Category: Medical Industry

Nearly Half of Care Home Nurses Report Medication Errors

Bottle of pills
Source: Pixabay CC0

In a questionnaire-based study published in Pharmacology Research & Perspectives, nearly half of all nursing staff made at least one error within the last year when administering medications.

The aim of the study was to find out how often medication errors occur and whether they are related to training, quality assurance measures (use of the double-check principle (DCP)), and other structural conditions of home care services. 

In the study, 41.6% of nurses reported medication errors within a 12-month period, and 14.8% did not provide an answer. Medication errors experienced by patients include taking the wrong dose or quantity of a particular drug, as well as omission of a drug or taking unlicensed drugs. 

Nurses who had attended medication training within the last 2 years were less likely to make errors.  Years of professional experience, patient numbers per shift, and full time versus part time work were not statistically significantly associated with reported medication errors. 

“The study results underline the need for regularly recurring medication training for nurses to ensure a high level of patient safety – especially in the home care sector, as nurses are the only professional group on site,” said lead author Sandra Strube-Lahmann, RN, MSc, PhD, of Charité – Universitätsmedizin Berlin, in Germany.

Source: Wiley

Cake Decoration Identifies Pills, Fighting Drug Fraud

Chocolate drops covered with candy nonpareils (left), a bowl of colourful candy nonpareils (centre), pharmaceutical caplets coated with nonpareils (right). Credit: William Grover/UCR

During lockdown, UC Riverside bioengineering professor William Grover kept busy counting the colourful candy sprinkles perched on top of chocolate drops. In the process, he hit upon a simple way to prevent pharmaceutical fraud and detailed it in the journal Scientific Reports.

He calls the technique ‘CandyCode’ and uses tiny multi-coloured candy nonpareils commonly known as ‘hundreds and thousands’ in South Africa as a uniquely identifiable coating for pharmaceutical capsules and pills.

Millions of people are harmed by counterfeit or substandard medicine, a problem which costs an estimated $200 billion annually. One in 10 medical products in developing countries is fake, according to a WHO estimate.

Prof Grover’s lab has previously worked on simple, low-cost ways of verifying the authenticity of pharmaceuticals. Other researchers have tried putting unique codes onto pills, but these solutions have drawbacks.

“The inspiration for this came from the little colourful chocolate candies. Each candy has an average of 92 nonpareils attached randomly, and the nonpareils have eight different colours. I started wondering how many different patterns of coloured nonpareils were possible on these candies,” explained Prof Grover. “It turns out that the odds of a randomly generated candy pattern ever repeating itself are basically zero, so each of these candies is unique and will never be duplicated by chance.”

This gave Prof Grover the idea that the nonpareils could be applied as a coating to each pill, giving it a unique pattern that could be stored by the manufacturer in a database. Consumers could upload a smartphone photograph of a pill and if its CandyCode matches one in the database, the consumer could be confident that the pill is genuine. If not, it is potentially fraudulent.

To test this idea, Prof Grover stuck nonpareils onto Tylenol (acetaminophen) capsules and developed an algorithm that converts a photo of a CandyCoded pill into text which could be stored on a database and accessed by consumers. Using this algorithm to analyse a set of CandyCode photos, he found they serve as universally unique identifiers, even after subjecting the CandyCoded pills to physical abuse that simulates the wear-and-tear of shipping.

“Using a computer simulation of even larger CandyCode libraries, I found that a company could produce 1017 CandyCoded pills – enough for 41 million pills for each person on earth – and still be able to uniquely identify each CandyCoded pill,” Grover said.

More colours and different shapes of nonpareils could generate even more unique CandyCodes. CandyCoded capsules or tablets have an unexpected benefit for the consumer as well. 

“Anecdotally, I found that CandyCoded caplets were more pleasant to swallow than plain caplets, confirming Mary Poppins’ classic observation about the relationship between sugar and medicine,” Prof Grover remarked.

Source: EurekAlert!

