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
What act regulated the authorisation, sale and supply of medicinal products for human use?
Name/Year + Previous Name/year
3
The Human Medicines Regulations 2012 consolidates most of the legislation regulating the authorisation, sale and supply of medicinal products for human use, made under the medicines act 1968.
What regulation covers the prescribing and supply of medicinal products for animals?
Name/Year
3
The veterinary medicines regulations 2013 covers the prescribing and supply for animals.
What Does The Programme Board For Rebalancing Medicines Legislation & Pharmacy Regluation do?
3
- Reviews relevant pharmacy leglislation and regulation to ensure it provides saftey for users of pharmacy services.
- It facilitates a systematic approach to quality in pharmacy, allowing innovation and development of pharmacy practice whilst reducing the burden of unnecessary and inflexible regulations.
- The programme will build on and propose ammendments to legislation as required to deliver a modern approach to regulation which maintains patient and public saftey, whilst supporting professional and quality systems development, including learning from dispensing errors made in registered pharmacies.
Can pharmacists refuse to sell or supply ANY medicines
3.1
Yes - pharmacists are empowered to refuse to sell or supply any medicine if it is contrary to their clinical judgement.
How many classes of medicinal products for humans are there under the Human Medicines Regulation 2012?
3.1
3:
General Sales List Medicines (GSL)
Pharmacist Present Medicines (P)
Prescription Only Medicines (POMs)
What is a General Sales List Medicine (GSL)?
- Medicines that can be made available as ‘self-selection’ items for sales in registered pharmacies.
- They can also be sold in other retail outlet that can ‘close so as to exclude the pubic’
Does a pharmacist have to be present for GSL medicines to be sold in a pharmacy?
3.1.1 General Sales medicines
Within a pharmacy, GSL medicines can only be sold when a pharmacist has assumed the role of responsible pharmacist.
- The pharmacist however may be physically absent for a limited period of time, while remaining responsible thus permitting sales of GSL medicines during this absence.
What is a Pharmacy (P) medicine?
3.1.2 Pharmacy (P) Medicines
A pharmacy medicine is a medicinal product that can be sold from a registered pharmacy premesis by a pharmacist or a person acting under the supervision of a pharmacist.
- P medicines must not be accessible to the public by self-selection.
Should/Are Pharmacy (P) Medicines accessible to the public by self-selection?
3.1.2 Pharmacy (P) Medicines
- P medicines must not be accessible to the public by self-selection.
What Classes of medicines are collectively known as OTC or non-prescription medicines?
3.1.2 Pharmacy (P) Medicines
GSL medicines & P medicines are collectively known as over-the-counter (OTC) or non-prescription medicines.
- The sale of some of these medicines is associatied with the additional legal and professional considerations.
What is a Prescription-Only Medicine (POM)?
3.1.3 Prescription-only Medicines (POM)
A prescription-only medicines (POM) id a medicine that is generally subject to the restriction of requiring a prescription written by an appropriate practitioner.
What Appropriate Practitioners can write prescriptions for Prescription-only Medicines (POMs)?
3.1.3 Prescription-only Medicines (POM)
- Doctors
- Dentists
- Supplementary Prescribers
- Nurse Independent Prescribers (NIP)
- Pharmacist Independent Prescribers (PIP)
- EEA and Swiss approved health professionals
- Community Practitioner Nurse Prescribers
- Optometrist Independent Prescribers (not for controlled drugs or parental medicines)
- Paramedic Independent Prescribers
- Physiotherapist Independent Prescribers
- Podiatrist Independent Prescribers
- Therapeutic Radiographer independent Prescribers (for certain medicines)
Can A Medicine Be Classed Under More Than One Class Of Medicinal Product?
3.1.3 Prescription-only Medicines (POM)
Yes
- Some medicines depending on the formulation, strength, quantity, indication or marketing authorsiation can be classified under more than one catagory.
What Is A Reclassified Medicine?
3.1.4 Reclassified Medicines
When a medicine moves from one class to another.
e.g. a POM becoming a P medicine or vice versa.
Why Would A Medicine Be Reclassified
3.1.2 Reclassified Medicines
POM to P: Pharmacists deemed competent to assess need for the drug and the drug deemed safe enough that its more free use will not affect patient saftey.
