Global patient safety

Alphonse Chapanis wrote a seminal paper in 1960 where he exposed the unusually high rate of medication-related errors in a 1100-bed hospital. There were seven major causes of errors in the administration of drugs:

  1. Omission of medicine
  2. Administration to the wrong patient
  3. Use of the wrong dosage
  4. Use of an unintended extra dosage
  5. Use by the wrong route
  6. Use at the wrong timing
  7. Administration of the wrong drug

Almost 60 years later, this issue is still critically relevant, even in developed nations, which has prodded policymakers, administrators and physicians to take the necessary corrective steps. Chapanis had identified 4 major areas:

  1. Written communication
  2. Medication procedures
  3. Working environment
  4. Training and education

In 2004 the World Health Organization (WHO) designed two major initiatives to promote clean care and surgery under the umbrella of the “Global Patient safety challenges.” On March 29, 2017, its Director General announced the launching of a third one dubbed as “Medication without Harm” in front of the national health ministers meeting in Bonn, Germany. The goal is to reduce harm related to medications by 50% over 5 years.

Initially countries will be required to target three areas of priority; high risk situations, polypharmacy and transitions of care. Afterwards the national experts will design tailored programmes to make improvements in 4 areas: health care guidelines, administration of medications, patient education and public awareness. Finally the WHO will intervene with its great human and material capacities to implement effective monitoring programs, provide technical assistance, engage with regulatory agencies and pharmaceutical companies to improve the labelling of packages and ultimately to provide the patients themselves with tools to safely manage their own medications.

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Need for community health workers

When I was a medical student I studied the novel Chinese experience of the “barefoot physicians”—community health workers in its vast countryside. With a basic training and a lot of enthusiasm they provided critically needed access to clinical and obstetrical services for its impoverished population. In the years that have passed by, the Chinese central government has made a big investment in economic and human resources for the medicalisation of maternal care, which now occurs usually in well-equipped care centers.

Community health workers now play a pivotal role in most health care initiatives around the globe as they provide preventive and curative care to underserved, poor communities in far away regions with difficult access. The scarcity of health care personnel has given new impetus to their training and deployment in order to complement and even spearhead care initiatives. They are responsible for the great strides in malaria control and eradication.

An editorial in “The Lancet Global Health” says, “a quick look at the CHW panorama shows great success as well as missed opportunities. Large-scale government-led programmes in countries like Brazil and Tanzania, where CHWs are part of the formal health system, trained, and remunerated, have led to increased health care coverage and improved health indicators. Conversely, man local smaller-scale programmes that lack the necessary support system—clear financial and administrative planning and coordination—have proven to be unsustainable or misaligned with local needs, and have fallen through attrition or lack of utilization.”

Even though they often shoulder the burden to provide access to basic health services to underserved communities, the CHWs dwell in a “grey area” of the formal care systems as their professional role is not properly formulated and they are not efficiently trained to obtain a final certificate or diploma. The World Health Organization (WHO) has promoted a labour strategy to streamline and rationalize their training to integrate them into the systems. These good Samaritans need resources, good pay and a clear career pathway.

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A CDC for Africa

The pathogens do not carry passports and can cross all the frontiers at will.

Three years ago we were all scared that the Ebola virus outbreak that started in Western Africa would spread to the rest of the planet unhindered. There was a health system failure in the three countries involved as the Ebola virus data arrived to the Public Health functionaries in a hotch-potch of formats, which could not be analyzed fast and efficiently enough for a good response.

An editorial at “The Lancet Global Health” quoted Kevin De Cock, director at the US Centers for Disease Control and Prevention (CDC) who said: “there was a ‘chasm’ between laboratory and clinical practice. The turning point came with the institution of CDC-assisted incident management systems, which rapidly improved coordination and reporting structures, and set clear goals and expectations.”

In January the members of the African Society for Laboratory Medicine met in Cape Town where they decided to create an “African CDC” in order to count with the necessary facilities and trained personnel “in situ” for the next dangerous pandemia. The design and implementation of modern and reliable laboratory facilities coupled with the professional training of personnel is considered as the first step in the long process of modernization.