Closure Threat for SA’s COVID Vaccine Plant as Orders Dry up

Female scientist in laboratory
Photo by Gustavo Fring on Pexels

South Africa’s COVID vaccine production plant, the first of its kind in Africa is at risk of closure after failing to secure a single according to a report from Reuters. President Cyril Ramaphosa is reported to be in talks with three other African nations in effort to save the venture.

The World Health Organization had called the licensing deal between Johnson & Johnson and Aspen Pharmacare to manufacture the Aspenovax COVID vaccine, a “transformative moment” in the pursuit of equitable access to vaccines. The vaccine is the J&J adenovirus vector vaccine sold under the Aspen brand.

However, after initial vaccine delivery shortfalls, the African continent is now well stocked with vaccines, while the poor infrastructure hampers vaccine distribution.

“There’ve been no orders received for Aspenovax,” Reuters reported, citing a phone conversation with Aspen senior director Stavros Nicolaou.

“If we don’t get orders, we would have to repurpose these lines back into other things that we were previously doing,” he told CapeTalk.

There are several other such vaccine plants in various stages, as the African Union aims at 60% of locally produced vaccines for continent locally by 2040, up from the current 1%.

“If Aspen doesn’t get production, what chance is there for any of the other initiatives?” Nicolaou remarked.

Regarding possible options, he said: “We are exploring various options. It is our medium-to-long-term objective to look at providing a sterile [processing] platform and solutions for the continent but the short-term needs to be sorted out.”

Moderna announced an agreement with Kenya to set up its first mRNA manufacturing facility in Africa with the aim of producing up to 500 million doses a year.

Source: Seeking Alpha

Life Insurance Premium Hike on the Cards for the Unvaccinated

Coffin in hearse at a funeral
Photo by adrianna geo on Unsplash

After a staggering increase of R24.9 billion in claims from COVID, South African life insurers are faced with little option but to implement a premium hike on policies for the unvaccinated. Death rates among unvaccinated people could remain elevated even as the pandemic eases, despite the lower severity of Omicron.

The Association for Savings and Investment SA (Asisa) provided death claims data from 1 April 2021 to 30 September 2021, a period which covered the third COVID wave (May to September). Compared to the same pre-pandemic period in 2019, there was a 53% surge in claims was reported, with a more than doubling of value of death claims. There were 565 522 claims, totalling R44.42 billion, compared to the pre-pandemic period’s 369 892 claims of R19.53 billion.

Though deaths were greatly reduced in the fourth wave, with Asisa acknowledging “anecdotal evidence” showing reduced severity from the Omicron variant, there was still “overwhelming evidence” that COVID mortality risks are far higher for the unvaccinated. Asisa’s data reflects that of the South African Medical Research Council (SAMRC), which shows a huge increase in the number of excess deaths over that period.

This information comes as the government debates easing lockdown measures even as various institutions warn of an impending fifth wave, which according to Absa bank could come as early as next month. However, Absa noted that its life claims were much reduced over the fourth wave as compared to the third, and therefore expects the fifth wave to be less severe.

Hennie de Villiers, the deputy chair of Asisa’s life and risk board committee, said that the importance of life insurance cover had been clearly demonstrated. “The reality is that most of us know at least one person who lost his or her life due to COVID. We also know of many more people who lost their income during the pandemic, highlighting the importance of having access to savings.”

He cautioned that, “While the death rate has been lower during the fourth wave than in previous waves due to vaccinations and the emergence of the Omicron variant, death claims rates have not yet returned to pre-pandemic levels. Also, less than 50% of our adult population has been vaccinated.

“There is overwhelming evidence that the risk of severe illness or death is significantly lower in those who are fully vaccinated.”

He added in a later statement that if the situation does not change and vaccinations are not embraced by the country, insurers may have “little choice but to adjust premiums in line with the higher risk presented by someone who is not vaccinated and therefore more likely to die from COVID”.

