As per PSNZ’s Pharmacy Practice Handbook

3.2.15  Pharmacist Only Medicines (Restricted Medicines)

New Zealand pharmacists have a unique professional opportunity to fulfil their roles as the ‘gatekeepers’ of non-prescription medicines (complementing their accepted role with prescription medicines) by providing the public with a particular group of medicines known as Pharmacist Only Medicines, or Restricted Medicines.  Pharmacist Only Medicine is the preferred term to use.

The benefit to the public is the ability to obtain readily-accessible efficacious medicines, where the sale is supervised by a health professional who identifies the need for the medicine and gives individualised information and advice.

As these medicines are, in the main, Prescription Medicines reclassified to Pharmacist Only Medicine status they carry special legislative responsibilities controlling their sale, record-keeping, storage and advertising.  Thus, specific intervention by the pharmacist is necessary to ensure appropriate sales, as within a pharmacy only a pharmacist can offer for sale or recommend for use a Pharmacist Only Medicine – section 18 Medicines Act 1981.  Also note the Pharmacy Council Code of Ethics for Pharmacists 2004 Code of Ethics – Obligations 1.3, 1.11, 1.12, 2.7, 2.8, 3.4, 3.15, 3.18 and 3.19.

Obligation 1.12 of the Code of Ethics states that where the Pharmacy Council has prescribed a protocol for the sale or supply of a medicine or a group of medicines, the pharmacist must comply with the protocol.  The Council has prescribed a protocol for the Sale or Supply of Pharmacist Only Medicines for Chronic Conditions (POMCC) and orlistat (Xenical) is a medicine to which this protocol applies.

The protocol requires pharmacists to adopt a case management approach which includes an initial face-to-face consultation with the patient, and detailed documentation and follow-up with repeat face-to-face consultations as dictated by best practice.  An exemption from the face to face requirement is possible for reasons of disability or isolation within New Zealand – this prohibits internet or mail order sales overseas.  Pharmacists will be required to maintain a record of the sale of POMCC in the patient’s own file so that it may be readily accessed and updated when necessary.  The protocol states that POMCCs should be sold in the manufacturer’s original packs, which contain accompanying consumer medicine information leaflets.  In order to meet these requirements and to be knowledgeable about the product, pharmacists should be appropriately trained in the medicine and the medical condition it is treating.

A list of Pharmacist Only Medicines can be found in Part 2 of Schedule 1 of the Medicines Amendment Regulations 2009/212, which contains a consolidated list of all scheduled medicines to May 2009.  Subsequent changes are notified in the New Zealand Gazette, including 22 July, 9 and 30 September 2010.   The complete schedules are reprinted every few years as an amendment to the Medicines Regulations.

The classification of any medicine can be found on the Medsafe website www.medsafe.govt.nz in the Health Professionals section under Classification of Medicines.  Select the Schedule of Classifications, scroll down and enter the generic name of the medicine whose classification you wish to check.

Role and responsibility of the pharmacist

Pharmacist Only Medicines should be regarded as pharmacist-prescribed medicines.  Accordingly, the pharmacist should undertake a thorough interview with the patient prior to making the decision to sell one of these medicines.

Sales of Pharmacist Only Medicines may only be made from a registered pharmacy or from a hospital – see definition at the end of section 3 of the Medicines Act.

Pharmacists should have a procedure in place to ensure that shop assistants always refer patients to the pharmacist when:

·     a Pharmacist Only Medicine is requested; or

·     a Pharmacist Only Medicine could be a suitable treatment for symptoms described by the patient.

Protocol for Selling Pharmacist Only Medicines

l. Provide a private area that will enable confidential and consultative patient interviews to be undertaken.

2. Determine and assess the following:

·         condition to be treated;

·         history of the symptoms or disease process;

·         current medications and any other treatments;

·         patient’s known risk factors eg allergies.

3. Determine the appropriateness of the medication.  Consider adverse reactions, interactions and side effects.  Alternatively, consider possible non-medication  therapy or referral for further medical attention.

4. Recommend the appropriate Pharmacist Only Medicine as a result of the patient interview.

5. Advise the patient using verbal and written information of:

·         adverse effects;

·         precautions;

·         correct use and storage of the medicine;

·         when the patient should seek medical advice; and

·         the availability of the pharmacist for further information if required.

Face to face consultation is preferable, however, telephone advice or written information, eg Self Care cards, may be used as alternatives when the patient is unable to come to the pharmacy.

6. Refer to or consult with the patient’s medical practitioner or other health professional  if appropriate and agreed to by the patient.

