"Identification of Essential Assessment Criteria in Facial Botulinum Toxin Injections".

INTRODUCTION: Facial botulinum toxin injections represent the most commonly performed aesthetic non-surgical procedures by plastic surgeons; however, post-graduate programs remain devoid of objective tools to adequately assess competence in trainees. In this study, the authors employ the Delphi methodology to establish a list of essential assessment criteria in facial botulinum toxin injections. METHODS: A list of 10 suggested criteria was generated through a literature search and in consultation with an expert plastic surgeon. A panel of content experts was selected to which an online survey was administered; skills were ranked for their relevance using a 1-10 Likert scale. Recommendations for additional skills were solicited and survey rounds were repeated until consensus was achieved. The latter was a measure of panelist reliability and assessed using Cronbach α (≥0.8); skills with a rating of 7 or above were taken to be essential. RESULTS: The survey process was successful at achieving consensus following two rounds of survey administration. Twenty-one participants completed the first round representing a response rate of 38%. Percent agreement among the panel was 83% and Cronbach α was computed as 0.78, necessitating further rounds. The response rate in the second round was 90%; one additional skill was added; percent agreement and Cronbach α improved to 88% and 0.87, respectively. CONCLUSION: Nine assessment criteria were identified as essential in facial botulinum toxin injections; these findings provide the groundwork necessary for the development of an objective assessment tool for the more appropriate training of marginalized aesthetic procedures in plastic surgery.

Safe injection practices among anesthesia providers: a scoping review protocol.

OBJECTIVE: The objective of this review is to identify and map literature related to safe injection practices among anesthesia providers in developed nations. The mapped literature will be used to determine if there is sufficient literature available to pose specific questions that can be valuably addressed, through a future systematic review, to reduce the prevalence of unsafe injections. INTRODUCTION: A safe injection is one that does not harm the recipient, does not expose the healthcare worker to avoidable risk, and does not result in waste that is a danger to the community. The literature is replete with examples of disease outbreaks connected to unsafe injections via the misuse of syringes, needles and medications. Many such outbreaks involve unsafe injections by anesthesia providers. INCLUSION CRITERIA: This scoping review will consider any research article or policy document, including unpublished reports, that provides information related to safe injection practices by anesthesia providers in developed nations. METHODS: For studies published in English from 2000, the databases to be searched include Ovid MEDLINE, CINAHL and Google Scholar. The search for unpublished literature will include the websites of anesthesia organizations, the Centers for Disease Control and Prevention, and the National Institutes of Health. Results will be screened by two independent reviewers who will use a standardized tool to independently extract data from each included source. The results of the review will be presented as a map of the data extracted in a tabular form and in a narrative descriptive summary.

Achieving "Zero" Defects for Visible Particles in Injectables.

The reduction of visible particles in injectable products is an important element in the consistent delivery of high-quality parenteral products. An important part of this effort is the control of particles that may emanate from the primary packaging materials. The Parenteral Drug Association (PDA), with the support of the Pharmaceutical Manufacturers Forum (PMF), has undertaken the task of developing test methods to assess the cleanliness of primary packaging components used in the manufacturing of sterile injectable products. Further work is focused on end-to-end analysis of the supply chain to identify additional points where particles may enter the finished product workflow. This includes shipment, receipt, transfer, and fill and finishing operations. This information and appropriate corrective actions and control methods, coupled with appropriate patient risk-based acceptance limits, are intended to provide better and more consistent supply of injectable products that meet current compendial and good manufacturing practice (GMP) expectations. Aligning control limits between supplier and pharmaceutical manufacturers will offer further improvement. This paper describes the formation of a task force to address these needs and current progress to date.LAY ABSTRACT: Visible particles must be controlled in parenteral products. Such particles come from many sources including the primary packaging materials. The Parenteral Drug Association (PDA), with the support of the Pharmaceutical Manufacturers Forum (PMF), has formed a task force to review and improve particle measurement methods and perform an end-to-end analysis of how particles may enter into parenteral products. These activities are intended to lead to more consistent control limits for visible particles and ultimately more consistent supply of high quality injectable products.

Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations.

