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© Paradigm Publishing, Inc. 1 © Paradigm Publishing, Inc. 1 Chapter 12 Medication Safety

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© Paradigm Publishing, Inc. 1 © Paradigm Publishing, Inc. 1

Chapter 12

Medication Safety

© Paradigm Publishing, Inc.

2

Medical Errors

• Medical errors result in unintended health outcomes.

• As many as 98,000 people die each year in the US as a result of medical errors.

• The pharmacy technician should be on the lookout for potential medical errors.

© Paradigm Publishing, Inc. 3 © Paradigm Publishing, Inc. 3

Terms to Remember

medical error any circumstance, action, inaction, or decision related to health care that contributes to an unintended health result

© Paradigm Publishing, Inc.

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Medication Errors

• Medication errors are among the most common types of medical errors.

• Medication errors result in an estimated 7,000 deaths each year in the US.

• About 1.7% of all prescriptions dispensed in a community pharmacy contain a medication error.

© Paradigm Publishing, Inc. 5 © Paradigm Publishing, Inc. 5

Terms to Remember

medication error any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer

© Paradigm Publishing, Inc. 6 © Paradigm Publishing, Inc. 6

Medication Errors

• Patient response • Categories of medication errors • Root-cause analysis of medication

errors

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Patient Response

• Some medication errors have a physiological cause.

• Medications may not be properly eliminated from the body due to – An enzyme deficiency – Decreased kidney function

• If the dose is not lowered, the medication may reach toxic levels.

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Patient Response • Some medication errors have a social

cause. • Patients can cause medication errors

through incorrect self-administration: – Forgetting to take a dose or taking it at the

wrong time – Taking too many doses – Not getting a prescription filled or refilled in a

timely manner – Not following dosing directions – Terminating the regimen too soon

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Categories of Medication Errors

• Omission error: prescribed dose not given • Wrong dose error: dose given is 5% above or

below correct dose • Extra dose error: more doses given than

prescribed • Wrong dosage form error: dosage form

incorrectly interpreted • Wrong time error: dose given at least 30

minutes before or after prescribed time

© Paradigm Publishing, Inc. 10 © Paradigm Publishing, Inc. 10

Terms to Remember

omission error an error in which a prescribed dose is not given

wrong dose error an error in which the dose is either above or below the correct dose by more than 5%

© Paradigm Publishing, Inc. 11 © Paradigm Publishing, Inc. 11

Terms to Remember

extra dose error an error in which more doses are received by a patient than were prescribed by the physician

wrong dosage form error an error in which the dosage form or formulation is not the accepted interpretation of the physician order

© Paradigm Publishing, Inc. 12 © Paradigm Publishing, Inc. 12

Terms to Remember

wrong time error a medication error in which a drug is given 30 minutes or more before or after it was prescribed, up to the time of the next dose, not including as needed orders

© Paradigm Publishing, Inc.

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Categories of Medication Errors

• Medication errors can also be categorized by the cause of failure.

• Human failure: an individual mistake by the healthcare worker or patient

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Terms to Remember

human failure an error generated by failure that occurs at an individual level

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Categories of Medication Errors

• Technical failure: an equipment malfunction

• Organizational failure: error caused by rules, policies, or procedures

© Paradigm Publishing, Inc. 16 © Paradigm Publishing, Inc. 16

Terms to Remember

technical failure an error generated by failure because of location or equipment

organizational failure an error generated by failure of organizational rules, policies, or procedures

© Paradigm Publishing, Inc.

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Root-Cause Analysis of Medication Errors

• Process to identify what, how, and why something happened

• List of specific potential causes identified • Three of the most common causes

– Assumption errors – Selection errors – Capture errors

© Paradigm Publishing, Inc. 18 © Paradigm Publishing, Inc. 18

Terms to Remember

root-cause analysis a logical and systematic process used to help identify what, how, and why something happened, in order to prevent recurrence

© Paradigm Publishing, Inc. 19 © Paradigm Publishing, Inc. 19

Terms to Remember

assumption error an error that occurs when an essential piece of information cannot be verified and is guessed or presumed

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Root-Cause Analysis of Medication Errors

Examples Assumption error: when a pharmacy technician misreads a poorly-written abbreviation on a prescription

© Paradigm Publishing, Inc. 21 © Paradigm Publishing, Inc. 21

Terms to Remember

selection error when two or more options exist and the incorrect option is chosen

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Root-Cause Analysis of Medication Errors

Examples Selection error: when a pharmacy technician mistakenly selects a look-alike or sound-alike drug instead of the prescribed drug

© Paradigm Publishing, Inc. 23 © Paradigm Publishing, Inc. 23

Terms to Remember

capture error an error that occurs when focus on a task is diverted elsewhere and therefore the error goes undetected

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Root-Cause Analysis of Medication Errors

Examples Capture error: when a pharmacy technician takes a phone call in the middle of filling a prescription and thus miscounts the number of tablets

Safety Note

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Root-Cause Analysis of Medication Errors

Maintaining focused attention when filling prescriptions is important to avoid errors.

