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A message about COVID-19

The global community is trying their best to cope with the rapidly evolving situation surrounding the spread of COVID-19. Governments are trying to quell panic while being appropriately cautious to contain the spread. Individuals are preserving their own and their families’ health by minimizing exposure. And businesses, particularly those that have logistics at the core, are struggling to find ways to mitigate damage to their bottom line and productivity. These are no doubt challenging times, and signs point to things getting worse before they get better.

As a profession, we need to observe and think deeply about what actions to take as this virus continues to spread around the globe, and how to be as helpful as we possibly can be. Here is what I came up with, as a direct result of the personal experience that I had with my own physician.

Dr. Michael Goodman, MD in Bellmore is a board certified internist who has been my physician for over 30 years. He has always been there for me and my wife, helping both of us try to achieve optimal health. Over the years, I was fortunate enough to establish a personal and professional relationship, as we both always looked for innovative ways to advance healthcare through collaboration. As two health care providers, we believed that having a Pharmacist, right in the office as a clinical partner of  the Physician, would help address the challenges in medication management that patients struggle with everyday. Delivering better adherence solutions, by utilizing cost saving and life saving resources as a medication expert in the office, can help create a new standard of patient engagement.

Today Dr. Goodman is sitting in his home, unable to deliver care, compassion and empathy to patients in his office, that always went hand in hand with his medical expertise. He is on a two week quarantine as a result of a positive COVID-19 test that he personally administered to one of his patients earlier this week.

I needed to see him yesterday when my wife experienced some flu-like symptoms that concerned me. As an asthmatic patient, over 60 years old (sorry honey, had to say that) her shortness of breath and cough was disturbing for obvious reasons. When I called Dr. Goodman, always available to his patients on his cell, I asked if I could bring her in to see him. It was at that moment , the world of healthcare as I knew it changed when he said that he was closing the office for two weeks.  This was not a time for him and his lovely wife to go on vacation or to visit with their grandchildren up in Boston, always with a covering doctor on call to handle any emergencies. This was THE OFFICE IS CLOSED.

After I hung up, I realized that the people putting their lives on the line to help patients during this coronavirus pandemic, are in fact putting themselves and their families at risk. As a patient, and as a caring Pharmacist and as a human being trying to deal with this health care crisis, I had to do something….immediately !

I called my partner Peter Bechtel, and said…”Remember that TeleHealth conversation we had a few months back to add that to our PharmD Concierge services ?…WE NEED IT TODAY !

I am not going to bore you with the dynamics or gymnastics over the past 12 hours that Peter did to accomplish, but today at 4PM we installed the first RXVIP Concierge TeleHealth platform for  Dr. Goodman so he can ‘meet’ with patients tomorrow. He now has the only telemedicine solution in the country that comes with a Pharmacist (me) in the box, making this a turnkey solution so that his practice can continue to serve his patients in what we both agree will be the “new normal” that will save lives.

I am personally reaching out to the next generation of licensed PharmDs who have entered our profession recently, plus those at the door to our great profession. We need YOUR leadership  to set the bar for social distancing and safe practices. As the youth of America, not just as future health care providers, you have the opportunity to save lives today by refraining from what comes naturally in your normal activities. There is no normal now so the responsibilities to set the ‘New Normal’ sits squarely on your shoulders.  As clinical experts, you must be following the trends that indicate much larger positive test results of testing for people not originally identified as high risk. No one knows who is carrying this deadly virus as numerous cases show that it is now showing up in patients before they show any symptoms. Please think of the impact that you can have by following the guidelines set for flattening the curve, even if it seems challenging. The end result of your ‘adherence’, a powerful word for Pharmacists, is that YOU will deliver the right drug at the right dose which will help the next generation of PharmDs reach Provider Status.

Finally, and with no political axe to grind, it just amazes me that with the leading experts in our nation coming together to deal with this horrific patient safety disaster, NO ONE has mentioned the word ‘Pharmacist’ in any guideline change or as a resource to leverage our profession for help. Now a new/old drug is coming into play plus tens of millions of Americans will struggle as a result of medication shortages on their life saving drugs, yet the value of Pharmacists to the healthcare continuum is based on the fact that CVS & Walgreens have big parking lots.
With TeleHeath guidelines being dramatically changed by CMS to allow physicians to stay engaged with their patients, and be compensated for their professional services, then there has never been or will never be a better time to allow Pharmacists to provide their medication expertise in the same fashion.

We have always advocated for provider status, and will continue to do so until our voices are heard. Now we are not advocating for the profession of pharmacy alone, but we are advocating for every person in America, who last year took over 4 BILLION prescriptions that physicians wrote. The need Pharmacists to help them manage their medication to stay alive during this pandemic wave that will crash on the healthcare system, but  also when it washes away.

My father was a community Pharmacist for over 60 years and I can assure you that he would have provided needed services in a crisis like this.  In his honor and memory, RXVIP Concierge will provide every Pharmacists with a TeleHealth solution that they can then implement and utilize with any physician practice who sees the value of what a Pharmacist delivers as a PROVIDER. There will be hundreds of telemedicine solutions hitting the market now, but you can offer the only one that comes with a Pharmacist In The Box !!

Just Call 1-844-MYRXVIP (1-844-697-9847) to get on the pathway to provider status with us.

Physicians are welcome to call as well because we can’t have doctors sitting at home (sorry Dr.G) not ‘seeing’ patients at this critical time for the health of our nation. RXVIP Concierge will make sure that those offices don’t stay closed forever.

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COVID-19: An In-Depth Look at the Virus That’s Shaking the World

It’s on the news, on social media and just about everywhere. Coronavirus is striking fear and causing panic around the world as it continues to spread like wildfire killing thousands in its path and affecting thousands more.

The virus that started in Wuhan City is now a worldwide problem that everyone is scrambling to find a cure or at least prevent this deadly virus from spreading even more.

Cases and death tolls are rising at unprecedented rates and they keep growing every day. As the world continues to fight the coronavirus, let’s look back at how it all began, how it spread all over the world and what we can do to protect ourselves against it.

Wuhan: The city where it all began

 A lot of people didn’t know about Wuhan city before the coronavirus outbreak. The capital city of Hubei province with over 11 million residents, Wuhan used to be known as the “Chicago of China” for being an economic, political, cultural and financial hub. But in December 2019, the first case of pneumonia with an unknown origin was identified in the city and Wuhan has never been the same.

Chinese authorities reported a string of similar cases of pneumonia in the city and soon determined that it was caused by a novel coronavirus named SARS-CoV-2. Although coronaviruses are common in humans causing common illnesses like the cold, this novel coronavirus has not been previously identified and its origin remains unknown to this day.

Spreading at such a rapid rate, the outbreak was declared a Public Health Emergency of International Concern on January 30 and on February 11, the World Health Organization finally released an official name for the novel coronavirus: COVID-19.

WHO Director General Tedros Adhanom Ghebreyesus said of the name: “We had to find a name that did not refer to a geographical location, an animal, an individual or group of people, and which is also pronounceable and related to the disease. Having a name matters to prevent the use of other names that can be inaccurate or stigmatizing.”

The beginning of an outbreak: A timeline

After China alerted WHO of several pneumonia cases in Wuhan, the US Center for Disease Control and Prevention identified a seafood market in the city as the suspected source of the outbreak. Starting January 1, 2020, passengers from Wuhan airport were screened for flu-like symptoms and a few days after, WHO issued travel and trade restrictions in China. But that didn’t prevent the coronavirus from spreading outside the country:

  • January 7 – The first suspected coronavirus cases outside China were detected in Thailand.
  • January 9 – A 61-year old man from Wuhan who was admitted on December 27 for flu-like symptoms dies from coronavirus.
  • January 11 – A Chinese woman returning from a visit to Wuhan became the first confirmed coronavirus case in Thailand.
  • January 13 – Japan reported its first confirmed case of the virus.
  • January 15 – A 69-year old man from Wuhan became the coronavirus’ second fatality in China.
  • January 17 – China confirmed its third fatality with over 200 cases in less than a month. A Chinese passenger from Wuhan to South Korea was also detected with the virus as well as a British tourist in Thailand.
  • January 20 – The United States confirmed its first coronavirus case with a patient admitted in a hospital in Washington after his trip from China. Australia also reported its first case after a patient from Brisbane tested positive.
  • January 23 – Chinese authorities started the construction of a temporary 1000-bed capacity hospital in Wuhan’s Caidian district. There are now 830 confirmed cases in China, 85 of which are in critical condition.
  • January 24 – Canada reported its first suspected coronavirus case of a 50-year old man returning from Wuhan and a Nepali student who tested positive of the virus. There are now 1,320 confirmed cases around the world, 1297 of which are in China with a death toll of 41.
  • January 25 – Mexico reported its first confirmed case while France had three confirmed cases. China’s National Health Commission reported that there are now 15 fatalities in the country making the death toll at 56 and the reported cases at 1,975.
  • January 26 – Sri Lanka reports its first case and China confirmed 2,744 cases, half of which are from Hubei province with a death toll of 81.
  • January 27 – Germany and Cambodia reported their first coronavirus cases bringing the number to 4, 515 confirmed cases and a death toll of 107.
  • January 28 – Finland confirms its first coronavirus case while four members of a Chinese family in the UAE have been infected. There are now 5,974 cases and 132 fatalities.
  • January 29 – Russia, India and the Philippines have confirmed their first cases while Italy had two affected patients. The US CDC also reported the first person-to-person transmission in the country with the virus now affecting 7,783 people with a death toll of 170.
  • January 30 – NHS confirmed the first two cases of coronavirus in the UK while New Zealand announced its first suspected case. Infected patients now reached 9,776 with a death toll of 213, prompting the WHO to declare the outbreak as a Public Health Emergency of International Concern.
  • January 31 – Russia, Spain and Sweden reported their first cases. The virus has spread to 26 countries with 11,374 confirmed cases and a death toll of 259.
  • February 1 – The first coronavirus fatality outside China was reported in the Philippines while the number of cases soared to 14,413 with over 300 deaths.
  • February 3 – Malaysia and Belgium reported their first cases and death tolls are now at 427 with over 20,623 confirmed cases. 646 patients have fully recovered from the virus.
  • February 4 – A cruise ship named Diamond Princess that docked in Japan had ten confirmed cases including three Japanese, two Australians, three Chinese from Hong Kong, one American and a Filipino crew member. There are now 24,527 cases and 492 deaths.
  • February 6 – A Chinese doctor who tried to issue an early warning about the outbreak died from the virus while Japan reported 41 new cases from the cruise ship.
  • February 8 – There are now 813 deaths from coronavirus surpassing the 774 lives claimed by the SARS epidemic in 2002.
  • February 11 – WHO officially names the virus “COVID-19.” There are now 43,000 confirmed cases globally with 1,018 deaths.
  • February 14 – Egypt confirmed its first case with the number reaching to 67,000 and a death toll of 1,526.
  • February 18­ – There are now 75,000 infected patients around the world with the death toll reaching 2,000.
  • February 26 – There are now 82,000 confirmed coronavirus cases with 32,000 recoveries and 2,800 deaths.
  • March 1 – The total confirmed cases worldwide are now at 89,000 with 45,000 recoveries and a death toll of 3,000.

