Pharmacy procedures and exemption to retail rules

What does PSD stand for?

patient specific direction

What are PSDs?

written instructions from a doctor, dentist or non-medical prescriber for a medicine to be supplied or administered to a named patient after the prescriber has assessed that patient on an individual basis

Who is authorised to supply and/or administer medicines under a PSD?

organisations may choose who

What is required on a PSD?

no list of criteria but must be enough information for the person to safely administer the medication, if it is for supply (e.g. after discharge) it should meet prescription requirements

What can happen with a PSD in an emergency situation

administration can occur after a verbal/telephoned directions (would then normally have two nurses involved in the administration to make it safer)

What do the specialist pharmacy service advise around PSD?

that they must be written

With a PSD there should be separation when possible of the……

prescribing and supply/administration roles

What does PGD stand for?

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

What must pharmacists do if they are involved in a PGD?

they must understand the scope, limitations and wider context to ensure safety and effectiveness

Are registered pharmacy technicians able to supply and administer medicines under the PGD?

yep

When are PGDs seen?

when they are to the benefit of patient care without compromising patient safety

Are PGDs prescriptions?

nah

What are the two different types of PGD schemes?

planned and unplanned (whether the patient pre books)

The sale and supply of a PGD can’t be ….. What?

delegated, has to be performed by the healthcare professional named and working under the PGD

When does a the supply of a P medicine not require a PGD?

where there is an exemption, when the supply is made from a registered pharmacy under the supervision of a pharmacist or the supply is made by a registered midwife in the course of their professional practice

How should PGDs be labelled?

as if they were supplied against a prescription

What are optometrist or podiatrist signed orders?

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 (however they cannot write prescriptions unless they are qualified as independent or supplementary prescribers)

What are the restrictions on the optometrist or podiatrist signed patient orders?

the medicines requested must be from a list, which can be legally sold or supplied by the optometrist or podiatrist rather than one they can only administer

What is required on the signed order?

usual prescription requirements are not needed, include sufficient advice to enable the patient to use the medicine safely and effectively and the details needed for the POM register as a minimum

What are the labelling requirements for a signed order?

label as a dispensed medicinal product, include a PIL and record it in the POM register

What is a signed order for supply of medicines to school?

supplies of adrenaline autoinjectors and/or salbutamol from a pharmacy via a signed order, this is only administered in an emergency by trained persons to pupils previously prescribed such medication and where parental consent has been obtained

What information is needed on the signed order for a school?

• school name

• product details

• strength

• purpose

• total quantity (no limit but small quantity on occasional basis)

• signature of principle or head teacher

• ideally on letter headed paper

What do you need to if you provide medication off a signed order?

retain it for 2 years from the date of supply, or make an entry in the POM register (best to do both)

What is Naloxone?

an opioid antagonist licenced for treatment of suspected acute opioid overdoses due to its ability to completely or partially reverse CNS depression especially respiratory depression caused by any opioids

Who can access Naloxone without a prescription, PSD or PGD? and what can they do?

individuals who are employed or engaged in the provision of lawful, recognised drug treatment centres, can obtain Naloxone from a wholesaler without the requirement of a responsible pharmacist, and make direct supplies to patients

What needs to be recorded in the POM register for a signed order?

• date the POM was supplied

• name, quantity, formulation and strength when not apparent, of the POM

• name, address, trade business or profession, of the person to whom the medicine was supplied

• purpose for which it was sold or supplied

What are the requirements for anyone trading medicines other than to a patient?

• hold a wholesale licence (also known as a wholesale distribution authorisation)

• comply with GDP standards and pass inspections

• have a suitable RP to ensure suitable procurement, storage and distribution of medicines

What are the exemptions to the wholesaling rules?

a pharmacy supplying stock to another pharmacy within the same legal entity are not required to have a wholesale licence but the quantities must be small, it must happen on a occasional basis, not for profit or for further onward wholesale distribution

What does SSP stand for?

