Why do dosage guidelines exist

In general, the guidelines represent a safe, effective, and efficient approach to timely administration of scheduled medications.

However, the details may differ from one organization to another based on differing patient populations and medication systems, including available technology. Please keep in mind that the policies and procedures developed by acute care organizations using these guidelines will require flexibility of the goals for timely administration, as appropriate, to accommodate the additional time needed to learn to operate new medication-related technologies. Scheduled medications include all maintenance doses administered according to a standard, repeated cycle of frequency e.

Time-critical scheduled medications are those where early or delayed administration of maintenance doses of greater than 30 minutes before or after the scheduled dose may cause harm or result in substantial sub-optimal therapy or pharmacological effect.

Non-time-critical scheduled medications are those where early or delayed administration within a specified range of either 1 or 2 hours should not cause harm or result in substantial sub-optimal therapy or pharmacological effect.

Identify a hospital-specific list: Identify a hospital-specific list of time-critical scheduled medications. While this list will include a limited number of drugs, a universal list is not desirable because hospitals that treat different patient populations e. Similarly, some hospitals that serve very diverse patient populations may decide to identify both hospital-wide and unit-specific time-critical scheduled medications.

Because some scheduled medications can be time-critical for certain patients given their diagnoses e. Policies should allow prescribers, pharmacists, or nurses to declare any scheduled medication to be time-critical i. Establish guidelines for time-critical medications: Establish guidelines that facilitate administration of the hospital-identified, time-critical scheduled medications at the exact time indicated when necessary or within 30 minutes before or 30 minutes after the scheduled time or more exact timing when indicated, as with rapid-, short-, and ultra-short-acting insulins.

MAR entries for hospital-identified time-critical scheduled medications should be designated to remind staff that these drugs require meticulous attention to timely administration. Establish guidelines for daily, weekly, or monthly medications.

Administer these medications within 2 hours before or after the scheduled time. Medications administered more frequently than daily but not more frequently than every 4 hours e. Current information technology associated with medication use may require vendor updates to: accommodate more than a single time interval to trigger an alert for delayed and early doses with bar-coding technology; change the appearance of a medication entry for delayed doses in electronic medication administration records eMARs ; and set different time limits for the removal of scheduled medications from automated dispensing cabinets.

Challenges also exist with highlighting time-critical scheduled medications on eMARs and differentiating between first doses and subsequent scheduled doses when using these technologies. ISMP is aware of these limitations and has been encouraging vendors to address them in updated versions of their technology.

Obtain medical staff approval of all policies and procedures related to timely administration of scheduled medications. While menstrual and contraceptive history may be useful, the assessment of pregnancy status should not be made solely by self-reported information. Such subjects must be given special considerations because they may be undergoing gradual changes in anatomy and physiology that may alter or be altered by the metabolism and short and long-term effects of drugs.

Investigators should specify the level of training and experience study personnel must have prior to their direct involvement in drug administration.

Persons that use drugs are often at special risk for contracting and transmitting HIV, tuberculosis TB , hepatitis, syphilis and other infectious diseases. Infection risk reduction interventions have been demonstrated to effectively reduce these behaviors. A concern is the possibility that individuals who have been administered drugs in a study may still be under the effects of those drugs and, upon leaving the laboratory, drive or engage in behavior that may be harmful to themselves or others.

The consent form and research protocol should address the estimated period of time that the research participant likely will have to stay at the research facility.

Participants must be kept under observation for that period and when dismissed from the laboratory, participants should be informed of the potential performance impairments to be expected during this period.

Investigators also should determine, depending on the nature of the study and the subject, the likelihood of any delayed reaction from participation in the study. Discharge personnel should have the necessary training and experience to determine whether the subject is impaired. If it is determined that the subject is impaired, provisions should be made to provide the appropriate intervention.

Another concern arises in studies that manipulate "cue reactivity," which may mimic a drug effect, to ensure that the research participant is not discharged in a heightened state of desire for drug that would put the individual at risk of drug use or relapse.

Discharge personnel should have the necessary training and experience to determine that the subject is not at such risk, and assessments to make this determination should be specified. If it is determined that the subject is at risk, provisions should be made to provide the appropriate intervention.

Investigators should be knowledgeable about available drug abuse treatment options and, where medically indicated, offer research participants referral to treatment before, during, and at the conclusion of study participation.