Visible particulate matter in injectables presents one important question for consideration: "What are the potential implications to the patient?" The risks of visible particulate matter to patient safety have been comprehensively reviewed elsewhere. However, the methods used to assess and characterize the risks have been explained with various degrees of specificity and supporting rationale. To date, the assessment process lacks the necessary consensus to permit a more standardized and consistent approach to evaluate the potential patient risks.The purpose of this commentary is to provide one model that might be used to evaluate the three most relevant factors impacting the risk of injections containing particulate matter: the source of the particle, particle-specific attributes, and characteristics of the intended patient population. Each of these factors is considered with a focus on the more important aspects that might be relevant to imposing untoward risk. The discussion also includes the importance of differentiating the concepts of risk assessment from risk acceptance when establishing criticality levels for product attributes.LAY ABSTRACT: Pharmaceutical products intended for injection or infusion may contain particles that can emanate from different sources. Some particles, such as suspensions, are intended. Others are not, and those particles are the subject of rigorous manufacturing process controls to limit their presence and reject units that might contain visible defects. However, no technology exists that can prevent or eliminate all particles from these products. As a result, comprehensive risk assessments must be conducted to identify the capability of manufacturing systems to limit particles and detect and reject atypical units. An essential component of this strategy includes understanding the potential impact that injected or infused particles might have to a patient receiving these medications. The purpose of this paper is to provide one approach that clinicians might use to conduct that risk assessment by discussing the important aspects of the source of the particle, its characteristics (such as size or composition), and the relevant patient factors such as the illness being treated or other medical conditions that might impact the risk to these patients if particles are injected or infused.

Assessment of safe injection practices in health facilities in Oman.

BACKGROUND: Unsafe injection practices put patients and providers at risk of infectious and noninfectious adverse events. A 2001 Ministry of Health survey on injection practices in Oman indicated that, while overall standards were good, in some areas there was a need for improvement. AIM: We aimed to evaluate injection safety practices to determine whether facilities meet the requirements for practices, equipment, supplies and waste disposal, and to identify unsafe practices. METHODS: We conducted a national cross-sectional survey in 2007 using the World Health Organization tool to evaluate injection safety practices. Using 2-stage cluster sampling, 80 government and 61 private health facilities were randomly selected and evaluated. RESULTS: There was no shortage of injection equipment nor evidence of attempts to sterilize disposable devices. Care providers immediately disposed of the used needle/syringe in sharps containers. Phlebotomy devices were taken from sealed packets in 96% of facilities. In private facilities, 66.3% of the care providers were fully immunized against hepatitis B. Wearing a new pair of gloves for phlebotomy was observed in only 46% of government and 38% of private health facilities. Many health facilities lacked alcohol-based handrub. CONCLUSIONS: Many injection safety aspects were satisfactory. However there are still opportunities for improvement. Actions are required to make alcohol-based handrub and appropriate sharps containers available and to provide hepatitis B vaccine and training to health care workers in all facilities.

Analysis of Particulate Matter in Liquid-Finished Dosage Forms.

Pharmacopeias recognize particulate matter as a common phenomenon. The current regulatory requirements relating to particulate matter in parenterals state that solutions for injections or infusions are clear and "practically" (or "essentially") free from ("readily detectable") particles when examined under defined conditions of illumination. Pharmaceutical companies are required to know their processes and have them under control. In order to control and reduce the potential influx of particulate matter, Novartis Technical Operations in Unterach developed a particle life-cycle program that involved an establishment of a dedicated particle laboratory operating under clean room conditions. The analytical capabilities of this particle laboratory were crucial for the characterization of particles and supported identification of potential sources of particulate matter. After implementing this program and respective actions, product and process understanding significantly improved. This resulted in a decrease of reject rates, AQL (Acceptable Quality Limit) failures, and corresponding batch rejections, thereby increasing the availability of Novartis products from Unterach for the patients. The main objective of this article is to show the detailed particle characterization approach including Quality by Design (QbD), methods, and equipment. Examples from projects and particulate matter investigations are presented.LAY ABSTRACT: Parenteral formulations should not contain particulate matter. However, as external contamination as well as formation of particles during manufacturing cannot be entirely excluded, pharmaceutical companies use visual inspection and AQLs to monitor occurrence of particles. To ensure patient safety, Novartis Technical Operation in Unterach established a particle-free analytical laboratory with a focus on particle characterization and root cause analysis of particle formation. The ultimate goal is to reduce occurrence of particles in formulations altogether, and increase process understanding. The approach toward particle characterization adopted at Novartis Technical Operations in Unterach is presented in the article.

