Section 3 - Underpinning knowledge: legislation and professional issue Flashcards

Question

**Signs Indicating Seeking Pseudoephedrine/Ephedrine for Possible Misuse** ## Footnote 3.2.1 Pseudoephedrine & Ephedrine

Answer 1

* Lack of Symptoms: Not suffering from cough, cold or flu symptoms. Or unable to describe these in the patient if buying for somebody else. * Rehearsed Answers: gives answers that appear to be rehearsed or scripted. * Impatient or Agressive: in a rush or hurrying to complete transaction * Opportunistic: waiting for busy periods in the shop or until less experienced staff are available. * Specific Product: wants to buy certain brands that contain only pseudoephedrine/ephedrine * Paraphernalia: wishes also to purchase other items which can be used to manufacture methylamphetamine (e.g. lithium batteries, acetone) * Quantaties: requests large quantaties * Frequency: makes requests frequently

Answer 2

Suspicions can be reported to: - your local GPhC inspector, - local controlled drugs liaison police officer - accountable officer.

Answer 3

**3** - Copper Intrauterine Device (CU-IUD) - Oral Ulipristal acetate - Oral Levonorgestrel

Answer 4

- Providing advice on all methods of emergency contraception - Assessing suitability - Approving sales or signposting to alternative providers.

Answer 5

Levonorgestrel 1500mcg tablet. Liscence: - Women over 16 years - For emergency contraceptive use - Within 72 hours of UPSI/contraceptive failure

Answer 6

Ulipristal 30mg tablet Liscence: - For Emergency Contraception use - Within 120hours (5 days) of UPSI/contraceptive failure

Answer 7

Pharmacists can provide an advance supply of oral emergency contraception (e.g. prior to UPSI or in case of failure of a contraceptive method) to a patient requesting it at a pharmacy. - The patient should be assessed to ensure that they are competent, they intend to use the medicine appropriately and it is clinically appropriate.

Answer 8

The patient should be assessed to ensure: - that they are competent, - they intend to use the medicine appropriately - it is clinically appropriate.

Answer 9

- Employer - Locum Agency - Colleagues you will be working with

Answer 10

- In some circumstances requests for oral emergency contraception could be linked to abuse (non-consensual intercourse) of children & vunerable adults. The Department of Health: published a document called *Responding to domestic abuse: A handbook for health professionals.* - This provides practical advice on dealing with domestic abuse, keeping records, confidentiality & sharing information. The Department for Education: had published a guidance document called *Working together to safeguard children*. - This includes sections for health professionals and on referral.

Answer 11

The supply of ulipristal acetate to patients under 16 years is not contraindicated by the manufacturer. - Pharmacists may need to consider other factors before supplying such as the childs age, maturity, ability to consent to sexual intercourse/treatment....

Answer 12

Children under the age of 13 are legally too young to consent to any sexual activity. - Instances should be treated seriously with a presumption that the case should be reported to social services unless there are exceptional circumstances backed by documented reasons for not sharing information.

Answer 13

Sexual activity with children under the age of 16 is an offence but may be consensual. - The law does not intended to prosecute mutally agreed sexual activity between young people of similar age unless it involves abuse or exploitation.

Answer 14

The general duty of patient confidentiality applies. - So where there is a decision to share information, consent should be sought wherever possible prior to disclosing patient information. - This duty is not however absolute and information may be shared if you judge on a case-by-case basis that sharing is in the childs best interest (e.g. to prevent harm or where the child welfare overrides the need to keep information confidential). - Remember where possible to seek advice from experts without disclosing identifiable details of a child and breaking patient confidentiality. - If a decision is made to share information this should be proportionate.

Answer 15

Other Service Providers: Family Planning Clinics, General practice Clinics, Providers of PDGs for oral emergency contraception & genitoruinary medicine (GUM) clinics. PDG - for oral emergency contraception (partiucalry if outwith marketing authorsiation for drug for sale)

Answer 16

**Non-effervescent:** No more than 100 non-effervescent tablets or capsules can be sold to a person at any one time. - Since more OTC packs are for 16 or 32 dose units this means that in practice 96 is the maximum number that can be sold. **Effervescent:** There are no legal limits on the quantity of OTC effervescent tablets, powders, granules or liquids that can be sold to a person at any one time. - Use professional judgement to decide the appropriate quantity to supply and what limits to impose. *[ The definition of effervescent for the purposes of the restrictions above is provided by medicines legislation. Soluble or dispersible formulations as defined by the British Pharmacopoeia may not meet ther definition of effervescent in medicines legislation. Where in doubt quantities of soluble or dispersible formulations sold should be restricted as non-effervescent preparations]*

Answer 17

**Non-effervescent:** No more than 100 non-effervescent tablets or capsules can be sold to a person at any one time. - Since most OTC pack sizes are for 16 or 32 unit doses this means in practice 96 is the maximum number that can be sold. **Effervescent:** There are no legal limits on the quantities of OTC effervescent tablets or powders that can be sold to a person at any one time. - Use professional judgement to decide the appropriate quantity to supply and what limits to impose. *[ The definition of effervescent for the purposes of the restrictions above is provided by medicines legislation. Soluble or dispersible formulations as defined by the British Pharmacopoeia may not meet ther definition of effervescent in medicines legislation. Where in doubt quantities of soluble or dispersible formulations sold should be restricted as non-effervescent preparations]*

Answer 18

- Formulation - Pack Size

Answer 19

These were introduced to minimise the risk of overuse and addiction to these medicines.

Answer 20

**Indication: ** Indication for solid dose OTC codeine & dihydrocodeine products are now restricted to the short-term treatment of acute. moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone. - All other previous indications including cold, flu, cough, sore throat & minor pain have been removed. **Pack Sizes:** Any pack containing more then 32 dose units (including effervescent) is a POM. **Patient Information leaflet & Labels** - The warning* "Can cause addiction. For three days use only" *must be positioned in a prominent clear position on the front of the pack. - In addition both the PIL & packaging must state the indication and that the medicine can cause addiction or headache if used continuosuly for more than three days. - The PIL must also contain information about the warning signs of addiction.

Answer 21

In theory yes, it is however recommended by RPS to limit the number of packs sold to a single person at one time to ONE. - Selling more undermines the tighter controls added to OTC pack sizes not being able to contain more than 32

Answer 22

- Play an important role in asking appropriate questions prior to the supply of OTC codeine/dihydrocodeine containing products to ensure patients are referred when required to manage long term pain treatment.

Answer 23

Human Medicines Regulations 2012

Answer 24

A Prescription from an appropriate practitioner. (e.g. Doctor, Dentist, Supplementary Prescriber, Independent Prescriber, Community practitioner Nurse...) Or via an exception (e.g. emergency supply...)

Answer 25

- The Human Medicines Regulations 2012 - The Controlled Drug legislation - The specific prescriber's regulatory & professional body.

Answer 26

1. **Signature of prescriber** (Prescriptions need to be signed in INK by an appropriate practitioner in his/her own name. An 'advanced electronic signature' can be used to authorise an electronic prescription) 2. **Adress of prescriber** (Prescription must include the adress of the appropriate practitioner) 3. **Date** (A prescription is valid for up to 6 months from the appropriate date: For an *NHS prescription*, the appropriate date is the later of either the date on which the prescription was signed or a date indicated by the appropriate practitioner as the date before which it should not be dispensed: For a *private prescription* the appropriate date will always be the date on which it was signed.) 4. **Particulars of prescriber** (Prescription require particulars that indicate the type of appropriate practitioner) 5.** Name of patient** 6. **Adress of patient** 7. **Age of the patient** (if under 12 years)

Answer 27

A prescription need to be signed in **INK** by an appropriate practitioner in his/her own name. - 'An advanced electronic signature can be used to authorise an electronic prescription'

Answer 28

A prescription must include the adress of the appropriate practitioner

Answer 29

A prescription is valid for up to 6 months from the appropriate date: - For an *NHS prescription*, the appropriate date is the later of either the date on which the prescription was signed or a date indicated by the appropriate practitioner as the date before which it should not be dispensed. - For a *private prescription* the appropriate date will always be the date on which it was signed.

