Pharmaceutical Packaging Research Articles

Past, present, and possible future policies on plastic use in the United States, particularly microplastics and nanoplastics: A review.

As the levels of plastic use in global society have increased, it has become crucial to regulate plastics of all sizes including both microplastics (MPs) and nanoplastics (NPs). Here, the published literature on the current laws passed by the US Congress and regulations developed by various federal agencies such as the US Environmental Protection Agency and the US Food and Drug Administration (FDA) that could be used to regulate MPs and NPs have been reviewed and analyzed. Statutes such as the Clean Water Act, the Safe Drinking Water Act, the Toxic Substances Control Act (TSCA), the Resource Conservation and Recovery Act, and the Clean Air Act can all be used to address plastic pollution. These statutes have not been invoked for MP and NP waste in water or air. The Federal Food, Drug, and Cosmetic Act provides guidance on how the FDA should evaluate plastics use in food, food packaging, cosmetics, drug packaging, and medical devices. The FDA has recommended that acceptable levels of ingestible contaminant from recycled plastic are less than 1.5 µg/person/day, which is 476 000 times less than the possible ingested daily dose. Plastic regulation is present at the state level. States have banned plastic bags, and several cities have banned plastic straws. California is the only state beginning to focus on monitoring MPs in drinking water. The future of MP regulation in the USA should use TSCA to test the safety of plastics. The other statutes need to include MPs in their definitions. For the FDA, MPs should be redefined as contaminants-allowing tolerances to be set for MPs in food and beverages. Through minor changes in how MPs are classified, it is possible to begin to use the current statutes to understand and begin to minimize the possible effects of MPs on human health and the environment. Integr Environ Assess Manag 2023;19:474-488. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Safety and Effectiveness of Molnupiravir in Covid-19 Treatment: A Rapid Review

In the first stage of viral replication, Covid-19 may cause a remarkable inflammatory response in patients. Molnupiravir is an oral antiviral medicine which functions through inhibiting the viral replication of RNA viruses including Corona virus (SARS-CoV-2). The present study intends to help the policymakers decide on using of this medication in Iran.
 This study is conducted on Jan. 22, 2022 (from Jan. 2014 -the year of molnupiravir production for treatment of RNA virus diseases), using a rapid review of evidence as well as reviewing reliable databases including the Cochrane library, PubMed and Google scholar. The inclusion criteria were the randomized controlled trials that investigated the safety and efficacy of Molnupiravir at different doses in patients with Covid-19, comparing with placebo or other routine care methods (Population: Covid-19 patients, Intervention: molnupiravir, Control: placebo or other routine care methods, Outcome: Safety, Efficacy and Economic status, Study design: the randomized controlled trials or HTA reports). Prescription for oral administration in 800 mg dose twice daily for 5 days to inpatients and outpatients with mild, moderate or severe symptoms in the early stages of the disease (viral phase) had the most desirable level of efficacy. This medicine has no serious side effects; since the mutations caused by this medication have not been clarified yet, it is not recommended during pregnancy and/or for women planning to become pregnant. According to the manufacturing company, in the United States, each drug package is priced at $712 for a 5-day treatment period. Molnupiravir can be used in outpatients and inpatients (Over 18 years old) with moderate or severe symptoms in the early stages of the disease. But it is not recommended during pregnancy and/or for women planning to become pregnant.

Evaluation of medication errors in the hospital environment.

Healthcare is inherently associated with a risk to patient health. One risk is associated with medication-related errors, which are commonly reported adverse events. By analyzing the root causes of medication errors, effective preventive measures can be proposed to reduce their likelihood. This study aimed to identify the reasons of medication administration errors, determine the number of medication administration errors reported, and describe the barriers hindering reporting. The study used a standardized Questionnaire Medication Administration Error Survey (MAE survey) that was quantitatively analyzed. The study involved 112 nurses from four hospitals in the South Bohemian Region. Risk factors that increase the likelihood of medication administration errors include similarity of drug names (3.7 ± 1.3) and packaging (3.9 ± 1.5), frequent prescription changes for patients (3.2 ± 1.5), illegibility of written prescriptions (3.1 ± 1.6), a lack of clarity of medical records (2.6 ± 1.5). Only a proportion of medication administration errors are reported by nurses (16% to 21%). The reluctance of nurses to report medication administration errors is linked to fear of being blamed for the deterioration of the patients health (3.3 ± 1.7), fear of the doctors reaction to a medication administration error (2.6 ± 1.4), and repressive responses from hospital management to reported misconduct (2.9 ± 1.5). Measures to reduce the likelihood of medication administration errors include building a non-punitive system for reporting adverse events and medication errors, introducing electronic prescription systems, promoting open communication within the team, involving clinical pharmacists in the pharmacotherapy process, and regular comprehensive training of nursing staff.

