Page 1168 - Basic _ Clinical Pharmacology ( PDFDrive )

1154 SECTION X Special Topics

through mandatory reporting by drug manufacturers and vol- “specialty drugs” represent one third of the drug spending in the
untary reporting by health care practitioners. Practitioners may USA.
submit reports on any suspected adverse drug (or medical device) Because the US Congress currently prohibits price negotiations
effect using a simple form obtainable from http://www.fda.gov/ by the largest purchaser of drugs (Medicare), the public has no
medwatch/index.html. The FDA is expected to use these data to protection from excessive pricing by manufacturers. Currently,
establish an adverse effect rate. It is not clear that the FDA has suf- only the Veteran’s Administration and the largest private pharmacy
ficient resources at present to carry out this mandate, but they are benefits manager (PBM) agencies are able to negotiate prices, and
empowered to take further regulatory actions if deemed necessary. as a result, drug expenses constitute a large and growing burden to
A similar vaccine-reporting program is in place to monitor vaccine patients, Medicare, and private health insurers.
safety (VAERS, vaccine adverse event reporting system). The FDA
homepage can be found at https://vaers.hhs.gov. Generic Prescribing
The FDA has also increased requirements for labeling on drugs
that carry special risks. Dispensers of medications are required to Generic drug dispensing represents 10% of the total US drug
distribute “Med Guides” to patients when these medications are expense but 90% of the drugs dispensed. Prescribing by generic
dispensed. These guides are generated by the manufacturers of the name offers the pharmacist flexibility in selecting the particular
medications. In addition, pharmacists often provide patient edu- drug product to fill the order and offers the patient a potential
cational materials that describe the drug, its use, adverse effects, savings when there is price competition. For example, the brand
storage requirements, methods of administration, what to do name of a popular sedative is Valium. The generic (public non-
when a dose is missed, and the potential need for ongoing therapy. proprietary) name of the same chemical substance adopted by
United States Adopted Names (USAN) and approved by the FDA
SOCIOECONOMIC FACTORS is diazepam. All diazepam drug products in the USA meet the
pharmaceutical standards expressed in the United States Pharma-
The Cost of Prescriptions copeia (USP). However, there are several manufacturers, and prices
vary. For drugs in common use, the difference in cost between the
Multiple factors are involved in the pricing of pharmaceuticals. trade-named product and generic products varies from less than
Research costs, marketing costs, production costs, shipping costs, twofold to more than 100-fold. For drugs with a limited market
regulatory costs, and profit all contribute to a drug’s price. Insur- (eg, pyrimethamine, Epi-Pen), the incentive for generic manufac-
ance companies pay for the drug because an extensive formulary turing and marketing is very low, so only one or two generics (or
is mandated by regulations. Federal law and regulations require none) may be available, and price competition is low or absent.
Medicare Part D pharmacy and therapeutics committees to make In most states and in most hospitals, pharmacists have the
prescription drug coverage decisions based on scientific evidence option of supplying a generically equivalent drug product even if a
and standards of practice, and also to prevent discrimination in proprietary name has been specified in the order. If the prescriber
a patient’s drug therapy. Because these companies are publicly wants a particular brand of drug product dispensed, handwritten
owned, the shareholders exert a strong influence to maximize instructions to “dispense as written” or words of similar meaning
profits. While the cost to make the drug may be 20% (or less) are required. Some government-subsidized health care programs
of the wholesale price, the aforementioned costs contribute to and many third-party insurance payers require that pharmacists
the cost of the drug to the pharmacist or physician. Greed and dispense the cheapest generically equivalent product in the inven-
the excessive influence of shareholder funds (as opposed to the tory (generic substitution). However, the principles of drug prod-
interests of consumers) add another component of cost and have uct selection by private pharmacists do not permit substituting
sometimes resulted in startling increases in the price of long- one therapeutic agent for another (therapeutic substitution); that
established drugs (which have no current development costs) is, dispensing trichlormethiazide for hydrochlorothiazide would
as well as newer ones. In the case of pyrimethamine, a simple not be permitted without the prescriber’s permission even though
and long-established drug used for toxoplasmosis, the US price these two diuretics may be considered pharmacodynamically
increased from approximately $13/tablet to $750/tablet in 2015 equivalent. Pharmacists within managed care organizations may
when a new company acquired the rights to this drug. In 2016, follow different policies; see below.
the price of the formulation of epinephrine most commonly used It cannot be assumed that every generic drug product is as
for anaphylaxis (Epi-Pen) increased from $50 to $300 per single satisfactory as the trade-named product, although examples of
dose, even though no changes were made in the drug, the vehicle, unsatisfactory generics are rare. Bioavailability—the effective
or the injection unit. absorption of the drug product—varies between manufacturers
A more complex situation applies to the pricing of new, com- and sometimes between different lots of a drug produced by the
plex molecules that, unlike the above examples, required massive same manufacturer. Despite the evidence, many practitioners
research, development, and manufacturing investment, eg, the avoid generic prescribing, thereby increasing medical costs. In the
new agents used for hepatitis B and C. These agents are extremely case of a very small number of drugs, which usually have a low
expensive in the USA ($75,000–$120,000 for one course of treat- therapeutic index, poor solubility, or a high ratio of inert ingredi-
ment), but the manufacturers justify the cost as being less than ents to active drug content, a specific manufacturer’s product may
the alternative (which is often a liver transplant). In fact, these give more consistent results. In the case of life-threatening diseases,