Complete Guide to Reference Listed Drugs (RLDs): Procurement and Supply Chain

Reference Listed Drugs (RLDs) are approved innovator medicines. These branded medicines are the first to be introduced on the world market and serve as reference products. Reference products are the benchmark for generic drugs when it comes to quality, safety, and efficacy. The procurement and supply of RLDs typically involve the research-based innovator pharmaceutical companies that develop these innovator medicines, as well as the listed wholesalers and pharmacies that act as depots and retail suppliers for these branded medicinal products. RLD sourcing is a crucial component in this process to ensure the availability and authenticity of reference-listed drugs.

The following are a few of the general steps in the procurement process:

1. Determine the need for RLDs: When treating patients, healthcare providers such as doctors or chemists may detect the requirement for reference listed drug supply. This may entail going over a patient’s medical history, symptoms, and other pertinent information.
2. Check availability: The healthcare provider or chemist can determine whether the RLD is currently on the market and, if so, whether it is in stock at their preferred source.
3. Order placement: If the RLD is in stock and available, the healthcare provider or chemist can make an order with their preferred source. Filling out a purchase order or using an online ordering system may be required. In a few countries, there could be requirements to obtain specific license from the health authorities. One must verify the legal procedures in advance. 
4. Obtain the RLD: After the order is placed and processed, the reference listed drug supply is carried out to the healthcare provider or chemist. The delivery time may vary depending on the location of the provider and the shipping method used.
5. RLD storage and dispensing: The storage and RLD sourcing should be done according to the manufacturer’s instructions by the healthcare provider or chemist.

The following are some general steps in the reference listed drug supply chain process:

1. Manufacturing: The owner of the RLD is the innovator pharmaceutical company who is licensed to manufacture the medicine in accordance with regulatory requirements and procedures in the country of manufacture and where it is marketed.
2. Distribution: After the RLD is manufactured, it is distributed to wholesalers/ distribution partners, who store and distribute it to pharmacies and other medical professionals.
3. Management of inventories: Wholesalers and pharmacies will manage their RLD inventory to ensure that they have enough RLD sourcing on hand to meet the needs of patients.
4. Dispensing: When a patient requires an RLD, the healthcare provider or chemist will either dispense the medicine from their inventory or order it from their chosen source. Before dispensing, the doctor’s prescription and applicable licenses if any require verification.
5. Patient administration: The patient will self-administer the RLD as prescribed by their healthcare professional, and they may need to refill their prescription at some point.

Pharmaceutical companies play an important role in the procurement and reference listed drug supply. The following are some general steps in the process:

1. Research and development: Pharmaceutical companies spend enormous resources on the research and development of novel drugs. This entails conducting preclinical studies and clinical trials to assess the drug’s safety and efficacy. This is a very long process that requires huge resources in terms of manpower, money, and time.
2. Regulatory approval: Once the novel medicine is developed, it undergoes several experiments in various animal models before the pharmaceutical company decides to submit it to regulatory agencies such as the FDA and EMA for approval. The agencies require clinical data before any new medicinal product is introduced on the market. Thus, heavy investments in terms of money, time, and extremely skilled human effort take place. The results generated from the clinical trials are then reviewed by the regulatory agency to evaluate the safety and efficacy of this novel medicine for the intended therapeutic indications.
3. Manufacturing: Once the drug has been approved following a robust review, the pharmaceutical company will manufacture the same as per GMP practices and regulatory norms.
4. Distribution: The RLD sourcing will be done by the pharmaceutical company to wholesalers/ distribution partners, who will store and distribute the medicine to pharmacies and other healthcare providers.
5. Marketing and sales: The pharmaceutical company will make the reference listed drug supply available in the market. The company, through its designated sales force, shall promote the product to healthcare professionals. They would provide all the possible information available with this new product to the healthcare professionals, who in turn may decide to prescribe the same to an appropriate patient in need of such treatment.
6. Management of the supply chain: The pharmaceutical company will manage the supply chain to guarantee that the reference listed drug supply is available at retail pharmacy shops. Patients, upon producing the prescription from their clinician, shall receive the drug product. To minimize any shortages, the pharmaceutical company must engage in forecasting demand, controlling inventory levels, and coordinating with suppliers and distributors at all times.

To reduce the risk of counterfeit copies of the RLD, the pharmaceutical manufacturer must guarantee that manufacturing and RLD sourcing is done to genuine partners. Pharmaceutical companies, wholesalers, and pharmacies should be aware of any regulatory requirements or restrictions on reference listed drug supply and use in their country or region. They should also be prepared to manage any supply chain interruptions, such as production or shipping delays, that may impact RLD availability.