Pharmacy Law and Ethics
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Explain the legal ramifications if a pharmacist dispenses a prescription one year and one day after the issue date.

Dispensing a prescription after one year of its issue date violates prescription validity regulations, potentially leading to legal penalties for the pharmacist and pharmacy, as well as compromising patient safety due to outdated medical information.

Describe the key differences in the dispensing process and legal requirements between a standard outpatient prescription and a medication order in an institutional setting.

Outpatient prescriptions require patient's full address, specific quantities, and refill information, whereas medication orders in institutions use room and bed numbers for patient identification, lack quantities and refills, and are subject to 'stop order' policies and formulary restrictions.

Analyze the ethical implications of a pharmacist making a therapeutic substitution on a medication order without consulting the prescribing physician in a hospital setting.

Therapeutic substitution without prescriber consultation undermines patient autonomy, and could violate regulatory standards if the substituted medication isn't clinically equivalent or appropriate, potentially harming the patient.

Outline the steps a pharmacist should take when receiving a prescription orally via telephone to ensure legal compliance and patient safety.

<p>The pharmacist must immediately write down the prescription details accurately, including drug name, strength, dosage, and directions, then verify the information with the prescriber on the phone, and obtain the prescriber's signature as follow-up, for record-keeping.</p> Signup and view all the answers

Discuss the potential liability a pharmacist faces if they fail to accurately record all legally required elements when receiving an oral prescription.

<p>Inaccurate or incomplete recording of an oral prescription makes the pharmacist liable for errors in dispensing, potential harm to the patient, and legal repercussions due to non-compliance with prescription documentation standards.</p> Signup and view all the answers

Explain the safeguards that should be in place when prescriptions are transferred electronically to protect patient confidentiality and prevent fraudulent prescriptions.

<p>Safeguards include secure, encrypted transmission channels, multi-factor authentication for prescribers and pharmacists, audit trails to track prescription modifications, and compliance with privacy regulations such as HIPAA.</p> Signup and view all the answers

Describe the legal and ethical considerations a pharmacist must evaluate before dispensing a prescription for a controlled substance, focusing on preventing abuse and diversion.

<p>A pharmacist must verify the prescriber's authority, assess the legitimacy of the prescription based on patient history and clinical indications, check for red flags indicating potential abuse or diversion, and use prescription drug monitoring programs (PDMPs).</p> Signup and view all the answers

Analyze the impact of electronic prescribing on prescription error rates compared to handwritten prescriptions, considering factors like legibility and automated checks.

<p>Electronic prescribing reduces errors by eliminating issues related to illegible handwriting and enabling automated checks for drug interactions, allergies, and appropriate dosing, leading to improved accuracy and patient safety although system errors can still occur.</p> Signup and view all the answers

A prescription lacks the patient's identification number. Is this prescription still legally valid in Singapore, assuming all other requirements are met?

<p>No, the prescription is not legally valid. Singapore law requires the patient's identity card number or other identification document number.</p> Signup and view all the answers

A doctor prescribes a medication but forgets to include their MCR (Medical Council Registration) number on the prescription. Although the doctor's name, signature, and clinic address are present, is the prescription legally valid?

<p>The prescription's validity is questionable. While the legal requirements explicitly state the name and address of the prescriber, the inclusion of the MCR number, while not explicitly stated, is a standard practice and may be required for verification purposes by pharmacies. Therefore, it should be clarified with the relevant health authorities.</p> Signup and view all the answers

A prescription for a controlled substance is written with the instruction 'Take as needed for pain'. Does this fulfill the legal requirement for clear instructions for use?

<p>No, the instruction 'Take as needed for pain' does not fulfill the legal requirement for clear instructions for use. It lacks specific details regarding dose, frequency, and maximum daily dosage, which are necessary for the safe and effective use of the medication.</p> Signup and view all the answers

A veterinarian writes a prescription for a medication that is intended for human use, but clearly marks it 'for animal treatment only'. Is the prescription legally valid, and under what conditions?