- Good for providing pharmacists with a larger range of medicines that they can select from to treat patients.
- Its important that pharmacists and pharmacy staff involved in the sale of medicines are appropriately trained to support patients with medicines that they need.
Examples of Medicines That have Been Reclassified
- POM to P
3.1.2 Reclassified Medicines
- Amorolfine nail lacquer
- Anti-malarials
- Chloramphenicol eye drops & ointment
- Desogestrol
- Emergency Contraceptives
- Mometasone 0.05% nasal spray
- Oral lidocaine-containing products for teething
- Orlistat
- Sildenafil
- Sumatriptan
What are pseudoephedrine & Ephedrine widely used for?
3.2.1 Pseudoephedrine & Ephedrine
- Decongestants
What Class of drug are Pseudoephedrine & Ephedrine?
3.2.1 Pseudoepedrine & Ephedrine
Pharmacy (P) medicines
Why are their restrictions on the quantiy of Pseudoephedrine & Ephedrine you are allowed to sell or supply without a prescription?
3.2.1 Pseudoephedrine & Ephedrine
Both have potential for misuse in the illicit production of methylamphetamine (crystal meth) - a Class A controlled drug
What is the quantity of Pseudoephedrine that is allowed to be sold or supplied without a prescription?
3.2.1 Pseudoephedrine & Ephedrine
It is unlawful to supply a product or combination of products containing more than 720mg of Pseudoephedrine at any one time without a prescription.
(regulation 237 of the Human Regulations 2012)
What is the quantity of Ephedrine that is allowed to be sold or supplied with a prescription?
3.2.1 Pseudoephedrine & Ephedrine
It is unlawful to supply a product or combination of products containing more than 180mg of ephedrine at any one time, without a prescription.
(Regulation 237 of the Human Regulations 2012)
Can you Sell or supply Pseudoephedrine & Ephedrine together without a prescription?
3.2.1 Pseudoephedrine & Ephedrine
It is unlawful to sell or supply any pseudoephedrine product at the same time as an ephedrine product without a prescription.
(Regulation 237 of the Human Regulations 2012)
Who Is Allowed to Sell or Supply Pseudoephedrine or Ephedrine?
3.2.1 Pseudoephedrine & Ephedrine
The sale or supply of Pseudoephedrine or Ephedrine should either be made personally by the pharmacist or by pharmacy staff that have been trained, are competent to deal with pseudoephedrine & ephedrine issues and know when it is necessary to refer to the pharmacist.
Can you refuse to sell or supply with Pseudoephedrine or Ephedrine
3.2.1 Pseudoephedrine & Ephedrine
Even when a request is made for a lawful quantity the sale or supply can be refused where there are reasonable grounds for suspecting misuse.
- A person purchasing pseudoephedrine/ephedine for illicit purposes may not be a user of methylamphetamine and therefore may not conform to stereotypes.
Signs Indicating Seeking Pseudoephedrine/Ephedrine for Possible Misuse
3.2.1 Pseudoephedrine & Ephedrine
- 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
If Suspicious That A Person May Be Requesting Pseudoephedrine/Ephedrine For Illicit Purposes Who Can You Report It To?
3.2.1 Pseudoephedrine & Ephedrine
Suspicions can be reported to:
- your local GPhC inspector,
- local controlled drugs liaison police officer
- accountable officer.
How Many Methods of Emergency Contraceptive is There?
What Are They?
3.2.2 Oral Emergency Contraception
3
- Copper Intrauterine Device (CU-IUD)
- Oral Ulipristal acetate
- Oral Levonorgestrel
What Should Be The Pharmacists Role In Relation To Emergency Contraceptive?
3.2.2 Oral Emergency Contraception
- Providing advice on all methods of emergency contraception
- Assessing suitability
- Approving sales or signposting to alternative providers.
Levonorgestrel For Emergency Contraceptive
Dose, License(age, use, time from UPSI/contraceptive failure)
3.2.2 Oral Emergency Contraception
Levonorgestrel 1500mcg tablet.