A low-cost transcervical laryngeal injection trainer.

OBJECTIVES/HYPOTHESIS: To develop a low-cost, easy-to-construct model for education in transcervical laryngeal injection techniques. To validate the simulator among both fellowship-trained laryngologists and otolaryngology resident learners. STUDY DESIGN: Survey. METHODS: A transcervical laryngeal injection model was constructed. Fourteen otolaryngology residents used the model to practice vocal fold injection techniques. Survey feedback was obtained from all residents. RESULTS: Most learners agreed or strongly agreed that the simulator was easy to use (93%), was a good method to learn transcervical laryngeal injection technique (79%), improved their confidence with the procedure (78%), and could be applied to patients (72%). One hundred percent of the learners agreed or strongly agreed that they would recommend the simulator to other learners. CONCLUSION: Residents can be taught transcervical laryngeal injection techniques with a low-cost, easily constructed simulator prior to treating patients. This allows for a low-stress environment in which the learner can practice injection techniques. Resident feedback about the transcervical laryngeal injection simulator was very positive, including unanimous recommendation for use in other learners. LEVEL OF EVIDENCE: N/A.

American Medical Society for Sports Medicine (AMSSM) position statement: interventional musculoskeletal ultrasound in sports medicine.

BACKGROUND: The use of diagnostic and interventional ultrasound has significantly increased over the past decade. A majority of the increased utilisation is by non-radiologists. In sports medicine, ultrasound is often used to guide interventions such as aspirations, diagnostic or therapeutic injections, tenotomies, releases and hydrodissections. OBJECTIVE: Critically review the literature related to the accuracy, efficacy and cost-effectiveness of ultrasound-guided injections (USGIs) in major, intermediate and small joints; and soft tissues. DESIGN: Systematic review of the literature. RESULTS: USGIs are more accurate than landmark-guided injections (LMGIs; strength of recommendation taxonomy (SORT) Evidence Rating=A). USGIs are more efficacious than LMGIs (SORT Evidence Rating=B). USGIs are more cost-effective than LMGIs (SORT Evidence Rating=B). Ultrasound guidance is required to perform many new procedures (SORT Evidence Rating=C). CONCLUSIONS: The findings of this position statement indicate there is strong evidence that USGIs are more accurate than LMGI, moderate evidence that they are more efficacious and preliminary evidence that they are more cost-effective. Furthermore, ultrasound-guided (USG) is required to perform many new, advanced procedures and will likely enable the development of innovative USG surgical techniques in the future.

Assessment of the safety of injection practices and injection-related procedures in family health units and centers in Alexandria.

BACKGROUND: The Safe Injection Global Network (SIGN) developed an intervention strategy for reducing overuse of injections and promoting the administration of safe injections. Tool C--Revised is designed to assess the safety of the most common procedures that puncture the skin within health services. OBJECTIVE: The aim of the study was to assess injection safety within the primary healthcare facilities in Alexandria using Tool C--Revised. STUDY SETTING: A total of 45 family health units and centers in Alexandria were selected by proportional allocation from the eight regions of Alexandria. DATA COLLECTION: The Tool C--Revised of the WHO was used for observation of the entire facility, injection practices and injection-related procedures, and sterilization practices. Interview of different health providers and immediate supervisor of injections was carried out. RESULTS: Indicators that reflect risk included: deficiency of alcohol-based hand rub for cleansing hands (13.3%), compliance with hand wash before preparing a procedure (56.9% before injection practices, 61.3% before phlebotomy, and 67.6% before lancet puncture), and wearing a new pair of gloves before new procedures (48.6% before injection practices, 9.7% for phlebotomy, 11.8% for lancet puncture, and 80% for both intravenous injections and infusions). Enough disposable equipment in all facilities for at least 2 weeks dependent on the statement of the average numbers of procedures per week was shown. Only 38% of the providers had received training regarding injection safety in the last 2 years and 62.5% had completed their three doses of hepatitis B vaccine. Only 42.2% of staffs who handled healthcare waste had access to heavy gloves. CONCLUSION: Indicators related to injection and injection-related practices that reflect risk to patients include deficiency of alcohol-based hand rub tools, nonadherence to hand hygiene before preparing an injection, and inadequate adherence to using a clean barrier when opening a glass ampule and use of gloves. Indicators that may reflect risk to patients and providers include inadequate injection safety training and incomplete hepatitis B vaccination of healthcare providers. Indicators that may reflect risk to providers include nonadherence to safety precautions related to injection practices, such as inadequate access to heavy gloves by staff handling healthcare waste.

