medicines act prescription only medicine

Document Sample
medicines act prescription only medicine Powered By Docstoc
					Medicines Act
   Records of sale and supply of
 Itis a legal requirement to record sale or
  supply of each supply of a POM in the
  Prescription Only Register. Prescription &
 Exceptions:
    Health Prescriptions
    Oral Contraceptives
    Supply for drug quality testing scheme
    Controlled Drugs where a separate record is made in
     the CD Register (still Good Practice to make POM
     entry for private, but NOT NHS, prescriptions)
    Wholesale supply where order/invoice retained for 2
    The POM Register

   Must be retained in the pharmacy for
    two years from the date of the last
   May be bound book or stored on
       All required details must be kept
       Adequate backups must be made
       Inspectors must be able to examine
        records, with minimal disruption to
        operation of the pharmacy.
    POM Register Requirements
   The entry must be made on the same day as
    the supply, or the following day
   Details to be recorded:
       Name and address of Prescriber
       Name and address of Patient
       The Name, Quantity, and except where it is
        apparent from the name, the Form and Strength of
        the medicine
       Date of prescription
       Date of supply
          NB Always enter both dates – even if they are the
      Book Entry
                             Appropriate Date
    Supply Date

Ref         Prescription Details                        Cost
A42         John Smith            Dr A Villa            Cost
20/10/’07   33 High Street        Aston Health Centre   +
            Astonbury             Astonbury             on-cost
                                  17/10/2007            +
            R                                           Container
            56 Atenolol 50mg Tablets                    +
            One Daily                                   Fee.
   Recording Repeat Prescriptions
      Subsequent issues of a repeat item only
       need a reference to the original entry if
       previously dispensed from the same

Ref         Prescription Details                         Cost
A42         Jane Jones                                   Cost
20/10/’07   First Repeat of prescription reference A35   on-cost
Recording Prescription Amendments

   Prescriptions amended in consultation with the doctor
    should have full details of the intervention recorded
    along with details of the original

Ref         Prescription Details                      Cost
A42         John Smith          Dr A Villa            Cost
20/10/’07   33 High Street      Aston Health Centre   +
            Astonbury           Astonbury             on-cost
                                17/10/2004            +
            R                                         Container
            56 Atenolol 50mg Tablets   One Daily      +
            Prescriber contacted to clarify
Recording an Emergency Supply

   Also use the POM register
   For supply at request of patient
       Nature of the emergency i.e. reason for
       Statement “Emergency Supply at Request
        of Patient”
   For supply at request of prescriber
       As above
       Date on prescription and date prescription
        received in pharmacy
POM Register Entry
Supply at Patient’s Request

 Ref        Prescription Details                          Cost
 A42        Emergency Supply at patient’s request         Cost + %+
            John Smith                                    Container
            33 High Street                                + Fee. +
            Astonbury                                     VAT
            1 x Salbutamol Inhaler
            1-2 puffs prn

            Saturday afternoon, Surgery closed; patient
            has lost his inhaler and suffers frequent
            asthma attacks
  POM Register Entry
  Supply at Doctor’s Request

Ref        Prescription Details                         Cost
A42        Emergency Supply at request of Dr Villa
4/10/’07   John Smith          Dr A Villa               NHS
           33 High Street      Aston Health Centre      supply:
           Astonbury           Astonbury
                                                        Patient is
           R 28 Atenolol 50mg Tablets One Daily         over 60
           Date on Prescription __________

           Called from patient’s home – unable to get
           prescription to us. Dr Villa will drop
           prescription in tomorrow

           Date on Prescription __________
           Date Prescription Received __________
“Wholesale Dealing” MEP 1.2.5

   Another pharmacy
   Practitioner for his/her use in practice
   Person requiring them to administer to human
    being in course of business (P or POM if
    subject to exemption order in S3)
   Person who may sell or supply P medicines
    under exemption order (Optician for certain
    POMs) – limited to exempt products
   Authorities or persons carrying out business of
    independent hospital/clinic
   Holder of wholesale licence
   NHS Trust
POM register Entry MEP 1.2.5