The financial impact of reducing drug waste with biosimilar transition of trastuzumab in the Oncology Care Model for the U.S. Oncology Network.

11 Background: The Oncology Care Model (OCM), a 6-year long Medicare value-based care program, rewards practices for decreasing total cost of care (TCOC) compared to a benchmark price, while maintaining high quality cancer care. Care services for enrolled patients are divided into 6-month episodes within 1-year time intervals called Performance Periods (PP). One approach to reducing TCOC is reducing the expenditure for drug waste. In mid-2017, trastuzumab (HER2-targeted monoclonal antibody) 420 mg multi-dose vial (MDV) was discontinued and replaced with a 150 mg single-dose vial (SDV), leading to wastage of the remaining partial quantities of the SDV after preparation of a patient-defined dose. The increased drug waste led to an increase in the total drug cost of trastuzumab and TCOC. Late 2019, MDV and SDV biosimilar trastuzumab products were introduced, and The US Oncology Network (The Network) practices adopted the MDV biosimilar as a strategy to reduce drug waste and TCOC. This study highlights the impact of trastuzumab drug waste on TCOC. Methods: Claims data for 14 Network practices, participating in OCM, were assessed. The financial impact of drug waste and TCOC for The Network’s transition from MDV trastuzumab to SDV trastuzumab in 2017, and from SDV trastuzumab to the MDV biosimilar trastuzumab in 2020 was evaluated. Results: With the use of MDV trastuzumab during OCM PP1, drug waste accounted for 0.05% of the total dose of trastuzumab. After having to shift from MDV to SDV during PP2, as a result of the packaging change, trastuzumab drug waste increased to 10.25% of the total dose, with an increase in TCOC by 0.25% ($2M) per PP during PPs 3-7. As The Network practices adopted the use of MDV biosimilar trastuzumab starting in PP8, drug waste declined 57% to 4.4% of the total dose in PP9, reducing the drug waste component of TCOC by $1.4M (0.16%). Had all SDV trastuzumab doses been transitioned to the MDV biosimilar, an additional $600K (0.09%) in TCOC could have been reduced in PP9. Conclusions: TCOC fluctuations can be driven by not just increasing costs or increased utilization, but also by drug packaging and increasing drug waste. The discontinuation of MDV trastuzumab resulted in a substantial financial impact on drug waste, TCOC, and cost for patients. Swift transition to biosimilar MDV trastuzumab within The Network helped to significantly reduce drug waste and its impact on TCOC in the OCM. Trastuzumab biosimilars, in addition to being cost-effective alternatives to biological therapeutics, offer significant cost savings via drug waste reduction.

Agreement Between Measures of Adherence to Isoniazid Preventive Therapy Among People With HIV in Uganda.

Isoniazid (INH) preventative therapy is recommended for people with HIV (PWH) in resource-constrained settings. Valid measures are needed to assess adherence. We aimed to examine agreement between measures overall and by level of social desirability. PWH with latent tuberculosis (TB) were recruited in Mbarara, Uganda. Past 30-day adherence was measured by the number of days with pill bottle openings using a medication event monitoring system (MEMS) and self-reported number of days pills taken. INH concentration (INH plus acetyl INH and their ratio) in hair samples was measured. We used Bland-Altman plots to examine agreement between adherence measures and calculated the area under the receiver operating characteristics curve (AUROC) to determine if INH hair concentration predicted optimal MEMS-measured adherence (≥90%). A total of 301 participants enrolled; 92% were virologically suppressed, and adherence was high. The median (interquartile range [IQR]) number of pill bottle openings in 30 days was 28 (24-30) compared with 30 (28-30) via self-report. The median INH concentration (IQR) was 36.2 (17.2-62.4), and the INH:acetyl ratio was 2.43 (0.99-3.92). Agreement between self-reported and MEMS adherence was greater at more optimal adherence levels. INH:acetyl INH ratio was not predictive of optimal adherence according to MEMS (AUROC, 0.62; 95% CI, 0.52-0.72) in a subset (n = 161). Lower MEMS adherence levels compared with self-report suggest the need for objective adherence measures. Biologic measures have potential, although in this study INH concentration was not predictive of MEMS measured adherence. More data are needed to assess the accuracy of biologic measures.

