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.

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.

U.S. pharmacists received a startling reminder of the urgent need for drug safety, when in November 2019, a statement was issued by the Drug Enforcement Agency (DEA) warning the public about an alarming number of counterfeit pills that had been seized throughout the nation.  “Mexican drug cartels are manufacturing mass quantities of counterfeit prescription pills containing fentanyl, a dangerous synthetic opioid that is lethal in minute doses, for distribution throughout North America,” the statement read.

The DEA said that 27 percent of the drugs seized contained potentially lethal doses of fentanyl.  Special Agent in Charge Ray Donovan, of the agency’s New York Division warned:  “Counterfeit pills have hidden dangers causing one in four users to die, according to DEA field testing.  This is a warning and a plea for parents to talk to their children about using counterfeit or diverted prescription pills – either one of them ends with death and/or devastation.”

News of the surge in potentially-lethal drugs comes as U.S. drug manufacturers, wholesale distributors, pharmacies and other parties involved in prescription drug distribution continue to implement key provisions of the 2013 Drug Quality and Security Act, which is intended to prevent counterfeit, stolen, contaminated or otherwise harmful drugs from entering the nation’s drug supply chain.

 

Drug Supply Chain Security Act – Working Toward a Track-and-Trace System

Specifically, Title II of that legislation, the Drug Supply Chain Security Act (DSCSA) mandates creation of “an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.”  The system, referred to as “track and trace,” is being spearheaded by the U.S. Food and Drug Administration (FDA), and is mandated to be operational by 2023.  When fully implemented, the system will be capable of tracking a drug at the unit level throughout its supply chain.

The FDA is working to build that system, namely by working with supply chain stakeholders, and through a pilot program that was launched earlier this year to identify, build, and test required capabilities.

DSCSA Implemented in Phases

As that work continues, progress is being made to implement other provisions of the law.

 

A. Product Tracing

In 2015, manufacturers, wholesale drug distributors, repackagers and dispensers (primarily pharmacies) were required to provide information about the handling history of each drug sold in the U.S. market.  Specifically, each drug transaction must now be accompanied by three separate documents that include FDA-required information including:

          Transaction information (TI)

• • • • Proprietary or established name of the product
      • Strength and dosage form of the product
      • NDC number of the product
      • Container size
      • Number of containers
      • Lot number of the product
      • Date of the transaction
      • Date of the shipment, if more than 24 hours after the date of the transaction
      • Business name and address of the person from whom and to whom ownership is being transferred.

          Transaction history (TH)

A statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

Transaction statement (TS)

A statement, in paper or electronic form that affirms the following points:

• • • • The entity transferring ownership in a transaction is authorized as required by DSCSA;
      • The product was received from a person who is authorized as required by DSCSA;
      • Transaction information and a transaction statement were received from the prior owner of the product, as required under the law;
      • The entity did not knowingly ship a suspect or illegitimate product;
      • The entity has system and processes in place to comply with verification requirements under the law; and
      • The entity did not knowingly provide false information, and did not knowingly alter the transaction history.

B. Product Verification

Also beginning in 2015, stakeholders are required to have in place systems and processes to comply with product verification requirements.  Specifically, this includes the ability to handle “suspect” and “Illegitimate products” that may be counterfeit, diverted, stolen, intentionally adulterated or appear otherwise unfit for distribution.

Stakeholders must have in place a process to:

• • Respond to verification requests from the FDA about suspected products;
  • Quarantine and investigate any suspect product to determine if it is illegitimate;
  • Notify trading partners and the FDA of any illegitimate product;
  • Respond to notifications of illegitimate product; and
  • Satisfy recordkeeping requirements.

C. Product Identification (Serialization)

The law established requirements for manufacturers and repackagers to print or affix a unique product identifier on the smallest individual sellable unit.  The product identifier is composed of four specific data elements:

• • National Drug Code
  • Serial number
  • Lot number
  • Expiration date.

The product identifier must be “human and machine readable,” with a two-dimensional (2-D) bar code adopted as the standard for machine processing.

The law sets out specific deadlines for compliance within each stakeholder group:

• • November 2017: Manufacturers
  • November 2018: Repackagers
  • November 2019: Wholesalers will only trade products with product identifiers
  • November 2020: Dispensers (Pharmacies) will only trade products with product identifiers.

2019:  Pharmacy Specific Requirements

Pew Charitable Trusts refers to pharmacies as “the last stop in the distribution supply chain before medicines reach patients,” and calls their participation “an essential component of the new DSCSA system.  It’s not surprising then, that several of the important components already implemented, directly affect pharmacies.  Current pharmacy responsibilities include:

1. Confirm all trading partners are properly licensed or registered.

a. Check the registration of manufacturers and repackagers by accessing the FDA’s Drug Establishments Current Registration Site — DECRS.

b. Check the licensing of wholesale distributors and third-party logistics providers. This can be done by searching the FDA’s Wholesale Distributor and Third-Party Logistics Providers Reporting database.

c. Check the licensing of pharmacies through the respective state authority.