<p>The prescription is valid only if the veterinarian is treating an animal. The inclusion of 'for animal treatment only' is mandatory to ensure the medication is not misused for human consumption and to comply with veterinary prescribing regulations.</p> Signup and view all the answers

A pharmacist receives a prescription that is 13 months old from the date it was written. Can the pharmacist legally dispense the medication?

<p>No, the pharmacist cannot legally dispense the medication. Prescriptions are generally valid for only one year from the date of issue.</p> Signup and view all the answers

What are the conditions in which an Advanced Practice Nurse (APN) or Pharmacist can legally issue a prescription in Singapore?

<p>APNs and Pharmacists can issue a prescription if a course of collaborative prescribing has been completed after registering as an APN and pharmacist.</p> Signup and view all the answers

A doctor provides a prescription with all legal requirements met, but intentionally omits the strength of the medication, assuming the pharmacist knows the standard dosage. Is this prescription considered legally valid?

<p>No, the prescription is not legally valid. The strength of the therapeutic product is a mandatory requirement. The pharmacist cannot assume the dosage nor should they attempt to adjust the prescription, as that is the responsiblity of the doctor.</p> Signup and view all the answers

A patient presents a prescription with a specified number of refills, but the time interval between each refill is not indicated. Can the pharmacist dispense refills without clarifying the interval?

<p>No, the pharmacist cannot dispense the refills without the time interval. Without proper time indications between refills, safe dispensing is difficult.</p> Signup and view all the answers

A registered doctor issues a prescription without including the patient's date of birth (DOB). Although all other required information is present, is the prescription legally valid?

<p>While not explicitly stated, the inclusion of the DOB may be required for verification purposes by pharmacies. Therefore, it should be clarified with the relevant health authorities.</p> Signup and view all the answers

A collaborative prescribing practitioner provides a prescription, but the prescription does not specify the collaborative agreement under which they are prescribing. Is this prescription legally valid?

<p>The validity is questionable. It is best to clarify with the relevant health authorities or practitioners.</p> Signup and view all the answers

Excluding legal requirements specific to controlled drugs (CDs), identify two missing elements that make the first prescription invalid.

<p>Any two of the following: Missing patient address, missing strength for Adalat 60mg I/I, missing quantity/duration for line 3/4.</p> Signup and view all the answers

Explain why a pharmacist might choose to make a partial supply of a prescription, even when all items are in stock.

<p>A pharmacist might make a partial supply if the patient requests it, or sometimes due to concerns about allergies or interactions discovered during dispensing.</p> Signup and view all the answers

Describe two potential consequences of failing to record the dispensing of a therapeutic product in the prescription register.

<p>Potential consequences include legal repercussions/fines and difficulties in auditing medication usage and tracking potential discrepancies. Or failure to comply with regulatory requirements and inability to track dispensing activities.</p> Signup and view all the answers

A prescription is presented for a cream, with the instruction 'apply thinly mane et nocte'. What clarification should the pharmacist seek from the prescriber, and why?

<p>The pharmacist should clarify the duration of treatment, as the prescription lacks this information. Without a specified duration, the pharmacist cannot determine a complete dosage regimen.</p> Signup and view all the answers

In the repeat prescription example, what crucial information is missing that could lead to potential dispensing errors or patient safety concerns?

<p>The total quantity to be supplied in each dispensing and/or the interval between repeats is missing, which may lead to dispensing errors, and affect patient adherance.</p> Signup and view all the answers

A prescription includes a controlled drug. What specific details, beyond those required for non-controlled medications, must be present to ensure its validity?

<p>The dose, the number (in words and figures) of dosage units or the total quantity (in words and figures) of the CD preparation.</p> Signup and view all the answers

Explain the rationale behind the legal requirement for a pharmacist to retain a fully supplied prescription, as opposed to returning it to the patient.

<p>Retaining the prescription provides a legal record of the medication supplied, which act as an audit trail and protect the pharmacist in case of legal inquiries.</p> Signup and view all the answers

Describe a scenario where a pharmacist might contact the prescriber to verify a prescription, even if all legal requirements appear to be met.

