Sale and Supply of Medicines - POMs - OSPAP MPHM15 - 2024 PDF

WEEK 10 11 Sale and supply of medicines – Part 3 Prescription Only Medicines (POMs) John Sherwood MRPharmS 2/9th October 2024 Slide 1 of 65 OSPAP MPHM15 Sale and supply of...

WEEK 10 11 Sale and supply of medicines – Part 3 Prescription Only Medicines (POMs) John Sherwood MRPharmS 2/9th October 2024 Slide 1 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 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 Describe how POMs can be lawfully administered and by whom List the legal requirements for a prescription for a POM List the details to be recorded in the POM register and describe when a record has to 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 and forged prescriptions, including photos or emails of prescriptions Explain how it is legally permissible to dispense a different quantity to that ordered on a prescription, and give examples when this should not be done Explain ‘hub and spoke’ dispensing and how the law applies to this arrangement Describe the legal defence that may be used for dispensing errors Explain what ‘serious shortage protocols’ are and when they can be used Describe the concerns that the GPhC has regarding supply of medicines from internet (online) pharmacies Describe the use of PCUs and know which medicines may not be suitable for these Slide 2 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Essential Reference Source Slide 3 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Definition of a POM A medicine listed in the POM Order or a medicine where the marketing authorisation lists the classification as POM Working definition: A medicinal product which may only be sold or supplied in accordance with a prescription signed by an appropriate practitioner A prescription can be called a ‘patient specific direction’ (PSD) No legal definition of 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 ‘A person may not sell or supply a POM except in accordance with a prescription given by an appropriate practitioner’ (HMR Reg 214) However, there are some exceptions to 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) Dispensing an NHS prescription for a POM is a supply but dispensing a private prescription for a POM is a sale Slide 4 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Some products are always POM Some examples are: Parenteral products CDs, unless the marketing authorisation of the product lists it as a P or GSL Cyanogenic substances, unless for external use Medicinal substances that on administration emit radiation New chemical entities Slide 5 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 DISPENSING PRESCRIPTIONS FOR POMS Slide 6 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Legal requirements for prescriptions for POMs (1) Must be issued by the appropriate practitioner and a) Be signed in ink by the appropriate practitioner giving it b) Written in ink or so otherwise be indelible. NHS prescriptions, not for 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 that person is under 12, that person’s age Slide 7 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 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 8 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Legal requirements for prescriptions for POMs (3) Additional considerations There are additional requirements if the prescription is for a controlled drug (see separate lecture) Repeats of any kind are not allowed on normal NHS prescriptions (except on the NHS repeat dispensing schemes – see separate lecture) Medicines must be supplied within a certain period from the appropriate date and this also applies to ‘owings’ i.e., the full quantity of medicine must be supplied within the legally valid period of the prescription Slide 9 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs  Definition of WEEK 10 11 ‘Appropriate Practitioner’ Doctor (‘registered medical practitioner’)* Dentist Community Practitioner Nurse Prescribers (see later) Supplementary prescribers Nurse independent prescribers Pharmacist independent prescribers Optometrist independent prescribers Physiotherapist independent prescriber Podiatrist independent prescriber Therapeutic radiographer independent prescriber Paramedic independent prescriber * Note that doctors must be registered with the GMC and have a license to practise issued by the GMC Slide 10 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Some important points ‘An indication of the kind of practitioner giving it’ – meaning? Dates The appropriate date on an NHS prescription The appropriate date on a private prescription Post-dated prescriptions Name of practitioner not needed, but….. Slide 11 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Mrs Una Well 4 Front Street 1.1.57 Gosforth NE3 4NN Ramipril capsules (28) 1 od I M Illegible 2.10.24 Dr I M Illegible The Practice 1 Front Street Gosforth NE3 4NN Slide 12 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 What else do you need to know? To dispense a prescription you also need to know Name of drug Strength Form Dose Frequency Quantity Slide 13 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Mrs Una Well 4 Front Street 1.1.57 Gosforth NE3 4NN Ramipril capsules 10mg 1 od I M Illegible 15.10.24 Dr I M Illegible The Practice 1 Front Street Gosforth NE3 4NN Slide 14 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Private prescriptions Follow the same legal requirements as on slides 7 and 8 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 you 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) Slide 15 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Repeatable prescriptions Definition of a repeatable prescription No repeats allowed on FP10 unless part of the NHS Repeat Dispensing scheme Number of repeats and ‘repeat’ No legal limit on number of times a prescriber may request to be repeated There is no expiry of a repeat prescription after it has been dispensed for the first time but professional judgement should be used, considering clinical issues Patients can retain the prescription between repeats – the pharmacy who dispenses the prescription for the final time 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 ‘NHS Repeat Dispensing’ lecture) Instalment dispensing for addicts (see ‘Controlled Drugs’ lecture) Patients