Pharm Y2S2 - Law Exam Part 3

Concerned with working detail, referring back to an act | Including regulations and orders 202

1- green paper for discussion 2- white paper, signal of intention 3- proposals set for other parties to give input 4- bill, proposes introduction of new legislation 5- debate in both Lords and Commons 6- formal enactment, royal assent received

Common law A statement of the legal position in a particular case/situation based on decisions of previous courts in similar situations

Where there is no legislation on a particular situation or the available legislation has a meaning that is unclear

1968 Controls medicinal products at all stages Over 200 statutory instruments

1971 Controls medicines that are misused Regulations published 2001

1972 Controls poisons Amended by deregulation act of 2015

2006 | Supervision and management of controlled drugs

1999 Amended by health and social care act of 2008 GPhC control of pharmacists 2010

2012 | Divided into 17 schedules covering everything relating to human medicines

Treating/preventing disease Diagnosing disease Contraception Inducing anaesthesia Otherwise preventing/interfering with normal operation of physiological function

Medicines act permits dentists to prescribe anything in the BNF GDC recommends that they prescribe drugs in their area of competency NHS limits them to DPF

Excessive quantity Appropriateness for patient/condition Known Rx-er Known patient Title 'Dr' present in signature Patient behaviour Commonly misused medicine

Yes as of 2015

Maybe supplied against kardex providing written direction to supply is patient specific and given by appropriate practitioner

NHS prescriptions Oral contraceptives Separate record kept, such as CD Sale is by way of wholesale deal, invoice kept for 2 years

Patient name Name/address of pharmacy Dispensing date Medicine name etc Directions for use Precautions relating to use of product 'Keep out of reach and sight of children'

Clearly defined dose, not mud or prn Formulation Strength where more than one exists Total quantity in words and figures, should not exceed 30 days 'For dental treatment only'

Including repeatable prescriptions. Within 28 days if Sch 2 or 3 Sch 4 first repeat must be within 28 days Schedule 5 first repeat within 6 months

Medicinal products which may only be sold/supplied by retail in accordance with a prescription given by an appropriate prescriber

Required medical supervision to prevent damage to human health Wide/frequent misuse New active substance Parenteral administration

No parenterals or CDs

No CDs other than oral diazepam, oral dihydrocodeine, fentanyl patches, oral lorazepam

No CDs other than diazepam, dihydrocodeine, fentanyl, temazepam, lorazepam, morphine, oxycodone

Voluntary prescribing partnership between an independent and supplementary prescriber to implement a care plan

Specific named patient Illness/conditions treated by SP Date of start and review Reference to description of medicinal products Restrictions (dose etc) Warnings Arrangements in case of suspected ADRs When to seek advice from IP

Signature Appropriate Rx-er address Date Rx-er type Patient name and address Age if under 12

Date of birth Rx-er qualifications Direct contact details for Rx-er Appropriate translation

Linked to personal control, physical presence in the pharmacy

Statutory duty to secure safe and effective running, allows ministers to produce regulations covering the ability of an RP to be absent

Required where a pharmacy is carried by a corporate body, any RP remains subject to SI direction

Name of RP GPhC number State that they are in charge of the pharmacy at that time

Name and reg number Date/time start and end of their role as RP Continuous daily record Absence details, with reason

For a maximum of 2 hours in 24 hours | Should remain contactable and able to return with reasonable promptness

Professional check of Rx Sale/supply of P medicines Sale/supply of POM, including handover of prescription items Supply under a PGD Emergency supply

Supervision by a suitable qualified person other than the RP

Generation of dispensing label Taking medicines off shelves Assembly of items Labelling containers Accuracy check

Ordering stock from wholesaler Receiving stock (exc. CDs) Date checking (exc. CDs) Accessing PMR Receiving prescriptions Delivery person handing over medication to patient

Sale of GSL medicines | Processing waste and patient returns (exc. CDs)

Business that consists of or includes the retail sale of medicinal products that are not subject to general sale

Individual pharmacist or partnership (do not all have to be pharmacists in Scotland) Body corporate (must be under SI management) Representative incase of death, illness or bankruptcy

Must notify GPhC of their name and address May act for 3 years in case of illness, disability or bankruptcy May act for 5 years in case of death

Must be a pharmacist Statement in writing sent to registrar signed by them and the body corporate Must not act in a similar capacity for any other body corporate May act as RP Must be appointed to manage pharmaceutical aspects of business

