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Drug Pricing, Let’s Get Real

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One out of every four Americans struggle to afford prescription drugs. Many skip days, do not fill prescriptions and sacrifice needed food for medicine or needed medicine to pay the rent. There are more bankruptcies in the United States due to medical costs, with the cost of drugs as one of the main culprits. This is an unconscionable situation, and after several years of trying, The U.S. Congress has failed to pass drug pricing legislation that protects the American patient population. And, yes, unlike every developed nation in the world, our government is currently prohibited from negotiating prescription drug prices to get the best deal for the American. People. This is unlikely to change at any time soon.
The price of the top 20 drugs is almost 3 times higher in the U.S, than in the UK; six times higher than in Brazil and sixteen times higher than in India. A 2016 study in the Journal of the American Medical Association (JAMA) found that “contrary to the hype about needing the profits from older medications to innovate and develop new remedies, there was no evidence to indicate that research and development costs should justifiably be passed on only to the American consumer.” The cost of prescription drugs in the United States, they wrote is “primarily based on what the market will bear.” The only way to counter these high prices, is to demand that stricter rules on drug pricing, are enforced.
Legislation passed by the U.S. Congress in 2003 during the George Bush presidency, allows pharmaceutical companies to set the cost of a new medication at whatever exorbitant unaffordable rate that they wish. Furthermore, pharmaceutical companies are granted a monopoly on certain drugs that they develop, for a limited number of years, at which time, a generic version can be manufactured and sold by other companies. However, there is a lot of manipulation that occurs. The original holder of the monopoly on a drug, can make the slightest change in the formulation, submit it as a completely new drug to the FDA, and it is often approved.

The reason for this situation is multifold and complex.
1. Many of our leaders in Congress lack the will to make changes to drug pricing because they are influenced by lobbyists who have contributed to their campaigns.
2. U.S. policy makers are faced with the difficult challenge of balancing the desire to incentivize innovation that improves population health, with the challenge of lowering costs of drugs, in a diverse patient population, with highly variable priorities and values. There is always the fear that if the pharmaceutical suppliers are forced to lower or control their drug prices, they will refuse to innovate and fund the research to develop new drugs, that address both existing disease problems, such as heart disease, diabetes and cancer, and new disease problems such as COVID-19.

Where that argument fails, is that much drug development is funded, not by the companies, themselves, but typically by the National Institutes of Health, and by venture capital funding. Furthermore, biotech companies who are anxious to succeed with a new drug, in the heavily competitive environment of drug development, will not stop innovating, even if, at the end of development, they are faced with regulation regarding what they can charge. Many policymakers seeking to lower drug spending suggest benchmarking U.S. prices against other countries, including: EU Nations, where the prices are controlled by National Health Systems. Although we know that reveals that U.S, consumers are paying much higher prices for the same drug, as a counterpart in another country, our leaders have not mobilized to change the system.

President Biden recently reintroduced legislation to address the drug pricing issue, with several elements that would:
1. Enable negotiation of drug prices by Medicare. for high-cost prescription drugs, including those that s seniors get at the pharmacy counter (through Medicare Part D), and drugs that are administered in a doctor’s office (through Medicare Part B)
2. End the practice by Pharma of unilaterally setting prices for a new drug without negotiation The legislation provides that drugs become eligible for negotiation once they have been on the market for a fixed number of years: 9 years for small molecule drugs and 12 years for biologics.
3. Establish a clearly defined negotiation process that is fair for manufacturers, and gets the biggest savings on drugs that have been on the market a long time. This discourages drug companies from abusing laws to prolong their monopolies, while encouraging investments in research and development of new cures. Drug companies that refuse to negotiate will owe an excise tax.
4. Impose a tax penalty if drug companies increase their prices faster than inflation. If prices for a drug increase faster than inflation, manufacturers will owe a tax, which should hold down prices for Americans with all types of health insurance.
5. Directly lower out-of-pocket costs for seniors. Today, there is no cap on how much seniors and people with disabilities have to pay for drugs, and millions of seniors pay more than $6,000 a year in cost-sharing. This proposal puts an end to this burden, and ensures that seniors never pay more than $2,000 a year for their drugs under Medicare Part D.
6. The plan will also lower insulin prices so that Americans with diabetes don’t pay more than $35 per month for their insulin. Lawmakers have also agreed to lower seniors’ cost-sharing for all types of drugs, and they are working expeditiously to finalize legislative text that will save seniors’ money at the pharmacy counter, without increasing their premiums.These provisions on drug pricing are a part of the Build Back Better legislation that was submitted to the Congress on Nov 1 2021

Decades ago, most major drugs were developed by the large pharmaceutical companies that sold them. But that system has changed. Today, most drugs originate in small biotech start-ups. These firms are devoted to the development of a single drug, and they are financed by venture capital firms that are willing to make risky bets, in the hopes that one will pay off big. In the case of biotech, the payoff usually comes when a promising drug comes along and the company is purchased by a bigger company.

The Pharmaceutical industry spent over $306 million in 2020 to lobby our countries’ leaders, regarding any attempts at the passage of new legislation that would restrict drug pricing. There were 1,502 registered pharmaceutical lobbyists in 2020, 63.58% of whom were former government employees. The pharmaceutical industry expenditures of $306 million on lobbying exceeds that of all other industries. by an order of magnitude. with electronics as second, spending $156.9 million and insurance as third, spending $151 million. In the last two decades, Pharma has spent over $600 billion to lobby politicians on the Federal and State levels which is why drug pricing has been so difficult to contain. This must be stopped!!

References,
The Commonwealth Fund, Blog, May 26,2021,
The White Press Room, Oct 28,2021,
Reuters: Carolyn Hummer, “Special Report: Big Pharma wages stealth war on drug price watchdog” Sept 11,2020
Kaiser Family Foundation: “”Cynthia Cox Follow @cynthiaccox on Twitter , Robin Rudowitz Follow @RRudowitz on Twitter , Juliette Cubanski Follow @jcubanski on Twitter , Karen Pollitz , MaryBeth Musumeci Follow @mmusumec on Twitter , Usha Ranji , Michelle Long , Meredith Freed , and Tricia Neuman Follow @tricia_neuman on Twitter “ Potential Costs and Impact of Health Provisions in the Build Back Better Act,” November 23, 2021

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Digital Technology Comes Alive During COVID

Digital health technology use exploded during the COVID-19 pandemic as existing applications became the only way that some people could get the care and the support they needed. New applications surfaced to keep us in touch with friends and family. The availability of our digital health records, and patient portals enabled many of us to easily communicate with new health providers or doctors we had not seen for a long time. Digital health records now ensure that an accurate summary of our health history, conditions, medications and test results are available to patients and providers, anywhere, anytime. Portals, which are secure online websites, house our data in one central location, and are accessed with an Internet connection. When COVID made it impossible for many of us to see our physician in a live setting, portals made it possible to have remote visits, and truly feel confident that all parties had full information at the point of care. Several other digital technologies have enabled important communication and connections. among patients and healthcare professionals including:

Telemedicine, the use of digital communication technology to provide and support clinical healthcare when distance separates the participants has become a feasible alternative to the more traditional face-to-face visit with a physician, which was not safe during the pandemic. Telemedicine eliminates distance barriers by providing access to medical services, particularly for underserved, elderly and rural communities. A combination of mobile technology. video, and remote patient monitoring tools, used on a telemedicine platform, enables doctors and patients to work together as long as they have a broadband connection.

Telehealth is similar to telemedicine, but where telemedicine focuses specifically on remote clinical services, telehealth includes a wider variety of non-clinical services and remote healthcare beyond the clinician-patient relationship, including: long-distance clinical health care, patient and professional health-related education, and public health and health administration. Telehealth uses electronic information and telecommunication technology, such as: videoconferencing, Internet, store-and-forward, imaging, streaming media, landline, and wireless communication. The legal barriers to the use of telehealth were lifted by the Centers for Medicare and Medicaid Services, during the pandemic and the resulting expanded use of telehealth became an important way that critical healthcare services could be available to patients.