Multiscale modeling intervention development and perspectives from early-stage breast cancer survivors on technology to improve long-term adherence to endocrine therapy.

442 Background: Despite the important role of endocrine therapy (ET) in preventing cancer recurrence, rates of long-term adherence are poor among certain breast cancer survivors (BCS). Traditional medication adherence (MA) interventions that have primarily incorporated medication-taking reminders mainly focused on a “one size fits all” approach, which may explain why many interventions have proven unsuccessful. However, when combined with other context, sensors (i.e., wearable sensors, smartphone sensors) can facilitate a better understanding of medication-taking behaviors leading to individualized interventions that are time and context appropriate. The project team is developing a multiscale modeling and intervention (MMI) system designed to improve adherence to ET among BCS. This study describes MMI development. Methods: MMI development has included: 1) usability testing; 2) review of research literature regarding factors associated with ET MA; and 3) a neural network analysis of previously collected ET MA data. In usability testing, 20 BCS were recruited via social media posts to participate in semi-structured usability interviews. Interviews were conducted via videoconferencing and assessed perceptions of and willingness to use an ecological momentary assessment (EMA) smartphone app, smartwatch, smart pill bottle, and smart pill box. The literature review examined multiple systematic reviews to identify constructs associated with ET MA. Randomized neural network analysis with 32 early stage BCS taking ET was used to determine important features of ET MA 4 weeks following completion of a 346-item survey. Four-week medication adherence was measured daily with a medication event monitoring system (MEMS). Results: Usability testing participants were accepting of each technology and willing to use each technology at various frequencies. Forty-two surveys were reviewed as predictors of MA in systematic reviews. Randomized neural network analysis found 104 survey items had absolute weights at the 70th percentile, indicating a strong influence on week 4 ET MA, and 11 surveys were determined theoretically relevant. Conclusions: BCS are willing to use 4 components of the MMI system. The MMI system will soon be deployed for 6 months of data collection. If shown to be effective, the MMI framework can be used by oncologists and researchers to develop personalized interventions focused on understanding and increasing ET MA.

SUDDEN CARDIOVASCULAR COLLAPSE DUE TO CALCIUM CHANNEL BLOCKER OVERDOSE: SUCCESSFUL MANAGEMENT WITH HIGH-DOSE INSULIN EUGLYCEMIC THERAPY

SUDDEN CARDIOVASCULAR COLLAPSE DUE TO CALCIUM CHANNEL BLOCKER OVERDOSE: SUCCESSFUL MANAGEMENT WITH HIGH-DOSE INSULIN EUGLYCEMIC THERAPY

Automatic Extraction of Medication Information from Cylindrically Distorted Pill Bottle Labels

Patient compliance with prescribed medication regimens is critical for maintaining health and managing disease and illness. To encourage patient compliance, multiple aids, like automatic pill dispensers, pill organizers, and various reminder applications, have been developed to help people adhere to their medication regimens. However, when utilizing these aids, the user or patient must manually enter their medication information and schedule. This process is time-consuming and often prone to error. For example, elderly patients may have difficulty reading medication information on the bottle due to decreased eyesight, leading them to enter medication information incorrectly. This study explored methods for extracting pertinent information from cylindrically distorted prescription drug labels using Machine Learning and Computer Vision techniques. This study found that Deep Convolutional Neural Networks (DCNN) performed better than other techniques in identifying label key points under different lighting conditions and various backgrounds. This method achieved a percentage of Correct Key points PCK @ 0.03 of 97%. These key points were then used to correct the cylindrical distortion. Next, the multiple dewarped label images were stitched together and processed by an Optical Character Recognition (OCR) engine. Pertinent information, such as patient name, drug name, drug strength, and directions of use, were extracted from the recognized text using Natural Language Processing (NLP) techniques. The system created in this study can be used to improve patient health and compliance by creating an accurate medication schedule.

