Wk 25 Intro to POMs.pdf

WEEK 25 Prescription Only Medicines (POMs) Susan Gault Dale 121 [email protected] Slide 1 PHA113 MPharm WEEK 25 Learning Outcomes On completion of this lecture you should be able to: • Give a definition for a POM and list three places where the legal classification may be found...

WEEK 25 Prescription Only Medicines (POMs) Susan Gault Dale 121 [email protected] Slide 1 PHA113 MPharm WEEK 25 Learning Outcomes On completion of this lecture you should be able to: • 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 • Explain issues surrounding the dispensing of forged, electronic and emailed prescription • Evaluate problems with prescriptions regarding legal requirements and make the necessary records 2 PHA113 MPharm WEEK 25 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 Rx: • Patient Group Directions • Emergency supplies • 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 PHA113 MPharm WEEK 25 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 was in schedule 1,2 or 3,in canyour be written by carbon paper or similar This covered week 17 recorded material lecture…… c) Shall contain the following particulars: i. ii. iii. iv. v. Address of the appropriate practitioner The appropriate date An indication of the kind of appropriate practitioner giving it Name and address of the person for whose treatment it is given If the person is under 12, that person’s age 3 minutes to discuss with your friends what the legal requirements are…… d) e) Slide 4 Is valid for 6 months from the appropriate date The practitioner must be registered in the UK or be an approved health professional in an approved country PHA113 MPharm WEEK 25 Legal requirements for prescriptions for POMs (2) 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) Slide 5 PHA113 MPharm WEEK 25 Legal requirements for prescriptions for POMs (3) Additional considerations: • There are additional requirements in the case of prescriptions for controlled drugs • Medicines must be supplied fully to the patient within the legal validity of the prescription. • 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 Rx in term 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 PHA113 MPharm WEEK 25 Definition of ‘Appropriate Practitioner’ • • • • • • • • • • • Slide 7 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 PHA113 MPharm WEEK 25 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 8 PHA113 MPharm WEEK 25 Electronic Prescriptions (2) • ‘Advanced electronic signature’ means i. Uniquely linked to the person giving the Rx ii. Capable of identifying the signatory iii. Created using means that the signatory can maintain under his/her control iv. 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 9 PHA113 MPharm WEEK 25 Private Prescriptions • • • • • • • • Slide 10 Follow the same legal requirements as on slides 4 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 Rx must be satisfied it’s genuine – how? No restrictions on what can be prescribed (so long as the prescriber is competent to do so) All prescriptions written by approved health professionals in an approved country are private prescriptions Can be repeated (a ‘repeatable’ prescription) PHA113 MPharm WEEK 25 Repeat prescriptions • • • • • • • • Slide 11 What is the definition of a repeatable prescription? No repeats allowed on FP10 unless part of NHS Repeat Dispensing 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 • Instalment dispensing for addicts • Patients ordering medicines which are on a ‘repeat list’ from their GP (as opposed to medicines which are ‘acutes’) PHA113 MPharm WEEK 25 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 12 PHA113 MPharm WEEK 25 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 • Rx 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 Rx • Name and address of practitioner giving the Rx • Name and address of person for whom medicine prescribed • Also need to give the entry a reference number and this is marked on the Rx 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 13 PHA113 MPharm WEEK 25 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 Rx back to patient or offer to retain at the pharmacy • If the final repeat has been dispensed, keep at the pharmacy for 2 years from the date of the final dispensing Slide 14 PHA113 MPharm WEEK 25 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 still not a legal prescription you require the signed original copy • They should not be considered as legal prescriptions for dispensing purposes Slide 15 PHA113 MPharm WEEK 25 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 Rx 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 16 PHA113 MPharm WEEK 25 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 17 PHA113 MPharm WEEK 25 18 PHA113 MPharm