 

Understanding COVID-19: Everything you need to know

COVID-19 is unlike any other outbreak that we’ve seen over the last decade. Within just two months after the first case was detected in Wuhan, the coronavirus has already affected 103,950 people around the world with over 3,524 deaths as of March 7. But how exactly does COVID-19 spread and what are its signs and symptoms?

Mode of transmission

Although it came from an animal source, the virus is now capable of person-to-person transmission. The most common mode of transmission for the coronavirus is through respiratory droplets released when an infected patient coughs or sneezes and transferred to someone in close contact with that patient. Touching an infected object or surface and then touching the mouth, nose or eyes can also be a form of transmission for COVID-19.

Signs and symptoms

Patients who tested positive of the coronavirus showed three common symptoms related to severe respiratory illness—fever, cough and tiredness. In worse cases, patients reported shortness of breathing and eventually, organ failure.

Some patients were also asymptomatic even if they tested positive of COVID-19, maybe because they had stronger immune systems.

Although COVID-19 has already claimed thousands of lives around the world, a lot of those who were affected by it were also able to recover back to full health. According to studies conducted in Wuhan, more than 80% of those who died of the coronavirus were over 60 years old with 75% of these individuals having existing medical conditions like hypertension, heart disease, cancer and diabetes.

The younger population are believed to have a lower risk of contracting the disease, as evidenced by a report from the World Health Organization where only 2.4% of the 75,465 confirmed cases as of February 20 where under 18 years old.

Precautionary measures

With COVID-19 spreading across the world at an unprecedented rate, the WHO advises the public to follow these precautionary measures to prevent the virus from affecting more people:

  • Practice frequent and proper hand washing. Hand washing is still the single most important preventive measure that you can do against COVID-19. Wash your hands with soap and water as frequently as possible. If you don’t have access to water, use alcohol because it helps kill the virus that could be on your hands.
  • Keep your distance. Whenever you’re in public, be extra cautious of your surroundings and keep at least a 1 meter distance from a person who is coughing or sneezing since liquid droplet is the most common mode of transmission for the
  • Embrace proper respiratory hygiene. If you need to cough or sneeze, always cover your mouth and nose with your bent elbow or tissue and dispose the tissue immediately afterwards. Teach members of your family, friends and colleagues to do the same.
  • Avoid public places and traveling for now. Unless it’s absolutely necessary, try to avoid public places where there’s a potential risk for getting the virus. You should also delay any travel, especially to places where there’s an ongoing outbreak.

If you recently travelled to an area where there’s an ongoing COVID-19 outbreak, make sure that you stay at home and quarantine yourself if possible for the next two weeks.

If you develop any symptoms during that time, seek medical care right away. Get in touch with your healthcare provider beforehand to let him know of your recent travel and symptoms so you could be given proper instructions on how to seek care without spreading the coronavirus to the people around you.

Since there have been reported cases of domestic transmission lately, it’s also very important to seek medical care early if you feel unwell, even if you haven’t travelled to affected areas. If you have a fever, cough, cold and breathing difficulty, get in touch with your healthcare provider right away.

If you tested negative for the virus but you’re still sick, stay at home and make sure to cover your mouth and nose when coughing or sneezing. You should also disinfect objects or surfaces that you constantly touch while sick.

Treatment and vaccination

As of today, there’s still no specific antiviral treatment for COVID-19 and experts are still looking to develop a vaccine for it. So the next best thing that we can all do is to take daily preventive measures like frequent hand washing, avoiding close contact with sick people and boosting the immune system.

Moreover, if you ever feel under the weather, have yourself checked right away to make sure that you don’t have the virus. If you do, getting early medical treatment increases your chance of recovery rather than waiting too long to get treated for your symptoms.

The future with an outbreak

COVID-19 definitely came without warning and it took the world by surprise with its aggressive nature. But like many other epidemics that we’ve been through, the best thing to do is to be aware of what’s happening around us and do our share in preventing the coronavirus from spreading further.

Experts from around the world are now in search for a cure to this deadly virus. But while we wait for that day when COVID-19 will finally be a thing of the past, we should also work together in making sure that we fight this virus and take it by the horn.

 

 

 

 

 

 

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American Pharmacy Purchasing Alliance Announces 2020 Open Membership Enrollment

The American Pharmacy Purchasing Alliance is excited to announce Membership Open Enrollment from Jan. 15– Feb. 29 2020, officially bringing their suite of fully managed pharmacy success solutions to the market. Pharmacy owners will enjoy a wealth of profitable turn-key benefits which are included in membership: New Patient Acquisition, Diversified Clinical Services, Population Health Management & Protected Group Purchasing with DIR Fee Insurance.

The American Pharmacy Purchasing Alliance has teamed up with industry leaders such as AmerisourceBergen, SureCost, PremierRX, MicroMerchant Systems, RXVIP & More to deploy an end-to-end solution engaging Payors, Providers, Patients, Pharmacies, Wholesalers & Manufacturers.

” Pharmacy Owners have fought an uphill battle for the last five years and deserve some much-needed relief from costly DIR Fees. Our fully managed Population Health model provides Independent Pharmacies with the clinical resources they need to be successful in today’s value-based care environment. APPA is much more than coaching. We’re actually doing the work.”  ~Nathan Purcell – Director Of Member Benefits

To learn more visit www.joinappa.com

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Prescription Deliveries – The New Normal in Customer Service?

When CVS Pharmacy announced in mid-2018 that it had launched a nationwide prescription delivery service capable of providing next-or-second-day delivery, the news garnered significant media coverage and quite a few headlines.  And so did news from Walgreens, that came a few months later, about a new partnership with Federal Express to offer next-day prescription deliveries.  Walgreen’s new service level was to complement  the “same day” service already offered in certain markets.

Less-well-noticed though, was a release issued by the National Community Pharmacists Association (NCPA), pointing out that locally-owned pharmacies had been in the business of home delivery for years.  “According to the NCPA’s 2017 Digest, sponsored by Cardinal Health,” the release stated, “72 percent of locally-owned community pharmacies offer same-day home delivery, and 76 percent of those offer home delivery as a free service.”  The release further noted that a 2017 “flash survey” of NCPA members found 68 percent of pharmacy managers said deliveries were made in less than six hours.

“What’s all the fuss?” noted an NCPA spokesman.  “Independent pharmacies have been offering same-day home delivery – most of them at no charge to the patient – for decades.”

Since then, availability of same-day prescription delivery services has only increased.  CVS now offers same day service at 6,000 pharmacy locations across the country, with patients charged a $7.99 delivery service charge.

“Consumers continue to demand faster delivery for online orders,” CNBC noted in reporting on CVS’s same-day service.  “This is especially true with groceries that need to stay fresh and prescription drugs that customers need to take right away.  If a person is diagnosed with strep throat and fills a prescription for an antibiotic, they’re not going to wait one or two days for it to arrive.”

All this is happening, of course, as online pharmacy PillPack, owned by Amazon, threatens to disrupt traditional patient/pharmacy relationships.  PillPack offers free, monthly deliveries of regularly-prescribed medications, along with 24/7 pharmacy support.   But, as CNBC’s analysis notes, pharmacies face threats that extend beyond PillPack:  “Other start-ups are also trying to woo consumers with the ease of filling their prescriptions without ever walking into a pharmacy or standing in line.”

Patient reliance on home delivery services became especially apparent, when a new federal regulation eliminated its availability for certain diabetes testing products.

A few years ago, the NCPA  surveyed pharmacy members about home delivery practices for homebound Medicare diabetes patients.  The survey was conducted in advance of a new mandate from the Centers for Medicare and Medicaid Services (CMS) requiring Medicare beneficiaries to obtain diabetic testing supplies through an approved mail-order supplier.  This mandate effectively removed the option of having those supplies delivered by a local pharmacy.  When asked what the effects would be on their patients, 65 percent of responding pharmacists said the impact would be significant.

