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Objectives. To characterize regulatory practices related to nonmedical cannabis warning labels in states across the United States that have legalized retail nonmedical cannabis. Methods. In March 2024, we conducted a content analysis of regulations for nonmedical cannabis warning labels required on product packages in 20 states where, as of March 2024, adults could legally purchase nonmedical cannabis in retail environments. For each state, we examined requirements related to warning label content and characteristics. Results. Required warning label content and characteristics varied widely across states. Only 2 states required a warning about mental health risks (10%) and 2 states required a warning for high potency products on risk of psychosis (10%). No states required front-of-package warning placement, only 2 states required rotating warnings (10%), and 4 states required contrasting colors (20%). Warnings were often verbose (mean = 57 words), vague, and had small or no minimum font size. Conclusions. Opportunities exist for states to improve the alignment of their nonmedical cannabis warning label regulations with evidence that has been generated so far in cannabis effects, cannabis warning efficacy, and warning label design. (Am J Public Health. 2024;114(S8):S681–S684. https://doi.org/10.2105/AJPH.2024.307722) [ABSTRACT FROM AUTHOR]

The United States (U.S.) Food and Drug Administration (FDA) oversees the safety and quality of drugs and vaccines that are used in the U.S. Administration of the FDA falls under the jurisdiction of the U.S. Department of Health and Human Services (HHS). The regulatory oversight of the FDA is complex and comprehensive, requiring the various roles and responsibilities to be divided across six main centers. The activities of two of these centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the primary focus of this review. [ABSTRACT FROM AUTHOR]

Background: Illicit substance sales facilitated by social media platforms are a growing public health issue given recent increases in overdose deaths, including an alarming rise in cases of fentanyl poisoning. However, little is known about how online users evaluate what features of social media posts convey safety, which can influence their intent to source illicit substances. Objectives: This study adapts conjoint analysis which assessed how attributes of social media posts (i.e., features) influence safety evaluations of mock posts selling illicit substances. 440 participants were recruited online for self-reporting use or purchase of controlled substances or prescription medicines recreationally. The following attributes were tested: drug packaging, drug offerings, profile photo of seller, payment info provided, and use of emojis. Results: Packaging was ranked the most important attribute (Average Importance =43.68, Offering=14.94, Profile=13.86, Payment=14.11, Emoji=13.41), with posts that displayed drugs in pill bottles assessed as the most safe. Attribute levels for advertising multiple drugs, having a blank profile photo, including payment information, and including emojis also ranked higher in perceived safety. Rankings were consistent across tested demographic factors (i.e., gender, age, and income). Survey results show that online pharmacies were most likely to be perceived as safe for purchasing drugs and medications. Additionally, those who were younger in age, had higher income, and identified as female were more likely to purchase from a greater number of platforms. Conclusions: These findings can assist in developing more precise content moderation for platforms seeking to address this ongoing threat to public safety. [ABSTRACT FROM AUTHOR]

The article focuses on the significant impact of infusion drug costs, particularly drug waste, on oncology care costs in the U.S. Topics include the role of single-use vials in contributing to drug waste, the historical lack of incentives for manufacturers and healthcare systems to address this issue, and six strategies to reduce cancer drug dosing and waste, taking advantage of the Infrastructure Investment and Jobs Act (IIJA) incentives.

The article highlights the professional policies approved by the American Society of Health-System (ASHP) House of Delegates at its March 2024 virtual meeting. Topics include the role of pharmacy workforce in improving mental health, the pharmacist access to provider networks, and risk assessment of health information technology.

In the article, the authors present their cross-sectional study to estimate the wasteful spending on aducanumab dispensing for treating Alzheimer's disease in the U.S. Also cited are how the widespread use of the drug could strain Medicare's budget, and the conduct of the study on Medicare beneficiaries with mild dementia or mild cognitive impairment (MCI).

Topical ophthalmic drug product development is a niche research domain as the drug formulations need to be designed to perform in the unique ocular physiological conditions. The most common array of small molecule drug formulations intended for topical ophthalmic administration include solutions, suspensions, emulsions, gels, and ointments. The formulation components such as excipients and container closure are unique to serve the needs of topical ophthalmic delivery compared to other parenteral products. The selection of appropriate formulation platform, excipients, and container closure for delivery of drugs by topical ophthalmic route is influenced by a combination of factors like physicochemical properties of the drug molecule, intended dose, pharmacological indication as well as the market trends influenced by the patient population. In this review, data from literature and packaging inserts of 118 reference listed topical ophthalmic medications marketed in the US are collected and analyzed to identify trends that would serve as a guidance for topical ophthalmic formulation development for small molecule drugs. Specifically, the topics reviewed include current landscape of the available small molecule topical ophthalmic drug products in the US, physicochemical properties of the active pharmaceutical ingredients (APIs), formulation platforms, excipients, and container closure systems., Competing Interests: Declaration of Competing Interest Anand Ubhe, Heidi Oldenkamp, Ke Wu are employees of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication., (Copyright © 2024 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

The article highlights the critical role that the investigational drug services (IDS) pharmacist plays in ensuring safe medical practices for patients receiving investigational medications. Topics include current gaps in investigational drug practices, IDS work group recommendations, and IDS participation in use of interactive response technology (IRT).