During COVID-19, social networking became one of the standard ways that many people remained in touch, to talk about feelings and exchange opinions. People accessed social networks to connect with friends, family, even business associates, while remaining socially distanced. Over 85% of Americans say that they are online frequently throughout the day, according to a survey conducted by PEW, (PEW Research Services is a nonpartisan fact tank that informs the public about the issues, attitudes and trends shaping the world.). A recent PEW survey that interviewed 1,500 adults in America, conducted between January and February 2021, found that nearly 100 percent of adults who are online use social networks, and over 50% are registered with several. Although social networks have initiated much controversy recently, they are a force in the world of Internet communication and in interaction among patients and healthcare organizations.

Remote patient monitoring (RPM) is a broad term that refers to the use of a variety of medical devices, used at home by patients to monitor and manage chronic conditions. These devices include wearable clothing and jewelry, portable home health monitors and online apps. RPM technology electronically tracks and transmits real-time information from the patients to clinicians, seamlessly, on multiple platforms, collecting information such as weight, blood pressure, and heart rate using an external cuff, a special scale, or a camera connected to an iPhone, iPad, or laptop. RPM have become smarter and more affordable over A survey by Insider Intelligence indicated that 23.4 million patients used remote patient monitoring services and tools in 2020. They predict that by 2024 they expect RPM tools to be used by more than 30 million patients. Interestingly, more than 80% of patients, when asked, indicate they are favorable toward incorporating RPM into their medical care. They report that they love the convenience but have concerns about reliability and accuracy as well as potential complications that might not be identified using RPM.

Robotics in Health
Robotics has become mainstream in healthcare with robots used to carry out tasks that have traditionally been handled solely by humans. During the pandemic, robots helped compensate for staff shortages among first responders, by doing routine tasks. They were used for patient monitoring and evaluation, the delivery of medical supplies, prescription disbursement from the pharmacy to patients, and more. Specialized robots roamed hospital corridors and disinfected rooms, delivered meals, transported infectious materials to laboratories. Many hospitals assigned robots to greet and register patients, send them to testing sites and admit them, to keep front line workers away from initial contact. Cylindrical shaped robots were rolled into patient rooms to remotely take temperatures, measure blood pressure and oxygen saturation of patients who were connected to a ventilator, again, keeping the human front line workers at a distance. A robot, designed as a pair of large blue fluorescent lights mounted on a machine that rotates vertically was used to travel throughout the hospital and disinfected patient rooms, waiting areas, labs, ERs and ORs These robots continue to be used in supermarkets, laboratories and factories. Robots in the shape of a cart, equipped with maps, roamed freely to pick up trash and laundry, and even bring food to healthcare workers during their break. Outside the hospital, quadcopter drones ferried test samples to laboratories..
Small, cuddly robots no more than two feet tall have been used successfully with young children, to improve their hospital experience or an office visit with a pediatrician.by, providing comfort and assurance as the young patient undergoes blood tests, removal of casts, insertion of IVs, injections inductions, and more.
In another example of robotic use, when doctors could not be physically present to visit their patients, telepresence robots, who directed a television screen an iPad or iPhone mounted on a moving base rolled from room to room and beamed in the face and the voice of the clinician, who had been videotaped. They became particularly useful in remote areas where there is a shortage of clinicians. The telepresence robot can also connect to a doctor remotely who wants a detailed, real-time look at a patient to evaluate their condition. They are interactive and carry on an actual conversation with the patient. They are also used to oversee patients in intensive care units, to monitor changes in a patient’s behavior, and send signals to alert nurses.

Online Meeting Technolog
During COVID-19, people became hungry for the opportunity to visually connect with friends and family. Company, employees who were working at home, found it vital to conduct virtual business meetings. Popular virtual meeting platforms, using video conferencing, include: Go to Meeting, Skype, Google Meet, ClickMeeting, Buzz, and Zoom. provide a simple interface and useability, specifically targeted to a non-technical individual Zoom became the popular choice, because with a user name and password for access, zoom filled a need and zooming became a part of the common lexicon. People even complained about being zoomed out. Zoom allowed anyone who registered to hold or access a meeting with a 40- minute limit and up to 100 participants, free of charge. For a fee, businesses could opt to have more extensive features and extended times that enabled them to hold longer meetings and conferences. Healthcare institutions used this technology for remote screening of symptomatic patients before they would be granted access to the ER or a clinical test site. Consumers are zooming everything from funeral services, and religious services to wedding celebrations and “happy hours,” and to simple visits among families and friends. The concern going forward is finding ways to ensure that privacy and security, is prioritized over ease of use,

Digital Tools for Mental Health
According to Kaiser Family Foundation, about half of adults (47%) nationwide have reported negative mental health impact during the pandemic — a significant increase from pre-pandemic levels.
Technology has opened a new frontier in mental health support and data collection that can help to address some of the impact of increasing mental health support needed. For example, telemedicine has opened up a new avenue for persons with mental health concerns stay in touch with their mental health counsellors on a regular basis, without leaving their home. Using telemedicine, treatment can take place anytime and from anywhere and can help mental health providers offer treatment to people in remote areas or at a time when someone has a sudden need. This approach could become more appealing to people than traditional in-person treatment protocols.
Mobile devices like cell phones, smartphones, and tablets are giving the public, doctors, and researchers new ways to access help, monitor progress, and increase understanding of mental health and well-being. These apps are often free or cost less than traditional care. Mobile mental health support can be very simple but effective. For example, anyone with the ability to send a text message can contact a crisis center.. There also new sensor apps built into mobile devices that are able to collect information on a user’s typical behavior patterns. If the app detects a change in behavior, it can provide a signal that help is needed and connect the person to the nearest crisis center. The jury is still out on the effectiveness of using apps to trace mental health issues, and regulation is clearly needed, but the promise of new adaptations of our always ready mobile devices has much potential for help.
As we continue to address variants and ongoing COVID health issues both physical and mental health issues, technology makes it easier and safer for us to stay in touch with our healthcare providers, care-takers, family and friends and feel safer and more secure. This is critical to a sustained healthy environment that will promote the well-being for public health throughout the nation,

Op-Ed: A Better Plan for COVID Vaccinations — Breaking transmission chain should be part of the strategy by Daniel Teres, MD, and Martin A. Strosberg, MPH, PhD December 28, 2020

Now that the first COVID-19 vaccines are being rolled out, Operation Warp Speed, the FDA, and the CDC have recommended that governors proceed first with vaccinating two groups: healthcare workers and residents in nursing homes. But what about after that?

Planning has started in all the states and territories regarding who will get the vaccine third on the priority list, potentially starting before the end of January. The choice can be reduced to two major categories: maintenance of essential services and reduction of hospitalizations and mortality.

Operation Warp Speed, FDA, and CDC have recommended that priority should go to workers who preserve essential services for the COVID-19 response and for the overall functioning of society. Estimated at 87 million, this category includes food and medicine supply chain workers (e.g., truck drivers, grocery store and pharmacy employees), infrastructure workers, teachers, and those working in national security. The essential worker category is logical and important but will have minimal impact on reducing hospitalizations and our high daily death rate. And it will take months to implement.

The alternative candidate for third priority is vulnerable populations where vaccination will have the effect of reducing hospitalizations and deaths. Joel Zivot, MD, recently suggested vaccinating all Medicare (53 million) and Medicaid (70 million) recipients ahead of healthcare workers. Presumably, vaccinating this large group would give vaccine to the most vulnerable and underserved populations and would have a sizable impact on reducing hospitalizations and deaths. We assume that this suggestion would also include indigenous populations, the homeless, and inmates in prisons. Vaccinating these pools of patients would go throughout spring and possibly early summer.