Investigators who identify co-morbid or coincident diseases in study participants should provide or refer them to appropriate medical care. On relatively rare occasions, an element of deception or incomplete disclosure of information about the research methods or goals may be justified in drug abuse as well as other research; for example, when researching expectancy and placebo effects. Any such withholding which results in the exclusion or alteration of some or all of the elements of informed consent in 45 CFR Section At the conclusion of participation in the research protocol, research participants should have a general and study specific debriefing.

In addition, participants should have the opportunity to be informed of study results and their significance upon completion of the study analysis. The consent form should clearly indicate that they might receive drugs, the types of drugs, and information on the amount they may receive.

Information about risks must never be withheld for the purpose of eliciting the cooperation of volunteer participants. Truthful answers must always be given to direct questions about research. See also page 6 of the Belmont Report. Payment to research participants for their time and inconvenience is an acceptable practice in drug abuse as well as other biomedical research.

The payment should not be exploitive or coercive in the sense of unduly tempting individuals to participate. In this regard, alternatives to cash payments should be considered e. When cash payments are considered important and appropriate, the payment could be made in installments or to a third party.

These principles represent a brief summary of basic issues relating to research involving the administration of drugs to human subjects. It should be recognized that there are benefits in addition to risks to individuals who participate in research.

Such benefits may include medical and psychological evaluation, HIV counseling and testing, and referral to drug abuse treatment. Further information on human subject research may be obtained from the Office for Human Research Protection and from the National Institute on Drug Abuse at the following locations.

William L. Dewey, Ph. Alan Marlatt, Ph. Marian Fischman, Ph. Thomas McLellan, Ph. Reese T. Jones, M. June Osborn, M. President Josiah Macy, Jr. The ANDA process does not, however, require the drug applicant to repeat costly animal and clinical human studies on ingredients or dosage forms already approved for safety and effectiveness.

This allows generic medicines to be brought to market more quickly and at lower cost, allowing for increased access to medications by the public. Detailed information on the critical factors the FDA reviews to make sure a generic medicine is as safe and effective as the brand-name drug. In addition to asking your local pharmacist for assistance, there are three ways to find out if there is a generic of your brand-name medicine available:.

If you are unable to locate a generic of your brand-name medicine, it may be that the brand-name medicine is still within the period of time when it has exclusive rights to the marketplace, which allows drug companies to recoup their costs for the initial research and marketing of the brand-name or innovator drug.

It is only after both patent and other periods of exclusivity are resolved that FDA can approve a generic of the brand-name medicine. FDA takes several actions to ensure safety and quality before and after a new or generic medicine is approved.

When a generic drug application is submitted, FDA conducts a thorough examination of the data submitted by the applicant and evaluates information obtained by FDA investigators while inspecting the related testing and manufacturing facilities to ensure that every generic drug is safe, effective, high quality, and substitutable to the brand name drug.

FDA staff continually monitors all approved drug products, including generics, to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients APIs to products being sold to consumers, are safe, effective, and high quality.

FDA also monitors and investigates reports of negative patient side effects or other reactions. The investigations may lead to changes in how a product brand-name and generic is used or manufactured, and FDA will make recommendations to health care professionals and the public if the need arises.

Contact your doctor, pharmacist, or other health care provider for information on generic medicines. For more information, you can also:. Some questions you might ask include:. For small amounts of delicate drugs, a subcutaneous injection can be a convenient way of getting a medication into your body. Has your doctor prescribed a transdermal patch? A transdermal patch attaches to your skin and contains medication.

They are easy to use, but to work…. An intramuscular injection is a technique used to deliver a medication deep into the muscles. This allows the medication to be absorbed quickly. When a medication is injected directly into muscle, it is called an intramuscular injection IM.

The Z-track method of IM is used to prevent tracking…. Drug interactions can occur when you take a medication with other substances that alter how that medication works. Learn how drug interactions may…. Experts say the current shortage of medications for cancer, COVID, and other treatments is nothing new. It's been happening for years.

Health Conditions Discover Plan Connect. Medically reviewed by Alan Carter, Pharm. Routes Training Dosage and timing Potential problems Takeaway Introduction We take medications to diagnose, treat, or prevent illness.