Policy into Practice - Elements Overview
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Policy into Practice - Elements Overview

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What is the correct order of steps in the policy implementation process?

  • Stimulus for change, Consult on proposals, Communications
  • Stakeholder engagement, Impact assessment, Implementation (correct)
  • Option appraisal, Review, Legislation
  • Consult on proposals, Impact assessment, Review

    • What distinguishes primary legislation from secondary legislation?

  • Primary legislation contains Schedules; secondary does not.
  • Primary legislation requires a Bill to become an Act, while secondary does not. (correct)
  • Secondary legislation is always more detailed than primary legislation.
  • Secondary legislation must be referenced within primary legislation.

    • Which of the following correctly describes the structure of an Act?

  • Acts consist only of Sections and are not divided into Parts.
  • Each Act includes multiple Chapters which must always be referenced.
  • Sections can exist without being part of a larger Part.
  • Acts are subdivided into Parts, which contain numbered Sections. (correct)

    • What is indicated by the Chapter number in legislation?

    <p>The order in which Acts are passed within a given year.</p> Signup and view all the answers

    How are Regulations typically numbered?

    <p>Through Statutory Instruments assigned a unique SI number.</p> Signup and view all the answers

    Which of the following statements about subsections and paragraphs is correct?

    <p>Subsections are subdivisions of Sections, and paragraphs are subdivisions of subsections.</p> Signup and view all the answers

    What role do Schedules play in Acts of Parliament?

    <p>They provide detailed explanations and contextual information.</p> Signup and view all the answers

    What outcome arises from the stakeholder engagement element of policy implementation?

    <p>Informed proposals that reflect community needs.</p> Signup and view all the answers

    What is the primary restriction for Prescription Only Medicines (POM) regarding their supply?

    <p>They can only be supplied to a patient with a valid prescription from an appropriate practitioner.</p> Signup and view all the answers

    Which condition does NOT exempt a medicine from being classified as POM under the 1997 order?

    <p>Product is in a non-prescription form</p> Signup and view all the answers

    What distinguishes Pharmacy Only (PO) medicines from General Sales List (GSL) medicines?

    <p>PO medicines can only be sold where a pharmacist is present.</p> Signup and view all the answers

    Under the Human Medicines Regulations 2012, which statement about GSL medicines is accurate?

    <p>They can be sold from any lockable premises and do not require pharmacist supervision.</p> Signup and view all the answers

    What happens to the inheritance of the Medicines Act 1968 after the Human Medicines Regulations 2012?

    <p>It is entirely repealed, with no sections remaining applicable.</p> Signup and view all the answers

    Which of the following is a requirement for Pharmacy medicines (P)?

    <p>They can be sold under the supervision of a pharmacist only.</p> Signup and view all the answers

    Which of the following accurately describes restrictions on the sale of GSL medicines?

    <p>Sales quantities are strictly controlled.</p> Signup and view all the answers

    Which types of medicines can be sold without the need for a prescription?

    <p>General Sales List (GSL)</p> Signup and view all the answers

    What is a primary requirement for the reclassification of a POM to a P medicine?

    <p>It has been safely used as a POM without unusual side effects.</p> Signup and view all the answers

    Which of the following medicines was the first to switch from POM to P in 1983?

    <p>Ibuprofen tablets</p> Signup and view all the answers

    What must the Minister of Health do before reclassifying a P medicine as GSL?

    <p>Ensure it poses no risk to the public without supervision.</p> Signup and view all the answers

    What is a consequence of POM to P switches for pharmacists?

    <p>Pharmacists need to retain competency and stay updated.</p> Signup and view all the answers

    Which of the following is NOT an offense under the Human Medicines Regulations 2012?

    <p>Loaning POM medication under supervision</p> Signup and view all the answers

    What does supervised sale or supply of POM and P medicines entail?

    <p>Presence of a pharmacist during sale.</p> Signup and view all the answers

    What effect does a repeat prescribing request form have in the NHS?

