Prescription Drug Marketing Act

Function

The Prescription Drug Marketing Act (PDMA) is an amendment of the Federal Food, Drug, and Cosmetic Act that was enacted on April 22nd, 1988. The primary goal of the PDMA is to establish a legal framework for the safe and effective distribution of prescription drugs. In addition, the PDMA was implemented to prevent the sale of compromised, expired, counterfeit, poorly labeled, and sub potent prescription drugs. The introduction of the PDMA was based on the growing presence of wholesale markets outside of legal distribution channels for prescription drugs, also known as the "diversion market."[3][4]

Specifically, the PDMA mandates prescription drugs manufactured within the US and exported abroad are no longer eligible for reimportation back into the US unless deemed by the drug's manufacturer. Importation is defined as the arrival of goods from outside countries into the United States. Importation of prescription drugs is legal if prescription drugs are purchased abroad for personal use or if a manufacturer purchases drugs produced in FDA-approved foreign facilities. In contrast, reimportation is defined as the return of previously exported products abroad back into the US.[3]

In addition to regulating the reimportation of prescription drugs, the PDMA restricts the sale of drug samples only to licensed providers who directly request them, as well as distribution channels specifically listed in the law. The law also encourages wholesale distributors to become authorized distributors of record (ADR), which involves a written agreement authorizing a wholesaler to sell a particular drug. Lastly, the PDMA also outlines steps for hospitals for returning prescription drugs to the manufacturer/wholesaler as long as hospitals document that the drugs were either received, returned, or destroyed.[3][4]

Issues of Concern

Relevant concerns surrounding the PDMA include the issue of drug affordability and the presence of loopholes seeking to circumvent the PDMA. Rising drug prices and lack of affordability for the uninsured have fueled the debate surrounding drug importation as foreign countries offer drugs at lower prices.[5] Studies have demonstrated drug prices in the US are generally higher when compared to countries abroad.[6] 

Seeking more affordable options, patients may resort to underusing their prescriptions to conserve medication supply. Government surveys have reflected such measures revealing cost-related underuse rates ranging from 1.6% to 5.3% among Medicare populations and 11.2% to 17.6% in Medicaid recipients.[7] Additional cost-saving efforts include the purchasing of cheaper medications online from foreign countries. The US Food and Drug Administration’s (FDA) Personal Importation Policy states individuals can legally import prescription drugs from abroad for personal use.[8] 

Although the policy was initially intended for US patients with limited treatment options, citizens have relied on the policy to purchase prescription drugs at a fraction of the price.[5] The primary concern surrounding the purchase of prescription drugs from abroad is the challenge of monitoring the storage and handling of the medications and the increased risk of counterfeit medications.[5] This leads to the lack of safety and efficacy of medications.  In a study evaluating 35,000 to 50,000 online pharmacies, the Alliance for Safe Online Pharmacies revealed 96% fail to comply with US laws and regulations implemented to protect patients.[1]

Clinical Significance

Over 45% of Americans are on at least one prescription medication. Therefore, product safety is paramount and is enforced by laws and regulations through the FDA.[9] The PDMA was implemented to ensure prescription drugs available to the US population are safe and effective. The FDA provides oversight by monitoring the integrity of all raw materials used to manufacture active pharmaceutical ingredients (APIs) and inactive ingredients to make up a finished drug product (FDP). It is reported that 72% of API facilities and 53% of FDP facilities are located outside the US.

The FDA is unable to track or inspect the individual ingredients used to make the product imported into the US. In 2018, the recalls of angiotensin II receptor blockers (ARB) were needed due to contamination and poor manufacturing of APIs. In 2020, the removal of ranitidine resulted from the chemical instability of the drug molecule.[2] These are just two examples of why the PDMA was created and is continually updated.

