5 Myths About Pharmacy DSCSA Compliance

5 Myths About Pharmacy DSCSA Compliance

Introduction

Strict compliance with the DSCSA is important and depends on the pharmacy undertaking the task, as it affects the supply chain in the best-selling pharmaceuticals distribution of drugs. However, certain misunderstandings may cause the general public to get confused and, therefore, fail to follow these regulations strictly. For pharmacies to discharge their responsibilities regarding DSCSA requirements, it is crucial for the parties involved to understand these myths and eliminate them. 

This article seeks to debunk five key misconceptions about DSCSA compliance for pharmacies to expand the understanding of the reality and put forward recommendations for the owners and operators of pharmacies. In dispelling the myths, we shall light a torch for pharmacies to continue operating within the confines of the set federal laws in a bid to safeguard the lives of their customers. 

What is the meaning and concept of pharmacy DSCSA compliance? 

DSCSA compliance in pharmacy is, therefore, the ability to follow the requirements of the Drug Supply Chain Security Act. This federal law, established in 2013, improves the security of drug distribution chains by striving to eliminate the entry of fake, stolen, infectious, or dangerous products into the drug supply chain. 

For pharmacies, DSCSA compliance involves several key responsibilities:

  • Product Tracing: Pharmacies need to maintain a record of the movement history of prescription drugs they receive and dispense. This entails preserving the TI, TH, and TS of each drug marketed in the country. 
  • Verification: Pharmacies need to be able to confirm the authenticity of drug business suppliers and the products they acquire with authorized trading counterparts.  
  • Detection and Response: Pharmacies must be equipped with strategies for dealing with and apprehending counterfeit products; this involves setting up a quarantine and investigation process. 
  • Product Identification: Pharmacies are required to ensure that they use appropriate product identifiers, which are one restricted number for serial tracing of drugs throughout the distribution chain. 

The reason why these requirements had to be met is because it would safeguard the drug supply chain from reaching patients with drugs that are adversely affected due to compromise. 

Busting myths about pharmacy DSCSA compliance

Myth 1: Getting compliant with DSCSA is not compulsory. 

There are operators in pharmacies that assume that DSCSA regulation is optional or not significant for their business. This is a misconception. Scores of states in the United States require compliance with the DSCSA as federal law seeks to enhance safety within the pharmaceutical distribution system. Penalties for non-adherence include fees and fines in court, besides posing threats to the lives of the patients by allowing substandard or fake products to be supplied into the market. All pharmacies have to meet and implement DSCSA rules and requirements, as all patients and clients must be protected from counterfeit medicines. 

Myth 2: It is costly to accomplish. 

It is important to note that some costs are incurred while implementing DSCSA compliance measures; these include technology expenditure and training expenditure, but the costs are usually highly inflated. A lot of bargain solutions and tools exist to help pharmacies get along with the necessary DSCSA requirements without hassle. Further, the gains that stem from compliance, like the goals of not incurring fines, gaining patients’ confidence, and increasing operational efficiency, outweigh the cost in the long run. Pharmacy ownership is wise to make expenditures to become DSCSA compliant because it is in the best interest of the business, as well as the patients. 

Myth 3: The plan is too complex

As has been discussed previously, there are indeed new processes and documentation provisions in the DSCSA, but the tasks it sets are manageable. Pharmacies have no reason to dread DSCSA compliance if they receive proper training and appropriate tools. Lots of remedies on the market are targeted to ease compliance by automating some records and product’ identification. Further, there are many MAPs and support materials provided to assist pharmacies in achieving compliance. In this way, such resources can be helpful for pharmacies that are trying to avoid significant problems related to the DSCSA. 

Myth 4: Compliance with DSCSA is not a requirement for smaller pharmacies since they will not be inspected anyway. 

Some small pharmacy stores may consider themselves exempted from observing the requirements of DSCSA, thinking that they wouldn’t be scrutinized. This is a dangerous assumption. Pharmacies are covered as far as the DSCSA is concerned; hence, they can be inspected at any time of the year, depending on ICH Q8 or Q10. Besides, failure to comply with the aseptic technique draws serious measures in case of exposure, such as fines, and the image of the pharmacy might be diminished. All stakeholder involved in the provision of pharmacy services, including small and big pharmacies, have to meet the set DSCSA to protect their clients as well as operate legally. 

Myth 5: My Primary Wholesaler Will Take Care of DSCSA Compliance Requirements for Me 

The critical mistake that many businesses and companies make is that they think that relying only on wholesalers can solve such a problem as DSCSA. Of course, wholesalers do have DSCSA requirements; however, pharmacists do, along with all the other stakeholders. Pharmacies need to set up a system for receiving and keeping up-to-date transaction information (TI), transaction history (TH), and transaction statements (TS) from their wholesalers. Also, according to the regulation, pharmacies are accountable for the suppliers’ identification and replies to any suspicions of illegitimate products. It may be said that compliance is everyone’s business, and pharmacies cannot sit idle waiting for the actualization of the DSCSA provisions but must embrace it to comply with the supply chain legalities and ensure safety in their pharmacies. 

Conclusion 

Therefore, every pharmacy must demystify the myths regarding DSCSA compliance so that they can be ready to meet the requirements as state and federal laws advise. Apart from being a legal necessity, compliance is an essential tool that helps protect the pharma distribution chain. In understanding that compliance is necessary, affordable, and manageable and admitting that all pharmacies must be compliant, they can safeguard their business and their people. Adopting DSCSA compliance with the essential tools and understanding is in the interest of pharmacies to avert possible risks and penalties, as well as to rebuild patients’ confidence in the healthcare system.