    <p>It allows patients to specify medications they need.</p> Signup and view all the answers

    Which of the following medicines switched from P to GSL in 2004?

    <p>Aciclovir</p> Signup and view all the answers

    Which case is NOT an example of relevant case law in the context of POM and P medicines?

    <p>Smith v Jones (1980)</p> Signup and view all the answers

    Which statement about repeat dispensing prescriptions is accurate?

    <p>Each repeat supply must be appropriately timed and necessary.</p> Signup and view all the answers

    What conditions make a patient unsuitable for repeat dispensing?

    <p>Patients undergoing dose changes.</p> Signup and view all the answers

    In the context of emergency supplies, which professional can order an emergency supply?

    <p>Community practitioner nurse prescriber.</p> Signup and view all the answers

    What is a requirement for making an emergency supply?

    <p>A registered pharmacist must verify the practitioner cannot supply immediately.</p> Signup and view all the answers

    How long can a repeat dispensing prescription be valid if it is dispensed for the first time within 6 months?

    <p>12 months.</p> Signup and view all the answers

    Which of the following is NOT a responsibility of pharmacy staff in repeat dispensing?

    <p>Change medications based on the patient’s current condition.</p> Signup and view all the answers

    What piece of information must a pharmacist retain when dispensing emergency supplies?

    <p>A record of the medication and details of the request.</p> Signup and view all the answers

    When might a repeat dispensing prescription allow for more than 12 batches to be issued?

    <p>If the dispensing interval is less than monthly.</p> Signup and view all the answers

    What is the primary purpose of a Marketing Authorisation (MA)?

    <p>To evaluate safety, efficacy, and quality of medicinal products</p> Signup and view all the answers

    Which type of license allows the manufacturer to produce unlicensed medicinal products?

    <p>Manufacturer 'specials' licence</p> Signup and view all the answers

    What must be provided alongside the medicinal products as stipulated by the regulations?

    <p>Patient information leaflets</p> Signup and view all the answers

    What is a requirement for a product to receive a Parallel Import licence?

    <p>The product must have a Marketing Authorisation in another EU state</p> Signup and view all the answers

    Which licence is required to import medicinal products from non-EEA countries by wholesale?

    <p>Manufacturer's/importer's licence</p> Signup and view all the answers

    What aspects are evaluated when issuing a Manufacturer’s/importer’s licence?

    <p>Skills and qualifications of personnel involved</p> Signup and view all the answers

    Which category of wholesale licences allows holders to sell Pharmacy Medicines and Prescription Only Medicines?

    <p>Wholesale Dealers Licence (WL)</p> Signup and view all the answers

    What is required from manufacturers in terms of product quality?

    <p>They must maintain and demonstrate quality standards</p> Signup and view all the answers

    What type of licence do companies need to import medicines to the UK from within the EU?

    <p>Parallel Import licence</p> Signup and view all the answers

    What is a characteristic of the Manufacturer 'specials' licence?

    <p>It permits the import of unlicensed medicinal products from outside the EEA</p> Signup and view all the answers

    Study Notes

    Policy into Practice - Elements

    • Stimulus or reason for change: This identifies the driving force behind policy changes.
    • Stakeholder engagement: This involves gathering input from all relevant parties affected by the policy.
    • Option appraisal: This step examines various potential solutions to achieve the desired policy objectives.
    • Impact assessment: This evaluates the potential consequences of implementing a policy, including both positive and negative effects.
    • Consult on proposals: This involves seeking feedback from stakeholders on proposed policy changes.
    • Communications: This involves effectively communicating the policy details to both the target audience and stakeholders.
    • Legislation - primary and secondary: Primary legislation refers to Acts of Parliament, while secondary legislation encompasses regulations, orders, and bylaws created under the authority of Parliament.
    • Implementation - guidance and support: This phase involves providing necessary resources and instructions for putting the policy into practice.
    • Review: This step assesses the effectiveness of the implemented policy, identifying areas for improvement or adjustments.
    • Passage of Legislation: This process involves the creation and enactment of legislation to support a policy change. It typically involves three stages:
      • Green Paper: A preliminary document outlining policy proposals and seeking public opinion.
      • White Paper: A more detailed document outlining policy proposals and outlining how they will be implemented.
      • Bill: Legislation proposed to Parliament for enactment.
      • Act: A law that has been passed by Parliament and is now in effect.