De Villiers said a “staggering” 1.59-million death claims were received in the 18 months from 1 April 2020 to 30 September, with life insurers paying out benefits of R92 billion.

Group life insurance premiums have already increased for the unvaccinated, De Villiers pointed out. Employers with mandatory vaccination policies are meanwhile benefitting from preferential rates.

When unvaccinated status is combined with age and comorbidities, premium increases, this resulted in premium increases of as much as 100% and in some cases coverage was even declined.

Source: Business Live

Generic Options for HIV Prophylactic Cabotegravir Locked Out, MSF Warns

Image of a syring for vaccination
Photo by Mika Baumeister on Unsplash

Médecins Sans Frontières (MSF) has warned that pharmaceutical company ViiV’s recent decision not to pursue voluntary licensing for the long-acting HIV prophylactic cabotegravir (CAB-LA) means that lower cost generic production in low- and middle-income countries (LMICs) is effectively locked out for countries like South Africa.

CAB-LA was approved for the prevention of HIV infection by the USFDA in December 2021, and ViiV currently charges $3700 (R55 000) per vial in the US ($22 200/R333 000 annually per person). The Clinton Health Access Initiative (CHAI) has shown that generic manufacturers could produce this drug for around $2.60 (R39) per vial (less than $20/R3000 per person per year). Although ViiV has publicly said they would provide CAB-LA for their at-cost price in many LMICs, they have yet to announce what that price is.

According to MSF, generic manufacturer prices are often much lower than the patented drug – and they can even produce complicated formulations like CAB-LA.  The generic equivalent [PDF] of ViiV’s paediatric formulation of the HIV drug dolutegravir costs 22 times less.

Amanda Banda, Infectious Diseases Policy and Advocacy Advisor of the MSF Access Campaign, said: “What good is HIV prevention if the people who need it can’t afford it? This is the most effective form of HIV prevention for vulnerable and marginalised communities and yet ViiV is delaying the ability of generic manufacturers to supply the drug, meaning that many people across low- and middle-income countries who would benefit from the medicine to prevent HIV infection won’t be able to access it. CAB-LA will need to be available at a price that is comparable to currently available oral PrEP if country treatment programs and donors are expected to scale up its use to the levels needed – and it’s hard to imagine that ViiV will make CAB-LA available at less than $40 (R600) per year.  ViiV needs to immediately sign a licensing deal with the Medicines Patent Pool so that more affordable generics can be produced, and more lives can be saved.”

Dr Tom Ellman, Head of MSF’s South African Medical Unit said: “We want to urgently make this drug available for people at high risk of HIV infection in our programs in sub-Saharan Africa – we don’t want a donation with many strings attached from the corporation; it is not the role of ViiV to control the use of a drug that is approved by the USFDA. We want ViiV to sell us this drug at an affordable price.”

Source: MSF

A Synthetic Alternative to Pig-derived Heparin

Photo by Corinna Widmer from Pexels

Scientists have developed a process to synthesise the vital blood thinner heparin, which is normally harvested from pig intestines. This synthetic heparin would help the quality control issues and shortages associated with pig-derived heparin.

The most expensive part of a pig is not a cut of bacon or a chop, but the part of the intestine used to make heparin. About 2000 pigs required to produce a kilogram of heparin, which provides medication to up to 6000 patients. In total, it is estimated that about one billion primarily Chinese food pigs each year also supply intestines for the extraction and processing of heparin.

However, this can cause problems for patients. When making medicines derived from animals, the chemical structure is rarely uniform. There are relatively common but harmless side effects, and in very rare cases severe and life-threatening immune reactions. Additionally, there are ethical and religious concerns for many patients. Bovine- and sheep-derived heparin are also produced but have the same concerns of being of animal origin. In fact, prior to 2000, heparin was derived from cows until the outbreak of mad cow disease.