Objective: Identify disease categories in which single-item global impression (GI) scales were included in product labeling of new drugs approved by the US Food and Drug Administration (FDA) in January 2009-December 2019 and review the characteristics of GIs included in product labeling of new FDA-approved drugs (January 2017-December 2019).Methods: FDA Clinical Outcome Assessment (COA) Compendium was reviewed for drug labels that included GIs for drugs approved in 2009-2016. The indication, year of approval, ICD-10 code, and GI respondent were noted. A manual review of labels of FDA-approved drugs (2017-2019) was undertaken to identify GIs included in the labels. Corresponding drug approval packages were reviewed to identify details of any regulatory reviewer comments related to GIs. GI characteristics were noted from the drug label or the review documents, including the respondent, type of measure (static or dynamic), item wording, concept assessed, and response options.Results: Product labeling containing GIs was most common in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs were included in 30/77 (39.0%) drug labels in the four disease categories.Conclusion: In the past 10 years, GIs have been included as endpoint measures in confirmatory clinical trials and have generated evidence of treatment benefit in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs frequently provide important insights into the patient experience. Before GIs are included in clinical trials to assess treatment benefit, it is important to ensure that they are valid, reliable, and responsive. [ABSTRACT FROM AUTHOR]

Transfer of xenobiotics from their original container to an unlabeled or secondary container is a well-identified risk factor for poisoning. Nonetheless, recent large-scale data on the practice are unavailable. The objective of this study is to describe the incidence and features of poisonings in the United States due to xenobiotics stored in a secondary container. This was a retrospective review of the National Poison Data System (NPDS) from 2007 to 2017. Non-suicidal exposures associated with the scenario "container transfer involved (product transferred from original container to unlabeled container, incorrectly labeled container, or food container for use or storage and patient accessed product from second container)" were included. Forty-five thousand five hundred and twelve cases were included. The median age of subjects was 30 years (interquartile range: 6–53); 52% were female. Cleaning products (38.2%), disinfectants (17.3%), and hydrocarbons (5.0%) were the most common xenobiotics reported. The annual incidence of cases increased over the study period. There were 9369 (20.6%) ED visits and 1856 (4.1%) hospital admissions. Most cases (72%) were deemed nontoxic or resulted in no effects; 4.4% resulted in serious outcomes (moderate effects, major effects, or death), including 23 deaths. Morbidity was highest for pesticides, prescription medications, and herbicides, with 10.3%, 9.8%, and 7.6% of cases resulting in serious outcomes, respectively. Hydrofluoric acid and herbicides were associated with the most deaths (13/23 [57%]). Transfer of xenobiotics to a secondary container is a scenario increasingly reported to U.S. poison centers. Although most exposures do not result in significant toxicity, ED visits are common and substantial morbidity can occur. This represents an opportunity for public health intervention to curb the practice. [ABSTRACT FROM AUTHOR]

Objectives: Real-world evidence (RWE) has gained increased attention in recent years as a complement to traditional clinical trials. The use of RWE to establish the efficacy of oncology drugs for Food and Drug Administration (FDA) approval has not been described. In this paper, we review 5 recent examples where RWE was submitted in support of the FDA approvals of original or supplementary indications for oncology drugs.Methods: To identify cases where RWE was used, we reviewed drug approval packages available at Drugs@FDA for oncology drugs approved between 2017 and 2019. Five cases were selected to present a broad overview of different types of RWE, different circumstances under which RWE has been used for regulatory approvals, and how FDA evaluated the data in each case. The type of RWE submitted, the indication, limitations identified by FDA reviewers, and the outcome of the submission are discussed.Results: RWE, particularly historical controls for rare or orphan indications, has been used to support both original and supplementary oncology drug approvals. Types of RWE included data from electronic health records, claims, post-marketing safety reports, retrospective medical record reviews, and expanded access studies. Small sample sizes, data quality, and methodological issues were among concerns cited by FDA reviewers.Conclusion: By bridging the gap between the constraints of the trial setting and the realities of clinical practice, RWE can add value to a regulatory submission. These early examples provide insight into how regulators evaluated RWE submitted as evidence of efficacy for oncology drugs. [ABSTRACT FROM AUTHOR]