    How to Use and Reference Legislation Effectively: Acts

    • Short title: Acts have a short title which can be used for quoting and referencing. For example, "Medicines Act 1968."
    • Chapter number: Each Act receives a chapter number that signifies its chronological order within a calendar year. For example, "Medicines Act 1968 c. 67" indicates it was the 67th Act published in that year.
    • Parts: Acts can be grouped into "Parts" based on common themes or divisions.
    • Sections: Sections are numbered enactments within an Act that address specific topics. For example, "Section 64 of the Medicines Act 1968" outlines the illegality of supplying medicines that don't meet the intended quality standards.
    • Subsections: Sections are further divided into subsections, which provide more detailed information on a specific aspect of the section.
    • Paragraphs: Subsections can be divided into numbered paragraphs.
    • Schedules: These resemble appendices in an Act and provide further details or explanations related to specific sections.

    How to Use and Reference Legislation Effectively: Regulations

    • Secondary Legislation: Regulations are created under the authority of an Act of Parliament to implement its requirements.
    • Statutory Instrument Number: Regulations are known as Statutory Instruments and have an SI number. For example, "Human Medicines Regulations 2012 are SI No. 1916."
    • Parts and Chapters: Regulations are structured similarly to Acts, often divided into parts and chapters.
    • Regulations: Numbered divisions within a set of regulations are called "Regulations."
    • Paragraphs and Subparagraphs: Regulations are further divided into numbered paragraphs, which can have subparagraphs marked with a letter.
    • Prescription Only Medicines (POM)
      • These are listed in the Prescription Only Medicines (Human Use) Order 1997.
      • Sales and supply are restricted, requiring a valid prescription from a qualified professional.
      • There are three legal exceptions to this rule within the Human Medicines Regulations 2012.
    • Exemption from POM status: Medicines listed as POM in the 1997 order can be exempt if they meet certain conditions, such as being below a specific strength, in a particular form, for designated conditions, or sold in limited quantities.
    • Pharmacy Medicines (P)
      • Can be purchased without a prescription.
      • Can only be purchased from a registered pharmacy.
      • Sales must be made under the supervision of a pharmacist.
    • General Sales List (GSL)
      • Medicines on this list can be sold from any lockable premises.
      • A pharmacist's presence is not required for sales.
      • Sales must be made in original packaging.
      • Quantities are strictly controlled.
      • GSL medications can be sold from vending machines.
    • Pharmacy Only (PO):
      • The Human Medicines Regulations 2012 does not legally define a class of medicines called "Pharmacy Only."
      • These medications are essentially GSL medicines that are designated within their Marketing Authorization (MA) as only being sold in a pharmacy.
      • Supervision is not required.

    Prescription Requirements

    • Who can write prescriptions: A doctor, dentist, or other qualified healthcare professional with the appropriate prescribing rights can write a prescription.

    Licensing, Manufacturing and Quality Assurance:

    • Human Medicines Regulations 2012:
      • Manufacturers must adhere to specific requirements.
      • They must use methods that align with the marketing authorisation.
      • They must adhere to quality standards and maintain documentation.
      • Labeling must meet specified standards.
      • Patient information leaflets must be provided.
    • Types of Licenses:
      • Marketing Authorisation (MA) – This grants permission to market a medicine in the UK.
      • Manufacturer's Licence – This permits a company to manufacture medicinal products in the UK.
      • Product Licence (Parallel Importing) – This allows for the import of medicinal products from other EU countries.
      • Wholesale Dealing Licence – This permits the wholesale purchase and sale of medicines.

