A site to transform Pubmed publications into these bibliographic reference formats: ADS, BibTeX, EndNote, ISI used by the Web of Knowledge, RIS, MEDLINE, Microsoft's Word 2007 XML.

Monica Adams - Top 30 Publications

An Inter-Company Perspective on Biopharmaceutical Drug Product Robustness Studies.

The BioPhorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share (FPS) group conducted an inter-company collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: 1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; 2) robustness integrates the principles of quality by design (QbD); 3) DP robustness is an important factor in setting critical quality attribute (CQA) control strategies and commercial specifications; 4) most companies employ robustness studies, along with prior knowledge, risk assessments and statistics, to develop the DP design space; 5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product understanding and process knowledge. The BPDG-FPS discusses identified industry challenges with regard to biopharmaceutical DP robustness, and presents some recommendations for best practices.

A High-Throughput Bioluminescent Assay to Monitor the Deamidation of Asparagine and Isomerization of Aspartate Residues in Therapeutic Proteins and Antibodies.

Since the introduction of Herceptin and Rituximab in 1986, therapeutic antibodies have gained tremendous momentum in the treatment of broad range of several diseases such as cancer and inflammation. Selection of the clinical candidate mAb usually starts with large-scale in vitro screening and profiling of multiple mAbs to identify candidates that show high in vitro or in vivo activity, and thus it is necessarily to identify and eliminate potentially unstable mAbs during the lead selection process. Antibodies undergo a variety of degradation reactions that may result in compromised bioactivity and safety profile. The nonenzymatic post-translational modification of both deamidation of asparagine and isomerization of aspartate residues is one of the major chemical reactions occurring in proteins during production and storage resulting in formation of protein variants that may affect the quality, safety, and functionality of the therapeutic proteins. Current methods (HPLC and liquid chromatography and mass spectrometry) for monitoring isoaspartate (isoAsp) formation are time consuming, require specialized equipment and trained personnel, and are not amenable to high-throughput scaling. We have developed a robust, homogenous, high-throughput formatted, and sensitive assay to accurately monitor the formation of isoAsp under several conditions, such as new formulations, storage periods, and temperature.

Particle Characterization for a Protein Drug Product Stored in Pre-Filled Syringes Using Micro-Flow Imaging, Archimedes, and Quartz Crystal Microbalance with Dissipation.

Micro-flow imaging (MFI) has been used for formulation development for analyzing sub-visible particles. Archimedes, a novel technique for analyzing sub-micron particles, has been considered as an orthogonal method to currently existing techniques. This study utilized these two techniques to investigate the effectiveness of polysorbate (PS-80) in mitigating the particle formation of a therapeutic protein formulation stored in silicone oil-coated pre-filled syringes. The results indicated that PS-80 prevented the formation of both protein and silicone oil particles. In the case of protein particles, PS-80 might involve in the interactions with the hydrophobic patches of protein, air bubbles, and the stressed surfaces of silicone oil-coated pre-filled syringes. Such interactions played a role in mitigating the formation of protein particles. Subsequently, quartz crystal microbalance with dissipation (QCM-D) was utilized to characterize the interactions associated with silicone oil, protein, and PS-80 in the solutions. Based on QCM-D results, we proposed that PS-80 likely formed a layer on the interior surfaces of syringes. As a result, the adsorbed PS-80 might block the leakage of silicone oil from the surfaces to solution so that the silicone oil particles were mitigated at the presence of PS-80. Overall, this study demonstrated the necessary of utilizing these three techniques cooperatively in order to better understand the interfacial role of PS-80 in mitigating the formation of protein and silicone oil particles.

A Fluorescence-Based High-Throughput Coupled Enzymatic Assay for Quantitation of Isoaspartate in Proteins and Peptides.

Formation of isoaspartate (IsoAsp) from spontaneous asparagine (Asn) deamidation or aspartate (Asp) isomerization is one of the most common non-enzymatic pathways of chemical degradation of protein and peptide pharmaceuticals. Rapid quantitation of IsoAsp formation can enable rank-ordering of potential drug candidates, mutants, and formulations as well as support shelf life prediction and stability requirements. A coupled enzymatic fluorescence-based IsoAsp assay (CEFIA) was developed as a high-throughput method for quantitation of IsoAsp in peptides and proteins. In this note, application of this method to two therapeutic candidate proteins with distinct structural scaffolds is described. In addition, the results obtained with this method are compared to those from conventional assays.

