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CHAPTER 65 Rational Prescribing & Prescription Writing 1155
the advantages of generic substitution may be outweighed by the from that group. For example, if a prescriber in such an organiza-
clinical urgency so that the prescription should be filled as written. tion decides that a patient needs a thiazide diuretic, the pharmacist
In an effort to codify bioequivalence information, the FDA automatically dispenses the single thiazide diuretic carried on the
publishes Approved Drug Products with Therapeutic Equivalence organization’s formulary. As noted below, the choice of drugs for the
Evaluations, with monthly supplements, commonly called “the organization’s formulary may change from time to time, depending
Orange Book.” The book contains listings of multisource prod- on negotiation of prices and rebates with different manufacturers.
ucts in one of two categories: Products given a code beginning
with the letter “A” are considered bioequivalent to a reference Other Cost Factors
standard formulation of the same drug and to all other versions of
that product with a similar “A” coding. Products not considered The private pharmacy bases its charges on the cost of the drug plus
bioequivalent are coded “B.” Of the approximately 8000 products a fee for providing a professional service. Each time a prescription
currently listed, 90% are coded “A.” Additional code letters and is dispensed, there is a fee. The prescriber controls the frequency of
numerals are appended to the initial “A” or “B” and indicate the filling prescriptions by authorizing refills and specifying the quan-
approved route of administration and other variables. tity to be dispensed. However, for medications used for chronic
Mandatory drug product selection on the basis of price is illnesses, the quantity covered by insurance may be limited to the
common practice in the USA because third-party payers (insur- amount used in 1 month or 30 days. Thus, the prescriber can save
ance companies, health maintenance organizations, etc) enforce the patient money by prescribing standard sizes (so that drugs
money-saving regulations. If outside a managed care organization, do not have to be repackaged) and, when chronic treatment is
the prescriber can sometimes override these controls by writing involved, by ordering the largest quantity consistent with safety,
“dispense as written” on a prescription that calls for a brand- expense, and third-party plan. Optimal prescribing for cost sav-
named product. However, in such cases, the patient may have to ings often involves consultation between the prescriber and the
pay the difference between the dispensed product and the cheaper pharmacist. Because of continuing increases in the wholesale
one. prices of drugs in the USA, prescription costs have risen dra-
Within most managed care organizations, formulary controls matically over the past three decades, and with the passage of the
have been put in place that force the selection of less expensive Affordable Care Act (ACA), prescription volume increased while
medications whenever they are available. In a managed care envi- hospital services decreased.
ronment, the prescriber often selects the drug group rather than
a specific agent, and the pharmacist dispenses the formulary drug
REFERENCES Drug Enforcement Administration: Mid-Level Practitioners Authorized by State,
Aiken M, IMS Institute for Health Care Informatics: Medicines use and spend- Title 21, Code of Federal Regulations, Section 1300.01 (b28), 5-24-16.
ing shifts: A review of the use of medicines in the U.S. in 2014. http:// Gabriel MH: E-Prescribing Trends in the US, ONC Data Brief, 18, July, 2014.
www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/ Graber MA, Easton-Carr R: Poverty and pain: Ethics and the lack of opioid pain
medicines-use-in-the-us-2014. medications in fixed-price, low-cost prescription plans. Ann Pharmacother
Allen L Jr: Remington’s The Science and Practice of Pharmacy, 22nd ed. Pharmaceuti- 2008;42:1913.
cal Press, 2012. Institute for Safe Medication Practices. http://www.ismp.org.
American Pharmacists Association and The National Association of Chain Drug Jerome JB, Sagan P: The USAN nomenclature system. JAMA 1975;232:294.
Stores: MTM in Pharmacy Practice, Core Elements v. 2, 2008. Kesselheim AS, Avorn J, Sarpatwari JD: The high cost of prescription drugs in
Bell D: A toolset for e-prescribing implementation. Rand Health, US AHRQ, the United States. Origins and prospects for reform. JAMA 2016;316:858.
2011. Kesselheim AS et al: Clinical equivalence of generic and brand-name drugs used
California Business and Professions Code, Chapter 9, Division 2, Pharmacy Law. in cardiovascular disease: A systematic review and meta-analysis. JAMA
Department of Consumer Affairs, Sacramento, California, 2016. 2008;300:2514.
Consumer Healthcare Products Association: OTC Retail Sales 1964-2015. http:// Levinson DR. Gaps in Oversight of Conflicts of Interest in Medicare Prescription
chpa.org/OTCRetailSales.aspx. Drug Decisions, DHHS, Office of Inspector General, March, 2013. https://
de Oliveira, DJ, Brummel AR, Miller DR: Medication therapy management: oig.hhs.gov/oei/reports/oei-05-10-00450.pdf.
10 years of experience in a large integrated health system. J Managed Care Schnipper JL et al: Role of pharmacist counseling in preventing adverse drug
Pharm 2010;3:185. events after hospitalization. Arch Intern Med 2006;166:565.
Department of Health and Human Services: About the (opioid) epidemic. https:// Trissel LA: Handbook on Injectable Drugs, 19th ed. American Society of Hospital
www.hhs.gov/opioids/about-the-epidemic/. Pharmacists, 2016.