The African Union’s Agenda for 2016 showed the impact of these factors:

  1. Rapid population growth
  2. Increased movement of people across the frontiers
  3. Existing endemic and emerging infectious diseases
  4. Resistance to the first line antibiotics
  5. High infant and Maternal mortality rates
  6. Insufficient and inefficient Public Health assets

The embryonic African CDC and its partner organizations like the WHO and nation-states decided to strengthen the capacity in four priority areas:

  1. Modern information systems to reach critical decisions much faster
  2. Linked clinical laboratories in five regions of the continent
  3. Support of national Public Health preparedness and response plans
  4. Develop Public Health knowledge and practice at a local level.

Based in Addis Ababa, the African CDC will operate in a decentralized way with five Regional Collaborating centres in Egypt, Nigeria, Gabon, Zambia and Kenya with fully equipped laboratory and advanced diagnostics sites, which will be closer to the involved member states in case of an emergency. The new CDC will promote the establishment of National Public Health Institutes (NPHI) in each member state to obtain a legal mandate for action.

They are planning to develop a more efficient response system that does not rely solely in the dispatch of supplies and personnel from developed nations; they will design a surge capacity with stockpiles in the regional centers.

In the initial stage of a disease outbreak, a few days can make a difference. Considering all the public health implications for the rest of the planet, this novel African initiative must be supported by all the national governments.

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Mass deworming in developing countries

In times of fiscal restraints in developed countries and private donor fatigue to contribute for massive Public Health initiatives in the developing world, many programs have come under intense scientific and political scrutiny. Mass deworming of people infected with soil-transmitted helminthiasis and schistosomiasis—affecting almost one billion people worldwide—has been implemented with drugs given to school-age children in national campaigns.

Mass deworming per se cannot eliminate helminthiasis if it is not coupled with complementary long-term strategies to improve people’s access to clean water, sanitation facilities, proper housing and labour opportunities. This holistic approach has been pushed by the “Global Health diplomacy.” Several national governments, private donors, aid agencies and big pharma companies signed the “London declaration” to commit to a sustained control and eradication of soil-transmitted helminthiasis in developing countries.

Vivian A. Welch et al. searched 11 databases up to January 2016, websites, trial registers and contacted experts to review reference lists together. They studied the results of massive deworming that involved more than one million children and follow-up of 160,000 children after those campaigns.

Mass deworming with albendazole twice per year compared to controls did not show any improvement in weight or height over a 12 months-period. There was little to no difference in weight-for-height, proportion stunted, performance on short-attention tasks, school attendance and mortality. Mass deworming for schistosomiasis improved children’s weight but not height.

Subgroup and sensitivity analyses are based on aggregate level data, which might conceal the differences in results at the individual level or interaction with other sociological factors like poor sanitation, housing and transport. Treating infected and non-infected children will dilute the resulting data.  Even though studies that used proper screening and targeted treatment for helminthiasis showed benefits in the meta-analyses of results, the massive campaigns are more inexpensive and easier to logistically deploy worldwide. Is economics enough of a reason to treat both the infected and non-infected?

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The risks of drug trials

Clinical research trials have been the gold standard to study the safety and effectiveness of new drugs in the human beings for several decades. Even though the “Good Clinical Practice” protocols (GCP) have been refined by expert professionals with the supervision of competent, national authorities, there is still much to be done for the safety of the participants.

A November editorial in the prestigious New England Journal of Medicine discusses the tragic consequences of a phase 1 clinical trial in France that left one patient dead and three others with severe neurological damage after they were given doses of an experimental drug dubbed as BIA 10-2474. It is a fatty acid hydrolase inhibitor that targets the endo-cannabinoid system.

The question of potential risks compared to benefits of any drug must be carefully evaluated, even in Phase I where the emphasis is on its safety as it involves healthy volunteers that do not have anything to gain from its use.  Other drug companies had tested that drug before and determined that there was insufficient evidence of its efficacy to warrant a costly clinical trial.

Its “first-in-human” phase I clinical trial started in January 2016 in France with eight volunteers, six of whom received 50 mg daily of BIA 10-2474 and two were given a placebo as control. Four of these volunteers were admitted to Rennes University Hospital for an acute neurological syndrome with headaches, cerebellar signs, memory loss and altered consciousness. One became brain dead, two others improved but one has residual deficits.