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Prescription-Filling Process

• To find potential causes for medication errors, it is helpful to examine each step of the prescription-filling process.

• There are three parts to each step: – Information that needs to be obtained or

checked – Resources that can be used to verify

information – Potential errors that might result from a failure

to check or obtain information

Safety Note

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Prescription-Filling Process

Each person who participates in the filling process has the opportunity to catch and correct a medication error.

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Prescription-Filling Process

• Step 1: Receive and review prescription.

• Step 2: Enter prescription into computer.

• Step 3: Perform drug utilization review and resolve medication issues.

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Step 1: Receive and Review Prescription

• Is the prescription legible? – If not, check with physician, nurse, or

pharmacist. • Is the prescription valid and legal?

– Be familiar with state requirements. – Check with physician, pharmacist, or

nurse, if necessary.

Safety Note

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Step 1: Receive and Review Prescription

Careful review of the prescription or order is very important. Outdated prescriptions should not be filled.

Safety Note

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Step 1: Receive and Review Prescription

A prescriber’s signature is required for a written prescription to be considered valid.

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Step 1: Receive and Review Prescription

Prescriptions contain three basic types of information:

– Physician information – Patient information – Medication information

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Step 1: Receive and Review Prescription

Physician information must be sufficient to determine whether the prescription was written by a qualified prescriber:

– Contact information – Signature

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Step 1: Receive and Review Prescription

Patient information should be detailed enough to pinpoint the individual:

– Full name – Address – Date of birth – Phone number

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Step 1: Receive and Review Prescription

Medication information must be unambiguous:

– Drug name – Dose and dosage form – Route of administration – Refills or length of therapy – Directions for use – Dosing schedule

Safety Note

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Step 1: Receive and Review Prescription

A leading zero should precede values less than 1, but a zero should not follow a decimal if the value is a whole number.

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Step 2: Enter Prescription into Computer

• Data entry involves inputting into the computer information from the hard copy of the prescription.

• Several pieces of information need to be checked to ensure that the patient receives the correct, drug, dose, and dosage formulation.

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Step 2: Enter Prescription into Computer

Do the drug choices on the computer screen include the exact drug on the prescription?

May need to cross-check brand names and generic names.

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Step 2: Enter Prescription into Computer

• Does the spelling on the prescription match the drug selection?

• Do the units and increments of measure (gram, milligram, microgram) on the drug selection options match those on the prescription? May need to cross-check the measure prescribed.

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Step 2: Enter Prescription into Computer

• For the dose selected, do the available strengths or concentrations match?

• Does the dose or concentration have leading or trailing zeros, and does it require a decimal? Cross-check doses that contain leading or trailing zeros.

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Step 2: Enter Prescription into Computer

• Do the available forms match the prescribed route of administration?

• The pharmacist and the technician should check each piece of entered information before proceeding.

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Step 3: Perform DUR and Resolve Medication Issues

• For every prescription, the pharmacy technician should complete a computerized DUR of the patient profile to check for allergies and multiple drug therapies.

• The pharmacist should perform a medication review to check for drug interactions and duplication of therapy.

Safety Note

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Step 3: Perform DUR and Resolve Medication Issues

Check the patient profile for existing allergies or possible drug interactions.

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Step 3: Perform DUR and Resolve Medication Issues

Dosage must be carefully checked for – Pediatric patients – Geriatric patients, where age-related

declines in liver and kidney function may necessitate a lower dosage

© Paradigm Publishing, Inc. 45 © Paradigm Publishing, Inc. 45

Prescription-Filling Process

• Step 4: Generate prescription label. • Step 5: Retrieve medication. • Step 6: Fill or compound prescription.

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Step 4: Generate Prescription Label

• The computer-generated label should be compared with the original prescription.

• Has the patient information been cross-checked?

• Are the label and the prescription identical? • Are the leading and trailing zeros and

unapproved abbreviations correct? • Do all the data elements on the label match

those on the prescription?

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Step 5: Retrieve Medication

• Use both the original prescription and the computer-generated label when selecting a drug product from storage.

• Drug look-alikes and sound-alikes can cause accidental substitution.

Safety Note

© Paradigm Publishing, Inc. 48 © Paradigm Publishing, Inc. 48

Step 5: Retrieve Medication

Confirm that information entered into the computer matches that in the original prescription.

