Legal Requirements And Industry Guidelines For Supplying Scheduled Medicines In Community Pharmacies

Scheduled Medicines: Pharmacy Medicine and Pharmacist Only Medicine

3 legal requirement that relate to supplying scheduled medicines to customers in community pharmacies-

• Consumer Law
• Environmental Law
• WHS Laws

2 industry guidelines for the supply of Pharmacy Medicines (S2) and Pharmacist Only Medicines (S3)-

• Staff members must have the training to ask specific questions of intending purchasers of Schedule 2 and Schedule 3 medicines, so that queries of individuals can be resolved
• The pharmacist must be satisfied that there is a therapeutic need (The pharmacy guild of Australia 2014)

2.

• Schedule 2 (Pharmacy Medicine)
• Schedule 3 (Pharmacist Only Medicine)
• Schedule 4 (Prescription Only Medicine)
• Schedule 8 (Controlled Drug)                  (Moles 2003)

4.

Schedule 2 (S2) medicines are Pharmacy Only items and need to be stored in an area that prevents physical access to the medicines by the public. The medicines are to be stored in a manner so that they are not visible to the public. Therefore, they are stored within the “Professional Service Area”.

Schedule 3 (S3) medicines are Pharmacist only medicines and need to be stored in a manner so that the public has no physical access to them, for example, behind the counter. Restricted S3 medicines are be stored in the dispensary, away from any retail area of the pharmacy (Boyd 2017)

 6.

Pharmacist Only Medicines- Direct-to-consumer advertisement cannot be done for these medicines unless all Schedule 3 ingredients are substances listed in Appendix H of the Poisons Standard. There are sixteen such substances in Appendix H, implying that many of schedule 3 substances are not permitted to be advertised

Pharmacy Medicines- Advertisement of Schedule 2 drugs can be done directly to consumers through radio, television, newspapers consumer magazines and billboards. However, approval is required prior to advertisement. If the advertisement is in a magazine or newspaper, the approval number must appear in the advertisement(tga.gov.au 2018).

7.

Two industry protocols commonly used are as follows-

• CARE protocol-

Check- this means that the customer is to be asked a number of closed and open ended questions for finding out patient details such as who the patient is; the health conditions presented by the patient; other mediations used by the patient; symptoms suffered by the patient.

Assess- this means that the pharmacist must decide whether the customer is to be referred to the pharmacist or whether a certain product requested is to be supplied or recommended.  

Refer or recommend- the prompts for referral are put in place to ensure that the role as a pharmacist assistant is distinct.

Explain- in case a product is recommended, the patient is to be explain how to use it. The dosage and frequency of the medicine, the side effects and potential hazards, and actions for heath decline are to be explained clearly.

• WHAT, STOP, GO protocol-

WHAT – this is the information one needs to have from the customer

W Who is the patient?

H How long have they had the symptoms?

Examples of Medicines in Different Categories

A Actual symptoms?

T Treatment

STOP – at the successive stage, one needs to decide the best course of action which entails the following

S- Symptoms?

T- Totally sure?

O- overuse or abuse?

P- Pharmacy only or Pharmacist referral

GO

 – once the decision is taken, one needs to provide suggestions on the use of the product and explain the customer the reason why a referral has been made to the pharmacist (psa.org.au 2005)  

8.

Maintenance of privacy while receiving information refers to the process of secluding the individual providing the information from the surrounding, so that the person can express himself selectively. Confidentiality involves limiting access on the information collected from the individual. Privacy can be maintained by collecting information in an environment where there is absence of any other individual who can influence information collection. Confidentiality can be maintained by storing the collected information in a safe and secured place, out of reach of external parties (Walker 2011).  

9.

• Is the person for whom the medicine is considered less than two years old, more than 65 years old, pregnant or breastfeeding?
• What are the symptoms and for how long are they lasting?
• Do have any other health conditions? (Beardsley et al. 2012)

10.

• Cold and cough
• Gastrointestinal infection’
• Eye infection

11.

• Fever
• Cough and sneeze
• Stomach pain
• Nausea and vomiting
• Redness of eyes and watery eyes (Newby 2012)

12.

• Young customers less than 2 years old 
• Pregnant or Breastfeeding 
• Repeat Symptoms or Excessive Duration of Symptoms
• Other health conditions 
• Taking other medicines

13.

