In 1999, an Utstein Template for Uniform Reporting of Data following Major Trauma was published. Few papers have since been published based on that template, reflecting a lack of international consensus on its feasibility and use. The aim of the present revision was to further develop the Utstein Template, particularly with a major reduction in the number of core data variables and the addition of more precise definitions of data variables. In addition, we wanted to define a set of inclusion and exclusion criteria that will facilitate uniform comparison of trauma cases.Over a ten-month period, selected experts from major European trauma registries and organisations carried out an Utstein consensus process based on a modified nominal group technique.The expert panel concluded that a New Injury Severity Score > 15 should be used as a single inclusion criterion, and five exclusion criteria were also selected. Thirty-five precisely defined core data variables were agreed upon, with further division into core data for Predictive models, System Characteristic Descriptors and for Process Mapping.Through a structured consensus process, the Utstein Template for Uniform Reporting of Data following Major Trauma has been revised. This revision will enhance national and international comparisons of trauma systems, and will form the basis for improved prediction models in trauma care. To permit data collection and statistics on major trauma care, in 1999 a working group from the International Trauma Anaesthesia and Critical Care Society (ITACCS) published a recommendation for the Utstein Template for Uniform Reporting of Data following Major Trauma ,3. This Due to the practical difficulties with performing randomised controlled trials in severe trauma cases, valid scientific evidence is often lacking. Systematic prospective registry-based data collection for documenting trauma care is performed by several local, regional and national trauma registries. However, such registries cannot replace randomised clinical trials, but allow for exploration of relationships present in the collected data. The primary aims of these trauma registries are to enable comparative analyses of trauma care and outcome to provide quality improvement and optimal care of the injured patients . The devOver the last two decades, the Trauma and Injury Severity Score (TRISS) method ,8, with In Europe, the UK Trauma Audit and Research Network (TARN) , along wDespite significant efforts ,5, compaThis revision of the Utstein template is based on a nominal group technique (NGT) process ,35 modifThe expert panel was comprised of those individuals who were central to developing and managing the largest European trauma registries; the panel included clinicians, database managers and epidemiology experts.A data variable should be unambiguously defined (with no misinterpretations) and reasonably simple to register. To meet this requirement, a data variable dictionary should contain information on 'data point number,' 'data point name,' 'descriptive field name,' 'type of data,' 'data point category/value,' 'definition of data point,' 'source of data information' and 'coding guidance.' We based recommended guidelines for data variable definitions on existing trauma registry databases, the Utstein Template for Uniform Reporting of Data following Major Trauma , the US A registry should differentiate between data variables that absolutely need to be collected (core data) and the type of additional data that may be desirable  ,37. The The predictive model is composed of patient and injury severity variables that are considered to be important for outcome prediction. Predictive models are not determinative; rather, they provide the probability of an outcome for a given patient . ComplexData variables in the System Characteristic Descriptor group describe trauma systems. Within Europe, there are large differences in philosophies and structures of trauma care systems, and these data variables should indicate key differences between systems and permit comparisons of the effect of system structure on outcomes.Process mapping variables are intended to describe trauma care at an individual trauma centre ; these are used for documentation of the patient journey, care process and care activities.At present, many trauma registries have difficulty in obtaining data for patients from all involved hospitals when patients are transferred between them; therefore, the expert panel based their consensus on the premise that the core dataset was intended to cover the main hospital where a patient is treated. However, the expert group recommended that all trauma registries develop methods to track patients through the trauma system and that both the primary  trauma hospital and the referral trauma hospital record the same set of core data variables. The introduction of a core outcome data variable will secure that the overall effect of the entire trauma system can be measured, even if part of the patient's treatment course is not recorded in detail.The modified NGT process consisted of four steps. First, each expert was supplied with necessary background documents Table , and askThe expert panel concluded that a New Injury Severity Score  (NISS) >NISS is a modification of the Injury Severity Score (ISS) method . ISS is Using NISS > 15 as a single inclusion criterion will include some patients that are at high risk of confounding data analysis. To remove such patients from the analysis, a set of exclusion criteria was defined. The expert panel recommended excluding first hospital admissions more than 24 hours after the injury , patients declared dead before hospital arrival, or those with no signs of life   upon hosPre-hospital deaths should be excluded for practical reasons, since in some countries patients declared dead in the pre-hospital setting are transported directly to the morgue; whereas in other countries, they are admitted to hospital. All patients who arrive in the ED with spontaneous circulation should be included, even if they have had a period of cardiac arrest before being admitted or if they die in the ED.Asphyxia, drowning and burns are sufficiently different from blunt and penetrating injuries to require other datasets, and need to be considered separately. The UK National Burn Injury Database  is curreAge is an independent predictor of survival after trauma ,54. WhilGender is recommended as a core data, since some studies have reported no association between gender and mortality after traumatic injury ; whereasAn evaluation of type of injury (blunt versus penetrating trauma) is useful for determining which patients are candidates for surgical haemostasis , and is The significance of the mechanism of injury (MOI) in prediction of trauma and outcome is, to a large extent, undetermined . The MOIIn the ICD, most injuries can be grouped into two dimensions: intent and mechanism . 'IntentThe presence of significant co-morbidity represents an independent predictor of mortality after trauma ,53,63,64Pre-hospital cardiac arrest after trauma has dismal outcomes -70; it wThe panel recommends using raw values (continuous data) of the GCS, SBP, RR, where they are obtainable, and coded values  according to the RTS  Table 77 in thosFor patients intubated before arrival at the hospital, the ED GCS is not attainable, and this could potentially result in large amounts of missing data . For thiChan et al. found that even in the case of normal SBP upon arrival in the ED, out-of-hospital hypotension was a clinical predictor of severe injury ; it was Missing RR values for patients arriving in the hospital  is the most common cause of a lack of RTS values . CollectAdmission arterial base excess (BE) is a predictor of mortality after trauma ,82-84; iThere is a high frequency of established coagulopathy in multiple-injured patients upon their arrival in the ED ,88. CoagThe term 'intensive care unit' (ICU) is variously defined across the world, and in some referral hospitals, many patients are intubated upon arrival or transferred back to a local hospital while still intubated and ventilated. This makes the calculation of length of stay (LOS) in the ICU difficult. The revised template recommends recording the total number of days spent on a mechanical ventilator, rather than ICU LOS, as a measure of resource consumption. Furthermore, these data permit the use of the concept of ventilator-free days to quantify morbidity after trauma.As outcome measures, the expert panel suggest hospital LOS, discharge destination, Glasgow Outcome Scale (GOS)  score atFor injury severity description, the expert panel recommends recording all AIS codes. It has previously been shown that a comparison of survival for trauma registries that use different AIS editions is potentially possible . A diffeThe expert panel considered the time between when the alarm call is answered (at the emergency dispatch centre) and when the patient arrives at the first hospital to be an important system characteristic descriptor  and recommend that this interval be reported.Recording the highest level of competence of the pre-hospital care providers was regarded by the expert panel as an important measure for describing the pre-hospital system, and for cross-border comparisons of pre-hospital trauma care and outcome. The highest available level of the providers may vary somewhat in Europe, but the revised template's categorisation of level of provider is based on the levels proposed by McSwain , since tPre-hospital intubation is an important parameter that represents pre-hospital advanced life support (ALS) . There iThe type of transportation delivering the patient to the hospital is an important descriptor of the pre-hospital trauma care system, but the use of a helicopter vs. ground ambulance remains controversial ,100, andThe expert panel recommends