<p>If the medication or dosage is unusual for the patient's age or condition or if there are concerns about potential drug interactions with the patient's other medications, the pharmacist may contact the prescriber for clarification.</p> Signup and view all the answers

A pharmacist receives a prescription for a Schedule 2 Controlled Drug that is faxed. Under what conditions, if any, can the pharmacist legally dispense the medication?

<p>A pharmacist cannot legally dispense a faxed prescription for Schedule 2 Controlled Drug in most jurisdictions, including those adhering to Misuse of Drugs Regulations. The original prescription is required.</p> Signup and view all the answers

Outline the steps a pharmacist should take when a patient requests a 'partial supply' of a prescription that includes both regular medications and controlled substances.

<p>The pharmacist should first assess the appropriateness of the partial supply, especially for the controlled substances. If approved, they must accurately record the quantity supplied and the remaining balance of each medication on the prescription and in the prescription register. Extra care and documentation requirements for controlled substances.</p> Signup and view all the answers

Explain the legal and ethical considerations a pharmacist must evaluate when a patient requests a partial supply of a prescription due to financial constraints.

<p>The pharmacist needs to ensure patient understanding of potential therapeutic consequences, document the partial supply, consider legal limits on partial dispensing, and explore options like generic substitution or financial aid programs while prioritizing patient well-being and adherence.</p> Signup and view all the answers

Describe the procedure a pharmacist should follow when dispensing a repeat prescription, including documentation and patient counseling.

<p>Verify remaining repeats, update records with quantity dispensed, calculate and record the new balance, return the prescription (if repeats remain), retain a copy, and counsel the patient on adherence and potential side effects.</p> Signup and view all the answers

A prescription reads: 'Amoxicillin 250mg TDS, repeat 6'. What is the maximum frequency at which this prescription can be dispensed, and what is the total number of possible dispenses?

<p>The prescription can be dispensed every three days. Since there are 6 repeats, the prescription can be dispensed a total of 7 times (original + 6 repeats).</p> Signup and view all the answers

Explain the risks associated with inconsistent adherence to a medication like Carvedilol, and how a pharmacist can address these risks during the dispensing process.

<p>Inconsistent adherence to Carvedilol can lead to rebound hypertension, increased risk of cardiovascular events, and reduced effectiveness. The pharmacist can counsel on the importance of consistent dosing, potential consequences of missed doses, and strategies for remembering medication.</p> Signup and view all the answers

Analyze the potential consequences of a pharmacist failing to accurately record the quantity supplied and remaining balance on a repeat prescription.

<p>Inaccurate records can lead to over- or under- dispensing, exceeding the prescribed quantity, potential drug diversion, and compromise patient safety due to incorrect medication supply.</p> Signup and view all the answers

A patient presents a prescription with repeats, but the prescribing doctor has moved overseas and is unreachable. How should the pharmacist proceed ethically and legally?

<p>The pharmacist should attempt to verify the prescription's validity through available channels. Dispensing should only occur if permissible under local regulations, often limited to a small supply for ongoing therapy until a new prescriber is found. Document all attempts to contact the prescriber and the rationale for any action taken.</p> Signup and view all the answers

Describe how a pharmacist ensures the authenticity and validity of a prescription, especially when there are concerns about potential forgery or alteration.

<p>The pharmacist can verify the prescriber's details (license, contact information) and signature, contact the prescriber's office to confirm the prescription, be alert for suspicious alterations or inconsistencies, and utilize prescription monitoring programs where available.</p> Signup and view all the answers

The prescription says to take Simvastatin at night. Explain the rationale behind recommending Simvastatin to be taken at night.

<p>Simvastatin is best taken at night because cholesterol production is highest during this time, maximizing the drug's effectiveness. Also, food decreases the absorption of Simvastatin, so taking on an empty stomach at night will maximize absorption.</p> Signup and view all the answers

Explain the key differences in legal requirements and professional responsibilities between dispensing an original prescription versus dispensing a repeat prescription.