In the same vein, former FDA Commissioner Scott Gottlieb, MD, proposed vaccinating all those 65 and older. That would be 53 million people or approximately half the number of adults with high-risk medical conditions. His plan has the advantage of simplicity. A more nuanced approach would be to vaccinate those elderly who have specific individual risk factors associated with COVID-19 mortality, such as sickle cell anemia, chronic renal disease, lymphoma/leukemia, chronic cardiovascular disease, obesity, and diabetes.

In weighing these two competing priorities, maintaining essential services versus reducing hospitalizations and mortality, we are struck by the urgency of rising hospitalization rates and mortality, now averaging 3,000 deaths per day. Many hospitals are at dangerously high capacity. In contrast, essential services seem to be holding up remarkably well. Reducing hospitalizations and mortality is becoming much more difficult.

We have gone from superspreader events such as the February Biogen conference in Boston to many smaller events in family settings heightened by the commencement of the holiday season. The ongoing spread continues despite testing frequently, creating “bubbles,” avoiding indoor restaurants, and “Zooming” many family and religious events. And the seniors are not the ones at bars and pubs.

For us, the scale should be tipped toward reducing hospitalizations and mortality. But we take a different approach to further this end. We previously suggested giving the vaccine to selected localized hot zones of infection where mortality is high and hospitals are reaching capacity. Vaccine would be administered in rapid sequence to tiers 1a-4 of the National Academies’ prioritization framework.

Within the hot zone there is no moral dilemma regarding which group gets the vaccine — everyone receives it. The only exclusions would be those with history of severe allergic reactions, immunocompromised patients, age <16, pregnant or lactating mothers (as dictated by the Pfizer phase III trial and the FDA evaluation) and those opposed to receiving a vaccine.

For mid-late January 2021 or later, we now suggest a dual approach. Each state should proceed with giving vaccines to either essential workers or to individual high-risk people and, also, give vaccine to one local hot zone where hospital and ICU capacity are high. The vaccine will not be effective for those already in the hospital but may prevent the progression of COVID-19 infection from the early first phase or incubation period from advancing to the more advanced stages that include respiratory infection (pneumonia) or cytokine surge. Blanketing the local community will have the added advantage of potentially breaking the chain of transmission by vaccinating those local spreaders who circle around the most susceptible.

We recognize that the extent to which the current COVID-19 vaccines prevent infection, as opposed to clinical illness, remains uncertain. But it seems probable that they will at least reduce viral loads among individuals who are super-spreaders. If that occurs, then we should see some impact on transmission. Deploying this strategy in hot zones would provide valuable early data on the vaccines’ real-world effectiveness in reining in the pandemic.

We feel that our approach would have a larger effect on reducing morbidity and mortality by focusing on breaking the chain of transmission and thereby reducing the stress on the healthcare system. Giving vaccine to those 65 and older (or other high-risk categories) protects high-risk individuals, but they are mostly not responsible for the virus’s spread.

Our approach includes the small community around the high-risk individuals. In under two months we would know: how the vaccine breaks the chain of transmission; how much test positivity is reduced 7 days after the first dose; how much is hospitalization reduced 7 days after the booster shot; and, what do the positivity and hospitalizations rate look like if only 40% of people take the booster shot at one hot zone compared to the curves in another hot zone where 90% of people take the booster shot.

Understandably, during a pandemic, it is hard to organize and collect useful information. But targeting local hot zones lends itself to just that, viz., the collection of useful data. This would also include comparing vaccines against each other. Our approach allows entry of vaccine 2, 3, and 4 to the market by giving each vaccine its own two or three hot zones.

What about states that do not have clearly identified local hot zones? They should follow the dictum of the great Wayne Gretzky: “Skate to the puck.” By that we mean, target the places that are likely to become hot zones in the near future. Officials should remember that hot zones come and go, and there is inherent delay between targeting an area and then implementing the vaccination program.

The CDC has given the governors the final responsibility for prioritizing vaccine distribution. There still may be time to modify the current prioritization plans and to consider and implement another approach.

Daniel Teres, MD, is a clinical instructor in public health and community medicine at Tufts University School of Medicine in Boston. Martin A. Strosberg, PhD, is emeritus professor of political science, healthcare policy, and bioethics at Union College in Schenectady, New York. Martin A. Strosberg, MPH, PhD, is emeritus professor of healthcare policy, and bioethics at Union College in Schenectady, New York.

Last Updated December 28, 2020

 

Optimizing Healthcare: Lessons Learned from COVID-19

COVID-19 has awakened the American public to the need to improve the quality of patient and population health services, advance equity and upgrade quality and outcomes, particularly for people of color , individuals with low income and residents of rural areas.  Additionally COVID-19 has demonstrated the fragility of our American healthcare system and pointed out the work that lies ahead, including the need to: improve the financial sustainability of healthcare institutions; provide equity across state, racial, urban and rural geographies; become independent of foreign commercial interests in our supply of vital medical equipment and incremental supplies; and recognize the guarantees of equality to provide access to care, fair pricing, quality and privacy of health information.

So many deficiencies in our U.S. healthcare system were exposed by the pandemic.  The weaknesses in our infrastructure of care have resulted in hospital closings in our rural communities and major health institutions currently facing financial crises at a time when more, not fewer, stable  hospitals are needed.  Our inability to respond quickly to protect our frontline workers with appropriate PPE , our slow response to providing enough testing, and the severe shortage of hospital beds, ventilators, and respirators all contributed to the mess we find ourselves in.  Over 300,000 deaths and rising, eclipsing the numbers in every other country in the world, and 64.2 new cases per 100 thousand people daily, point out the shocking deficiencies in our ability to provide proper care to our population.

Regulations/legislation, that has guided how decisions are made and executed, need complete overhaul, from governance of drug pricing to the cost of care for procedures and treatments, both in-patient and out-patient in centers of care.  COVID-19, that came as a shock to all of us, was clearly not addressed by an organized strategy. That is because our system has been eroded from many years of abuse and neglect.  We now have seen the reckless disregard for our most vulnerable citizens which reinforces the need for fast response systems so critical in times of national disasters.  We were confronted with the dangers of inadequate control over our healthcare supply chains that provide critical equipment and medical supplies including ventilators, test kits, respirators, gloves, face shields, hand sanitizers, FDA approved N95 masks, masks for the public, and medications needed for the seriously ill.  Lacking a national health agenda, we floundered.  We must take steps to mitigate this in the future so we can keep our country and our citizens safe, our businesses and schools open.

Achieving and sustaining more equitable high-quality and less costly health care delivery going forward will require a paradigm shift that must include reliable digital information systems, better data collection, flexibility in care delivery, and support for communication systems. The technology is available. This can be done if we have the will. Immediate attention must be given to reforming the payment systems that support primary care and basic health services. We must reduce the cost of care services and of prescription drugs. We also must increase the supply and retention of primary care clinicians with better pay incentives and  free or vastly reduced  medical school education costs  so that medical students do not incur enormous loans. By these actions, we will be able to fulfill the need for clinicians in medically underserved and rural areas.  We must promote new forms of communication between clinicians and patients such as telemedicine use, short message systems to mobile devices and patient portals that provide a platform for patient/clinician discussions, e-visits, managing and monitoring of chronic conditions, informing patients about tests, labs, diagnoses, overdue appointments, inoculations and screenings, all of which empower the patient to take control of their care.

Part of an innovative re-structing of our current dysfunctional system is to locate public health facilities in the neighborhoods where people live.  This includes the expansion of community health centers and establishing mini-clinics in housing sub-divisions and in schools. The high  number of deaths in nursing homes and among the elderly also point out the need for better trained, better paid  staff that is  engaged and committed to their work and the communities they serve.

