NPA

STANDARD OPERATING PROCEDURE

The Safe and Effective Supply of Medicinal Products

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STANDARD OPERATING PROCEDURE

The Safe and Effective Supply of Medicinal Products

This SOP has been designed to be used in a working pharmacy environment however we recommend that the SOP is tailored to reflect processes in your pharmacy where appropriate. Changes should be considered carefully as some processes are based on legislative or good practice requirements, and if deemed necessary should be amended following the procedures detailed in the NPA SOP: Review and Notification of Standard Operating Procedures.

SCOPE

This SOP does not apply to repeat dispensing services in England and Wales. A separate NPA SOP exists for this purpose entitled Standard Operating Procedure for repeat dispensing services.

This SOP does not apply to the supply of prescribed medicines in a compliance aid. A separate NPA SOP exists for this purpose entitled Standard Operating Procedure for supplying prescribed medicines in a compliance aid.

Further relevant information is available for the supply of anticoagulant therapy, opioid medicines, oral anti-cancer medicines, oral methotrexate and paraffin based skin products within our range of NPA SOPs based on National Patient Safety Agency guidance.

PROCEDURE

P1Taking in a prescription

Authorised pharmacy staff

  • Greet the customer
  • Receive prescription
  • Check whether the customer presenting is the patient or a representative
  • Confirmpatient details
  • Name
  • Address
  • Age or date of birth
  • Clarify unclear details where necessary with the customer
  • For NHS prescriptions ensure that the reverse of the prescription has been completed and the declaration signed where necessary.
  • Where applicable confirm exemption status
  • Where no evidence of exemption is presented place a cross in the Pharmacy Use Only box on the reverse of the prescription
  • Where applicable calculate the appropriate NHS prescription charge(s). (At the time of writing NHS prescriptions charges do not apply in Wales and are due to be phased out in Northern Ireland and Scotland)
  • For private prescriptions – advise that the charge will need to be calculated.
  • Check with the dispensary staff how long it will take to calculate this charge (Depending upon the workload of the dispensary team this may be immediate or may require a period of time to produce)
  • Complete a prescription receipt docket and offer to charge the customer where the charge is known.Indicate payment status and whether or not the customer is waiting or calling back
  • Where the patient asks to speak to the pharmacist, indicate this on the prescription or docket
  • Attach the appropriate section of the prescription receipt docket to the prescription
  • Give the appropriate prescription receipt docket stub to the customer
  • Transfer the prescription to the dispensary team and check on an approximate waiting time
  • Advise customer on approximate waiting time

P2Legal and clinical assessment

Pharmacist only

  • Check that the prescription complies with legal requirements being particularly careful with controlled drug prescriptions and prescriptions written by an EEA doctor or dentist not registered in the UK. (If in doubt refer to the latest edition of the MEP or call NPA Information on 01727 891800)
  • Take into account the following factors where thought to be significant and assess the prescription for clinical appropriateness:
  • Age of patient
  • Sex of patient
  • Weight of patient
  • Pregnant or breastfeeding?
  • Relevant clinical condition
  • Patient Medication Record (PMR)
  • Interactions with other drugs, foods, supplements or disease states
  • Dose and dose changes
  • Strength and strength changes
  • Formulation
  • Route of administration
  • Contra-indications
  • New medicines
  • Where in your professional judgement the prescription may not be clinically appropriate take steps to obtain additional information in order to come to a final decision. Consider:
  • Discussing issues with the prescriber
  • Discussing issues with the patient
  • Checking appropriate reference materials(e.g. BNF, Martindale, Stockley’s Interactions etc)
  • Where an intervention or referral is required – complete a Pharmacy Referral & Intervention form and give two copies to the patient (one for the doctor) and leave the 3rd copy within the pharmacy. (This applies to England and Wales where evidence of intervention is a contractual requirement. Optional in Scotland and Northern Ireland)
  • Where in your professional judgement, your final decision is that the prescription is not legally valid and/or clinically appropriate then inform the patient or representative of the decision and the rationale and refer them back to the prescriber or liaise with the prescriber directly.
  • Where in your professional judgement, your final decision is that the prescription IS legally valid and clinically appropriate then prepare and attach any appropriate notes for the patient or relevant alert sticker.