Answer 30

Prescriptions require that particulars indicating the type of appropriate practitioner are present.

Answer 31

Prescriptions must be written in indelible INK - They may be computer generated or typed.

Answer 32

Same as General Prescription Requirements for NHS Prescriptions. - Dont need to be written of the NHS prescriptions forms though.

Answer 33

Same as that of a general prescription: 1. **Signature of prescriber** (Prescriptions need to be signed in INK by an appropriate practitioner in his/her own name. An 'advanced electronic signature' can be used to authorise an electronic prescription) 2. **Adress of prescriber** (Prescription must include the adress of the appropriate practitioner) 3. **Date** (A prescription is valid for up to 6 months from the appropriate date: For an *NHS prescription*, the appropriate date is the later of either the date on which the prescription was signed or a date indicated by the appropriate practitioner as the date before which it should not be dispensed: For a *private prescription* the appropriate date will always be the date on which it was signed.) 4. **Particulars of prescriber** (Prescription require particulars that indicate the type of appropriate practitioner) 5.** Name of patient** 6. **Adress of patient** 7. **Age of the patient** (if under 12 years) Some homecare service providers however may also require additional information e.g. **GMC number **of prescribing doctor.

Answer 34

It is permissible to issue carbon copies of NHS prescriptions as long as they are signed in INK.

Answer 35

An advanced electronic signature is a signature that is linked uniquely to the signatory, capable of identifying the signatory and created using means over which the signatory can maintain sole control. (Regulation 219(5) Human Medicines Regulations 2012) The RPS is unable to confirm whether or not individual systems are able to issue advanced electronic signatures. - Suitable assurances should be obtained from the systems manufacturer and buisness indemnity providers. Electronic Prescriptions are normally sent to the pharmacy by the prescribing organisation. - Copies of 'electronic prescriptions' on an email or on a patient's phone in their online account do not normally meet the requirements of an advanced electronic signature.

Answer 36

Electronic Prescriptions are normally sent to the pharmacy by the prescribing organisation. - Electronic Prescriptions must still meet the general prescription requirements - A copy of a prescription in an online account, does not constitute a legitimate electronic prescription even if it is emailed to the pharmacist.

Answer 37

Lanuage is not specified in the medicines leglislation describing the requirements which need to be met on a legally valid prescription. There is currently no law or act that specifies that prescriptions in wales have to be bilingual. If a pharmacist is not a welsh speaker and cant understand the prescription, the RPS advice is to put patient saftey first. The pharmacist is responsible for finding the best way to help the patient. If the pharmacist is presented with a prescription they do not fully understand this might be though translation services or informal networks. Some local health boards use languageline. In the interests of patient saftey, the RPS welsh pharmacy board recommends that medicines should be labelled in english to ensure that if a patient is seen by non-welsh speaker these important instructions are understood.

Answer 38

Pharmacists may be presented with prescriptions written by prescribers from the Crown Dependencies (Jersey, Guernsey and Isle of Man) - You should be satisfied that all prescription requirements are present from the prescription to be legally valid (For schedule 2 & 3 drugs the prescribers adress must be within the UK) A report published by the GMC "*GMC regulation in crown dependencies and other overseas territories"* advises the following: We have nevertheless established agreements with those territories to facilitate the revalidation of doctors within their jurisdiction using local system. Therefore, doctors from crown dependencies are expected to be registered with GMC.

Answer 39

Requests for emergency supply from a patient or prescriber should be considered on a case by case basis considering the legal requirements and using your professional judgement in the best interests of the patient.

Answer 40

Peach: GP10/GP10SS - GPs Lilac: GP10(N) - Nurse Prescribers Yellow: GP14 - Dentists Blue: HBP - issued in secondary care Pink: HBP(A) - Instalment dispensing prescription for drug addicts.

Answer 41

Reapetable prescriptions are private prescriptions which contain a direction that they can be dispensed more than once e.g. repeat x5 - They are commonly used in the community hospital (where a prescriber can issue a private prescription in a private hosiptal or NHS hospital providing private services) and the homecare setting.

Answer 42

- Repeatable prescriptions can be repeated as indicated by the prescriber. - If the number is not stated, they can only be repeated once (dispensed twice) unless the prescription is for an oral contraceptive in which case it can be repeated five times (dispensed 6 times in total).

Answer 43

Prescriptions for schedule 2 & 3 CDs are not repeatable (schedule 4&5 CDs are though) - NHS prescriptions are also not repeatable (installment prescriptions used instead)

Answer 44

**POM/Schedule 5 CDs**: The first dispensing for a POM or schedule 5 CD must be made within SIX months of the appropriate date, following which there is no legal time limit for the remaining repeats. **Schedule 4 CDs**: If the prescription is for a schedule 4 CD the first dispensing must be made within the validity period for schedule 4 CD prescriptions (i.e schedule 4 CD prescriptions are valid for 28 days after the appropriate date). Following which there is no time limit for reamaining repeats. [- While there are no time limits for remaining repeats, pharmacists should use professional judgement taking into consideration clinical factors , to determine whether further repeat dispensing is appropriate.] [- The patient can choose to have repeats dispensed from different pharmacies, and can retain the prescription. To maintain an audit trail mark on the prescription the name and adress of the pharmacy from where supply had been made and the date of supply.]

Answer 45

**Repeat Slips**: these are not prescriptions themselves but a list of medications which patients can use to reorder theiur regular medication **Instalment Prescriptions**: These provide for a single prescriptio for a CD to be dispensed in several instalments. *NHS Repeat Dispensing Service*: Where the prescriber authorises a prescription with a specified number of 'bath' issues that may be dispensed at specified intervals from a pharmacy (England/Wales only)

Answer 46

Priosns & other residential custodial secure evironemtns in england provide NHS healthcare & pharmacy services to detained people. FP10 forms are not used for routine prescribing, as a customised prescription form generated by the clinical IT system is used instead. - These are still considered NHS prescriptions. FP10s are available in these settings but are only used to access urgent medicines (e.g. out of hours), or are supplied to a released person to access medcines that couldnt be supplied to them on release. Therefore the NHS repeat dispensing scheme using FP10s or EPS cannot be used.

Answer 47

**POMs & Schedule 5 CD**s: Six months from the appropriate date *POMs on Pregnancy Prevention Programme (PPP)* - Supply of owing can exceed 7 days from when the prescription is written only if the pharmacist follows the PPP checklist to ensure there is not risk of pregnancy. (e.g. Oral retinolds) **P & GSL**: Six months from the appropriate date. **Schedule 2.3.4 CDs**: 28 days after the appropriate date. [Medicines must be supplied within a certain period from the appropriate date (i.e. the date on which the prescription was signed by the prescriber or the date indicated as being the start date), therefore any owed medicines should be supplied within this validity period.]

Answer 48

Private prescriptions for a **POM **must be retained for 2 years from the date from supply or sale. - If for a repeatable prescription record must be kept for 2 years after date of last supply/sale. Private prescriptions for **Schedule 2/3 CDs** must be submitted to the relevant NHS agency. **------------------------------------------------------------------------------------------------------------------** **POM Register:** Records must be made in the POM register (written or electronically) which should be retained for two years from the date of the last entry in the register. The record must include: - *Supply Date*: The date on which the medicine was sold or supplied - *Prescription Date* - The date on the prescription - *Medicine Details:* The name, quantity, formulation & strength of medicine supplied (where not apparent from the name) - *Prescriber Details*: The name and adress of the practitioner - *Patient Details*: The neam and adress of the patient. [The supply should be made on the day the sale or supply take place, or if that is not practical on the next day following] **--------------------------------------------------------------------------------------------------------------------------------------------** **Record Keeping Excemptions** - Prescriptions for *oral contraceptives* are exempt from record keeping - As are prescriptions for *schedule 2 CDs* where a seperate CD register record has been made.