ordering medicines which are on a ‘repeat’ list from their GP (as opposed to those on which are considered as ‘acute’ medicines) Slide 16 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Prescribing by dentists FP10(D) prescription (yellow) 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 17 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Prescribing by Community Practitioner Nurse Prescribers These are community nurses (District Nurses and Health Visitors) who have undertaken extra training Community nurse prescribers may prescribe a limited range of medicines on an NHS prescription FP10P (lilac) The medicines are listed in the Nurse Prescribers’ Formulary for Community Practitioners (NPF) (found in BNF) Same 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 18 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Electronic prescriptions (1) All the legal requirements for a POM must apply Must be signed by an appropriate practitioner – but this is the problematic part because there is nothing physical to sign 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 19 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 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 to the pharmacy from the GP surgery via the NHS spine Electronic prescriptions are printed out in the pharmacy are known as ‘dispensing tokens’ Pharmacies print out the tokens on special stationary (FP10DT) which is supplied by the NHS Undispensed tokens or tokens containing any prescribing errors can be sent back to the NHS spine for cancellation by the GP Slide 20 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 Some practical considerations when 11 dispensing prescriptions 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. You must supply exactly what the prescriber has requested (form, strength)(unless a serious shortage protocol is in place (see later slide). You can supply a different quantity (see next slide) If you are unable to supply the full quantity, an owing slip for the remainder should be given to the patient (remember that the remainder of the supply must be collected by the patient within the validity of the prescription) Slide 21 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Original Pack Dispensing (OPD) A future change in the law (due to start on 1st January 2025) will allow pharmacists to supply a drug in its ‘original outer packaging’ (‘original pack’) even if the quantity dispensed is a different quantity to that on the prescription The quantity of the drug dispensed must be within 10% (above or below) of the quantity on the prescription Only applies to EPS NHS prescriptions and private prescriptions. Does NOT apply to supplies under a SSP and non-prescription supplies Does not apply to CDs in schedules 2-4 and Specials This legislation is enabling and not mandatory The pharmacist must believe that providing a different quantity to that prescribed is ‘reasonable and appropriate’ and will not cause the patient to fail to follow ‘the medication regimen as intended by the prescriber’ (e.g., antibiotics, steroids) This will end a lot of the ‘blister cutting’ and repackaging of medicines – saves time for the pharmacy team Slide 22 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Mrs Una Well 4 Front Street 1.1.57 Gosforth NE3 4NN Levothyroxine 100mcg 1 mane 60 tablets I M Illegible 2.10.24 Dr I M Illegible The Practice 1 Front Street Gosforth NE3 4NN Slide 23 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Dispensing valproate-containing medicines Valproate-containing medicines are sodium valproate, valproic acid and valproate semisodium Exposure of an unborn baby to valproate during pregnancy is associated with a high risk of congenital malformations (11%) and neurodevelopmental disorder (30-40%) which may lead to permanent disability Note that valproate use in men who father a child has also been associated with an increased risk of neurodevelopment disorders in the child A change in the law (in October 2023) now requires that only full packs of valproate- containing medicines can be supplied to patients. These medicines must NOT be re-packaged or packs split This applies to all prescriptions (i.e., NHS and private) for men and women Patients should be supplied with the nearest quantity to that prescribed on the prescription, that can be dispensed with using complete pack(s) Supplying complete packs ensures that the patient sees the warnings on the box (in relation to risks to the unborn child) and always has a PIL and a patient card Rare exceptions to this would include supplies in MDS. For these exceptions, a risk assessment must be in place and the patient should be supplied with a PIL When labelling the packs be careful not to cover any patient safety warnings printed by the manufacturer on the pack See pharmacy poster here: https://mhra-gov.filecamp.com/s/i/dr66W7LuRQ3pY7u5 Slide 24 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 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 25 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 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 26 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Non-UK prescriptions (3) Caution is needed with these prescriptions because Prescription 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 27 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Prescription records (1) A record must be made of every supply of a POM unless: On a ‘health prescription’ or it is a prescription for an oral contraceptive or A separate record is made in the CD register or Wholesale dealing and the order or invoice (or a copy of it) is retained for two years Records may be kept: In a bound book (called the ‘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 GPhC Slide 28 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Prescription records (2) Entry must be made on same day as sale or supply (or, if that is not reasonably practicable) the following day Records must be kept for 2 years from date of the last entry in the record 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 of the POM supplied Date on prescription Name and address of practitioner giving the precsription 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 29 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Fate of a dispensed prescription