Therefore, it has long been an ambition among researchers to make heparin in a laboratory to get cleaner heparin without side effects. Now researchers from the Copenhagen Center for Glycomics at the University of Copenhagen are ready with a study that shows that it is possible to make heparin without the use of animals.  which was published in Science Advances.

“By making heparin without the animal, you get a much cleaner and more uniform chemical structure. We show that we can do it in the laboratory, i.e. in a so-called ‘cell factory’, in the same way as many other types of medicine are made. It is a step in the direction of the development that has also happened with insulin, which was previously extracted from the pancreas in pigs before we learned to produce it in the laboratory,” explained Associate Professor Rebecca Miller, who led the study. 

There is already a synthetic alternative to heparin, but it is difficult to dose and can lead to overdose. Because of this, GPs often prescribe pig-derived heparin to their patients.

Heparin is today extracted from pig intestines’ mucosa. Due to the sheer number of patients who need the medicine, the scale of the production is vast, making quality control a recurring problem for manufacturers.

In 2008, a number of stocks of heparin from Chinese pigs were recalled when it was found that the medicine was contaminated. The case ended up costing the lives of more than 100 Americans.

“Of course you want to avoid that, in addition to moving the source from animals to laboratory cells. With our new technology, we have made a design for how to make heparin in a cell that is clean and uniform and it suggests that it has the same medicinal effect as market heparin. In this way, you potentially get a product that leads to neither common nor life-threatening side effects,” said Richard Karlsson, PhD, who has also contributed to the main author of the study.

Right now, the world is facing a shortage of heparin because swine flu has thinned the pig population in China, the largest heparin producer.
Next steps would be to scale up production to provide much larger quantities of the new synthetic heparin. 

Source: University of Copenhagen

ICD-11 Comes into Effect

Source: Pixabay

The World Health Organization (WHO) has announced that the Eleventh Revision of the International Classification of Diseases (ICD-11) has now come into effect, with the latest update going online on Friday, 11th February.

Compared with previous versions, ICD-11 is entirely digital with a new user-friendly format and multilingual capabilities that reduce the chance of error. It has been compiled and updated with input from over 90 countries and unprecedented involvement of health-care providers, enabling evolution from a system imposed on clinicians into a truly enabling clinical classification and terminology database that serves a broad range of uses for recording and reporting statistics on health. It also allows entries to appear in multiple categories: for example, stroke appears under both the cardiovascular and neurological categories.

“International classification of diseases is the cornerstone of a robust health information system”, said Dr Samira Asma, the Assistant Director-General for Data, Analytics and Delivery for Impact at the World Health Organization (WHO). “ICD has been instrumental in helping us respond to the COVID pandemic using standardised data and continues to be crucial for tracking progress towards universal health coverage. We hope all countries will take advantage of ICD-11’s powerful new features.”

Among other updates, ICD-11 improves the clarity of terms for the general public and facilitates the coding of important details such as the spread of a cancer or the exact site and type of a fracture. The new version also includes updated diagnostic recommendations for mental health conditions and digital documentation of COVID certificates.

These updates reflect recent progress in medicine and advances in scientific understanding. For example, codes relating to antimicrobial resistance are now aligned with the Global Antimicrobial Resistance Surveillance System (GLASS). ICD-11 is also more capable of capturing data on health-care safety, thus identifying and reducing unnecessary events that may harm health such as unsafe workflows in hospitals.

ICD is used by health insurers who make reimbursement decisions on the basis of ICD coding, by national health programme managers, by data collection specialists, and by anyone who tracks progress in global health and determines health resource allocation.

“A key principle in this revision was to simplify the coding and provide users with all necessary electronic tooling – this will allow health-care professionals to more easily and completely record conditions,” says Dr Robert Jakob, Team Lead, Classifications Terminologies and Standards, WHO.

In addition to coding and capability updates, ICD-11 includes new chapters on traditional medicine, sexual health, and gaming disorder – which has now been added to the section on addictive disorders.