Answer 49

Although details of the medicinal product such as the: name, strength, form, quantity and dose are not legal requirements for POM prescriptions they are important to identify which medicine to supply, how much to supply and at what dose. - They are also important from a pricing and remuneration perspective.

Answer 50

The Falsified Medicines Directive (FMD) is a set of rules to protect people from fake medicines in the European Union (EU). It includes additional anti-tampering security on packaging, and tracking of medicines using a unique identifier, like a barcode. The saftey features elements of the falsified medicines directive (FMD) leglislation and delegated regulation no longer apply in GB The government are looking at alternative options.

Answer 51

Dentists can legally write prescriptions for any POMs - The General Dental Counsel advises that dentists should restrict their prescribing to areas in which they are competent and generally onlu prescribe medicines that have uses in dentistry.

Answer 52

Whilst legally dentists cna prescribe any POMs, when they are prescribing on NHS dental rescriptions, they are restricted to the medicines listed in the Dental Prescriber's Formulary (part 8a of the drug tariff for scotland, or XVIIa of the drug tariff for england or wales or reproduced also in the BNF)

Answer 53

NO A fax of a prescription does not fall within the definition of a legally valid prescription within the human medicines legislation becasue it is not written in indelible ink and has not been signed in ink by an appropriate prescriber. | Note: legally like emergency supply at request of prescriber

Answer 54

No Like with a fax of a prescription a digital copy of a prescription does not fall within the definition of a legally valid prescription within the human medicines legislation becasue it is not written in indelible ink and has not been signed in ink by an appropriate prescriber. | Note: not same as private prescription with advance electronic signature

Answer 55

1. Uncertaintly that the supply has been made in accordance with a legally valid prescription. 2. Risks of poor reproduction 3. Risks of non-receipt of the origional prescription and therefore inability to demonstrate that a supply had been made in accordance with a prescription. 4. Risks that the origional prescription is subsequently amended by the prescriber in which case the supply would not have been made in accordance with the prescription. 5. Risks the fax/digital copies of prescription is sent or recieved by multiple pharmacies and duplicate supplies made. 6. Risks that the prescription is not genuine 7. Risks that the system of sending and receiving of the fax/digital copies of prescription is not secure or from a reputable source.

Answer 56

Alternative mechanisms for the supply of medicines in an emergency exist for pharmacies qorking in registered pharmacies and can achieve a similar outcome in many scenarios with a better risk profile. - Where this option can be used, it should be used.

Answer 57

**Emergency Supply** **Electronic Prescriptions** - recognised in Human Medicines Regulations 2012 and where a system is being developed should be considered as an option. **PGD **- Patient Group Directive

Answer 58

- That it is an informed decision - Steps are taken to safe guard patient saftey - Where possible risks are mitigated. - Consider making a record of the decision-making process and your reasons leading to a particular couse of action. THE SUPPLY OF A SCHEDULE 2/3 CD WITHOUT POSSESSION OF A LAWFUL PRESCRIPTION COULD BE PROSECUTED AS A CRIMINAL OFFENCE.

Answer 59

No THE SUPPLY OF A SCHEDULE 2/3 CD WITHOUT POSSESSION OF A LAWFUL PRESCRIPTION COULD BE PROSECUTED AS A CRIMINAL OFFENCE.

Answer 60

Although it can be difficult to detect a forged prescription, every pharmacist should be alert to the possibility that any prescription could be a forgery. 1. Is a large or excessive quantity prescribed and is this appropriate for the medicine and condition being treated. 2. Is the prescriber known 3. Is the patient known 4. Has the title "Dr" been inserted before the signature 5. Is the behaviour of the patient indicative (e.g. nervous, agitated, agressive...)

Answer 61

1. Scrutinise the signature carefully - possibly checking against a known genuine presciption from the same prescriber 2. Confirm the details with the prescriber (e.g. whether or not a prescription has been issued, the origional intention of the prescriber and whether or not there has been an alteration) 3. Use contact details for the prescriber that are obtained from a source other then the suspicious prescription (e.g. directory enquiries)

Answer 62

Depending upon the nature of the fradulent prescription, use your professional judgement to assess whether or not it is a matter that required referral to: - the police, - NHS Counter Fraud Services (for NHS prescriptions only) - or whether the matter can be resolved by discussion with the patient and prescriber

Answer 63

Prescriptions and repeatable prescriptions issued by an approved health professional in an approved country are legally recognised in the UK.

Answer 64

Yes Emergency supplies at the request of a patient or at the request of an approved health professional are legally possible. - Follow the usual Emergency supply process, remembering that where the request originates from an approved health professional the a prescription needs to be recieved within 72 hours. - Schedule 1/2/3 CDs (excluding phenobarbital) or unlicensed products cannot be supplied in an emergency to a patient of an approved health professional !!!

Answer 65

- Doctors - Dentists - Other Professions with prescribing rights ( i.e chiropodists or podiatrists, Nurses (including community nurses), Optometrists, Paramedics, Pharmacists, Physioptherapists & therapeutic radiographers).

Answer 66

The prescription is not valid if it does not originates from the approved list. - You should use your professional judgement (e.g. refer to local GP) in finding the best way to help the patient.

Answer 67

Prescription Requirements: 1. **Patient Details**: Patient's full name(s), Surname and date of birth 2. **Prescriber Details**: Prescriber's full first name(s), Surname, Professional Qualifications, Direct Contact details including email adress and telephone or fax numbet (with international prefix), Work Adress (including country work in). 3. **Prescribed Medicines Details:** Name of the medicine (brand name where appropriate), Pharmaceutical Form, Quantity Strength & Dosage Details. 4. **Prescriber Signature** 5. **Date Of Issue**: Prescriptions are valid for up to 6 months from the appropriate date (prescriptions for schedule 4 CDs 28 days). For prescriptions from these countries the appropriate date is the date on which the prescription was signed. **--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** It is important to remember that as well as meeting the legal perscription requirements for dispensing a prescription from an EEA prescriber you need to aslo be satisified the medicine(s) supplied is clinically appropriate for the patient. - The GPhC have updated "guidance for registered pharmacies providing pharmacy services at a distance, including on the internet" March 2022. They expect all pharmacy professionals to follow the guidance to provide pharmacy services safely and effectively at a distance (including the internet). **--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** NOTE: even if the prescription requirements have been written in a foreign language the prescription is still legally acceptable. However, you will need to have enough information to enable the safe supply of medicines considering patient care and wellbeing.

Answer 68

An international database of prescribers does not exist and , indeed, not all of the approved countries have a register of practitioners or online registers in english. Therefore is may not always be possible to check the registration of approved health professionals. Up to date contact details for EA competent authorities to check registration details of doctors and dentists can be obtained from: - Doctors: General Medical Council (GMC) - Dentists: General Dental Council (GDC) European Commission Website: can search regulated professionals and competent authorities in the approved countries.

Answer 69

If it is not possible to confirm the registration status of the approved health professional after taking all reasonable steps to do so, then it may still be possible to make a safe and legal supply in the interests of patient care. - It would be beneficial to keep a record of the details of any interventions and stpes taken. - This would require checking (and being satisfied) that prescription requirements are fulfilled, questioning the patient and careful use of professional judgement. A due diligence defence exists for EEA prescriptions. However only a court could decide ultimately on a case-by-case basis whether due diligence has been exercised.

Answer 70

Schedule 1/2/3 CDs Medicinal Products without a marketing authorisation valid in the UK - Consider referral to an appropriate UK-registered prescriber if such items are required.

Answer 71

It is important to bear in mind that the details outlined for EEA/switzerland prescriptions are enabling - but it is not obligatory to dispense a prescription from an approved country if presented with one. You should always use professional judgement when handling prescriptions ir emergency supply requests from approved health professionals from approved countries. If you are not satisfied that a prescription is clinically appropriate or legally valid and an emergency supply is not appropriate, then it may be appropriate to refer the patient based in the uk as an alternative.

