Chapter 2

The prescription and drug names

I. Parts of a prescription

Q. What are the different parts of a written prescription?

• Heading:
  • Prescriber’s name, address, phone number, license number, DEA number and NPI (national provider identifier) number (the DEA number can also be located at the bottom of the prescription by the prescriber’s signature)
  • Patient’s information (name, address, age, weight)
  • Date of the order (must be written or it is not legal).

• Body:
  • Rx symbol
  • Medication prescribed (drug name, strength and formulation) and quantity to be dispensed
  • Instructions to the pharmacist. For example: Dispense 10 capsules.

• Closing:
  • Signature (Sig): directions to the patient
  • Signature of prescriber
  • Substitution permissible
  • Number of refills
  • Label (informs the pharmacist how to label the medication).

Q. What does “Rx” mean?

A. Rx is a symbol referring to “prescription”. Rx is the Latin meaning “recipe” or “take thou” or “take thus” or “to take”. Essentially, it is a command to take a specific compound.

Q. What does “Sig” mean?

A. Sig is an abbreviation for the Latin signatura, meaning “write”, “make” or “label”. These should always be written in English; however, prescribers sometimes use Latin abbreviations, e.g. “1 cap tid pc,” which the pharmacist translates into English, “take one capsule three times daily after meals.”

Q. Does the age of the patient need to be written on the prescription?

A. Yes. Generally, it is helpful to write in the age (in years) of the patient. For pediatric prescriptions it is recommended to write in the age of the child if the patient is less than twelve and the age in years and months if less than five. Including the weight of the child is also helpful. For Schedule II drugs it is mandatory to include the age of the patient on the prescription. The reason for writing the age of the patient is that in some cases the dose may need to be adjusted.

Q. Is my DEA number required on all prescriptions?

A. The DEA number must have a space on the prescriber’s prescription blank. It is required to write the DEA number on the prescription blank when prescribing controlled substances. A separate DEA number is required in each state the dentist is licensed and the DEA license is renewed every 2 years.

Q. What is the NPI?

A. NPI stands for national provider identifer. It is an identification number given to health care providers by the CMS (Centers for Medicare and Medicaid Services). Health care providers must apply for an NPI number through an ­application process on the CMS website. Health practitioners need to have this number in order to receive ­reimbursement from insurance companies and to prescribe medicines.

Q. What is the label box at the bottom of the prescription mean?

A. Any information about the medication to be dispensed is provided on the label that is affixed to the drug container.

II. Generic substitution

Q. When does a brand name drug become generic?

A. A brand name drug can become generic when the patent for that drug expires. Once the brand name drug goes off-patent, several drug companies can begin to manufacture a generic equivalent drug. In the United States, one company is given 180 days of exclusivity to manufacture a generic version of a drug. After 180 days, other manufacturers of generic ­medications can then start to make their own generic form of the drug. For example, the patent on Celebrex® expires in 2013. Until then, Celebrex is not available in a generic form (www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm).

Q. At the bottom of the prescription there is a section that says “dispense as written” or “substitution permissible”. What is the difference between a generic drug and a brand name drug?

A. A generic drug is manufactured and distributed usually without a patent. However, the generic drug may still have a patent on the entire formulation but not on the active ingredient. A drug that has a trade (brand) name is protected by a patent whereby it can only be manufactured and sold by the company holding the patent. Once the patent expires (­between 7 and 12 years) on a brand name drug the generic form will be available (Welage et al., 2001).

Q. What is generic equivalency mean?

A. Generic equivalency was developed to save consumers and insurance companies high costs. Generic drugs are much cheaper because of competition between drug manufacturers once the patent has expired. Also, it costs less to ­manufacturer generic drugs. Many brand name drugs have less expensive generic drug substitutes that according to the FDA are ­therapeutically and biochemically equivalent to the brand name drug. The FDA requires the bioequivalence of the generic drug (active ingredient) to be between 80% and 125% of that of the brand name drug. Generics are considered by the FDA to be identical in dose, strength, safety, efficacy, and intended use (Balthasar, 1999; Greene et al., 2001).

Q. Is a generic drug always equivalent to a brand name drug?

A. According to the law, drug companies are required to prove bioavailability. Many drugs that are available generically are equally efficacious with the equivalent brand name (Birkett, 2003).

Q. What is generic substitution and how do I know if a generic drug substitute is available?

A. Generic substitution is the process by which a generic equivalent is dispensed by the pharmacist rather than the brand name. There is a book called the “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations” that all pharmacies have, and since February 2005, there is a daily Electronic Orange Book (EOB) product information for new generic drug approvals. The downloaded Annual Edition and Cumulative Supple­ments are also available in a paper version (Approved Drug Products with Therapeutic Equivalence Evaluations, ADP 2008) from the US Government Printing Office: http://bookstore.gpo.gov/; toll free telephone number 866-512-1800.

Q. How do I write for a generic substitute on a prescription?

A. Prescriptions have instructions on whether the prescriber will allow the pharmacist to substitute a generic version of the drug. This instruction is communicated in a number of ways which differs among States. Usually, the prescription contains two signature lines. One line has “substitution permitted” or “substitution permissible” printed at the bottom of the prescription and the other line has “dispense as written” or “do not substitute”. The prescriber signs either line. Some States have a “daw” (dispense as written) box printed at the bottom of the prescription. This means that the prescription will be filled generically unless the prescriber writes “daw” in the box in which case the prescription will be filled the way it is written by the prescriber. For example, if you write a prescription for the trade name of a drug such as Vibramycin (the patient only wants to take a brand name drug) and signs the line “do not substitute” or write “daw” in the box, the prescription will be dispensed with the brand name drug (Vibramycin) rather than the generic substitute (doxycycline) (Meridith, 2003).

