The pharmacist is the custodian of the nation’s medicines. Stuart Hamilton stresses that this must include the very hackneyed environmental phrase ‘from cradle to grave’.

Role and responsibilities of the pharmacist

Creation of the medicine
A pharmacist is involved in the creation of medicine in the following manner:
A manufacturing facility will be registered as a pharmacy and must have a legal representative known as a Responsible Pharmacist (RP). The RP is answerable to the South African Pharmacy Council (SAPC) for all legal responsibilities under the Pharmacy Act 53 of 1974. The RP is also required to comply with the requirements of the Medicines and Related Substances Act 101 of 1965. This pharmacist is responsible for the acquisition and approval of the raw ingredients (chemicals) from various suppliers who are audited and must comply with GMP (Good Manufacturing Practice) requirements. This will involve extensive auditing of the suppliers of active ingredients as well as inactive ingredients.

An active ingredient is one which will be effective in the medicine formulation. An inactive will be a substance which will aid in the formulation of the medicine in order to make the active ingredient effective. For example, paracetamol syrup will contain a very small percentage of paracetamol (active) compared to the syrup (inactive) required delivering the active substance to the patient in a safe, effective and quality dosage form.

Once the medicine has been produced in the manufacturing facility it must be tested to ensure that it complies with the high standards required by the Medicine Control Council (MCC) which registers all medicines before release to the public market. On registration of a medicine at the MCC the final release specifications must be laid down in the registration dossier. The registration procedure of a medicine with the MCC must be signed off by a pharmacist.

After pharmaceuticals are tested and comply, they will be approved by a pharmacist. If there is a problem with the analysis of a medicine it will be failed and will not be released to the market. If the medicine is approved according to the release parameters it will be released for distribution to the market. The distribution of medicines may be done on behalf of the manufacturers by distribution experts.

Distribution companies and wholesalers have warehouses and transport systems to service many manufacturing or marketing clients’ products. The distribution or wholesaler company will be registered as a pharmacy and will also have a legal representative, namely the RP as mentioned above.

Destruction
Destruction of pharmaceuticals can be required by the Medicines Regulatory Authority (MRA) if there is reason to believe that the medicine may be harmful to the public or circumstance requires that the medicine is re-called from the market. Included in harmful medicines are many products ordered by the public over the internet. Most of these imports if found, are confiscated by the Port Health Authority and consigned for destruction as they are generally not approved or registered for sale in South Africa.
A medicine has a ‘shelf life’ or expiry date depending on how long the medicine will be effective. This is determined by the manufacturer after a lengthy process of stability tests under varied conditions. The date is determined by the time when the medicine will no longer deliver the required active ingredient at the effective dose to the person taking the medicine or it becomes toxic.

The two Acts mentioned above do not give guidance to the pharmacist when it comes to the very important subject of destruction of pharmaceuticals. The essence of the guidance is that you may not use the sewerage system and most important – the process must render the substance irretrievable. Destruction of pharmaceuticals is required for the following:
 Expired stock
 Damaged stock
 Re-called stock i.e. defective, sub-standard or declared unsafe by the MRA
 Product is no longer part of a treatment protocol
 Stock is short-dated and thus not saleable although not expired
 Clinical trial stock
 Retention sample stock
 Various other marketing reasons

Why is destruction so important?
The supply chain integrity of pharmaceuticals is paramount. The reasons are obvious – who would like to be taking medicine for HIV/AIDS or cancer if you were not sure that it was ‘real’ medicine and not something created by someone in the backyard to copy the real medicine?
Counterfeit medicines are a huge problem throughout the world. It is estimated that in Africa up to a third of medicines are counterfeit. South Africa is also a victim of this scourge and this emphasises that pharmaceutical destruction sites in SA must take serious measures to help safeguard the destruction of pharmaceuticals as often stolen medicines are ‘recycled’ into the legitimate market.
The South African Pharmacy Council has recently published ‘Minimum Standard for the Destruction of Pharmaceuticals’ for comment in the Government Gazette. This standard will be incorporated into the Good Pharmacy Practice Manual (GPP). It is then incumbent on all pharmacists and pharmacies to comply with the standard. This document should be carefully studied by all involved in the destruction of pharmaceuticals as non-compliance by treatment facilities will mean that the Responsible Pharmacist will be held accountable by the SAPC inspectors as well as the Department of Health Inspectorate.