Injection practices in Nepal: health policymakers' perceptions.

BACKGROUND: The unnecessary and unsafe use of injections is common in developing countries like Nepal. Policymakers have an important role in promoting rational and safe injection use. Hence, the present study was carried out to explore the perception of health policymakers regarding safe injection practice in Nepal. METHODS: An exploratory qualitative study design was used in this study. Key policymakers from both the central and regional level were selected using purposive sampling. A semi-structured questionnaire advocated by the World Health Organization (WHO) was used after modifying the context. Interviews were conducted to clarify doubts and obtain additional information. The data was analyzed manually using deductive content analysis technique. RESULTS: In total, eleven policymakers participated. All unanimously agreed that injection safety is a problem and seven participants reported that injections are overused. They shared the opinion that injections are administered by various providers, including formal and informal health providers, and also quacks. Almost half the respondents reported that the National Drug Policy discourages injection overuse, while others reported that the policy contains no provisions regarding injection overuse. Most policymakers stated that only single-use disposable injection equipment is used to provide injection, while others thought that sterilizable glass syringe is also used. More than half of the participants believed that the quality of injection equipment available in the Nepalese market is not regulated by any government institution. Almost two-third of the policymakers stated that syringes and needles are not reused, while the rest thought syringes might be reused without sterilization in some parts of the country. Almost half of the respondents stated that illegal commercialization of used syringes exists in Nepal. Almost all respondents thought that health care institutions have a waste management plan, while more than half of them opined that such plans are limited to tertiary care hospitals located in the capital. CONCLUSIONS: The result of this study revealed a divergence of views among policymakers, even among those in the same ministry. Though there has been some effort from the government to increase the safety of injection practices, greater efforts are required, especially with regard to standardization of policies and procedures related to injection practice.

Barriers to utilizing long-acting injectable antipsychotic medications.

BACKGROUND: Long-acting injectable (LAI) antipsychotic medications are superior to their oral equivalents in reducing relapse, yet schizophrenia treatment guidelines favor oral formulations. A minority of eligible patients receive LAI preparations in the United States. The purpose of the present study is to examine barriers faced by psychiatrists in implementing the use of LAI antipsychotics. METHODS: An internet survey sent to Michigan State University-affiliated psychiatrists examined psychiatrists' practice locations and characteristics, access, opinions, and barriers to utilizing LAI antipsychotic medications in patients with schizophrenia. Thirty-six psychiatrists completed the survey. RESULTS: Thirty-three psychiatrists (83%) acknowledged having patients in their practices who would benefit from LAI antipsychotics; however, only 22 (61%) had the capacity to utilize these formulations. Barriers to utilizing LAI antipsychotic medications included: 1) lack of ancillary support at the practice location; 2) personal preference for oral compounds; and 3) limited insurance coverage. Psychiatrists who had the capability of administering LAI antipsychotic compounds were 10 times more likely to utilize them when compared with others who lacked the capacity to do so (9.67% [SD=10] vs 1.43% [SD=3]; df=1; F=8.59; P<.005). CONCLUSIONS: Psychiatrists practicing in Michigan face formidable barriers to utilizing LAI agents. Strategies to mitigate these barriers are reviewed.