    Marketing Authorisation (MA)

    • The Medicines and Healthcare products Regulatory Agency (MHRA) must consider several factors before granting an MA:
      • Safety: The medicine's safe use.
      • Efficacy: The medicine's effectiveness in treating a particular condition.
      • Quality: The medicine's manufacturing and production standards.

    Manufacturer's/Importer's Licence (MIA)

    • This license is required for companies that:

      • Manufacture or package medicines: This covers the production of medicines in the UK.
      • Import medicines from non-EEA countries: This includes importation from outside the European Economic Area.
      • Wholesale trade of licensed medicines: This authorizes the wholesale trade of medicines imported from non-EEA countries.

    • The MHRA considers the following factors when issuing MIA licenses:

      • Premises, equipment, and processes: The manufacturing facilities and processes must meet specific standards.
      • Equipment: The machinery and equipment used in manufacturing must meet specific standards.
      • Skills and qualifications: Personnel working within the manufacturing process must have the necessary expertise.
      • Storage conditions: Medicines must be stored under appropriate conditions.

    Parallel Import Licences (PI)

    • These licenses are required for importing medicines into the UK from within the European Union.
    • The product must have a Marketing Authorisation in another EU country.
    • PI licenses fall into three categories:
      • Simple: For products that are authorized in several EU countries.
      • Standard: For products that have not yet been marketed in the UK.
      • Complex: For products that have complex regulatory requirements.

    Manufacturer 'Specials' License (MS)

    • This license allows holders to manufacture unlicensed medicinal products, often referred to as "specials."
    • Examples include Martindale and BCM, which specialize in compounding pharmaceuticals.
    • The MS license also permits importing unlicensed medicinal products from outside the European Economic Area.
    • Examples include Clinigen, a company that specializes in supplying medicines for rare diseases.

    Wholesale Dealing Licences (WL/WDL)

    • Wholesale Dealers Licence (WL): This license authorizes the wholesale purchase and sale of:

      • Pharmacy Medicines (P)
      • Prescription Only Medicines (POM)
      • General Sale List (GSL) Medicines
      • Some herbal medicines

    • Wholesale Dealers Licence (GSL): This license authorizes the wholesale purchase and sale of:

      • General Sale List (GSL) Medicines

    Quality Assurance

    • The Human Medicines Regulations 2012 mandates that manufacturers maintain the quality of their products.

    Human Medicines Regulations 2012

    • Supervision by a Pharmacist:
      • POM and P medicines must be sold or supplied under the supervision of a pharmacist. The definition of supervision can vary depending on the task.
      • Relevant case laws include Roberts v Littlewoods (1943) and RPSGB v Boots (1953)

    Reclassification of Medicines - POM to P:

    • The MHRA can reclassify medicines from POM to P. To be considered for reclassification, a medicine must meet the following criteria:
      • It is not likely to present a danger to human health if used correctly.
      • It is not likely to present a danger to human health if used incorrectly.
      • It has a history of safe use as a POM medicine.
      • There are no unusual side effects requiring investigation by the MHRA or EMEA.
      • It is not an injection.

    Switching from POM to P: The Process

    • A manufacturer seeking to reclassify a POM medicine to P status must submit relevant data to the MHRA.
    • The MHRA assesses the product against specific standards.
    • A consultation period occurs to ensure the proposed reclassification is necessary and desirable.
    • If the MHRA deems the information satisfactory, an MA is granted, specifying conditions for selling the product as a P medicine.

    POM to P Switches: Why are they Important?

    • The first POM to P switch occurred in 1983 with Ibuprofen tablets.
    • POM to P switches allow pharmacists to supply effective treatments over the counter.
    • These switches necessitate continued competency and up-to-date knowledge for pharmacists.
    • POM to P switches generate significant press attention, raising awareness of potential errors by pharmacists and their staff.

