Pharmaceutical Packaging Research Articles

Systematic review of pharmaceutical drugs serialization

The purpose of this paper is to review systematically serialization process evaluation. Generally, pharmaceutical drug serialization is a regulatory compliance adopted by major countries for fighting against pharmaceutical drugs counterfeiting. Since 19th century, the drug counterfeiting is major problem for healthcare industry. Periodically, the regulatory and healthcare agencies are struggling to mitigate the risk of adverse events caused by the counterfeit drugs. The World Health Organization (WHO) has estimated that 4 out of 10 drugs available in poor or under developing countries are potentially adulterated. Ultimately, the drug manufacturers are losing billions of dollars every year due to stolen, diverted and counterfeit drugs. Currently, the regulatory authorities are adopting the stringent guidelines to restrict criminals to supply and divert counterfeit/stolen medicine in the supply chain. Healthcare industry need rigorous regulations and secure traceability technologies to provide safe and genuine drugs to the patients. Basically, the pharmaceutical drug serialization reveals advantages by improving the drug security in supply chain by reducing adverse events and investigations. Further, pharmaceutical drug serialization is based on tracking and tracing technological capabilities which leverage the benefit of tracing individual drug package in supply chain.

Comment on 'Oral ivermectin to treat scabies: a comparison of two different regimens'.

Current guidelines recommended the use of oral ivermectin (taken with food) 200 µg kg–1 as two doses 1-week apart as the first-line treatment option; however, the drug package of the ivermectin formulation recently approved for the Italian market recommends a single dose. In this context, we read with great interest the article recently published by Balestri et al. comparing two regimens of oral ivermectin. Similarly, we performed a retrospective analysis at our Dermatological Clinic of Mycology and Parasitosis and report our results.

A Survey-Based Analysis of the Language of the Prescription Bottles and Instructions for the Medications of Limited English Proficiency Patients.

American Journal of Medical Quality 38(2):p 113-114, March/April 2023. | DOI: 10.1097/JMQ.0000000000000111

Arduino-based Reverse Vending Machine Metal Medicine Packaging Exchange

As technology develops, the use of vending machines also develops. In addition to purchasing food and drinks, it can also be used to exchange medicine packaging for coins. To simplify the exchange process to make it more practical and not to spend a lot of time, a reverse vending machine was built for drug packaging containing metal as input. Collecting data using the method of observation and literature study. This type of research is prototyping because the results obtained are in the form of a prototype. This prototype used 3 buttons in main process. The first stage is pressing button 1 to detect metal, then pressing button 2 to weigh, and button 3 to release coins. The test results obtained from the Arduino-Based Reverse Vending Machine Metal Medicine Packaging Exchange indicate that the prototype is able to be used as a medium of exchange for drug packaging trash containing metal into a medium of exchange in money form. The prototype is able to provide a solution for reducing or managing medical trash which contains metal.

Drug Discoveries and Packaging Challenges

Presently Packaging plays, a significant role for drug discoveries. The process of selecting materials and the type of packaging also offers an opportunity for the Packaging scientist to look for biological delivery choices. Most injectable protein products were supplied in some sort of glass vial, prefilled syringe, cartridge. Those products having high Ph content there is a chance of “delamination “from inner surface of glass vial. With protein-based drugs, the biggest issue is the effect of packaging derivatives on the protein’s three- dimensional and surface structure. These are any effects that relate to denaturation or aggregation of the protein due to oxidation or interactions from contaminants or impurities in the preparation. The potential for these effects needs to be carefully considered in choosing the container and the container closure system to avoid putting patients in jeopardy

Residual contamination in antineoplastic drug packaging.

