Data Mining and Signal Detection in Pharmacovigilance

Data Mining and Signal Detection in Pharmacovigilance

A signal is described by the World Health Organization as any information that is reported on a possible or potential causal relationship between a drug and the adverse event it spawns. This relationship can be of virtually any nature, so long as it concerns the drug and the subject, and it could be either new or one with a precedent.

Data mining can be described as the method of obtaining data from target groups to help the clinical study come to important assessments and conclusions. Many a time, it is not clear whether a drug’s expected benefits outweighs the potential risks it brings about or vice versa, till the drug goes for marketing authorization. In order to assess this to the extent possible, clinical pharmacologists weigh the benefit and risk evaluation of medicines using tools such as data mining. Data mining is done both at the individual level of a subject and at the macro level of the population at large. These two methods are usually inseparable from each other, in that almost no study is done exclusively for one group.

Given its ability to help pharmacologists discern the various patterns that emerge from a clinical study; data mining is acquiring a position of importance of late and is being used in almost all stages of drug development. This could range from the earliest stage, namely drug discovery and could go up to post-marketing surveillance.

The WHO’s Uppsala Monitoring Centre

Data Mining and Signal Detection in Pharmacovigilance1

In order to make the results of very clinical study done in every part of the world accessible to everyone – a formidable task without doubt – the WHO has formulated the Uppsala Monitoring Center. This is a universal database of all the results obtained from clinical research the world over. Although voluntary and missing data from a many studies; the UMC is a comprehensive attempt at establishing a data mining and signal detection system that is accessible to everyone concerned. The UMC can thus be considered the universal data mining and signal detection database.

With over 2.5 million case reports of various clinical studies done all around the world, the UMC has evolved over time as a data mining and signal detection database. It initially started by requiring principals of clinical studies to generate new drug and Adverse Drug Reactions (ADR) combinations every three months. With the growth in the number of studies and the variety of issues they threw up; this was no longer considered feasible.

The UMC then started out to create its own method, by which the principles of making an objective initial assessment of all new drug and ADR combinations started getting implemented as they emerged. To this were added the requirements of bringing about a transparent selection of drug – ADR combinations for review, as well as suggest a quantitative aid to data mining and signal detection.

Data Mining and Signal Detection in Pharmacovigilance3

Today, the UMC uses several methodologies to carry out its task of being at the forefront of data mining and signal detection. It uses the Bayesian Confidence Propagation Neural Network, which uses Bayesian statistics within the architecture of a neural network for data mining and signal detection.

click to continue reading

What is logistics and supply chain management?

What is logistics and supply chain management

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.

Logistics and supply chain management is emerging as a major area of business because of the evolution and growth of globalization. Many products and goods are produced in one country and consumed in another situated thousands of miles away. The right logistics and supply chain management helps to deliver the goods and products to the right person, at the right time, at the right place and in the right condition. Lack of proper logistics and supply chain management is a recipe for disaster.

logistic-and-supply-chain-management
What is logistics and supply chain management?Among the lay people, there is a tendency to use the two words synonymously and interchangeably. In trade, however, there are major differences between the two. Logistics is just a part of the supply chain. In simple, general and broad terms, one can understand the difference between logistics and supply chain in the following ways:

Logistics is a part of supply chain, meaning that it is a set of activities that are carried out within an organization. Supply chain, on the other hand, is the full set of activities that are carried out from start to finish, i.e., from the time it departs the organization that it is leaving till the time it reaches its logical destination. In this process, supply chain management involves the coordination and collaboration of many entities. In this sense, supply chain is a whole set of activities, of which logistics is only a part.

Another way of understanding logistics and supply chain management 

logistic-and-supply-chain-managementAnother way of understanding logistics and supply chain management is this:

Logistics can be understood as being a discipline in which the following activities are involved:

logistic-and-supply-chain-management

On the other hand, supply chain management can be said to include more extended activities, which include:

logistic-and-supply-chain-management

Logistics and its extended activitiesLogistics often is described in terms of inbound and outbound logistics. Simply put, inbound logistics is the movement of raw materials and goods that are bought by and transported into a company. When these are processed and finished and shipped to customers; they become part of outbound logistics.