7. Document the sale.  In November 2000 an amendment to regulation 55 of the  Medicines Regulations replaced it with a new regulation 54A and a new 55 which now permit the electronic recording of sales of Pharmacist Only Medicines.   The new legislation is enabling rather than prescriptive in that it defines the outcome  rather than how it must be achieved.  Details of the sale can now be recorded in a  book or electronically.  Whichever method is used, the information must be arranged in such a way that the information about each sale can be conveniently inspected, or retrieved and inspected.  If recording by book, Sale of Medicines Registers are available from wholesalers or from David Lewis Products, phone/fax 03 332-3001.

This amendment also changed the requirement for the signature of the pharmacist making the sale, instead it is now the name of the pharmacist that must be recorded.

The Society encourages pharmacists recording these sales to use the electronic method and process the sale through their computers as they would when dispensing a prescription.  The record must contain the following information:

·         date of transaction;

·         name and address of purchaser.  If the purchaser is not the patient, it is  recommended that the details of the sale are also recorded in the patient’s history.  If recording the purchase in a book, take care that details of  previous purchasers are not displayed;

·         name and quantity of medicine sold;

·         name of pharmacist making the sale.

8 Pharmacist Only Medicines should be sold in manufacturers’ original packs, which  usually have accompanying consumer information leaflets.   For some, such as cimetidine, clobetasone, fluconazole and ibuprofen 400mg, this is a legal requirement.

9. Provide shop staff with a protocol that will ensure Pharmacist Only Medicine sales are referred to a pharmacist.

10. Report any adverse reactions to the NZ Pharmacovigilance Centre for Adverse Reactions Monitoring  (CARM).

Pharmacy Council Protocol for Sale and Supply of Pharmacist Only Medicines for Chronic Conditions  (January 2005)

1. In order to sell or supply Pharmacist Only Medicines to treat Chronic Conditions (POMCC), the pharmacist must conduct face-to-face consultations with the patient whenever possible as dictated by best practice, unless, due to disability or geographical isolation within New Zealand as well as the inability to visit a pharmacy regularly, this is impractical. In this case the pharmacist must document the reason that a face-to-face interview did not take place and conduct the same detailed consultation with the patient by telephone or electronic means to ensure the safe and appropriate supply of the medicine to that person. Pharmacists must not offer these medicines for sale to patients who reside outside New Zealand, without fulfilling the requirement for face-to-face consultations as detailed elsewhere in this protocol.

2. A private area must be provided for consultations and the patient’s personal information must be kept secure, either in a locked file or pass-word protected in a computer.

3. Information must be recorded and assessed and stored in the patient’s own file (paper and/or electronic) allowing ready access and update when necessary. The following information, and any other details deemed relevant by the pharmacist, must be recorded:

  • date, name of the patient, address and contact details e.g. phone number, email address
  • condition to be treated
  • that the medicine is intended only for the use of the patient
  • history of the symptoms or disease process
  • current medicines and any other treatments
  • relevant medical history e.g. diabetes
  • patient’s known risk factors e.g. allergies.

4. The appropriateness of the medicine must be determined – consider age of the patient, concomitant medical conditions, pregnancy or breastfeeding, adverse reactions, interactions and side-effects. Also consider possible non-medicine therapy or referral for further medical attention and/or support and advice from other health practitioners.

5. As a result of the consultation, recommend the appropriate POMCC. Under this protocol, the pharmacist is expected to comply with Obligation 3.15 of the Code of Ethics, which requires the pharmacist to exercise professional judgement to prevent the supply of medicines (including sale and supply via the internet) that are unnecessary or in excess to the patient’s needs.

6. Advise the patient using verbal and written information of:

  • adverse effects
  • contraindications and precautions, including other medicines to be avoided during treatment
  • correct use, including dosage, frequency, how to manage missed doses
  • correct storage of the medicine
  • when the patient should seek medical advice
  • lifestyle and self-care advice to complement the medical treatment
  • expected outcomes of treatment
  • the importance of follow-up and
  • when follow-ups should occur

7. The sale of the medicine must be recorded electronically as for a prescription, as part of the patient’s prescription history. The record must contain the following information:

  • the name and address of the purchaser
  • the name of the pharmacist
  • the date of the transaction
  • name and quantity of the medicine sold

8. POMCCs should be sold in manufacturer’s original packs, which contain accompanying consumer medicine information leaflets.