Travel-Associated Zika Virus Disease Cases Among U.S. Residents--United States, January 2015-February 2016.

Zika virus is an emerging mosquito-borne flavivirus. Recent outbreaks of Zika virus disease in the Pacific Islands and the Region of the Americas have identified new modes of transmission and clinical manifestations, including adverse pregnancy outcomes. However, data on the epidemiology and clinical findings of laboratory-confirmed Zika virus disease remain limited. During January 1, 2015-February 26, 2016, a total of 116 residents of 33 U.S. states and the District of Columbia had laboratory evidence of recent Zika virus infection based on testing performed at CDC. Cases include one congenital infection and 115 persons who reported recent travel to areas with active Zika virus transmission (n = 110) or sexual contact with such a traveler (n = 5). All 115 patients had clinical illness, with the most common signs and symptoms being rash (98%; n = 113), fever (82%; 94), and arthralgia (66%; 76). Health care providers should educate patients, particularly pregnant women, about the risks for, and measures to prevent, infection with Zika virus and other mosquito-borne viruses. Zika virus disease should be considered in patients with acute onset of fever, rash, arthralgia, or conjunctivitis, who traveled to areas with ongoing Zika virus transmission ( or who had unprotected sex with a person who traveled to one of those areas and developed compatible symptoms within 2 weeks of returning.

Dehydration and Stabilization of a Reactive Tertiary Hydroxyl Group in Solid Oral Dosage Forms of BMS-779788.

BMS-779788 contains a reactive tertiary hydroxyl attached to a weakly basic imidazole ring. Propensity of the carbinol toward dehydration to yield the corresponding alkene, BMS-779788-ALK, was evaluated. Elevated levels of BMS-779788-ALK were observed in excipient compatibility samples. Stability studies revealed that BMS-779788 degrades to BMS-779788-ALK in capsules and tablets prepared by both dry and wet granulation processes. An acid-catalyzed dehydration mechanism, in which the heterocyclic core contributes resonance stability to the cationic intermediate via charge transfer to the imidazole ring, was proposed. Therefore, neutralization via a buffered (pH 7.0) granulating solution was used to mitigate dehydration. Solution studies revealed degradation of BMS-779788 to BMS-779788-ALK over the pH range of 1-7.5. Reversibility was confirmed by initiating reactions with BMS-779788-ALK over the same pH range. Accordingly, a simple reversible scheme can be used to describe reactions initiated with either BMS-779788 or BMS-779788-ALK. To eliminate potential for charge delocalization across the heterocycle and probe the degradation mechanism, the imidazole ring of BMS-779788 was methylated (BMS-779788-Me). The propensity for acid-catalyzed dehydration was then evaluated. The acid stability of BMS-779788-Me confirmed that the heterocyclic core contributes to reactivity liability of the tertiary hydroxyl.

An Approach to Mitigate Particle Formation on the Dilution of a Monoclonal Antibody Drug Product in an IV Administration Fluid.

To support dose reduction, low dose of a monoclonal antibody (mAb) was required to be administered via IV infusion at a concentration of 0.1 mg/mL. To achieve the target protein concentration, the infusion solution was prepared by diluting the drug product containing 10-mg/mL mAb with normal saline, a 0.9% sodium chloride injection solution. However, particles were observed in the diluted solution. Particle formation must be avoided to administer the low dose using the existing drug product. To mitigate the particle formation, an unconventional compounding approach was used. With this approach, a stabilizing vehicle containing polysorbate-80 was added to saline before drug-product dilution to maintain suitable surfactant level to prevent precipitation of the mAb. In this way, use of the stabilizing vehicle to support low doses ensured suitable quality across a wider range of mAb concentrations, thereby allowing additional flexibility to the clinical trial. Such an approach may be useful for broader application in early-stage clinical trials where there is an uncertainty regarding doses or the need to revise to lower doses based on clinical observations or other drivers.

A Road Map to Address the Social Determinants of Health Through Community Collaboration.