Electron spin resonance study on free radicals in cyclic olefin copolymers irradiated by gamma rays at cryogenic and room temperatures

Cyclic olefin copolymers (COCs) are amorphous thermoplastic polymers that require radiation sterilizations when used in prefilled syringes and drug packaging. In the radiation sterilization process, COCs are ionized, and thus, they produce free radicals, which lead to free radical reactions that affect their performance and biosafety. In this study, species of free radicals generated in COCs by γ-ray irradiation and their decay behaviors under different conditions were investigated using electron spin resonance spectroscopy. Results indicated that many alkyl radicals were produced by the irradiation of COCs in liquid nitrogen, which were transformed to peroxy free radicals upon exposure to air. It was confirmed that free radicals centered on secondary and tertiary carbons were predominant after being irradiated at room temperature by an isotropic simulation, and their concentrations depended on the absorbed dose. After 576 h of storage at room temperature, free radicals were nearly annihilated, or almost decayed, near the glass transition temperature. In addition, this study proposes a free radical reaction mechanism for COCs under different post-processing conditions.

An Audit on Design of Pharmaceutical Packaging

An Audit on Design of Pharmaceutical Packaging

Kyra Markham: Letters to Louis Sheaffer (1962–63)

Kyra Markham: Letters to Louis Sheaffer (1962–63)

Accuracy and User Satisfaction for an Audible Prescription Reader Among Adults With Low Vision and Blindness

Introduction: Research is needed to support accuracy and safe self-management of prescriptions among individuals living with low vision or blindness. This study evaluated user accuracy & satisfaction with the ScripTalk® device, an audible prescription reader, among participants with low vision and blindness. Methods: This mixed methods study utilized snowball and convenience sampling through low vision support groups in Indiana. Researchers trained 23 participants (69.6% female, 30.4% male, M age = 64.04, SD = 14.7 years) to use the ScripTalk® device for reading three empty prescription bottles, equipped with radio-frequency ID labels. Accuracy represented correct responses to 12 questions about the labels’ content. The QUEST 2.0's Device Subscale (intraclass correlation coefficient = 0.82) evaluated user satisfaction with the device. Participants answered six qualitative questions about their perceptions of the device. Results: Statistical analysis indicated highest frequencies of satisfaction occurred for Ease in Adjusting (100%), Comfort (100%), Ease of Use (95.6%), and the Weight (95.6%) of the device. Spearman rank order correlation coefficient tests revealed inverse relationships between participants’ accuracy rates and their satisfaction with the device's durability (rho = −0.690, p < .001) and safety & security (rho = −0.834, p < .001). Participants perceived the device as easy to use, adjustable, comfortable, and lightweight for reading prescription labels. However, the auditory quality posed challenges to identify unfamiliar prescription names. Health care professionals may need to provide additional training and practice opportunities with audible prescription readers to support consumers with low vision or blindness, particularly when new medications are prescribed.

Exploiting Augmented Reality and Computer Vision for Healthcare Education: The Case of Pharmaceutical Substances Visualization and Information Retrieval.

Augmented Reality (AR) is already used as the primary visualization and user interaction tool in several scientific and business areas. At the same time new AR technologies and frameworks considerably facilitate both the development of innovative applications and also their wide adoption in different domains of everyday life. In the area of healthcare AR solutions make use of mobile or wearable devices and glasses to support, among others, education and healthcare professionals training. The aim of this paper is to present a prototype mHealth app for education, which uses AR and computer vision technologies for pharmaceutical substances recognition on drug packaging. The conceptual design of the system includes three main components which are responsible for a) Text recognition, b) Drug identification and c) AR operations for interactivity. The prototype application is available in Android or iOS platforms and has been evaluated in real-world scenarios. Camera and screen of the mobile phones fulfill the text recognition and AR operations, which eliminates the need for special equipment, while PubChem and 3D Model databases provide assets required for the drug identification and AR visualizations. The results highlight the value of AR for educational purposes, especially when combined with advanced image recognition technologies to build interactive AR encyclopedias.

Structure elucidation and risk assessment of degradation products in gamma irradiated rubber closures