The clinical and radiological data suggested direct toxicity of the drug in an “off-target” location as increasing daily doses were used. On day five the volunteer that eventually died presented with blurred vision and gait problems; by day seven he was hypotensive and his heart rate dropped to 40/ minute. In spite of this development, the trial was not stopped immediately.

Even if they follow the protocol, investigators must have clinically-guided common sense to know when to stop a trial in spite of the potential financial losses. If this grave incident happened in a country like France, with its long civic tradition of protection of individual citizens’ rights, what can we expect in other countries with less patients’ safeguards?

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The Health Care personnel shortage

 

In November 2013, the World Health Organization (WHO) released a report stating that there would be a shortage of almost 13 million Health Care workers worldwide by 2035. The report identified several key factors including an aging workforce with staff retiring or leaving for better-paid jobs without being replaced and the parallel phenomenon of not enough young people joining the ranks or getting the needed professional formation. The global modernization with its increased incidence of cardiovascular diseases and the migration of qualified personnel compound the problem.

There is a generalized consensus that investing in human resources in the Health Care arena has economic and societal gains. The Lancet Commission on Investing in Health showed “that, based on the value of life-years lived between 2001 and 2011, the return on investment was close to 10:1. Despite wide variations between countries—health workers comprise less than 4% of the workforce in Mexico, 14% in the UK and almost 20% in Norway—over time the health sector accounts for a growing share of total employment.”

The supply of Health Care personnel is shaped by the market demands; there is an oversupply of medical specialists with a dearth of general practitioners. Unable to meet the educational demands many governments have approved private teaching institutions of dubious credentials and worse outcomes. Moreover the medical career attracts wealthier students that settle in urban areas after graduation, perpetuating the economic and social imbalances.

In the USA the healthcare worker shortage crisis is expected to intensify as the baby boomers retire en masse and newly insured citizens by Obamacare apply pressure on an already over-burdened system. As the older workers retire, there are far fewer young recruits entering the health care system. The industry’s turnover rate is almost 20% due to burnout and frustration. The biggest complaint of health workers is lack of professional advancement.

If so many health care workers are retiring and so few are replacing them, who is going to take care of all of us when we really need their services?

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The Medicaid coverage gap

When the “Affordable Care Act” was designed, the legislators envisioned the expansion of the Medicaid program to all Americans with household incomes up to 138% of the “Federal Poverty Level” (FPL). Literally the law expands the Medicaid coverage up to 133% of FPL but it has an income calculation equation that does not include the top five percentage points.

The law required states to markedly expand the Medicaid coverage in order to continue the transfer of federal funds to match their funding. The federal government would pay the full cost of the expansion for the first three years (2014 through 2016) and the states would begin to pay a small amount that would eventually reach 10% of the total cost by 2020. In 2012, the Supreme Court allowed the states to voluntarily decide whether to expand it or not.

In the nineteen states, including Florida, that have decided not to expand the Medicaid program, the eligibility is quite limited: the median income for parents in 2016 is 44% of the FPL or an annual income of aprox.US 8,800 a year for a family of three and childless adults are not eligible for benefits. In those states that do not expand Medicaid, many adults fall into a “Coverage gap” of having incomes above the eligibility limits but below the lower limit to qualify for the Marketplace premium tax credits set by Obamacare.

Even though the individuals trapped in the coverage gap are spread in all states, 90% of them live in the South (25% in Texas, 20% in Florida, 11% in Georgia and 8% in North Carolina) where eligibility requirements are high. Given that Minorities are more likely than Whites to live in families with low incomes, they are disproportionately represented in the coverage gap. Nearly half of them are of a mature age with unmet care needs; a quarter of them are poor parents of eligible children, making the latter hard to reach.

Almost two thirds of individuals in the coverage gap are in a family with a worker and almost half of them actually work. In turn, half of those who work are in small businesses or service industries that do not give coverage. If those “renegade” states would expand coverage, they would all qualify.A study from the Department of Health and Human Services showed that, in the states that have expanded Medicaid coverage, the insurance in the marketplace for middle income citizens cost less than in states that did not.

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