Economic, environmental, and psychosocial needs are common and wide-ranging among families cared for in primary care settings. Still, pediatric care delivery models are not set up to systematically address these fundamental risks to health. We offer a roadmap to help structure primary care approaches to these needs through the development of comprehensive and effective collaborations between the primary care setting and community partners. We use Maslow's Hierarchy of Needs as a well-recognized conceptual model to organize, prioritize, and determine appropriate interventions that can be adapted to both small and large practices. Specifically, collaborations with community organizations expert in addressing issues commonly encountered in primary care centers can be designed and executed in a phased manner: (1) build the case for action through a family-centered risk assessment, (2) organize and prioritize risks and interventions, (3) develop and sustain interventions, and (4) operationalize interventions in the clinical setting. This phased approach to collaboration also includes shared vision, codeveloped plans for implementation and evaluation, resource alignment, joint reflection and adaptation, and shared decisions regarding next steps. Training, electronic health record integration, refinement by using quality improvement methods, and innovative use of clinical space are important components that may be useful in a variety of clinical settings. Successful examples highlight how clinical-community partnerships can help to systematically address a hierarchy of needs for children and families. Pediatricians and community partners can collaborate to improve the well-being of at-risk children by leveraging their respective strengths and shared vision for healthy families.

Investigating the Degradation Behaviors of a Therapeutic Monoclonal Antibody Associated with pH and Buffer Species.

This study aimed in understanding the degradation behaviors of an IgG 1 subtype therapeutic monoclonal antibody A (mAb-A) associated with pH and buffer species. The information obtained in this study can augment conventional, stability-based screening paradigms by providing the direction necessary for efficient experimental design. Differential scanning calorimetry (DSC) was used for studying conformational stability. Dynamic light scattering (DLS) was utilized to generate B 22*, a modified second virial coefficient for the character of protein-protein interaction. Size-exclusion chromatography (SEC) and hydrophobic interaction chromatography (HIC) were employed to separate degradation products. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) was used for determining the molecular size and liquid chromatography mass spectrometry (LC-MS) were used for identifying the sequence of the separated fragments. The results showed that both pH and buffer species played the roles in controlling the degradation behaviors of mAb-A, but the pH was more significant. In particular, pH 4.5 induced additional thermal transition peaks occurring at a low temperature compared with pH 6.5. A continual temperature-stress study illustrated that the additional thermal transition peaks related to the least stable structure and a greater fragmentation. Although mAb-A showed the comparable conformational structures and an identical amount of aggregates at time zero between the different types of buffer species at pH 6.5, the aggregation formation rate showed a buffer species-dependent discrepancy over a temperature-stress period. It was found that the levels of aggregations associated with the magnitudes of protein-protein interaction forces.

Ebola infection control in Sierra Leonean health clinics: A large cross-agency cooperative project.

The Ebola virus disease outbreak occurring in West Africa has resulted in at least 199 cases of Ebola in Sierra Leonean health care workers, many as a result of transmission occurring in health facilities. The Ministry of Health and Sanitation of Sierra Leone recognized that improvements in infection prevention and control (IPC) were necessary at all levels of health care delivery. To this end, the U.S. Centers for Disease Control and Prevention, United Nations Children's Fund, and multiple nongovernmental organizations implemented a national IPC training program in 1,200 peripheral health units (PHUs) in Sierra Leone. A tiered training of trainers program was used. Trainers conducted multiday trainings at PHUs and coordinated the delivery of personal protective equipment (gloves, gowns, masks, boots) and infection control supplies (chlorine, buckets, disposable rags, etc) to all PHU staff. Under the ongoing project, 4,264 health workers have already been trained, and 98% of PHUs have received their first shipment of supplies.

Support services for survivors of ebola virus disease - Sierra Leone, 2014.

