POMs 2024 PHA221 PDF

WEEK 10 MPharm Programme Prescription Only Medicines (POMs) John Sherwood MRPharmS 4th October 2024 Slide 1 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Lear...

WEEK 10 MPharm Programme Prescription Only Medicines (POMs) John Sherwood MRPharmS 4th October 2024 Slide 1 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Learning outcomes Give a definition for a POM and list three places where the legal classification may be found List the legal requirements for a prescription for a POM and list who is authorised to prescribe POMs List the details to be recorded in the POM register and describe when a record must be made Describe limitations on dentists prescribing POMs on an NHS prescription and on a private prescription Describe limitations of community nurses prescribing on an NHS prescription Explain issues surrounding the dispensing of faxed, forged, electronic and emailed prescriptions List the legal requirements for non-UK prescriptions and describe how they can be dispensed Describe how POMs can be lawfully administered and by whom Evaluate problems with prescriptions regarding legal requirements, resolve them and make the necessary records and correctly Slide 2 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Definition of a POM Legally defined as a medicine listed in the POM Order or if the medicine’s marketing authorisation lists the classification as POM ‘A person may not sell or supply a POM except in accordance with a prescription given by an appropriate practitioner’ (HMR Reg 214) There are some exceptions to this – i.e., when a POM may be legally supplied without a prescription: Patient Group Directions (see separate lecture) Emergency supplies (see separate lecture) Patient specific directions in hospitals (see later) A prescription is a ‘patient specific direction’ (PSD) No legal definition of a PSD but it is generally accepted to mean a written instruction from a prescriber for a medicine to be supplied or administered to a named patient after the prescriber has assessed the patient on an individual basis - this is the safest way to supply a POM Slide 3 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Legal requirements for prescriptions for POMs (1) Must be issued by an appropriate practitioner and a) Signed in ink by the appropriate practitioner giving it b) Written in ink or so otherwise to be indelible. NHS prescriptions, not for a CD in schedule 1,2 or 3, can be written by carbon paper or similar material c) Shall contain the following particulars: i. Address of the appropriate practitioner ii. The appropriate date iii. An indication of the kind of appropriate practitioner giving it iv. Name and address of the person for whose treatment it is given v. If the person is under 12, that person’s age Slide 4 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Legal requirements for prescriptions for POMs (2) d) Is valid for 6 months from the appropriate date e) The practitioner must be registered in the UK or be an approved health professional in an approved country Repeatable Prescriptions Repeatable prescriptions must be dispensed for the first time within 6 months of the appropriate date and in accordance with directions contained on the prescription Repeatable prescriptions that do not specify the number of repeats may be repeated only once, unless it is a prescription for an oral contraceptive, in which case it can be dispensed a total of six times (i.e., 5 repeats) or is not dispensed after the end of the period of 6 months from the appropriate date Slide 5 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Legal requirements for prescriptions for POMs (3) Additional considerations: There are additional requirements in the case of prescriptions for controlled drugs (see separate lecture) Medicines must be supplied fully to the patient within the legal validity of the prescription. So, if you are unable to supply the full quantity, an owing slip for the remainder should be given to the patient. The remainder of the supply must be collected by the patient within the legal validity of the prescription. The medicine must be dispensed exactly as it is written on the prescription in terms of form, strength, dose, frequency and quantity If a medicine is prescribed by brand name, only this branded product may be dispensed. A therapeutically equivalent generic product must not be dispensed. An alternative brand must not be dispensed. Slide 6 of 27 MPharm PHA221 Prescription Only Medicines (POMs)  Definition of WEEK 10 ‘Appropriate Practitioner’ Doctor (‘registered medical practitioner’) Dentist Community Practitioner Nurse Prescribers (see later) Supplementary prescribers (see separate lecture) Nurse independent prescriber Pharmacist independent prescriber Optometrist independent prescriber Physiotherapist independent prescriber Podiatrist independent prescriber Therapeutic Radiographer independent prescriber Paramedic independent prescriber Slide 7 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Some important meanings ‘An indication of the kind of appropriate practitioner giving it’ ‘The appropriate date’ – NHS prescription ‘The appropriate date’ – private prescription Post-dated prescription What information isn’t legally needed on a prescription? Name of practitioner (but……) Drug name, strength, dose and quantity Slide 8 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Mrs Una Well 4 Front Street Gosforth NE3 4NN Atorvastatin tablets 20mg 1 nocte I M Illegible 4.10.24 Dr I M Illegible The Practice 1 Front Street Gosforth NE3 4NN Slide 9 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Mrs Una Well 4 Front Street Gosforth NE3 4NN Atorvastatin tablets 20mg 1 nocte Mitte: 28 tablets I M Illegible 6.11.24 Dr I M Illegible The Practice 1 Front Street Gosforth NE3 4NN Slide 10 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Private Prescriptions Follow the same legal requirements as on slides 4 and 5 Can be written on anything (there is no template or form) Can be written by any ‘appropriate practitioner’ Date on private prescriptions is the date when it was signed Like any prescription, must be satisfied it’s genuine – how? No restrictions on what can be prescribed (so long as the prescriber is competent to do so) Note that all ‘overseas’ prescriptions (i.e. written by approved health professionals in an approved country) are private prescriptions Can be repeated (‘a repeatable prescription) Slide 11 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Repeat