registering the initial key emergency intervention (EI) conducted during the hospital stay . These interventions Table  represenA formal trauma team is an essential part of an organised trauma system . ActivatThe revised template recommends recording the highest level of in-hospital care for the trauma patient in the main trauma hospital Table .The "Chain of Survival" concept emphasises that all time-sensitive interventions must be optimised to maximise the chance of patient survival . The expAs an overall marker of the efficiency of patient treatment , the expert group suggested to consider the time required to achieve normal arterial BE. A good evidence basis does not exist for this recommendation, however, if BE worsens after arrival, prognosis worsens as well . The BE The efficiency of the initial in-hospital management is assessed by the time from hospital admission until the time marked on the first CT scan images. This data represents the time required to perform key in-hospital diagnostic tests.The time to the first key EI should be recorded; this measure represents how quickly an urgent intervention fundamental to the treatment and stabilisation of a patient's specific injuries  is perfoThe present paper represents a further development of the previous Utstein Template for Uniform Reporting of Data following Major Trauma , and refThe template classifies fall-related injuries as low or high (category options of the MOI data variable in Table We are aware that the best way of assessing the GOS as a measure of disability (morbidity), is after at least six months, but since this was not considered feasible, registration at discharge from the hospital was chosen as the endpoint. The assessment of GOS as an outcome measure at discharge from a trauma centre in trauma systems based on early discharge to specialised rehabilitation services represent a limitation, and the GOS endpoint should therefore be interpreted with caution. Nevertheless, assessment of this endpoint data can be used as a rough estimate of the amount of care needed for a patient beyond the acute hospital stay. Although GOS was developed for patients with head injuries, it represents a rough disability outcome score, and as such it should be possible to use for assessing all trauma patients.The revised Utstein Template considers time to normalised arterial base excess as a measurement of importance for evaluating the total quality of trauma treatment. This data is not a precisely timed measurement and will probably vary from hospital to hospital. However, collecting it is considered valuable and might be important for future comparisons. The inclusion of this data also has some educational reasons; the trauma centres should be encouraged to include this value regularly in the trauma patients' charts.The expert panel recommends reporting the first EI, and the time to first EI, disregarding the fact that some patients may have received several of the listed interventions. The first intervention is, by clinical judgement, the most important one for comparison. This does not preclude trauma registries from documenting each of these interventions separately, or even each operation that is performed. However, the type of first EI and the time elapsed prior to its application is of significant importance; for this reason, this measure was chosen as part of the core dataset. For the purpose of comparison, focusing on the first EI performed in the current system will be adequate. However, if comparisons based on all EI are desired, the present recommendation will not be adequate. Comparison of systems based on all interventions can only be used if it is coupled with data on the time of each intervention. This will be difficult to use if the order in which the interventions occur is not known. If the first intervention is not among those listed under the EIs in the template, time to intervention is not important in our context , and it should therefore not be part of the Utstein core dataset.The panel acknowledges that no indicator has 100% validity and careful judgement is therefore needed. For example, in some selected cases earlier emergency surgery may imply both later CT imaging and better practice. Definition of data variables is a complex and ongoing process and in order to widen the implementation of the core dataset, facilitate participation in European trauma audit and comparisons and increase the quality of the next updates of the core dataset, we encourage all readers to ask for clarifications and point out potential improvements., , , .One concern with the Utstein Template is implementation, since none of the participants from the previous Utstein trauma process changed their registries to accommodate the recommendations of that meeting. The solution for the revised template was to develop a letter of consent that all members of the expert panel signed where they agreed on implementing the core data in the revised Utstein Template [see Additional file This paper represents a major step in perfecting the Utstein Template for Uniform Reporting of Data following Major Trauma, making the core data variables more uniform and applicable. Collecting this core dataset should be a basic component of all future studies on trauma care, and a uniform dataset such as this, will facilitate accurate description of the patient population and allow comparisons of outcome from trauma systems. It is extremely important that the data variables are collected in a uniform manner. For this reason, each variable and response category has been specifically defined in a way that is designed to promote the collection and reporting of a comparable core dataset. A letter of consent has been signed by the expert panel, where the participants of this consensus process agreed to implement the inclusion and exclusion criteria and core data variables in their respective systems and registries.The authors declare that they have no competing interests.KGR and HML designed the study and organised the consensus meetings. TJC was the chairman of the consensus process, while LH and OR were co-chairmen. The core dataset was developed by the expert panel. KGR, TJC, RL, SDB, OR, LH, PAS and HML wrote the article. The rest of the panellists read the manuscript once, made comments to it and approved the manuscript. All authors read and approved the final version of the manuscript.Letter of Consent. The letter provided was signed by the Utstein TCD expert panel. With this letter, the expert panel members confirm that they will implement the core data agreed upon.Click here for file


The adherence to the principles of the Universal Protocol for preventing wrong site, wrong procedure and wrong person surgical or invasive procedures is a requirement for all Joint Commission accredited organizations. Fine needle aspirations are considered invasive procedures, and cytopathologists performing this procedure need to be cognizant and compliant with the requirements of this Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Protocol. This article gives background perspective on the development of the Universal Protocol. It also elaborates the JCAHO National Patients Safety Goals regarding the performance of fine needle aspirations. The compliance with the Universal Protocol for performance of fine needle aspirations is now mandated for all cytopathologists who perform fine needle aspirations and this present paper provides a guideline for fulfilling the requirements of the Universal Protocol for practicing cytopathologists. The "time out" or immediate preprocedural process is the implementation and expectation of completion, for JCAHO mandated requirements.The subject of wrong site surgery and factors leading to it, have been a topic of discussion in medical and legal publications as well as mainstream press . This isThe Joint Commission on Accreditation of Healthcare Organizations (JCAHO), hosted a Wrong Site Surgery Summit on May 9, 2003 ,5. The gA broad consensus on the draft of the Universal Protocol was sought, subsequent to which, JCAHO approved the Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery™ in July 2003 ,5. This The 2007 JCAHO National Patient Safety Goals address the specific application of the Universal Protocol to invasive procedures performed by the clinical laboratory professionals, which includes pathologists performing fine needle aspirations . The goaThe rationale for this goal is to prevent the occurrence of wrong patient identification. Hence, the intent for this goal is two fold: first to reliably identify the individual as the person for whom the service or treatment is intended and secondly, to match the service provided to that patient. This goal has two main requirements, and the failure to comply with these requirements may trigger loss of JCAHO accreditation status, for JCAHO accredited institutions.This requirement states that at least two patient identifiers (neither to be a room number) be used, whenever collecting laboratory samples, which also include pathologist performed, fine needle aspirations. To implement this requirement for fine needle aspirations, acceptable identifiers may be the patient's name, an assigned identification number, telephone number, photograph, or other person-specific identifiers. A bar code on a wrist band that includes two or more person-specific identifiers will comply with this requirement. This requirement covers the pre-procedural verification process, and should be performed before the fine needle aspiration procedure is performed.time out".This requirement states that prior to the start of any invasive procedure, conduct a final verification process to confirm the correct patient, procedure, site and availability of appropriate documents. This verification process uses active, and not passive, communication techniques. The patient's identity has to be re-established if the pathologist leaves the patient's location, prior to initiating the procedure. Marking the site is also required unless the practitioner is in continuous attendance from the time of the decision to do the procedure and patient consent to the initiation of the procedure . The marThe "time out" is the immediate preprocedural process, and must occur in the location where the procedure is to be done . The "time out" should involve the entire procedural team which, at a minimum, includes the pathologist doing the procedure, the anesthesia provider (if any), and the circulating nurse, resident, or other assistant. In addition, there should be no barrier to anyone speaking up if there is a concern about a possible error. "Active" communication, in this context, means an affirmation, orally or by some action that the patient, procedure and site are correct.An important component of fostering a culture of patient safety in a health care setting is having all health care providers adopt common procedures and safeguards to decrease the risk of harm to patients . This isLike most hospitals, the Emory University Hospital has implemented this Protocol and has put into place a policy and process for clinicians, including pathologists, to follow. The first step is to verify the patient's identity using at least two patient identifiers, which can be the patient's name, birth date or medical record number. Then the intended procedure also is confirmed by checking the procedure consent form, the history or progress notes, nursing assessment and, if applicable, the procedure/surgical operating room schedule Table  4,5].,5.4,5].The second step is that the procedure site must be properly marked to identify the area of the patient's body that will undergo the procedure before an incision is made Table  4,5]. F,5. F4,5]time out" is initiated by the physician conducting the procedure to give all members of the clinical team an opportunity to perform a final verification of the correct patient, correct procedure, correct side, correct site, correct patient position and availability of any special equipment or requirements that are needed for the fine needle aspiration procedure (Table Before the procedure starts, a third step or "re Table  4,5].,5.time o"The patient is identified using two identifiers. The site of the fine needle aspiration procedure is also verified with the patient. The lesion is palpated, correctly identified, and marked with ink during time out completion", incorporated in the Fine needle aspiration report will conform completion of "time out" for the procedure.JCAHO requires that pathologist performed fine needle aspiration procedures adhere to the rules of the Universal Protocol including the implementation of "time out" for these procedures. The "time out" procedure also needs to be documented for JCAHO inspectors to review. This can be done either by documenting "time out" as a note in the patient's medical file, which is retained as a hard copy in the patient's medical records. Alternatively, "time out" can be also be documented by incorporating it as part of the fine need aspiration report. A text reading out as At our institution, the Universal Protocol has been implemented for all pathologist performed fine needle aspirations. This has been in effect since January 01, 2005. In the years 2005 and 2006, a total of 1,779 and 2,079 fine needle aspirations, respectively, were performed by pathologists. In reviewing this data, no errors were detected based on wrong person or wrong site. In summary, at our institution, the implementation of the Universal Protocol has been successful, since conforming to it necessitates that appropriate time be allocated for its compliance and hence prevent any error in patient identity or site identification, for patients about to undergo a fine needle aspiration.


Patient experience is commonly monitored in evaluating and improving health care, but the experience of carers (partners/relatives/friends) is rarely monitored even though the role of carers can often be substantial. For carers to fulfil their role it is necessary to address their needs. This paper describes an evaluation of the reliability, validity and acceptability of the PCQ-C, a newly developed instrument designed to measure the experiences of carers of men with prostate cancer.The reliability, acceptability and validity of the PCQ-C were tested through a postal survey and interviews with carers. The PCQ-C was posted to 1087 prostate cancer patients and patients were asked to pass the questionnaire on to their carer. Non-responders received one reminder. To assess test-retest reliability, 210 carers who had responded to the questionnaire were resent it a second time three weeks later. A subsample of nine carers from patients attending one hospital took part in qualitative interviews to assess validity and acceptability of the PCQ-C. Acceptability to service providers was evaluated based on four hospitals' experiences of running a survey using the PCQ-C.Questionnaires were returned by 514 carers (47.3%), and the majority of questions showed less than 10% missing data. Across the sections of the questionnaire internal consistency was high , and test-retest stability showed moderate to high stability (intraclass correlation coefficients ranging from 0.52 to 0.83). Interviews of carers indicated that the PCQ-C was valid and acceptable. Feedback from hospitals indicated that they found the questionnaire useful, and highlighted important considerations for its future use as part of quality improvement initiatives.The PCQ-C has been found to be acceptable to carers and service providers having been used successfully in hospitals in England. It is ready for use to measure the aspects of care that need to be addressed to improve the quality of prostate cancer care, and for research. In England, a major programme of investment and reform in cancer care was set out in the NHS Cancer Plan 2000 . A natioWe interpreted carers' experience of prostate cancer care to relate to carers' reports of specific aspects of care, including their experience of being provided with information and advice, involvement in care and decision making, provision of support, delays in care, and coordination of care. Thus carer experience focuses on the process of care, and is conceptually distinct from concepts such as satisfaction , and quality of life . Furthermore, the findings from measures of experience are usually are regarded as easier to put into practice than measures of satisfaction .The research undertaken to inform this measure established both the importance of the role of carers (partners/relatives/friends) of men with prostate cancer and the need for a separate measure of their experience of care that would enable their needs to be addressed. While patient experience (or satisfaction) is commonly monitored in evaluating and improving health care, the experience of carers is monitored more rarely and is usually focused on their views of the care that the patient receives . However, this approach does not consider the experiences or needs of carers themselves who may experience significant distress  and may This paper describes the development of a questionnaire to measure the experiences of carers of men with prostate cancer- the Prostate Care Questionnaire for Carers (PCQ-C). Measures of experience suitable for wide use must be developed systematically to ensure they address the issues that are important to patients or carers, are readily understood, and are reliable and valid. They must also meet the needs of providers so that the measures can be used flexibly and at different phases of care depending on the providers' focus for quality improvement, and be administered and analysed efficiently. Our aim was to develop a valid, reliable and usable measure that can be used in routine practice as well as in studies of new ways of delivering care. This paper reports the formal evaluation of the reliability and validity of the complete PCQ-C, as well as assessments of its acceptability to carers and service providers. A companion paper describes the development of the measure for use with men with prostate cancer (PCQ-P) .The PCQ-C (Prostate Care Questionnaire for Carers) was developed in response to preliminary research with healthcare professionals that identified a need for a separate measure of carers' experience of care. The format and content of the measure were identified through a literature review  and, intFive hospitals in England were selected to participate in the study to test reliability, validity and acceptability, representing a range in terms of urban and rural locality, teaching and non-teaching hospitals and foundation trust status. Each hospital drew a consecutive sample of all patients who had been diagnosed with, or treated for, prostate cancer within the past two years, excluding patients who had died or were too ill to participate; this produced a list of between 152 and 253 patients per hospital. Details of the participating hospitals and patients are given in the accompanying paper . All 108Test-retest reliability was undertaken in two hospital sites . In these sites, 210 carers who had responded to the original mailing were posted the PCQ-C again three weeks later. In addition, nine carers from one hospital site who had completed the PCQ-C took part in semi-structured interviews to explore acceptability and face validity. Four face-to-face and five telephone interviews were carried out. Interviews were not transcribed, but notes were taken during the interview by the interviewer.Key properties of the sections of the PCQ-C, including aspects of validity, reliability, and acceptability to carers were analysed. Overall scores were calculated for each section of the questionnaire, by summing up scores across questions and converting to a score out of 100, with higher scores indicating more positive experiences of care . StatistAcceptability was evaluated through examination of completion rates for individual questions and whole sections of the questionnaire, and by analysing distributions of responses for individual questions. Acceptability was also assessed in interviews, by asking carers about their experience of completing the questionnaire.Face and content validity were investigated through the carer interviews. Carers were asked to recount their experiences of the care process and their involvement in it, and to reflect on their responses to the questionnaire. Carers were also asked whether there were any issues that were important to them that were not included in the PCQ-C. Content validity was also assessed through exploratory principal components analysis (PCA), to identify if key aspects of care identified in the preliminary research ,10 had bIn the absence of a comparable carer questionnaire further validity testing was undertaken by comparing the scores for patients and carers in corresponding sections of their respective questionnaires. A moderate to high correlation (0.3) between patient and carer scores was expected, reflecting differences in the questions included in the patient and carer questionnaire, but also reflecting the fact that patients and carers may have different perspectives on the same experience.Internal consistency reliability for each section was measured using Cronbach's alpha . StabiliThe usability and acceptability of the questionnaire to service providers was assessed through a sample of four hospitals surveying carers' experiences using different sections of the PCQ-C, and then seeking feedback on their experiences of this process. Four hospitals in England were selected to ensure a range in terms of urban and rural locality, teaching and non-teaching hospitals, and foundation trust status. Hospitals were provided with questionnaires, a user guide developed as part of the study, and software to enable them to enter their data and produce basic summary results. Hospitals were asked to survey around 100 carers (via the patients) and feedback on staff's experiences was gained through semi-structured interviews with one or two key persons who had administered the survey in each hospital , along with informal discussion with other members of hospital staff. Interviews were not transcribed, but notes were taken by the interviewer during the interview.Questionnaires were returned by 514 carers. As the carer questionnaires were sent to 1087 patients this equates to a response rate of 47.3%. However, the number of patients who did not have a carer or who chose not to pass the invitation pack to their carer is unknown, meaning that the true response rate cannot be calculated. Sections A and B were completed by 244 carers, and 350 completed Section C. The demographic characteristics and health status of responders are summarised in Table 2 = 38.3, p < 0.001). For carers who completed more than 50% of the questionnaire, missing data for individual questions ranged from 0% - 32.4%. However, the majority of questions showed less than 10% missing data. Responses to most questions were well distributed across response options. Overall, carers more often reported positive experiences, with mean overall scores ranging from 57.0 to 86.0 across the sections. Descriptive statistics of section scores are shown in Table The proportion of carers completing fewer than 50% of the questions in each section was low to moderate: 52 carers (15.9%) for Section A, 28 carers (13.5%) for Section B, and 62 (27.1%) for Section C. Missing data were usually due to carers omitting whole sections, and in many cases this may have been appropriate. For example, carers who indicated that the patient was not undergoing active treatment were more likely to leave Section C  blank  emerged as a single component, including all questions. In Section B (diagnosis and treatment decision) and Section C (treatment and monitoring) three components emerged. On inspection the components in Section B were related to 'involvement and information', 'explanation', and 'treatment decision'. In Section C the components related to 'explanation, information and support', 'discharge', and 'continuity and communication'. Comparison of these components with themes from the initial carer interviews  and liteThe comparison of patient and carer scores for corresponding sections of their respective questionnaires showed moderate to high, significant, correlations . The test-retest intraclass correlation coefficients for the three sections were between 0.52 and 0.83, and all were significant at p < 0.05 (see Table Ninety-two carers 43.8%) completed the retest questionnaire; 43/88 (48.9%) completed Sections A and B, and 49/122 (40.2%) completed Section C. Carers completing retest questionnaires did not differ significantly from other carers in terms of age, health status, ethnic group, or employment status . In interviews with hospital staff the importance of introducing the measure sensitively was emphasised, as was the need to be clear about how the results would be used, as this would help to ensure staff co-operation. Their feedback on the questionnaire itself was that it was relevant and would provide useful data, allowing comparison between hospitals as well as identifying specific aspects of service delivery that should be examined.In England, men's reported experiences of prostate cancer care has been worse than for patients with other cancers, and since a high proportion of patients and their carers are relatively old, deficiencies in care are likely to have a significant impact on both patients and carers. However, there are no measures specifically designed to address the experiences of these carers and that could be used to monitor their needs. This paper has explained the development of the measure for carers, PCQ-C, which has been designed so that it can be used independently or alongside the measure of patients' experience of prostate cancer care, PCQ-P . CorrespThe strengths of the PCQ-C are that the form and content have been based on research with users and healthcare professionals . The questionnaire has been subjected to a range of tests for validity and reliability in a variety of hospital settings, so that it is ready for use in hospitals. The PCQ-C can be used as a complete questionnaire, or sections of the measure can be used individually. A short version, covering carer experiences across the whole patient journey, is also available . FeedbacThere are several limitations that should be noted. It was not possible to test for criterion validity because there was no accepted, valid carer experience questionnaire available with which PCQ-C could be compared. The stability of section B is somewhat lower than for the other sections. The majority of the carers who completed Section B on both the first and the second occasion gave high overall scores for the section, and lack of variance in scores for Section B may account for the lower ICC. In addition sample size for the analysis of carer data is relatively small. There remain significant barriers to accessing carers, not least the requirement to invite carers to participate in studies via patients, and some consideration of how best to recruit carers when using the PCQ-C is required. Opportunistic sampling (e.g. via support groups and charities) may provide a convenient alternative route to the approach used in this study, although this will carry an increased risk of bias .There are several opportunities for further research. Firstly, this study covered experiences of prostate cancer care from initial consultation through to treatment and monitoring. To cover all the phases of care a measure is needed that addresses experiences during palliative and end-of-life care. Secondly, to further understanding of carers and their experiences comparisons between groups of carers may be carried out using the existing measure (e.g. looking at responses and socio-demographic characteristics). Thirdly, while the questionnaire was able to detect different experiences of carers between different hospitals its sensitivity to change has yet to be tested. This could be carried out for example by using PCQ-C to measure carer experience before and after a change to service delivery.There are two aspects of the PCQ-C that are worth noting. Firstly, it is a questionnaire that has been tested and exhibits satisfactory reliability, validity and acceptability to carers of men with prostate cancer. The PCQ-C is ready to be used in service monitoring and improvement, and could also provide a starting point for the development of instruments for other cancer groups, as many of the issues that it covers are relevant to other cancers. Secondly, the questionnaire has been developed as a measure of carers' own experience of prostate cancer care so that service delivery can be tailored to meet carers' needs, and enable them to be more effective in providing patient support. This is in contrast to other measures that address carers' experience of, or satisfaction with, the care that the patient has received , or that measure emotional wellbeing or strain on carers . The PCQThe PCQ-C described here has the potential to provide valuable carer feedback to those working in health care throughout the different phases of care of prostate cancer patients, from testing to monitoring. These data can be used to tailor service delivery to improve carer experience, and equip them better to cope with providing support for the patient.The authors declare that they have no competing interests.RB was lead of the project and participated in the design of the study reported in this paper. PS, SA and CT participated in the data collection and analysis of the study reported in this paper, and PS prepared the first draft of this paper. All authors participated in the design and management of the study, and in reading and approving the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/9/229/prepubExploratory Principal Components Analysis with Varimax rotation for each section of the PCQ-C. Table showing results of an exploratory PCA for all sections of the PCQ-C.Click here for file


As sub-Saharan African countries continue to scale up antiretroviral treatment, there has been an increasing emphasis on moving provision of services from hospital level to the primary health care clinic level. Delivery of antiretroviral treatment at the clinic level increases the number of entry points to care, while the greater proximity of services encourages retention in care.In Tete City, Mozambique, patients on antiretrovirals were rapidly down referred from a provincial hospital to four urban clinics in large numbers without careful planning, resulting in a number of patients being lost to follow-up.We outline some key lessons learned to support down referral, including the need to improve process management, clinic infrastructure, monitoring systems, and patient preparation. Down referral can be avoided by initiating patients' antiretroviral treatment at clinic level from the outset. As sub-Saharan African countries continue to scale up antiretroviral treatment (ART), there has been an increasing emphasis on moving provision of services from hospitals to primary heath care (PHC) clinics. Decentralization is an important strategy for improving access to ART, particularly in rural areas. Decentralization is defined as the process of moving delivery of ART from hospitals to clinics, thereby improving access (proximity) to care, and encouraging greater retention in care (less defaulting) -3.A recent review of loss to follow-up in ART programmes in resource-limited settings concluded that retention rates are better in services that have smaller numbers of patients and that population coverage should be supported by smaller decentralized facilities rather than by a few large programmes .Despite the logic and evidence that supports the decentralization of HIV/AIDS care to the PHC level, in many settings, HIV care is provided only at hospital level. As hospital services become saturated, there will be a need to "down refer" patients to lower levels of the health system.However, this process of down referral must be carefully planned and executed to avoid overwhelming primary care services and to maximize patient retention. Reports from TB programmes have shown that almost a third of patients are lost on referral between the hospital and clinic . This arTete City  is the capital of the Tete Province in central Mozambique, and has an adult HIV prevalence of 19% (± 5%) ,7. In 20By the end of 2006, 2,350 patients had been initiated on ART at Tete Provincial Hospital, of which 1,637 (70%) remained in care, resulting in an overwhelming patient load at hospital level. Only 218 patients had been initiated on ART in the four urban PHC clinics by the end of that year.In May 2007, the hospital directorate issued a mandate to down refer around 1,000 patients (61%) followed at the provincial hospital. This was in preparation for major reconstruction work at the hospital, which resulted in a six-fold reduction in consultation rooms for HIV.Due to the inadequate capacity of the clinics to manage so many new patients at that time, only stable patients  were considered for down referral. Within nine months, the number of patients managed at the clinics increased nearly eight-fold, from 218 to 1,704 patients . Capacity and human resources at the PHC level were rapidly overwhelmed until structural and human resource solutions were proposed and implemented.The down referral process began before the completion of planning with all involved stakeholders because of pressure to implement the decision to down refer. Staff at the PHC clinics, although trained in ART care, did not fully appreciate the extent of the services that would need to be provided, and were not experienced enough to manage the large influx of patients on ART.Although the criteria for down referral were well defined, some non-eligible patients were also down referred in the drive to move patients out of the hospital. Finally, too many patients were referred at once, instead of a phased approach being implemented.As a result of the influx of patients, the overall number of consultations (HIV and non-HIV) at each clinic more than doubled. Initially, each PHC clinic had only one ART consultation room. Consequently, other rooms, such as sterilization areas or changing rooms, were used for consultations.Waiting time was often several hours, and waiting areas became overcrowded. The increased patient load put a severe strain on other clinic services: laboratories could not keep up with the increase in blood collections; and pharmacies became congested with long waiting lines as insufficient staff members were trained to dispense antiretrovirals (ARVs).Drug supply management also became a problem as PHC clinics were not aware of the extent of referral numbers to expect and could not forecast consumption. When medications ran out, patients returned to the hospital to fill their prescriptions. Some patients initially asked to be transferred back to the hospital due to frustration with the chaotic process.The transfer of patients between the hospital and the clinics was not well monitored. With many providers down referring, there was no master list of all patients to be transferred. Referral letters were supposed to accompany patients, but these were sometimes lost. The electronic database maintained at the hospital was not updated when patients were down referred.No systematic active tracing of these "loss to follow-up" patients was conducted until the following year. Lists of "loss to follow-up" patients were sent to the clinics in an attempt to trace and update the database, but the clinics had meanwhile issued new patient identification numbers, so records did not match. Therefore, the true outcomes for those patients lost during referral remain unknown. As these were stable patients with no clinical complications, mortality is unlikely to have contributed to this rapid attrition over a short time period .In the beginning, some patients were reluctant to be down referred as they did not fully understand the advantages (easier access to services) and disadvantages  of follow-up at the PHC clinics. Consequently, they feared a decrease in the quality of care; several patients refused to be down referred or they decided, without informing the medical team, to self-transfer from one clinic to another.The hospital and clinic staff, along with the provincial health department, identified the problems described here, and jointly proposed a number of actions Table . A jointThis team oversaw a number of actions, including the establishment of monthly quotas of patients to be down referred to prevent overwhelming the clinics. The actions allowed for: better stock forecasting; reorganization of clinic laboratories so that routine blood collection was done on specific days; training in stock management for the PHC pharmacists; and establishment of a buffer stock of ARVs and medications to treat opportunistic infections in case clinic stocks became depleted.Human resources were also restructured: two nurses were moved from the hospital to the clinics, and receptionists were hired to register patients at the clinics and collect demographic data. The latter is an example of "task shifting" of work previously done by the clinicians or counsellors .To improve patient flow, a fast track system was created for stable patients so that they only needed to come to the clinic every three months. A simplified data collection system was implemented for monitoring and evaluation, including the use of check lists of patients to be down referred and of those who actually registered at the PHC clinics. Finally, counsellors at the hospital were trained to explain the reasons for the down referral, while counsellors in the PHCs were trained to receive the referred patients.In other settings in southern Africa, decentralization has proven to be a successful strategy for supporting scale-up of antiretroviral therapy ,3,10-12.In Tete City, the majority of clients referred to clinic services continued their follow-up at clinic level. Down referral was, in the end, broadly accepted as these services were more accessible.However, a number of issues should be considered to ensure that appropriate support is given to PHC clinics. The mass transfer of patients enrolled in care at the hospital level can quickly overwhelm minimally staffed clinics if appropriate steps are not taken. In addition to the extra workload, clinic staff may feel uncomfortable with their new level of responsibility, particularly if training and supervision mechanisms are not in place. The Tete experience serves to highlight a number of simple steps that can be taken to ensure a smooth transition from hospital-based to clinic-based care.The short-term chaos has been outweighed by the broader benefits of establishing a decentralized programme. As of December 2008, more than 2,700 patients on ART were being followed in the four PHC clinics, compared to around 800 in the hospital.Most problems during down referral were successfully resolved through the creation of a team that worked across different areas of the health service to address a range of challenges, from drug supply to human resources. At the same time, a number of changes were made to reinforce the capacity and efficiency of the primary health care clinics.Down referral requires careful planning, implementation over a realistic timeframe, and attention to monitoring at all levels. Perhaps the most obvious lesson is the need to take time to explain to the patients the reasons behind the decisions taken for the down referral, and explain that they would benefit from more proximal services without any compromise in care. Criteria for referral should ideally be determined in consultation with all stakeholders, including service users.Finally, given the growing evidence that most ART cases can be initiated at clinic level, the problems associated with down referral could have been avoided by initiating newly enrolled patients directly at PHC clinic level from the outset.The authors declare that they have no competing interests.MB, TD, and KC provided the initial conception and design. FM and IP analyzed the data. All authors contributed to the interpretation and discussion of the data. KC and IP drafted the article. MB, TD, CD and NF provided critical revision of the article for important intellectual content. The final version of the manuscript was seen and approved by all authors.


Work satisfaction of nurses is important, as there is sufficient empirical evidence to show that it tends to affect individual, organizational and greater health and social outcomes. Although there have been several studies of job satisfaction among nurses in South Africa, these are limited because they relate to studies of individual organizations or regions, use small samples or are dated. This paper presents a national study that compares and contrasts satisfaction levels of nurses in both public and private sectors.This was a cross-sectional survey of professional nurses conducted throughout South Africa using a pretested and self-administered questionnaire. Univariate and bivariate statistical models were used to evaluate levels of satisfaction with various facets of work and to elicit the differences in satisfaction levels between different groups of nurses. A total of 569 professional nurses participated in the study.Private-sector nurses were generally satisfied, while public-sector nurses were generally dissatisfied. Public-sector nurses were most dissatisfied with their pay, the workload and the resources available to them. They were satisfied only with the social context of the work. Private-sector nurses were dissatisfied only with their pay and career development opportunities. Professional nurses in the more rural provinces, those intending to change sectors and those more likely not to be in their current positions within the next five years were also more likely to be dissatisfied with all facets of their work.This study highlighted the overall dissatisfaction among South African nurses and confirmed the disparity between the levels of job satisfaction between the public and private sectors. Health managers should address those factors that affect job satisfaction, and therefore retention, of nurses in South Africa. Improving the work environment so that it provides a context congruent with the aspirations and values systems of nurses is more likely to increase the satisfaction of nurses and consequently have a positive effect on individual, organizational and health outcomes. South Africa has a dual health system. The public sector, comprising government health institutions, serves predominantly the indigent population, while the private sector, comprising for-profit organizations and individuals, serves the insured population or those who can afford care on an out-of-pocket basis. Although the public sector is responsible for the well-being of 82% of the population, it accounts for only 40% of the total health expenditure in South Africa. In contrast, the private sector consumes 60% of the health expenditure and is responsible for less than 20% of the population . The pubGiven the pivotal role that nurses play in determining the efficiency, effectiveness and sustainability of health care systems, it is important to understand what motivates them and the extent to which the organization and other contextual variables satisfy them. Job dissatisfaction has frequently been cited as the primary reason for a high turnover of nurses -5, as weWork satisfaction is also an essential part of ensuring high-quality care. Dissatisfied providers not only give poor quality, less efficient care , there iThere is also compelling evidence of a positive relationship between job satisfaction and employee health. Blegen et al.  demonstrJob satisfaction has primarily been defined by two approaches: a global approach that encompasses overall attitudes, feelings and emotions towards their work experience ,25, and Although international research varies in its specific findings, the general conclusions seem to support a sentiment of growing dissatisfaction experienced by nurses around the world -32. Key In South Africa, nurses were also found to be generally dissatisfied ,42, withData for this study came from a survey of professional nurses throughout South Africa that formed part of a broader study of attraction, work satisfaction and retention issues. Based on a population of 99 534 professional nurses registered with the South African Nurses Council, the minimum sample size was calculated at 367, at a 95% level of certainty and allowing for a margin of error of 5%. Based on a response rate of around 40% for similar studies , a compuThe objective of this study was to determine the extent of work satisfaction among nurses and to examine variables influencing 13 aspects of job satisfaction. Scales combining multiple items were used to measure satisfaction with autonomy, relationship with nursing colleagues, patient care, relationship with doctors, personal time, relationship with management, career opportunities, safety, the community, pay, resources, workload and satisfaction with their careers. Some of the items and scales were developed by the researcher, while others were adapted from the literature ,49-51.Factor analysis using principal components analysis was used to evaluate the construct validity of the satisfaction subscales and the Kaiser's eigenvalue rule was used to determine the factors to be extracted from the 58 satisfaction items. Satisfaction was measured by means of a five-item Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). The reliability of the factors was estimated by assessing the internal consistency of the scales by means of Cronbach's alpha. The ultimate score that each nurse received for each factor was based on the simple summation of the item scores for that measure. Mean factor scores at the lower end of the score range denote lower satisfaction with a particular facet, while higher scores denote satisfaction.The independent variables in the study were the respondent's personal characteristics, work experience and future work plans. One-way analysis of variance (ANOVA) was used to test the statistical significance of the differences in work satisfaction between nurses in the public and private sectors and other categorical variables, while the chi-square test was used to test the statistical significance of the association between categorical variables.After the primary and two follow-up surveys, questionnaires were returned from 569 of 907 valid addresses of professional nurses. This represents a total response rate of 62.7%. There were no significant differences between primary respondents (297) and the sample of primary non-respondents in terms of demographics, future work plans and satisfaction levels.As shown in Table About 40% of respondents worked in the private sector, while 60% worked in the public sector. Some 34.8% of respondents indicated an intention to change their sector of employment within the next five years, while 30.2% reported that they would most likely still be in their current positions as professional nurses in five years' time.Factor analysis yielded the same 13 facets that captured 76% of the variance in nurses' responses to the satisfaction items. Cronbach's alpha–a measure of internal consistency–was well within acceptable range for all scales (α > 0.70).Overall, professional nurses in South Africa were marginally dissatisfied mean 2.935) . They expressed greatest satisfaction with the gratification they obtained from patient care (3.984), their relationship with their nursing colleagues (3.697), their sense of belonging in the communities within which they work (3.598), safety in the work environment (3.570) and their relationship with doctors. They were dissatisfied only with their pay (2.397) and career development opportunities 2.987).Public-sector nurses were generally dissatisfied (2.693). They did, however, express satisfaction with the gratification they obtained from patient care (3.571), their relationship with their nursing colleagues (3.514) and doctors (3.317) and their sense of belonging in the communities within which they work (3.226). They were most dissatisfied with their pay (1.787) and workload (1.940), followed by the resources available to them (2.306), career development opportunities (2.337) and safety of the work environment (2.351).Analysis of variance showed significant differences between the satisfaction levels of nurses with different bio-demographic characteristics, from different provinces, with different levels of experience, in the different sectors, as well as those who intended to change sectors or had other work plans within the next five years Table .Female nurses were generally more satisfied with resources than their male colleagues , while nurses above age 40 were significantly more satisfied than their younger colleagues with their relationships with management  and with doctors . Nurses with more than 20 years' experience were also significantly more satisfied than their less-experienced colleagues with most of the facets of their work.Nurses in the Western Cape, Free State, Kwa-Zulu Natal and Gauteng were significantly more satisfied than their colleagues from other provinces with most of the facets of their work except for their relationships with the community, where nurses in Limpopo and North West were more satisfied.Nurses in the private sector were also significantly more satisfied with all facets of their work than their colleagues in the public sector. The greatest differences in satisfaction levels were with regard to safety, resources available, workload, their careers and their relationship with management, respectivelyNurses who intended to change their sector of employment were significantly less satisfied in all the work facets than those who indicated that they would not be changing their sector of employment. Nurses who intended to remain active in the profession for the next five years were also significantly more likely to report being satisfied with all the facets of their work, as opposed to those whose work plans included either quitting the profession, working abroad or pursuing further training in nursing.Given that it is difficult to achieve desirable response rates in surveys of health professionals, the relatively high response rate of more than 60% suggests that the iterative process is appropriate in this context. It may also indicate high interest among nurses in the subject area. The similarity in response rates between respondents and a sample of primary responders suggests that non-response bias was minimal and the sample was therefore representative of all professional nurses in South Africa.Results from the survey demonstrate that although nurses are generally dissatisfied, discrepancies are masked between levels of satisfaction with different aspects of their work, between nurses with different bio-demographic characteristics, between nurses in the different sectors and from different geographic regions, and between nurses with different future work plans.The overall dissatisfaction among the cohort surveyed is disconcerting, given that work satisfaction is positively correlated to increased absenteeism  and turnOverall, nurses in the public sector were generally dissatisfied, while nurses in the private sector were satisfied. This contradicts the general management literature, which suggests that public sector satisfaction has improved relative to the private sector over the last decades . It doesPublic-sector nurses were most dissatisfied with their pay, workload and the resources available to them, while private-sector nurses were moderately dissatisfied with pay and workload and marginally dissatisfied with their career opportunities. Although both sectors have identified pay and workload as being an important source of dissatisfaction, private-sector nurses are relatively more satisfied with these factors than their public-sector counterparts. The question then arises: Why are private-sector nurses significantly more satisfied than their public-sector colleagues? The data suggest that nurses in both sectors were satisfied with the social context of their work  and the intrinsic satisfaction they receive from patient care. In other words, they are happy with the work they do and the people with whom they work. This is positive, given that optimal health provision depends on teamwork and interprofessional cooperation and communication.The differences in satisfaction are related to the work context: safety, resources, workload and work schedule, management, pay and autonomy. The biggest difference in satisfaction levels was in the perceived levels of safety in the workplace–personal safety, risk of infection, risk of injury and the physical work environment. Public-sector nurses were extremely dissatisfied, while private-sector nurses were satisfied. The emergence of deadly diseases such as extreme drug-resistant tuberculosis (XDR TB) and HIV/AIDS, in the wake of the already burdened public health care system, probably contributes to the weakening of the safety of the nursing work environment. In addition, patients with these illnesses generally require more specialized care and longer-term treatment than other patients, further increasing the workload.Andrews & Dziegielewski  in theirThe difference in satisfaction levels with resources available–working equipment, medication, examination facilities, time and staff–is also stark, with nurses working in private health care afforded the ideal opportunity to improve the health care status of patients in an optimal setting with adequate resources and time. This translates into more efficient, effective health care in a more comfortable environment, which ensures that patients become the priority and patients' needs are met.The issue of nurse remuneration, especially in the public sector, has been an enduring one ,47,42,41An increased workload for nurses–resulting from the severe shortage of nurses as well as an increase in demand for care–has been associated with burnout and intention to leave . ExcessiThe general dissatisfaction of public-sector nurses with their careers and the career opportunities available to them is a further measure of demoralization of nurses and offers some substantiation of the disaffection associated with working in the public sector. The decreasing attractiveness of nursing as a career is of great concern, given that nurses play a central role in the government's primary health care approach. Attraction, retention and motivation difficulties may in the long run offset the gains of attempts to improve efficiency within the health delivery system. The results were marginal, but the data indicated that private-sector nurses were also dissatisfied with career opportunities available to them as nurses in South Africa. Although this finding is not supported by Barrows & Wesson , who fouCareer opportunities and training afford individuals the prospect of further developing themselves and growing within the ranks of their career. They also acknowledge experience and time dedicated to nursing, which provides much-needed recognition in the field of nursing. These findings are in line with the suggestion by Horwitz et al.  who propThe significantly different responses to the satisfaction factors by nurses intending to leave their current employment sector and those not intending to leave are confirmation of the push factors that direct the ultimate movement of nurses out of the public sector into the private sector. Responses to all factors were significantly different and the levels of satisfaction experienced by the nurses who intend to leave their current sector were significantly lower for all factors than those who intend to stay. These results support the findings of Shields & Ward  that worThe finding that nurses in the more urbanized provinces  were significantly more satisfied than their colleagues from the more rural provinces may also partly explain the gravitation of nurses from rural to urban areas. This further supports that assertion of Pillay  that:work satisfaction is an important predictor of where health professionals intended to work. Health managers in rural provinces should therefore focus on key dissatisfactors if they are to improve retention of nurses in their regions. It was however interesting to note that that nurses in the more rural provinces were significantly more satisfied with their relationships with the communities within which they work. The role that communities can play in the recruitment and retention of nurses therefore offers us a key point of leverage to improve recruitment and retention efforts and definitely warrants more research.The work experience of a nurse was also a significant variable that resulted in varying responses to the levels of satisfaction among the given factors. Nurses with more than 20 years' experience were more satisfied with most of the satisfaction facets than those nurses with less work experience. Years of experience bring with them a sense of security in nursing, and fewer surprises. Relationships with patients and colleagues are built and strengthened over the years that are more difficult to establish when one is less experienced. Experience also has the advantage of promoting nurses within the ranks and reserving the more menial tasks to the less experienced and younger nurses, thereby offering a manageable workload and flexible working hours. These factors are satisfying to nurses and help explain the overall higher levels of satisfaction among the more experienced nurses. This augurs well for the retention of the more experienced nurses, with the associated benefits of institutional memory retention and coaching and mentoring of new entrants.This study had limitations that must be acknowledged. First, responders may have been more dissatisfied than non-responders, leading to exaggerated estimates of dissatisfaction. Second, the research relied on subjective assessments of respondents to the survey and it was not possible to externally validate these responses.This study highlighted the overall dissatisfaction among South African nurses and confirmed the disparity between the levels of job satisfaction between the public and private sectors. Nurses are pivotal to the effective and efficient delivery of health care in South Africa; the chronic shortages of nurses impose a real threat to its future. It therefore becomes imperative for health care managers to identify and address those factors which are the stumbling blocks to job satisfaction and therefore retention of nurses in South Africa. Improving the work environment so that it provides a context congruent with the aspirations and values systems of nurses is more likely to increase the satisfaction of nurses and consequently have a positive effect on individual, organizational and health outcomes.The author declares that they have no competing interests.


In a blow to the revenues of India's largest pharmaceutical manufacturer and one of the world's leading generic companies, the United States Food and Drug Administration (FDA) has blacklisted about 30 generic drugs being manufactured by the company at two of their manufacturing sites, citing failure to adhere to current Good Manufacturing Practices requirements. The US has not sought a ban nor sought withdrawal of the products manufactured from the blacklisted sites, as the FDA's repeated testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of blacklisted drugs.There are many who feel that this action by the FDA is unduly harsh and probably protectionist. However, the FDA wants to send a clear signal that drug products intended for use by American consumers must meet their standards of safety and quality. To thoseLancet in 2001[India has the notoriety of being a major producer of the world's counterfeit drugs. Counterfeit drugs form 10% of the world's drug trade according to the World Health Organisation (WHO). Globally, this trade in fake medicines is one of the fastest growing grey economies – after prostitution, narcotics, terrorism, and arms trade. The Masht in 2001 ostensibt in 2001 This kudAccording to the WHO, counterfCounterfeit products may include i) products with correct ingredients, but containing insufficient or erroneous quantities of active ingredients, or expired active ingredients either to save cost or owing to poor quality control factors; ii) wrong ingredients with possibly toxic elements and impurities and therefore directly harmful to patients; iii) without active ingredients or using similar class of cheaper ingredients to escape detection; iv) produced by unhygienic manufacture, or lack of rigorous cleaning between production batches; or v) products with false or misleading packaging.6The situation is complicated by the fact that counterfeit drugs often contain active pharmaceutical ingredients, if only because the producers are keen to both avoid detection and generate repeat business. The drugs may be ineffective and dangerous as well as difficult to spot because they use active ingredients which are from similar class, for e.g., swapping a patented statin for a cheaper generic form or ChineDespite the best efforts of all those crusading against spurious drugs, unfortunately, malevolent dealings in counterfeit drugs are very much a contemporary reality. The modus operandi includes recycling using used vials with intact labels, refilling and re-labelling with packaging similar to branded drugs, imitation, manufacturing without knowledge, reuse beyond expiry date, and large scale counterfeiting. NotoriouIn wealthier countries, the most frequently counterfeited medicines are new, expensive lifestyle medicines, such as hormones, steroids, antihistamines and of course sex performance enhancers like sildenafil. In developing countries, however, the most counterfeited medicines are unfortunately those used to treat life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS.There is a view that counterfeiting is a crime with no real victims. People desire well-known brands, but at a lower cost, and unscrupulous mercenaries are ready with carefully crafted replicas. With shoes, garments, chocolates, and electronic goods the cheating is relatively innocuous giving the customer the thrill of a ‘great’ product. However, the dangers inherent in fake medication make nonsense of any cozy collusion between a knowing consumer and helpful supplier. Counterfeiting is attractive because relatively small quantities of counterfeit medicines can provide huge profits to the counterfeiter, and is seen to carry less risk than trafficking addictive drugs.Counterfeiting certainly damages legitimate commerce. It undermines margins of legitimate drug companies, reducing profit for reinvestment in new drugs and for low cost, high quality generics. It reduces the tax revenues of the country, which could be ploughed back in health infrastructure. It also damages reputation of drug companies, demolishes public confidence in medicines, and hence companies are reluctant to publicize incidents of counterfeiting of their products.Spurious drugs are a cause for concern for all those who are working in health sector such as doctors, pharmacists, nurses and health regulators. The worsThere are 20,000 registered brands as well as an approximate of around 1300 molecules in India as per the Indian Drug Review (IDR) Drug compendium, 2008, but the Most of the spurious drugs find their way into the government institutions like defense and civil hospitals and dispensaries, which bulk purchase drugs through the tender system and settle for the lower bids. The presence of corrupt purchase officials in these deals, the absence of any appropriate system of monitoring the quality of drug, aids spurious and sub-standard drugs finding their way into these places. These spInternet-based sales of pharmaceuticals, which should have been a boon to those seeking cheaper, stigmatized or unauthorized treatments, has unfortunately now become a major source of counterfeit medicines. Some intNon-response of illness to treatment prompts physicians to test out an algorithm of reasons. This algorithm in its list has inadequate dosage as one of the causes. It is prudent to consider spurious drugs in this algorithm, given the enormity of the problem. Failure to consider this may cause change of diagnosis with an unnecessary battery of tests to clarify it. Further,The Indian regulatory system has dual responsibility a) protecting Indians from the menace of spurious and substandard drugs and b) preparing Indian companies to meet the highest standards of the global market. It is high time the regulatory system works. It is when the existing laws are reinforced uniformly and stringently, and if the guilty manufacturers, up to those involved in dispensing are caught and punished accordingly, this menace can be curbed to a large extent. The end users of the drugs, namely, the doctors and the patients should be educated and made aware of the problem, and they should also take responsibility in curbing the menace. This will be discussed in the next issue..