As of December 6, 2014, Sierra Leone reported 6,317 laboratory-confirmed cases of Ebola virus disease (Ebola), the highest number of reported cases in the current West Africa epidemic. The Sierra Leone Ministry of Health and Sanitation reported that as of December 6, 2014, there were 1,181 persons who had survived and were discharged. Survivors from previous Ebola outbreaks have reported major barriers to resuming normal lives after release from treatment, such as emotional distress, health issues, loss of possessions, and difficulty regaining their livelihoods. In August 2014, a knowledge, attitude, and practice survey regarding the Ebola outbreak in Sierra Leone, administered by a consortium of partners that included the Ministry of Health and Sanitation, UNICEF, CDC, and a local nongovernmental organization, Focus 1000, found that 96% of the general population respondents reported some discriminatory attitude towards persons with suspected or known Ebola. Access to increased psychosocial support, provision of goods, and family and community reunification programs might reduce these barriers. Survivors also have unique potential to contribute to the Ebola response, particularly because survivors might have some immunity to the same virus strain. In previous outbreaks, survivors served as burial team members, contact tracers, and community educators promoting messages that seeking treatment improves the chances for survival and that persons who survived Ebola can help their communities. As caregivers in Ebola treatment units, survivors have encouraged patients to stay hydrated and eat and inspired them to believe that they, too, can survive. Survivors regaining livelihood through participation in the response might offset the stigma associated with Ebola.

Rapid assessment of Ebola infection prevention and control needs--six districts, Sierra Leone, October 2014.

As of October 31, 2014, the Sierra Leone Ministry of Health and Sanitation had reported 3,854 laboratory-confirmed cases of Ebola virus disease (Ebola) since the outbreak began in May 2014; 199 (5.2%) of these cases were among health care workers. Ebola infection prevention and control (IPC) measures are essential to interrupt Ebola virus transmission and protect the health workforce, a population that is disproportionately affected by Ebola because of its increased risk of exposure yet is essential to patient care required for outbreak control and maintenance of the country's health system at large. To rapidly identify existing IPC resources and high priority outbreak response needs, an assessment by CDC Ebola Response Team members was conducted in six of the 14 districts in Sierra Leone, consisting of health facility observations and structured interviews with key informants in facilities and government district health management offices. Health system gaps were identified in all six districts, including shortages or absence of trained health care staff, personal protective equipment (PPE), safe patient transport, and standardized IPC protocols. Based on rapid assessment findings and key stakeholder input, priority IPC actions were recommended. Progress has since been made in developing standard operating procedures, increasing laboratory and Ebola treatment capacity and training the health workforce. However, further system strengthening is needed. In particular, a successful Ebola outbreak response in Sierra Leone will require an increase in coordinated and comprehensive district-level IPC support to prevent ongoing Ebola virus transmission in household, patient transport, and health facility settings.

Utilization of Zwitterion-based solutions to dissect the relative effects of solution pH and ionic strength on the aggregation behavior and conformational stability of a fusion protein.

Solution pH and ionic strength (I) have complex effects on protein stability. We developed an experimental approach based on exploitation of the zwitterionic characteristic of amino acid molecules to probe the relative contribution from each. A variety of types of amino acid solutions were adopted to investigate the effects of pH and I in a manner that allows independent evaluation of each factor. The same effect could not be achieved using conventional buffer solutions. Size-exclusion chromatography, capillary differential scanning calorimetry, and fluorescence spectroscopy were utilized to probe the protein aggregation and conformation. The results suggested that, in addition to pH, solution ionic strength as a function of ionization state of the amino acid molecules and the ions introduced by pH adjustment played an important role in the aggregation and conformation of the protein studied. This experimental approach offers a useful tool to aid fundamental understanding of the relative effects of solution pH and ionic strength on protein stability.

Sensitive fluorescence-based method for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody products.

Abstract A sensitive and effective method has been developed for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) products. The method is based on the detection of the fluorescence emission of 4,4'-dianilino-1,1'-binaphthyl-5,5'-disulfonic acid dipotassium salt (bis-ANS) enhanced by the presence of polysorbate-80. The developed method includes two approaches. One requires removal of the mAb from solution prior to analysis, while the other requires only simple sample dilution. The limits of detection and quantitation, calculated from the calibration curve generated in the absence of mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable linear range and linearity of the linear line between the solutions, with or without mAb, the limit of detection and quantitation is assumed to be similar. The dilution method is not only fast and simple in terms of sample preparation, but it is also particularly useful for analyzing the level of polysorbate-80 contained in highly concentrated mAb products. However, given that this method does require availability of polysorbate-80-free materials of mAb for preparation of calibration standards, the protein removal method may be useful for the cases where appropriate protein materials for standard preparation are limited or unavailable.