“We have a large elderly population and are in a rural area in Minnesota,” one pharmacist noted.  “Especially in the winter during storms, many of our customers cannot leave their homes and rely on our home delivery service.”  Another pharmacist suggested patients would “be unable to follow up in maintaining their goals,” and cited the increased risk of patients developing complications and incurring added costs.

Whatever the reason, it’s clear that patients prefer the option of having their prescriptions delivered, and increasingly expect seamless, same-day service.  For pharmacy managers wanting to meet those expectations, the concept of home delivery raises a number of issues – regulatory, logistics, operational – that must be considered and addressed.

Foremost of course, is the need to ensure deliveries are made in accordance with all state and federal requirements.  HIPAA signature requirements must be met, and precautions must be taken to ensure that only eligible medications are delivered.  Prescriptions for controlled substances, for example, are subject to both federal and state regulations.  And some plans expressly prohibit home delivery of Schedule 2 controlled substances, which include oxycodone, codeine and hydrocodone, among other substances.  In addition, pharmacies certified to process electronic prescriptions for controlled substances (that demonstrate use of a technology system approved by the DEA), must meet strict recording keeping requirements.

Then there are internal pharmacy processing requirements.  How to manage inventory levels, for example, keep track of payments, update signature logs, and maintain patient records.  A pharmacy must also ensure the efficiency of the delivery process itself, by making sure drivers’ routes are optimized, and enabling real-time communication between the driver and the pharmacy.

Which is where the choice of a pharmacy technology management system comes in.

Quite frankly, with many different technology systems to choose from, pharmacy managers will need devote a fair amount of time to identify the best system to meet their overall pharmacy needs.  In investigating current offerings, a pharmacy manager may find that certain systems may excel in workflow management, or pharmacy recordkeeping, but cannot accommodate patient-friendly services like home delivery, or online reorders.

Other technology providers, start-ups for example, tend to focus on developing solutions to address a specific category of pharmacy needs.  Solutions that target inventory management, electronic prescribing, immunization management – and home delivery – are good examples of this.

A better bet though, is to identify a comprehensive pharmacy management solution that offers a “one-stop solution” for all pharmacy needs.  The PrimeRx™ operating system, offered by Micro Merchant Systems, is one example of solution that fits this bill.

The PrimeRx™ core operating system serves as “command central” for the overall system,  and offers essential functions including prescription processing, workflow management, report generation, inventory management, automated refill management, patient record management, and patient communication capabilities.

Pharmacies can build upon these critical functions, by taking advantage of any number of software modules, designed to address specific pharmacy needs.  These software modules  seamlessly integrate with PrimeRx™ and include PrimePOS™, which ensures fast, seamless point-of-sale transactions; PrimeESC™ which allows for HIPAA-compliant electronic signature capture; PrimeRxSP™ which meets the unique needs of specialty pharmacies; PrimeDMS™ document management system; and the FillMyRefills™ automatic reordering capability.

The system enables remote deliveries through its innovative PrimeDELIVERY™ module, which allows the convenience of home delivery with all transactions wirelessly transmitted back to the core PrimeRx™ management system.  Through PrimeDELIVERY™, the pharmacy essentially goes “on the road,” by ensuring an electronic paper trail records all transactions, including critically-important HIPAA-compliant electronic signatures and privacy acknowledgements.

Pharmacies can install PrimeDELIVERY™ on any Android or IOS device, which allows a high degree of flexibility in selecting a preferred tablet or phone to accompany delivery personnel.  The delivery module is HIPAA-compliant, and interacts directly with PrimeRx™ and PrimePOS™ to manage prescription deliveries and collect and record all copays.

What differentiates PrimeDELIVERY™ from other pharmacy delivery services though, is the broad range of functionality it provides, along with its attention to detail.  For example, just as busy consumers have grown tired of waiting around to sign for product deliveries, so too have patients come to expect higher levels of convenience from their pharmacies.

PrimeDELIVERY™  addresses this need  through a new “remote signature capture” capability.  This feature allows the system to generate an advance electronic signature request, which is sent to the patient ahead of a scheduled delivery.  The patient provides a signature, which is transmitted back to the pharmacy via PrimeDELIVERY™, and integrated into the patient’s record.

By collecting the signature in advance, a delivery can be made, even if the patient is not present when the delivery person arrives.

PrimeDELIVERY™ includes other capabilities that facilitate deliveries to homes, workplaces and other preferred locations.  These capabilities include:

  • Seamless tracking of each prescription. All prescriptions set for delivery are marked as “out for delivery” in the pharmacy’s system.  Once the delivery is actually made, that notation is changed to “delivered.”  If a prescription needs to be returned to the pharmacy, the patient record will automatically be updated.
  • Inventory management. Any undelivered medications are returned to inventory, with stock levels automatically adjusted.
  • HIPAA Compliance. In addition to capturing prescription pickup signatures, PrimeDELIVERY™ captures a HIPAA acknowledgement signature, and stores that information in the patient’s record.
  • One signature for multiple prescriptions. A patient can sign once to accept multiple prescriptions.  The system also allows a patient to “uncheck” specific prescriptions they may not wish to take delivery of at that specific time.
  • Data and patient security are priorities. All data is encrypted and remains highly secure throughout the transaction.
  • Seamless integration with patient records. All remote transactions are automatically uploaded to a patient’s record.  This allows the pharmacist to accurately track patient adherence and/or medication therapy progress, while also ensuring full compliance with all record-keeping requirements.

Home delivery capability is a win-win for pharmacies and patients.  Pharmacies can meet patients expectations for convenient deliveries, while also ensuring meticulous record-keeping and full compliance with all applicable regulatory mandates.  And patients benefit from not having to schedule their day around an expected delivery.

As home delivery increasingly becomes an industry standard, pharmacy managers are looking to technology providers for solutions to facilitate the integration of this service into pharmacy operations.  And as the innovative features of PrimeDELIVERY™ demonstrate, certain technology providers are already prioritizing home delivery, and helping pharmacies stay a step ahead of patient expectations.

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2020 Star Ratings – Pharmacies Likely to Feel Pressure for Greater Efficiency and Improved Patient Outcomes

The Centers for Medicare & Medicaid Services (CMS) has announced that during 2020, an increased number of senior citizens will have access to higher quality Medicare Advantage (MA) and Part D prescription drug plans.  That announcement came as the agency released 2020 Star Ratings for plans operating under these programs, which indicated improved performance averages on the determinative star rating index.

“Most people with Medicare will have access to Medicare Advantage and Part D plans with four or more stars in 2020,” CMS explained in a press release, “and approximately 81 percent of Medicare Advantage enrollees with prescription drug coverage will be in plans with four and five stars in 2020, an increase from 69 percent in 2017.”

Specifically, CMS expects 52 percent of Medicare Advantage plans that offer prescription drug coverage to have an overall rating of four stars or higher, compared to approximately 45 percent during 2019.  Further, the agency notes the average star rating for all Medicare Advantage plans with prescription drug coverage has improved to 4.16 out of 5 stars, increasing from 4.02 in 2017.

With regard to Part D plans, analysis by AARP found that while scores are “much lower than those of the MA plans,” they too had shown improvement over the past year, “mainly because beneficiaries have moved from plans with lower scores to those with higher ratings.”

Overall, CMS estimates that during 2020, 28 percent of individuals enrolled in stand-alone Part D plans will be covered by plans with four or five stars, compared to three percent covered by such plans in 2018.  The average star rating for a stand-alone prescription drug plan has improved from 3.34 in 2019 to 3.50 in 2020.

In announcing these improvements, CMS Administrator Seema Verma noted improvements that have been made to Medicare Advantage and Part D programs.  “Due to recent actions CMS has made to protect and strengthen Medicare Advantage, plans are better able to compete on the basis of cost and quality,” Administrator Verma noted.  “As a result, beneficiaries are benefiting from more plan choices, lower costs, and increased quality.”

While this improvement among Medicare Advantage and Part D plans is certainly positive news, it does hold important implications for pharmacies – even though pharmacies are not specifically part of the CMS Star Rating system.

Let’s explain that.

In 2008, the Centers for Medicare and Medicaid Services (CMS) created the Five-Star Quality Rating System as a way to assess Medicare health and drug plan performance on a number of key criteria.  The purpose is to provide patients and their families with an easy way to compare plans, and ensure access to high-quality choices for their Medicare coverage.

In addition, by rewarding strong performers with financial benefits, the star ratings system seeks to incentivize low-scoring plans to improve performance.

Medicare plans are rated on a scale of 1 to 5 with, according to  CMS, a 1-star rating representing poor performance, and 5-stars representing excellent performance.  The official scoring matrix breaks down as follows:

5-star rating:  Excellent

4-star rating:  Above Average

3-star rating:  Average

2-star rating:  Below Average

1-star rating:  Poor.

High performers receive significant rewards for their good ratings that include major incentive bonuses (for Medicare Advantage Drug Plans)  and the ability to enroll patients year-round.  A poor performing plan will naturally not be eligible for financial bonuses, but runs the greater risk of losing eligibility to serve as a Medicare plan.

In addition, highly rated plans will attract larger numbers of patients, while poor performers will tend to lose members.  Dr. Zac Renfro, PharmD. explained in an Elements Magazine article why the ability to attract new members is critical to today’s health plans.  “Due to the Affordable Care Act (ACA), health plans and pharmacy benefit managers (PBMs) can now only keep a certain percentage of their profits,” he explained.  “The remaining amount must be used to cover the cost of the services they provide, as well as reinvesting back into the health plan or PMS’s program.”

Which is where plan enrollment becomes a factor.  “The only way that they can increase their profits,” Renfro noted, “is by increasing their patient numbers in their health plan.  Health plans that have a lower star rating tend to have a lower number of patients choosing them over higher rated plans that have similar costs.