    Key POM - P Switches (Timeline)

    • 1983: Ibuprofen tablets
    • 1987: Hydrocortisone 1% topical
    • 1991: Nicotine gum 2mg
    • 1992: Antifungal products
    • 1993: Non-drowsy antihistamines
    • 1994: H2 antagonists
    • 2000: Domperidone
    • 2001: Levonorgestrel
    • 2005: Chloramphenicol eye drops
    • 2008: Azithromycin
    • 2017: Atorvaquone (Antimalarial)
    • 2018: Sildenafil (Viagra)

    Switching from P to GSL

    • To be reclassified from P to GSL, the Minister for Health, guided by the MHRA, must be satisfied that the medicine does not pose a risk to the public and can be sold safely without pharmacist supervision.
    • A good example of a medicine that underwent this reclassification process is aciclovir. Moving from POM to P in 1993 and P to GSL in 2004.

    Offences under the Human Medicines Regulations 2012 and the Medicines Act

    1968

    • Improper use of restricted titles
    • Failure to correctly label a medicine
    • Selling or supplying a product that does not match its intended description
    • Failure to provide a patient information leaflet
    • "Loaning" POM medications
    • Purchasing medicines from unlicensed wholesalers
    • Sale and supply of certain unlicensed medicines
    • Adulteration of medicines
    • Failure to identify the responsible pharmacist

    Repeat Prescribing, Repeat Dispensing, Supplies Without a Prescription

    Repeat Prescribing:

    • Private

      • Prescribers can specify how many times a prescription can be repeated.
      • It must be dispensed at least once within 6 months.
      • Repeats can be collected as needed provided they remain clinically relevant.

    • NHS

      • Repeat prescribing requests are submitted with a patient's Rx.
      • Patients tick off items needed.
      • The request goes to the doctor or pharmacy for a new prescription.
      • Patients collect the prescription after the doctor or pharmacist issues it.

    Repeat Dispensing:

    • Essential service: Repeat dispensing is an essential part of the pharmacy contract.
    • Electronic and paper formats: It is available electronically and in paper format, with electronic being more common.
    • Pharmacy staff responsibilities:
      • Dispense repeat prescriptions received.
      • Ensure requested repeats are appropriate for the patient.
      • Verify the safety of repeat prescriptions for the patient.

    Repeat Dispensing- Suitability

    • Suitable:

      • Regular medication
      • Stable conditions
      • Regular patients

    • Not Suitable:

      • Changing medication
      • Patients with dose changes
      • Certain controlled drugs
      • Patients who don't use a regular pharmacy.

    Repeat Dispensing - Prescription Validity

    • Validity: 12 months, provided the first dispensing occurs within 6 months.
    • Number of batches: There is no limit on the number of batches that can be supplied.

    Considerations When Dispensing Repeat Prescriptions:

    • Paper Prescriptions:

      • Patients must provide the repeat authorization form (RA) and repeat dispensing form (RD).
      • These forms should be securely kept at the pharmacy.

    • Electronic or Paper Prescriptions:

      • Batches should be dispensed in order, ensuring that earlier batches are used first.
      • Patients should be informed when to return for their next supply.
      • Patients should be advised as their medication is nearing depletion.

    Emergency Supplies:

    • Legal Basis: Emergency supplies are permitted by registered pharmacists under the Human Medicines Regulations 2012.
    • Practitioners Authorized to Request Emergency Supplies:
      • Doctors
      • Supplementary prescribers
      • Community practitioner nurse prescribers (CN)
      • Nurse independent prescribers
      • Optometrist independent prescribers
      • Pharmacist independent prescribers
      • Dentists
      • Doctors and Dentists from the European Economic Area (EEA) or Switzerland.
      • Patients whose doctors or dentists practice in an EEA country or Switzerland can request emergency supplies.

    Emergency Supplies - Practitioner Requirements:

    • The pharmacist must be satisfied that the practitioner is unable to provide a prescription immediately.
    • The pharmacist may also need to satisfy themselves that the patient needs immediate medical attention because the practitioner cannot supply a prescription.

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