Orthogonal high-throughput thermal scanning method for rank ordering protein formulations.

A high-throughput thermal-scanning method to rank-order formulation conditions for therapeutic proteins is described. Apparent transition temperatures for unfolding and aggregation of four different proteins are determined using the dyes SYPRO Orange and thioflavin T (ThT) under a variety of buffer conditions. The results indicate that the ThT-based thermal scanning method offers several advantages over the previously described SYPRO Orange-based thermal scanning and allows rapid rank ordering of solution conditions relevant toward long-term storage of therapeutic molecules. The method is also amenable to high protein concentration and does not require sample dilution or extensive preparation. Additionally, this parallel use of SYPRO Orange and ThT can be readily applied to the screening of mutants for their unfolding and aggregation propensities.

Exploration of the link between tobacco retailers in school neighborhoods and student smoking.

School smoking bans give officials the authority to provide a smoke-free environment, but enacting policies within the school walls is just one step in comprehensive tobacco prevention among students. It is necessary to investigate factors beyond the school campus and into the neighborhoods that surround schools. The purpose of this study was to explore the relationship between the density of tobacco retailers and the illegal tobacco sales rate within school neighborhoods and smoking behaviors among students.

Investigation of freeze/thaw-related quality attributes of a liquid biopharmaceutical formulation: the role of saccharide excipients.

Saccharides, including sucrose, trehalose, mannitol, and sorbitol, are commonly employed as stabilizers, cryoprotectants, and/or tonicity adjusters in protein formulations. During the thawing of a protein-containing formulated bulk drug substance conducted prior to a drug product (DP) filling operation, a white, crystalline precipitate was observed. In addition, upon thawing, vial breakage was observed for filled DP that had been previously frozen at -40 °C. To investigate the causes of both phenomena, the freeze/thaw behavior of the formulation components was studied. Multiple physical characterization techniques, including differential scanning calorimetry (DSC), electrical resistance measurements, thermomechanical analysis (TMA), and powder X-ray diffraction (PXRD), were utilized to characterize the formulations. The PXRD pattern of precipitate collected from thawed bulk was consistent with that of a mannitol control. An exothermic transition observed by DSC, a sharp increase in electrical resistance detected via resistivity measurements, and the onset of volumetric expansion of the frozen matrix evident in the TMA curve offer evidence that the frozen mannitol solution undergoes transitions at or near the vial breakage temperature (-22 to -23 °C) observed during warming. In addition, osmolality measurements taken from fractionated aliquots of frozen samples indicated that non-uniform concentration gradients contributed to precipitation of mannitol observed at larger scales. Small-scale laboratory experiments (i.e., 10-125 mL) failed to adequately predict behavior at larger scale (i.e., in 1 L and 2 L bottles). Upon linking the detrimental behavior to the freeze/thaw properties of the tonicity adjustor, mannitol, alternative saccharide excipients, including sorbitol, sucrose, and trehalose, were evaluated at isotonic concentrations over a temperature range of -80 to 25 °C using physical-chemical techniques and visual observation. Neither precipitation nor vial breakage was observed for the alternate saccharides. Recommendations for saccharide selection are provided based on storage conditions and scale considerations for liquid biopharmaceutical formulations.

Investigation into stability of poly(vinyl alcohol)-based Opadry® II films.

Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry® II 85F was used as the model PVA-based coating formulation. The additives and impurities were incorporated into the polymer suspension prior to film casting. Control and test films were analyzed before and after exposure to 40°C/75% relative humidity. Tests included film disintegration, size-exclusion chromatography, thermal analysis, and microscopy. Under stressed conditions, acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH(4)HSO(4))) negatively impacted Opadry® II 85F film disintegration while NaOH, formaldehyde, and peroxide did not. Absence of PVA species from the disintegration media corresponded to an increase in crystallinity of PVA for reacted films containing HCl. Films with NH(4)HSO(4) exhibited slower rate of reactivity and less elevation in melting temperature with no clear change in melting enthalpy. Acidic additives posed greater risk of compromise in disintegration of PVA-based coatings than alkaline or common impurities. The mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs. NH(4)HSO(4)) may be different.

Scale considerations for selection of saccharide excipients for liquid formulations.