“With pharmacies impacting a plan’s star rating so much,” Renfro added,  “they’re starting to put an emphasis on pharmacy quality scores to determine preferred networks and other performance contracting programs.”

Star Ratings – Key Criteria

While many factors contribute to a health plan’s star rating, Medicare.gov offers a “summary” of key considerations that include:

  • Staying healthy – screening tests and vaccines: Whether members receive various screening tests, vaccines, and other check-ups to help them stay healthy.  For example, plans are assessed based on percent of plan members who receive flu vaccinations each year, the percent of female members who have regular mammograms, and the percent of plan members screened for colon cancer.
  • Managing chronic conditions: How often members with certain conditions undergo recommended tests and treatments to manage their conditions.  This includes ensuring patients with diabetes receive recommended care; that patients with high blood pressure follow recommended treatments, and that patients with bone fractures are treated for brittle bones.
  • Member experience with the health plan: Based on member ratings of a particular plan.
  • Member complaints and changes in the health plan’s performance: How often members had problems with the plan.  Includes how much the plan’s performance improved (if at all) over time.
  • Health plan customer service. How well the plan handles member calls and questions.

Prescription drug considerations

Medicare plans that cover prescription drugs are assessed on factors that include:

  • Drug plan customer service: How well the plan handles member calls and questions.
  • Member complaints and changes in the drug plan’s performance: How often members had problems with the plan.  This includes how much the plan’s performance improved (if at all) over time.
  • Member experiences with the drug plan: Member ratings of the plan.
  • Drug safety and accuracy of drug pricing. Assesses accuracy of the plan’s pricing information, and the frequency with which members are prescribed drugs in a way that is safe and clinically recommended for their condition.

Within these broad categories are several considerations that directly relate to pharmacy performance.  These factors include:

  • Ease of getting prescriptions filled when using the plan.
  • Accuracy of the plan in providing drug pricing information: This is a score based on prices members actually pay for drugs, compared with prices listed on the plan’s website.  Higher scores in this category generally mean the plan accurately listed drug prices.
  • Diabetes, blood pressure, and cholesterol medication adherence: Percent of plan members with prescriptions for these conditions “who fill their prescription often enough to cover 80 percent or more of the time they are supposed to be taking the medication.”
  • Members who had a pharmacist (or other health professional) help them understand and manage their medications. This is especially relevant for patients with medication therapy management programs.  Programs are assessed to determine frequency and quality of interactions and discussions between the pharmacist and patient.
  • Extent to which patients with diabetes are taking drugs to treat high cholesterol. As a way to lower the risk of developing heart disease, most people with diabetes should take cholesterol medication.  This rating is based on the percent of diabetic plan members who take the most effective cholesterol-lowering drugs.
  • Plan members’ complaints about prescription drug coverage: Every year, Medicare surveys people who leave their plan to determine reasons behind that decision.  Patients are specifically asked if problems with prescription drug coverage played a role with regard to:
    • Any change in medications covered by the plan
    • Any problems getting the plan to pay for their medications
    • Any problems obtaining medications, including brand name drugs; or
    • Frustration with the plan’s approval process.
  • Comprehensive medication reviews (CMRs) were added to the list of star rating categories in 2017, as a way for Centers for Medicare & Medicaid Services to assess the quality of medication therapy management services provided to Medicare beneficiaries.
  • The list was further expanded in 2019, when CMS announced that statin use for treating diabetes had been added to the list of performance indicators. According to McKesson, plans will be assessed based on the number of diabetes patients ages 40-75 who receive a statin.  For pharmacies, this means identifying diabetes patients who are not currently on a statin, and contacting their physician to recommend that one be prescribed.

According to analysis by McKesson, pharmacy-related measures are weighted heavily, and can impact up to 50 percent of a Medicare plan’s overall star rating.  It’s easy to see then, why plan administrators scrutinize pharmacy performance, and only want to engage with high-performers.

This high level of scrutiny is likely to become even more intense in 2020, as the average star rating among Medicare Advantage and Part D plans continues to increase.  Plans wishing to improve their attractiveness among beneficiaries will look to continue to improve their star ratings, with pharmacy performance an important part of that success.

Improving Pharmacy Performance with an Integrated Technology Solution

As pharmacies look to improve performance, technology will play an integral role.  Most pharmacies already rely on technology to perform at least a perfunctory level of pharmacy-related services.  But in recent years, tremendous advances in pharmacy system capabilities allow extensive data analysis, tracking and reporting functions that simply did not exist as recently as a few years ago.

With regard to improving pharmacy performance on 5-Star related categories, technology can be especially helpful in ways that include:

  • Medication Adherence. Pharmacists have a clearly-defined role in helping meet CMS directives for overseeing medication adherence for patients with chronic conditions including diabetes, high blood pressure and high cholesterol.  This is because of pharmacists’ unique position to engage patients about the importance of taking medications as prescribed, and to facilitate the adherence process.

With regard to technology, a pharmacy-specific solution can maintain patients’ prescription histories, which means a pharmacist can have immediate access to patient records when filling a prescription, or speaking with a patient about a particular medication.  Ready access to this information can help a pharmacist explain how a particular drug works, and discuss any potential side effects, which can allay patient concerns.

In addition, a pharmacy can automatically generate outbound text messages, emails and phone calls, as a way to remind patients about renewals and pickups.  These simple messages can have a tremendous impact in reminding patients that a prescription is about to run out, thereby helping to avoid a missed dosage, or even worse, a patient simply deciding to forego renewing a prescription.

  • Comprehensive Medication Review. According to the American Journal of Health-System Pharmacy, CMS directs that medication therapy management programs target patients who have two or more chronic diseases, take Medicare Part D-covered drugs, and have estimated drug spending that exceeds a CMS-established threshold.

Pharmacists may perform the CMR, which must include an action plan for improving the patient’s medication use.

Similar to technology’s role in addressing adherence, an integrated system can manage the CMR process in key ways that include:

  • Identification of eligible patients
  • Determination of ideal medication dosage and usage schedule
  • Synching of all medications so that all pick-ups occur on a single day
  • Availability of information describing purpose of each medication, along with information about potential side effects
  • Tracking of all pharmacist-patient interactions
  • Outbound texts and phone calls to remind patients about scheduled refills.

 

  • Ease of Obtaining Medications. According to Surescripts 2018 National Progress Report, 85 percent of all prescriptions were delivered to pharmacies electronically during 2018, a greater than 500 percent increase since 2015.  For patients, e-prescriptions eliminate an extra step in the process, since it is no longer necessary to travel to the pharmacy to drop off a prescription.  Instead, a patient can wait until notified that the prescription is ready, and then set out for a quick pick up.  One study found patient adherence improves by 10 percent when the medication is e-prescribed, compared with written prescriptions.

A comprehensive technology system ensures seamless processing of the prescription from the point it is received and recorded, entered into the queue, filled and marked for pickup.

Use of Statins.  With CMS now assessing information about diabetes patients who are prescribed statins, a pharmacy’s technology system can easily identify eligible patients, notify them about the role of statins in diabetes management, and initiate the process for obtaining a prescription.

 

At the same time CMS released its overall 2020 star ratings, it also released the average rating for each area of measurement.  Among areas that directly affect pharmacy performance, “medication adherence for diabetes medications” carries an average star rating of 3.9; “medication adherence for cholesterol (statins)” increased to 3.6, and “getting prescription drugs” showed an average rating of 3.5.

As beneficiaries become savvier about the importance of star ratings as a way to compare plan effectiveness, plan administrators will want to ensure their preferred pharmacy partners will help improve their ratings.  Smart pharmacy managers in turn, understand the critical role a fully-integrated technology system can have in helping to improve patient outcomes, and to document all star-related services provided to patients.

 

 

 

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How Do Pharmacy Benefit Managers Cost Medicaid?

Drug costs are rising at an alarming rate and there is no end in sight—or at least that’s what a recent study finds. The past six years has seen a substantial increase in the cost of many prescription drugs, especially those used to treat major health conditions like diabetes and cancer.

According to a study published in the journal JAMA Network Open, one of the biggest culprits for this seemingly unending problem is the lack of regulation in the price increases happening in the pharmaceuticals market.

The study conducted by researchers from the Scripps Research Transitional Institute assessed claims from Blue Cross Blue Shield Pharmacy from 2012 to 2017 and they discovered that almost all of the drugs included in the study had an annual or biannual cost increase. 36 of the drugs included in the study increased in cost by as much as 50% over a six-year period.

The median cost of these drugs increased by up to 76%, which is a lot for patients who are suffering from chronic health conditions that demand long-term medication compliance.

Pharmacy benefit managers and their role in rising drug costs

 According to the researchers, “given the median annual cost increase of 9.5%, our results suggest the costs for popular brand-name drugs would double every 7 to 8 years.”

With these findings affecting the quality of healthcare that’s provided to patients in the United States, 33 states across the country have passed laws that will somehow help control the rising costs of prescription drugs and they are setting their eyes on pharmacy benefit managers or PBMs who have a big role to play in addressing the issue.

What are pharmacy benefit managers?

A pharmacy benefit manager is essentially a professional who serves as an intermediary between employers, insurers and other members of the healthcare system. PBMs offer services that aid patients including educational programs, counseling and administering drug coverage.

Medicare Part D drug plans, health insurance companies, large employers and other businesses usually hire pharmacy benefit managers to help them control and manage different prescription benefits. PBMs play an important role in the distribution of drugs because they close deals with pharmaceutical companies that affect the prices and availability of prescription medication for more than 266 million Americans, according to the Pew Charitable Trusts.