Due to significant dietary supplement use in the US, product manufacturers must understand the importance of implementing a robust approach to establishing safety for all ingredients, including dietary ingredients, components, and finished dietary supplement products. Different regulatory pathways exist by which the safety of dietary ingredients can be established, and thus allowed to be marketed in a dietary supplement. For individual dietary ingredients, safety information may come from a variety of sources including history of safe use, presence of the ingredient in foods, and/or non-clinical and clinical data. On occasion safety data gaps are identified for a specific ingredient, particularly those of botanical origin. Modern toxicological methods and models can prove helpful in satisfying data gaps and are presented in this review. For finished dietary supplement products, issues potentially impacting safety to consider include claims, product labeling, overages, contaminants, residual solvents, heavy metals, packaging, and product stability. In addition, a safety assessment does not end once a product is marketed. It is important that manufacturers actively monitor and record the occurrence of adverse events reported in association with the use of their products, in accordance with the law. Herein, we provide a comprehensive overview of considerations for assessing dietary supplement safety., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jay E Sirois reports a relationship with Consumer Healthcare Products Association that includes: employment. Corresponding author is employed by a trade association (Consumer Healthcare Products Association) that represents manufacturers and marketers of dietary supplement products. Other co-authors are employed by companies that manufacture and or market dietary supplements., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Cannabis-infused edibles have grown in popularity particularly among young people in the United States. Youth-appealing cannabis packaging is common and associated with concerns on its public health impacts. This study aims to assess associations of youth-appealing cannabis edible package attributes with appeal ratings and visual attention of young adults., Methods: Seventy-two young adults participated in an eye-tracking experiment, in which each participant viewed seven randomly ordered cannabis edible package images with varying youth-appealing attributes, including a cartoon character, a young adult model, bubble font, berry flavor, and gummy bear shape. Two primary outcomes were assessed: 1) appeal ratings elicited on a scale from 0 to 10 based on self-reporting, and 2) fixation durations on predefined areas of interest in the package images based on eye-tracking data. Multivariate linear regressions were conducted to assess associations., Results: Packages containing a cartoon character, bubble font, berry flavor, or gummy bear shape received higher appeal ratings than the package with no youth-appealing attributes. Youth-appealing attributes received longer fixation durations than non-youth-appealing attributes. The presence of any youth-appealing attribute is associated with reduced fixation durations on the warning label, with the largest reduction in the package with multiple youth-appealing attributes., Conclusions: Youth-appealing attributes on cannabis edible packages are associated with higher appeal ratings, more visual attention towards those attributes, and less visual attention towards warning labels among young adults in the United States. Regulations banning youth-appealing attributes may be effective in reducing appeal of cannabis edibles and increasing attention towards warning labels., Competing Interests: Declaration of Competing Interest No conflict of interest declared., (Copyright © 2023 Elsevier B.V. All rights reserved.)

The article focuses on the importance of the sports medical team to be compliant with the federal laws and medical laws inorder to provide proper medical care to the injured athlete. It talks about a sports medicine team including physicians, athletic trainers and nurses which provide care based on their duties. It tells about the sports medicine team providing proper medication for the treatment.

Objectives. To evaluate and describe outcomes of state and local medical countermeasure preparedness planning, which is critical to ensure rapid distribution and dispensing of a broad spectrum of life-saving medical assets during a public health emergency. Methods. We used 2007 to 2014 state and local data collected from the Centers for Disease Control and Prevention’s Technical Assistance Review. We calculated descriptive statistics from 50 states and 72 local Cities Readiness Initiative jurisdictions that participated in the Technical Assistance Review annually. Results. From 2007 to 2014, the average overall Technical Assistance Review score increased by 13% for states and 41% for Cities Readiness Initiative jurisdictions. In 2014, nearly half of states achieved the maximum possible overall score (100), and 94% of local Cities Readiness Initiative jurisdictions achieved a score of 90 or more. Conclusions. Despite challenges, effective and timely medical countermeasure distribution and dispensing is possible with appropriate planning, staff, and resources.However, vigilance in training, exercising,and improving plans from lessons learned in a sustained, coordinated way is critical to ensure continued public health preparedness success. [ABSTRACT FROM AUTHOR]

This paper reviews the main tools for communicating benefit-risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit-risk medicines communication is first contextualised within the broader risk communication literature. Three distinct goals are then made explicit before critically examining the evidence for and against tools developed in the US (e.g. at the Food and Drug Administration [FDA]) and Europe (e.g. at the European Medicines Agency [EMA]). These goals are (i) sharing information (e.g. publishing clinical trial and adverse event data online); (ii) changing patients' beliefs by conveying factual knowledge (e.g. patient information leaflets and the drugs facts box); and (iii) changing behaviour (e.g. patient alert cards and warning labels). The mental models approach and traffic-light labelling, developed outside the pharmaceutical context, are then examined. Ultimately, the paper provides a helicopter view of the variety of benefit-risk communication tools that are used, or could be used, by pharmaceutical regulators in the US and Europe. [ABSTRACT FROM AUTHOR]