Colloidal phase behavior of pH-responsive, amphiphilic PEGylated poly(carboxylic acid)s and effect on kinetic solubility under acidic conditions.

PEGylated poly(carboxylic acid)s, PEG-b-PCAs, were evaluated as additives for solubilized oral formulations of weakly acidic compounds. Micelles of poly(ethylene glycol)-block-poly(acrylic acid), PEG-b-PAA, and poly(ethylene glycol)-block-poly(methacrylic acid), PEG-b-PMAA, were prepared. Fluorescence spectroscopy and dynamic light scattering revealed that both polymers assemble into nanoscopic structures (< 200 nm) in acidic media and exhibit pH-sensitive colloidal phase behavior. Using a solvent evaporation technique, the block copolymers and corresponding PCA homopolymers were incorporated into PEG3350-based solid dispersions. The kinetic solubility profile of a BMS compound, BMS-A (Seq ~ 12.5 μg/mL at pH 1.1) in 0.1 N HCl was monitored as a function of polymer composition. While BMS-A precipitated rapidly in 0.1 N HCl in the absence of PEG-b-PCAs, a supersaturated level of ca. 400 μg/mL was maintained for variable lengths of time in the presence of PEG-b-PCAs. Although the kinetic solubility of BMS-A was also enhanced in the presence of the PCA homopolymers, the relative magnitude and duration of supersaturation as a function of polymer composition suggests that micellar solubilization, rather than specific interaction, contributes to enhanced solubility of BMS-A in 0.1 N HCl. Under acidic conditions, pH-responsive PEG-b-PCAs may offer the kinetic supersaturation necessary to minimize precipitation of compounds which have limited solubility in acidic milieu.

Cracking Down On Youth Tobacco May Influence Drug Use.

This study evaluated the influence of tobacco Possession-Use-Purchase (PUP) law enforcement and illicit drug use and offers. Twenty-four towns were randomly assigned into two conditions. Both conditions focused on reducing minors' access to commercial sources of tobacco. The communities assigned to the experimental condition also increased their PUP law enforcement, whereas among communities in the control condition, PUP law enforcement remained at low levels. A Hierarchical Linear Modeling analytical approach was selected due to the multilevel data and nested design. The likelihood of a child currently using drugs, ever having used drugs, or illicit drug offers was lower in the experimental versus control conditions. These outcomes suggest that police efforts to reduce specific substance use behaviors (i.e., underage tobacco use) may have a positive spillover effect and help reduce teen drug use and illicit drug offers.

Youth tobacco access and possession policy interventions: effects on observed and perceived tobacco use.

This study evaluated the effects of tobacco Purchase, Use and Possession (PUP) laws on student perceptions of adolescent tobacco use within towns and schools. Twenty-four towns were randomly assigned into two conditions, the experimental condition (E PUP) involved efforts to increase both PUP law enforcement and reduce minors' access to commercial sources of tobacco, whereas the control condition (C) focused only on efforts to reduce minors' access to commercial sources of tobacco. A hierarchical linear modeling analytical approach was selected due to the multilevel data and nested design. The present study found that over time, youth in the experimental PUP condition observed less youth tobacco usage at school and in their town, and perceived lower rates of tobacco among their peers at school and among friends than youth in the control condition. The findings suggest that PUP law enforcement might be used to strengthen community norms against youth tobacco use.

Effects of youth tobacco access and possession policy interventions on heavy adolescent smokers.

This study evaluated the effects of tobacco PUP (Purchase, Use and Possession) laws on tobacco use patterns among students in twenty-four towns, which were randomly assigned into an experimental and a control group. The experimental group involved both PUP law enforcement and reducing minors' access to commercial sources of tobacco, and the condition for the control group involved only efforts to reduce minors' access to commercial sources of tobacco. The present study found that adolescents in the control group had a significantly greater increase in the percentage of youth who smoked 20 or more cigarettes per day when compared to the experimental group.

Youth smoking status: perceptions versus measurements.

To determine whether youths who have smoked cigarettes in the past 30 days perceive themselves as smokers.

The relationship between school policies and youth tobacco use.