Major payers like Medicaid and Medicare also work closely with pharmacy benefit managers and rely on them for drug procurement rather than do the task themselves.

In fact, the deals made by PBMs will help consumers and health plans save at least $654 billion between 2016 and 2025, according to the Pharmaceutical Care Management Association, which is a national advocacy group for PBMs.

What are the responsibilities of pharmacy benefit managers?

Being the middleman between consumers and healthcare providers, PBMs have the responsibility to ensure patient’s compliance to prescription medications, operate mail order so drugs are delivered to the right patients and negotiate rebates with pharmaceutical companies so consumers can have the most affordable options.

PBMs also have the responsibility to manage formularies to help consumers know what drugs are covered by their health plans and they help ensure the accessibility of prescription drugs through proper distribution across a network of pharmacies.

Some pharmacy benefit managers also offer specialty services where they connect consumers or pharmacists with biologic manufacturers and orphan drug suppliers.

Who are the three biggest PBM companies in the US?

These three largest PBM companies in the United States cover a good chunk of patients with pharmacy benefits:

    • ExpressScripts

ExpressScripts is not linked to or owned by any pharmaceuticals company, which is why it’s the most reliable when it comes to consumer benefits. The company offers novel solutions for improving patient care and managing pharmacy costs.

    • CVS Caremark

A growing PBM, CVS Caremark offers a comprehensive drug benefit service to more than 2,000 healthcare plan beneficiaries and sponsors all over the country.

    • Argus

Being one of the last independent providers of healthcare information and services that support Medicare Part D and Medicaid, Argus has a wide range of clients and the company serves some of America’s most vulnerable populations.

What are the roles of PBMs in effecting drug prices?

Pharmacy benefit managers effect the availability and price of prescription drugs in three ways:

    • Formularies

PBMs have a list of prescription drugs that are covered by health plans known as formularies. These formularies will determine which medications can consumers under Medicaid and other health plans use and how much they need to may for them.

    • Purchasing power

Because pharmacy benefit managers procure drugs in bulk, they have the purchasing power to negotiate discounts and rebates from drug manufacturers, especially those who want their drugs to be added to the PBMs’ formularies.

    • Reimbursement

As part of their job pharmacy benefit managers work with pharmacies in reimbursing drugs that were sold and dispensed to consumers.

What are the issues thrown at PBMs?

Over the last few years, PBMs have faced scrutiny over consumer complaints and issues on rising drug prices.

    • Lack of transparency

Pharmacy benefit managers have been called out for not having enough transparency in their operations where both consumers and regulators are not aware of how deals are closed and if rebates and savings are really passed down to consumers.

A recent study conducted by the Pew Charitable Trusts found out that “PBMs passed through 78% of manufacturer rebates to health plans in 2012 and 91% in 2016.”

The United States Government Accountability Office also said that pharmacy benefit managers passed nearly all of their Medicaid and Medicare Part D rebates on to consumers in 2016, but there are still questions on whether this is applied to the entire health care market.

    • Rising drug costs

Politicians have also started pointing their fingers at PBMs regarding issues of rising prescription drug costs. In fact, 33 states across the country have passed laws targeting pharmacy benefit managers.

Rep. Mary Felzkowski, R-Irma talked about a personal experience that led her to support a bipartisan bill aiming at lowering drug costs in Wisconsin: “I just got a prescription for a generic (drug) and my pharmacy benefit manager will not let me have the generic because they get a kickback on the formulary.

So instead of paying my $5 copay for the generic I paid $35. Now I’m very fortunate. I can afford that. Not everyone can. So this is a real issue.”

    • Spread pricing

Spread pricing has been a longstanding practice for PBMs. This model means that the PBM will charge a payer like an employer or health plan more than what it reimburses the pharmacy for a medication. The PBM then keeps the difference. This has become an issue for some because the exact difference has always been kept confidential from both regulators and health plans.

What changes will Medicaid be implementing for PBMs?

Although pharmacy benefit managers were once thought to help lower down the cost of prescription drugs that benefit patients, many state Medicaid programs are implementing changes to pharmacy benefits due to the different issues faced by PBMs lately.

For instance, the Medicaid program in Michigan is proposing to eliminate all PBMs that negotiate drug prices and handle its prescription drug claims. Beginning December 1, Medicaid will be handling all its drug coverage internally to try to manage the cost of prescription drugs in the state. This was after a study revealed that state Medicaid agencies didn’t really get the dramatic savings that they were promised by outsourcing negotiations and procurement of drugs through pharmacy benefit managers.

According to Michigan officials, the state would save at least $40 million by extracting bigger rebates from pharmaceutical companies and cutting operational costs in handling Medicaid drug benefits. This move could mean that companies like CVS Health, MedImpact and OptumRx could stand to lose business.

Other states are also following suit with bills regulating pharmacy benefit managers in the effort to reduce drug prices. According to the National Academy for State Health Policy, 47 states have already proposed 275 bills to address the issue of increasing drug prices. 123 of these bills were aimed at PBMs. In the state of Wisconsin, small pharmacies continue to push for the oversight of pharmacy benefit managers.

What reforms are being considered to regulate PBMs?

The issues with pharmacy benefit managers and their role in skyrocketing drug prices have resulted in a lot of bills trying to eliminate them as a part of the drug distribution process. But as Rep. Joe Sanfelippo, R-New Berlin pointed out, he is concerned about PBMs but he isn’t dismissing the fact that a lot of employers are relying on these professionals to control the cost of prescription drugs.

To address the issues with the operations of PBMs, there major reform ideas have been formulated by several states that will hopefully ensure that consumers get the best benefits from the deals they make with pharmaceutical companies:

    • Improving transparency

Several federal lawmakers are pushing to add new rules and regulations that would require PBMs to submit more information on how they negotiate prices and rebates. This will help the government determine if consumers get the largest portion of savings from rebates and negotiations.

    • End spread pricing

Several states are looking into creating legislations that would end the longstanding practice of spread pricing in pharmacy benefit managers. Instead of using the spread pricing model, legislators want PBMs to use a pass-through model where they would have to charge payers the same amount they reimburse to pharmacies with the addition of a fixed administrative fee.

The federal government is also now requiring all Medicaid fee-for-service programs to use the pass-through model and ditch the spread pricing model.

    • Rebates

Several policymakers are considering new rules that would require pharmacy benefit managers to pass through a bigger chunk of rebates to consumers. PBMs will still be allowed to keep part of these rebates in order to maintain the benefit of them negotiating for the price reduction of some of the most important prescription drugs in the market.

The Commonwealth Fund has suggested that 90% of all rebate savings should be passed on to payers.

The move to transform the healthcare system in the United States has got different legislators scrambling for rules that will help benefit consumers more. There have been numerous debates on whether there is still a need to hire pharmacy benefit managers or just take control of drug distribution internally. In Ohio, for instance, the legislative committee that manages the state’s $28 billion Medicaid program has conducted a meeting in September to review the progress of addressing the issues regarding pharmacy benefit managers profiting off the distribution of prescription drugs for the poor and disabled.

According to a Pew study this year, the rebates given by manufacturers to PBMs have increased dramatically from $39.7 billion in 2012 to a staggering $89.5 billion in 2016. The U.S. Department of Health and Human Services also stated that the average price difference between the list price of a drug and its cost after a rebate is between 26 to 30%.

Some pharmaceutical companies also admitted that they had to raise the list prices of some of their products due to the increasing rebates imposed by pharmacy benefit managers. If this amount is passed on to consumers, the prices of prescription drugs would definitely be lower than it is today.  There is also the issue of PBMs favoring more costly drugs because they get bigger rebates for them.

The bottomline

Whether there is still a need for pharmacy benefit managers or not is still up for debate. But at the end of the day, it will all boil down to what decision will benefit the consumers best.

After all, prescription drugs should be accessible to everyone because they are an important part of the treatment plan of patients, which will ultimately decide if they get to enjoy excellent prognosis or not.

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This is Medicine Redefined

This winter (December 13-15, 2019) will mark the American Academy of Anti-Aging Medicine (A4M) 27th Annual World Congress in Las Vegas, their Annual World Congress hopes to deliver world-class education focused on integrative health: through the most recent emerging clinical research, newly discovered therapies, and future scientific advances.

With an agenda specifically engineered to allow attendees to learn the newest, most innovative protocols and practices. This event is considered to be the largest event in Anti-Aging Medicine, every year the conference features a combination of unique programming, a diverse audience, and a collaborative learning environment.

The countdown begins: only 3 more weeks! This year, as the world prepares for the start of a new decade, The American Academy of Anti-Aging Medicine invites all to take part in leading the charge towards a new era of health care that puts patient health, first.

Join us and hear from the field’s foremost leaders and return home with real knowledge that can change the trajectory of patients’ lives. (Purchase ticket here https://www.a4m.com/world-congress-2019/home.html#register

Take part in an educational experience unlike any other:

  • Learn directly from the foremost thought leaders in Anti-Aging medicine
  • Network at the largest event in Anti-Aging medicine in the globe
  • Browse the latest products, services, and devices in the field
  • Take part in a patient-centered medical movement

Join thousands of healthcare practitioners and professionals from across the globe as A4M continues to redefine their mission and transform the field of modern medicine through top-tier education: with the ultimate goal of enhancing and enriching the entire landscape of health.

Learn more: https://www.a4m.com/world-congress-2019/home.html

 

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The Ten Pharmacy Trends to Watch Out For in 2020

Just like that, 2019 is coming to a close and what a year it has been for healthcare and especially for pharmaceuticals. This year, the industry has taken center stage, as governments, businesses and individuals are now recognizing the important role of good quality medications in maintaining an excellent healthcare system.