P2 Legal and clinical assessment - continued

Pharmacist only

  • Where an Accredited Checking Technician (ACT) is responsible for accuracy checking - discreetly mark the prescription on the upper left hand corner to indicate that the prescription has been clinically assessed and initial the annotation.

NBFurther relevant information is available for the supply of anticoagulant therapy, opioid medicines, oral anti-cancer medicines, oral methotrexate and paraffin based skin products within ourrange of NPA SOPs based on National Patient Safety Agency guidance.

P3 Assembling a prescription

Authorised dispensary staff

  • Using the actual prescription as a reference carefully gather the medicines, checking the name, strength, formulation and quantity for each item and place into a dispensing basket.
  • Assemble the correct quantity, or volume of medicine required. This may require cutting blister packaging, counting loose tablets or capsules or measuring the correct volume of liquids.

NEW OWINGS

  • Where there is insufficient stock to fill the prescription – inform the patient and ask the patient or representativeif they will return when the prescription is complete or if they intendto take what is available and an owing ticket for the remainder or if they will be taking their prescription elsewhere.
  • If the patient or representative wishes to take their prescription elsewhere then politely return the prescription and request the return of prescription receipt docket stub. (If the patient has lost the prescription receipt docket stub then make a note that the prescription was returned to the patient on the PMR.)
  • If the patient is returning when the prescriptions is complete, order the stock required following the procedure outlined in the NPA SOP The safe and effective ordering of medicines and proceed to P4.
  • If the patient is chooses to take what is available and an owing ticket for the remainder, order the stock required following the procedure outlined in the NPA SOP The safe and effective ordering of medicinesand proceed to “assembling existing owings” below.

P3 Assembling a prescription - continued

Authorised dispensary staff

ASSEMBLING EXISTING OWINGS

  • Following receipt of stock of medicines owed locate the prescription and “owing note”. This is located ______.
  • Using the actual prescription as a reference carefully gather the medicines, checking the name, strength, formulation and quantity for each item and place into a dispensing basket.
  • Assess whether it is appropriate to label, check and bag the item(s) now or whether it would be best to wait for the patient to return for the balance. (Some medicines have a short expiry upon reconstitution).

P4Labelling and dispensing prescription

Authorised dispensary staff

  • The software manual for the patient medication record (PMR) system can be accessed ______

Or electronically by:

______

  • Check patient has a PMR record, carefully cross checking address and date of birth to ensure that the correct patient is selected. If the patient does not have a PMR then create a PMR following the instructions within the software manual.
  • Where available, read any patient notes which have been entered into the system
  • Generate labels in accordance with the instructions on page _____ of the software manual.
  • Where there areexisting owings to process – generate dispensing labels in accordance with the instructions on page _____ of the software manual.

P4Labelling and dispensing prescription - continued

Authorised dispensary staff

  • If you are generating labels using the existing PMR check that the following have not changed against the prescription for each medicine, and where they have amend as applicable:
  • Dose
  • Strength
  • Quantity
  • Where the prescription is for an animal ensure that any labelling required for a veterinary prescription is included on the label. Refer to the latest edition of the Medicines Ethics and Practice (MEP) for the latest legal requirements.
  • Peel off one label at a time and carefully apply to the assembled appropriate medicinal product checking the name, strength, formulation and quantity..
  • Apply the label to the space deliberately designed by the manufacturer for this purpose otherwise apply to the medicinal product being wary not to cover up the name or strength or other important information.
  • Initial the “Dispensed” box on the label

NEW OWINGS

  • Where there are new owings – generate owings labels in accordance with the instructions on page ______of the software manual.
  • Attach a copy of the owings label to the patient copy of the tear out owing note from the NPA Prescription Remainder Owing Book and keep this with the docket or prescription ready for the patient.
  • Attach another copy of the owings label to the pharmacy copy of the owing note