This article, which is part 1 of a series on compounding with antioxidants, discusses specific preparation methods and techniques along with packaging, storing, and labeling issues. Also presented are the allowable overages from the United States Pharmacopeia's discussion on "Commercial Parenteral Products". Some considerations related to potential issues when compounding with commercial products are also discussed using specific examples. The article ends with a discussion of product standardization and look-alike products. The formulation of an antioxidant system is accomplished primarily through trial and error. With some experimentation and patience, a suitable, stable system with the required characteristics can be obtained., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Our objective was to compare the pharmacogenetic information provided in the package inserts (PIs) of 7 drugs marketed in the United States and India, namely, abacavir, capecitabine, carbamazepine, clopidogrel, irinotecan, valproic acid, and warfarin. We evaluated the pharmacogenetic information provided in Indian PIs for the highest level where it was included, robustness and completeness, clinical validity, and clinical utility and compared it with corresponding data of US PIs. Pharmacogenetic studies carried out in India were identified using PubMed. Pharmacogenetic information was provided in Indian PIs of all the drugs except irinotecan. It appeared in the same section as in US PIs for abacavir, capecitabine, carbamazepine (HLA-*3101), valproic acid (urea cycle disorders), and warfarin (protein C and protein S), whereas it appeared at lower levels for other drug-gene combinations. The robustness of pharmacogenetic testing was graded convincing for abacavir, adequate for carbamazepine and clopidogrel, and incomplete for the remaining drugs, and only abacavir and clopidogrel PIs provided full details of supporting studies. These details, when provided in the Indian PIs were identical to those in the US PIs. The Indian PIs did not provide data on Indian patients, although published studies are available. Both US and Indian PIs lacked critical information on the clinical validity and utility of pharmacogenetic testing. The pharmacogenetic information should provide country/ethnicity-specific data so that they are useful to clinicians. Where data are not available, the prevalence of genetic variation in the population of a country needs to be determined and should then be translated to the PIs. [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

Prehospital dosing errors affect approximately 56,000 US children yearly. To decrease these errors, barriers, enablers and solutions from the paramedic (EMT-P) and medical director (MD) standpoint need to be understood. We conducted a mixed-methods study of EMT-P and MDs in Michigan utilizing focus groups (FG). FGs were held at EMS agencies and state EMS conferences. Questions focused on the drug dose delivery process, barriers and enablers to correct dosing and possible solutions to decrease errors. Responses were coded by the research team for themes and number of response mentions. Participants completed a pre-FG survey on pediatric experience and agency characteristics. There were 35 EMT-P and 9 MD participants: 43% of EMT-Ps had been practicing > 10 years, 11% had been practicing < 1 year; and 25% reported they had not administered a drug dose to a child in the last 12 months. EMT-Ps who were “very comfortable” with their ability to administer a correct drug dose to infants, toddlers, school-aged, and adolescents were: 5%, 7%, 10%, and 54%, respectively. FGs identified themes of: difficulty obtaining weight, infrequent pediatric encounters, infrequent/inadequate pediatric training, difficulties with drug packaging, drug bags that were not “EMS friendly,” difficulty with drug calculations, and lack of dosing aids. Simplification of dose delivery, an improved length based tape for EMS, pediatric checklists, and dose cards in mL were given as solutions. This mixed-methods study identified barriers and potential solutions to reducing prehospital pediatric drug dosing errors. Solutions should be thoroughly tested prior to implementation. [ABSTRACT FROM PUBLISHER]

The article offers information on the guidance issued by the U.S. Food and Drug Administration (FDA) on January 12, 2017 on repackaging drug products. Topics discussed include guidelines on the beyond-use-date (BUD) for tablets taken from a manufacturer's large container and repackaged into smaller containers, explanation given by the FDA on BUDs for pharmacy-repackaged drug products, and the biggest challenge to pharmacists, according to Eric Kastango of consulting company Clinical IQ LLC.

Ophthalmic preparations are sterile liquid, semi-solid, or solid preparations intended for application to the conjunctiva, the conjunctival sac, or the eyelids. Sterility is a key issue in manufacture and use of ophthalmic products. Preservative selection is a critical activity in product design. Other important aspects requiring assessment in the manufacture of ophthalmic products include sterility, tonicity, pH, buffering, drug toxicity, solubility, stability, viscosity, aseptic filling, packaging and storage. Microbial content or bioburden of the raw materials, in process intermediates, and drug substance or active product ingredient are potential sources of contamination and require incoming testing of ingredients. Most ophthalmic products are sterilized by aseptic filtration through a 0.22-?m filter. Preservatives in the ophthalmic solution will, to varying degrees, bind or be adsorbed onto many common membrane filter materials. Most commercial liquid ophthalmic products are packaged in plastic containers fitted with nozzles for drop wise administration. Plastic containers are generally sterilized by gamma irradiation or ethylene oxide. Facilities used to prepare ophthalmic preparations are required to operate within a controlled environment using HEPA filtration to minimize contact of airborne contamination with critical sites such as open product prior to application of closures, injection ports, and vial septa. Aseptic filling ophthalmic medications is typically achieved through the use of blow-fill-seal (BFS) technology in which product containers are formed from plastic granules on-line and then filled with drug solution and sealed in one operation. Blow-fill-seal technology has a theoretically lower risk of microbial contamination compared with conventional aseptic filling. Quality control of these products includes traditional tests such as identification, potency, purity, impurities, sterility, and particulate matter and performance tests such as dissolution or drug release. Physical or chemical instability will be demonstrated by noticeable changes in the dosage form such as changes in color, consistency, agglomerates, grittiness, emulsion breakdown, crystal growth, shrinking due to evaporation of water, or evidence of microbial growth. The finished product must also be subject to the sterility test and endotoxin tests. [ABSTRACT FROM AUTHOR]

