Pharmaceuticals Best Practices

Proven Pharmaceuticals Leading Practices to Adopt

  • Best Practices (#214) / Pharmaceuticals / Research & Development

    Best Practice (Good)
    Focus R&D efforts on a relatively small selection of products for which the company has, or can adequately develop, a competitive advantage and appropriate resources to facilitate successful development.
    Typical Practice (Bad)
    Maintain a broad research and development (R&D) program that covers a wide variety of options and product lines to take rapid advantage of innovation and development.
    Benefits: Focused research and development programs allow a company to exploit its strengths more effectively and to devote more resources to areas in which the company excels, rather than to spread resources more thinly across a broader program.
  • Best Practices (#215) / Pharmaceuticals / Research & Development

    Best Practice (Good)
    During the pre-clinical testing of potential compounds, develop a standard process that aligns with corporate strategy to determine which compounds pass through to the next stage of R&D.
    Typical Practice (Bad)
    Allow R&D Department leadership to drive the passage of certain compounds through R&D stage gates on an ad hoc basis and/or based on siloed agendas.
    Benefits: By creating and adhering to a standard process for managing stage gates within the R&D process, compounds with a low potential of success will be eliminated before substantial time and money is wasted on further research and testing. Rigorously managing the stage gate process can also free up capacity that would otherwise be wasted on further developing low potential targets.
  • Best Practices (#216) / Pharmaceuticals / Pharmaceutical Manufacturing

    Best Practice (Good)
    Develop a demand plan sufficient to forecast product orders and ensure maximization of production, while limiting interruptions to production runs caused by “rush” orders.
    Typical Practice (Bad)
    Align pharmaceutical production with incoming orders to satisfy known demand and limit excess inventory.
    Benefits: Unexpected “rush” orders can interrupt a product run and force the machinery to be stopped and cleaned to run the product necessary to fill the “rush” order, which cause unnecessary delay.
  • Best Practices (#217) / Pharmaceuticals / Pharmaceutical Manufacturing

    Best Practice (Good)
    Conduct quarterly product quality reviews to assess the consistency of manufacturing processes. These reviews should assess the quality of starting materials, investigate of failed batches, audit facility equipment (heating, ventilation, etc.), inspect packaging quality and examine in-process controls.
    Typical Practice (Bad)
    Conduct product quality reviews on an ad hoc basis or based on demands from upper management. Report findings to key stakeholders through a collection of non-standard reports or meetings.
    Benefits: Standardizing quarterly product quality reviews, related adjustments to the production process and report generation can help in streamlining the production process and reduce duplication of quality assurance efforts.
  • Best Practices (#218) / Pharmaceuticals / Clinical Trials

    Best Practice (Good)
    Stratify patients in a drug trial into groups of similar genetic or proteomic molecular markers.
    Typical Practice (Bad)
    Confirm and correlate patient identity manually with specimens at point-of-test or at bedside.
    Benefits: Eliminating manual data entry in laboratory settings leads to a substantial reduction of error rates as well as improved ease of trial data analysis and reporting.
  • Best Practices (#219) / Pharmaceuticals / Product Compliance

    Best Practice (Good)
    Use online compliance training to educate new and existing employees on regulatory compliance requirements. Use online tests to assess employee compliance knowledge and store results in a centralized database.
    Typical Practice (Bad)
    Set aside a defined amount of time to train employees on compliance-related subjects. Perform these trainings face-to-face at each respective facility or office in operation.
    Benefits: Using online training and testing provides compliance leadership with a simple, effective method of assessing compliance knowledge across the organization and also cuts down on time and expense devoted to training sessions.
  • Best Practices (#220) / Pharmaceuticals / Product Compliance

    Best Practice (Good)
    Promote self-regulation related to product labeling by producing an exhaustive checklist used to produce and inspect product labeling. This list would include guidelines on items such as word use (i.e., avoid guarantees), positive messaging, color use and imagery.
    Typical Practice (Bad)
    Produce pharmaceutical product labeling based on requirements set forth by regulatory agencies. Develop label text by relying on the experience of product compliance and medical information staff.
    Benefits: Creating a standard checklist that can be used to assess the compliance of each pharmaceutical product label can reduce instances of non-compliance and cut down on rework related to correcting labeling issues.
  • Best Practices (#221) / Pharmaceuticals / Patient Services

    Best Practice (Good)
    Support an internal team sufficient to handle the majority of projects underway to limit costs of producing patient educational and marketing materials and to maintain tighter control of literature.
    Typical Practice (Bad)
    Use a small internal team to draft literature, but rely on an outside advertising or creative agency to produce finished marketing and patient education material.
    Benefits: Internal document production teams reduce the costs associated with multiple revisions, which can be substantial for an outside advertising/creative agency. Greater control of pharmaceutical literature also helps to mitigate the risk of reporting inaccurate product information.
  • Best Practices (#222) / Pharmaceuticals / Patient Assistance Programs

    Best Practice (Good)
    Ensure that enrollment into patient assistance programs (PAP) is electronic and involves no physical paperwork from either a patient or an attending physician.
    Typical Practice (Bad)
    Maintain restrictive enrollment procedures for patient assistance programs (PAP).
    Benefits: Streamlining PAP patient enrollment will enhance customer satisfaction, reduce enrollment cycle time and improve relationships with medical professionals in the field.
  • Best Practices (#223) / Pharmaceuticals / Patient Assistance Programs

    Best Practice (Good)
    Consider adopting an Institutional Patient Assistance Program (PAP) model by sending medicines in bulk directly to enrolled clinics to reach a greater number of patients for the same cost.
    Typical Practice (Bad)
    Ensure that Patient Assistance Programs (PAPs) enroll patients one at a time and require renewals on a quarterly basis.
    Benefits: Sending medication in bulk to healthcare facilities improves PAP profitability by reducing distribution costs while simultaneously increasing the number of patients using a certain product and enhancing relationships with healthcare providers.

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