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Journal of Oncology Pharmacy Practice :... Dec 2023The handling of antineoplastic drugs should follow strict supervision and safety rules to minimize the occupational exposure risks to professionals involved. The...
INTRODUCTION
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).
METHODS
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).
RESULTS
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.
CONCLUSIONS
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.
Topics: Humans; Tandem Mass Spectrometry; Cross-Sectional Studies; Antineoplastic Agents; Cyclophosphamide; Doxorubicin; Drug Packaging; Occupational Exposure; Equipment Contamination; Environmental Monitoring; Drug Contamination
PubMed: 36659825
DOI: 10.1177/10781552231151693 -
Journal of Pharmaceutical and... Apr 2021Falsified medicines affect public health all around the globe. Complex distribution routes, illegal online webshops and reuse of packaging materials make them hard to... (Review)
Review
Falsified medicines affect public health all around the globe. Complex distribution routes, illegal online webshops and reuse of packaging materials make them hard to detect. In order to tackle this problem, detection methods for the recognition of suspicious medicines and subsequent confirmation of falsification by analytical techniques is required. In this review, we focus on the developments and challenges that existed in the last five years (2015-2020) in the detection and analysis of falsified medicines. These challenges might have not been solved yet or arisen with new types of falsifications, new analytical techniques or detection strategies. Detection of suspicious medicines starts with visual inspection of packaging materials. However, re-use of packaging materials and high-quality imitations complicate visual inspection. Recent developments in the analysis of packaging by microscopic and spectroscopic techniques such as optical microscopy, X-ray fluorescence, infrared spectroscopy and Raman spectroscopy or microscopy, in combination with multivariate analysis show promising results in the detection of falsified medicines. An ongoing big challenge in the analysis of falsified medicines is the affordability of analytical devices. Yet, recent reports showed that lower cost devices, such as Counterfeit Drug Indicator or Counterfeit Detection device version 3 show promising use in the detection of falsified medicines. Furthermore, combining the outcomes of different low-cost analytical techniques, such as Minilab, colorimetry and Counterfeit Drug Indicator significantly increased selectivity and sensitivity in the detection of falsified medicines. Also, recent developments make it possible to link a low-cost technique, such as TLC, to mobile phones. Proper training of personnel has shown room for improvement and remains a challenge, even for relatively simple techniques. With an increased use of analytical fingerprints, an upcoming challenge is the accessibility of the growing pool of data. There is also the need of validated reference libraries on both national and international levels. Developments of the last few years bring us a step closer in the fight against falsified medicines, however challenges remain in the worldwide accessibility of affordable, easily operable and sensitive techniques.
Topics: Counterfeit Drugs; Drug Packaging; Spectrophotometry, Infrared; Spectrum Analysis, Raman
PubMed: 33582458
DOI: 10.1016/j.jpba.2021.113948 -
Forensic Science International. Genetics Jul 2023Forensic laboratories often sample weapons and clip-seal plastic bags (CSPB) used to package illicit material for the purpose of identifying the handler(s). However,...
Forensic laboratories often sample weapons and clip-seal plastic bags (CSPB) used to package illicit material for the purpose of identifying the handler(s). However, there may be other explanations as to how a person's DNA was transferred to such items. This may include an individual storing the item among their personal belongings for somebody else or the item being stored among their belongings without their knowledge. Here we investigate the direct transfer of DNA to knives and CSPB during handling and explore two feasible alternative explanations related to the indirect transfer of DNA to these items in residential environments. The handling of DNA-free items was performed by 10 individuals who were instructed, on separate occasions, to cut a foam board in half and fill a CSPB with a drug substitute. To explore indirect transfer, sets of these items were (a) placed on kitchen benches and coffee/dining tables for ∼1 min, or (b) stored for two days in kitchen and bedroom drawers within the homes of 10 individuals. After each of the three scenarios, samples were collected from the knife handle and blade, the body and seal of the CSPB, and the surface the items were placed on, the latter as a measure to gain insight into the presence of prevalent and/or background DNA. DNA transfer was observed under all three scenarios, though more frequently when items were handled or stored for 2 days, compared to when placed on a surface for ∼1 min. Under the latter scenario, DNA, if present, was below the level of detection in many samples and produced no profile, suggesting that detectable DNA transfer occurs to a lesser degree from static brief contacts. The study results and associated probabilities will assist forensic examiners with their interpretation of case circumstances regarding the transfer and recovery of DNA from these items.