prescriptions What is the definition of a repeatable prescription? No repeats allowed on FP10 unless part of NHS Repeat Dispensing (see separate lecture) The number of repeats will be specified on the prescription (e.g., ‘repeat’, ‘repeat x 3’ etc) No legal limit on number of times a prescriber may request to be repeated What is the validity of a repeat prescription? Patients can retain the prescription between repeats – the pharmacy who supplies the final repeat must retain the prescription Repeatable prescriptions should be marked with the name and address of the pharmacy and date of dispensing to maintain an audit trail Do not confuse ‘repeat prescriptions’ with NHS Repeat Dispensing (see separate lecture) Instalment dispensing for addicts (see separate lecture) Patients ordering medicines which are on a ‘repeat list’ from their GP (as opposed to medicines which are ‘acutes’) Slide 12 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Prescribing by dentists FP10(D) prescription written by a dentist is valid only if the medicinal products ordered are in the Dental Practitioners’ Formulary (DPF) (list can be found in the BNF) It is against a dentists’ Terms of Service not to follow this It is against a pharmacists’ Terms of Service to dispense such a prescription DPF only includes generic names but dentists may prescribe a branded version of a generic in the DPF A private prescription written by a dentist can legally be for any POM, P or GSL medicine but….. Dentists are required by their registration body (GDC) to restrict their prescribing to areas in which they are competent, and this would therefore mean that a dentist should generally prescribe only medicines which have uses in dentistry Slide 13 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Prescribing by Community Practitioner Nurse Prescribers These are community nurses (District Nurses and Health Visitors) who have undertaken extra training Community nurse practitioners may prescribe a limited range of medicines on an NHS prescription FP10P The medicines are listed in the Nurse Prescribers’ Formulary for Community Practitioners (NPF) (found in BNF) Similar Terms of Service issue to dental prescriptions Prescribers are recommended to prescribe generically, except where this would not be clinically appropriate, or where there is no approved generic name Do not confuse these prescribers with nurse prescribers who are independent prescribers or supplementary prescribers (see separate lecture) Slide 14 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Electronic prescriptions (1) All the legal requirements for a POM must apply However, the ‘signature of the prescriber’ is the most problematic part because there is nothing physical to sign Electronic prescriptions must be signed with ‘an advanced electronic signature’ and sent electronically to the person who is dispensing it (whether through one or more intermediaries) The electronic signature must be uniquely linked to the signatory and to the data which it relates to in such a way that any subsequent change to the data is detectable (and changes made after signing should not be possible) All drugs (including controlled drugs in schedules 2 or 3) can legally be sent as electronic prescriptions Slide 15 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Electronic prescriptions (2) ‘Advanced electronic signature’ means Uniquely linked to the person giving the prescription Capable of identifying the signatory Created using means that the signatory can maintain under his/her control Linked to the data to which it relates in such a way that any subsequent change of the data is detectable NHS electronic prescriptions are sent from the prescriber to the pharmacy via the NHS spine The pharmacy prints out the electronic prescription on a ‘dispensing token’ Undispensed tokens or tokens containing any prescribing errors can be sent back to the NHS spine for cancellation by the GP Slide 16 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Prescription records (1) A record must be made of every supply of a POM unless: On a ‘health prescription’ or it is a Rx for an oral contraceptive or A separate record is made in the CD register or Wholesale dealing and the invoice (or a copy of it) is retained for two years (see wholesaling lecture for more details) Records may be kept: In a bound book (often called a ‘POM register’ or ‘Prescription Book’) Electronically, but with all particulars, adequate backups and a facility for inspectors to examine them without disrupting the dispensing process Even if exempt from legal requirement, still good practice to make a record (but not for every NHS prescription!) Hospital pharmacies only need to make such records if they are registered as a pharmacy with the GPhC Slide 17 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Prescription records (2) Entry must be made on same day as the sale or supply (or, if that is not reasonably practicable) the next following day Records must be kept for 2 years from date of the last entry in the book Prescription must be kept for 2 years from date of (last) supply or sale Details to be recorded: Date of sale or supply Name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength Date on prescription Name and address of practitioner giving the prescription Name and address of person for whom medicine prescribed Also need to give the entry a reference number and this is marked on the prescription and typed onto the dispensing label For second and subsequent supplies on a repeat, record date and original reference number of the first supply Slide 18 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Fate of a dispensed prescription NHS prescription Send to NHS Business Services Authority (NHSBSA), Prescription Services Division (PSD) at the end of the month Private prescription (non-repeatable) Keep at the pharmacy for 2 years Private prescription (repeatable) If there are still repeats outstanding, hand it back to patient or offer to retain at the pharmacy If the final repeat has been dispensed, keep it at the pharmacy for 2 years from the date of the final dispensing Slide 19 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Faxed prescriptions Since April 2020 the use of fax machines is no longer recommended in any NHS setting to transmit confidential information Not a legally valid prescription (not signed in ink by the prescriber) but can confirm that, at the time of receipt, a valid prescription is in