The 5 key areas that are to be considered are-

• Symptom
• Duration
• Severity
• Medicines
• Medical conditions (Beardsley et al. 2012)

Such a question is to be asked to gain understanding of the comprehensive range of symptoms and conditions that the individual is suffering from. The question would allow the person to inform the pharmacist assistant about all health conditions that he has suffered in the past or is suffering at present.

15.

• Whether the symptoms of the customer match with the recommended product
• The dosage forms of the medicine (capsules, tablets, inhalants, applicants)

16.

A pharmacist assistant is to counsel the patient regarding whether the needs of the patient have been met. Further, self-care advice is to be given to the individual (Boyd 217)

17.

Information sources are as follows-

• Product leaflets and brochures supplied by a pharmacist
• Manufacturer information
• Industry and professional publications
• Consumer Medicine Information (CMI) website and phone line
• Reliable internet sites which can be official supplier and government or  manufacturer websites (Walker 2011)

18.

Self-care advice is the recommendations provided by the professional to the individual so that the person can care for his own health as per his needs. Assistance is provided to an individual to ensure that health conditions suffered by the person can be taken care of without seeking professional help from care providers. Such form of advice helps to maintain and improve quality of lives of heath consumers (who.int 2011).

19.

Cold and flu-Pharmacy only medicine

Analgesics- Pharmacist only medicine

Gastrointestinal- Both

Skin and fungal- Both

First aid and wound care- Pharmacy only medicine

20.

Q1. What are the symptoms your are having?

Reason- to understand the symptoms presented by the person

Q2. For how long have you been having these symptoms?

Reason- to understand the severity of the symptoms

Q3. Have you suffered such symptoms in the recent past?

Reason- to understand whether the patient suffers from the condition frequently

Q4. Do you suffer from any medical conditions such as diabetes and hypertension?

Reason- to understand whether the patient has been suffering from a long-term health condition

Q5. Have you taken any medication in the past due to the same symptoms? Did you benefit from them?

• Reason- to understand whether the person is allergic to similar medicine that can be recommended at present (Beardsley et al. 2012)

21.

• Responsible steps are to be taken for ensuring the dispensing of medicines is as per the prescription, if present
• Records for the drugs supplied are to be maintained properly

22.

Industry Guidelines are developed by the concerned industry of the country by taking into considering the intent of the Acts and regulations set in place. Organizational procedures are commonly developed by individual organizations on the basis of Industry Standards and guidelines.

23.

• Pharmacy Board Guidelines and Directives- procedures for supplying drugs to consumers
• Pharmaceutical Society of Australia Professional Practice Standards-patient communication guidelines  
• Therapeutic Goods Administration guidelines and requirements- dose of drugs

24.

• The active medicinal agents
• Possible side effects
• Advice required including diagnosis (Beardsley et al. 2012)

25.

Prescription Only Medicine (S4) – in the dispensary to prevent physical access by the public Controlled Drugs (S8) – in approved drug safes always (The Pharmacy Guild of Australia 2011)

References

Apps.who.int. (2018). The Role of the Pharmacist in Self-Care and Self-Medication. [online] Available at: https://apps.who.int/medicinedocs/pdf/whozip32e/whozip32e.pdf [Accessed 7 Mar. 2018].

Beardsley, R.S., Kimberlin, C.L. and Tindall, W.N. eds., 2012. Communication skills in pharmacy practice: a practical guide for students and practitioners. Lippincott Williams & Wilkins

Boyd, M., 2017. Community pharmacy: Symptoms, diagnosis and treatment.

Community Pharmacy. (2014). The Pharmacy Guild of Australia.

Moles, C. (2003). Case Studies in Pharmacist Only and Pharmacy Medicines : A Process Guide for Pharmacists. Pharmaceutical Society of Australia.

Newby, D., 2015. Community Pharmacy ANZ-eBook: Symptoms, Diagnosis and Treatment. Elsevier Health Sciences.

Psa.org.au. (2018). Standards for the Provision of Pharmacy Medicines and Pharmacist Only Medicines in Community Pharmacy. [online] Available at: https://www.psa.org.au/download/standards/s2s3-standards.pdf [Accessed 7 Mar. 2018].

Therapeutic Goods Administration (TGA). (2018). Advertising medicines to consumers. [online] Available at: https://www.tga.gov.au/advertising-medicines-consumers [Accessed 7 Mar. 2018].

Walker, R., 2011. Clinical Pharmacy and Therapeutics E-Book. Elsevier Health Sciences.

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