Topics: Humans; Drug Packaging; DNA Fingerprinting; DNA; Weapons; Laboratories
PubMed: 37182457
DOI: 10.1016/j.fsigen.2023.102888 -
The Veterinary Record Feb 2021
Topics: Animals; Drug Labeling; Product Labeling; Veterinary Drugs
PubMed: 34651921
DOI: 10.1002/vetr.159 -
Pain Medicine (Malden, Mass.) Aug 2019
Topics: 2-Propanol; Disinfectants; Drug Packaging; Humans; Infection Control; Practice Guidelines as Topic
PubMed: 31169297
DOI: 10.1093/pm/pnz125 -
Vaccine Jan 2021
Topics: Adenoviridae; Antibodies, Viral; COVID-19; COVID-19 Vaccines; Drug Packaging; Drug Storage; Genetic Vectors; Humans; RNA, Messenger; Vaccine Potency
PubMed: 33339671
DOI: 10.1016/j.vaccine.2020.12.017 -
Journal of Pharmaceutical Sciences Jul 2024Oligonucleotide drug products commercially approved in the US and the EU are reviewed. A total of 20 products that includes 1 aptamer, 12 antisense oligonucleotides... (Review)
Review
Oligonucleotide drug products commercially approved in the US and the EU are reviewed. A total of 20 products that includes 1 aptamer, 12 antisense oligonucleotides (ASOs), 6 small interfering ribonucleic acids (siRNAs), and 1 mixture of single-stranded and double-stranded polydeoxyribonucleotides have been identified. A typical oligonucleotide formulation is composed of an oligonucleotide with buffering agent(s), pH adjusting agents, and a tonicity adjusting agent. All the products are presented as 2.1 - 200 mg/mL solutions at pH between 6 and 8.7. Majority of the products are approved for intravenous (IV) and subcutaneous (SC) routes, with two for intravitreal (IVT), two for intrathecal (IT), and one for intramuscular (IM) routes. The primary packaging includes vials and prefilled syringes (PFS). Products approved for IV and IT administration routes and requiring >1.5 mL dose volumes are supplied in vials, while those approved for SC, IM, and IVT and requiring ≤1.5 mL dose volume are supplied in PFS. Based on the compiled dataset, we propose a generalized starting point for an oligonucleotide formulation during early phase development for IV, SC, and IT administration routes. Overall, we believe this harmonized evaluation and understanding of various oligonucleotide drug product attributes will help derive platform generalizations and allows for accelerated early phase development for first-in-human studies.
Topics: Humans; Oligonucleotides; Oligonucleotides, Antisense; Drug Approval; RNA, Small Interfering; United States; Drug Packaging; Chemistry, Pharmaceutical
PubMed: 38679232
DOI: 10.1016/j.xphs.2024.04.021 -
PDA Journal of Pharmaceutical Science... 2020Elemental impurities in drug products arise from different sources and via a number of different means, including leaching of elemental entities (including the elements... (Review)
Review
Elemental impurities in drug products arise from different sources and via a number of different means, including leaching of elemental entities (including the elements themselves or element-containing compounds) from the drug product's manufacturing or packaging systems. Thus, knowledge about the presence, level, and likelihood of leaching of elements in manufacturing and packaging systems is relevant to understanding how these systems contribute to a drug product's total elemental impurity burden. To that end, this manuscript updates a previous review of available literature on elemental entities in pharmaceutically relevant polymers and the presence of these elemental entities in material extracts and/or drug products. This updated review contains the information that has been published subsequent to the publication of the initial review and considers two questions: (1) What elemental entities are present in the relevant polymers and materials and at what levels are they present? (2) To what extent are these elemental entities leached from these materials under conditions relevant to the manufacturing and storage/distribution of solution drug products? The compiled recent data reaffirms the conclusions drawn from the original review: (1) Elemental entities are present in the materials used to construct packaging and manufacturing systems as these materials either contain these elemental entities as additives or are exposed to the elemental entities during their production. (2) Unless the elemental entities were parts of the materials themselves (e.g., SiO in glass) or intentionally added to the materials (e.g., metal stearates in polymers), their incidental amounts in the materials were generally low. (3) If elemental entities were present in materials and systems, generally only a very small fraction of the total available amount of the entity could be leached under conditions that were relevant to the packaged drug products. Thus, although sources of certain elemental impurities may be ubiquitous in the natural environment, they were not ubiquitous in materials used in pharmaceutical packaging and manufacturing systems and when they were present, they were not extensively leached under relevant conditions of use for those systems. This conclusion, supported by an ever-increasing body of literature, suggests that in general the manufacturing and packaging systems, by themselves, do not contribute sufficiently large quantities of elemental impurities that the impurities pose a meaningful threat to patient safety. Furthermore, this conclusion should be considered when standards are developed for the characterization and qualification of manufacturing systems, packaging systems, and their associated materials and components of construction.
Topics: Drug Contamination; Drug Packaging; Humans; Materials Testing; Pharmaceutical Preparations; Trace Elements
PubMed: 31843988
DOI: 10.5731/pdajpst.2019.010033 -
The Veterinary Record Dec 2020
Topics: Animals; Drug Labeling; Humans; Veterinary Drugs; Veterinary Medicine
PubMed: 33334988
DOI: 10.1136/vr.m4885 -
Yakugaku Zasshi : Journal of the... 2021When taking a drug one must keep in mind certain risks and benefits based on the safety and efficacy information. One of the most reliable sources of information that... (Review)
Review
When taking a drug one must keep in mind certain risks and benefits based on the safety and efficacy information. One of the most reliable sources of information that enables patients to use drugs properly is package inserts, which are regulated under the law and therefore should include valid and accurate contents. With the recent revision of the Pharmaceutical and Medical Device Act, the information contained in the package insert, which was provided together with the drug, will now also be provided electronically and separately from the drug itself. In addition, a digital code will be displayed on the product packaging so that the latest information of the drug can be obtained from outside the package by scanning the code. The more drug information gets shared among healthcare professionals, patients and the public, the less the asymmetry in drug information among them will exist. It is necessary now more than ever to establish a framework and a system to ensure that sufficient information is provided to patients and the public to encourage their proper use of drugs. I believe that it is important for patients and the public to strive for a better understanding of drug information. It is also crucial for all relevant parties involved in drug information to work together on how best to utilize the information. In this way they would keep trying so that therapeutic effects could be maximized and the risks of side effects are minimized.
Topics: Drug Information Services; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Health Personnel; Humans; Information Dissemination; Patients; Safety
PubMed: 33642508
DOI: 10.1248/yakushi.20-00207-2