Liscence:
- Women over 16 years
- For emergency contraceptive use
- Within 72 hours of UPSI/contraceptive failure
Ulipristal Acetate For Emergency Contraceptive
Dose, Liscence(use, time from UPSI/contraceptive failure)
3.2.2 Oral Emergency Contraception
Ulipristal 30mg tablet
Liscence:
- For Emergency Contraception use
- Within 120hours (5 days) of UPSI/contraceptive failure
Can A Pharmacist Supply An Advance Supply Of Oral Emergency Contraception?
3.2.2 Oral Emergency Contraception
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.
What Should A Pharmacist Assess of A Patient Before Providing Oral Emergency Contraception?
- Particualry when it is an advance supply request
3.2.2 Oral Emergency Contraception
The patient should be assessed to ensure:
- that they are competent,
- they intend to use the medicine appropriately
- it is clinically appropriate.
Who Should You Inform If Your Religious or Moral Beliefs Impact On Your Willingness To Supply Oral Emergency Contraception?
3.2.2 Oral Emergency Contraception
- Employer
- Locum Agency
- Colleagues you will be working with
Vunerable Adults & Children - What To Consider When Oral Emergency Contraceptive Requested
3.2.2 Oral Emergency Contraception
- 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.
Can Ulipristal Acetate Be Supplied to Someone Under 16?
- Manufacturers liscence/recommendations
3.2.2 Oral Emergency Contraception
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….
Children Under The Age of 13 Asking For Supply of Oral Emergency Contraception
- What to consider/do
3.2.2 Oral Emergency Contraception
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.
Children Under the Age of 16 Asking For Supply of Oral Emergency Contraception
- What to consider/do
3.2.2 Oral Emergency Contraception
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.
Can Pharmacists Provide Contraception or Sexual health Advice to Children Under The Age Of 16?
Yes/No
3.2.2 Oral Emergency Contraception
Yes
How Does Patient Confidentiality Apply To Children Under The Age of 16 When it Comes To Pharmacists Providing Contraception/Sexual Health Advice?
3.2.2 Oral Emergency Contraception
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.
What Are Other Ways You Could Supply Emergency Contraception?
Other providers/services/routes other than selling
3.2.2 Oral Emergency Contraception
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)
What Are The Legal Restrictions For Selling Paracetamol?
Non-effervescent & Effervescent
3.2.3 Paracetmol & Aspirin
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]
What Are The Legal Restrictions For Selling Aspirin?
Non-effervescent & Effervescent
3.2.3 Paracetamol & Aspirin
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]
What Changes The Marketing Authorisation of Aspirin & Paracetamol?
- Means they are a POM, P or GSL
3.2.3 Paracetamol & Aspirin
- Formulation
- Pack Size
Why Are There Tighter Controls & Warnings On Packaging Of OTC Solid Dose Medicines Containing Codeine or Dihydrocodeine?
3.2.4 Codeine & Dihydrocodeine
These were introduced to minimise the risk of overuse and addiction to these medicines.
What Are The Added Tighter Controls & Warnings on Packaging of Solid Dose Medicines Containing Codeine & Dihydrocodeine?
Indication, Pack Sizes, Patient Information leaflet/Lables
3.2.4 Codeine & Dihydrocodeine
**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.
Can You Sell More Than One Pack of an OTC Codeine or Dihydrocodeine Product?
3.2.4 Codeine & Dihydrocodeine
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
Role Of Pharmacists/Pharmacy Team in OTC Sales of Codeine/Dihydrocodeine Products?
3.2.4 Codeine & Dihydrocodeine
- 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.
The Sale, Supply & Administration Of Prescription-only-medicines (POMs) Is Restricted By What?
3.3.1 General Prescription Requirements
Human Medicines Regulations 2012
A Pharmacists Is Able To Supply or Sell a POM Under The Authority Of What?
3.3.1 General Prescription Requirements
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…)
The Prescribing Of POMs Is Restricted By What?
3.3.1 General Prescription Requirements
- The Human Medicines Regulations 2012
- The Controlled Drug legislation
- The specific prescriber’s regulatory & professional body.
What Are The Requirements Of A General Prescription?
7 Total + Details
3.3.1 General Prescription Requirements
- 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)
- Adress of prescriber (Prescription must include the adress of the appropriate practitioner)
- 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.)