Answer 72

Military primary healthcare medical centres are broadly similar to dispensing doctors practices in the NHS, where the doctor in charge delegates the dispensing function to a suitably trained individual. However only large medical centres have retained their in-house dispensary. The remaining smaller medical centres have outsourced the dispensing process to designated community pharmacies under a Ministry Of Defence (MOD) contract. - Community pharmacies not covered by the contract will not routinely handle militray prescriptions.

Answer 73

Military prescriptions are written on a military form **FMed 296.**

Answer 74

Pharmacies with a dispensing contract with the MOD will usually invoice thr MOD directly.

Answer 75

In the unusual event that an FMed 296 is presented to a non-contracted pharmacy then the prescription should be treated as a private prescription. - In these circumstances, non-contracted pharmacies are not to invoice the MOD directly but are to charge the patient the appropriate fee. It is then up to the indivudual patient to recover any costs incurred from their military unit (please note this practice should only be used in exceptionalk circumstances). - Similarly any military personnel that presents an NHS or other private prescription (including using an FMed 296 as a private prescription) should pay the appropriate fee and request a receipt to reclaim any costs if eligible. This is unless for an NHS prescription they fall into an NHS exemption category and present an exemption certificate.

Answer 76

Prescriptions for schedule 2 & 3 CDs should be written on pink FP10PCD forms (or equivalent in Devolved Administration) which prescribers obtain from their regional Defence Primary Health Care headquarters supplied by NHS England & Scotland. *[A Schedule 2 or 3 written on an MOD FMed 296 form cannot be legally dispensed by community pharmacies!!!]*

Answer 77

Normal procedures should be followed: 1. Scrutinise the signature carefully - possibly checking against a known genuine presciption from the same prescriber 2. Confirm the details with the prescriber (e.g. whether or not a prescription has been issued, the origional intention of the prescriber and whether or not there has been an alteration) 3. Use contact details for the prescriber that are obtained from a source other then the suspicious prescription (e.g. directory enquiries)

Answer 78

**Handwritten FMed 296**: The majority of FMed 296 prescriptions will be computer generated. It is highly unusual to see handwritten prescriptions, especially for MOD accountable drugs (these include schedule 3,4 & 5 CDs, codeine, sedatives & medicines for erectile dysfunction). **British Forces Post Office (BFPO) Adress Stamp**: Prescriptions with BFPO adress stamp have been generated abroad and are normally not seen in the UK. If there are any doubt, pharmacists are advised to check the registration status of the doctor, dentist or independed prescriber. Other Normal Considerations: 1. Is a large or excessive quantity prescribed and is this appropriate for the medicine and condition being treated. 2. Is the prescriber known 3. Is the patient known 4. Has the title "Dr" been inserted before the signature 5. Is the behaviour of the patient indicative (e.g. nervous, agitated, agressive...)

Answer 79

It is a legal requirement for the following to appear on dispensed medicinal products: - Name of the patients - Name & Adress of the Supplying Pharmacy - Date of Dispensing - Name of the Medicine - Directions For Use - Precautions Relating to the Use of the Medicine: (e.g. For external use only) **--------------------------------------------------------------------------------------------------------------------------------------------------------------------------** The RPS also Recommends the following appears on the dispensing label: - 'Keep out of reach and sight of children' - 'Use this medicine only on your skin' where applicable **----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** In secure Environments it is strongly recommended that the prisoners number is also included on the label as a definitive patient identifier. **-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** Additional Information can be added to the dispensing label if the pharmacist considers it to be necessary.

Answer 80

**Outer Container:** Whilst it is lawful to label the outer container, we advise that the labelling recommendations of the National patient Saftey Agency are followed. - These guidelines raise the issue that the outer container may be discarded and therefore the labelling information could be lost, so the actual container (e.g. inhaler or tube of cream) should be labelled rather than the outer container.

Answer 81

Subject to the professional skill and judgement of a pharmacist, if she/he is of the opinion that the following: *- the directions for use, - name/common name of the medicine, - or precautions relating to the use of the medicine * On the prescription are not approriate they can substitute these with appropriate particulars of a similar kind when producing the dispensing label without contacting the prescriber It would be good practice to make a record to maintain a clinical audit train underpinning patinet care. It is important to understand that the above is enabling and not mandatory. - The option to contact the prescriber or refer the patient to the prescriber remain available and should be used where this is appropriate in the opinion of the pharmacist having exercised professional skills and judgement.

Answer 82

The assembly or pre-packaging of medicines by the pharmacy to be supplied to a seperate legal entity (e.g. for a NHS trust to supply a different NHS trust or an out of hours medical practice) requires the appropriate licence from the MHRA (i.e Manufacturer's/importer's licence (MIA) or Manufacturer 'specials' licence (MS)). - The MHRA can be contact for further details on the licence and any additional requirements. For activities that include over-labelling for supply the RPS also advises you contact the MHRA for further details.

Answer 83

Yes- Pharmacists are able to break down bulk containers into smaller quantities more appropriate for dispensing against prescriptions which have already been recieved and are being dispensed or in anticipation of these prescriptions.

Answer 84

1. Name of the medicine 2. Quantity of the medicine in the container 3. Quantitative particulars of the medicine (i.e the ingredients) 4. Handling and storage requirements where appropriate 5. Expiry date 6. Batch reference number (e.g. LOT number or BN) **---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** Plus the usual labelling requirements upon dispensing: - Name of the patients - Name & Adress of the Supplying Pharmacy - Date of Dispensing - Name of the Medicine - Directions For Use - Precautions Relating to the Use of the Medicine: (e.g. For external use only) RPS recommended warnings: "keep out of reach and sight of children", "Use this medicine only on your skin" where applicable. Prisoners number in secure environments

Answer 85

In healthcare settings organisational policies define who can administer medicines, or the appropriate delegation of the administration of medicines within that setting. [NOTE: The organisation should have a policy for self administration of medicines. Patients maintain responsibility for the administration of some or all of their medicines during a stay in the healthcare setting unless a riks assessment indicates otherwise] **----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** **Parental POMs** can only be administered to another person in accordance with the driections of an appropriate practitioner or be an approproate practitioner. - There is an excemption allowing administration for saving life in an emergency. (e.g. naloxone as emergency first aid for drug related overdose; or administering adrenaline for the emergency treatment of anaphylaxis) [A list of parental medicines authorised for this puprose can be found in schedule 19 of the Huamn Medicines Regulations 2012.] **---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** - Further exemptions apply to the administration of **smallpox vaccine** or administration linked to **medical exposure** (including radioactive medicines) **-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** Specific classes of persons such as **midwives,** **paramedics** and others can also administer POMs under certain conditions. - Details are available in schedule 17 of the Human Medicines Regulations 2012. **------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** Certain healthcare professionals can also administer medicines in accorance with a **Patient Group Direction.** **-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** **Non-POMs:** medicines that are not POMs may be administered according to a locally agreed homely remedy protocol.

Answer 86

Registered healthcare professionals who administer medicines, or when appropriate delegate the administration of medicines are accountable for their actions, non-actions and omissions, and excercise professionalism and professional judgement at all times. - They would be expected to meet their own professional and regulatory standards and guidance. **-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** Non regiatered healthcare professionals are appropriately trained, assessed as competent and meet relevant organisational guidance on medicines administration.

Answer 87

Before administration the person administering the medicine must have an overall understanding of the medicine being administered and seeks advice if necessart from a prescriber or a pharmacy professional.

Answer 88

Wherever possible the actions of prescribing, dispensing/supply and administration are performed by separate healthcare professionals. Exceptionally where clinical circumstances make it necessary and in the interests of the patient. the same healthcare professional can be responsible for the prescribing and supply/administration if medicines. - Where this occurs an audit train, dcouments and processes are in place to limit errors.

Answer 89

Covert administration is the term used when medicines are administered in a disguised format without the knowledge or consent of the person recieving them - e.g. in food or in a drink.

Answer 90

Medicines are administered covertly only to people who actively refuse their medication, and who are considered to lack mental capacity in accordance with an agreed management plan.