BACKGROUND: In October 2007, manufacturers voluntarily withdrew over-the-counter (OTC) infant cough and cold medications (CCMs) from the US market. A year later, manufacturers announced OTC CCM labeling would be revised to warn against OTC CCM use by children aged <4 years. We determined whether emergency department (ED) visits for CCM adverse drug events (ADEs) declined after these interventions. METHODS: We used National Electronic Injury Surveillance System- Cooperative Adverse Drug Event Surveillance data from 2004 to 2011 to estimate the number of ED visits for CCM ADEs before and after each intervention. RESULTS: Among children aged <2 years, ED visits for CCM ADEs decreased from 4.1% of all ADE ED visits before the market withdrawal to 2.4% of all ADE visits afterward (difference in proportion: -1.7%, 95% confidence interval [CI]: -2.7% to -0.6%). Among children aged 2 to 3 years, ED visits for CCM ADEs decreased from 9.5% of all ADE ED visits before the labeling revision announcement to 6.5% of all ADE visits afterward (difference in proportion: -3.0%, 95% CI: -5.4% to -0.6%). Unsupervised ingestions accounted for 64.3% (95% CI: 51.1% to 77.5%) of CCM ADE ED visits involving children aged <2 years after the withdrawal and 88.8% (95% CI: 83.8% to 93.8%) of visits involving children aged 2 to 3 years after the labeling revision announcement. CONCLUSIONS: After a voluntary market withdrawal and labeling revision, ED visits for CCM ADEs declined among children aged <2 years and 2 to 3 years relative to ADE ED visits for all drugs. Interventions addressing unsupervised ingestions are needed to reduce CCM ADEs. [ABSTRACT FROM AUTHOR]

Compounding pharmacies play an increasing and increasingly important role in our healthcare system, but recent media attention has exposed limited regulatory control over these organizations at the same time their role is expanding. Compounding pharmacies are not regulated in the same manner as pharmaceutical companies and are governed largely by Chapter <797>, a monograph on the pharmaceutical compounding of sterile products, issued but not enforced by the U.S. Pharmacopeial Convention. Not all states require adherence to Chapter <797>, and those that do may choose not to enforce it stringently. Furthermore, Chapter <797> is not a strong standard-for example, it does not require documentation of drug lot numbers or cross-references for patient identification. Thus, there have long been many potential quality issues associated with compounding pharmacies. As these compounding pharmacies provide important products and services, better regulation is urgently needed. Moreover, clinicians should be better aware that some injectable products they use may have been prepared by a compounding pharmacy. [ABSTRACT FROM AUTHOR]

Background: Recent media reports have highlighted copycat/lookalike cannabis edibles as a public health concern. No empirical papers have described this phenomenon., Methods: From May 2020-August 2021, we collected photos of cannabis products via an online survey of cannabis users and through personal contacts. Copycat/lookalike products are defined as those that use the same or similar brand name, logo, and/or imagery as an existing commercial non-cannabis counterpart (CNCC). We assessed each package for similarities with its CNCC with respect to brand name, product name, font, color, flavors, and brand/promotional characters. We examined cannabis content indicators including: THC content per package and serving, cannabis leaf symbol, product warnings, cannabis terms, cannabis motifs, activation time, and guidance on edible use., Results: We collected photos of 731 cannabis products; 267 (36%) were edibles of which 22 (8%) represented 13 unique copycat/lookalike products. Eight used exact brand/product names as existing CNCCs, and five used similar names. Packages copied or imitated a mean of 3.9 of six features and indicated cannabis content with a mean of 4.1 of eight features. Thirteen packages indicated a mean THC content of 459 mg/package. Four reported THC dose per serving, with a mean dose of 47.5 mg., Conclusions: Our content analysis highlights three key concerns. First, copycat/lookalike edibles subtly indicate cannabis content while using high fidelity replication or imitation of their CNCC. Second, THC content is high and there were multiple 10 mg THC doses in the equivalent of 1 serving of a CNCC. Third, these products may be attractive to children., (Copyright © 2022 Elsevier B.V. All rights reserved.)

The article presents abstracts on medication safety and error incident topics including the prevalence of medication errors in hospitals during public holidays in Australia, intravenous acetaminophen overdose in children in the U.S., and the regulation of the reuse of insulin pens in U.S. hospitals.

The article discusses several reports related to problems with medication safety, including one on a drug overdose, one on the prevention of drug delivery device errors and one on the case of a hospital patient who was given the wrong medication. Medication safety incidents from Australia and the U.S. are discussed.