Member Fellow Associate Student

Best interests of the patient

Interests of pharmacists

Pharmacists Pharmacy technicians Premises

Establish and maintain register Promote standards for safety and effective practices Fitness to Practice requirements Standards relating to education, training, CPD and experience

14 members, 7 lay members and 7 registrant members Appointed by a committee At least one member from each GB country Registrar appointed by committee, may appoint a deputy

Pharmacists (protected title) Pharmacy technicians (protected title) Premises Pharmacists visiting as a practitioner Pharmacy technicians visiting as a practitioner

Appropriate qualification Fitness to practice Prescribed fee paid Intend to practice in GB, channel island or the isle of man

UK MPharm, pre-registration year and exam EEA equivalent Overseas qualification, OSPAP course and pre-registration year

Full name Postal town Annotations Registration number FtP issues

Trading name Owner Address Subject to conditions Internet logo Registration number

Form Copy of degree Certified copies of birth certificate, marriage certificate, proof of identity Final declaration from tutor Letter of good standing Certified photograph

Additional qualifications SI Supplementary/independent prescriber

In the case of emergencies, loss of life or health epidemics

Training/education courses Qualifications granted upon successful examination Institutions Tutors Premises

Health Care and Associated Professions order 2015 makes it a legal requirement for all registrant to have necessary knowledge of English

Safeguarding health, safety and wellbeing of patients Clear definitions of accountability and risk management Staff are empowered and competent Environment and conditions Delivery of pharmacy services Equipment and facilities

All parts of pharmacy service take place in the same registered premises

Any activities being carried out at different registered pharmacies or locations Or where the member of staff and person using the same service are not both in the same registered pharmacy together

Made up of 38 inspectors across GB | Proactively assess premises routinely every 5 years

Enforce standards Securing compliance with the law Enforce article 38 regarding offences relating to the register Assist council in FtP matters

Able to enter any registered premises at any reasonable hour Must provide identity and authorisation Not obliged to notify prior to visit

Served to SI and RP State grounds for belief of failure in complicance Specify measures to rectify failures State right of appeal

Results in a fine Inspector must notify registrar in writing May suspend or remove the premises from the register

Annual declaration of competence submitted with 4 CPD records

Misconduct towards a patient/customer Deficient professional performance Adverse health Failure to comply with requirement imposed by assessor Conviction of criminal offence Fixed penalty Police caution Inclusion in barred list

Where evidence suggests: Conduct presents risk, undermines confidence in pharmacy professionals, serious failure to meet standards Honesty/integrity can no longer be relied upon It is in public interest

Speaking to complainant and witnesses Speaking to pharmacist Visiting location of alleged incident Collect witness statements Formally interview employees, owners and pharmacist Seize evidence

Screening cases before referral to FtP committee | Do not hear oral evidence, may give warning to appear in register

Consider all referred cases to determine if impairment is present

Give advice Issue a warning Impose conditions to register entry for up to 3 years Suspend for up to 12 months Remove from register

Following review, the suspension may be extended for a further 12 months or the entry may be removed completely May suspend indefinitely where it has been in place for over 2 years On termination of suspension, conditions may be imposed for 3 years

Where it is impaired by ill health alone

Registrant must supply details of their employer within 14 days Employer must be notified of the referral Professional performance assessor may demand records within 14 days or seek a court order

Imposed when the FtP committee feel that it is in the best interests of the public or the registrant May be suspension for up to 18 months or conditional re-entry Reviewed every 6 months or where new evidence is available

Application cannot be made for 5 years after removal or within 12 months of another application Restoration may be conditional for up to 3 years FtP committee can direct that no further applications can be made

Direction to remove entry Direction fro suspension or conditional entry Direction to alter conditions Direction to prevent further applications

Dismissal Allow appeal and quash direction Substitute for alternative direction FtP committee could have given Referral

After period of appeal or appeal itself is complete | May be sooner or immediately where to committee deem necessary to protect public safety

Independent offices of the crown Usually a doctor or solicitor Appointed by local councils Investigate deaths that are unnatural or unexpected

Deceased not seen by a doctor during final illness No death certificate available Death certificate cannot be signed by a doctor within 14 days Death during surgery or before anaesthetic wears off Death from industrial disease or poisoning Sudden, unexplained Violent or due to neglect Suspicious In police custody or prison

Formal letter issued by a coroner to interested parties in order to prevent future deaths Must be responded to in writing and acted upon

Used to assess medical negligence against what other people would do Cannot defend case on the basis of current practice that is not legal or reasonable