Gamma-ray irradiation has been widely applied in large-scale industrial pharmaceutical packages sterilization however, high-energy rays may result in degradation of packaging materials comprising polymers and additives. These degradation products (DPs) can migrate into drugs, reducing their efficacy and safety. Therefore, a holistic study about structure elucidation and toxicity assessment of DPs is necessary. In this work, the effect of γ irradiation on rubber closures and additives was investigated by supercritical fluid extraction (SFE) coupled with UHPLC-QTOF MS and GC-MS. Comprehensive DPs were screened and identified by high-resolution mass spectrum and the potential degradation way was proposed. However, as there is no standard present for these DPs, Density-functional theory (DFT) was incorporated to verify degradation way and their structures by analyzing energy barriers and thermodynamic parameters. The initial step of the degradation mechanism was determined and structures and intensity difference of isomers were validated to be consistent experimentally and theoretically. Then based on toxicity prediction consistency by three (Q)SAR tools, the risk of DPs was evaluated and most DPs were negative for carcinogenicity and mutagenicity but positive for developmental toxicity. 7,9-di-tert-butyl-1-oxaspiro [4,5] deca-6,9-dien-2,8-dione was predicted to be carcinogenic in consensus which should be focused on in the further leachable study. Finally, risk assessment in the simulated lyophilized drug showed that exposure of all DPs was within the threshold. The present work addresses the structure elucidation of DPs, especially Irganox 1076, and helps to access a deeper insight into the safety evaluation of rubber closures with more confidence.

Could paper package leaflet be left out from hospital products?

BackgroundPackage leaflet provides information about medicinal product to the user. Printed leaflet is familiar and available, however poorly legible, especially when containing multiple languages. It is resourceful to update, has potential to go missing or get damaged, and is environmentally burdensome. The pharmaceutical manufacturers in the Baltic countries have been granted permission to market selected hospital medicinal products without printed package leaflet. The industrial pilot project is expected to promote availability of medicinal products and patient safety via increased access to medicinal information. ObjectiveOnly few countries in Europe have derogated from Article 58 of Directive 2001/83/EC. Knowledge about the effects of removal of paper package leaflet from the medicinal product is limited, and related publications are scarce. Current interview study is identifying the obstacles during the implementation of the industrial project, investigating the potential environmental impact, and searching for further opportunities for the package leaflet in development of medicinal products. MethodsReal-time person-to-person semi-structured interviews with relevant stakeholders were conducted, and transcripts were analysed by content analysis to identify themes. ResultsResults demonstrated general support for removing package leaflet from selected hospital products. Main difficulties of the industrial project regarded the need for clear communication and practical disadvantages of project setup. Main benefits included educational aspect of increasing awareness about product information and strengthened collaboration. Majority of participants felt doubtful about the impact of the industrial project on people's awareness of ecological issues and they admittedly lacked sufficient information on the environmental impact of pharmaceutical packaging. ConclusionThe removal of paper leaflet could be extended to more products based on the positive feedback for the industrial pilot project. However, it is paramount that the format of electronic product information would need to be enhanced first to improve readability.

Identification and quantification of extractables and leachables in laminated film and pouches for pharmaceutical packaging

Extractables and leachables from pharmaceutical packaging material can potentially be detrimental, which may affect the safety of the drug products. In this study, two compounds were found to be the possible extractables from the secondary packaging material. A strategy combining high performance liquid chromatography (HPLC), fourier transform ion cyclotron resonance mass spectrometry (FT-ICR-MS) and nuclear magnetic resonance (NMR) spectroscopy was utilized for identification of the two compounds. Afterwards, a simple and sensitive HPLC method was developed and validated for the simultaneous quantification of both. The results indicated that this method was suitable for quantificating the two extractables in the pharmaceutical packaging material.

Evaluation of factors associated with medication adherence in patients with bipolar disorder using a medication event monitoring system: a 6‐month follow‐up prospective study

BackgroundNon-adherence in patients with bipolar disorder (BD) results in symptoms, such as aggravation, BD recurrence, emergency room visits, re-hospitalization, and poor psychosocial outcomes. Though non-adherence rates have been reported to range between 30–50% in patients with BD, the problem of adherence is often either overlooked by the physician or denied by the patient. An essential first step to enhancing medication adherence is to objectively estimate adherence. The Medication Event Monitoring System (MEMS), which is a pill bottle cap with a microprocessor, is an accurate device for assessing medication adherence. Using the MEMS, we aimed to measure medication adherence in patients with BD and evaluate the factors associated with and 6-month changes in medication adherence.MethodsParticipants with BD were recruited from the psychiatric outpatient clinic of the Korea University Guro Hospital. The medication adherence of each participant was assessed using the MEMS, a self-report, pill count, and clinician rating. MEMS-measured adherence was reassessed after 6 months. Patient demographics were recorded and clinical assessments were conducted. Data were analyzed using Kappa statistics and Pearson’s correlation analysis.ResultsOf the 59 participants, 50 records were included in the analysis. Patient adherence and adherence rate assessed by the MEMS were lower than those assessed by the other measures. MEMS-measured adherence was correlated more closely with pill counts than with self-reports or clinician ratings. MEMS-measured adherence was negatively associated with prescription duration and the Brief Psychiatric Rating Scale—Affect Subscale Score. Six-month changes in MEMS-measured adherence were positively associated with attitude toward drugs and negatively associated with weight gain assessed by the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale.ConclusionsClinicians may have to consider the limited accuracy of self-reporting and clinician rating methods and exercise caution when assessing the medication adherence of patients with BD using these methods. Our findings may assist clinicians in the assessment and improvement of medication adherence in patients with BD and, consequently, may be useful for the treatment and prevention of BD recurrence.

