interaction of medication and family, and (3) the physician's place in the scripting. This curriculum has been well received by medical students at the Medical College of Wisconsin. The 2007 lecture was highly rated by students who attended. The average rating was 1.5 (1 = Strongly Agree, 2 = Agree, 3 = Disagree, 4 = Strongly Disagree) for the various objectives, speaker, and content. Keeping the pharmaceutical examples and policies up to date can be challenging. Students have strong feelings and thoughts about pharmaceutical representatives, physicians, and advertising. They have already been exposed to a tremendous quantity of advertising as well as a wide range of personal experiences regarding pharmaceuticals. This is a contemporary, ever-changing topic that students will need background on and perspective from which to operate in their future careers.

Background: During the 1980s, manual repackaging of multi-dose medications from pharmacies in Sweden was successively substituted with automated multi-dose drug dispensing (MDD). There are few studies evaluating the consequences of automated MDD with regard to patient safety, and those that investigate this issue are not very extensive. Objectives: To investigate Swedish health care professionals’ perceived experience of automated MDD and its effects on patient adherence and patient safety. Methods: Three questionnaire forms, one for physicians, nurses, and assistant nurses/nursing assistants, were developed based on reviews of the literature and pilot testing of the questions in the intended target groups. The target groups were health professionals prescribing or administrating MDD to patients. A sample (every sixth municipality) was drawn from the sampling frame of Swedish municipalities, resulting in 40 municipalities, about 14% of all municipalities in Sweden. Email addresses of general practitioners were obtained from county councils, while the municipalities assisted in getting contact details for nurses, assistant nurses and nursing assistants. A total of 915 questionnaires were distributed electronically to physicians, 515 to nurses, and 4,118 to assistant nurses/nursing assistants. The data were collected in September and October 2012. Results: The response rate among physicians, nurses and assistant nurses/nursing assistants was 31%, 43% and 23%, respectively. The professionals reported that automated MDD reduces duplication of medication, contributes to correct dosages, helps patients take their medication at the right time, and reduces confusion among patients. Fifteen per cent of the physicians and about one-third of the nurses and assistant nurses/nursing assistants reported that generic substitution makes it more difficult for the patient to identify the various medicines available in the sachets. The physicians did, however, note that prescribing medicine to patients with automated MDD is complicated and can be a risk for patient safety. Both physicians and nurses requested more information on and training in automated MDD. They also asked for more medication reviews. Conclusions: The professionals generally had a positive attitude to automated MDD with regard to improved medication adherence, but said they believed that the electronic prescribing system posed a safety risk for patients.