NHS prescription Send to NHS Business Services Authority (NHSBSA), Prescription Services Division 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 prescription 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 30 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 HUB AND SPOKE DISPENSING Slide 31 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Dispensing Prescriptions Dispensing a prescription involves several different steps (including receipt of prescription, legal check, clinical check, assembly, label generation, accuracy check and handing out to a patient) usually undertaken in ONE pharmacy In a ‘hub and spoke’ model some of these processes are done in the hub pharmacy but the prescription goes to the hub pharmacy via the spoke pharmacy Currently the dispensing of a prescription and supply to a patient can only be done by pharmacies in the same retail business – the law specifically requires this Therefore, only ‘chain’ pharmacies can use this model 2 proposed models: In both cases the prescription is handed into the spoke, then sent to the hub then hub sends meds to spoke, spoke supplies pt hub supplies patient (via post or delivery) The hub must still be registered as a pharmacy with the GPhC (although it does not need an NHS contract to dispense NHS prescriptions) Note that this is not dispensing from a Distance Selling (internet) Pharmacy where the pharmacy receives the prescription direct from the prescriber Slide 32 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Slide 33 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Advantages of dispensing from a hub Better efficiency Lower operating costs (although initial set up costs may be high) Free up pharmacist time at the spoke pharmacy to do other clinical activities Use of automation in the hub (e.g. dispensing robots) can lead to reduced errors, safer dispensing and cheaper – but hubs are not under any obligation to use automated dispensing systems (e.g., dispensing robots) Slide 34 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Disadvantages of dispensing from a hub There are concerns about accountability and liability (*) Legally, the responsibility for the dispensing of the prescription is thought to rest with the pharmacist who supplies the medicine to the patient – there has been no case law to test this Some have suggested that the clinical check is the responsibility of the spoke and the accuracy check is the responsibility of the hub Operational failure in a hub could have serious consequences for patients Confidentiality and security of information is more complicated (*) Could it affect the patient/pharmacy relationship (especially if the hub supplies the medicine to the patient directly) Not suitable if the patient needs the medicine quickly/urgently Points marked (*) are likely to be more complicated if two different pharmacy companies are involved in the dispensing of a prescription Slide 35 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 What is the situation now? The Medicines and Medical Devices Act 2021, which includes a section relating to hub and spoke dispensing, became law on 11/2/21 This Act allows the Government to make changes (which are due to be made by January 2025) to allow the wider use of hub and spoke dispensing, allowing more than one pharmacy company to be involved in the dispensing of a prescription These proposed changes will allow larger pharmacy chains who own a hub pharmacy to sell this service to independent pharmacies or would allow new companies to set up hub pharmacies and market their service to any pharmacy This will ‘level the playing field’ between independent pharmacies and chain pharmacies so the former can make use of hub pharmacies The situation regarding liability for any errors is still unclear There is no guidance on what roles should be undertaken at the hub or spoke Which pharmacy address should appear on the dispensing label? Proposal is either hub or spoke but not both Spoke pharmacy must ‘conspicuously display’ a notice giving name and address of the hub pharmacy And finally, supply from a hub to a spoke is NOT wholesale dealing (the law has been amended to remove this concern) Note that the use of hub and spoke dispensing arrangements is voluntary Slide 36 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 INTERNET (ONLINE) PHARMACIES Slide 37 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Internet (online) Pharmacies (1) These are sometimes called ‘distance-selling pharmacies’ In 2023 there were 398 such pharmacies in England The number of prescription items dispensed by internet pharmacies quadrupled between 2016 and 2021 (compared to a 2.3% increase in dispensing from non-internet pharmacies) The proportion of items dispensed by internet pharmacies is still small (around 5%) If these pharmacies have an NHS contract they are contractually obliged to offer their services and deliver prescriptions to anywhere in England Supplying medicines online does involve additional risks to supplying medicines from a ‘traditional’ pharmacy Internet pharmacies are eight times more likely to fail GPhC regulatory standards Some of the current FtP investigations relate to the sale of certain OTC medicines without proper checks or safeguards Slide 38 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Internet (online) Pharmacies (2) Slide 39 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Internet (online) Pharmacies (3) Some online pharmacies also offer a prescribing service (using GP or pharmacist independent prescribers) Some of these pharmacies may be based outside of the UK and/or use EEA prescribers. Currently, both are legal. The GPhC has highlighted concerns regarding the prescribing of medicines which are liable to abuse, misuse and overuse. In many cases the prescribing was based on the completion of an online questionnaire. Other GPhC highlighted concerns relate to: Prescribing of high-risk medicines or medicines which require monitoring, with no adequate safeguards Prescribing medicines outside the prescriber’s scope of practice High volumes of prescriptions being issued within a short period of time The GPhC has produced guidance for internet pharmacies (and other pharmacies providing services ‘at a distance’ from patients) The RPS has also produced a checklist of points