Expansion of health and wellness programs is needed that is aimed at building trust, that has been eroded for such a long time, between  patients and clinicians. We also learned that we must change the way millions of individuals are insured for healthcare. Currently in the U.S., 30 million people do not have health insurance.  Another 44 million have such bare-bones coverage that only addresses a fraction of what is needed for them to be safely buffered with manageable costs that do not put them into bankruptcy. The majority of Americans receive healthcare as part of their benefits from their employer-provided health payer programs.  When the pandemic hit, many of these individuals were laid off from work. They not only lost their jobs but their healthcare as well. There are also a large number of people who work for very small companies or are self-employed, who struggle to find a good healthcare coverage plan.  When a situation such as the pandemic explodes, without warning, millions of uninsured and under-insured individuals are left without the funds to pay for the care that they need.

Basic health care through national health systems is a provided to all citizens in every other democratic country in the world. As we return to a “new normal” we cannot get so involved in our busy lives that we ignore the changes that must occur in our health system. It is going to require hard work, extensive funding, revision of laws and regulations to tear down the barriers, correct the inequities and problems that led to the chaos we experienced. We must ensure that if we have to face another health disaster, and the scientists assure us that this will happen, we will be prepared.

References that contributed to this post:

  1. David Blumenthal, M.D. Sara Collins, The Commonwealth Fund
  2. Stuart M. Butler, PhD, Brookings Institute JAMA, COVID-19 Update, December 12, 2020, “COVID-19 Lessons for Achieving Health Equity”  JAMA  2020.324(22):22425-2246. doi:10, 1001/jama.2020.23553.

 

 

 

 

Covid-19: Have we Learned our Lessons?

Covids-19 has clearly demonstrated that our healthcare system is not addressing the needs of the American people.  From shortages of PPE, ventilators, ICU beds, medications, to lack of test kits and a plan for testing, the U.S. has failed its citizens, particularly those who are elderly, Black, Latino and Indigenous where mortality rates are twice as high as they are among white populations. Many are asking how this could have happened.  Clearly the U.S. along with the rest of the world was caught completely off guard by this worldwide pandemic that hit with such force, that in a few short months more than 16 million individuals have been diagnosed with the virus and nearly 700,000 have died worldwide.  The U.S. death toll is the highest in the world and continues to rise daily, compared to several countries, where the death toll and the number of cases is declining, and to countries which are continuing to surge, but at a much lower rate, because they are stricter with social distancing and wearing masks.

The pandemic has also hit the nation hard, economically, and once again Black, Latino and Indigenous populations have suffered egregiously.  It becomes a vicious cycle, when people are asked to social distance, while they lack resources such as food, a clean water supply, adequate housing. and basic healthcare, that precludes social distancing.  As they grapple with the reality of life in America during this wrenching time, many are opting to protest their situation. We clearly cannot indict them for expressing their outrage!

From the beginning of the pandemic, we have lacked the leadership to properly address health and economic disparities and prevent this disaster from spiraling out of control. Long before the pandemic, we failed to recognize the power we were placing in the hands of big business as they sent their manufacturing overseas, taking jobs away from American citizens and leaving us vulnerable and unable to obtain the needed medical supplies, devices and medications that are essential to protect our citizens from suffering. Business interests have dominated and controlled this country far too long, at the expense of the public good. This is a lesson we cannot ignore!

Addressing Covid-19 has also informed the public of these deficiencies and of the great damage that has ensued.  Now is the time for planning and action to address these issues.  We need a comprehensive public health strategy that determines how to eradicate this virus once and for all.  We need policies that address the inequities in our system and evens the playing field.  We need strategies that protect and control the availability of critical medical supplies required to grapple with unexpected challenges.  We need new legislation that corrects the dysfunction in our healthcare system and removes the enabling legislation that allows pharma, payers and healthcare institutions to destroy lives by crippling citizens with outrageous high costs of care for emergency room and hospital fees, medications and co-pays.

Large allocations of funds have been made available recently by Congress.  This is providing a necessary “quick fix” to get people through the economic disaster they are dealing with, so that they can feed their families and keep a roof over their heads.  Longer term, we must have a comprehensive plan that incorporates new legislation to address the disparities among various segments of the population, so blatantly pointed out by our Covid-19 experience.  Specifically we need to expand affordable basic healthcare and mental health services in rural and urban America,that will  better serve the people. We need to continue to support  telehealth options  and ensure that telehealth is included in provider reimbursement plans.   We need to better manage distribution of  PPE, critical medications and diagnostic testing services and foster private/public partnerships that will improve public health.  Let us learn from the lessons of Covid-19 and not make the same mistakes again.

Our Shameful Disregard for the Elderly

 

Last July CMS (Centers for Medicare and Medicaid), acting on orders from the Trump Administration, proposed that the rules that had been put in place by the Obama Administration to curb deadly infections among elderly residents in nursing homes be relaxed. The proposed  rules would change a mandate that oversight including assessments of needed staffing and equipment be done every other year instead of annually, and infection specialists that were required to be on site at nursing homes  be eliminated.  These specialists were there to ensure that employees understood how to properly wash hands and follow other safety protocols. The changes to the rules were proposed before the pandemic was on anybody’s radar and were supported by  the industry.  According to the New York Times, many nursing homes in the United States are owned by large for profit companies and the owners are individuals who have contributed to large sums of money to Donald Trump’s re-election campaign.  They lobbied for these changes.  The Times also reported that Attorney Generals representing 17 states called the proposed rule a “threat to the mental and physical security of some of the most vulnerable residents of our states.”

Even before COVID-19, nursing homes were overwhelmed caring for their residents because they are crowded, understaffed and their employees are typically poorly paid workers who move between multiple jobs and return home to communities where disease and infection are common.  That put the industry right into the pathway for disaster.  When COVID-19 hit, that disaster happened.  More than 2 million people live in nursing homes or residential care facilities.  They represent just 0,6% of the U.S. population.  However residents in such facilities as of June, 2020, accounted for 42% of all deaths in the U.S. from COVID-19, based on a state by state analysis.  The reasons include limited testing, lack of person protective equipment (PPE) such as masks and gowns for staff taking care of the residents, and staff who were poorly trained to use PPE when they did have it. Because tests were not readily available, most states’ nursing homes have only been able to test residents with symptoms, even though the disease is known to spread asymptomatically.

Dr. Tom Frieden, the former head of the CDC told CNN on March 8, “One thing that stands out as the virus has spread throughout the United States is that nursing homes and other long-term care facilities are ground zero.” Frieden called on federal authorities to ban visitors from nursing homes to reduce the risk of infection coming from the outside.  It was not until April 19 that the head of CMS promised to track all deaths in nursing homes.  It then took two more weeks before the tracking went into effect and nursing homes began to ban visitors from the outside.  During that two week period alone approximately 13,000 elderly people in the nation who resided in nursing homes died from COVID-19.

What has happened in the care facilities where our most vulnerable members of the population, the elderly, the frail and the handicapped individuals who cannot any longer care for themselves now live is shamful and horriffic.  What makes it worse is an attitude by many of “what is the difference, these people will die soon anyways.” Like everything else in our capitalist system, much of the problem in nursing homes stems from money.  Nursing home revenue is based on a fragmented payment system where Medicare overpays for short term residents – people who are there for rehabilitation following surgery, and Medicaid underpays for long-term residents.  One option that has been proposed is to expand health insurance programs for nursing home residents that combine Medicare and Medicaid coverage into one plan that is the Federal government oversees.  This would eliminate  inequities that exist across state lines that penalize the poorer urban and rural areas.