P5Checking and bagging a prescription

Pharmacist OR accuracy checking technician

  • Read the whole prescription.
  • Check each item individually in the order that it appears on the prescription
  • For multiple packs or labels ensure that each pack is checked
  • Cross check the labels(s) and medicinal products(s) against the prescription (and not each other) for:(In some circumstances not all the fields of information will apply e.g. appliances)
  • Name of the medicine(Be careful with drug names which are spelt or sound similar)
  • Strength of the product(Be careful with the units e.g. mg and mcg)
  • Formulation of the product
  • Quantity of the product (A physical inspection of the actual quantity of the product should be conducted wherever reasonably possible for unsealed solid formulations – for Controlled Drugs the quantity mustbe checked)
  • Check the label(s) against the prescription, for:
  • Name of the patient
  • Dosage instructions
  • Also check that:
  • A patient information leaflet (PIL) is included for each medicinal product including those dispensed from bulk packs.
  • For medicines which were dispensed from bulk packs – visually check that the contents of the stock pack match the contents of the dispensed medicinal product.
  • Check the expiry date on each of the patient packs or the stock pack.
  • The appropriate warnings from the BNF appear on the label. (This is particularly important where labels have been manually generated – usually the warning labels are automatically and correctly generated by the programme)

P5Checking and bagging a prescription - continued

Pharmacist OR accuracy checking technician

  • Where the check has revealed an error – alert the colleague who dispensed the medicines to the error and make an entry into the near miss log. Correct the error.
  • Following the successful completion of the accuracy check – initial the “checked box” on the dispensing label.
  • Once all items on the prescription have been checked – separate fridge items and CDs subject to safe custody (schedule 2 and some schedule 3 CDs).
  • Place the items into the appropriately sized bags ensuring that stock packs are not placed into the patient’s bag. Bag fridge items, and CDs separately.
  • For liquid formulations add an appropriate plastic spoon or oral syringe.
  • Seal the bag(s) with a bag label for easy identification.
  • Where the patient is waiting for the prescription – hand out the prescription following the procedure P6.
  • Where the patient is calling back or no longer present.
  • Attach the prescription, docket, and any owings slips or notes to the main bag.
  • Attach an appropriate prescription alert sticker to the main bagwhere any of the following apply.
  • The pharmacist wishes to speak to the patient and handover the medicines personally
  • An additional controlled drug accompanies the sealed bag
  • A fridge item accompanies the sealed bag
  • A prescription charge is still due
  • The customer is a suitable candidate for a Medicines Use Review (MUR) (England and Wales only)
  • Store sealed fridge item bags in the fridge.
  • Give sealed CD item bags to the pharmacist to store in the CD cupboard
  • Store the main package in the appropriate collection area.

P5Checking and bagging a prescription - continued

Pharmacist OR accuracy checking technician

NEW OWINGS

In addition to the procedure outlined above:

  • Ensure that where there are owings an “owing note” has been attached to package ready to be given to the patient.
  • Calculate when the owing needs to be collected by and write this date onto both the patient and pharmacy copy of the “owing note” (6 months from the appropriate date on the prescription or 28 days from appropriate date for a schedule 2, 3 or 5 controlled drug – if unsure refer to pharmacist)

P6Giving out a prescription

Authorised pharmacy staff

  • Greet the customer or representative or where a customer has been waiting call out the patient’s name or docket number when the items have been checked and are ready.
  • Request the prescription receipt stubwhere this is not available:
  • Check whether the customer is the patient or a representative
  • Ask the customer for the first name and surname for the patient
  • Where the customer is collecting an owing – ask for the “owing note”
  • Where the customer has lost their “owing note” ask for the name and address of the patient and check the PMR and the pharmacy copy of the “owing note” and the prescription to confirm that the medicine is still owing. Make a note in the PMR to indicate that the date and time that the owing was collected.
  • Locate the correct bag by checking the number on the docket stub/owing note against the docket number on the sealed bag or where this is missing by checking the customer’s first name and surname against the details on the sealed bag.
  • Check the sealed bag for any prescription alert stickers or notes which might indicate that:
  • The pharmacist wishes to speak to the patient and handover the medicines personally
  • An additional controlled drug accompanies the sealed bag
  • A fridge item accompanies the sealed bag
  • A prescription charge is still due
  • The customer is a suitable candidate for a Medicines Use Review (MUR) (England and Wales only)