Answer 91

- Where deemed necessary covert administration of medicines should take place within the context of existing legal and best practice framework. - Organisational policies and procedures in place covering cover administration should be followed.

Answer 92

Pharmacists who are asked to sign covert administration documentation should check carefully what they are being asked to sign off as this may indicate they have performed a clinical medication review. They should also provide advice on how mediciens should be administred or what ti do if a patient consumes only part of their food or drink.

Answer 93

Adrenaline is a POM an dis given intramuscularly for the treatment of anaphylaxis. - Brands of adrenaline intramuscular injections may include Epipen, Emerade, Jext.

Answer 94

Where a pharmacist is expected to recognise and treat an anaphylactic reaction as part of their usual clinial role (e.g. if they are offering a vaccination service) they **must have access to an anaphylaxis pack** (as outlined in the *Immunisation against infection disease* [the green book]) and **have the required training** in the recognition of anaphylaxis and administration of adrenaline.

Answer 95

The anaphylaxis pack will include: - Ampoules of adrenaline and - Syringes, needles or prefilled syringes [The above should be used in preference to auto injectors]

Answer 96

Regulation 238 of the Human Medicines Regulations 2012 allows adrenaling to be administered by anyone for the purpose of saving a life in an emergency. Therefore pharmacists using their professional and clinical judgement can administer adrenaline in an emergency to persons presenting with symptoms of anaphylaxis.

Answer 97

If a pharmacist administers adrenaline they must also ensure that an ambulance is called by dialling 999 and reporting that there is a case of suspected anaphylaxis.

Answer 98

The Human Medicines Regulations 2012 provides a range of exemptions on the restrictions on the sale, supply and administration of medicines. - A number of these exemptions are colectively described as patient specific directions (PSDs). Leglislation does not specifically define a PSD. It is however generally accepted to mean a written instruction from a doctor, dentist or non-medical prescriber for a medicine to be supplied or administered to a named patient after the prescriber had assessed that patient on an individual basis.

Answer 99

Some organistations may limit who is authorised to supply and/or administer medicines under a PSD within their local medicines policies and governance arrangements. - Any trained and competent health professional would be suitable.

Answer 100

No PSDs related to a specific named patient but do not need to comply with the requirements specified for a prescription.

Answer 101

In a hospital ward written PSDs are encountered on inpatient charts as directions to administer. Typically the directions within an inpatient chart are also copied onto an order form for the pharmacy to prepare discharge ('take home') medicines. - The pharmacist in this instance is not prescribing, and the supply is made under the authority of the origional written direction to supply. - This process should be carried out or counter checked by a pharmacist. - This form does not replace a discherge letter, however it can form part of the discharge letter.

Answer 102

While the law does not stipulate what should be included in a PSD, sufficient information must be available for the person administering the specified medicine to do so saftely. In addition a PSD if sufficiently clear may also be a direction to make a sale or supply.

Answer 103

Some hospitals have formulated policies for the supply and/or administration of POMs (& P or GSL medicines) to ensure that medicines are handled saftley, securely and appropriately. - Such policies should be carefully considered and agreed bu medical, nursing and pharmacy staff to ensure that patients are not put at risk. - The policy should be cross-referenced against standards set by any applicable body, including regulatory and professional bodies of relevant healthcare professionals involved in the process. - If in doubt the Department of Health should be consulted for hospitals in England (along with the hospitals legal advisors). or Scottish Executive for hospitals in Scotland, or The Department of health and Social Services in Wales.

Answer 104

There are several exemptions that allow POMs to be sold or suppliued without a prescription: - Patient Group Directions (**PGDs**) - Patient Specific Directions (**PDSs**) - **Emergency Supplies** - **Optometrist or Podiatrist signed patient orders** - Supply of **salbutamol **inhalers to **schools** - Supply of **adrenaline** autoinjectors to **schools** - Supply of** naloxone **by individuals providing **recognised drug treatment services**.

Answer 105

A PDG is a written direction that allows the supply and/or administration of a specified medicine or medicines, by named authorised health professionals, to a well-defined group of patients requiring treatment for a specific condition.

Answer 106

It is important that pharmacists involved with PGDs understand the scope and limitations of PGDs as well as the wider context into which they fit to ensure safe, effective services for patients.

Answer 107

The supply & administration of medicines under a PDG should be reserved for those limited situations where this offers an advantage for patient care, without compromising patient saftey.

Answer 108

A PGD should only be developed after careful consideration of all the potential methods of supply and/or administration of medicines including prescribing by medical or non-medical prescribers.

Answer 109

Yes Pharmacists Can supply, offer to supply and administer diamorphine or morphine under a PDG for the immediate, necessary treatment of sick or injured persons.

Answer 110

POMs supplied under a PGD should be labelled in the same way as if supplied against a prescription. - Name of the patients - Name & Adress of the Supplying Pharmacy - Date of Dispensing - Name of the Medicine - Directions For Use - Precautions Relating to the Use of the Medicine: (e.g. For external use only) RPS recommended warnings: "keep out of reach and sight of children", "Use this medicine only on your skin" where applicable. Prisoners number in secure environments

Answer 111

In an emergency a pharmacist working in a registered pharmacy can supply POMs to a patient (Human not animals) without a prescription on the request of a 'relevant prescriber' or a patient (conditions apply). Each request should be considered on a case-by-case basis, using professional judgement in the best interests of the patient.

Answer 112

- Doctor - Dentist - Supplementary Prescriber - Nurse Independent Prescriber (NIP) - Pharmacist Independent Prescriber (PIP) - Community Practitioner Nurse Prescriber - Physiotherapist Independent Prescriber - Podiatrist Independent Prescriber - Theapeutic Radiographer Independent Prescriber - Optometrist Indpendent Prescriber - EEA or Swiss Health Professional - Paramedic Independent Prescriber [Healthcare professionals from countries outside of the EEA or Switzerland are not recognised as 'relevant prescribers' in the UK]

Answer 113

**Relevant Prescriber** - The pharmacist is satisfied that the request is from one of the prescribers deemed relevant in the UK and allowed to make an emergency supply request. **Emergency** - The pharmacist is satisfied that a prescription cannot be provided immediately due to an emergency (e.g. patient cannot collect the prescription from the prescriber, the prescriber is unable to drop off the prescritpion at the pharmacy & the patient urgently needs the medicine(s),...) **Prescription Within 72 hours** - The prescriber agrees to provide a written prescription within 72 hours. (their legal responsibility to supply you with the prescription, not your job to chase it). **Directions** - The medicine is supplied in accordance with the directions given by the prescriber **Not For CDs, Except Phenobarbital** - Schedule 1,2 or 3 CDs cannot be supplied in an emergency whether requested by UK, EEA or Swiss health professionals. - Phenobarbital (also know as phenobarbitone or phenobarbitone sodium) is the exception and can be authorised by UK *doctor,* *dentist*, *nurse* or *pharmacist independent prescriber* or s*upplementary prescriber* in an emergency *for the treatment of epilepsy*.

Answer 114

**Not For CDs, Except Phenobarbital** - Schedule 1,2 or 3 CDs cannot be supplied in an emergency whether requested by UK, EEA or Swiss health professionals. - Phenobarbital (also know as phenobarbitone or phenobarbitone sodium) is the exception and can be authorised by UK *doctor,* *dentist*, *nurse* or *pharmacist independent prescriber* or s*upplementary prescriber* in an emergency *for the treatment of epilepsy*.

Answer 115

An entry must be made into the POM register on the day of the supply (or if impractical on the following day). The entry must include: - The date the POM was supplied - The name (including the strength & form where appropriate) & Quantity of medicine supplied. - The name & adress of the prescriber requesting the emergency supply - The name and adress of the patient for whom the POM was required. - The date on the prescription (this can be added to the entry when the prescription is recieved by the pharmacy) - The date on which the prescription is recieved (this should be added to the entry when the prescription is recieved by the pharmacy).