If there is one thing we have learned from the pandemic it is that our healthcare system, especially the way we care for the elderly,  is totally broken and we can no longer leave it up to the politicians to fix. Change will only happen if the people want it to happen. Those who are young and middle aged may think it is not their problem to worry about, until it is, when their own elderly parents, relatives or friends suddenly end up in a nursing home or when they themselves, in not too many years, could end up there as well.  We owe it to our elderly citizens who  built and defended this country, who spent long hard years working and contributing to the economy and the society,  to ensure that when they need ,safe, high quality, affordable nursing home care it  will be available.

Innovation and the Impact of Covid-19

The World Medical Innovation Forum (WMIF) was established to spotlight innovation and radical transformation in healthcare.  The founders of this unique conference believed that the center of healthcare needs to be a shared, fundamental commitment to collaborative innovation.  WMIF brings together senior healthcare leaders from around the world, representing academia, industry and government, who are working on solutions to improve clinical care and change patient’s lives. The first WMIF was launched in May, 2015 in Boston and focused on neuroscience.  Advances in brain-scanning technology, ultrasound and neuro-imaging diagnostics were featured.  “The Disruptive Dozen” segment of the conference, which has become unique part of WMIF, highlighted 12 technologies predicted to have the greatest impact on neurological disease in the 21st century.  WMIF 2016 focused on cancer and featured advances in imaging, along with cutting-edge research to understand tumor development and growth, as well as advantages and risks in a variety of treatment approaches and standards on how clinicians monitor patients’ responses to treatment.  WMIF 2017 turned to cardiac care and the role that innovation plays in improving patient outcomes and development of  devices and diagnostic technologies  that significantly affect treatment of cardiac disease. “Disruptive technologies” consisted of 19 presentations of game-changing approaches to cardiology research and clinical care.

Since 2018 WMIF has focused on artificial intelligence (AI).  WMIF 2018 featured early AI breakthroughs of that period. WMIF 2019 featured the impact of AI in clinical care, investigating the future of medicine and examining how machine learning affects hospital operations, drug discovery, population management and physician empowerment.

This year Covid-19 threw a wrench into the World Medical Innovation Forum and was held as a virtual meeting of over 11,000 healthcare leaders from around the Globe, who learned about the myriad innovative tools and discoveries that have become essential in managing healthcare during this pandemic, including:

  • Logistics for mass notification and data collection
  • How to communicate with patients when whole populations are sheltered in their homes
  • How to quickly  but safely scale research to find the effective therapeutics and a vaccine, based on former research
  • How to educate the public to effectively use devices  such as thermometers, oximeters and cellphone apps for contract tracking and geo tracking.
  • How to manage the supply chain
  • Developing the software to match patients with platform trials

Much discussion centered on electronic automated screening tools, how clinicians are using telehealth to connect with their patients, the use of bots,  digital interactions as a standard of care in the future, the balance between virtual and in-patient care, mental health of patients and front line workers, the benefits and risks of a massive shift to home care, expanded use of wearables requiring patients to be more responsible for their care, and investments in healthcare needed going forward. An extensive poll of the participants conducted throughout the day revealed the following:

  • 80% of the attendees believe there will be a significant spike in Covid-19 cases in their local communities in the Fall of 2020 and beyond.
  • 60.7% believe that there will be sufficient testing available in the Fall 2020.
  • 49.9% believe that after Covid-19 is over in the United States, the country will be materially diminished and there will be high unemployment.
  • 40% believe that remote encounters (telehealth visits) will shrink between 10% and 50%.
  • 52.4% believe that regulations that have been rolled back in healthcare are temporary and will return to what they were.
  • 45.4% believe that the impact of remote work technologies will result in their  employers/industry  will be shrinking their real estate committed to administrative roles
  • 56.5% believe the Federal government will modestly increase spending on public health/prevention
  • 58.6% believe U.S. government and private industry investment in infectious disease and monitoring will increase more than 20% in the next five years.
  • 42.6% expect to be wearing a mask outside of their home in the next year.
  • 33.8% feel that society will never return to what it had been prior to the pandemic and 30.7% said this will happen but not for two years.

Covid-19 has clearly changed our thinking. our priorities, and our ability to implement change and foster innovation, as we keep a sharp focus on economics, budgets, and especially the health and well-being of ourselves, our families and our loved ones. The conference attendees, a representative cross-section of individuals from around the Globe revealed that they believe it will be sometime before we emerge from this pandemic and move on to refocus our energies on innovation, including the practical implementation of technologies to foster better communication among all stakeholders in healthcare. Covid-19 has also shown all of us how dysfunctional our U.S. healthcare system is and how urgent it is that we support changes to this system, so that the failures that we are currently experiencing including supply chain gaps, swift efficient response and readiness, availability of care for everyone, reasonable cost of care, and lack of  protection of  front line workers never happen again.

 

 

 

 

 

Time to Appreciate our Clinicians, Heroes of the Day

(Photo courtesy of “The Hill”)

 

 

The devotion to their work that we have seen from our clinicians, doctors, nurses, nurse practitioners, physician assistants and EMT’s, in the face of such huge adversity, says everything about why they are the nation’s heroes.  It also speaks volumes about why we need significant changes in our U.S. healthcare system.  These health professionals, who are on the front lines of the Covid-19 epidemic, deserve better treatment than they are getting.  They are sent in every day to battle Covid-19 without the proper equipment and with a lack of processes or protocols that have been drilled into them since their training days.  They have received no preparation to help them help their patients in this fight.  In spite of the deficiencies in our system, our clinicians continue to show devotion and caring for their patients above and beyond. They have stepped up and taken on responsibilities that, in many situations are not in their sphere of specialty.  They handle whatever they have to without question or complaint, regardless of what this might mean to their own personal safety and that of their families.

All of this is taking place in an environment where we have routinely taken for granted the untenable position and personal needs that our doctors, nurses, physician assistants and nurse practitioners experience daily. We have universally failed to appreciate the burdens that our  society and the healthcare industry put upon them.  From the massive loans that doctors have accumulated coming out of medical school, to their struggles, in many cases, to pay their bills, as they work for less pay and longer hours than their counterparts in other industries with similar education and background.  Hospital systems and consumers of healthcare have failed to treat our front-line medical personnel with the respect and rewards they deserve.  Orders and regulations that emanate from our profit-driven hospitals and payers are forcing clinicians to see too many patients, perform too many procedures and surgeries and complete massive amounts of paperwork, all crushed into too short a time.  This creates an environment of concern about the standards that enable safe, high quality care.

A from the National Academy of Medicine, Taking Action Against Physician Burnout: A Systems Approach to Professional Well-Being,” indicates that clinician burnout – a workplace syndrome resulting from chronic job stress – is a major problem across the nation.  Substantial stress and burnout symptoms are present in 35-54 percent of nurses and  physicians and 45-60 percent of medical students and residents.  That burnout is a growing public health concern. The results showed that nurses and physicians feel substantial symptoms of exhaustion, depression and emotional numbness.  For medical students and residents, the prevalence of burnout ranges from 45 to 60 percent.  Contributing factors include: increased demand for health services, increased workloads, administrative burdens resulting from implementation of electronic health records, lack of resources that stem from organization culture and policies, leadership expectations, excessive documentation and reporting requirements that detract from patient care, and the stigma that prevents clinicians from seeking help and support.  The study reported that emotional exhaustion, and a loss of sense of professional efficacy are barriers to professional well-being.  Addtessing burnout requires improving the environments in which clinicians train and work.