Q. When should a generic drug rather than a brand name drug be prescribed?

A. Anytime. It is the decision of the patient. Generic substitution is intended for the pharmacist to use a form of the drug which may be less expensive to the patient. It is usually the cheaper drug yet still has same FDA guidelines in ­manufacturing and should be equal in efficacy to the brand name drug. However, if the prescriber writes a prescription for the brand name drug and signs “do not substitute”, the patient cannot request the generic (Food and Drug Administration – Center for Drug Evaluation and Research (CDER). Statistical approaches to Establishing Bioequivalence, 2001).

Q. Who decides to choose a generic substitute?

A. The patient makes the decision as long as the prescription is signed by the prescriber to allow for substitution. If the prescriber does not sign the appropriate place to allow for generic substitution, the pharmacist has to dispense the generic.

III. Controlled drugs

*Note: Always confirm any drug laws with your state regulations because the most restrictive clause will prevail, whether state or federal.

Q. What are controlled substances?

A. Controlled substances come under the jurisdiction of the Controlled Substances Act of 1970. The Federal agency is the Drug Enforcement Administration (DEA. and the State agency is the Division of Narcotics and Dangerous Drugs of DHHR. The Controlled Substances Act of 1970 was developed to educate and monitor the prescribing and dispensing of potentially addictive substances into five Schedules according to their potential for abuse or physical or psychological dependence.

Q. What is the definition of physical dependence?

A. Physical dependence is a physiological state characterized by the development of an abstinence syndrome on abrupt withdrawal of the medication. Physical dependence does not imply abuse or addiction.

Table 2.1 Controlled drugs.

*Note: in certain states like New York, Schedule IV benzodiazepines (e.g., Valium, Xanax) are treated as Schedule II.

Q. What is the definition of tolerance?

A. Tolerance is a physiological state characterized by the need to increase doses of a drug to produce the initial effects of the drug or a markedly diminished effect with continued use of the same amount of the substance. Tolerance does not imply physical dependence or addition (Vilensky, 2002).

Q. Sometimes controlled substances are seen as written as Schedule III or “C-III”. Is there a difference?

A. No. The C refers to controlled substance. Drugs which are subject to control under the Controlled Substances Act are assigned to one of five schedules: Schedule I, Schedule II, Schedule III, Schedule IV and Schedule V depending on the abuse potential. These schedules are commonly shown as C-I, C-II, C-III, C-IV, and C-V.

Q. What are the different controlled (Scheduled) drugs?

A. Refer to Table 2.1.

Q. Is a DEA number required to prescribe a narcotic?

A. Yes. A dentist is required by law to register with the Drug Enforcement Administration (DEA) in Washington, to dispense, store or prescribe controlled drugs. A DEA number will be issued to the prescriber in the State where he/she is practicing dentistry. If the State where the dentist is practicing requires that the dentist have a State Controlled Substance Number, in addition to the DEA number, then the DEA will require that this number be issued before the DEA number can be issued. Twenty-six States that require a Controlled Substance Number and a DEA number including New Jersey, Alabama, South Carolina, Nevada, Iowa, District of Columbia, Utah, Oklahoma, Massachusetts, Michigan, Illinois, Connecticut, South Dakota, Louisiana, Guam, Wyoming, Puerto Rico, Rhode Island, Missouri, Indiana, Delaware, Texas, New Mexico, Maryland, Hawaii, and Idaho. There must be a space on the prescription to write in the DEA number.

Q. Are prescription writing rules for controlled substances state or federal regulated?

A. Both. Regulations can be under state or federal. Prescriber must review individual laws in the state he/she is a ­prescriber. For example, under federal law, a prescription for Schedule II substances most be filled within 30 days of the written prescription. A state could establish rules tighter than the federal rules and the most restrictive clause will ­prevail, whether state or federal.

Q. According to state and federal law, are there limits to the amount of controlled drugs that can be prescribed?

A. While states may have more restrictive rules, the federal law does not limit the amount prescribed. The most restrictive clause will prevail, whether state or federal.

Q. Can Schedule I substances be prescribed by a private practitioner?

A. No. Schedule I substances have the highest abuse potential and there are no indications to prescribe them and are not legally available to the public. This is a federal law and does not vary from State to State.

Q. Can Schedule II substances be prescribed by a private practitioner?

A. Yes. Schedule II drugs have a high abuse potential and include narcotics, and amphetamines. There cannot be any refills and the prescription becomes invalid after a certain number of days which is state regulated. For example, in New Jersey any controlled substance prescription can be filled in a pharmacy within 30 days of writing the prescription. After the limit a new prescription is required. A Schedule II drug can be phoned into the pharmacy only in emergency situations and must be followed up by a written prescription immediately within 72 hours. Only a 3 day supply is allowed to be dispensed.

Q. What are the regulations for schedule III drugs?

A. Schedule III drugs have a lesser abuse potential than Schedule II drugs. Prescriptions for Schedule III substances expire 6 months after the date written. Refills are allowed but only five refills within 6 months. Refill authorization can be transferred from one pharmacy to another once within the 6-month period. A practitioner may issue a new prescription for the Schedule III substance within a 6-month period if necessary.

Q. What is the refill regulation for Schedule IV and V drugs?

A. Five refills in 6 months.

Q. Can the prescriber presign prescriptions for controlled substances?

A. No. Federal law prohibits prescribers from presigning prescriptions. All prescriptions for controlled substances have to be dated and manually signed on the day the prescription was written.

Q. What are Prescription Drug Monitoring Programs?

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