9. To ensure safe and appropriate subsequent supply of the POMCC the pharmacist must follow the guidelines below on every occasion:

  • face-to-face consultations will occur for repeat consultations, as dictated by best practice.
  • the pharmacist must determine whether the patient has had an initial face-to-face consultation, or in cases where the requirement has been waived, has been adequately assessed for the safety and appropriateness of the POMCC. This requirement may necessitate the sharing of patient information between pharmacists and other healthcare providers (permitted by section 22F of the Health Act).
  • follow-up information is to be collected and added to the patient’s own record.
  • other health practitioners caring for the patient are to be referred to or consulted with if necessary and with the patient’s permission.

10. Follow-up information must include the following:

  • how the medicine has been taken by the patient.
  • changes/benefits in the patient’s health status since starting the medicine.
  • symptoms experienced since last consultation: check to determine whether they could be possible side-effects of the medicine? (If so, consider reporting to the Centre for Adverse Reactions Monitoring – CARM). Are there any symptoms that could signify changes in the patient’s condition that require referral to a medical practitioner or other health practitioner?
  • Does the patient still require the medicine? Need further treatment with the same or other medicines? Have any questions or further need for clarification of any issue relating to the medicine or the condition being treated?

Storage

Section 47 of the Medicines Act requires that Pharmacist Only Medicines be stored in the pharmacy such that members of the public cannot self-select them. It is recommended that they be kept in the dispensary or displayed behind the counter or in a secure display cabinet.  In this way customers can see that the pharmacy stocks the medicines, without being able to directly access them.  The use of dump bins or open shelving in the shop area contravenes the legislative requirements for storage of Pharmacist Only Medicines, and is professionally unacceptable.

Pharmacist Only Medicines must not be stored in any cupboard, box or shelf where food or drink is packed, prepared, or consumed.

Advertising

All advertisements for Pharmacist Only Medicines must comply with regulations 7 – 11 of the Medicines Regulations and sections 56 – 62 of the Medicines Act (see guidelines in section 3.2.18), and contain the following statements:

·        the name(s) of the active ingredient(s);

·        the quantities of the active ingredients;

·        the classification of the medicine, ie Pharmacist Only Medicine;

·        the authorised uses of the medicine;

·        the appropriate precautions to be taken in the use of the medicine, such as  “may cause drowsiness (avoid alcohol and driving)” and “do not exceed the recommended daily dose”;

·        the contraindications to the use of the medicine and the likely adverse effects, in a form that is both relevant to and easily understood by the consumer;

·        prominently direct the consumer to an easily accessible source of appropriate additional information, such as a toll free telephone number, a website address, a brochure or to consult their pharmacist;

·        the name and address of the advertiser.

All advertising or promotion of Pharmacist Only Medicines must also comply with the Pharmacy Council Code of Ethics for Pharmacists 2004 Obligations 8.5, 8.6 and 8.7 and the Advertising Standards Authority Code for Therapeutic Advertising.  The ASA code is available from the Advertising Standards Authority, PO Box 10-675, Wellington, phone 04 472-7852, fax 04 471-1785, email asa@asa.co.nz or from its website http://www.asa.co.nz.

If uncertain whether a proposed advertisement is acceptable contact the Therapeutic Advertising Pre-Vetting System (TAPS) c/- the Association of New Zealand Advertisers, PO Box 9348, Newmarket, Auckland, phone 09 300-5932, fax 09 300-5931, e-mail anza@anza.co.nz, from which an explanatory brochure is available.  It is also on the website http://www.anza.co.nz.

List of Pharmacist Only Medicines

A list of Pharmacist Only Medicines can be found in Part 2 of Schedule 1 of the Medicines Amendment Regulations 2009/212, which contains a consolidated list of all scheduled medicines to May 2009.  Subsequent changes are notified in the New Zealand Gazette, including 22 July, 9 and 30 September 2010.  The complete schedules are reprinted every few years as an amendment to the Medicines Regulations.

The classification of any medicine can be found on the Medsafe website www.medsafe.govt.nz in the Health Professionals section under Classification of Medicines.  Select the Schedule of Classifications, scroll down and enter the generic name of the medicine whose classification you wish to check.

Every reference to a medicine in this schedule applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

a)  preparations and admixtures containing any proportion of any substance listed

b)  salts and esters of any substance listed

c)  preparations or extracts of biological materials listed

d)  salts or oxides of elements listed.

Unless specific reference is made otherwise, every reference to a medicine in this schedule applies:

(i)  if the medicine is an injection or eye preparation, to any concentration of the medicine; and

(ii)  if the medicine is not an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol, or element unless specifically stated otherwise.