ICD-11 was adopted at the World Health Assembly in May 2019 and Member States committed to start using it for mortality and morbidity reporting in 2022. Since 2019, early adopter countries, translators, and scientific groups have recommended further refinements to produce the version that is posted online today.

Source: World Health Organization

SA Healthcare Bolstered With Vaccine Lab Investment and Loans

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Last week, South African healthcare received a double shot in the arm with the opening of a local vaccine manufacturing facility and the approval of a World Bank loan to bolster social safety nets and health systems.

On Wednesday, President Cyril Ramaphosa and health technology billionaire Dr Patrick Soon-Shiong officially opened a new vaccine manufacturing facility in Brackenfell, Western Cape.

The South African-born entrepreneur has been strongly supporting local healthcare, with R3 billion invested to help SA share vaccine technology with the rest of Africa. His company, ImmunityBio, is developing a T-cell based universal COVID vaccine, currently in Phase III trials in SA. The same adenovirus vector technology it uses is also being tested in cancer vaccines.

“It has been a dream of mine, since I left the country as a young physician, to bring state-of-the-art, 21st century medical care to SA and to enable the country to serve as a scientific hub for the continent,” Dr Shoon-Siong had previously said. The technology transfer will help “establish much-needed capacity and self-sufficiency.”

The hub will transfer technology, know-how and materials for DNA, RNA, adjuvant vaccine platforms and cell therapies to SA.

“There is no reason we couldn’t make 500 million doses a year,” said Dr Soon-Shiong, who is also a Wits alumnus. “Subject to the raw material being available.”

He said he wants to tap the country’s expertise on prevalent diseases such as HIV and cervical cancer. “There are fantastic scientists with deep knowledge about these diseases,” he said. “More so than in America because they see these patients every day.”

President Ramaphosa and Dr Soon-Shiong also launched the Coalition to Accelerate Africa’s Access to Advanced Healthcare, which aims to drive the development of innovative therapeutics and ensure the continent is prepared for future pandemics.

The coalition aims to manufacture a billion doses of the COVID vaccine by 2025 and to develop treatments for conditions including cancer, COVID, tuberculosis and HIV.

South Africa also received approval from the World Bank for a US$750 million COVID relief loan aimed at reducing the worst of the pandemic’s impact on the poor.

“The World Bank budget support is coming at a critical time for us and will contribute towards addressing the financing gap stemming from additional spending in response to the COVID crisis,” said Dondo Mogajane, Director General of the National Treasury. “It will assist in addressing the immediate challenge of financing critical health and social safety net programs whilst also continuing to develop our economic reform agenda to build back better.”

Meanwhile, Health Minister Dr Joe Phaahla warned that South Africa will likely enter a fifth wave when cold temperatures in May, though what COVID variants may drive it remain to be seen.

Health Tech Startup Set to Grow in Africa

Photo by Ivan Samkov from Pexels

Ghanaian health tech startup mPharma is building a network of community pharmacies across Africa as it plans to be the go-to primary healthcare service provider for millions of people. Drug supply in Africa is often unaffordable and counterfeits are rife.

The startup’s community (Mutti) pharmacies are essentially mini-hospitals offering affordable services, ranging from medical consultation to diagnostic and telehealth services. 

The company plans more Mutti pharmacies to extend its reach ater raising $35 million, bringing the total amount raised by mPharma to $65 million.

According to mPharma co-founder and CEO Gregory Rockson told TechCrunch, the new financing will be used to ramp up its infrastructure, staff and expansion into African markets.

“We are hiring over 100 engineers to build all our technology in-house and this includes a massive data infrastructure we are creating. We are also investing in other skilled talent like doctors and nurses, professionals that are critical in the work we do,” Rockson told TechCrunch.

Originally founded in 2013, mPharma aims to manage prescription drug inventory for pharmacies and their suppliers, retail pharmacy operations and to provide market intelligence to hospitals, pharmacies and patients.