-
Particulars of prescriber (Prescription require particulars that indicate the type of appropriate practitioner)
5.** Name of patient** - Adress of patient
- Age of the patient (if under 12 years)
What Are The Signature Requirements On A General Prescription?
1-Prescription Requirements
3.3.1 General Prescription Requirements
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’
What Are The Adress Of Prescriber Requirements On A General Prescription?
2-General Prescription Requirements
3.3.1 General Prescription Requirements
A prescription must include the adress of the appropriate practitioner
What Is The Date Requirements On A General Prescription?
3-General Prescription Requirements
3.3.1 General Prescription Requirements
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.
What Is The Particulars Of Prescriber Requirements On A General Prescription
4-General Prescription Requirements
3.3.1 General Prescription Requirements
Prescriptions require that particulars indicating the type of appropriate practitioner are present.
What Are The INK Requirements Of A Prescription?
3.3.1 General Prescription Requirements
Prescriptions must be written in indelible INK
- They may be computer generated or typed.
What Are The Requirements For Private Prescriptions?
3.3.1 General Prescription Requirements
Same as General Prescription Requirements for NHS Prescriptions.
- Dont need to be written of the NHS prescriptions forms though.
What Are The Requirements For Homecare Prescriptions?
3.3.1 General Prescription Requirements
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.
What Are The Rules About Carbon Copies of NHS Prescriptions?
3.3.1 General Prescription Requirements
It is permissible to issue carbon copies of NHS prescriptions as long as they are signed in INK.
What Is An Advanced Electronic Signature?
What is it/Issues with it/When conditions not met for it
3.3.1 General Prescription Requirements
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.
Electronic Prescriptions
Requirements/Validity not met
3.3.1 General Prescription Requirements
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.
Dispencing A Presciption In The Welsh Lanuage
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.
Prescriptions From The Crown Dependencies (Jersey, Guernsey & Isle of Man)
Prescription Requirements/Agreements with these territories
3.3.1 General Prescription Requirements
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.
Emergency Supply Requests From A Patient/Prescriber From The Crown Dependencies (Jersey, Guernsey & Isle of Man)
Requirements/Considerations
3.3.1 General Prescription Requirements
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.
Prescription Forms Allowed on NHS
- Scotland
3.3.1 General Prescription Requirements
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.
Repeatable Prescriptions
What Are They/When Commonly Used
3.3.1 General Prescription Requirements
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.
Repeatable Prescriptions
- How Many Times Can They Be Repeated
3.3.2 General Prescription Requirements
- 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).
Repeatable Prescriptions
- What Cannot Be Repeated
3.2.2 General Prescription Requirements
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)
Repeatable Prescriptions
- Time valid for (POM/Schedule 5 /4 CD) first dispense/repeats?
3.2.2 General Prescription Requirements
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.]
Word Repeat Used Often In Relation To Prescribing & Dispensing Of?
3.2.2 General Prescription Requirements
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)
Prison & Other Residential Custodial Secure Environments In England Prescription forms.
3.2.2 General Prescription Requirements
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.
**Validity of Ownings On Prescriptions
POM/Schedule 5,4,3,2 CDs/P/GSL**
Pharmacy Owning Stock To Patient.
3.2.2 General Prescription Requirements
POMs & Schedule 5 CDs: 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.]
Record Keeping - Legal Requirements for:
- Retainment of Private POM/CD physical Prescriptions.
- POM register entry: what must include/how long need to retain it
- Exemptions
3.2.2 General Prescription Requirements
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.
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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]
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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.
Incomplete Prescriptions
- Implications of
3.2.2 General Prescription Requirements
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.
What is the Falsified Medicines Directive (FMD)
3.2.2 General Prescription Requirements
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.
What Can Dentists Legally Prescribe?
3.3.2 Dental Prescriptions
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.
What Are The Restrictions On Dental Prescribing On NHS Dental Prescriptions?
3.2.2 Dental Prescriptions
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)
Is A Fax Of A Prescription A Legally Valid Prescription?
3.3.3 Faxed/Digital Copies Of Prescriptions
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
Is A Digital Copy Of A Prescription A Legally Valid Prescription?