Answer 116

Usual Labelling Requirements: - Name of the patients - Name & Adress of the Supplying Pharmacy - Date of Dispensing - Name of the Medicine - Directions For Use - Precautions Relating to the Use of the Medicine: (e.g. For external use only) RPS recommended warnings: "keep out of reach and sight of children", "Use this medicine only on your skin" where applicable. Prisoners number in secure environments.

Answer 117

**Interview** - Regulation 225 Human Medicines Regulations 2012 requires a pharmacst to interview the patient. The RPS recognises that in some circumstances that might not be possible, e.g. if the patient is a child or being cared for...In these circumstances the RPS advises pharmacists to use their professional judgement and consider the best interests of the patient. **Immediate Need** - The pharmacist must be satisfied that there is an immediate need for the POM and that it is not practical for the patient to obtain a prescription without undue delay. *[Legislation does not prevent a pharmacist from making an emergency supply when a doctor's surgery is open. As with any request for an emergency supply, pharmacists must consider the best interests of the patient. Where a pharmacist believes that it would be impractical in the circumstances for a patient to obtain a prescription without undue delay that could potentially harm the patinet they may decide that an emergency supply is necessary. Automatically referring patients who are away from home and have forgotten or run out of their medication to the nearest local surgery to register as a tempoary resident may not always be the most appropriate course of action]* **Previous Treatment** - The POM requested must previosuly have been used as a treatment and prescribed by a relevant UK, EEA or Swiss health professional. [NB: the time interval from when the medicine was last prescribed to when it is requested as an emergency supply would need to be considered and you should use your professional judgement to decide whether a supply or referral to a prescriber is appropriate] **Dose** - The pharmacist must be satisfied of knowing the dose that the patient needs to take (e.g. refer to the PMR, electronic health record, prescription repeat slip, labelled medicine box... **Not For CDs, Except Phenobarbital** - Phenobarbital can be supplied to patients of UK-registered prescribers for the purpose of treating epilepsy. - Medicinal products cannot be supplied if they consist of or contain any other schedule 1,2 or 3 CDs. - Medicinal products consisting or containing the following also cannot be supplied: ammonium bromide, calcium bromide, calcium bromidolactobionate, embutramide, fencamfamin hydrochloride, fluanisone, hexobarbitone, hexobarbitone sodium, hydrobromic acid, meclofenoxate hydrochloride, methohexitone sodium, pemoline, piracetam, potassium bromide, prolintane hydrochloride, sodium bromide, strychnine hydrochloride, tacrine hydrochloride, thiopentone sodium. **Marketing Authoristation In UK** - requests made by a patient of an EEA or Swiss health professional cannot be supplied if they are for medicines that do not have a marketing authorisation valid in the UK. **Emergency Supply Abuse** - Pharmacists should be mindful of patients abusing emergency supplied (e.g. where a patient medication record shows that a patient had requested a medicine as an emergency supply on several occasions).

Answer 118

**Not For CDs, Except Phenobarbital** - Phenobarbital can be supplied to patients of UK-registered prescribers for the purpose of treating epilepsy. - Medicinal products cannot be supplied if they consist of or contain any other schedule 1,2 or 3 CDs. - Medicinal products consisting or containing the following also cannot be supplied: ammonium bromide, calcium bromide, calcium bromidolactobionate, embutramide, fencamfamin hydrochloride, fluanisone, hexobarbitone, hexobarbitone sodium, hydrobromic acid, meclofenoxate hydrochloride, methohexitone sodium, pemoline, piracetam, potassium bromide, prolintane hydrochloride, sodium bromide, strychnine hydrochloride, tacrine hydrochloride, thiopentone sodium. **Marketing Authoristation In UK** - requests made by a patient of an EEA or Swiss health professional cannot be supplied if they are for medicines that do not have a marketing authorisation valid in the UK.

Answer 119

**CD** - if the emergency supply is for a CD (i.e phenobarbital or schedule 4/5 CD), the maxium quantity that can be supplied is for* FIVE days treatment.* **Any Other POM** No more than *30 days* can be supplied except in the following circumstances: - if the POM is insulin, an ointment, a cream, or an inhaler for asthma (i.e the packs cannot be broken), the smallest pack available in the pharmacy should be supplied. - If the POM is an oral contraceptive a full treatment cycle should be supplied. - If the POM is an antibiotic in liquid form for oral administration, the smallest quantity that will provide a fully course of treatment should be supplied. [NB: pharmacists should also consider whether it is appropriate to supply less than the maximim quantity allowed in legislation. Professional judgement should be used to supply a reasonable quantity that is clinically appropriate and lasts until the patient is able to see a prescriber to obtain a further supply.]

Answer 120

An entry must be made into the POM register on the day of the supply (or if impractical on the following day) The entry must include: - The date the POM was supplied - The name (including strength & form where appropriate) & the quantity of medicine supplied) - The name & adress of the patient for whom the POM was supplied. - Information on the nature of the emergency, such as why the patient needs the POM and why a prescription cannot be obtained....

Answer 121

In addition to the standard labelling requirements, the words 'Emergency Supply" needs to be added to the dispensing label. Standard Requirements: - Name of the patients - Name & Adress of the Supplying Pharmacy - Date of Dispensing - Name of the Medicine - Directions For Use - Precautions Relating to the Use of the Medicine: (e.g. For external use only) RPS recommended warnings: "keep out of reach and sight of children", "Use this medicine only on your skin" where applicable. Prisoners number in secure environments.

Answer 122

If a pharmacist decides not to make an emergency supply after gathering and considering the information/Situation the patient should be advised on how to obtain a prescription for medicine or appropriate medial care. - This could involve referral to a doctor, NHS 111, NHS walk-in centre, or to Accident & Emergency Department. [A record could be made of why request was refused for audit purposes]

Answer 123

In England an NHS Advanced Service enables NHS 111, urgent care settings & 999 providers to refer patients to a community pharmacy for an emergency supply of regular medicines under the NHS.

Answer 124

In Scotland a national PGD allows participating pharmacies & pharmacists to supply medicines for the urgent provision of current repeat medicines, appliances and ACBS(borderline) items. - Emergency supply remains an option for patients who are not eligible for treatment under the national PGD.

Answer 125

Optometrists & Podiatrists cannot authorise supplies of POMs by writing prescriptions unless they are additionally qualified as independent or supplementary prescribers. - However pharmacists working in a registered pharmacy can supply certain POMs directly to patients in accordance with a signed patient order from any registered optometrist or podiatrist. - The medicine requested must be one which can be legally sold or supplied by the optometrist or podiatrist rather than one which they can only administer (MHRA website has list). NOTE: Optometrists who have undertaken additional training and are accredited by the GOC as 'additional supply optometrists' can issue signed patient orders for an extended range of medicines. *[The patient will have to pay for the medicine recieved throguh a signed patient order]*

Answer 126

The signed patient order is not a prescription: therefore the usual prescription requirements would not be needed. However, you should be satisfied the optometrist or the podiatrist had provided sufficient advice to enable the patient to use the medicines saftey and effectively. - Also want to check the registration status of the optometrist or podiatrist if not know to you.

Answer 127

If the supply is made, the pharmacist should ensure that the medicines is labelled accordingly as a dispensed medicinal product. Standard Requirements: - Name of the patients - Name & Adress of the Supplying Pharmacy - Date of Dispensing - Name of the Medicine - Directions For Use - Precautions Relating to the Use of the Medicine: (e.g. For external use only) RPS recommended warnings: "keep out of reach and sight of children", "Use this medicine only on your skin" where applicable. Prisoners number in secure environments.

Answer 128

- A patient information leaflet needs to be supplied as usual to a patient. - Any additional advice shoudl aslo be provided if it had not already been provided by the optometrist or podiatrist.

Answer 129

An appropriate record must be made in the POM register: The entry must include: - The date the POM was supplied - The name (including the strength & form where appropriate) & Quantity of medicine supplied. - The name & adress of the podiatrist/optometrist making the signed patient order - The name and adress of the patient for whom the POM was required.