Jessica Gold, M.D. , an assistant professor of psychiatry at Washington University in St Louis wrote that “mental health cannot be an afterthought but must be considered now in copig with the pandemic, particularly for healthcare workers.  “Our mental health system is deeply flawed and understaffed, she said, “and is in no way prepared to manage the onslaught of issues in healthcare providers and the citizenry in general after such a mass tragedy.  We must think about way to prevent mental health from deteriorating while also coming up with innovative ways to target at risk groups, particularly healthcare workers”

Covid-19 has put a new perspective on so many failings in our dysfunctional healthcare system.  We now understand that once we are done with this initial crisis, we have a long way to go toward implementing changes to our system that fails all of us. Clinicians need to be able to treat all patients, at all times, in a safe environment with the proper support and equipment.  We are going to need a radical re-engineering of the healthcare system, including interventions that protect both the physican and mental health of our front-line workers, whom today we salute!

Limiting Coronavirus Spread with Telemedicine

The CDC advises that the best way to prevent infection from Corona virus is to avoid exposure.  We now have the technology, using virtual digital communication, to remain in our homes and engage in dialogue and consultations with our healthcare providers via the internet.  Telemedicine (telehealth) can provide and support healthcare when distance separates the participants.  Recent studies indicate that there are 80 million people who live in areas who live in areas where there  are not nearly enough primary care physicians to take care of them.  There are 117 million people who live in areas where there is a severe shortage of mental health professionals.  For Americans who have a regular physician, only 57% report access to same or next-day appoitments and 63% have difficulty getting access to care on nights, weekends or holidays without going to the emergency room.  Over 20% of adults wait six days or more to see a doctor when they are sick.  These healthcare shortcomings happen all the time.

Now, in the midst of a pandemic, there are serious legitimate concerns about how to manage the huge numbers of people who need and will need immediate healthcare services.  One solution is telehealth to connect people with qualified licensed providers and get advice and authorization for care.  The Centers for Medicare and Medicaid Services (CMS) has broadened access to Medicare telehealth services so beneficiaries can receive a wider range of services from  doctors without having to travel to a healthcare facility. These policy changes build on the regulatory flexibilities granted under the President’s emergency declaration.  CMS is expanding this benefit on a temporary,emergency basis.  The benefits are part of the broader effort by CMS to ensure that all Americans, particularly those at high risk of complications from the Covid-19 virus, are aware of easy-to-use accessible benefits that can help keep them healthy while  containing  the community spread of the virus.

http://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet

Telemedicine includes video-based e-visits and remote patient monitoring tools to address many of the issues that have traditionally been treated with face-to-face visits.  Examples of telemedicine interactions include:

  1. Basic consultations between patients and health professionals sharing audio, video and medical data to render a diagnosis, treatment plan, presription or advice.  This might involve patients located at a remote clinic, in a physician’s office, or at home, or consultations with super-specialsts.  Labs, x-rays, photos and readings of vitals can be sent ahead.  An interactive conference enables the clinicans to see, hear, examine and question patients and have them respond and ask questions.
  2.  A radio link between an EMT on the road and emergency medical personnel in a trauma center that helps the EMT keep the patient stable and alive while they are being transported.
  3. Remote surgeries performed by robots hooked to cameras that are monitored by distant specialists as local clinicians standby while the robots perform the surgeries and procedures.
  4. The eICU where doctors are able to watch over many intensive care units at the same time from a remote site.
  5. Store-and forward of data, images or videos that provide the basis for these interactions.
  6. Remote patient monitoring which uses medical equipment or devices to collect and send data from a patient’s home or a nursing home to a monitoring station for interpretation.  This includes monitoring of vitals such as blood pressure, hypertension, blood sugar and weight loss with a device connected to the cloud with real-time data transmitted to a physician in an office often hundreds of miles away and with feedback to patients based on their readings.  Studies have found that patients using the tele-monitoring devices were 90% more likely to have controlled blood pressure.  These results persisted after 12 months.
  7. m-health (mobile) applcations.

Although technicians cannot take a chest x-ray, or collect a sample for lab testing remotely, virtual visits can be effective for initial symptom assessments and can handle the millions of non-covid-19 virus-related appointments that are being cancelled due to quarantines and precautions.  Another twist in adding telemedicine to help manage the number of patient visits to the ER might be to use kiosks in a separate area where initial assessments  are done using virtual video systems to collect information while a patient is isolated, minimizing the spread of the virus.

There are many anecdotal eamples of how telemedicine has been used effectively.

A pharmacist, physician assistant or nurse practitioner  uses video conferencing to demonstrate to a patient how to use an inhaler or the proper way to administer an injection.  The provider can watch and evaluate in real-time the patient’s technique and further their understanding to how to take their medication. 

A physician based in rural Arkansas is able to examine a patient who is on a trip to another country and developed a severe rash.  Through a video-based skype call or a standard call after the patient has sent photos of the rash, the clinician can  determine the cause and severity and decide what next steps would be to address the problem until the patient returns home. 

There are several online telehealth services such as American Well, Teledoc, Zoc Doc, Doctor on Demand, Icliiq that retain primary care, family physicians, psychologists, pharmacists, dentists, dietitians, and fitness experts as well as 24-hour advice lines staffed by nurses or physician assistants.  These services are already used by millions of individuals in all 50 states and most foreign countries and can be accessed by a phone app and two-way video services.  They are convered by insurance and available during off hours such as holidays, nights and weekends when patients need quick access to a clinician for an immediate need.

To address the Covid-19 pandemic Amwell Medical Group reports that it has been working proactively to ensure care delivered across its national telehealth network conforms to national and international standards.  They have trained thousands of their doctors who deliver care on their platform and established an always-on-call infection control officer.  They have put together Covid-19 specific workflows to guide clinical operations and established a Covid-19 Readiness Team.  Other online service groups  are doing similar activities to ensure that their subscribers and others who may register with them have similar service opportunities available.

During this Pandemic, online screening for Covid-19 involves asking the appropriate questions, gathering the right answers and a triage plan.  Although telehealth providers cannot do a full examination of someone, they can determine whether the patient is at high or low risk and make appropriate recommendations.  They can also provide hotlines open 24 hours a day, 7 days a week to review with people the CDC guidelines  and  reduce the burden on emergency rooms and urgent care centers.

The public health response to this global outbreak has to be as efficient and effective and widespread use of telemedicine is one way to ensure that this will happen. It keeps people who do not need to be exposed to others who may be carriers away from health settings and able to learn all they need to know about their own symptoms and risks so that they can make intelligent choices.

 

 

 

 

Safe Prescription Drug Use by DrugWatch

The following resource was put together by Drugwatch a group of medical and legal experts whose mission is to provide quality, accurate, and free information about prescription drug side effects, medical device complications and related lawsuits for patients. This health guide explains how prescription painkillers, anti-anxiety medications and other drugs can lead to physical dependence, addiction and other issues. Understanding the risks of these medications and having frank discussions with your doctor can help head off complications. To read more about DrugWatch or to access the resource directly from the website, click on the link below.

https://www.drugwatch.com/health/safe-prescription-drug-use/

The Drugwatch AHREF code (some people need this when adding, please disregard this code if you don’t need it):  <a href=”

<a href=” https://www.drugwatch.com/health/safe-prescription-drug-use/ “>Safe Prescription Drug Use by Drugwatch</a>

In this era of modern medicine, there’s a pharmacological fix for many ailments, but sometimes, the remedies can cause their own set of problems. Prescription painkillers, anti-anxiety medications and other drugs can lead to physical dependence, addiction and other issues.Understanding the risks of these medications and having frank discussions with your doctor can help head off complications. Powerful prescription drugs are the go-to remedy for a host of ailments.