to consider when providing services online Slide 40 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Internet (online) Pharmacies (4) GPhC Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet Five key principles: 1. The governance arrangements safeguard the health, safety and wellbeing of patients and the public 2. Staff are empowered and confident to safeguard the health safety and wellbeing of patients and the public 3. The environment and condition of the premises….. safeguards the health, safety and wellbeing of patients and the public 4. The way in which pharmacy services…….are delivered safeguards the health, safety and wellbeing of patients and the public 5. The equipment and facilities………. safeguard the health, safety and wellbeing of patients and the public Slide 41 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Internet (online) Pharmacies (5) The GPhC has raised concerns about the risk to patient and public safety by the sale of habit-forming medicines or those liable to abuse or overuse Examples include CDs, z-drugs and weight-loss medicines Examples of poor practice identified by the GPhC include: Prescribing decisions being made in a relatively transactional way and minimal checking with their own GP Operating models that lack a real-time or face-to-face consultation between the prescriber and patient A commercial rather than a clinical focus Poor or weak checking and monitoring of multiple or repeat supplies History and symptoms of patients being taken at face value without adequate verification or appropriate identity checks Slide 42 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Internet (online) Pharmacies (6) There have been reports of illegal websites claiming that they are online pharmacies, selling medicines which are counterfeit The GPhC operates a voluntary internet pharmacy logo scheme to provide reassurance to patients and the public that they are purchasing medicines online from registered pharmacies who must meet GPhC standards Note that this logo (see below) can only be used by pharmacies The MHRA is considering a logo which can be used by any retailer selling medicines online so long as they are registered with the MHRA Patients should be encouraged to check carefully when they buy medicines online. The GPhC has produced a guide for patients about what to ask for and look out for when buying medicines online Slide 43 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 SERIOUS SHORTAGE PROTOCOLS Slide 44 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Serious Shortages Protocols (1) Legislation came into force in 2019 to allow pharmacists to supply a different medicine to that which is specified on a prescription This is only allowed in accordance with a ‘serious shortage protocol’ (SSP) issued by DHSC, specifying the medicine and action to take Legal authority for four possible actions Dispense a smaller quantity Dispense an alternative formulation or strength (but same drug) Dispense a generic equivalent (for a branded medicine) Dispense an alternative drug with a similar therapeutic effect The patient’s GP must be informed if a switch of medicine has occurred but not if a different form or quantity has been dispensed The supply is the professional responsibility of the pharmacist under whose supervision it takes place Pharmacists must use their professional judgement to determine whether it is appropriate to supply using a SSP to the patient or not based on the individual circumstances of the patient Slide 45 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Serious Shortages Protocols (2) SSPs can only be used if the prescription presented is legally valid The patient/carer must consent to receiving the medicine supplied under the SSP – if they do not, then they need to be referred to the prescriber The pharmacist must ensure that the patient understands the difference between the prescribed drug and the alternative The dispensing label needs to indicate that a supply was made under a SSP and state the reference number of the SSP. This is so that there is a permanent record in the patient’s PMR. Patients who usually pay a prescription charge but who receive a smaller quantity of the medicine are exempt from a prescription charge payment Once a supply is made under a SSP (even if a lower quantity of the medicine is supplied) the original prescription is no longer valid and no further supply can be dispensed from it Slide 46 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Serious Shortages Protocols (3) SSPs may specify other checks/actions to be undertaken prior to the switch so it is important to read each SSP carefully Each SSP is time limited (has an expiry date or review date) which may be extended if the medicine is still in short supply Some drugs are not be eligible for certain types of SSP (e.g., where brand prescribing is therapeutically important or for certain drugs used for epilepsy) Several SSPs have been issued for drugs for which certain strengths/presentations are in short supply e.g., fluoxetine, haloperidol, HRT Pharmacy contractors are notified of any new SSP by an email to their NHS email address Current SSPs can be found on the NHSBSA website https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance- contractors/serious-shortage-protocols-ssps Slide 47 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Prescription Collection Units Slide 48 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Prescription collection units Prescription collection units (PCUs) are automated prescription collection machines and lockers Collection of medicines is allowed at anytime, 24 hours/day on any day of the week, even when the pharmacy itself is closed and no pharmacist is on the premises. Patient should consent (‘opt in’) to use this method for collection of their medicines This method is not suitable to be used for all medicines (e.g., fridge items, CDs requiring safe custody, bulky items, are not suitable) Patients should only be able to access the PCU using a password or secure code (in some cases sent in a text or email to the patient) There should be a clear audit trail available of when medicines are stored in the machine and when they are collected by patients The storage space in these machines is limited so this is likely to be used by small numbers