Answer 130

Schools can obtain supplies of adrenaline auto-injectors (AAIs) and/or salbutamol inhalers from a pharmacy by writing a signed order. - These can then be administered in an emergency, by persons trained to administer them to pupils previosuly prescribed such medicines and where parental consent has been recieved. *[They will have to purchase them when using a signed order]*

Answer 131

The signed order should contain: - The name of the school - Product details (including spacer if relevant) - Strength (if relevant) - Purpose for which the product is required - Total quantity required - Signature of the principle or head teacher [Ideally appropriately headed paper should be used, hwoever this is not a legislative requirement.] NOTE: Different brands of AAIs and salbutamol are available and each brand may have different instructions for administration. The Department Of Health advises schoold to hold an appropriate quantiy of a signle brand of AAI devices to avoid confusion in administraton/training. The decision as to how many brand the school can purchase will depend on local circumstances and is left to the discretion of the school.

Answer 132

The number that can be obtained by individual school is not specified in legislation. - Schools can purchase slabutamol inhalers/AAId from pharmacies provided it is for small quantities, on an occasional basis and not for profit. Pharmacists should excercise their professional judgement when responding to requests from schools. Factors to consider include: - School size and number of sites it is comprised of - Number of children known to affected - Past experiences e.g. of children not having access to an AAI or inhaler.

Answer 133

The signed order needs to be retained for TWO years from the date of supply or an entry made into the POM register. - Even when the signed order is retained, it is good practice to make a record in POM register for audit purposes. POM Register Entry Requirements: - Date the POM was supplies - Name, Quantity and where not apparent Formulation & Strength of POM supplied. - Name & Adress, Trade, Buisness or Profession of the person to whom the medicine was supplied. - Purpose for which it was sold or supplied

Answer 134

There is no centralised database containing details of schools and head teachers across Great Britain. Possible Sources of information: - Department for Education's register of educational establishment in England and Wales - Ofsted reports - Indivudual School Website

Answer 135

All primary and secondary schools in the UK including: - Maintained schools - Independent schools - Pupil referral units - Maintained nursery schools

Answer 136

-How to use & store correctly - Advice on the most appropriate spacer device for the different age groups and how to use them correctly - Advice on correct storage, care and disposal - Importance of record keeping, regular date checking and when to replace.

Answer 137

Deaths in the UK involving heroin and/or morphine have significantly increased in recent years. Naloxone is an opioid/opiate antagonist which can completely or partically reverse the central nervous system depression, especially respiratory depression caused by natural or synthetic opioids and is licensed for the treatment of suspected acute opioid overdose. A number of naloxone products are licensed for use in reversing acute opioid overdose.

Answer 138

Following legislative changes in **October 2015** naloxone falls into a unique category: Naloxone remains a POM but the Human Medicines (amendment) (No 3) Regulations 2015 allow staff engaged or employed in '*lawful drug treatment services*' to **obtain naloxone from a wholesaler** and **make direct supplies to patients without a prescription**, Patient group direction (PGD), or Patient specific direction (PSD). - From **Febuary 2019** this includes **nasal naloxone**

Answer 139

Lawful drug treatment services is defined as Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies: (a) an **NHS body** (b) a** local authority** (c) **Public Health England** (d) **Public Health Agency** **----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** This definition extends to commissioned services providing needle and syringe programmes (including those provided by pharmacies) and pharmacies providing drug treatment services (includes instalment and supervised dispensing of Opioid Substitute Therapies (OST))

Answer 140

Anyone can administer naloxone for the purpose of saving a life (Schedule 19 of the Human Medicines Regulations 2012) and there is evidence for the effectiveness of training family members or peers in how to administer the drug. - The 2015 amendments widen the groups of people who are eligible to recieve supplies of naloxone. - This has been extended to cover people likely to witness an overdose and includes family mambers, peers and staff in regular contact with drug users where naloxone may be required.

Answer 141

A pharmacy may be commissioned to participate in a local take home naloxone scheme. NOTE: This is a service that can contin ue to be provided by appropriately trained staff in the absence of the PR.

Answer 142

The Pregnancy Prevention programmes (PPP) protect females of childbearing potential by minimising the risk of becoming pregnant while taking these medicines. **-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** Medicines Involved: *- Oral retinoids - Valporate - Thalidomide - Lenalidomide - Pomalidomide* [These medicines carry a high risk of causing foetal malformations and/or can increase the risk of spontaneous abortion when taken by women and girls] **------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** Pharmacists can help by ensuring that such medicines are not dispensed for women or girls who might be pregnant or are considering becoming pregnant unless they follow the manufacturer's Pregnancy Prevention Programme or the prescriber agrees there are compelling reasons that indicate there is no risk of pregnancy e.g. hysterectomy

Answer 143

Full details on all PPPs can be found in the manufactures's 'Summary Of Product Characteristics' and risk materials available at www.medicines.org.uk

Answer 144

Oral retinoids (including Acitretin, Alitretinoin & Isotretinoin) are used for severe skin conditions. - They are described in their Summary of Product Characteristics (SPCs) as a 'powerful human teratogen inducing a high frequency of severe and life-threatening birth defects' and therefore contraindicated in pregnant women and women of childbearing potential unless all of the conditions of the PPP are met.

Answer 145

The programme is a combination of **education** for healthcare professionals and patients, **therpy management **(including pregnancy testing before, during and after treatment; contraceptive requirements) and **distribution control**.

Answer 146

Oral Retinoids should only be initiated by or under the supervision of a dermatologist, prescribing GP with an extended role in dermatology, or a specialist dermatology nurse, and under the conditions of the PPP. - The prescriber must check that the patient complies with, understands and acknowledges the reasons for pregnancy prevention and agrees to monthly follow-up, contraceptive precautions and pregnancy testing.

Answer 147

1. **Prescription Validity**: Under the PPP, prescriptions are valid only for 7 days and ideally should be dispensed on the date the prescription is written. Prescriptions which are presented after 7 days should be considered expired and the patient should be referred back to the prescriber for a new prescription. Pregnancy status may need to be reconfirmed by a further negative pregnancy test. 2. **Quantity**: Check that the quantity is for a maximum of 30 days supply. A quantity for more than 30 days can only be dispensed if the patient is confirmed by the prescriber as not being under the PPP. [- Pharmacists should not accept repeat prescriptions, free sample distribution, or faxed prescriptions for oral retinoids. - A telephone request should only be accepted if this is an emergency supply at the request of a PPP specialst prescriber together with confirmation that pregnancy status has been established as negative within the preceding 7 days]

Answer 148

Valproate: Is used to treat epilepsy, bipolar disorder and for preventing migrane (unlicensed). - However valproate can seriously harm an unborn child when taken during pregnancy.

Answer 149

Valproate should not be taken by women and girls unless nothing else works and the person taking valporate part of a pregnancy prevention programme (PPP)

Answer 150

- Have a conversation with female patients of child-bearing age who are prescribed valproate to find out if they have had a review with their doctor, are aware of the risks and are on a PPP - Those planning pregnancy should be advised to schedule an appointment with their prescriber to review treatment and to continue with contraception and valproate treatment in the meantime. - If there is an unplanned pregnancy whilst a patient is taking valproate medicines advise the patient NOT to stop their treatment and to arrange to see their prescriber urgently to review treatment. - Provide a patient care everytime valproate is dispensed. - Dispense valproate preparations in origional packs whenever possible. If dispensing in 'white boxes' ensure a patient information leaflet is provided and a valproate warning labe/sticker added to the box. - Ensure the dispensing label does not cover the warning label/sticker - Emphasize the importance of the need for an annual specialist review. - Report any suspected side effects to valproate medicines via the Yellow Card Scheme.