The use and cost of different drugs have also been a hot topic in debates and headlines for 2019.

From specialty medications to the use of technology to speed up the development of drugs, this year was all about innovation and breakthroughs for the pharmaceuticals industry.

The top pharmacy trends for 2020 and the year that was

 The end of 2019 is just right around the corner and people are already looking forward to what the top pharmacy trends for 2020 are. But before we look into what the coming year has to offer, let’s do a recap of some of the biggest pharmacy trends and advancements for 2019:

    • Artificial intelligence

The introduction of artificial intelligence into the development of new drugs has been one of the hottest pharmacy trends for 2019. Taking the lead in this area is IBM Watson, a computer that could interpret millions of pages of scientific literature and data that will help researchers and pharmaceutical companies speed up the development of new medications.

Artificial intelligence is set to be used in more areas of drug development and will be part of the top pharmacy trends for 2020.

    • Mobile health apps

Data gathering has always been one of the most challenging areas of clinical research. But this year, more pharmaceutical companies are taking advantage of mobile health technology to gather relevant data for clinical studies that will help in the development of new drugs.

These apps are considered to provide accurate information on a patient’s health status, which is why they’ve been used to study diseases like Parkinson’s disease, diabetes, breast cancer, asthma and cardiovascular disease.

    • Gene-specific drugs

 Precision medication is one of the most significant pharmacy trends for 2019 because it targets specific genes based on the patient’s health condition.

Genetic information is gathered through genome sequencing where researchers are able to identify specific abnormalities and come up with drugs and therapies targeted towards them.

This trend, which will also be part of the top pharmacy trends for 2020 helps increase the efficiency of drugs to help patients get better outcomes for their treatment.

    • Printable medication

This year, the drug Spritam made history as the first 3D-printed drug to be approved by the FDA. Manufactured by Aprecia Pharmaceuticals, the drug is created through a 3D printing process that allows the pill to be porous enough to be dissolved quickly while delivering the dosage required for the patient.

One of the most talked about pharmacy trends this year, printable medication is expected to pave the way for the future of drug development and lower the cost for manufacturing drugs.

These breakthroughs have created a better landscape for the pharmaceuticals industry. And the best part is, more advancements are coming as we welcome another year. Here are some of the top pharmacy trends for 2020?

    • Specialty medication

Specialty products and services were considered the most profitable among all the pharmacy trends for this year, and 2020 will see a bigger market for these medications as they become part of the top pharmacy trends for 2020.

Specialty drugs are developed mostly for chronic and degenerative diseases like rheumatoid arthritis, cancer and multiple sclerosis.

They are so rare and highly in-demand because of the complexity and cost of creating them. But they are also very important in helping treat the symptoms of chronic diseases so patients can enjoy better quality of life.

One of the top pharmacy trends for 2020 is the growing spending for these specialty medications where system pharmacies will procure them so they can be made available to patients and health plans will reimburse these pharmacies after.

    • 340B drug discount program

The 340B drug discount program has been part of the pharmacy trends for many years, and the ongoing discussion for its improvement is not expected to die down in 2020. In fact, the coming year will see more focus on the program’s path for pharmacies: compliance and performance.

As a pharmacy, it’s very important to monitor the efficiency of your existing 340B program to know how to make the most of helping patients and your health system. You also need to stay on top of new rules, enforcements and audits so you can easily adjust your program for compliance.

    • Over the counter medications

According to research, the average American household spends about $338 on over the counter products every year. With the growing cost of hospital treatments and health insurance plans, more Americans are turning to self-medication as a way to treat minor health issues.

Over the counter medications are easily accessible and don’t require a prescription, which helps in cutting down time and cost for treatment.

Their popularity will continue to grow as part of the top pharmacy trends for 2020, so it’s very important for pharmacies to ensure that staff members are well trained to guide consumers in buying the best over the counter medications. They should be able to offer the best options for their customers so they don’t need to see a physician.

    • Next-door healthcare

The world has never been more fast-paced than it is today, especially with the advent of mobile apps and other technological advancements. This also means that consumers are now expecting on-demand care, especially with the procurement of medications.

Next-door healthcare will be one of the top pharmacy trends for 2020 where pharmaceutical services will be made more easily accessible to consumers.

Pharmacies need to find ways to not only extend their hours of service but also offer ways for patients to easily fill their prescriptions and comply with their medications after they leave the pharmacy. Some pharmacies will even start to offer deliveries for patients who have difficulty going to the establishment to buy their medications.

    • Virtual healthcare

With more people relying heavily on technology, virtual healthcare is expected to be one of the most significant pharmacy trends for next year. The pharmaceuticals industry will see an increased use of e-commerce and mobile channels for marketing, and the competition will definitely be stiff.

But virtual healthcare also transcends to other services like apps, online prescription forms, patient portals and even delivery services that will be the future of procuring medications.

With its significance in shaping the landscape of pharmaceuticals, virtual will healthcare will not only be part of the top pharmacy trends for 2020 but also in the coming years.

    • Data tracking and management

All health system pharmacies will surely agree that data tracking and management can be one of the hardest tasks in the business—but it is also one of the most important. As an integral part of the healthcare system, pharmacies should be able to use their data wisely to make smarter decisions for patients.

The first step to a more efficient data management system is to make data more accessible. One of the top pharmacy trends for 2020 will be the use of a single platform to integrate all health IT systems.

This will help pharmacies cut down on costs for managing different information systems and increase efficiency in pulling out data to use for research and in creating better treatment plans for patients.

Integrated IT systems will also help pharmacies save time in performing day-to-day activities, as they help in optimizing inventories, generating more accurate reports and managing customer loyalty programs.

    • Drug approvals

The development of new drugs has always been a long and sometimes tedious process for pharmaceutical companies, especially with the FDA being at odds with them. But this time, the FDA under Commissioner Scott Gottlieb, MD promises that the agency’s Center for Drug Evaluation and Research will be supportive of the industry throughout the process of developing new drugs.

Considered to be one of the top pharmacy trends for 2020, the onslaught of drug approvals started as one of the pharmacy trends for 2018 where drugs like Patisiran for treating polyneuropathy in hereditary transthyretin-mediated amyloidosis and Migalastat for treating Fabry disease have been approved.

This year, drugs like Selinexor and Quizartinib have also been approved. At the beginning of 2020, Mirvetuximab soravtansine for ovarian cancer and Pegilodecakin for pancreatic cancer are set to be approved by the FDA.

    • Health care megamergers

2019 has been the year of the healthcare megamergers. From Aetna and CVS Health to Prime Therapeutics and Walgreens with AllianceRx, these megamergers have been one of the top pharmacy trends for this year and their impact will surely be felt throughout 2020.

According to the CEO of CVS Larry Merlo, the primary goal of their merger was to lower down the coast of medication to increase adherence, offer better services in stores and build the pharmacy’s member base. Other big names in the industry are expected to follow suit, which will surely make healthcare megamergers one of the top pharmacy trends for 2020.

    • Public policy

There has been a longstanding discussion on the transparency of healthcare costs for patients and payers. In fact, things heated up this year as more pressure is placed into making the cost of healthcare services more transparent to the public, especially the real prices of drugs.

More health plans are expected to become more critical in reimbursing medications, especially for specialty drugs that are limited in supply and are more expensive than regular drugs.

Manufacturers should also notify healthcare providers about shortages or plans of discontinuing drugs because many of these specialty drugs are life saving. This means that any disruption to the supply chain could put many lives at risk.

    • Biosimilar

The biosimilar market has not only been a part of top pharmacy trends for many years, but it has also been controversial topic in the industry. In its essence, biosimilar is a medical product that’s almost an identical copy of the original but manufactured by a different company.

The biosimilar market in America has been behind from other markets due to approval restrictions. But 2020 will see more of these biosimilars making their way into the market, thanks to the FDA’s commitment to increasing the competition, especially for specialty pharmacies.

While the use of biosimilar medication has been subject to some scrutiny due to misconceptions about the efficacy of generics, it will be one of the top pharmacy trends for 2020 because of how the FDA is working on raising the bar for makers of biosimilar products. The coming years will also see more money being invested in the biosimilar market, especially with the increasing rate of approvals for drugs from the FDA.

2019 felt like a “déjà vu” moment for the pharmaceuticals industry with both new and longstanding discussions brought to the table. The cost and use of different medications has taken center stage as well as the introduction of methods that will help speed up drug development.

As a pharmacy, it’s very important to remember a few things as you look into the top pharmacy trends for 2020 and create your game plan for the year ahead. For one, consumers are now smarter than ever. They will be more critical of everything including the price of medications because it will affect their compliance to treatment and the outcome of their health condition.

Pharmacists will also play a bigger role as part of the healthcare team and better distribution models will be implemented to increase the efficiency of delivering medications, especially for patients with chronic and debilitating diseases.

At the end of the day, the evolution of the pharmaceuticals industry will be a huge factor in the overall landscape of the world’s healthcare system. These top pharmacy trends for 2020 are a good way to kickstart another big year for the industry, and we can only look forward to bigger things ahead as we say goodbye to the year that was and welcome the year that is 2020.

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How Do You Start a Long-Term Care Pharmacy?

It is a cold, hard fact: the American population is growing older. Today, there are more than 46 million Americans over the age of 65 and a 2018 U.S. Census Bureau Report said that in 2035, “there will be 78.0 million people 65 years and older compared to 76.4 million under the age of 18.”