Serious shortage protocol

When was the Human medicines act changed to introduce SSPs?

in 2019

What is an SSP?

the sale or supply of certain medicines can be made under the supervision of a pharmacist in accordance with a SSP after a government minister has determines that the UK or part of the UK is or may experience a shortage of that certain POM

What does an SSP permit a pharmacist to sell/supply?

• different strength, quantity or form of a POM to that prescribed

• different POM to the one prescribed (e.g. generic rather than branded)

What rules do you need to follow when using the exemptions under the SSP?

• the requirements of the SSP must be followed

• the supervising pharmacist uses their professional judgement and skill to determine that the substitution is appropriate

• the patient needs to agree to the switch for the dispensing month

What is an emergency supply?

when a pharmacist working in a registered retail pharmacy can legally provide a POM in the absence of a prescription in an emergency at the request of a patient or prescriber

Why would you get an emergency supply at the request of a prescriber?

if they couldn’t get to the pharmacy to drop off a prescription or they have forgotten their prescription pad for a patient that couldn’t come down either, there would be an urgent need for the patient to receive this medicine

What do you need to do when you receive an emergency supply request?

consider each case on a case by case basis, using your professional judgement in the best interests of the patient

What are the criteria for providing an emergency supply at the request of a prescriber?

• must be from a relevant prescriber (not healthcare professionals from outside the EEA and Switzerland)

• determine and justify whether the situation is actually an emergency, a prescription cannot be provided immediately due to an emergency

• a written prescription must be provided within 72 hours

• the medicine must be supplied in accordance with directions given by the prescriber

• not supplies of Sch 1,2 and 3 except phenobarbital for the treatment of epilepsy

What do you need to include in the POM register for an emergency supply at the request of a prescriber?

• the date the POM was supplied (this should be the same date as the entry)

• the name, strength, form and quantity of medicine supplied

• the name and address of the prescriber requesting the emergency supply

• the name and address of the patient for who the POM was required

• the date on the prescription (added when the prescription is received)

• the date on which the prescription is received (added when the prescription is received)

What labelling is required on an emergency supply requested by a prescriber?

the usual labelling

What are the criteria for an emergency supply at the request of a patient?

• interview patient (exceptions for children, elderly with memory difficulty)

• there must be an immediate need for the POM and it is not practical to obtain a prescription without undue delay

• the POM requested must previously have been used as a treatment and prescribed by a UK, EEA or Swiss health professional, the medicine must have a UK MA

• the pharmacist must be satisfied of knowing the dosage requirements

• not for supplies of CDs Sch 1,2, or 3 except phenobarbital for treating epilepsy, if the prescription is from a UK-registered prescriber

If a patient has requested an emergency supply of a sch 4 or 5 CD how long of a supply can you provide?

maximum 5 days

If a patient has requested an emergency supply of a POM how long of a supply can you provide?

maximum 30 day (may be appropriate to supply less)

If a patient has requested an emergency supply of insulin, ointment, cream, inhaler, etc. how long of a supply can you provide?

the smallest pack available

If a patient has requested an emergency supply of oral contraceptive how long of a supply can you provide?

the full treatment cycle

If a patient has requested an emergency supply of an antibiotic how long of a supply can you provide?

the smallest quantity for full treatment

What needs to be included on the entry into the POM register when a patient requests an emergency supply?

• the date the POM was supplied (should be the same as the day unless it is impractical)

• the name, strength, form and quantity of medicines supplied

• name and address of the patient

• information on the nature of the emergency, why they need a POM, why they can’t get a prescription, etc.

What are the labelling requirements for an emergency supply at the request of a patient?

standard labelling requirements and ‘Emergency supply’ needs to be on the dispensing label

What are the practice points to consider when giving an emergency supply?

