No. The instruction “take as directed” or “take as needed” is not satisfactory and should be avoided. Patients may fail to understand or forget the instructions given in the prescriber's office. Similarly, most insurance companies will only reimburse the patient or pharmacist for a specific number of doses or duration of treatment. The same thing holds true with writing “as needed.” The directions to the patient should include a reminder of the intended purpose of the medication by including such phrases as “for relief of dental pain” or “for dental infection” (Warner and Mitchell 2008).15 Q. What about recommending over‐the‐counter drugs?
16 A. Even though OTC drugs are not prescription or legend drugs, if the dentist recommends an OTC in the dental office the same responsibilities for proper prescribing apply. For example, after a surgical procedure the patient asks which OTC analgesic is good to take. Do not recommend any OTC drug without reviewing the medical history. If the patient has controlled hypertension and is taking a beta‐blocker, NSAIDs (e.g., ibuprofen, naproxen sodium) in doses adequate to reduce inflammation and pain can increase blood pressure in both normotensive and hypertensive individuals. In addition, NSAID use may reduce the effect of all antihypertensive drugs except calcium channel blockers (nifedipine [Procardia®], amlodipine [Norvac®]). The manufacturer recommends that NSAIDs be used for a maximum of five days in patients taking any antihypertensive drugs except for calcium channel blockers (White 2007).
17 Q. Is there any special labeling of OTC drugs?
18 A. Yes. In the Federal Register of March 1999, the FDA published the OTC Drug Facts Label regulation. This regulation required most OTC drug products to comply with the new format and content requirements by May 2002. This “new” drug labeling of OTC was intended to inform the consumer about the medication in an easy‐to‐read label. OTC medicines also differ from prescription drugs in their labeling. The OTC Drug Facts label contains all the information a consumer needs in order to select an appropriate OTC medicine, to use the medicine safely and effectively, and to decide when to consult a physician, if needed. Some changes to the labeling include the word “uses” which replaces “indications,” and terms such as “precautions” and “contraindications” have been replaced with more easily understood words. The label is written in large font and formatted with bullet points, so it is easier to read.
References
1 Balthasar, J. (1999). Bioequivalence and bioequivalency testing. American Journal of Pharmaceutical Education 63: 194–198.
2 Birkett, D. (2003). Generics – equal or not? Australian Prescriber 26: 85–87.
3 Food and Drug Administration (2008). Approved Drug Products with Therapeutic Equivalence Evaluations. www.fda.gov/drugs/resources‐information‐approved‐drugs/approved‐drug‐ products‐therapeutic‐equivalence‐evaluations‐orange‐book.
4 Food and Drug Administration – Center for Drug Evaluation and Research (CDER) (2001). Statistical Approaches to Establishing Bioequivalence. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf.
5 Greene, W.L., Concato, J., and Feinstein, A.R. (2001). Claims of equivalence in medical research: are they supported by the evidence. Annals of Internal Medicine 132: 715–722.
6 Meridith, P. (2003). Bioequivalence and other unresolved issues in generic drug substitution. Clinical Therapeutics 25: 2875–2890.
7 Messerli, F.H. and Sichrovsky, T. (2005). Does the pro‐hypertensive effect of cyclooxygenase‐2 inhibitors account for the increased risk in cardiovascular disease? American Journal of Cardiology 96: 872.
8 Posner, J. and Griffin, J.P. (2011). Generic substitution. British Journal of Clinical Pharmacology 72 (5): 731–732.
9 Warner, T.D. and Mitchell, J.A. (2008). COX‐2 selectively alone does not define the cardiovascular risks associated with non‐steroidal anti‐inflammatory drugs. Lancet 371: 270–273.
10 Welage, L.S., Kirking, D.M., Ascione, F.J. et al. (2001). Understanding the scientific issues embedded in the generic drug approval process. Journal of the American Pharmaceutical Association 41: 856–867.
11 White, W.B. (2007). Cardiovascular effects of the cyclooxygenase inhibitors. Hypertension 49: 408–418.
Additional Resources
www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm
www.fda.gov/Drugs/DrugSafety/ucm239821.htm
FDA Guidance for Industry. Dissolution Testing for Immediate Release Solid Oral Dosage Forms. US Department of Health and Human Services. www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/dissolution‐testing‐immediate‐release‐solid‐oral‐dosage‐forms
3 Basic Prescribing and Drug Dosing for the Dental Patient
3.1 Basic Principles of Drug Dosing
1 Q. What is the difference between dose and dosage form?
2 A. The dose of a drug is a specified quantity of a drug – the size or frequency at which the drug doses are administered. The dosage form of a drug is the drug formulation such as a tablet, capsule, syrup, liquid suspension, solution, ointment, or cream that generally contains the active drug substance in association with one or more inactive ingredients. The FDA has stated that a dosage form is the way of identifying the drug by its physical form, which is linked both to physical appearance of the drug product and to the way it is administered (www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/05/fda‐petition‐response‐reaffirms‐fda‐orange‐book‐dosage‐form‐nomenclature‐policy.html).If a patient is instructed to take one 500 mg capsule po (orally) qid (four times a day), the total dose is calculated from the dose multiplied by the number of times a day the dose is administered; one tablet (500 mg) qid is 2000 mg or 2 g.
3 Q. Why are some tablets “candy coated”?
4 A. These “candy‐coated” tablets are what is known as enteric coated. Some drugs are either irritating to the stomach lining or are inactivated, to different degrees, by acid in the stomach. To prevent the drug from being inactivated or destroyed in the stomach and allow it to travel to the intestine where it will ultimately be absorbed, enteric‐coated buffered tablets protect the drugs from gastric juices. Examples include erythromycin base, ibuprofen, and aspirin.
5 Q. Is it important to know the patient's baseline hepatic and renal function when deciding on the proper