Assessment of injection practice in primary health care facilities of Shiraz, Iran.

BACKGROUND: Occupational risk for several bloodborne viruses is attributable to unsafe injection practices. To understand injection frequency and safety, we surveyed injection rates and factors influencing injection prescription in primary health care facilities and associated health clinics in Shiraz, Iran. METHODS: We used both quantitative and qualitative approaches to study the frequency and safety of injections delivered in 27 primary health care facilities. We used observations and 3 data collecting tools. Patterns of 600 general practice physicians' (GPs) prescriptions were also reviewed. In-depth interviews to elicit the factors contributing to injection prescriptions were conducted. RESULTS: The annual per capita injection rate was 3.12. Corticosteroids were prescribed more frequently than antibiotics (P < .001). Knowledge of participants concerning transmission risks for 3 of the most common bloodborne infections (BBIs) was less than 75%. Factors affecting use of injections by GPs included strong patient preference for injections over oral medications and financial benefit for GPs, especially those in private practice settings. CONCLUSION: Frequency of therapeutic injections in the participating facilities in Shiraz was high. Sociocultural factors in the patient community and their beliefs in the effectiveness of injections exerted influence on GP prescribing practices. Programs for appropriate and safe injection practices should target GP and injection providers, as well as patients, informing them about alternative treatments and possible complications of unnecessary and unsafe injections.

Application of propensity scores to estimate the association between government subsidy and injection use in primary health care institutions in China.

BACKGROUND: The problem posed by therapeutic injection is a clinical practice issue that influences health care quality and patient safety. Although sufficient government subsidy was one of the 12 key interventions to promote rational drug use initiated by WHO (World Health Organization), limited information is available about the association between government subsidy and injection use in primary health care institutions. In 2009, National Essential Medicines System (NEMS) was implemented in China. The subsidy policy plays an important role in maintaining primary health care institutions. This study explores the impact of government subsidies on the injection use in primary health care institutions in China. METHODS: 126 primary health institutions were included in this study. Institutions were divided into two groups (intervention and control groups) according to the median GS (General subsidy per personnel). Propensity score matching (PSM) was used to minimize the observed covariate differences in the characteristics of the primary institutions between the two groups. Kappa score was calculated to determine the consistency between the groups. Paired chi-square test and Relative Risk (RR) were calculated to compare the differences in injection use between the groups. RESULTS: Among all the investigated prescriptions, the overall percent of people who received an injection prescribed was 36.96% (n = 12600). PSM showed no significant covariate difference among the 34 groups obtained through this analysis. Kappa score (k = -0.082, p = 0.558) indicated an inconsistency between groups and paired chi-square test revealed a significant difference (p < 0.05) in injection use between the two groups. Relative Risk = 0.679 (95%CI [0.485, 0.950]) indicate that high General subsidy per personnel is a protective factor for primary health care institutions to prescribe injections properly. The intervention group obtained a higher possibility of using injection properly. CONCLUSIONS: The overall effect of government subsidy on the use of injection was positively significant. However, the mechanism by which government subsidy influence injection administration remains unclear, and thus requires further study.

Economic and technological drivers of generic sterile injectable drug shortages.

Over the past few years, an increasing number of critically needed medicines have been in short supply. Using economic theory to frame the drug-shortage problem, this paper explores why and how manufacturing-quality problems could combine with other economic and technological factors to result in shortages of generic sterile injectable drugs. The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments. The US Food and Drug Administration's (FDA's) need to use its regulatory flexibility, on behalf of patients, to avoid shortages of medically necessary drugs may further strengthen the incentive to "push the envelope" on quality. These dynamics may have produced a market situation in which quality problems have become sufficiently common and severe to result in drug shortages.

A comprehensive situation assessment of injection practices in primary health care hospitals in Bangladesh.