This is mainly because the last of the baby boomer generation will reach the age of 65 between 2020 and 2030, which means that 1 in 5 Americans will be an elderly by 2030. This number is even set to balloon by up to 90 million by 2050 and for the first time in history, there will be older people than younger ones.

While ageing is a natural process in the human life cycle, it also comes with a series of medical conditions that are mostly progressive and can affect an individual’s capability to perform activities of daily living and even care for himself.

That is why long-term care facilities are needed now more than ever and with that also comes the need for a fully functional long-term care pharmacy that will help guarantee the quality of medications given to patients suffering from these chronic health conditions and ensure their compliance to the treatment plan.

Understanding long-term care and long-term care pharmacies

 If you are one of those who would like to answer the growing demand for a long-term care pharmacy, it’s very important to understand the premise of long-term care and long-term care facilities as well as the roles and responsibilities of a long-term care pharmacist.

What is long-term care?

In its essence, long-term care encompasses a wide variety of services that cater to the healthcare and personal care needs of individuals who may not be able to care for themselves because of their disability or the complications of their health condition.

The main goal of long-term care is to offer individualized and patient-centered services that help a patient stay as independent as possible, maximize quality of life and meet the patient’s needs over a period of time.

While a good percentage of patients needing long-term care are part of the elderly population, long-term care also caters to patients from all ages who are affected with disabling health conditions over an extended period of time.

What are long-term care facilities?

A long-term care facility generally provides skilled nursing care and restorative and rehabilitative services aimed at helping patients in need of assistance with activities of daily living and compliance with their treatment plan. Long-term care facilities are usually composed of nursing homes, assisted living facilities and skilled nursing facilities.

As of 2016, 63% of long-term care facilities in the United States are hospice care providers and a good 99.5% of nursing homes offer therapeutic services for patients.

More than one million people reside in assisted living facilities in the United States and each year, over 4 million Americans are admitted or recommended to reside in skilled nursing facilities or nursing homes.

What is a long-term care pharmacy?

 The idea of a long-term care pharmacy goes back to the time when apothecaries played an important role in addressing health issues within communities. Before there were clinics, urgent care centers and hospitals, most people relied heavily on pharmacists to help diagnose and provide the right medications for common ailments.

Today, other healthcare facilities have fulfilled this role, but in terms of long-term care, the idea of having a long-term care pharmacy still follows the same premise as the traditional apothecary and the role of a long-term pharmacist is still as significant as before.

This is due to the increasing demand for quality healthcare in long-term care facilities as the elderly population grows and the number of chronic progressive diseases is becoming a bigger concern for the entire healthcare system.

In general, a long-term care pharmacy could take over some of the roles of a physician, especially when it comes to monitoring the conditions of individuals in long-term care facilities and regulating the dispensing of medications to maintain proper compliance. In fact, the two major roles of long-term care pharmacists are to help in the actual dispensing of long-term medications and serve as consultants in the proper use of these medications.

What are the benefits of a long-term care pharmacy?

Compared to a regular pharmacy, a long-term care pharmacy is especially beneficial to patients requiring long-term care with a consistent drug protocol. This includes the elderly and individuals who have chronic blood conditions, cancers and autoimmune diseases.

A long-term care pharmacy does more than just dispense medication. Since a long-term care pharmacist is able to establish a strong relationship with a patient, he can take on some of the responsibilities of a primary care physician, especially in terms of monitoring the compliance of a patient to his treatment plan.

Patients requiring long-term care can benefit from having a long-term care pharmacy as a service provider and a dispensary for medications.

Where can you find a long-term care pharmacy?

A long-term care pharmacy is generally found in long-term care facilities and nursing homes. But any pharmacy can also be a long-term care pharmacy depending on its managing business plan and the type of specialized services that it offers.

Long-term care pharmacies can also be found in mental institutions, rehabilitation centers, correctional institutions, hospice care, adult day care and even ambulatory and urgent care facilities. As of 2016, 97.2% of nursing homes have pharmacies or pharmacist services.

What are the duties of a long-term care pharmacy?

A regular pharmacy simply files incoming prescriptions, dispenses medications and acts as a mediator between the patient and doctor. But a long-term care pharmacy goes beyond the responsibility of appropriately dispensing prescription drugs in long-term care facilities under PDPs and MA-PD plans. It could also offering services that are not usually available in a regular pharmacy.

A long-term care pharmacy usually has a bigger inventory since it caters to the long-term needs of patients and it could also have several laboratory equipment and supplies. It also does drug research and reviews the drug regimen of patients, offers clinical visits and reviews medical records, and provides counseling to patients undergoing long-term care to ensure their compliance to the treatment plan.

A long-term care pharmacy could also help monitor a patient’s condition and response to medications, provide nutritional support services and offers IV therapy, fitting for surgical appliances and provisions for medical equipment.

As a care-centered practice, a long-term care pharmacy can also perform these additional services:

    • Quality assurance programs for medications and delivery of care
    • Assessment and evaluation of drug information
    • Medication delivery systems
    • Patient education programs, forms and reports
    • Proper packaging of medication to ensure patient compliance
    • Diagnostic services and laboratory testing

What is a long-term care pharmacist?

A long-term care pharmacist plays a vital role in the function of a long-term care pharmacy since he provides care and ongoing support to patients who are admitted or treated over long periods of time. These patients may be in rehabilitation facilities, skilled nursing centers and nursing homes.

Since a long-term care pharmacy usually caters to an ageing demographic, a long-term pharmacist usually deals with elderly patients who need treatment for specific diseases. He will be responsible for ensuring proper dosage requirements, compliance with drug therapy regimens, advising with drug interactions and helping patients make formulary decisions.

What does it take to become a long-term care pharmacist?

The minimum requirement for becoming a pharmacist in a long-term care pharmacy is a degree in Pharm.D with training in a long-term care setting. The successful completion of an undergraduate course will help a student prepare for pharmacy school and increase the chance of success during his advanced pharmacy course and in obtaining a doctorate degree.

Pharmacy school usually takes for years to complete and will cover the different aspects of medication and medical therapies including its uses, interactions and sciences.

After completion of pharmacy school, a state licensure is required and if a professional wishes to work as a long-term care pharmacist or start a long-term care pharmacy, some on-the-job experience may be required.

The average annual salary of a long-term care pharmacist in the United States is $116,000. This pay rate is based on experience, length of service, the responsibilities involved and the location of the long-term care pharmacy. A long term-care pharmacist may also enjoy benefits like a 401(k) and other compensation programs, health insurance, vision, dental and prescription coverage, bonuses and continuing education reimbursement.

What are the new rules of Medicare for long-term care pharmacies?

Medicare doesn’t cover any type of long-term care, but it may offer coverage for medical services rendered in long-term care settings such as nursing homes and assisted living facilities. Medicare also provides coverage for short-term stays in skilled nursing facilities given that the patient has been admitted for at least three days in a regular hospital.

But since Medicare and Medicaid programs still cover medications, recent additions to Medicare long-term care pharmacy rules put more responsibility on pharmacists in a long-term care pharmacy setting.

This rule from the Centers for Medicare and Medicaid Services (CMS) still follows the same requirement for a monthly drug-regimen review (DRR) but it requires an additional simultaneous review of a patient’s medical chart.

Both these requirements are stated in the new pharmacy services section of the nursing home rules, which also includes the restrictions of the use of psychotropic medications that are often overused in nursing homes. According to Khristy McClelland, the President of Guardian Pharmacy in Jacksonville, Florida, “the new regulation expands pharmacist services, and in many cases will increase the costs to provide these services.”

McClelland acknowledges that there are barriers that inhibit pharmacists from accessing medical charts and medical administration records that are routinely reviewed during DRRs. “In order to maintain compliance with the new regulations, facilities will have to ensure that pharmacists have access to these records,” she added.

It’s also very important for facilities to have proper reporting procedures for pharmacists that will be helpful when an issue needs immediate action based on a DRR. This new rule also cites provisions that are aimed at improving the speed and quality of the services provided in long-term care facilities and reduces avoidable hospital re-admissions.

These additional provisions will add more weight to the tasks of pharmacists working in a long-term care pharmacy setting. For instance, all long-term care facilities will be required to develop, implement and maintain an effective assurance and performance improvement program to help patients get the best outcomes of care and improve their quality of life.

They also need to develop and implement a baseline care plan for each resident within 48 hours of his admission. This care plan should include instructions that will help ensure patient-centered effective care that meets professional healthcare standards.

Long-term care facilities will also be required to develop an infection prevention and control program, especially since infections are prevalent in a lot of these facilities and would require proper dispensing of medications from a long-term care pharmacy.

What is the future of long-term care pharmacies?

The demand for an efficient long-term care pharmacy in different long-term care facilities will continue to grow as the population ages. As the government pushes to improve the quality of care offered to patients admitted in long-term care facilities, the role of long-term care pharmacists as one of the primary members of the healthcare team will also continue to expand.

There is a lot to learn about running a long-term care pharmacy—from the growing list of responsibilities to the new provisions implemented by Medicare—but it’s all for the benefit of elderly patients who deserve the best care as they battle through chronic and often progressive medical conditions.

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Here’s Everything You Need to Learn About Orphan Drugs

The field of medicine is one of the most studied areas of science for a good reason. With thousands of diseases affecting millions of people around the world, it’s been a mission for many countries to find the right treatments and medications to improve quality of life and prevent mortality rates from skyrocketing to unprecedented numbers.

But while most of us know about popular diseases like diabetes mellitus, cardiovascular disease, cancer and hypertension, there are also those orphan diseases that are so rare they only affect a small percentage of the world’s population. They are usually treated using medications called orphan drugs.