Someone struggling with anxiety is handed a prescription for a benzodiazepine, such as Xanax (alprazolam) or Ativan (lorazepam). The patient who’s having trouble sleeping receives a prescription for Ambien (zolpidem). A person suffering from chronic pain is given a prescription opioid, such as Percocet (oxycodone) or Vicodin (hydrocodone).At first, the drugs may seem to work like magic — and they work quickly. The Xanax takes the edge off. The Ambien provides a restful night’s sleep. The Percocet eliminates the pain.But over time, the dark side of these drugs often emerges. One day, the patient needs more than the usual dose of medication to get relief. Or the patient tries to stop taking the pills and feels horrible. The patient is suffering from withdrawal because his or her body has become dependent on the medication.

For many patients, this is how the cycle of dependence and addiction starts, and the toll is tremendous. Nearly 218,000 Americans died between 1999 and 2017 from overdoses related to prescription opioids, according to the Centers for Disease Control and Prevention, and millions more are struggling with ongoing substance use disorders.Physicians sometimes fail to mention these risks when they prescribe the medications to patients, and many provide little or no information about when or how to stop taking the drugs.That’s why it’s essential to get as much information as possible before you start taking these ​types of drugs​. When you understand the risks, you can take steps to avoid them.

Talking To Your Doctor

Before taking any medication, it’s crucial to talk to your health care provider about the benefits and risks of the drug. This is especially the case with prescription painkillers and other central nervous system depressants, which have a host of ​serious side effects ​and are notoriously hard to quit when you take them for a long time. Asking your doctor why they’ve selected a particular medication and how the drug works is a good starting point for this critical conversation.

It’s important to understand your diagnosis and the sort of results the medication will deliver. If your doctor has prescribed opioids for back pain, for instance, find out what he or she thinks is causing your pain. Will the medication improve your condition or just treat the symptoms? Or is there another way to get to the root of the problem and fix it?

Here are some other important questions to get you started:

  1. What are the benefits and risks of taking this medication?
  2. What are my treatment options?
  3. Are there better, safer (or non-addictive) alternatives?
  4. What are the medication’s side effects?
  5. How will this interact with my other medications?
  6. Can I safely drive while taking this medication?
  7. How long should I take this drug?
  8. How should I stop taking this drug? (Can I stop it suddenly or will I need to be weaned off of it?)

If you find this sort of conversation nerve-racking or uncomfortable, know that you’re not alone. Many people find doctors intimidating or worry that their doctors will think they are questioning their judgment. With the typical medical appointment lasting about 15 minutes, other patients simply feel too rushed to bring up their concerns.

But a good doctor will make time for these conversations and encourage you to be an active participant in your health care decisions. If you’re too shy or tongue-tied, take a friend or relative with you who can advocate for you. And remember, your doctor works for you — not vice versa.

Did You Know? ​In a 2016 survey of patients using prescription opioids, six out of 10 patients said their physicians provided no instructions about how to stop taking the drugs, or when they should stop. ​Source: ​The Washington Post/Post-Kaiser (Long-Term  Prescription Opioid Painkiller Users Poll)

Understanding the Risks

Not everyone who fills a prescription for an opioid will become addicted. But a ​2017 report by the National Academies of Sciences, Engineering and Medicine ​suggests that approximately 8 percent of those given prescription painkillers will end up with a diagnosed “opioid use disorder” and up to a quarter will engage in behaviors that suggest a substance abuse problem.Physical dependence on opioids can occur in as little as eight weeks. And dependence on benzodiazepines and hypnotic sleep medications like Ambien can occur within three to four weeks of regular use, according to studies.That’s why many physicians will prescribe the lowest dose needed for as short a time as possible.

​Dr. Chris Johnson​, an emergency room physician who has worked on the front lines of the opioid epidemic, told Drugwatch that “there is no ‘risk-free’ dose of opioids,” and the risk of dependence and addiction escalates the longer you take them.

Did You Know? ​One-third of patients taking prescription opioids for eight weeks developed an addiction or physical dependence on the medication. ​Source: ​2016 survey conducted by The Washington Post and Kaiser Family Foundation

Dependence and Withdrawal

Tolerance is a physiological change that occurs when you repeatedly use a drug. Tolerance is usually characterized by needing to take higher levels of a drug to get the same effect. Drug dependence often follows.When you’re dependent on a drug, your body needs it in order to function normally, and you may feel sick and suffer withdrawal symptoms if you don’t take it. Dependence develops because the drug causes changes to your brain’s neurochemistry.Dependence may be hard to identify at first, and the signs of trouble may seem counterintuitive.

With opioids, for instance, withdrawal may first manifest as an increase in pain, and a patient with chronic pain may interpret this as a“flare up” of their condition, according to  Dr. Johnson.But if your pain level has increased, that’s often the first warning sign that you’re dependent on the medication. Withdrawal symptoms often follow, but patients shouldn’t wait for severe symptoms to manifest to suspect they’re becoming dependent on a drug.You should talk to your doctor as soon as you suspect you’re showing signs of dependence or experiencing withdrawal symptoms. He or she may be able to create a tapering schedule for you to gradually reduce your dose and minimize withdrawal. Depending on the drug you’re taking and how long you’ve been taking it, common drug withdrawal symptoms will vary:

Prescription painkillers (such as Vicodin, Percocet, Oxycontin) While opioid withdrawal feels miserable, it’s not usually life-threatening. Common withdrawal symptoms may include: anxiety, muscles aches, nausea, vomiting, diarrhea, goosebumps, sweating, agitation, stomach cramps, dilated pupils, runny nose and watery eyes.

Benzodiazepine sedatives (such as Xanax, Valium, Ativan) Common symptoms of benzodiazepine withdrawal may include: a return of anxiety, sleep difficulty, panic attacks, tremors, sweating, trouble concentrating, nausea, dry heaves, weight loss, palpitations, headaches, muscle tension and spasms, seizures and other problems.

Some people develop a protracted withdrawal syndrome that can drag on for months or years. Hypnotic sleeping pills (such as Ambien) Patients suffering Ambien withdrawal may experience a return of insomnia, uneasiness, abdominal and muscle cramps, vomiting, sweating, tremors and convulsions.

Physical dependence can occur with the chronic use of many drugs, even if you take your medication exactly as directed. Dependence is not the same as addiction, although addiction may accompany or follow dependence.

Safety Tip ​Physical dependence on opioids, benzodiazepines and other medications can happen in a matter of weeks. For this reason, doctors usually recommend using such drugs for as brief a time as is necessary.

A Closer Look at Benzodiazepine Dependence

Benzodiazepine dependence doesn’t get nearly the attention that opioid dependence does, but the problem is significant. A ​2017 article in The New England Journal of Medicine ​found that benzodiazepine dependence occurred in approximately one half of patients who took the sedatives for more than a month. Those who’ve experienced it say it can happen even more quickly.

Dr. Christy Huff, a cardiologist and co-director of the Benzodiazepine Information Coalition, told Drugwatch that her doctor gave her a prescription for a low dose of Xanax (0.25 mg) in 2015 when she was suffering from insomnia and anxiety related to an excruciating bout of dry eye syndrome. “I was warned about addiction. I don’t have a history of abuse or an addictive personality, so I thought as long as I was following my doctor’s instructions, I was safe,” Huff said in a phone interview. “What I didn’t realize is dependence is different and can develop quickly— in the matter of a week.”

After about three weeks of taking the drug to sleep at night, Huff developed a tremor and worsening anxiety. The symptoms were so unbearable that she soon began taking a second dose of Xanax in the middle of the day for relief. When she told her doctor what was going on, her doctor put her through a battery of medical tests that turned up nothing.  “Nobody ever said the medication could be causing your problem,” she recalled.  “I don’t have a history of abuse or an addictive personality, so I thought as long as I was following my doctor’s instructions, I was safe. What I didn’t realize is dependence is different and can develop quickly — in the matter of a week.”