Atorvastatin for reduction of 28-day mortality in hospitalized COVID-19 patients: study protocol for a randomized, double-blinded, placebo-controlled, clinical trial

BackgroundAlthough mass vaccination has reduced the severity of COVID-19, mortality is still high among hospitalized patients. Being a sepsis-like disease, an anti-inflammatory drug as atorvastatin would reduce mortality and severity in COVID-19.MethodsWe designed a randomized clinical trial that recruited 220 COVID-19 patients admitted in the COVID-19 isolation hospital at Mansoura University, Egypt. One hundred ten cases were assigned to receive 40 mg atorvastatin once daily for 28 days, and 110 were assigned to receive placebo. Delta Pharm company supported the study with the drug and the placebo, which mimics the drug as regards the drug package, the tablet color, consistency, and size. All patients received the standard treatment as per the hospital protocol. The Institutional Review Board approval and the informed consent from all participants were obtained.The primary outcome is the 28-day all-cause mortality. Additionally, we will collect the in-hospital mortality, the need for mechanical ventilation, time to clinical improvement, in-hospital thrombo-embolic events, acute kidney injury, and the hospital and the intensive care duration of stay. We plan to follow the patients up for 6 months for reporting mortality and long-term neurological, psychological, and respiratory consequences.We will report the un-adjusted 28-mortality using χ2. Then, we will report the adjusted odds ratio with a pre-planned multiple logistic regression model. We will report our results using the point estimate and the 95% confidence interval and the P-value.DiscussionThe additional issue that we would like to discuss is the added workload on the clinicians and the allied healthcare workers who performed research at the time of the pandemic. Therefore, doing research at the pandemic era was, indeed, challenging.Trial registrationThe study was registered at the Clinical Trial Registry (NCT04952350) on July 1st, 2021.

Integrating ART adherence support technologies in the care of pregnant and postpartum people with HIV: a qualitative study

BackgroundWe have a limited understanding on how to best integrate technologies to support antiretroviral therapy (ART) adherence in routine HIV care.MethodsWe conducted semi-structured interviews with multidisciplinary providers caring for pregnant and postpartum people with HIV and asked providers about their perspectives on utilizing adherence support technologies such as text messages, video check-ins with providers or automated with facial recognition for directly-observed-therapy, signaling pill bottle, and signaling pill to support ART adherence. Each approach generated an adherence report. The interview instrument was guided by the Consolidated Framework for Implementation Research and included questions on the implementation climate, barriers, and facilitators to the clinical integration of the adherence approach and strategies that could be used to maximize this integration. The order of adherence support technologies was randomized to minimize bias. We used a modified grounded theory to develop the coding structure and two coders applied the codebook to the transcripts after establishing strong inter-rater reliability with 20% of interviews (kappa = 0.82).ResultsBetween March and December 2020, we conducted 26 in-depth, semi-structured interviews with providers who weighed several factors when considering each approach, including the approach’s effect on patient-provider interaction in and outside of the clinic visit, timing for and duration of the approach’s utility, threat of disclosing status, and added burden to providers (e.g., needing to act on generated information) or to patients (e.g., needing to hide the signaling pills, responding to text messages). Providers’ most preferred approach was text-messages, and the least preferred was the signaling pill. Barriers to acceptability varied by approach and included perceived surveillance, violation of privacy, added time demand for providers, potential inaccuracy of the adherence data generated, and negative impact on the patient-provider relationship, particularly if the approach was perceived as coercive. Payers anticipated regulatory hurdles with unfamiliar approaches, particularly the signaling pill and signaling pill bottle. Facilitators included strengthened therapeutic alliance, predictable reminder mechanisms, and options for customization according to patient preference.ConclusionsOur study elucidates barriers and facilitators to integrating technology-based adherence support approaches in clinical care to support adherence of pregnant and postpartum people with HIV.

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