• clinical need (pros and cons - what would happen if they went without, anxiety, time without if not provided )

• abuse (multiple requests)

• refusal to supply (patients should be told where else to seek care and what else to do, reassurance)

• CPCS

• fee

• lending medicines (this is not a legally established route to provide medicines without a prescription)

What does CPCS stand for?

community pharmacy consultation service

What is the CPCS?

an NHS advanced service that allows 111 to refer people to the community pharmacy for an emergency supply of a regular medication

How do fees work with regard for an emergency supply?

• if prescription will follow that the pharmacy will be reimbursed

• if at the request of a patient, the pharmacy will need to be reimbursed so may ask for a fee

What does SOP stand for?

standard operating procedures

What are SOPs?

written instructions describing how a routine task is to be carried out, when, where and by whom

What year have SOPs been needed in every pharmacy since?

2005

What is clinical governance?

organisations are accountable for improving the quality of services and safeguarding high standards of care, managing risk and harm minimisation

What processes need to follow a SOP to comply with the clinical governance requirements?

everything (Pharmaceutical related)

What are the advantages of a SOP?

• standardisation of processes and practice towards a specific outcome

• maintains consistency

• improves quality assurance and safety

• saves time, training and cognitive workload

What is included in a SOP?

purpose, scope, responsible person, procedure, risk, review arrangements, acceptance, reference guides/further information

What are the disadvantages of SOPs?

they don’t reflect the true clinical process, so need flexibility

How do you make sure the SOP reflects the true working environment?

keep it updated

Who is responsible for the SOP?

the pharmacist but they can delegate it, detail in the SOP who certain tasks have been delegated to

What types of dispensing errors are there?

selection errors, labelling errors, bagging errors

What are common error causes?

• misreading the prescription

• similar drug names

• selecting the previous drug or dose from the patient’s medication record on the computer

• similar packaging

What are the main causes of prescribing errors?

therapeutic training, drug knowledge and experience, knowledge of the patient, knowledge of risk, physical and emotional health, patient characteristics, communication, workload and time pressures, interruptions, computer system factors, transfer of care

What ways can you reduce the risk of errors?

• SOPs

• reporting - using an error log, recognising patterns and learning from them, investigating contextual factors

• culture - based upon principles of fairness, quality, safety, transparency, learning and reporting

What are the key principles if there is an error?

• patient safety is paramount

• deliberate harm and unacceptable risk impacting on patient safety must not be tolerated

• patent safety is maintained by healthcare professionals being candid, raising concerns, and learning from incidents to improve systems, standards, policies, legislation and people

• to ensure that concerns will be raised and learning from incidents occurs, individual accountability must be fair, proportionate and viewed in the context of the root cause, system deficiencies, mitigating circumstances, and the entirety of contributing factors.

How do you handle a dispensing error?

1. take steps to let the patient know promptly

2. make things right (may need to contact the prescriber)

3. offer an apology

4. let colleagues involved in the error know

What does the pharmacy order 2018 and the draft pharmacy preparation and dispensing errors order 2022 provide?

A legal defence to prevent automatic criminalisation of inadvertent dispensing errors

When can a legal defence of preparation and dispensing errors be used?

when an error has been all of the following:

• dispensed in a registered pharmacy

• dispensed by or under the supervision of a registered pharmacist/ technician

• supplied against a prescription, PGD or direction from a prescriber

• promptly notified the patient once the pharmacy team are aware of the error

What happens if you report an error to the GPhC? (not every error)

it is reviewed and investigate the individual against a set of criteria to determine the next steps, the investigation is then reviewed against the threshold criteria and it is decided whether to refer to an investigating or fitness to practice committee

What are the GPhC threshold criteria to go to fitness to practice?

• the error presents an actual or potential risk to patient safety or public safety

• it undermines or is likely to undermine confidence in the pharmacy professions

• there has been a series or persistent failure to meet any of the standards for pharmacy professionals

• the honesty or integrity of the pharmacy professional can no longer be relied on

• there is adverse physical or mental health which presents a risk to the pharmacy professional’s ability to practice safely or effectively

• and it is in the public interest to refer