Pharmacovigilance or collecting, monitoring, research, assessment and evaluation of information obtained from the manufacturer, health workers and patients about the adverses of the drugs, biological products, traditional medicines, with the aim to detect new information on the dangers of the drugs as well as prevention of new adverse sideeffects harmful for the patients which is obligatory for the regulatory agencies, authorized by the authorities in almost every country. Modern trends of treating the patients in connection with rising number of new drugs in all pharmaceutical forms on the market demand continued improvement of the pharmacovigilance system with the accent on the feedback information towards the final consumers and doctors who prescribe them. One of very efficient communication tools between the regulation agency and final consumers/prescribers is created and implemented by Food and Drug Administration in the USA (FDA) called "boxed warning" - "black box". "Black box" warnings are the most serious warnings of FDA on the drugs, which point out potentially fatal, life threatening risks, or disabling side-effects of the drugs. It is named for the black border surrounding the text of the warning. The border was designed to draw attention on the warning and to emphasize it in relation to other information as a part of the drug packing. Looking into the studies monitoring the way the drugs with this kind of warning were used showed that explicit, well-publicized warning can change the prescribing habits of doctors and influence the patients to be more careful in using specific drugs or even classes of drugs. [ABSTRACT FROM AUTHOR]

This article discusses the intersection of science and culture in the marketplace and explores the ways in which radium quack and medicinal products were packaged and labelled in the early twentieth century US. Although there is an interesting growing body of literature by art historians on package design, historians of science and medicine have paid little to no attention to the ways scientific and medical objects that were turned into commodities were packaged and commercialized. Thinking about packages not as mere containers but as multifunctional tools adds to historical accounts of science as a sociocultural enterprise and reminds us that science has always been part of consumer culture. This paper suggests that far from being receptacles that preserve their content and facilitate their transportation, bottles and boxes that contained radium products functioned as commercial and epistemic devices. It was the 1906 Pure Food and Drug Act that enforced such functions. Packages worked as commercial devices in the sense that they were used to boost sales. In addition, 'epistemic' points to the fact that the package is an artefact that ascribes meaning to and shapes its content while at the same time working as a device for distinguishing between patent and orthodox medicines. [ABSTRACT FROM AUTHOR]

The article presents information about medication safety issues, medication errors and strategies to prevent medication errors drawn from Australian incidents and US experiences. A discussion of medication errors and potential medication errors regarding human error and drug labeling errors is presented. Safety briefs on prescription drugs and safe practice recommendations are offered.

Abstract: Background: Calendar blister packaging (CBP) that incorporates a day or date feature is a simple medication packaging technology that is designed to improve medication adherence and persistence. Objective: This study was conducted to assess the effect of a new calendar packaging technology on prescription refill adherence and persistence for daily, self-administered, long-term medication use. Methods: Anonymized pharmacy dispensing data from a large US mass merchandiser were analyzed. This retrospective cohort study included people aged 18 to 75 years who filled prescriptions for oral lisinopril or enalapril (control group) at a study pharmacy during 1 year before and after the switch of lisinopril packaging from vials to CBP. Cohorts were stratified into new and prevalent medication users. We used linear and logistic regression modeling and propensity score matching to assess the impact of CBP on refill adherence, using medication possession ratio (MPR) and proportion of days covered (PDC), and persistence using length of therapy (LOT). Results: Our sample comprised 76,321 new users and 249,040 prevalent users. Across all user, medication, and packaging groups, the mean unadjusted LOT decreased in the follow-up year, possibly due to economic recession. The LOT decline was attenuated in the CBP cohort. After adjustment for covariates, CBP use in new and prevalent medication users was associated with significantly higher LOT and PDC but not MPR. The odds of achieving PDC ≥80% were higher by 15% in new users (odds ratio [OR] = 1.15; 95% CI, 1.09–1.21) and 12% in prevalent users (OR = 1.12; 95% CI, 1.09–1.15) who switched to CBP, compared with continued vial use. Conclusions: CBP of medication prescribed for daily, self-administered, long-term use was associated with modest improvement in prescription refill adherence and persistence. An adherence strategy of even small effect size that is broadly implemented on a population level could significantly leverage therapeutic effect and provide substantial cumulative public health benefit. Clinical benefit, or harm, associated with use of CBP should be investigated. Usability assessments of CBP in patient subgroups may provide insight about differential impact on adherence and persistence. [Copyright &y& Elsevier]

The article presents news related to medication safety. In the U.S. an updated list of transdermal medication patches which contain a metallic component was issued after research revealed that patients with the patches who undergo magnetic resonance imaging are at risk of serious burns. 2010 research revealed the top 31 drugs that are associated with increased rates of violence. Australian research found that the chances of medication errors with the drugs coumadin and coversyl are high.

