Procurement and Inventory Management Flashcards
Procurement drug _, purchasing _, responsibility and control:
The selection of pharmaceuticals is a _ and _ important function of the _ pharmacist, who is in charged with making decisions regarding products, quantities, _ specifications and sources of supply. It is the pharmacists obligation to establish and maintain _ assuring the _, _, , and _ use of all pharmaceuticals and related supplies ( administration sets); this responsibility must _ delegated to another individual. Although the actual purchasing of drugs and supplies may be performed by a _, the setting of quality standards and specifications requires professional knowledge and judgment and must be performed by the pharmacist.
Procurement drug selection, purchasing authority, responsibility and control:
The selection of pharmaceuticals is a basic and extremely important function of the institutional pharmacist, who is in charged with making decisions regarding products, quantities, product specifications and sources of supply. It is the pharmacists obligation to establish and maintain standards assuring the quality, proper storage, control, and safe use of all pharmaceuticals and related supplies (fluid administration sets); this responsibility must not be delegated to another individual. Although the actual purchasing of drugs and supplies may be performed by a nonpharmacist, the setting of quality standards and specifications requires professional knowledge and judgment and must be performed by the pharmacist
Four strategic objectives of pharmaceutical procurement
- Procure the most cost-effective drugs in the right quantities
- Select reliable suppliers of high-quality products
- Ensure timely delivery
- Achieve the lowest possible total cost
a continually updated list of available medications and related information, representing the clinical judgment, resulting from a review of the clinical evidence, of physicians, pharmacists, and other clinicians in the diagnosis, prophylaxis, or treatment of disease and promotion of health.
Formulary
the ongoing process through which a healthcare organization establishes policies regarding the use of drugs, therapies, and drug-related products, including medication delivery devices, and identifies those that are most medically appropriate, safe, and cost-effective to best serve the health interests of a given patient
population
Formulary System
Formulary Development
• _ medicines are those that _ the priority health care needs of the population.
• They are selected with due regard to disease _ and evidence of efficacy, safety, and comparative _.
• Essential medicines are intended to be available within the context of _ health systems at _ times in _ amounts, in the appropriate _, with assured _ and adequate _, and at a _ the individual and the community can afford
Formulary Development
• Essential medicines are those that satisfy the priority health care
needs of the population.
• They are selected with due regard to disease prevalence and evidence of efficacy, safety, and comparative costeffectiveness.
• Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford
Benefits of Formulary System:
- Approved and efficacious medicines that all practitioners will be required to use.
- Better experience with fewer medicines. Training will be easier because there will be fewer medicines on which to concentrate teaching activities.
- Drug therapy at a lower overall cost
- Consistent supply of medicines
Formulary Management Principles
- Medicines should be selected based on the _ of the community; they should _ the _ identified diseases and conditions.
- Medicines selected for the formulary are “_.”
- The formulary list should have a _ number of medicines, only those necessary to provide for the needs of the _ or _; _ of agents that have _ equivalence should _ occur.
- _should be used.
- _ should be used only in _ proven conditions (e.g., to treat tuberculosis).
- Medicines need to be selected based on _ that include proven efficacy, safety, quality, and _.
- The _ must be consistent with any _ or _ formulary or approved standard _ guidelines.
- Medicines should be _ to appropriate practitioners
Formulary Management Principles
- Medicines should be selected based on the needs of the community; they should treat the locally identified diseases and conditions.
- Medicines selected for the formulary are “medicines of choice.”
- The formulary list should have a limited number of medicines, only those necessary to provide for the needs of the hospital or clinic; duplication of agents that have therapeutic equivalence should not occur.
- International nonproprietary names (INN) (i.e., generic names) should be used.
- Combination (fixed-dose) products should be used only in specific proven conditions (e.g., to treat tuberculosis).
- Medicines need to be selected based on explicit criteria that include proven efficacy, safety, quality, and cost.
- The formulary must be consistent with any national or regional formulary or approved standard treatment guidelines.
- Medicines should be restricted to appropriate practitioners
Process for Selecting New Medicines
- A request for _ of a medicine to the formulary, which can be made only by a _ or , is done by completing a “” form.
- Medicine information _ are obtained, including _ literature, _ newsletters, standard _ guidelines, _, and _ sources. _ sources of information must be _ and _.
- The _ is performed using established _
- The medication information _ is _. The medication monograph should include details about the medicine obtained from several information _.
- Medicine _
- Cost _
- Sources of _ (to ensure _)
- Formulary _ are developed. After a thorough research of the literature, the _ should formulate recommendations concerning the medicines on _ information. Recommendations should include _ and _ that will be purchased. If a specific _ or _ is necessary because of _ problems, then this issue should be addressed in these recommendations. Specific guidelines for _ or _ should _ placed in these formulary recommendations.
- Expert _ and _ should be obtained from knowledgeable and respected _ and _. Opinions should _ complement (not replace) the information provided in a medicine information _.