P6Giving out a prescription

Authorised pharmacy staff

  • Follow up on any actions required by the prescription alert stickers including charging the customer for the medicines where applicable. Where a controlled drug is required – speak to the pharmacist in charge of the CD key to obtain this.
  • Cross check the patient’s first name and surname and address against the details on the docket stub, the prescription and each bagged medicine package.
  • Check that the prescription is still legally “in date” – prescriptions are generally valid for 6 months from the appropriate date or 28 days for prescriptions for controlled drugs in schedule 2, 3 and 4.(Where in doubt – refer to the pharmacist)
  • Detach the prescription and the prescription dockets/owing note from the bagged medicines and return to the dispensary staff.
  • Confirm the patient’s first name, and surname and address before handing over to the customer.
  • Check if the customer has any questions about their medicines. If so follow the procedures outlined in the NPA SOP Provision of advice by pharmacy staff who are not pharmacists referring to the pharmacist where appropriate.
  • Remind the dispensary staff or pharmacist about any appropriate records that may need to be made – for private prescriptions an entry into the Prescription Only Medicines Register and for controlled drugs an entry into the CD register.

NEW OWINGS

  • Explain that some medicine is owed to the patient and be clear about the reason for this.
  • Where there is a stock shortage – explain when it is anticipated further supplies will be available.
  • If there are clinical or pharmaceutical reasons (such as reconstitution and expiry) – explain when the customer should return for the final supply.
  • File the prescription in the designated place for owing prescriptions. This is located ______.
  • Check the date by which the owing must be collected (as indicated on the owing note) and explain this to the patient or representative.
  • Give the “owing note” to the person collecting the medicines and explain it is important to present the note when collecting the balance.

P7Emergency Supply – Practitioner Request

Pharmacist only

  • Check that the practitioner is either a doctor, a dentist, a supplementary prescriber, a community practitioner nurse prescriber, a nurse independent prescriber, an optometrist independent prescriber, a pharmacist independent prescriber, an EEA or Swiss doctor, or an EEA or Swiss dentist.
  • Confirm and be satisfied that you are speaking directly to the practitioner
  • Where the practitioner is not known to you or where the surgery is not known to the pharmacy then due diligence to check that the practitioner is genuine may be required.(This may involve checking registration status with the appropriate regulatory body)
  • Obtain an assurance that the practitioner will supply the pharmacy with a prescription within 72 hours.
  • Interview the practitioner and ask for and record the following details
  • The name of the medicine
  • The formulation of the medicine,
  • The strength of the medicine
  • The quantity of the medicine
  • The name and address of the practitioner
  • The name and address of the patient
  • The date on the prescription
  • Assess whether or not the individual practitioner can legally and professionally prescribe the item taking into account:
  • Qualification of the practitioner
  • Controlled drugs in ANY schedule (1,2,3,4 or 5) cannot be prescribed by an EEA or Swiss doctor or dentist.
  • Medicines without a UK market authorisation cannot be prescribed by an EEA or Swiss doctor or dentist
  • Controlled drugs in schedule 1, 2 and 3 cannot be prescribed by any practitioner except for phenobarbitone or phenobarbitone sodium for treating epilepsy and prescribed by
  • A UK doctor
  • A UK dentist
  • A UK supplementary prescriber
  • Where the prescriber requests an item which they cannot legally authorise consider
  • Whether a clinically appropriate substitute can be prescribed instead
  • Whether referral is required to a different category of prescriber
  • Where it is possible for a physical prescription to be obtained

P7 Emergency Supply – Practitioner Request - continued