   Entry must be made in POM register or keep
    copy of invoice or order for supply
   Details required for register entry:
       Date POM sold or supplied
       The Name, Quantity and except where it is
        apparent from the name, the Form and Strength of
        the medicine
       Name and Address, and Trade, Business or
        Profession of person supplied
       The Purpose for which the medicine was supplied
   Orders/POM entry to be kept for 2 years.
Supply of POMs not on Prescription
POM register Entry

Ref         Prescription Details                Cost
20/10/’07   Wholesale supply                    Cost of
            Dr A villa MbCHb                    +
            The Health Centre Astonbury         On-cost
            100 Co-codamol 500/30 Tablets

            For use in practice

      NB it is Good Practice to make an entry
      even when a written order is retained
     Exemption from Control on Retail Sale
     MEP 1.2.4
   To Hospitals and Health Centres
   By Practitioners: Dr or dentist to a patient of his hers
    or vet for admin by himself or under his directions
   To other Specified Classes – for supply and/or
       Midwives:
       Chiropodists:
       Registered Opticians
       Ambulance Paramedics:
       Owners and Masters of Ships:.
       Persons required under the Factories Act 1961
       RNLI
       Red Cross
       Occupational Health schemes
       First Aid personnel on offshore installation
       Others
    Example: supply to Chiropodists
   Chiropodists may supply certain POMs to
    patients if they hold a certificate of
    competence issued by the Chiropodists
   They may also supply GSL medicines that
    are for external use and
   A defined list of Pharmacy medicines that
    are for external use.
   See MEP 1.2.4 for details
Labelling of Medicinal Products:
   Container: the receptacle that holds the
    tablets, caps, liquid etc.
   Packaging: The box, packet etc. in
    which the the container is enclosed
   The dispensing label should be applied to
    the Container of dispensed medicines
       MEP 1.2.6
      Types of Label

    Standard Label: applies to all sold
     products and covered by EU law.
    Dispensed Label: reduced detail and
     applicable to all medicines dispensed in
     a pharmacy for a named patient
    Products prepared in a pharmacy for an
     individual patient (pharmacy
     nostrums) may be labelled with
     slightly extended dispensed medicines
Medicines Marketing Authorisations etc Regulations 1994
Standard Labelling Requirements
EU Directive 2001/83/EC

   Applies to “relevant medicinal products” i.e. all
    except magistral and official. Exceptions apply
    for medicinal product on prescription.
   Also labelling must be
       Legible
       Comprehensive
       Indelible
       Either in English Language only or in English with
        one or more but with all particulars in English.
        (SI1992 No3273).
   Fines (and Imprisonment) for failure to comply
Label for Appropriate MP (MEP pg 20)

   Details of Product
       Name, active ingredients, excipients, contents by
        strength, form
   Uses
       Method of use, route of administration
   Warnings
       “Keep out of the reach and sight of children”,
        special warnings, expiry, storage instructions,
        disposal instructions
   Manufacturer/Supplier
       Name and address of MA holder, MA number,
        capitals MA, batch number,
   Instructions for use if for self
        Labelling for Sale
   “Sale” Includes to the public (retail) and by
    means of wholesale supply e.g. to doctors for
    their surgery

   RPSGB Statement:
    “It is not possible to fulfil the requirements of
    the [European] directive, or provide a product
    information leaflet, for medicines packed
    down from bulk. For this reason pharmacists
    are advised to use commercially available
       NB Extemporaneously dispensed products are not
        covered by these requirements.
Statutory Warning Requirements MEP 1.2.6

   Other Statutory Warning Requirements - MEP
       In addition to regulations for Relevant Medicinal
        Product labelling and labelling of Nostrums, there
        are a series of specific warnings and other
        particulars that must appear on medicine labels.
       These apply for products other than dispensed
   Cautionary labels are those recommended by
    the BNF for dispensed medicines (and required
    by code of ethics – service spec 3)
    Statutory Warning Labels – Aspirin
   “Contains Aspirin” plus “If symptoms
    persist consult your doctor”
    (together with the recommended dosage)