The handling of antineoplastic drugs should follow strict supervision and safety rules to minimize the occupational exposure risks to professionals involved. The external surface contamination of drug vials is recognized as a health risk. So, our goal was to determine if there is residual contamination on the vials and containers surface of the antineoplastic drugs doxorubicin (DOX) and cyclophosphamide (CP). A cross-sectional study was conducted. Samples were collected using a uniform sampling procedure on the inner surfaces of the packages/boxes and the outer surfaces of the vials. The analyzes were executed by high-performance liquid chromatography/mass spectrometry (UHPLC-MS/MS). A total of 209 samples were analyzed, 66 of CP and 143 of DOX. CP levels were detected in nine samples (13.63%), three were below the lower limit of quantification (LLQ) and the other six had contamination levels ranging from 1.24 to 28.04 ng/filter. DOX levels were detected in 36 samples (25.17%), two were below the LLQ and the others had levels between 1.32 and 664.84 ng/filter. The majority of samples with residual contamination were in vials (80.0%), however, boxes also showed contamination. The results revealed the presence of residual contamination in the vials and packages of CP and DOX drugs. Although the residues found in each sample are small, special care should be taken in the handling and disposal of the antineoplastic drugs. The use of personal protective equipment is fundamental while handling the vials and packaging of cytotoxic drugs.

Revision of precautions for drug package inserts in Japan

Revision of precautions for drug package inserts in Japan

Interaction-aware Drug Package Recommendation via Policy Gradient

Recent years have witnessed the rapid accumulation of massive electronic medical records, which highly support intelligent medical services such as drug recommendation. However, although there are multiple interaction types between drugs, e.g., synergism and antagonism, which can influence the effect of a drug package significantly, prior arts generally neglect the interaction between drugs or consider only a single type of interaction. Moreover, most existing studies generally formulate the problem of package recommendation as getting a personalized scoring function for users, despite the limits of discriminative models to achieve satisfactory performance in practical applications. To this end, in this article, we propose a novel end-to-end Drug Package Generation (DPG) framework, which develops a new generative model for drug package recommendation that considers the interaction effects between drugs that are affected by patient conditions. Specifically, we propose to formulate the drug package generation as a sequence generation process. Along this line, we first initialize the drug interaction graph based on medical records and domain knowledge. Then, we design a novel message-passing neural network to capture the drug interaction, as well as a drug package generator based on a recurrent neural network. In detail, a mask layer is utilized to capture the impact of patient condition, and the deep reinforcement learning technique is leveraged to reduce the dependence on the drug order. Finally, extensive experiments on a real-world dataset from a first-rate hospital demonstrate the effectiveness of our DPG framework compared with several competitive baseline methods.

Validity of donor-reported iron supplementation practices obtained at the time of donation.

Iron supplementation (IS) improves blood donors' iron stores and allows more frequent blood donation. Understanding the accuracy of self-reported IS is helpful for potential application of IS practices to donor eligibility or donation intervals. Successful whole blood and red cell apheresis donors completed a survey at donation on the use of select dietary supplements. Respondents reporting use of either iron pills (IP) or multivitamins (MV) were invited by email to complete a similar follow-up survey 6-8 weeks later and to provide the quantitative iron content of IS by referring the donor to the pill bottle label. Consistency between baseline and follow-up responses was assessed overall and by pill type and demographic variables. Of 2444 donors answering the baseline survey, 40% (978) reported MV or IP at donation, 354 of whom completed the follow-up survey. A majority of survey respondents (56%-61%) reported taking iron across the two surveys, and 21%-24% took MV but were uncertain if their pills contained iron. Of 215 reporting IS at baseline, overall concordance at follow-up was 68% and was higher for donors who were female, ≥50-years old, and taking iron as an iron pill rather than in a multivitamin. Consistency of donor responses may be insufficient for use in guiding donor eligibility. Referring donors to their pill bottles was unsuccessful in improving the high frequency of uncertain responses. Incorporating IS into donor eligibility determinations is a complex endeavor that will benefit from careful planning and from post-implementation monitoring.

Safemedchain — drug counterfeit prevention and recommendation using blockchain and machine learning