**e.g. photo/scan of private/NHS prescription emailed/on patients phone*
3.3.3 Faxed/Digital Copies Of Prescriptions
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
What Are The Risks Associated With Supplying Medicines Against A Fax/Digital Copy Of A Prescription?
3.3.3 Faxed/Digtial Copies Of Prescriptions
- Uncertaintly that the supply has been made in accordance with a legally valid prescription.
- Risks of poor reproduction
- Risks of non-receipt of the origional prescription and therefore inability to demonstrate that a supply had been made in accordance with a prescription.
- 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.
- Risks the fax/digital copies of prescription is sent or recieved by multiple pharmacies and duplicate supplies made.
- Risks that the prescription is not genuine
- Risks that the system of sending and receiving of the fax/digital copies of prescription is not secure or from a reputable source.
If There Is An Alternative Method To Dispensing A Medicine Off A Fax/Digital Copy Of A Prescription Should You Use It?
3.3.3 Faxed/Digital Copies Of Prescription
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.
What Are Alternative Methods To Dispensing a Medicine Off A Fax/Digital copy Of A Prescription?
3.3.3 Faxed/Digital Copies Of Prescriptions
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
What Should Be Considered When Deciding If To Make A Supply Of A Fax/Digital Copy Of A Prescription?
3.3.3 Faxed/Digital Copies Of Prescription
- 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.
Can A Schedule 2/3 CD Be Supplied From A Fax/Digital Copy Of A Prescription?
3.3.3 Faxed/Digital Copies Of Prescription
No
THE SUPPLY OF A SCHEDULE 2/3 CD WITHOUT POSSESSION OF A LAWFUL PRESCRIPTION COULD BE PROSECUTED AS A CRIMINAL OFFENCE.
Checklist For Helping Identify Possible Fradulent Prescriptions/Prompting Further Investigations.
3.3.4 Forged Prescriptions
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…)
Potential Options For Further Investigation If Suspicious A Prescription May Be Fradulent
3.3.4 Forged Prescriptions
- Scrutinise the signature carefully - possibly checking against a known genuine presciption from the same prescriber
- 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)
- Use contact details for the prescriber that are obtained from a source other then the suspicious prescription (e.g. directory enquiries)
Who Can You Report Your Suspicions To When Believe A Prescription To Be Fradulent?
3.3.4 Forged Prescriptions
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
Are Prescriptions From The EEA or Switzerland Legal In the UK?
[Approved Countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germacy, greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourgh, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland]
3.3.5 Prescriptions Fom The EEA Or Switzerland
Prescriptions and repeatable prescriptions issued by an approved health professional in an approved country are legally recognised in the UK.
Can You Make An Emergency Supply To Patients From The EEA or Switzerland
[Approved Countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germacy, greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourgh, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland]
3.3.5 Prescriptions From The EEA Or Switzerland
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 !!!
What Are Approved Healthcare Professionals From The EEA or Switzerland That Can Write Prescriptions That Are Legally Valid In The UK?
[Approved Countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germacy, greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourgh, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland]
3.3.5 Prescriptions From The EEA Or Switzerland
- Doctors
- Dentists
- Other Professions with prescribing rights ( i.e chiropodists or podiatrists, Nurses (including community nurses), Optometrists, Paramedics, Pharmacists, Physioptherapists & therapeutic radiographers).
What To Do If A Prescription Originates From A Country Outwith The Approved List?
[Approved Countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germacy, greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourgh, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland]
3.3.5 Prescriptions From The EEA Or Switzerland
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.
Prescription Requirements For EEA or Switzerland Prescriptions
[Approved Countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germacy, greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourgh, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland]
Legal + Clinical Considerations
3.3.5 Prescriptions From The EEA Or Switzerland
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.
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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).
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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.
How To Check The Registration Status Of Approved Health Professionals From EEA or Switzerland?
[Approved Countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germacy, greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourgh, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland]
3.3.5 Prescriptions From The EEA Or Switzerland
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.
What To Do If Cannot Confirm The Registration Status Of Approved Health Professionals from EEA or Switzerland?
[Approved Countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germacy, greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourgh, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland]
3.3.5 Prescriptions From The EEA Or Switzerland
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.