In addition, the PDMA seeks to combat the growing presence of counterfeit drugs worldwide, a $75 billion industry accounting for approximately 10% of all medicines worldwide.[10] Counterfeit drugs appear similar in appearance to prescription drugs but may contain hazardous or ineffective compounds. Serious examples of counterfeit drugs have been implicated during law disputes, such as counterfeit versions of bevacizumab containing salt and starch without the active drug component.[11] 

Long and convoluted pharmaceutical supply chains pose a significant risk to counterfeiting as drugs experience varying levels of oversight during change of custody. The PDMA addresses this risk factor by encouraging wholesale distributors to become authorized distributors of record (ADR), which involves a written agreement authorizing a wholesaler to sell a particular drug. The PDMA also initially stated wholesale distributors without an ADR must possess a drug pedigree which included the entire chain of custody from the manufacturer to the distributor.[12] 

However, the pedigree provision of the PDMA was abandoned after passing the Drug Supply Chain Security Act (DSCSA) in 2015, which established an electronic system to trace prescription medications. In addition, the DSCSA requires all distributors to provide transaction information, transaction history, and a transaction statement (a triad also known as T3 information).[1]

Other Issues

Since its original founding in 1906, the US Food and Drug Administration (FDA) has played a central role in regulating and safety of prescription drugs. The first regulatory law for prescription drugs was the 1906 Pure Food and Drug Act which required medications to accurately listed their ingredients. This law was passed to address the growing number of medications with potentially hazardous ingredients. Although this law was a critical step towards ensuring the safety of prescription drugs, it took nearly sixty years until laws were passed requiring evidence of drug efficacy before a prescription drug was approved for public use.

Following the thalidomide crisis in which an antinausea medication was discovered to cause severe congenital disabilities, the Kefauver-Harris Drug Amendments were passed in 1962 to prohibit the marketing of prescription drugs without documentation of efficacy. In the years following, the regulation of prescription drugs has evolved with new laws to address challenges in healthcare delivery and methods seeking to circumvent FDA regulation.[13] 

Included within these new laws are efforts to regulate the importation of prescription drugs. Although such laws were intended to ensure drug safety, regulations such as the PDMA have been under increasing pressure to address how such laws restrict the public to more affordable prescription drugs abroad. Legislative proposals have been introduced that seek to increase patient access to drugs abroad; however, such proposals have been limited in their ability to address the challenges facing the FDA in monitoring the safety of such imported drugs.[5]

Enhancing Healthcare Team Outcomes

Enhanced interdisciplinary cooperation between all interprofessional healthcare team members is critical to developing safe and effective prescription drug delivery. Pharmacy leaders can develop policies and procedures within healthcare systems, ensuring the effective tracing of prescription drug data, as defined by the DSCSA.[1] 

Pharmacists are directly involved with patients in medication decision-making as well as the healthcare team in drug procurement. In addition, a pharmacist’s extensive training in medication safety and prescription drug laws make them well-equipped to improve the delivery of reliable medication. Therefore, pharmacist leadership is essential in the implementation of safeguard strategies within a healthcare setting.[2] 

Such leadership was reflected in 2008 when the International Pharmaceutical Federation gathered hospital pharmacists to develop strategies (known as Basel Statements) reflecting the vision of a pharmacist’s role in a hospital setting. In addition, the Basel Statements also emphasized the importance of creating a framework of prescription drug safety in a hospital setting.[14] 

Included within these statements is the critical role of the pharmacist in drug procurement which is as follows: “Hospital pharmacists should be involved in the complex process of procurement of medicines and health products, promoting equity and access. They should ensure transparent procurement processes are in place in line with best practice and national legislation, are free from conflict of interest, and are based on the principles of safety, quality, and efficacy.”[15]

Familiarizing the interprofessional healthcare team with the PDMA and recent laws such as the DSCSA will ensure drug integrity and distributor accountability. Healthcare teams can enhance patient outcomes by maintaining a legitimate drug supply through verified distributors. In addition, prescribing clinicians must maintain a high level of suspicion by examining drug packaging and evaluating for any presence of tampering. Clinicians can also educate their patients on prescription drug safety and government strategies implemented to ensure safe and effective drugs. Interprofessional teams can also foster patient education focusing on drug safety and the dangers of purchasing unregulated drugs through illegal online pharmacies.