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Step 5: Retrieve Medication

Has information on the manufacturer’s label been used to verify the medication selection?

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Step 5: Retrieve Medication Be sure the label and the product container match in terms of

– Brand name and generic name

– Dose strength and form

– NDC and manufacturer name

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Step 6: Fill or Compound Prescription

• Calculation and substitution errors are frequent sources of pharmacy-related medication errors.

• Do not allow interruptions or distractions during filling or compounding.

• All equipment should be maintained, cleaned, and calibrated regularly.

Safety Note

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Step 6: Fill or Compound Prescription

When compounding, do not allow interruptions. Prepare products one at a time.

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Step 6: Fill or Compound Prescription

• Have the amount to be dispensed and the increment of measure been verified? – Check the original prescription. – Count the medication twice.

• Does the prescription require a calculation or conversion? – Write out the calculation or conversion. – Have another person review it.

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Step 6: Fill or Compound Prescription

• Has the equipment been calibrated recently? – Check the calibration. – Verify it with the pharmacist.

• Does the medication require warning or caution labels? – Check the patient information handout and the

package insert. – Check with the pharmacist.

© Paradigm Publishing, Inc. 55 © Paradigm Publishing, Inc. 55

Prescription-Filling Process

• Step 7: Review and approve prescription.

• Step 8: Store completed prescription. • Step 9: Deliver medication to patient.

Safety Note

© Paradigm Publishing, Inc. 56 © Paradigm Publishing, Inc. 56

Step 7: Review and Approve Prescription

The pharmacist must always check the technician’s work.

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Step 7: Review and Approve Prescription

• The pharmacist is legally responsible for verifying the accuracy of any prescription that is filled.

• The pharmacy technician should provide all available resources that are useful to ensure accurate verification.

• The pharmacist should be able to retrace the technician’s steps in filling the prescription.

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Step 7: Review and Approve Prescription

• Did the pharmacist review the prepared medication?

• Given the information provided, can the pharmacist verify – The validity of the prescription? – The patient information? – The correctness of the prepared

prescription?

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Step 8: Store Completed Prescription

• Ensuring integrity of medications is an important part of medication safety.

• Many medications are sensitive to light, humidity, or temperature and must be stored appropriately.

• A well-organized and clearly labeled storage system can keep a patient’s medications together and separate from those of other patients.

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Step 8: Store Completed Prescription

• Are the storage conditions appropriate for the medication?

• Are each patient’s medications adequately separated?

• Are the storage areas neat and orderly?

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Step 9: Deliver Medication to Patient

In a community pharmacy, the technician should confirm the patient’s identity, usually by verifying

– Address – Date of birth

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Step 9: Deliver Medication to Patient

The “show-and-tell” technique can be used to prevent medication errors and provide patient education.

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Step 9: Deliver Medication to Patient

In a hospital setting, a nurse or caregiver is another person to confirm the accuracy of the medication.

Safety Note

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Step 9: Deliver Medication to Patient

Pharmacy technicians cannot instruct patients. If a technician suspects that a patient requires instruction, the technician should alert the pharmacist.

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Step 9: Deliver Medication to Patient

• Will the appearance of the pill be new to the patient?

• Is the patient receiving medication intended for him or her?

• Does the patient understand the instructions for use?

• Does the patient know what to expect? • Are all of the prescribed medications

included?

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Medication Error Prevention

The pharmacy technician often has the most opportunities to prevent a medication error:

– The first person to examine the prescription

– The last person to handle a medication before it reaches a patient

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Medication Error Prevention

• Prescribers are responsible for ensuring the “five Rs”: – Right patient – Right drug – Right strength – Right route of administration – Right time

• Pharmacy practice overlays the prescriber responsibilities and enhances patient safety.

Safety Note

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Medication Error Prevention

Incorrect drug identification is the most common error in dispensing and administration.

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Medication Error Prevention

• The responsibility of the healthcare professionals

• Patient education • Innovations to promote safety

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The Responsibility of the Healthcare Professionals

• Healthcare workers must put safety first.

• Pharmacists and pharmacy technicians can work together to increase the margin of safety.

Safety Note

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The Responsibility of the Healthcare Professionals

The only acceptable level for medication errors is zero errors.

Safety Note

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The Responsibility of the Healthcare Professionals

If information is missing from a prescription or medication order, never assume. Obtain the missing information from the prescriber.

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Patient Education

• Patients and caregivers must have the basic knowledge needed to safely administer medication.

• Pharmacy technicians cannot counsel patients, but they can encourage patients to become informed about their condition and to ask questions.