   In case of Aloxiprin: “Contains an Aspirin
    Derivative” plus “If symptoms persist
    consult your doctor”
    (together with the recommended dosage).
    Statutory Warning Labels –
   “Do not take with any other Paracetamol
    containing products”
       “If symptoms persist consult your doctor”
        (together with the recommended dosage)
       “Do not exceed the stated dose”
       “Immediate medical advice should be sought
        in the event of an overdose, even if you feel
       For Child <12 years “Immediate medical
        advice should be sought in the event of
        overdose, even if the child seems well”
    Paracetamol, Aspirin & Aloxiprin

   Unless the product is for external use

   “Do not give to children under 16
    years, unless on the advice of a
Labelling of Dispensed Medicines
Legal Requirements (MEP Pg18/19)
   Name of person that the medicine is for
   Name and address of supplier (i.e. the
   Date of Dispensing
   Directions for use
   “Keep out of the reach and sight of children”
   Details requested by prescriber
       e.g. Product name, directions and warnings
   For External Use Only (where appropriate)
   Hexachlorophane warning (where appropriate).
Sample Label

               10 Oct 2007
RPSGB Advice
MEP Service Specification 4
   Labels must:
       Be Clear and Legible
            Mechanically or Computer-generated in
       Comply with legal requirements
       Include BNF Cautionary and Warning labels
   Also: previous advice, now accepted as
    standard practice
       Labels must include the Quantity in each
    Patient Information Leaflets
   A legal requirement for a Patient Information
    Leaflet (PIL) to be supplied with ALL Relevant
    Medicinal Products (a Marketing Authorisation
    granted or renewed after 13th Feb 1994

   Leaflets must contain the particulars set out in
    Council Directive 92/27/EEC.
       The Medicines Act 1968 was amended in 1994 to
        make the supply of a leaflet a legal requirement.
    PIL – Required Information

   Product Information e.g. name, ordinary
    name, strength, all active ingredients and
    exipients and quantities, pharmaceutical
    form, drug group, MA holder
   Therapeutic Indications
   Information on taking the product e.g.
    contra-indications, precautions, special
   Instructions on use
   Description of undesirable effects
   Reference to expiry date and storage
   Date of Leaflet
    PILs: The conflict…

   We are required to give a PIL and
    provide a fully labelled pack with every
    dispensed medication but…
       We are not always permitted to supply a
        complete pack or packs under the NHS if
        this does not match the prescribed quantity
       Manufactures do not often provide spare
       To copy a leaflet may infringe copyright.
       Legal issues about printing an own version
PILs: RPSGB Advice

 “Pharmacists should, where
 possible, supply fully labelled
 packs accompanied by a patient
 information leaflet and continue
 as at present for dispensing by
 breaking bulk until the
 problems are resolved”.
    PILs: in Hospital

    Advice provided by the Chief Pharmacist
    at the Department of Health:
   For In-patients
       PILs are not required to be included in the
        packaging of hospital dispensed products –
        but should be held in the pharmacy or on the
        ward so that the PIL can be provided to
        patient or prescriber on request
   For Out-patients
       PILs should always be provided.
    Packaging –
    Fluted Bottles
   MEP 1.2.7
   A fluted bottle must be used for any liquid
    product for external use listed in S1 1978 No
    40 (as in MEP)
   “External Use” in this context, for human
    beings means application to skin, hair, teeth,
    and the mucosa of the mouth, throat, nose,
    ear, vagina or anal canal
       The following are exempted from the above
        definition: Throat sprays, pastilles, lozenges, nasal
        drops, nasal sprays, nasal inhalations, teething
        preparations and dental gels.
    Packaging - Child Resistant

   All solid dose and liquid preparations for
    internal and external use must be dispensed
    in a reclosable child resistant container
       It is already in an original pack that would make
        this inadvisable
       The patient will have difficulty opening the
       A specific request is made not to
       No suitable closure exists
       In any case suitable advise must be given
        regarding safe storage, out of children’s reach

Shared By: