Jason W. Nickerson

Surgical care during humanitarian crises: a systematic review of published surgical caseload data from foreign medical teams.

OBJECTIVE Humanitarian surgery is often organized and delivered with short notice and limited time for developing unique strategies for providing care. While some surgical pathologies can be anticipated by the nature of the crisis, the role of foreign medical teams in treating the existing and unmet burden of surgical disease during crises is unclear. The purpose of this study was to examine published data from crises during the years 1990 through 2011 to understand the role of foreign medical teams in providing surgical care in these settings. METHODS A literature search was completed using PubMed, MEDLINE, and EMBASE databases to locate relevant manuscripts published in peer-reviewed journals. A qualitative review of the surgical activities reported in the studies was performed. RESULTS Of 185 papers where humanitarian surgical care was provided by a foreign medical team, only 11 articles met inclusion criteria. The reporting of surgical activities varied significantly, and pooled statistical analysis was not possible. The quality of reporting was notably poor, and produced neither reliable estimates of the pattern of surgical consultations nor data on the epidemiology of the burden of surgical diseases. The qualitative trend analysis revealed that the most frequent procedures were related to soft tissue or orthopedic surgery. Procedures such as caesarean sections, hernia repairs, and appendectomies also were common. As length of deployment increased, the surgical caseload became more reflective of the existing, unmet burden of surgical disease. CONCLUSIONS This review suggests that where foreign medical teams are indicated and requested, multidisciplinary surgical teams capable of providing a range of emergency and essential surgical, and rehabilitation services are required. Standardization of data collection and reporting tools for surgical care are needed to improve the reporting of surgical epidemiology in crisis-affected populations.

Consensus Statements Regarding the Multidisciplinary Care of Limb Amputation Patients in Disasters or Humanitarian Emergencies: Report of the 2011 Humanitarian Action Summit Surgical Working Group on Amputations Following Disasters or Conflict

Limb amputations are frequently performed as a result of trauma inflicted during conflict or disasters. As demonstrated during the 2010 earthquake in Haiti, coordinating care of these patients in austere settings is complex. During the 2011 Humanitarian Action Summit, consensus statements were developed for international organizations providing care to limb amputation patients during disasters or humanitarian emergencies. Expanded planning is needed for a multidisciplinary surgical care team, inclusive of surgeons, anesthesiologists, rehabilitation specialists and mental health professionals. Surgical providers should approach amputation using an operative technique that optimizes limb length and prosthetic fitting. Appropriate anesthesia care involves both peri-operative and long-term pain control. Rehabilitation specialists must be involved early in treatment, ideally before amputation, and should educate the surgical team in prosthetic considerations. Mental health specialists must be included to help the patient with community reintegration. A key step in developing local health systems the establishment of surgical outcomes monitoring. Such monitoring can optimizepatient follow-up and foster professional accountability for the treatment of amputation patients in disaster settings and humanitarian emergencies.

Best Practice Guidelines on Surgical Response in Disasters and Humanitarian Emergencies: Report of the 2011 Humanitarian Action Summit Working Group on Surgical Issues within the Humanitarian Space

The provision of surgery within humanitarian crises is complex, requiring coordination and cooperation among all stakeholders. During the 2011 Humanitarian Action Summit best practice guidelines were proposed to provide greater accountability and standardization in surgical humanitarian relief efforts. Surgical humanitarian relief planning should occur early and include team selection and preparation, appropriate disaster-specific anticipatory planning, needs assessment, and an awareness of local resources and limitations of cross-cultural project management. Accurate medical record keeping and timely follow-up is important for a transient surgical population. Integration with local health systems is essential and will help facilitate longer term surgical health system strengthening.

Emergency surgery data and documentation reporting forms for sudden-onset humanitarian crises, natural disasters and the existing burden of surgical disease

Following large-scale disasters and major complex emergencies, especially in resource-poor settings, emergency surgery is practiced by Foreign Medical Teams (FMTs) sent by governmental and non-governmental organizations (NGOs). These surgical experiences have not yielded an appropriate standardized collection of data and reporting to meet standards required by national authorities, the World Health Organization, and the Inter-Agency Standing Committees Global Health Cluster. Utilizing the 2011 International Data Collection guidelines for surgery initiated by Médecins Sans Frontières, the authors of this paper developed an individual patient-centric form and an International Standard Reporting Template for Surgical Care to record data for victims of a disaster as well as the co-existing burden of surgical disease within the affected community. The data includes surgical patient outcomes and perioperative mortality, along with referrals for rehabilitation, mental health and psychosocial care. The purpose of the standard data format is fourfold: (1) to ensure that all surgical providers, especially from indigenous first responder teams and others performing emergency surgery, from national and international (Foreign) medical teams, contribute relevant and purposeful reporting; (2) to provide universally acceptable forms that meet the minimal needs of both national authorities and the Health Cluster; (3) to increase transparency and accountability, contributing to improved humanitarian coordination; and (4) to facilitate a comprehensive review of services provided to those affected by the crisis.

The inadequate treatment of pain: collateral damage from the war on drugs.

Jason Nickerson and Amir Attaran examine the vast inequities in medical pain relief around the world and argue that the global control of licit narcotics be shifted from the International Narcotic Control Board to WHO.

Monitoring the ability to deliver care in low- and middle-income countries: a systematic review of health facility assessment tools.

Introduction Health facilities assessments are an essential instrument for health system strengthening in low- and middle-income countries. These assessments are used to conduct health facility censuses to assess the capacity of the health system to deliver health care and to identify gaps in the coverage of health services. Despite the valuable role of these assessments, there are currently no minimum standards or frameworks for these tools. Methods We used a structured keyword search of the MEDLINE, EMBASE and HealthStar databases and searched the websites of the World Health Organization, the World Bank and the International Health Facilities Assessment Network to locate all available health facilities assessment tools intended for use in low- and middle-income countries. We parsed the various assessment tools to identify similarities between them, which we catalogued into a framework comprising 41 assessment domains. Results We identified 10 health facility assessment tools meeting our inclusion criteria, all of which were included in our analysis. We found substantial variation in the comprehensiveness of the included tools, with the assessments containing indicators in 13 to 33 (median: 25.5) of the 41 assessment domains included in our framework. None of the tools collected data on all 41 of the assessment domains we identified. Conclusions Not only do a large number of health facility assessment tools exist, but the data they collect and methods they employ are very different. This certainly limits the comparability of the data between different countries’ health systems and probably creates blind spots that impede efforts to strengthen those systems. Agreement is needed on the essential elements of health facility assessments to guide the development of specific indicators and for refining existing instruments.

Access to controlled medicines for anesthesia and surgical care in low-income countries: a narrative review of international drug control systems and policies

PurposeThis article describes the functioning of the international drug control system, its integration into national legislation and policy, and the collective impact on access to medicines.SourceWe conducted a review of the three international drug control conventions, peer-reviewed articles, and grey literature known to the authors that describes national and international drug control systems and their impact on access to controlled medicines. This review was supplemented with literature derived from a structured search of MEDLINE® for articles relating to medical uses of ketamine in low- and middle-income countries conducted to strengthen an advocacy campaign. We illustrate the impact of the drug control system on access to medicines through an analysis of current levels of availability of opioids in many countries as well as through a description of the ongoing advocacy work to ensure the availability of ketamine for medical care in low-income countries.Principal findingsThe complexity of the international drug control system, along with health providers’ lack of knowledge regarding key provisions, presents a barrier to improving access to safe anesthesia care in low- and middle-income countries. Fifteen of the 46 essential medicines of potential relevance to perioperative care are listed under one or more of the schedules of the three international drug control conventions and, subsequently, are required to be under national controls, potentially decreasing their availability for medical use.ConclusionImproving the capacity and quality of anesthesia care in low- and middle-income countries requires attention to improving access to controlled medicines. Anesthesiologists and others involved in global health work should collaborate with policymakers and others to improve national and international drug control legislation to ensure that attempts to thwart illicit drug trafficking and use do not compromise availability of controlled medicines.RésuméObjectifCet article décrit le fonctionnement du système de contrôle international des médicaments, son intégration dans les législations et politiques nationales, et l’impact collectif sur l’accès aux médicaments.SourceNous avons passé en revue les trois conventions internationales de réglementation des médicaments, des articles révisés par les pairs, et la littérature grise connue des auteurs pour décrire les systèmes de réglementation des médicaments nationaux et internationaux et leur impact sur l’accès aux médicaments réglementés. Ce compte rendu a ensuite été complété par la littérature issue d’une recherche structurée dans la base de données MEDLINE® pour en extraire les articles liés aux utilisations médicales de la kétamine dans les pays à faible et moyen revenu, recherches visant initialement à soutenir une campagne de sensibilisation. Nous illustrons l’impact du système de réglementation des médicaments sur l’accès aux médicaments par une analyse des taux actuels de disponibilité des opioïdes dans plusieurs pays ainsi qu’en décrivant le travail continu de plaidoyer afin de garantir la disponibilité de la kétamine pour les soins médicaux dans les pays à faible revenu.Constatations principalesLa complexité du système international de réglementation des médicaments, ajoutée au manque de connaissances des fournisseurs de soins de santé quant aux dispositifs clés, constituent d’importants obstacles à l’amélioration de l’accès à des soins anesthésiques sécuritaires dans les pays à faible et moyen revenu. Quinze des 46 médicaments essentiels potentiellement pertinents aux soins périopératoires sont inscrits dans un programme ou plus des trois conventions internationales de réglementation des médicaments et doivent par conséquent être réglementés au niveau national, ce qui pourrait potentiellement réduire leur disponibilité pour usage médical.ConclusionSi l’on souhaite améliorer les capacités et la qualité des soins anesthésiques dans les pays à faible et moyen revenu, il faut améliorer l’accès aux médicaments réglementés. Les anesthésiologistes et autres professionnels impliqués dans l’amélioration des soins de santé dans le monde devraient collaborer avec les responsables politiques et les législations de réglementation internationale des médicaments afin de garantir que les tentatives destinées à contrecarrer le trafic et l’utilisation illicite de médicaments ne mettent pas en péril la disponibilité des médicaments réglementés.

Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?

Background Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as “evergreening”, can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. Materials and Methods We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration’s Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product’s device patents and medicine patents. Results Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3–15.2 years). Conclusion Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes “evergreening” depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic improvements in the standard of care, which is highly debatable.

The Commission on Narcotic Drugs' attempt to restrict ketamine

On March 13, the Commission on Narcotic Drugs will convene in Vienna, Austria, for an annual meeting on drug control. On the Commission’s agenda is a proposal to place ketamine—the leading anaesthetic used in developing countries—under Schedule I of the 1971 Convention on Psychotropic Substances, the same sort of international control reserved for the most highly illicit psychotropic drugs, such as mescaline and LSD. If the proposal passes, it will be a catastrophe for access to ketamine and safe surgery in developing countries. The 1971 treaty contains a legal requirement that WHO must consent before the Commission can add any drug to Schedule I. In particular, the treaty gives WHO sole authority to decide whether “there is sufficient evidence [...] warranting the placing of [a] substance under international control”, and stipulates that, in this medical and scientifi c context, WHO’s “assessments shall be determinative”. Thus, while the Commission has normative responsibility and the United Nations Office on Drug Control (UNODC) has operational responsibility for the treaty, WHO can, by law, veto them taking steps to put a drug in Schedule I. WHO’s Expert Committee on Drug Dependence reviewed the evidence for the use and abuse of ketamine after a submission from the Government of China in June 2014, and has previously reviewed submissions in 2006 and 2012. WHO has consistently recommended against placing ketamine under international control (scheduling) because of insufficient evidence for widespread public health consequences resulting from its abuse and fear that scheduling would reduce medical access. The Expert Committee reviewed 32 submissions from anaesthesiology organisations, including several from low-income and middle-income countries, and advised against the scheduling of ketamine for the same reason. Despite WHO’s veto, UNODC has now committed the Commission to voting on whether to place ketamine under Schedule I. Not only is this unprecedented, but the UN’s own commentary on the 1971 treaty states that “The Commission could [...] not place in Schedule I [...] a substance which the World Health Organization has found to have more than a ‘very limited’ therapeutic usefulness” and warns that if the Commission tried to do so it “would act ultra vires” (ie, beyond its legal powers). This attempt to restrict ketamine is a simultaneous affront to global public health, human rights, and the rule of law. Access to controlled drugs in low-income countries is deplorably poor; the Commission should not repeat its mistakes by restricting access to yet another essential medicine.

Assessments of health services availability in humanitarian emergencies: a review of assessments in Haiti and Sudan using a health systems approach

BackgroundAssessing the availability of health services during humanitarian emergencies is essential for understanding the capacities and weaknesses of disrupted health systems. To improve the consistency of health facilities assessments, the World Health Organization has proposed the use of the Health Resources Availability Mapping System (HeRAMS) developed in Darfur, Sudan as a standardized assessment tool for use in future acute and protracted crises. This study provides an evaluation of HeRAMS’ comprehensiveness, and investigates the methods, quality and comprehensiveness of health facilities data and tools in Haiti, where HeRAMS was not used.Methods and findingsTools and databases containing health facilities data in Haiti were collected using a snowball sampling technique, while HeRAMS was purposefully evaluated in Sudan. All collected tools were assessed for quality and comprehensiveness using a coding scheme based on the World Health Organization’s health systems building blocks, the Global Health Cluster Suggested Set of Core Indicators and Benchmarks by Category, and the Sphere Humanitarian Charter and Minimum Standards in Humanitarian Response.Eight assessments and databases were located in Haiti, and covered a median of 3.5 of the 6 health system building blocks, 4.5 of the 14 Sphere standards, and 2 of the 9 Health Cluster indicators. None of the assessments covered all of the indicators in any of the assessment criteria and many lacked basic data, limiting the detail of analysis possible for calculating standardized benchmarks and indicators.In Sudan, HeRAMS collected data on 5 of the 6 health system building blocks, 13 of the 14 Sphere Standards, and collected data to allow the calculation of 7 of the 9 Health Cluster Core Indicators and Benchmarks.ConclusionsThere is a need to agree upon essential health facilities data in disrupted health systems during humanitarian emergencies. Although the quality of the assessments in Haiti was generally poor, the large number of platforms and assessment tools deployed suggests that health facilities data can be collected even during acute emergencies. Further consensus is needed to establish essential criteria for data collection and to establish a core group of health systems assessment experts to be deployed during future emergencies.