OBJECTIVE: A voluntary market withdrawal of orally administered, over-the-counter, infant cough and cold medications (CCMs) was announced in October 2007. The goal of this study was to assess CCM-related adverse events (AE5) among children after the withdrawal. METHODS: Emergency department (ED) visits for CCM-related AEs among children <12 years of age were identified from a nationally representative, stratified, probability sample of 63 US EDs, for the 14 months before and after announcement of withdrawal. RESULTS: After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children <2 years of age were less than one-half of those in the prewithdrawal period (1248 visits [13.3%] vs 2790 visits [28.7%]; difference: -15.4% [95% confidence interval [Cl]: -25.9% to -5.0%]), whereas the overall number of estimated ED visits for CCM-related AEs for children <12 years of age remained unchanged (9408 visits [95% Cl: 6874-11 941 visits] vs 9727 visits [95% Cl: 6649 -12 805 visits]). During both periods, two-thirds of estimated ED visits involved unsupervised ingestions (ie, children finding and ingesting medications). CONCLUSIONS: ED visits for CCM-related AEs among children <2 years of age were substantially reduced after withdrawal of over-the-counter infant CCMs. Further reductions likely will require packaging improvements to reduce harm from unsupervised ingestions and continued education about avoiding CCM use for young children. Monitoring of CCM-related harm should continue because recommendations were updated in October 2008 to avoid the use of CCMs for children <4 years of age. [ABSTRACT FROM AUTHOR]

The article presents news items on medication safety. The U.S. Food and Drug Administration has warned that menopausal women who use topical oestradiol sprays should avoid touching children and pets with sprayed skin. The U.S. Food and Drug Administration in 2010 approved the use of the drug Exalgo for treatment of severe pain. The Institute for Safe Medication Practices has reported that inaccurate doses of the drug magnesium sulfate bolus can lead to patient harm.

The article presents medication safety news briefs from Australia and the U.S. There are concerns that the medication packaging for Epistatus buccal solution made by Phebra is confusing and could lead to administration errors. Nursing errors relating to medication labeling of multilumen catheters have been reported in Australia. The National Patient Safety Agency in England and Wales have released a safety alert regarding the safe administration of lithium.

Objective: The pharmacoeconomic guidelines available in the literature or promulgated in many countries are either vague or silent about how drug costs should be established or measured so an international comparison of cost-effectiveness analysis (CEA) results can be made. The objective of this report is to provide guidance and recommendations on how drug costs should be measured for CEAs done from an internationally comparative perspective. Methods: Members of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (Drug Cost Task Force [DCTF]) subgroup from several countries were experienced developers or users of CEA models, and worked in academia, industry, and as advisors to governments. They solicited comments on drafts from a core group of 174 external reviewers and more broadly, from the members of the ISPOR at the ISPOR 12th Annual International meeting and via the ISPOR Web site. Results: Drug units should be standardized in terms of volume of active ingredient, regardless of packaging and dosing strength variations across countries. Drug costs should be measured in local currency per unit of active ingredient and should be converted to other currencies using sensitivity analyses of purchasing power parities (PPP) and exchange rates, whichever is more appropriate. When using drug prices from different years, the consumer price index for the local currency should be applied before the PPP and/or exchange rate conversion. Conclusion: CEA researchers conducting international pharmacoeconomic analysis should tailor the appropriate measure of drug costs to the international perspective, to maintain clarity and transparency on drug cost measurement in the context of international drug comparison and report the sensitivity of CEA results to reasonable cost conversions. [ABSTRACT FROM AUTHOR]

Research has documented the drastic reduction of unintentional poisonings of children since the introduction of child resistant (CR) packaging. However, studies also indicate that consumers report difficulty using CR packages, in part because tests which determine the ‘senior friendliness’ of CR designs that are used throughout the world disallow people with ‘overt or obvious’ disabilities from being test subjects. Our review of drug package usability suggests that the current tests of CR packaging can and should be revised to correct this problem. We use US legislation, regulation and data to exemplify these points, but the conclusions are applicable to all protocols that include the exclusionary provision. [ABSTRACT FROM AUTHOR]

OBJECTIVES. Free drug samples frequently are given to children. We sought to describe characteristics of free sample recipients, to determine whether samples are given primarily to poor and uninsured children, and to examine potential safety issues. METHODS. We analyzed data on 10295 US residents <18 years of age from the 2004 Medical Expenditure Panel Survey, a nationally representative survey that includes questions on receipt of free drug samples. We performed bivariate and multivariate analyses to evaluate characteristics associated with receipt of ≥1 free drug sample in 2004. We identified the most frequently reported sample medications and reviewed potential safety issues. RESULTS. Ten percent of children who received prescription medications and 4.9% of all children received ≥1 free drug sample in 2004. In bivariate analyses, poor children (family incomes of <200% of the federal poverty level) were no more likely to receive free samples than were those with incomes of ≥400% of the poverty level (3.8% vs 5.9%). Children who were uninsured for part or all of the year were no more likely to receive free samples than were those who were insured all year (4.5% vs 5.1%); 84.3% of all sample recipients were insured. In multivariate analyses, routine access to health care (≥3 provider visits in 2004) was associated with free sample receipt. The 15 most frequently distributed pediatric free samples in 2004 included 2 schedule II controlled medications, Strattera (atomoxetine) and Adderall (amphetamine/dextroamphetamine), and 4 medications that received new or revised black box warnings between 2004 and 2007, Elidel (pimecrolimus), Advair (fluticasone/salmeterol), Strattera (atomoxetine), and Adderall (amphetamine/dextroamphetamine). CONCLUSIONS. Poor and uninsured children are not the main recipients of free drug samples. Free samples do not target the neediest children selectively, and they have significant safety considerations. [ABSTRACT FROM AUTHOR]

The article focuses on drug inserts. It says that a patient package insert (PPI) aims to provide specific information about medication to patients and is available in a small number of drugs while a package insert (PI) is targeted to physicians and is included with most drugs. It mentions the first PI was developed in 1968 by the U.S. Food and Drug Administration (FDA) while true PPI were issued in 1970. Some suggestions on improving the current system of drug inserts are offered.