Logistics and supply chain management in a broader contextWhen one tries to get an understanding of logistics and supply chain management at a higher or broader level in the way logistics has been described above; supply chain management can be understood as consisting of these elements:

logistic-and-supply-chain-managementA sound supply chain system seeks to create value for the organization by building and utilizing logistics infrastructure. Logistics and supply chain management become meaningful when the organization synergizes demand with supply, stock and supply and inventory management

 

click to continue reading

Risk Management and Compliance in the Healthcare Industry

Risk Management and Compliance in the Healthcare Industry.jpg

Risk management and compliance in the healthcare industry requires a high degree of foresight, observation and knowledge of the regulatory rules and principles. Apart from being aware of the regulations, risk management and compliance in the healthcare industry is a lot about being smart, inventive and observative about the day-to-day aspects of the workings of the industry, as this highly operationalized activity is changing at a rapid pace.

Risk managers in charge of risk management and compliance in the healthcare industry need to equip the Board of Directors of the healthcare settings in which they work with much more than just the regulations that need to be put in place. They also need to impart insights into how this is to be done while keeping the costs low and at the same time, improving business.

These are the most important factors that make risk management and compliance in the healthcare industry extremely important:

risk-management-and-compliance-in-the-healthcare-industry

Regulatory pressure is too much to bear

 

In the current scenario of highly reinvigorated regulatory oversight in the healthcare industry, there is heavy pressure on risk managers to implement risk management and compliance in the healthcare industry in an optimal manner. The fervor of regulatory requirements and level of supervision from the regulatory bodies have gone up so drastically of late that in a recent survey, PriceWaterhouseCooper found out that half the people on the corporate board governance in hospitals said that they regard risk management as their greatest priority for the next few years.

This trend is triggered by a host of factors, all of which could contribute to making risk management and compliance in the healthcare industry all the more critical in the years ahead. Some of the factors that have accelerated this sense of urgency and criticality are:

Burgeoning cost of healthcare: 

risk-management-and-compliance-in-the-healthcare-industryAs the US healthcare industry grows into a multi-trillion dollar industry; there is a need for ensuring risk management and compliance in the healthcare industry.

Rapid increase in many diseases: Many diseases in the US are mostly a result of undisciplined and profligate lifestyles. This has placed a heavy burden on the healthcare sector to both implement preventive measures and improve standards in healthcare administration.

Technological improvements: History has shown that every improvement in technology has brought about more and more illnesses and disease, as technology makes people more sedentary. This has increased the pressure of risk management and compliance in the healthcare industry, as they are under higher pressure to implement strategies aimed at containing these.

Need to reinvent to stay ahead of the curve

 

All these factors are pushing corporate boards in healthcare to take a relook at the way risk management and compliance in the healthcare industry has been functioning. They have realized the need to implement these with a fresher and more urgent, yet intuitive approach. They need not just the judiciousness needed for grasping the present state of affairs in the industry; they need to also have sufficient foresight in anticipating the kind of change the industry is likely to undergo in the next few years.

risk-management-and-compliance-in-the-healthcare-industryThe proper understanding and implementation of risk management and compliance in the healthcare industry sits at the core of this need for hospitals to stay abreast and ahead of the competition. Relying on traditional models of risk management and compliance in the healthcare industry is likely to take them only that far. The risk managers need to have the ability to develop enterprise-wide risk management strategies that withstand the onslaught of rapid changes and absorb them into the system.

 

click to continue reading

 

 

What are the potential areas of risk management?

 

What are the potential areas of risk management.jpgThe most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.

In a very broad sense, the potential areas of risk management include all areas of a business, because simply no area of the business is exempt from a risk. Talk about finance, and it comes with a risk. What about manufacturing? And what about operations or marketing? How about human resources? In this very expansive sense, every area or activity of the business is among the potential areas of risk management.

Potential areas of risk management could lie simply anywhere

potential-areas-of-risk-managementOn top of these potential areas of risk management that each part of the business is prone to; there are also the other industry-related risks that inhere into any business. The risks of running, say, a firecracker business, are much higher than running a grocery store. So, potential areas of risk management should ideally include a very broad discussion on every aspect of risk management.

However, when one takes an overview of the potential areas of risk management instead of trying to break down the elements of each function in which there are potential areas of risk management; one can classify these among them:

Generic risks: As we have been discussing, any business, absolutely any business, comes with some degree of risk. And, each business comes with its own generic risk, such as falling short of funding at crunch times, core people leaving the organization at important times, logistics failures at critical times, and so on.

potential-areas-of-risk-managementProduct specific risks: As the title suggests, this kind of risk is specific to the product that the business deals with. Some products come with their unique risks, and hence, this kind of risk counts among the potential areas of risk management.