of patients in specific circumstances The GPhC have included guidance about the use of PCUs in their Guidance on providing pharmacy services at a distance Slide 49 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 DISPENSING ERRORS Slide 50 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 What is a dispensing error? No universal definition An error made during the dispensing process from receipt of the prescription through to the supply of the dispensed medicine, where the error means the patient receives a medicine which differs in some way from that intended by the prescriber Errors could include: incorrect labelling of the medicine a medicine intended for another patient being dispensed to the wrong patient the wrong medicine being dispensed the medicine being dispensed at the wrong strength or in the wrong dosage form the supply of an out-of-date medicine Some criminal prosecutions have occurred in the past Slide 51 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Medicines Act 1968 Section 64 ‘No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser’ This part of the Medicines Act has not been repealed Applies to other healthcare professionals too Also applies to all retailers of medicines NB Dispensing an incomplete/illegal prescription is still a criminal offence Slide 52 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 Why should dispensing errors 11 be ‘decriminalised’? This law means that if a dispensing error is made the pharmacist has committed a criminal offence For many years this has been recognised as being a hindrance to pharmacists reporting errors and learning from errors to improve patient safety This law was drafted at a time when extemp dispensing was common and it was intended to guarantee the quality of the ingredients being used in the medicine The RPS argued that errors should be a matter handled by the professional regulatory body (GPhC) and not by the legal system BUT need to ensure that errors are not deliberately made Slide 53 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 Pharmacy (Preparation and Dispensing Errors – 11 Registered Pharmacies) Order 2018 Came into force on 16 April 2018 Applies to community pharmacies, hospital pharmacies and prison pharmacies The legislation does not decriminalise dispensing errors Section 64 has been retained It provides a statutory (legal) defence which could be used when a dispensing error is made Slide 54 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Legal defence Making a dispensing error is not a criminal offence if Medicines are prepared by a registrant (pharmacist or PT) or acting under their supervision AND Medicines were supplied from a registered pharmacy premises AND Registrant was acting in the course of their profession AND Medicines were supplied in pursuance of a prescription or from the direction of a prescriber AND If you are aware of the error there was a prompt notification of the error If all above apply, this is the legal defence to Section 64 Slide 55 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 However….. If the intention was to cause harm (i.e., the error was deliberate) Or if criminal negligence was suspected Then criminal sanctions would still apply AND…… Accountability is important ‘Fitness to Practise’ – the GPhC have stated that it is unlikely that a single dispensing error would result in referral to the FtP committee unless aggravating factors were present Slide 56 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 OTHER ISSUES Slide 57 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 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 and not written in indelible ink) but it 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 faxed prescription 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 CD prescription (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 58 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 Photos, scans or 11 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 59 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Forged prescriptions (1) Pharmacists always 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) such as excessive quantity, spelling errors, behaviour of the patient, etc Slide 60 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Forged prescriptions (2) A possible forged prescription should be carefully checked: Signature of prescriber – check against a known genuine prescription from the same prescriber Contact the prescriber to verify what has been prescribed – do not use the contact number on the prescription since this may not be a genuine number – obtain the prescribers telephone number from another source (e.g., directory enquiries, website etc) Altering details on a prescription is fraud and the NHS Counter Fraud Service (for NHS prescriptions), and possibly the police, should be contacted The prescriber should also be informed of any alteration to a prescription that they have issued Slide 61 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 Prescribing POMs in hospitals 11 for inpatients In a hospital ward, a written direction (Patient Specific 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 62 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 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 63 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Self-checking prescriptions Self-checking means the same person dispenses the prescription and performs the accuracy check It is good professional practice for two people to be involved in the dispensing process to reduce the risk of errors and maximise patient safety The person performing the accuracy check should not be involved in the assembly process to reduce the potential risk to the patient of a dispensing error There may be some instances where self-checking may be necessary. In such cases it is advised that you take a short ‘mental break’ between dispensing and accuracy checking The RPS has issued ‘self-checking guidance’ Slide 64 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs WEEK 10 11 Further information Medicines, Ethics and Practice, Edition 47 (online), Section 3.3 and 3.4 The RPS website has further information and resources, including Prescriptions from the EEA and Switzerland Slide 65 of 65 OSPAP MPHM15 Sale and supply of medicines - POMs