Counterfeit drugs are without a doubt becoming a greater hazard to consumers and the pharmaceutical sector. As a result, real-time visibility of drug manufacturing and management is required. The proposed system uses Ethereum blockchain as the main technology. The primary advantage of blockchain technology is that the transactions are maintained in immutable digital ledger format and it may be read easily without jeopardizing the users’ security and privacy. In our proposed system, the admin validates and adds the manufacturers. The manufacturer after registering and logging in can perform tasks like adding the drug and seller list. The seller can place order to the manufacturer which the manufacturer can accept or reject. The seller can update status of order of accepted orders to delivered. The customer can view the order details by entering the serial number on the drug package. Any transaction or exchange that occurs in the network is recorded in the chain. It functions similarly to other networks, but blockchain technology is distinguished by the fact that no data can be removed or altered by anyone in the network. No changes to the network can be made unless it has been validated by all of the network’s authorized users. All the information stored can be read by anybody so to incorporate more security, AES has been used to store data in the blockchain. The use of AES encryption technique distinguishes this system from all the existing implementations. Thus, this makes it easy to trace to the exact point in the supply chain and detect any counterfeit drugs in movement. As an extension to the drug counterfeit prevention system a Drug Recommendation System is also performed using the ensemble model with a combination of Random Forest and Logistic Regression for sentiment analysis training. Furthermore, when compared to the existing Linear SVM model, which has an accuracy of 90.39%, the suggested model has the best accuracy of 93.31%. Using the obtained sentiment for each drug, the drug is predicted accurately for the specified medical condition.

Pharmacoeconomical affordability of antipsychotic drugs for patients with mental disorders in the structure of dementia at the regional level

Objective. To analyze the pharmacoeconomical affordability of antipsychotic drugs (APD) in patients with mental disorders in the structure of dementia at the level of the Gomel region of the Republic of BelarusMaterials and methods. The study used data from the State Register of Medicines of the Republic of Belarus (2022); Clinical Protocol for providing medical care to patients with mental and Behavioral Disorders (2010); website data https://myfin.by about the average pension amount and the minimum subsistence budget of the Gomel region for 2022; data from «State Register of Medicines of the Republic of Belarus» website. For the analysis, the price list for medicines (drugs) of the largest pharmacy chains in Belarus was used, which included the state pharmacies of the Gomel UP «Pharmacy» and commercial pharmacies of the well-known brands in Belarus «ADEL» and «Dobrya Leki». Parameters such as the price affordability of the APD and 4 availability coefficients (Cd) were determined, allowing to correlate the average cost of antipsychotic drugs packaging and the cost of the average daily dose of antipsychotic drugs with the consumer income, as well as the total affordability coefficient (Cd total.).Results. According to all criteria, the most economically affordable drug from the group of typical APD was the generic Haloperidol–Ozone (Ozon, Russia), and the least affordable from the group of atypical ones was the generic Olanzapine (Belmedpreparaty, Republic of Belarus).Conclusion. There is a large selection of APD on the pharmaceutical market of the Gomel region. Generic APD predominate on sale, which are more affordable compared to the original APD. But one should not forget about the advantages of the original drugs – efficiency, safety, innovativeness, reproducibility of the effect and strict quality control, confirmed in clinical trials. However, the genetic drug Olanzapine (Belmedpreparations, RB) is not in any way more superior in terms of affordability, but even inferior to some drugs. This study allowed us to establish that in the Gomel region of the Republic of Belarus, a patient with dementia is provided with a wide choice of APD and the ability to determine the criteria for preference when buying a specific drug.

Labels and package inserts – A study to determine if official guidelines are being followed by pharmaceuticals in India

Background: A package insert is a document within a medication package that provides information about the product. Labels similarly covey information regarding the product but are printed on the packaging rather than separately within. Aims and Objectives: This study aimed to determine whether pharmaceuticals in India adhere to the national guidelines laid down by CDSCO with regards to the packaging and labeling of drugs. Materials and Methods: 100 drugs (labels + package inserts) were collected within duration of 1 month, beginning June 6th, 2023,–July 5th, 2023, from the central drug store of a tertiary care government hospital and nearby pharmacies. After entering pertinent data into a Microsoft Excel sheet, analysis was carried out using descriptive statistics. Results: Most companies (in and around 70%) followed requirements with respect to drug labels barring “warning about the drug” and use of the “red line,” while package inserts showed divisive results, with patient-centric information such as posology, special warnings, and contraindications being followed by more than 80% of the manufacturer’s while taking a backseat with regards to technical details such as shelf life and incompatibilities. Conclusion: Labels and package inserts do largely convey the information that they intend to, with scope for improvement from both companies and regulatory authorities in order to perfect the balance of information conveyed.

The nature of dispensing errors in hospital pharmacy; a systematic review

Medication errors can result in several unfavorable outcomes. Dispensing medication is the fundamental function of pharmaceutical care. Dispensing error is the discrepancy between the prescription and the drug delivered to the patients. The rates of dispensing errors vary in the literature across different countries and settings, and there are several forms and a wide range of dispensing errors as well as various causes. Hence, this review aimed to identify the prevalence, types, and causes of dispensing errors in hospital pharmacy by reviewing the previous studies that investigated this subject. Obtaining eligible articles required exploration of electronic databases, including PubMed, Scopus, Science Direct, Elsevier, Springer, and Google Scholar. The exploration process involved using search terms such as \"Nature, Prevalence, Incidence, Types, Causes, Dispensing errors, Hospital Pharmacy, Hospitals, and Rate\". The inclusion criteria were English original articles reported dispensing errors in hospital pharmacies published after the year 2016. A total of seven studies were included as they met the inclusion criteria. The studies were from six countries with a total number of prescriptions of 66,849. The nature of dispensing errors included prevalence rates, types, and causes of dispensing errors. Dispensing errors in hospital pharmacies are a significant issue that varies between different studies, even hospital settings. The major dispensing errors included labeling errors, content errors, and documentation errors. There were various factors that led to such dispensing errors, including a shift of work, heavy work, similar drug names and packaging, poor handwriting, interruption, a high number of drugs, and quantified drugs.

Disparities in Guideline Concordant Statin Treatment in Individuals With Chronic Obstructive Pulmonary Disease.

Cardiovascular disease (CVD) affects the prognosis of patients with chronic obstructive pulmonary disease (COPD). Black women with COPD have a disproportionate risk of CVD-related mortality, yet disparities in CVD prevention in COPD are unknown. We aimed to identify race-sex differences in the receipt of statin treatment for CVD prevention, and whether these differences were explained by factors influencing health care utilization in the REasons for Geographic And Racial Differences in Stroke (REGARDS) COPD study sub-cohort. We conducted a cross-sectional analysis among REGARDS Medicare beneficiaries with COPD. Our primary outcome was the presence of statin on in-home pill bottle review among individuals with an indication. Prevalence ratios (PR) for statin treatment among race-sex groups compared to White men were estimated using Poisson regression with robust variance. We then adjusted for covariates previously shown to impact health care utilization. Of the 2032 members within the COPD sub-cohort with sufficient data, 1435 participants (19% Black women, 14% Black men, 28% White women, and 39% White men) had a statin indication. All race-sex groups were less likely to receive statins than White men in unadjusted models. After adjusting for covariates that influence health care utilization, Black women (PR 0.76, 95% confidence interval [CI] 0.67 to 0.86) and White women (PR 0.84 95% CI 0.76 to 0.91) remained less likely to be treated compared to White men. All race-sex groups were less likely to receive statin treatment in the REGARDS COPD sub-cohort compared to White men. This difference persisted in women after controlling for individual health care utilization factors, suggesting structural interventions are needed.

Abstract B119: Effect of a smart pill bottle and text messaging-based intervention on medication adherence and side effect management in African American women with breast cancer new to endocrine therapy