People-specific risks: These can happen in a business in which much depends on a few important people. The inefficiency or departure of such people could be among the potential areas of risk management for businesses or projects that are dependent on people.

potential-areas-of-risk-managementFinancial risks: Obviously among the top potential areas of risk management; financial risks come into play when the organization is not able to meet its bottom lines due to a variety of factors. Not getting funds on time, not getting payments from customers on time, not being able to service debts are some of the factors of financial risks.

Technology risks: Technology is a high area of risk, because it keeps changing at a breakneck speed. If organizations don’t keep up with the pace, technology risks could count among potential areas of risk management.

potential-areas-of-risk-managementMarket risks: Market risks are yet another of the potential areas of risk management because most businesses are run on the assumption or speculation that a market is going to grow at a certain rate or pace. If the estimate of this market goes wrong, it affects the business negatively.

Customer risks: The ultimate decider of the business is the customer. If a customer gets irate at a bad product or service and issues bad press, it could become one of the biggest of the potential areas of risk management.

potential-areas-of-risk-managementReal estate risks: For some businesses, especially retail, the location of the business is a major factor. In many instances, the choice of location could often decide the fate of the business. Imagine setting up a high end retail store in the vicinity of a slum. Does that make sense? Yet, even if a business chooses the right location, it could sometimes be forced to relocate due to factors such as legal issues of the property, making this among the potential areas of risk management.

Finally, what needs to be said is that the list above is by no means a comprehensive one. The potential areas of risk management, as we have discussed at the beginning, are simply too many and too fluid and subjective. They could vary from market to market, product to product and business to business. A business that is perceptive about the market has to make the right assessment of the potential areas of risk management before it starts one. It should also be ready to face the potential areas of risk management if it is up against any factor that lies beyond its reach or forecast.

 

click to continue reading

Understanding the importance and benefits of auditing Quality Management Systems

Understanding the importance and benefits of auditing Quality Management Systems.jpg

Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet customer requirements – are updated and kept in compliance with regulatory requirements. The ISO 9001 set of standards is a step towards helping organizations achieve this end.

The ISO 9001 series, aimed at facilitating and ensuring that organizations of various kinds audit their Quality Management Systems in tune with regulatory requirements set out in this standard; was first implemented in the 1980’s. Today, across the globe, over a million organizations have been certified for complying with its requirements. The ISO 9001 is a tool for auditing Quality Management Systems across all kinds of organizations: big, small or medium to one stop providers to multinational organizations that operate in various geographies.

Why is auditing of Quality Management important?

Understanding the importance and benefits of auditing Quality Management Systems2

ISO standards have been arrived at after years of practice, observation and trial and error endeavors. These standards have evolved over continuous implementation of many best practices that are suited to particular organizations based on the size of their operations and the nature of their business.

An organization that has been in the practice of auditing Quality Management Systems is said to be implementing a better way of dealing with risk management. It is also considered an organization that enjoys enhanced stakeholder and customer confidence, as well as an improved, efficient and effective management and operational systems.

More than anything else, auditing Quality Management Systems are the surest means to ensuring that products and services from an organization meet certain prescribed processes and standards. An auditing Quality Management System officially certifies that the organization task a risk-based, process oriented, streamlined approach to ensure the safety, reliability and consistency of its products and services. A company that puts auditing Quality Management Systems in place is said to be more conscious of meeting customer expectations and makes continuous efforts and improvements into its products and services and complies with the law.

Certification is proof that the organization is auditing its Quality Management Systems

Businessman with a compass holding in hand

Certification is like the proof of the pudding in Quality Management Systems audits. A company may claim to be implementing quality standards, but how does the world come to know about it? It is only through auditing Quality Management Systems certification that this happens. For a company to earn auditing Quality Management Systems certification; it has to be audited by the ISO. Upon careful scrutiny of its practices, the ISO awards the organization the 9001 Quality Management Certification.

What are the benefits of auditing Quality Management Systems certification?Certification from the world’s leading Quality Management Systems auditing certifying body gives such an audited and certified company a host of credentials and benefits. These are some of them:

auditingQualityManagementSystems

Forward brings its personalized healthcare service to Los Angeles

Forward, the San Francisco-based startup that’s looking to refashion healthcare services in Apple’s image, is expanding with its first location in Los Angeles.