In October 2021, the startup added telehealth services to its portfolio, catching the telemedicine wave brought in by the COVID pandemic. Rockson told TechCrunch the startup was planning to have 100 virtual centres after six months. The number of virtual centres is primed to grow further alongside mPharma’s plan to increase its community pharmacies from 200 to over 2000 in three years.

Patients in Ghana, Nigeria, Kenya, Zambia, Malawi, Rwanda and Ethiopia, where mPharma has a presence, can access these virtual services. Startups like mPharma aim to address healthcare gaps in Africa. 

Sub-Saharan African countries have an average of 0.23 doctors for every 10 000 people against the best ratio of 84.2 doctors in some of the most developed countries. In addition, healthcare infrastructure remains critically underdeveloped.

“COVID showed us that the best form of care is local, it is in the community, and the closest thing in communities are pharmacies. We believe that the pharmacy of the future, which is what we are creating, is one built around longitudinal care not episodic care,” said Rockson.

“We are transforming community pharmacies into the foundation of a modern health system in Africa. We will have a Mutti pharmacy in every community on the continent, guarantee the availability and safety of medicines for each community and utilise the physical infrastructure of Mutti pharmacies to expand Mutti Doctor (the telemedicine service), creating the largest network of doctor offices and diagnostic centres.”

Source: TechCrunch

‘Extensive Network’ of Opaque Medical Industry Ties

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A study published by the BMJ shines a light on an extensive network of financial and non-financial ties maintained by the medical product industry with all major healthcare parties and activities.

The researchers called for greater oversight and transparency for this largely opaque and unregulated network, “to shield patient care from commercial influence and to preserve public trust in healthcare.”
While the medical product industry is a critical partner in advancing healthcare, especially with the development of new tests and therapies, they have financial returns to shareholders as their main objective.

In a landmark 2009 report [PDF], the Institute of Medicine described a multifaceted healthcare ecosystem rife with industry influence.

To date most research into medical industry conflict of interests have focused on a single party (eg. healthcare professionals, hospitals, or journals) or a single activity (eg. research, education, or clinical care). Thus, the full extent of industry ties across the healthcare ecosystem remains uncertain.

To address this gap, a team of US researchers set out to identify all known ties between the medical product industry and the healthcare ecosystem.

They searched the medical literature for evidence of ties between pharmaceutical, medical device, and biotechnology companies and parties (including hospitals, prescribers and professional societies) and activities (including research, health professional education and guideline development) in the healthcare ecosystem.

The researchers drew in data in 538 articles from 37 countries, along with expert input, to create a map depicting these ties. These ties were then verified, catalogued, and characterised to ascertain types of industry ties (financial, non-financial), applicable policies on conflict of interests, and publicly available data sources.

The results show an extensive network of medical product industry ties – often unregulated and non-transparent – to all major activities and parties in the healthcare ecosystem.

Key activities include research, healthcare education, guideline development, formulary selection (prescription drugs that are covered by a health plan or stocked by a healthcare facility), and clinical care.

Parties include non-profit entities (eg foundations), the healthcare profession, the market supply chain (eg payers, purchasing and distribution agents), and government.

For example, the researchers describe how opioid manufacturers provided funding and other assets to prescribers, patients, public officials, advocacy organisations, and other healthcare parties, who, in turn, pressured regulators and public health agencies to stifle opioid related guidelines and regulations.

They also warned that harms from industry promoted products remain unexplored. All party types were found to have financial ties to medical product companies, with only payers and distribution agents lacking additional, non-financial ties.

They also show that policies for conflict of interests exist for some financial and a few non-financial ties, but publicly available data sources seldom describe or quantify these ties.

The researchers acknowledge that their findings are limited to known or documented industry ties, and that some data might have been missed. However, they say their strategy of systematic, duplicative searching and feedback from an international panel of experts is unlikely to have missed common or important ties.

In light of this, they conclude: “An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patients from commercial influence and to ensure public trust.”

Source: EurekAlert!