The school setting is frequently used both to educate youth about risks involved in tobacco use and to implement tobacco prevention and cessation programs. Given that school-based programs have resulted in limited success, it is necessary to identify other setting-level intervention strategies. School tobacco policies represent a type of universal intervention that might have some promise for preventing or reducing tobacco use.

Assessing police community readiness to work on youth access and possession of tobacco.

Researchers are only beginning to investigate how to measure a community's readiness to engage in an intervention. In this study, we investigated the readiness of police departments to deal with tobacco policies about youth access to tobacco and youth possession of tobacco. Police officers in 24 towns completed structured interviews designed to assess each police department's community readiness to enforce tobacco sales and possession laws. Community readiness ratings were compared to outcome measures in the community, such as tobacco sales and possession enforcement activity, youth knowledge of such activities, and youth reports of smoking history. Higher readiness ratings on the youth tobacco possession enforcement scale was related to higher youth possession citation rates, higher number of youth reporting knowing someone who received a possession ticket, and a smaller number of youth reporting seeing minors smoking in their community. Youth in communities with higher possession readiness ratings in Efforts and Knowledge Regarding the Efforts had lower reports of youth reporting ever having smoked. Higher readiness ratings in the Leadership dimension of tobacco sales enforcement was related to lower tobacco commercial sales rates in the community. Higher tobacco sales readiness ratings in the Efforts, Knowledge Regarding the Efforts, and Knowledge Regarding the Problem dimensions were related to a lower number of youth reporting ever having smoked. The implications of these findings are discussed.

A randomized trial evaluating tobacco possession-use-purchase laws in the USA.

Tobacco Purchase-Use-Possession laws (PUP) are being implemented throughout the US, but it is still unclear whether they are effective in reducing smoking prevalence among the youth targeted by these public health policies. In the present study, 24 towns in Northern Illinois were randomly assigned to one of two conditions. One condition involved reducing commercial sources of youth access to tobacco (Control), whereas the second involved both reducing commercial sources of youth access to tobacco as well as fining minors for possessing or using tobacco (Experimental). Students in 24 towns in Northern Illinois in the United States completed a 74 item self-report survey in 2002, 2003, 2004 and 2005. At the start of the study, students were in grades 7-10. During each time period, students were classified as current smokers or nonsmokers (i.e., completely abstinent for the 30 consecutive days prior to assessment). The analyses included 25,404 different students and 50,725 assessments over the four time periods. A hierarchical linear modeling analytical approach was selected due to the multilevel data (i.e., town-level variables and individual-level variables), and nested design of sampling of youth within towns. Findings indicated that the rates of current smoking were not significantly different between the two conditions at baseline, but over time, rates increased significantly less quickly for adolescents in Experimental than those in Control towns. The implications of these findings are discussed.

Do fines for violating possession-use-purchase laws reduce youth tobacco use?

The present brief report followed children exposed to consequences for violating Purchase, Use, and Possession (PUP) laws over time to assess changes in their smoking status. Youth in 24 towns were surveyed once a year for 3 years, and rates of tobacco use for those fined for PUP law violations were assessed. Of those who were given a ticket for a PUP law violation, 35 (39%) reported not smoking during year 1. Students in grade 7 were more likely to have quit smoking (84%) than those in grade 8 (35%), grade 9 (32%), or grade 10 (21%). For the two follow-up years, 45% and 41% reported not smoking. Assuming those who attrited were smokers, it is possible that about 15% to 24% of the original sample of children cited actually quit smoking over the follow-up period. The implications of these findings are discussed.

Youth caught in violation of tobacco purchase, use, and possession laws: education versus fines.

Each day, thousands of children are caught for violation of tobacco purchase, use, and possession (PUP) laws. Little is known about their impact on violators; we do not know how the youth who are caught perceive these consequences or the effects they have on their tobacco use. Moreover, many communities are beginning to use brief tobacco education programs as a diversion from the normal processing of PUP law violators (i.e., fining the youth violator) without knowing the consequences of these classes. Consequently, it is important to review the literature and studies that have evaluated the effects of civic fines versus tobacco education as a consequence for PUP law violations. A consolidation of this information along with a presentation of pilot data on this issue might suggest areas of needed future research as well as help policy officials make decisions about best practices in their communities regarding these types of laws.

Strengthening communities' youth access policies may facilitate clean indoor air action.