When a pharmacy – wholesaler, manufacturer, distributor or even community pharmacy has pharmaceutical stock to destroy there is a process that should be carefully followed. The RP should be closely involved in the choice of treatment facility, transporter or waste management company. Often the RP will work closely with the Quality Assurance Manager in order to ensure that the correct procedures are in place throughout the process in order to be certain that the pharmaceuticals will be safely transported and destroyed according to the requirements of the Acts mentioned above as well as compliance with the GPP Manual. The treatment facility as a third party supplier to the pharmacy must be properly audited according to a sensible audit program. The RP and QA department are usually assigned with the task of undertaking such audits. Apparent costs of destruction must be carefully considered. Cheap is usually so for a good reason!

The pharmacy must ensure that requirements of all the Acts pertaining to Waste handling are complied with. The pharmacy is classified as a waste generator and must comply with the requirements of NEMA Waste Act 59 0f 2008. The pharmacy must also ensure that the transporter is reputable and understands the implications of handling pharmaceuticals. In the years that I have been associated with Thermopower, I have seen many cases of waste management companies transporting pharmaceuticals under conditions that are totally irresponsible – open trucks, open skips, unsealed boxes, thin plastic bags which tear! Pharmaceutical waste happens to ‘fall’ off the truck in the suburbs with subsequent pilferage by passersby. The client is often ignorant of how the waste he has consigned for destruction must be transported to the treatment facility. Pharmaceutical waste must be transported in closed sealed boxes, (small generators can use sealed green bucket), packed on pallets and shrink-wrapped for secure transport in a closed truck which can be locked and sealed for load integrity. Thermopower encourages clients to seal the truck on departure from their site. The seal numbers are entered on the documentation and checked at Thermopower on acceptance of the load. Clients can also e-mail or SMS the seal numbers to the treatment facility before arrival of the load.

The treatment facility should be audited with reference to permit operating conditions, waste tracking ability within the facility from receiving to destruction. The security of the pharmaceutical waste while in transport and at the treatment facility is paramount. Drug syndicates are exceptionally active throughout South Africa. Most manufacturing facilities, distribution and wholesalers have active syndicate members working inside. The company that claims that they do not have a theft problem is either lying or they do not have the means of detecting the shrinkage.

Methods of destruction
• Landfill
• Encapsulation
• Incineration
• Thermal desorption (pyrolysis).
The Acts mentioned above require the substance to be rendered irretrievable. In my opinion landfill does not fulfil this requirement. The leaching of untreated pharmaceuticals into groundwater, a scarce commodity in South Africa, should negate this option as the toxicity of some pharmaceuticals substances is immense. Encapsulation is merely storing the problem for future generations and will be prohibitive in price for large scale pharmaceutical disposal.

Thermal treatment remains the true option for pharmaceutical destruction. Not only is the weight and volume substantially reduced but the residue or ash is rendered safe for controlled landfill. The main aim is to render the substance irretrievable to comply with the requirements of the Acts and the minimum bulk is sent to landfill.

The incinerator has its place in pharmaceutical destruction, but is hampered in that pure pharmaceutical feed will damage the refractory lining of the incinerator. Feed must generally be restricted to a low percentage of the total feed. Incineration produces high volumes of exit gases and particulates which must be cleaned in a gas clean-up system.

Thermal desorption on the other hand can safely handle high volumes of straight pharmaceutical feed whether solid, liquid or mixed. The process involves heating the waste in the absence of air and volatilising organic compounds to produce gases and steam. The volatile gases are then oxidised at 1100°C. The gas emissions are continually monitored after passing through a quench to prevent dioxin and furan creation and a packed column to neutralise acid gases and reduce particulate emissions. The volume of gas discharged to atmosphere is approximately 20 times less than produced by an incineration process. There is no liquid effluent produced at such a facility and the only liquid produced is steam, discharged with the effluent gases. The residue produced is sterile, inert and can be safely landfilled after the de-listing process. Volume and weight reduction of waste feed is 75 to 85% which saves landfill space.

The pharmacists in the country must be educated about their responsibilities and must insist on waste treatment facilities assuring the integrity of the total supply chain and complying with the requirements of the Acts and GPP Minimum Standards.

About the author
Stuart Hamilton, Dip. Pharm. MPS: Hamilton qualified at the Witwatersrand Pharmacy School in 1976. He married Trudi, a pharmacist, and together owner-managed Steenkamp Pharmacy in Brakpan. In 1995 Stuart started at Roche Products and left in 2001 as Production Manager.

Stuart worked as a consultant for Pharmacia Animal Health in the Regulatory Division at the Midrand Distribution Warehouse. After Pfizer purchased Pharmacia, he acted as Responsible Pharmacist at the Midrand Warehouse. When Pfizer closed the Midrand Site in December 2004, the destruction of tons of unwanted substances was required. Thermopower, the Pfizer preferred provider, was used. He was offered a consultancy position at Thermopower in 2005 to liaise with the pharmaceutical industry and promote a reliable, safe and environmentally acceptable option to the industry.