- The _ makes a formulary decision (at the _ meeting). Information should be presented to the DTC at a regularly scheduled meeting. The _ must vote on the recommendations as presented by the individual who performed the medicine evaluation.
- The _ of the evaluation and _ recommendations and actions must be disseminated to the_ in the form of _ or _, or through _ meetings.
Process for Selecting New Medicines
- A request for addition of a medicine to the formulary, which can be made only by a physician or pharmacist, is done by completing a “Request for Addition/Deletion” form.
- Medicine information resources are obtained, including primary literature, international newsletters, standard treatment guidelines, textbooks, and Internet sources. All sources of information must be credible and unbiased.
- The evaluation is performed using established criteria
- The medication information monograph is written. The medication monograph should include details about the medicine obtained from several information sources.
- Medicine interactions
- Cost comparison
- Sources of supply (to ensure availability)
- Formulary recommendations are developed. After a thorough research of the literature, the DTC should formulate recommendations concerning the medicines on evidence- based information. Recommendations should include dosage forms and strengths that will be purchased. If a specific manufacturer or supplier is necessary because of bioavailabililty problems, then this issue should be addressed in these recommendations. Specific guidelines for administration or use should also be placed in these formulary recommendations.
- Expert opinions and recommendations should be obtained from knowledgeable and respected physicians and pharmacists. Opinions should only complement (not replace) the information provided in a medicine information search.
- The DTC makes a formulary decision (at the DTC meeting). Information should be presented to the DTC at a regularly scheduled meeting. The DTC must vote on the recommendations as presented by the individual who performed the medicine evaluation.
- The results of the evaluation and DTC’s recommendations and actions must be disseminated to the health care staff in the form of minutes or newsletters, or through department meetings.
Information needed from the physician or pharmacist of the Request for Addition/Delete includes—
a. List of specific pharmacological actions of the medicine
b. Information on why the medicine is superior to current formulary medicines
c. Specific literature support for use
d. Background on any financial support received from the supplier or other organization
At a minimum, the monograph should include—
a. Pharmacology
b. Pharmacokinetics
c. Efficacy compared to placebo and other medicines
d. Clinical trial analysis
e. ADRs
Selection Criteria for New Medicines
_ for the formulary is the most important function of the formulary system. The process, which is _, ultimately brings the best medicines to the health care system. The following represent _ criteria to be considered when evaluating all new requests for addition to the formulary:
• Country disease patterns
• Efficacy, relative efficacy, effectiveness
• Safety
• Quality
• Cost and cost-effectiveness
• Medicines that are well known
• Health system personnel available to manage the medicine
• Financial resources available
Non formulary Medicines
- Most formulary systems are designed as “_” systems. The _ system allows for the introduction of _ medicines on a _ basis, usually for a _ patient use
- _ medicines are usually _, in _ amounts, for patients who require _ treatments or patients who have been _ on medicines from practitioners _ of the health care system.
- _ of non-formulary medicines is important because an open system will _ become _ and _ the system of formulary management
Non formulary Medicines
- Most formulary systems are designed as “open” systems. The open system allows for the introduction of nonformulary medicines on a limited basis, usually for a single patient use
- Non-formulary medicines are usually necessary, in limited amounts, for patients who require specialized treatments or patients who have been stabilized on medicines from practitioners outside of the health care system.
- Control of non-formulary medicines is important because an open system will invariably become problematic and impede the system of formulary management
Cost and Cost-Effectiveness
• The _ of a medicine in relation to its _ is an important consideration with any new product.
• A medicine with questionable _ or _ at a _ cost would have an unfavorable _ ratio.
• A new _ medicine with good _ efficacy, _ incidence of _, and a _ overall cost than current medicines on the formulary, however, would represent a medicine with excellent _ relationship. This medicine would therefore have a _ status for being added to the formulary. When a new medicine with _ efficacy and possibly _ adverse side effects at a _ cost is requested, however, the decision becomes more _
Cost and Cost-Effectiveness
• The cost of a medicine in relation to its benefits is an important consideration with any new product.
• A medicine with questionable efficacy or benefits at a high cost would have an unfavorable cost-effectiveness ratio.
• A new antihypertensive medicine with good comparative efficacy, decreased incidence of ADRs, and a lower overall cost than current medicines on the formulary, however, would represent a medicine with excellent cost-effectiveness relationship. This medicine would therefore have a favorable status for being added to the formulary. When a new medicine with equal efficacy and possibly fewer adverse side effects at a higher cost is requested, however, the decision becomes more complicated
Define Pharmacoeconomics
Pharmacoeconomics can be defined as the branch of economics that uses cost-benefit, cost-effectiveness, cost-minimization, cost-of-illness and cost-utility analyses to compare pharmaceutical products and treatment strategies
Pharmacoeconomics is vitally important to _ in terms of _ to _ decision-makers (_, _, _) the _ of their products, achieving _ and _ approval and contributing to _ success
Pharmacoeconomics is vitally important to drug manufacturers in terms of communicating to external decision-makers (payers, prescribers, patients) the value of their products, achieving regulatory and reimbursement approval and contributing to commercial success