<p>Original prescriptions require rigorous verification and assessment of appropriateness; repeat prescriptions focus on ensuring continued need and monitoring ongoing therapy, with specific rules about intervals and quantities. Both require accurate record-keeping, but original prescriptions have more intensive initial scrutiny.</p> Signup and view all the answers

Analyze the ethical implications of a pharmacist prioritizing speed and efficiency in dispensing over comprehensive patient counseling, especially for medications with complex dosing or potential side effects.

<p>Prioritizing speed can compromise patient safety and understanding, potentially leading to medication errors, adverse effects, and reduced adherence. Ethically, pharmacists have a duty to ensure patients are fully informed, even if it requires additional time and effort.</p> Signup and view all the answers

Explain the legal ramifications a pharmacist might face if they fail to accurately record the dispensed quantity and remaining balance on a prescription during a partial supply, particularly in the context of controlled substances?

<p>Failure to accurately record dispensed quantities and remaining balances, especially for controlled substances, can lead to legal ramifications for pharmacists, including fines, suspension or revocation of licenses, and potential criminal charges due to violations of prescription monitoring program regulations and controlled substance laws.</p> Signup and view all the answers

Describe the procedures a pharmacist should follow when presented with a prescription that contains ambiguous Latin abbreviations for dosage instructions, and how they can ensure patient safety and adherence?

<p>When faced with ambiguous Latin abbreviations, a pharmacist should consult reliable drug information resources, contact the prescribing doctor for clarification, and provide clear, non-technical instructions to the patient. Documenting these steps is crucial.</p> Signup and view all the answers

A prescription for a Schedule II controlled substance includes an alteration without the prescriber's explicit initials and date of the change, in addition to lacking the total quantity of dosage units written both in words and numerically. Outline the steps a pharmacist must take according to legal and professional standards?

<p>The pharmacist must not dispense the prescription as it is. They need to contact the prescriber to verify the alteration, obtain written confirmation or a new prescription with the correct information (quantity in words and numbers, and the alteration initialed and dated), and document the communication before dispensing.</p> Signup and view all the answers

Explain the difference in the handling and record-keeping requirements for prescriptions that are fully dispensed versus those that are partially supplied, especially concerning the storage and retention of the original prescription and any copies.

<p>For fully dispensed prescriptions, the original is retained and stored in the prescription register. For partially supplied prescriptions, a copy is kept after each dispensing, and the original is returned until the prescription is fully dispensed, at which point the original is retained.</p> Signup and view all the answers

A patient presents a prescription with instructions written in Latin that could be interpreted in multiple ways due to antiquated or uncommon abbreviations. Detail the pharmacist's responsibility in clarifying the instructions to ensure the patient's safety and therapeutic outcome.

<p>The pharmacist must verify the intended meaning with the prescribing doctor. If clarification cannot be obtained immediately, dispensing should be delayed until verification. The pharmacist should then translate the directions into plain language for the patient and document all communication.</p> Signup and view all the answers

Flashcards

What is a Prescription?

A direction from a prescriber to a pharmacist for preparing and using medication.

Methods of Receiving Prescriptions

Hardcopy given to the patient, oral (telephone), or electronically.

Medication Orders

Medication supply orders for patients in hospitals or nursing homes.

Patient Identification (Inpatient)

Identifies the patient by room and bed number.

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Quantity on Medication Orders

Orders have no quantities specified

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Refills on Medication Orders

Orders have no refills authorized.

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Elements Inside a Prescription

Name, address, DOB, issue date, drug name/strength, directions, and refills.

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Prescription Validity

Prescriptions are only valid for one year from the issue date.

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Partial Prescription Supply

After dispensing part of a prescription, the pharmacist records the quantity dispensed and remaining balance on the original prescription.

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Prescription Retention (Partial)

The pharmacist keeps a copy of the prescription after each partial dispensing and retains the original only after the entire prescription is fulfilled.

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Who Can Prescribe?

Doctors, dentists, vets, and collaborative prescribing practitioners are authorized to issue prescriptions.

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Dispensing Record

Dispensing of medication as per the prescription must be documented in a prescription register.

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CD Prescription Requirements

For controlled drugs prescriptions must include the number of installments and frequency, and the number of dosage units and total quantity in both words and figures.