In fact, Huff had developed a physical dependence on alprazolam and was suffering from what’s known as “interdose withdrawal.” The phenomenon, which causes withdrawal symptoms in between doses, is common with short-acting benzodiazepines such as Xanax. Like many who end up dependent on benzodiazepines, Huff developed an array of excruciating withdrawal symptoms. Hers included profound fatigue, cognitive problems, brain fog, muscle spasms, muscle weakness, stomach upset, and sensitivity to light and sound.

To ease her agony, her doctor switched her to Valium, a longer-acting benzodiazepine, and began a long, slow taper. In the end, it took her three years and three months to taper off of benzos completely and now, she said, she is working on rebuilding her health.  She also works with the ​Benzodiazepine Information Coalition ​to educate others about the dangers of benzodiazepine use and provide resources for those who are dependent.

Addiction and Overdose

Addiction is another risk associated with opioids, benzodiazepines, sleeping pills and other types of mind-altering drugs. Addiction is different than physical dependence and less common, Johnson said, because it involves not just having withdrawal symptoms, but an inability to stop using the drug despite its adverse effects on ​your health and life​. A person who is addicted to a drug will usually experience intense cravings and compulsively use the drug. The user may spend a great deal of time thinking about the substance and figuring out ways to obtain it.

With prescription drug addiction, people may attempt to obtain more pills than they need or refill their prescriptions early. They may also try and obtain the same prescription from several practitioners, a phenomenon known as “doctor shopping.”

Misusing Prescriptions ​An estimated 18 million people — 6 percent of the population over the age of 12 — misused a prescription medication in 2017. ​Source: ​National Institute on Drug Abuse.  Once addiction occurs, “things get ugly, even with treatment,” Johnson said. He pointed to a ​2017 study in the Journal of Addiction Medicine ​that showed that even when getting treatment at a medical clinic, the fatality rate for people with an opiate use disorder is extremely high.

One in five who sought medical treatment for addiction died within 10 years. The risk of dying from a drug overdose is especially high right after treatment. That’s because a person’s tolerance drops quickly after any sort of prolonged period of drug abstinence, and if they return to their prior level of drug use, their body won’t be able to handle it.

Knowing the signs of an overdose is crucial. The signs and symptoms of an opioid overdose may include:

Excessive drowsiness or sedation

Sluggish reflexes Confusion or altered mental status

A weak or rapid pulse Cool or clammy skin

Pale face Slow or stopped breathing

Bluish lips or fingers (darker-skinned Low blood pressure people may appear gray or ashen)

The signs and symptoms of benzodiazepine overdose may include: https://www.drugwatch.com/health/safe-prescription-drug-use/ 7/12

Unresponsiveness Vomiting Loss of consciousness

Anxiety and agitation Confusion or altered mental status Drowsiness Blurred Vision

Unresponsiveness Trouble breathing Low blood pressure Muscle weakness

Slurred speech Hallucinations

The signs and symptoms of an Ambien (zolpidem) overdose may include:

Drowsiness

Trouble breathing Slowed heartbeat

Coma

Mixing medications ​can increase the risk of an overdose. More than a third of fatal opioid overdoses occur when people use opioid painkillers and benzodiazepines together. Both types of drugs suppress breathing, and those effects are greatly multiplied when used in combination, creating a fatal drug cocktail.

If someone is grappling with an addiction to opioids, it’s wise to have an antidote on hand. Naloxone, also known as Narcan, can reverse an opioid overdose if it’s given in time. It comes in several forms, including a nasal spray and an injection. Emergency responders usually carry naloxone with them, so if you or a loved one is overdosing, call 911 immediately.

Safety Tip ​If you or a loved one take prescription painkillers, print out the ​Opioid Overdose Resuscitation Card​. Follow the instructions on the card in the event of an overdose and ask your doctor whether you should keep naloxone on hand.

PTSD and Other Risk Factors

Anyone can become physically dependent on a drug. But some people, including those with post-traumatic stress disorder, have a higher risk of developing an addiction to opioids and other substances.

As Johnson explained, addiction is linked to distortions in the brain’s reward system. Chemicals, such as opioids and benzodiazepines can effectively hijack this reward system — as can pleasant activities, such as gambling, social media and video games.

But people who’ve had their normal reward systems disturbed through traumatic events face an even higher risk, Johnson said, because the reward pathways are also responsible for us feeling comfortable in our skin from minute to minute. As a result, people with PTSD may turn to substances to ease their discomfort.

Did You Know? ​Approximately 50 percent of people who seek treatment for substance use disorders meet the criteria for post-traumatic stress disorder. ​Source: ​Current Psychiatry Reports

“Furthermore, opioids and addiction deaths have been described as part of the phenomenon as ‘deaths of despair,’”

Johnson said. “These deaths of despair include suicide and alcohol along with opioids. Anyone from any socioeconomic status can develop addiction, but the rates of addiction still hit those with lower status and more difficult prospects harder than those better off.”

Other risk factors — including genetics, a family history of substance abuse, and a history of ​mental health problems — can also increase a person’s chance of developing an addiction.

Certain psychological and social stressors can also lower the bar. A person might be more vulnerable to misuse substances after losing a job, moving or going through a divorce, for instance. You should make your doctor aware of any difficult or stressful situations in your life.

Safety Tip ​If you have a history of addiction or alcoholism, let your doctor know. This can raise your risk of developing an addiction to certain prescription medications.

Safe Use of Painkillers After Surgery

In some situations, taking an opioid may unavoidable. ​Opioids ​are often the only reliable method to control pain related to cancer or other terminal diseases.

Likewise, if you’re undergoing major surgery or have suffered trauma from an accident, an opioid may be the only feasible method of providing adequate pain relief. There are still important precautions you and your healthcare team can take to avoid becoming dependent on the drug.

According to the CDC, doctors should prescribe the lowest effective dose of an opioid and provide no greater quantity than is needed: usually three days’ worth of medicine or less. Only in rare cases, will more than a week’s worth of medication be necessary.

“Patients with an acute injury such as fracture or kidney stone should plan on taking these medicines no more than a few days and plan to stop altogether in no more than a week as a general guideline,” Johnson said.

If you’re being prescribed opioids for pain after surgery, you should also understand responsibilities as a patient. According to the CDC, that includes knowing how often to take your medication, how to properly store it and how to dispose of any unused pills.

Opioid Dos and Don’ts:

Never take a larger dose of the medicine than your doctor has prescribed and never take your pills more frequently than it says to on the pill bottle. Don’t combine your painkillers with alcohol, sedatives or other drugs (including over-the-counter medications) that cause drowsiness. Never share or sell your pills. Store your medication in a secure (locked) cabinet out of the reach of children, relatives and visitors, and keep track of your pills. Dispose of any unused pills through a community drug take-back event or by disposing of them in the garbage. You can learn more about ​proper disposal methods from the FDA​.

Patients also need to have realistic expectations about post-surgical pain relief.

“[You] should expect some ongoing pain, which is normal,” Johnson said. “Patients should not expect opioids to be taken to make one pain free until the healing has progressed to the point that when they stop taking opioids they are also pain-free. Opioids after an injury or a surgery should be taken only with the expectation that the worst of the pain will be mitigated for a few days.” Please seek the advice of a medical professional before making health care decisions.

Written By Amy Keller, RN ​ ​Registered Nurse

Amy Keller is a registered nurse and award-winning journalist with 22 years of experience writing about politics, business, health and other topics. At Drugwatch, she draws on her clinical experience and investigative reporting skills to write about consumers’ health concerns such as the safety of online pharmacies. She also provides informed analysis on complex health issues. Some of her qualifications include:

Recipient of USF’s Nurse Alumni Nightingale award for excellence in nursing Guest Faculty Speaker,

“Moving Forward with Patient- and Family-Centered Care Intensive Training Seminar” Member of Sigma Theta Tau International Honor Society of Nursing

Edited By

Emily Miller ​Editor

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