2. Receive, store and provide product tracing documentation.

a. Only accept prescription drugs that are accompanied by three pieces of product tracing documentation:

i. Transaction Information

ii. Transaction History

iii. Transaction Statement.

b. Store the product tracing documentation in paper or electronic format for six years.

c. Generate and provide all product tracing documentation whenever a prescription drug is sold to a trading partner. (This documentation does not need to be provided when a prescription is dispensed to a patient, or sold to another pharmacy for dispensing to a patient.)

3. Investigate and properly handle suspect and illegitimate drugs.

a. Quarantine and investigate suspect prescription drugs to determine if they are illegitimate.

b. If a drug is found to be illegitimate, a pharmacy must work with the manufacturer and take specific steps to avoid inadvertent dispensing to patients. The pharmacy must also notify the FDA and the trading partner from whom the drug was purchased, and to which it may have been sold.

Looking ahead, pharmacies will face additional responsibilities that include:

• • 2020: Pharmacies will only be permitted to purchase products that include a unique product identifier.
  • 2023: The entire drug supply chain – including pharmacies – will be required to utilize the electronic track-and-trace system.

 

Protecting Drug Safety – the Role of Technology

As the “final link” in the drug supply chain, pharmacists have a tremendous role in the successful implementation of the DSCSA.  By the time a drug is received by a pharmacy, it has already passed through several other trade partners, and is just one step away from being dispensed to a patient.

Therefore, pharmacies must have a fail-safe process in place to ensure — not only full compliance with DSCSA – but accuracy and safety of its overall operations.  In today’s busy pharmacies, that process increasingly comes in the form of a fully-integrated technology system.  Certain technology solutions, including the PrimeRx™ system offered by Micro Merchant Systems, can allow a pharmacy to seamlessly manage compliance requirements, monitor patient wellbeing, protect against expired drugs, and seamlessly maintain records and documentation.

Important to note though, not every technology system offers the same capabilities.  This means a pharmacy manager must spend time carefully reviewing different systems, to ensure a system has the required functionality.  With regard to compliance with the Drug Supply Chain Security Act, for example, it’s important to ensure that a system’s manufacturer is aware of the evolving requirements, and understands the need to provide required capabilities.  With regard to PrimeRx™, DSCSA and safety-related competencies include:

Access to National Drug Code and other databases.  Pharmacies have long recognized the need for immediate access to the National Drug Code listing as a way to verify prescribed medications and list proper drug codes on all documentation.  Going forward, the NDC code will be an integral part of each drug’s unique identifier, which means access to the NDC registry will be essential.  In addition, pharmacies must have access to the required FDA databases to validate trading partners’ proper licensing and certification.  PrimeRx™ offers seamless access to this information, and allows pharmacy staff to quickly confirm and document all required information.

Recordkeeping.  The PrimeRx™ system offers extensive recordkeeping that allows pharmacy managers to efficiently store documentation and information about essentially all aspects of pharmacy operations.  This includes the ability to record unique notes and observations about patient interactions, along with extensive medication histories.  The system also allows for detailed inventory-related records management, including chains of custody for all drugs, expiration dates, and dispensing histories.  With regard to DSCSA compliance, the system can seamlessly process and store mandated transaction documents.  Should those documents need to be transmitted to another pharmacy, the system can automatically send the required materials.

Report generation.   In addition to storing this information, PrimeRx™ allows the pharmacy manager to generate detailed reports on a wide range of patient, inventory and operations topics.  This includes reports to satisfy FDA information requests regarding specific transactions, or drug investigations.  Should a pharmacy determine that a drug is illegitimate, PrimeRx™ can facilitate compliance with all FDA reporting requirements.

Bar Code Scanning.  Since the DSCSA requires all product identifiers to be available in 2-D format, it’s essential for a pharmacy technology system to be able to easily import that information.  PrimeRx™ offers the required scanning capability, and allows for information to be quickly and accurately loaded and filed.

Continuous Upgrades.  Micro Merchant Systems is a leader in the pharmacy technology industry, and has long been a pioneer in anticipating pharmacy needs.  As the FDA continues its work to identify core components of the national track-and-trace system, Micro Merchant Systems will again be at the forefront with required capabilities.  As such, PrimeRx™ customers can be assured that as the system is developed, the necessary software upgrades will be provided in a timely, efficient manner.

Counterfeit and contaminated drugs pose a legitimate threat to the global drug supply chain.  The World Health Organization reports one in 10 drugs sold in developing countries is fake or substandard, “leading to tens of thousands of deaths, many of them of African children given ineffective treatments for pneumonia and malaria.”

And while developing countries may bear the brunt of the counterfeit drug problem, no country is immune.  In a single week, officials from Health Canada seized $2.5 million worth of fake pharmaceuticals at the border.  Earlier this year the WHO reported on fake leukemia medicine circulating across Europe.  And in the United States, which has the safest drug supply in the world, as many as 19 million Americans buy medicines from foreign online pharmacies or other unlicensed sources.

Clearly, the DSCSA comes at a good time for the U.S. prescription drug industry – and American consumers. And armed with a fully-integrated technology system, the nation’s pharmacies will continue to be at the forefront of efforts to protect patients from harmful prescription drugs.