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Prescription Requirements

Prescriber's signature, date, name/address; Patient's name/ID/contact; Medication name/quantity; Instructions; Dose; Refills; Dentist/Vet use.

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Prescriber Information

Name and address of the person authorized to prescribe the medicine.

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Patient Identification

The full name, identification number, and contact details of the individual receiving the medication.

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Medication Name

The complete name of the medication.

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Total Quantity

The total amount of medication to be dispensed to the patient.

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Instructions for Use

Specific directions on how the medication should be administered.

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Dosage

The amount of medication to be taken at each administration.

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Frequency of Dose

How often the medication should be taken.

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Repeat Scripts

Medication can be refilled, it must indicate the number of times and intervals.

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Repeat Dispensing Rule (No Interval)

If repeats are stated without an interval, do not dispense more than once every 3 days.

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Repeat Dispensing Rule (No Total)

If intervals are specified but no total repeats are given, do not dispense more than 3 times.

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Recording Repeat Dispensing

After dispensing a repeat, the pharmacist records the quantity supplied and remaining balance on the original prescription.

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Prescription Return Policy

The original prescription is returned to the customer unless it's the final repeat.

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Prescription Register

The pharmacist keeps a copy of the prescription in the prescription register for record-keeping.

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Final Repeat Retention

During the last repeat, the pharmacy retains the original prescription for their records.

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Partial Supply Defined

When a patient requests to purchase only a portion of the prescribed medication.

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Reasons for Partial Supply

Lack of funds or not wanting certain items are common reasons for requesting partial supply.

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Columns 'Supplied' and 'Balance'

The 'Supplied' and 'Balance' columns are used to log what has been dispensed.

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Date Supplied

The date supplied is recorded when medicine is supplied

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CD Prescription: Quantity

Dose, number of units, or quantity of Controlled Drugs (CDs) must be in both words and figures on a prescription.

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CD Prescription: Installments

For CDs, prescriptions allowing dispensing in installments must specify the number of installments and the intervals between them.

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CD Prescription: Handwriting

CD prescriptions should be written in the prescriber's own handwriting using ink.

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CD Prescription: Validity

CD prescriptions are valid for only 30 days from the date they were written.

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Checking a Prescription

Legal requirements include: prescriber's signature & address, date, patient's name & address, dose, frequency, duration/quantity, and repeats if needed.

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Register: Information Recorded

Details to record: dispensing date, Rx serial number, medicine ingredients/name, quantity, prescriber's details, patient's details and the date the prescription was issued.

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Full Supply

When all meds are given, the pharmacist keeps the prescription and mark that full supply

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Repeat Supply

Repeat supply is where patients can receive the same medicine a few times.

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Retaining Full Supply

If all medicines are dispensed, the pharmacist retains the prescription with an indication of 'full supply'.

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Study Notes

  • A prescription serves as a direction, usually written, from a prescriber to a pharmacist for preparing and dispensing a medicine or remedy.

Methods of Receiving Prescriptions

  • Prescriptions can come directly from the prescriber to the pharmacist via a patient's hardcopy
  • Prescriptions can come directly from the prescriber to the pharmacist orally through telephone
  • For oral prescriptions, the pharmacist must write it down and have it followed up by a doctor's signature later
  • Prescriptions can be transferred electronically, which is the latest method

Medication Orders (Inpatient Prescriptions)

  • Medication orders are used to supply medication to patients in institutional settings such as hospitals or nursing homes.
  • Regular reviews are needed since the patient's medication needs may change during their stay ("on" and "off").
  • Differences between a regular prescription and a medication order include:
    • Patient identification by room and bed number
    • No quantities specified
    • No refill
    • Required stop order policy
    • Order within the formulary
    • Drug presented in the institution
    • Possible therapeutic substitution

Prescription Components

  • A prescription should include:
    • Patient's name, address, and date of birth
    • Date the script was issued (valid for one year)
    • Drug name, strength, and dosage form
    • Directions for the pharmacist and patient
    • Refill information
    • Prescriber information and signature

Who Can Issue a Prescription?