existence (somewhere!) If dispensed, the pharmacist must ensure that the original prescription will be in his/her possession within a short period of time Dispensing a prescription against a fax is associated with several risks (see MEP) There are other ways which carry less risk that can be used to obtain a prescription medicine quickly (e.g., emergency supply, electronic prescriptions) Dispensing a controlled drug (schedules 2 and 3) from a fax is a criminal offence because this is dispensing a CD without a prescription being present in the pharmacy Slide 20 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Photos or emails of prescriptions With the existence of online and remote private GP services it is common for patients to receive a photo or email of their prescription after the consultation Some NHS online GP services may provide the patient with a photo or digital copy of the prescription in their app This is useful for the patient in confirming what has been prescribed and for showing to any healthcare professional involved in their care These are not legally valid prescriptions for the same reason as for faxes Printing out the photo or email of the prescription is rather like the printed fax – the printed document is not the original, legal copy They should not be considered as legal prescriptions for dispensing purposes Slide 21 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Forged prescriptions Pharmacists need to be alert to the possibility of receiving a forged prescription Dispensing a prescription which you know to be a forgery is a criminal offence But this is not the case ‘provided the pharmacist has exercised all due diligence and believes on reasonable grounds that the prescription is genuine’ (this is called the ‘due diligence clause’) The RPS have given some advice on factors which may indicate a prescription is a forgery (see MEP) Altering details on a prescription is fraud and the NHS Counter Fraud Service, and possibly the police, should be contacted The prescriber should also be informed of any alteration to a prescription that they have issued Slide 22 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Non-UK prescriptions (1) Prescriptions issued by approved health professionals in an approved country are legally recognised in the UK Approved health professionals include doctors and dentists as well as other professions with prescribing rights in their own country (which could be chiropodists or podiatrists, nurses (including community nurses), optometrists, paramedics, pharmacist, physiotherapists and therapeutic radiographers) Approved countries include EEA countries (full list in MEP) and Switzerland Note that in the future the list of ‘approved health professionals’ may increase, as may the number of countries included on the ‘approved countries’ list The MHRA publishes the lists of ‘approved countries’ and ‘approved health professionals’ Note that non-UK prescriptions which do not comply with the above (i.e., from a country or prescriber not on the allowed list) must not be dispensed and the patient should be advised on other routes to access their medicines Slide 23 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Non-UK prescriptions (2) Legal requirements for these prescriptions are: Patients full first name(s), surname and date of birth Prescriber’s full first name(s), surname, professional qualifications, direct contact details, including email address and telephone number or fax number (with international prefix), work address (including the country they work in) Name of medicine(s) (brand name where appropriate), pharmaceutical form, quantity, strength and dosage details Prescriber’s signature Date of issue Controlled drugs in schedules 1, 2 and 3, and products without a UK marketing authorisation may not be prescribed Slide 24 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Non-UK prescriptions (3) Caution is needed with these prescriptions because Likely to be written in a foreign language (this is legally ok but understanding it may be difficult) Need to check the registration status of the prescriber and there is no international database of prescribers You still need to check if is clinically safe to dispense the prescriptions (as with any prescription) A ‘due diligence’ defence exists for these prescriptions if you are unable to confirm the registration status Note that it is not obligatory to dispense such a prescription if you have any doubts or concerns - these could be related to legality or clinical appropriateness If you are unable to dispense then you need to consider how you can help the patient to obtain the medication that they need Slide 25 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Administration of a POM Unlawful to administer a parenteral POM other than to yourself unless you are an appropriate practitioner or you are acting in accordance with the directions of an appropriate practitioner However, certain injectable products are exempt from this restriction when administered for the purpose of saving life in an emergency, e.g., adrenaline (epinephrine) injection, glucagon injection etc Smallpox vaccine is exempt under certain conditions Some specific classes of persons are exempt (e.g., midwives, paramedics) for specified POMs under certain conditions Certain healthcare professionals can also administer medicines in accordance with a Patient Group Direction (see separate lecture) There are no legal restrictions on the administration of non-parenteral POMs but organisations should have policies covering this Additional notes for the administration of POMs in hospitals (see MEP) Slide 26 of 27 MPharm PHA221 Prescription Only Medicines (POMs) WEEK 10 Prescribing POMs in hospitals for inpatients In a hospital ward, a written direction (PSD) of a doctor or other independent prescriber is usually found on an inpatient chart The law does not specify what should be included on a PSD Most entries on inpatient charts are directions to administer but can be taken as authority to supply, which can be transposed onto an order form to be used in the pharmacy for take home medication for discharge PSDs do not need to comply with prescription requirements for this to occur Good practice for this transposition to be made by a pharmacist or checked by a pharmacist Pharmacist is not prescribing as the original written direction was done by a practitioner Further information, see MEP Slide 27 of 27 MPharm PHA221 Prescription Only Medicines (POMs)