BACKGROUND: Understanding injection practices is crucial for evidence-based development of intervention initiatives. This study explored the extent of injection use and injection safety practices in primary care hospitals in Bangladesh. METHODS: The study employed both quantitative and qualitative research methods. The methods used were--a retrospective audit of prescriptions (n = 4320), focus group discussions (six with 43 participants), in-depth interviews (n = 38) with a range service providers, and systematic observation of the activities of injection providers (n = 120), waste handlers (n = 48) and hospital facilities (n = 24). Quantitative and qualitative data were assessed with statistical and thematic analysis, respectively, and then combined. RESULTS: As many as 78% of our study sample (n = 4230) received an injection. The most commonly prescribed injections (n = 3354) including antibiotics (78.3%), IV fluids (38.6%), analgesics/pain killers (29.4%), vitamins (26.7%), and anti-histamines (18.5%). Further, 43.7% (n = 1145) of the prescribed antibiotics (n = 2626) were given to treat diarrhea and 42.3% (n = 600) of IV fluids (n = 1295) were used to manage general weakness conditions. Nearly one-third (29.8%; n = 36/120) of injection providers reported needle-stick injuries in the last 6 months with highest incidences in Rajshahi division followed by Dhaka division. Disposal of injection needles, syringes and other materials was not done properly in 83.5% (n = 20/24) of the facilities. Health providers' safety concerns were not addressed properly; only 23% (n = 28/120) of the health providers and 4.2% (n = 2/48) of the waste handlers were fully immunized against Hepatitis B virus. Moreover, 73% (n = 87/120) of the injection providers and 90% (n = 43/48) of the waste handlers were not trained in injection safety practices and infection prevention. Qualitative data further confirmed that both providers and patients preferred injections, believing that they provide quick relief. The doctors' perceived injection use as their prescribing norm that enabled them to prove their professional credibility and to remain popular in a competitive health care market. Additionally, persistent pressure from hospital administration to use up injections before their expiry dates also influenced doctors to prescribe injections regardless of actual indications. CONCLUSIONS: As far as the patients and providers' safety is concerned, this study demonstrated a need for further research exploring the dynamics of injection use and safety in Bangladesh. In a context where a high level of injection use and unsafe practices were reported, immediate prevention initiatives need to be operated through continued intervention efforts and health providers' training in primary care hospitals in Bangladesh.

Estimates of intraclass correlation coefficient and design effect for surveys and cluster randomized trials on injection use in Pakistan and developing countries.

BACKGROUND: To assess injection practices and to test interventions aimed at reducing unsafe injections in developing countries, cluster surveys and cluster randomized trials are needed. The design of cluster-based studies requires estimates of intraclass correlation coefficients that have to be obtained from previous studies. This study presents such estimates. METHODS: Data were derived from a cross-sectional study of injection use and health seeking in Pakistan that used 34 clusters to select 1150 study subjects aged > or =3 months. We analysed variance to separate its components. RESULTS: Most of intraclass correlation coefficients were in the range of 0.01-0.05. For proportion of injections received during last 3 months, mean number of injections received and health seeking during the past 3 months the intraclass correlation coefficients were 0.02, 0.04 and 0.02, respectively. CONCLUSION: These estimates can be useful in designing cluster surveys and cluster randomized trials for injection safety in Pakistan and other developing countries.

'Clean Care is Safer Care': the Global Patient Safety Challenge 2005-2006.

BACKGROUND: Each year the treatment and care of hundreds of millions of patients worldwide is complicated by infections acquired during healthcare. The impact of healthcare-associated infection may imply prolonged stays in hospital, long-term disability, massive additional financial burden, and deaths. ACTION: Patient safety is a global issue that affects both developed and developing countries. In October 2004, the World Health Organization launched the World Alliance for Patient Safety to co-ordinate and accelerate improvements in patient safety internationally. A core element of the Alliance is the identification of a topic to be addressed as a Global Patient Safety Challenge over a two-year cycle. The first topic chosen for 2005-2006 is healthcare-associated infection. PERSPECTIVES: The Challenge aims at implementing several actions to tackle healthcare-associated infections worldwide, regardless of the level of development of healthcare systems and the availability of resources. Implementation strategies include the integration in different healthcare settings of multiple interventions in the areas of blood safety, injection safety, and clinical procedure safety, as well as water, sanitation, and waste management, with the promotion of hand hygiene in healthcare as the cornerstone.