  • Registered Medical Professionals in Singapore, including:
    • Registered doctors
    • Registered dentists
    • Registered veterinary surgeons
    • Registered Collaborative Prescribing Practitioners
    • APNs and pharmacists who have undergone a specific course
  • Must be written and signed by the prescriber
  • Must include the date of the prescription.
  • Must include the name and address of the prescriber.
  • Must include the patient's name, identification details, and contact information.
  • Requires the name and total quantity of the therapeutic product (or the duration).
  • Requires precise instructions for use.
  • Requires the appropriate dose.
  • Repeat scripts must indicate the number of times and the time between each repeat.
  • Dentists’ prescriptions are "for dental treatment only."
  • Veterinary surgeon prescriptions are "for animal treatment only."
  • Prescriptions are valid for one year from the date of issue.
  • The dose must be specified in words and figures.
  • The number of dosage units and total quantity must be specified in words and figures.
  • For prescriptions with a total quantity intended to be dispensed by installments, the direction to specify the number of installments, and also the intervals must be observed.
  • Must be written in ink by the prescriber's own handwriting.
  • CD prescriptions are valid for 30 days from the date of the prescription.

Checking a Prescription

  • It is important to verify these details before dispensing:
    • All the elements required for a prescription are present.
    • The signature and address of the prescriber.
    • The prescription date.
    • The patient's name and address.
    • The dose, frequency, duration/total quantity, and number of repeats if necessary.
    • The authenticity of the prescription, prescriber, and signature.
    • Whether the patient wants a partial supply.

Prescription Register

  • Keeping a prescription record is a legal necessity for tracking the dispensing of therapeutic products.
  • Records must be made the same or the next day that they are dispensed.
  • Information to record includes:
    • Date of dispensing
    • Serial number or other identification number
    • Ingredients or Proprietary name of medicine
    • Quantity supplied
    • Name and address of prescriber
    • Name and address of the person who got the prescription
    • Date on which the prescription was given

Recording Prescriptions in Different Situations

  • Full Supply: All medicines on the prescription have been dispensed, the pharmacist keeps the prescription and indicates full supply.
  • Repeat Supply: Prescription allows patients to receive the same medicine a few times
  • Partial Supply: Occurs when the patient requests only a portion of the prescribed medication
    • Possible Reasons:
      • Insufficient funds
      • Not wanting all items
      • Already having some of the items

Repeat Supply Specifics

  • If number of repeats is stated but no interval is specified, the prescription must be dispensed no more than once every three days.
  • If intervals are specified but number of dispensed times isn't specified, the prescription can't be given out more than three times.
  • After dispensing a repeat prescription, the pharmacist must note the quantity supplied and the balance on the prescription
  • The pharmacist keeps a copy of the prescription; if it's still valid for future use, it's returned to the customer
  • During the last repeat, the pharmacist keeps the original prescription and puts it in the prescription register.

Partial Supply Specifics

  • After dispensing a partial supply, the pharmacist will note on the prescription the amount given and the remaining balance.
  • If there is still a balance on the prescription, it gets given back to the customer
  • A copy of the prescription is retained and kept in the prescription register
  • After fully dispensing all drugs on the prescription, the pharmacist will retain the prescription and keep it in the prescription register

Summary

  • Prescriptions can only be issued by doctors, dentists, vets and collaborative prescribing practitioners.
  • Prescriptions are commonly written in Latin.
  • Knowing the Latin abbreviation for the common dosage forms, strength, instructions, times of the day & duration is very important
  • Legal requirements for CD prescriptions are similar to other prescriptions, but also require the number of instalments and frequency, number of dosage units in words and figures, and total quantity in words & figures
  • Dispensing the medication in the prescription is recorded in the prescription register
  • The hard copy of the prescription is kept once all the medication is dispensed
  • For prescriptions and partial supply of medication, the copy is kept after each dispensing, while the original won't be kept until after all of the medication has been dispensed

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Description

Explore legal and ethical pharmacy practices, including prescription validity, dispensing regulations in different settings, and ethical therapeutic substitutions. Learn about oral prescription protocols, liability for inaccurate records, and electronic transfer safeguards.

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