Orphan diseases and orphan drugs: A closer look

 To gain a better understanding of orphan drugs, we need to learn about what orphan diseases are and how they affect the world’s population.

Orphan disease defined

A disease is categorized as a rare or orphan disease when it only affects a small number of people in comparison with the general population. In European standards, for instance, a disease is considered rare when it affects only one in every 2,000 individuals. In general, 1 in 17 people will suffer from a rare disease in their lifetime.

Today, there are at least 7,000 types of rare diseases, many of which are considered chronic and life threatening. Most orphan diseases also appear early in life where 30% of children affected by them die before their fifth birthday.

More than 250 new medical conditions are also being described in medical literature every year. However, there is still no proper definition of orphan diseases because they differ in each territory.

The most notable orphan diseases

Medical breakthroughs and the development of orphan drugs may have saved millions of lives, but more than 350 million people around the world are still suffering from a group of orphan diseases. The most common types of rare diseases include:

    • Multiple sclerosis

Multiple sclerosis is a potentially disabling disease of the brain and central nervous system where the immune system attacks the myelin sheath that covers the nerve fibers causing miscommunication problems between the brain and the rest of the body.

It affects 90 in every 100,000 individuals and if not treated with orphan drugs, it can cause permanent damage to the nerves.

    • Narcolepsy

Narcolepsy is a neurological disorder where the individual has difficulty controlling sleep and wakefulness. It is characterized by hallucinations, excessive sleepiness, sleep paralysis and even episodes of cataplexy where the patient experiences partial or total loss of muscle control. Narcolepsy affects 50 in every 100,000 individuals.

    • Primary biliary cholangitis

Formerly known as primary biliary cirrhosis, primary biliary cholangitis is an autoimmune disease of the liver resulting from a slow and progressive destruction of the liver’s small bile ducts. This results in a buildup of toxins in the liver called cholestasis. This orphan disease affects 40 in every 100,000 individuals.

    • Fabry disease

Also known as Anderson-Fabry disease, this rare genetic disease is part of a group of conditions known as lysosomal storage disease. It affects the skin, kidneys and heart due the genetic mutation that interferes with the function of sphingolipids. Fabry disease is usually diagnosed in childhood and affects 30 in every 100,000 individuals.

    • Cystic fibrosis

Cystic fibrosis is a rare inherited disease that affects the lungs, digestive system and other organs of the body. A defective gene that affects the cell’s ability to produce sweat, mucus and digestive juices usually causes the disease and it affects 25 in every 100,000 individuals.

Orphan drugs defined

With at least 90% of the known orphan diseases still lacking treatment, the need for high quality orphan drugs has never been more important. An orphan drug is generally defined as a pharmaceutical agent that is developed specifically to treat medical conditions called rare or orphan diseases.

Because orphan drugs are used for conditions that are so rare, developing them would not be profitable enough for private pharmaceutical companies without the help of the government.

In many countries, research and development for orphan drugs is often a subject of public policy and those with the right support from the government have resulted to breakthroughs that otherwise might not have been possible if only private companies funded them.  But patients with orphan diseases are still spending more for treatments because orphan drugs are priced higher because of their limited availability.

As of 2014, 281 orphan drugs are available on the market while more than 400 are still undergoing clinical trials. The United States is leading the development of these drugs with more than 300 clinical trials underway followed by Europe. There is a total of 600 clinical trials today, 231 of which are on phase 2.

The cost of orphan drugs

Since orphan diseases are not widely known around the world, the cost of developing orphan drugs are considered higher than traditional drugs. However, many countries are starting to find ways to back the research and development of these drugs to help give patients better quality of life.

The United States is leading the charge with government-backed incentives like tax credits for the cost of research and development and clinical trials. This will help lower the cost of orphan drugs and speed up their delivery to the market. Countries like Australia, Europe and Japan are also following the same strategy.

The estimated worth of pharmaceutical companies focusing on developing medications for rare diseases are about half a trillion, roughly about 17.5% of the total value of the big pharmaceutical industry. The total enterprise value of the market is at $508 billion.

In the United States, the average cost of an orphan drug for every American patient can reach up to $151,000 per year as compared to only $34,000 for non-orphan drugs. This cost is set to grow further in the future, as orphan drugs will make up one-fifth of the total prescription sales around the world by 2024.

It’s easier for pharmaceutical companies to get marketing approval for an orphan drug in the United States and Europe because of initiatives that are geared towards encouraging the development of these types of drugs. This can include financial incentives and extended exclusivity periods for producers to enjoy sole rights to market their drug.

The Orphan Drug Act (ODA) of 1983

On January 4, 1983, President Ronald Reagan signed the Orphan Drug Act (ODA) into law to help incentivize the research and development of orphan drugs.

    • What is the purpose of the act?

The main goal of the ODA is to encourage pharmaceutical companies to develop more drugs to treat rare or orphan diseases.

The act was amended in 1984 to classify rare diseases as those affecting less than 200,00 people in the United States, but it also covers drugs for medical conditions that affect more than 200,000 but the cost of making them would exceed their revenue if marketed in the United States.

    • What are the incentives of the ODA?

One of the biggest incentives provided by the ODA is the 7-year marketing exclusivity of orphan drugs for pharmaceutical manufacturers. This gives them the chance to get their investment back without pricing their drugs too high. The ODA also awards several grants to academic-based researchers and pharmaceutical companies annually for the development of orphan drugs and offers a 50% tax credit for expenses incurred during the evaluation of an orphan drug.

There are also some exemptions given only to companies developing orphan drugs. Although they follow the same development path as regular drugs, the government acknowledges that since rare diseases affect only a small percentage of the population, it may not be possible to test the drug on 1,000 patients during a phase III clinical trial.

    • What is the impact of the ODA?

Since it was enacted in 1983, the ODA already had a huge impact on the development of orphan drugs. A 2011 paper by Aaron S. Kesselheim of the Harvard Medical School showed that from a single orphan designation in 1983, the number increased to 40 in 1984 and as high as 121 in 2007.

From January 1983 to May 2010, the FDA already approved 353 orphan drugs and granted designations to 2,116 compounds. And as of 2010, 200 of the 7,000 officially designated rare diseases are now treatable.

Roche is one of the biggest manufacturers of orphan drugs in the world producing Rituxan, a drug primarily used to treat rheumatoid arthritis. When combined together with another Switzerland-based company Novartis, both companies were able to generate more than $20 billion in worldwide revenues for orphan drugs in 2018.

Although not designated as an orphan disease, the FDA has approved the use of the ODA for the research and development and creation of orphan drugs to treat AIDS. In 1995, 13 of the 19 FDA-approved drugs were designated orphan status, 10 of which have received marketing rights. There are also more than 70 designated orphan drugs for the treatment of other HIV-related conditions.

    • What are some of the popular orphan drugs?

With the help of the ODA and EU legislation, several orphan drugs have been developed to treat rare diseases such as cystic fibrosis, glioma, snake venom poisoning, multiple myeloma and phenylketonuria.

One of the first orphan drugs to be developed was for cystic fibrosis. In the 80s, patients diagnosed with this rare disease didn’t survive beyond their early teenage years. But with the development of Tobramycin and Pulmozyme, the life expectancy and prognosis of patients with cystic fibrosis have improved immensely.

Wilson’s disease is another rare disease that’s now treating using an orphan drug. The hereditary medical condition results in the body accumulating fatal levels of copper. Penicillamine was developed specifically for the treatment of Wilson’s disease, but it has been tested to be effective in treating arthritis as well. Another drug, Bis-choline tetrathiomolybdate is now under investigation as another treatment for the disease.

Another huge breakthrough in orphan drugs is the development of statin drugs to treat familial hypercholesterolemia. Two researchers who worked on the drug, which is now used to treat high cholesterol received a Nobel Prize in 1985.

    • What is the future of the ODA?

While the goal of the ODA is clearly benefiting those suffering from orphan diseases, the act hasn’t been free from controversies. Some skeptics believe that pharmaceutical companies are manipulating the benefits of the ODA to take advantage of bigger revenues.

According to America’s Health Insurance Plans, the pharmaceutical industry has reportedly “gamed the system” by turning orphan drugs into multibillion-dollar products. An investigation published by Kaiser Health News in 2017 showed some drugs being designated as orphan drugs after first being designated as non-orphan.

These issues are not falling on deaf ears. Last year, FDA Commissioner Scott Gottlieb, MD said that he was open about the possibility of re-evaluating some aspects of the Orphan Drug Act. In a statement to Kaiser, Gottlieb said that it’s time to ask, “Do we have the right incentives in place?” He also mentioned in a separate blog post that the agency would study the proper application of orphan incentives.

The Rare Diseases Act was also enacted in 2002 to amend the Public Health Service Act, which aims to properly designate and control orphan diseases and orphan drugs. The act also increased funding for the research and development of orphan drugs to help people suffering from orphan diseases.

The European Union (EU) has followed suit in enacting a similar legislation from the ODA. In 2000, Regulation (EC) No 141/2000 was enacted and it referred to orphan drugs as “orphan medicinal products.”

Aside from diseases affecting only a small number of the world’s population, the EU’s definition of orphan diseases also include some tropical diseases that are mainly found in developing countries. The European Commission offers a 10-year marketing exclusivity benefit for an orphan drug after its approval. The European Medicines Agency (EMA) and the Committee on Orphan Medicinal Products administer this legislation.

Over the years, other countries have also implemented legislations that support the development of orphan drugs. Nations like Singapore, Japan and Australia have offered subsidies and other incentives for researchers and pharmaceutical companies that want to develop drugs to treat different orphan diseases.

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