Purpose. The transit temperature profiles, mean kinetic temperatures (MKTs), and stability of insulin samples in both insulated and noninsulated containers exposed to summer and winter temperatures were evaluated. Methods. Regular insulin, isophane insulin human (NPH) insulin, and 70% isophane-30% regular (70/30) insulin were packaged in the most commonly dispensed quantity of four vials in noninsulated mailers and insulated containers with frozen gel packs. After packaging, sealed containers and mailers were placed in an environmental chamber for 24–120 hours and exposed to summer and winter transit conditions. Temperatures inside the environmental chamber were recorded every 15 minutes and maintained within 3 °C of the specified transit temperature. After exposure to the transit conditions, insulin cartons were removed from their packaging, visually inspected for changes in physical appearance, and stored at 4 °C until analysis. The MKT of each package was calculated. High-performance liquid chromatography was performed to determine sample stability, and size-exclusion chromatography was conducted to detect aggregate products of insulin. Results. Regardless of shipping conditions or packaging, all samples met the United States Pharmacopeia's (USP's) specified limits and retained product stability. Visual inspection of the physical appearance of insulin samples before and after temperature exposure revealed results similar to those described in the product inserts. Microscopic analysis of the injectable suspensions confirmed similar crystal morphologies before and after temperature exposure. Conclusion. Regular, NPH, and 70/30 insulin maintained potency within USP limits when stored in programmable environmental chambers simulating summer and winter overnight or three- to five-day ground delivery conditions, regardless of packaging material. [ABSTRACT FROM AUTHOR]

The article focuses on the need for U.S. hospitals and health systems to develop a medication patient safety program in order to prevent medical errors, including medication errors that occur at an average of 19% to 36% in hospitals. The report "Preventing Medication Errors," released by the Institute of Medicine suggested a national agenda for preventing such errors which included improving drug packaging and labelling and funding medication safety research.

The article reports on a study of the U.S. poison control centers by researchers from the U.S. Centers for Disease Control and Prevention (CDC), Emory University School of Medicine and the Georgia Poison Center, on children get into prescription pills. It presents the views of the study's senior author Daniel Budnitz on encouraging adults to keep medicines in containers with children resistant features.

The Food and Drug Administration (FDA) has recently attempted to improve the safety of over-the-counter (OTC) drugs by creating a regulation aimed at redesigning their labels. One portion of this regulation attempts to improve the legibility of OTC labels by individually specifying certain elements of their design. The FDA's approach looks at the elements of label design as distinct entities that can be isolated and manipulated to improve legibility. Reality does not match the simplicity of this approach. Legibility is the overall goal in a complex system of interrelated elements that come together to create a message. This research challenges the regulation by using an instrument that meaasures what is trule important: the legibility of the label. [ABSTRACT FROM PUBLISHER]

Objective: To determine the degree of cross-contamination and to validate a cleaning process for an Automated Personalised Dosing System (APDS), respecting the permitted residue transfer limits., Method: An analytical determination by high pressure liquid chromatography with mass spectrometry was performed for 11 drugs considered critical for their potential for contamination, toxicity (National Institute for Occupational Safety and Health (NIOSH) List 2016) and/or narrow therapeutic index. The test was carried out for three consecutive weeks, seven repetitions per week, in a state of maximum contamination and maximum cleanliness. The main validation criterion of the cleaning protocol was to quantify that the active ingredients measured were below the Permitted Daily Exposure index or fraction 1/1000 of the minimum daily dose, both in a state of maximum contamination and when the APDS is in a clean condition, for an average number of tablets consumed per person per day., Results: In all the samples analysed, some compound could always be quantified below 2% of the permitted transfer limits, highlighting the presence of paracetamol and carbamazepine. In the state of maximum contamination, the mean±SD values of paracetamol and carbamazepine were 5.83±1.56 µg and 0.22±0.07 µg, respectively, without significant differences in mean values over the 3 weeks of the study. After the cleaning protocol was executed, only paracetamol and carbamazepine were detected, with the average values being 4.67 µg (95% CI 3.92 to 5.43, p<0.05) and 0.07 µg (95% CI 0.03 to 0.10, p<0.05) lower than the state of maximum contamination, respectively., Conclusions: In all cases the level of cross-contamination for an APDS was below the pre-established limits. The cleaning protocol has been validated, confirming APDS decontamination of the most critical medicines., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2022. No commercial re-use. See rights and permissions. Published by BMJ.)