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Innovations to Promote Safety

• Automate and bar-code all fill procedures. • Maintain a clean, organized, and well-lit

work area. • Provide adequate storage areas with clear

drug labels on the shelves. • Encourage prescribers to use common

language and only safe abbreviations. • Provide adequate computer applications

and hardware.

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Innovations to Promote Safety

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Innovations to Promote Safety

• eMAR allows the administration of medication to be documented electronically rather than on paper.

• eMARs can reduce dispensing and administration errors by 75%.

© Paradigm Publishing, Inc. 77 © Paradigm Publishing, Inc. 77

Terms to Remember

eMAR an electronic medication administration record that is used to minimize medication errors

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Medication Error Reporting Systems

• The first step in preventing medication errors is to identify problems.

• Fear of punishment is always a concern.

• Anonymous or no-fault reporting systems have been developed.

• The focus is on fixing the problem, not assigning blame.

© Paradigm Publishing, Inc. 79 © Paradigm Publishing, Inc. 79

Medication Error Reporting Systems

• State boards of pharmacy • The Joint Commission • United States Pharmacopeia • Institute for Safe Medication Practices • Personal prevention strategies

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State Boards of Pharmacy

• Many states have mandatory error reporting systems.

• Most officials admit that errors are under-reported due to fear of punishment.

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State Boards of Pharmacy

• Most state boards of pharmacy do not punish pharmacists for errors as long as a good-faith effort was made to fill the prescription correctly.

• Some states are also considering new laws that protect error reports from subpoena.

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The Joint Commission

• The Joint Commission established the Sentinel Event Policy in 1996.

• A sentinel event is an unexpected occurrence involving death, serious physical or psychological injury, or the potential for such an occurrence to happen.

© Paradigm Publishing, Inc. 83 © Paradigm Publishing, Inc. 83

Terms to Remember

sentinel event an unexpected occurrence involving death or serious physical or psychological injury or the potential for such occurrences to happen

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The Joint Commission

For sentinel events, the organization is expected to

– Analyze the cause of the error – Take action to correct the cause – Monitor the changes made – Determine whether the cause of the

error has been eliminated

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United States Pharmacopeia

• USP supports the MEDMARX medication error reporting system.

• MEDMARX allows users to anonymously document, analyze, and track adverse events specific to an institution.

• Data from MEDMARX suggests that contributing factors to errors include distraction in the workplace, excessive workload, and inexperience.

© Paradigm Publishing, Inc. 86 © Paradigm Publishing, Inc. 86

Terms to Remember

MEDMARX an Internet-based program of the USP for use by hospitals and healthcare systems for documenting, tracking, and identifying trends for adverse events and medication errors

© Paradigm Publishing, Inc. 87 © Paradigm Publishing, Inc. 87

Terms to Remember

Institute for Safe Medication Practices (ISMP)

a nonprofit healthcare agency whose primary mission is to understand the causes of medication errors and to provide time-critical error reduction strategies to the healthcare community, policymakers, and the public

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Institute for Safe Medication Practices

• USP and ISMP provide a confidential program called the Medication Error Reporting Program (MERP).

• MERP is designed to allow medical professionals to report medication errors directly.

© Paradigm Publishing, Inc. 89 © Paradigm Publishing, Inc. 89

Terms to Remember

Medication Error Reporting Program (MERP)

a USP program designed to allow healthcare professionals to report medication errors directly to the Institute for Safe Medication Practices (ISMP)

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Institute for Safe Medication Practices

MERP medication errors include – Incorrect drug, strength, or dose – Confusion over look-alike or sound-alike

drugs – Incorrect route of administration – Calculation or preparation errors – Misuse of medical equipment – Errors in prescribing, transcribing,

dispensing, or monitoring medications

© Paradigm Publishing, Inc. 91 © Paradigm Publishing, Inc. 91

Terms to Remember

MedWatch a voluntary program run by the FDA for reporting serious adverse events for medications and medical devices; serves as a clearinghouse for information on safety alerts and drug recalls

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Institute for Safe Medication Practices

ISMP makes these recommendations to minimize dispensing errors:

– The order-entry person should be different from the person who fills the order.

– Prescriptions should not be prepared from the computer-generated label but from the original prescription.

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Institute for Safe Medication Practices

Recommendations (continued) – Keep the original prescription, stock

bottle, computer label, and medication container together during the filling process.

– The pharmacist should verify dispensing accuracy by comparing the original prescription with the labeled product with the NDC code of the manufactured product.

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Personal Prevention Strategies

The pharmacy technician must take care of himself or herself:

– Get adequate sleep. – Exercise regularly. – Take breaks at work. – Be wise about food. – Avoid alcohol. – Cut the caffeine.