Abstract Background For women with hormone receptor-positive breast cancer (BCa), approximately 75-80% of all BCa cases, long-term use of endocrine therapy has been demonstrated to improve disease free survival. However, data reported that non-adherence rates range from 28% to 59%, and African American (AA) women had lower odds of being adherent to endocrine therapy than other racial/ethnic groups, suggesting that medication adherence might be an important level for targeting racial disparities in AA BCa outcomes. Emerging adherence-promoting interventions using technologies to provide at-home medication management support, however, few studies have formally assessed their effects in minority groups. The objective of this study was to evaluate the impact of an interactive text messaging (TXT) intervention and a smart pill bottle (SPB) on adherence to endocrine therapy and symptom management among AA women with early stage BCa. Method This prospective and random assignment study recruited 48 AA women with early stage ER+ or PR+ BCa who completed active treatments and were new to endocrine therapy. Participants were randomized to 1:1: between the txt2adhere and control groups. The txt2adhere group received interactive text messages three times a week, that were culturally tailored addressing barriers on the cognitive, affective interpersonal and symptom levels. The intervention group also received a SPB with light and chimes reminders. The control group received an identical SPB with all alerts deactivated. Patient adherence was calculated by % days adherent over the study time. The study was 3 months and patient-reported outcomes were collected at 1-month, 2-month and 3-month. A post-intervention interview was conducted to understand participant’s satisfaction and feedback. Results Forty-eight women were enrolled with 22 randomized in the txt2adhere group and 26 in the control group; 4 patients in the txt2adhere and 3 in the control were lost of follow up. Participants are in average 57 years old; 71% had an annual household income of $45K and lower; and 67% had a stage I BCa. Overall, the txt2adhere group has a 91% adherence rate at the end of 3-month study compared with 89% in the control group. Post-intervention interviews revealed the utility and feasible of the intervention, areas for TXT content improvement in symptom management such as joint pain and hot flashes were also identified. Conclusion In this study, a culturally-sensitive TXT intervention equipped with a SPB were associated with increased medication adherence, which need to be tested in a fully powered study. This pilot provides preliminary data on the feasibility of adherence technology used in an underserved AA population. Citation Format: Kuang-Yi Wen, Suzanne Miller, Aruna Padmanabhan, Rita Smith, Emmanuel Lapitan, Lori Goldstein. Effect of a smart pill bottle and text messaging-based intervention on medication adherence and side effect management in African American women with breast cancer new to endocrine therapy [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B119.

Design Study of Adjuvant Treatment and Prevention of Chilblain in Children with Ginger

In rural areas of central and Western China, chilblain is a common seasonal skin disease among local children. Its symptoms are mainly skin redness, itching, peeling and even ulceration, which has a negative impact on children's body and psychology. Due to the lack of attention and scientific cognition on the treatment and prevention of chilblain, children with chilblain are prone to serious symptoms and have a high probability of recurrence. This study conducted field investigation and user visits, earnestly considered the multiple needs and scientific basis of users. This study combined with the different characteristics of treatment and prevention and redesigned the primary methods of chilblain disease treatment and the acceptability of various schemes for children in the initial stage of chilblain prevention and treatment. Using the local traditional methods and natural materials, this design tests and improves the treatment methods of local ginger soup and ginger juice smearing. Through the test of children's preferences, the application methods of ointment and the redesign of medicine bottles that can be accepted and used by children are added in the traditional treatment stage, as to design and produce new forms and carriers for chilblain treatment for children, more loved and accepted by children.

Miniaturized and Battery-Free Temperature and Humidity Sensor for Smart Pharmaceutical Packaging

Miniaturized and Battery-Free Temperature and Humidity Sensor for Smart Pharmaceutical Packaging

A Step toward Sustainability: A Review of Biodegradable Packaging in the Pharmaceutical Industry

Abstract In an era marked by a burgeoning environmental crisis, the pharmaceutical industry’s reliance on nonbiodegradable packaging has become a pressing concern. This comprehensive review marks a pioneering effort to examine the entire spectrum of pharmaceutical packaging, from traditional materials to innovative biodegradable alternatives, with an emphasis on the industry’s role in sustainability. Beginning with a detailed investigation into the prevalent materials and their environmental impact, the review unveils a landscape riddled with challenges but ripe with opportunities. By delving into biodegradable packaging technologies, including polylactic acid, polyhydroxyalkanoates, and other biopolymers, we present a cogent roadmap toward an eco-friendly future. Our analysis further extends to the intricate web of regulations, market dynamics, consumer behavior, real-world applications, and critical future directions. The study culminates in a robust set of recommendations that amalgamate scientific innovation with practical strategies, thus setting a precedent for collaborative action. This review stands as a seminal contribution to the field, offering a holistic perspective on an issue central to global sustainability and human well-being. Its findings not only underline the feasibility of transitioning to sustainable packaging within the pharmaceutical industry but also underscore the urgency of this shift. The paper concludes with a resonant call to action, inviting all stakeholders to partake in a collective endeavor that transcends conventional boundaries and illuminates a path toward a greener, healthier world.

Аналіз дефектів маркування фармацевтичних паковань глибоким способом друку

Аналіз дефектів маркування фармацевтичних паковань глибоким способом друку

Дослідження якості маркування фармацевтичних паковань цифровим способом друку

Дослідження якості маркування фармацевтичних паковань цифровим способом друку