Answer 151

A biologic is a medicine made from a variety of natural sources that may be human, animal or microorganism in origin. Advances in biotechnology have resulted in an increasing number of biological molecules & materials being used as medicines.This is a trend that is expected to continue, at least for the foreseeable future. Examples of a biologic: - Vaccines - Blood & Blood products - Somatic Cells - DNA - Human Cells & Tissues - Therapeutic Proteins [In general the first or origional biologic on the market is termed the originator or reference product]

Answer 152

- A biosimilar is a biological medicine that is similar to an already licensed biologic medicine in terms of quality, saftey and efficiacy. - A biosimilar is specifically developed and licensed to treat the same disease(s) as the original innovator product. - A biosimilar can only be marketed after the patent protecting the originator product and any period of marketing exclusivity have expired. [A biosimilar is not the same as a generic medicine & as a pharmacist you will need to be aware of the guidance around the use of biosimilars in order to ensure their safe & effecitve use] **------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** A number of patents & periods of marketing exclusivity for biological medicines are expiring & biosimilar vesions of the medicines are becoming more widely available e.g. Insuling Glargine. - The introducton of biosimilars offers potential benefits in terms of cost savings for the NHS & increased access to treatment for patients.

Answer 153

- Due to the complexity of structure and greater molecule size of biologics as well as their inherent heterogeneity resulting from their production methods, it is not possible to make an identical copy of the originatory biologic. - Biosimilars are licensed for use based on extension data on quality, saftey and efficacy compared to the originator product. - It is not possible to characterise a biologic to the same extent as a small molcule drug, where an identical copy can be produced, known as a generic medicine.

Answer 154

Any decision to change the brand of a biologic used to treat a patient must only be made by a prescriber following discussions with the patient. - It is recommended that at the point of dispensing, the pharmacist confirms the patient has recieved the biologic they expect & that they are aware of how to store & use the medicine.

Answer 155

In contrast to generic products, all biosimilars will have their own unique brand name. - The MHRA has recommended that all biologics should be prescribed by brand to avoid automatic substitution.

Answer 156

It is important that both the brand name and batch number of a biologic medicine are provided when reporting suspected adverse drug reactions to biologics to facilitate effective saftey monitoring. - To support patient saftey pharmacists should consider it good practice to record the brand name and batch numbers of any biologic medicine (including biosimilars) supplied to a patient.

Answer 157

An advanced therapy medicinal product (ATMP) is a biological medicinal product based on genes, tissues or cells which is either: - A gene therapy medicinal product - A somatic cell therapy medicinal product - A tissue engineered product **--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------** In addition some ATMPs may contain one or more medical devices as an integral part of the medicine, which are referred to as combined ATMPs. - e.g. cells embedded in a biodegradable matrix or scaffold

Answer 158

**Gene therapy medicines:** these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting 'recombinant' genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer or long-term diseases. A recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources

Answer 159

**Somatic-cell therapy medicines:** these contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases

Answer 160

**Tissue-engineered medicines**: these contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue

Answer 161

The majority of ATMPs are used in clinical trials, however some are now available as licenced medicines: - Talimogene laherparepvec (for metastatic melanoma) - Axicabtagene ciloleucel (for large B cell lymphoma - treatment commonly known as CAR-T therapy)

Answer 162

Yes As ATMPs are medicines they are subject to the same requirements as for other medicinal products. - The chief pharmacist is responsible for their governance & management.

Answer 163

All prescribers should recognise the limits of their own knowledge & skills & prescribe within their own competence & clinical expertise.

Answer 164

Schedule 1 CDs can only be prescribed under Home Office licence

Answer 165

Yes - A Home Office licence is required to prescribe cocaine, diamorphine or dipipanone for treatment addiction. - The adress of the doctor must be within the UK when prescribing a schedule 2 or 3 CD

Answer 166

Yes - Including Phenobarbital for epilepsy but not other schedule 2 or 3 CD as long doctors is a UK doctor

Answer 167

To practice medicines in the UK, doctors are required to be registered with the GMC & hold a licence to practice.

Answer 168

Yes - The adress of the dentist must be within the UK if it is for a schedule 2 or 3 CD - A Home office licence is required to prescribe cocaine, diamorphine or dipipanone for treating addiction.

Answer 169

Yes - Includes Phenobarbital for the treatment of epilepsy but no other schedule 2 or 3 CD if they are a UK dentist.

Answer 170

Dentists should restrict prescribing to treatment of dental conditions but legally can prescribe any medicine within their clinical expertise. NHS dental prescriptions are restricted to the medicines list in the Dental Practitioners Formulary

Answer 171

Yes - Prescriptions for schedule 2 & 3 CDs do not need to be on the standardised forms but must include the RCVS registration number of the prescriber.

Answer 172

Yes - Where the medicine is not licensed for the animal intended then it needs to be prescribed under the veterinary cascade.

Answer 173

No (Emergency supply legislation applies to human use only)

Answer 174

No Can only prescribe for the treatment of animals.

Answer 175

Yes - But not cocaine, diamorphine or dipipanone for treating addiction.

Answer 176

Yes - Unlicensed medicines are excluded from the Nurse Prescribers Formulary in the Scottish Drug Tariff and therefore are not reimbursed on NHS prescriptions in Scotland.

Answer 177

Yes - Includes Phenobarbital for epilepsy but no other scehdule 1,2 or 3 CDs if they are a UK NIP or MIP

Answer 178

Only 'off-label' medicines (i.e using a licensed medicine outside of its approved use)

Answer 179

For treating conditions affecting the eye and surrounding tissue only; but not parental preparations

Answer 180

No - At the time of writing proposed changes to legislation in realtion to certain CDs were being considered by the Home Office.

Answer 181

Only 'off-label' medicines (i.e using a licensed medicine outside of its approved use)

Answer 182

Yes - But not schedule 1,2 or 3 CDs (including Phenobarbital)

Answer 183

Yes - But not cocaine, dimorphine or dipipanone for treating addiction

Answer 184

Yes - Including Phenobarbital for epilepsy but not other schedule 1,2 or 3 CDs if they are a UK PIP.

Answer 185

Only the following CDs: For oral administration - Diazepam, Dihydrocodeine, Lorazepam, Morphine, Oxycodone & Tempazepam For Injection - Morphine For transdermal - fentanyl

Answer 186

Only Off-label Medicines (i.e using a licensed medicine outside of its approved use).

Answer 187

Yes - But not schedule 1,2 or 3 CDs (including Phenobarbital)

Answer 188

Only the following CDs for oral administration: - Diazepam - Dihydrocodeine - Lorazepam - Temazepam

Answer 189

Only Off-label medicines (i.e using a licensed medicine outside of it approved use)

Answer 190

Yes - But not for schedule 1, 2 or 3 CDs (including Phenobarbital)

Answer 191

No - At the time of writing proposed changes to legislation in relation to certain CDs were being considered by the Home Office.

Answer 192

Only Off-label medicines (i.e using a licensed medicine outside of its appropriate use)

Answer 193

Yes - But not schedule 1, 2 or 3 (including phenobarbital)

Answer 194

Yes - But not cocaine, dimorphine or dipipanone for treating addiction

Answer 195

Yes - Including Phenobarbital for epilepsy but not other schedule 1,2 or 3 CD if they UK supplementary prescribers

Answer 196

Prescribing is restricted to areas of clinical competence & included within an agreed written clincial management plan (written & agreed with a prescriber & often the patient)

Answer 197

No - Other than Nystatin off-lable for neonates

Answer 198

Prescribing restricted to dressings, appliances & licensed medicines listed in the Nurse Prescribers Formulary (BNF)

Answer 199

Schedule 4 & 5 CDs only. - For schedule 2 & 3 CDs prescriber needs to have a UK adress

Answer 200

Only 'off-label' medicines (i.e using a licensed medicines outside its approved use)

Answer 201

Yes - But not schedule 1, 2 or 3 CDs (including phenobarbital) as not UK based prescriber

Answer 202

Can only prescribe items which have a recognised marketing authorisation within the UK.

Section 3 - Underpinning knowledge: legislation and professional issue Flashcards

3.1 Classifications of medicines 3.2 Professional and legal issues: pharmacy medicines 3.3 Professional and legal issues: prescription-only medicines 3.4 Wholesaling 3.5 Veterinary Medicines 3.6 Controlled Drugs 3.7 Additional legal and professional issues (235 cards)