Weaving together a number of Silicon Valley’s favorite healthcare trends, the company’s services combine proprietary, purpose-built medical devices with algorithmically enabled diagnostic tools, and the latest in gene, bacteria and blood tests to provide a holistic view of its patients’ health.

These technologies and services include: unlimited access to its medical staff; baseline screening; blood and genetic testing; wellness and nutrition counseling; and ongoing monitoring from wearable sensors provided at the clinic. Support and access to its AI and 24/7 access to medical staff through the app are available exclusively to anyone who’s willing to pay the $149 per month fee.

At its launch, Adrian Aoun told us about 15 percent of its early users come from underserved communities and had received free membership. Members also get their first month of prescription medicine free through Forward’s onsite pharmacy, which also offers vitamins and supplements.

Forward also plans to offer vitamins and other supplements and wearables through the onsite store, and Aoun said he would like to offer other alternatives, such as acupuncture, in the future.

Opening in a small office on the first floor of the Westfield Century City mall, Forward’s Los Angeles office will contain all of the bells and whistles that brought it so much attention when it opened its first San Francisco location in January.

There are custom-built exam rooms kitted up with interactive, touch-screen displays — part of what the company touts as an integrated, paperless system for new electronic health records.

The centerpiece of the company’s facility is a purpose-built body scanner that collects basic vital signs like temperature, pulse and arterial health, which are then sent to the company’s staff doctors.

Those aren’t the only diagnostic tools. The company also has an app and is rolling out services around fertility and sleep tracking, as well as dermatological and optometry services in its two offices.

 

click to continue reading

Rural health care centers provide low-cost care

Putting an effective complaint and recall management system in place.jpg

Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

To get dental services she can afford, 73-year-old Juanita Jenkins has one of her sons drive her 16 miles from her home in the Duval neighborhood in northeast Gainesville to the Alachua County Organization for Rural Needs (ACORN) Clinic in Brooker. The 32-mile round trip is worth it, she says.

Jenkins is one of thousands of people in Alachua County and surrounding counties who need the inexpensive services provided by nonprofit organizations, such as ACORN, which was established in 1974 to serve area migrant workers.

“I started coming here last year and I’ve been here to the dentist about four or five times,” said Jenkins, after getting fitted for dentures. “They take good care of you here, and I would recommend their services to anybody.”

Thursday is National Rural Health Day, created to recognize rural health workers for their efforts and their collaborations that address the unique challenges faced in rural communities.

Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

ACORN has grown from a singlewide trailer on a sandy lot of land to several modular buildings that house dental, medical and administrative offices at 23320 N. State Road 235 in Brooker.

The clinic provides a range of medical, dental and mental health care services, referrals to other health services and social services and professional education and training, King said.

Like ACORN, Archer Family Healthcare, an arm of the University of Florida College of Nursing, started out in a small building before moving into a larger building to better serve its patients. According to Joan Newell-Walker, manager of the clinic, retired Dr. Dee Williams lobbied to establish the clinic after being urged to do so by Archer residents. Williams’ efforts led to the clinic opening in 2001, and it has grown from an approximately 1,000-square-foot, two-story bungalow to a more than 5,000-square-foot facility composed of six modular buildings that were built in downtown Archer in 2007.

“We have grown to accommodate approximately 5,000 patient visits annually,” Newell-Walker said.

Patients visit the Archer clinic for a variety of reasons, including chronic diseases like diabetes, hypertension, chronic obstructive pulmonary disease, as well as prenatal care, medication consultations, health education and disease prevention, immunizations, physical exams and more, Newell-Walker said.

The clinic in Archer was established to meet the needs of residents who live in the rural community in southwest Alachua County who didn’t have a health care facility before the clinic opened. But it’s grown to serve patients from throughout North Central Florida, Newell-Walker said.

The clinic’s funding comes from local, state and federal sources, and it’s run by advanced registered nurse practitioners, Newell-Walker said.

The nurse practitioners provide expert care for patients and are supported by other health care professionals, including a case manager, community health nurses and a consulting physician, Newell-Walker said.

At ACORN, a wide variety of dental, medical and mental health care services are provided, including disease management education, general medical care, reduced cost X-rays, women’s health care, dental exams and X-rays, extractions, orthodontics, root canals and more.

click to continue reading